AVISO IMPORTANTE


A partir del día 14 de junio de 2015, domingo, este blog dejará de ser actualizado como se ha venido haciendo hasta la fecha. La primera idea fue la de cerrar el blog, pero el deseo que que cuanto aquí se ha publicado pueda seguir siendo útil en el futuro, nos hace que mantengamos abierto el blog. Si tuviera alguna duda o quisiera hacer algún comentario, no tema hacerlo: seguiremos publicando cuantos comentarios se hagan y seguiremos contestando a las dudas que puedan surgir.
Gracias y hasta siempre.
Andrés Guerrero Serrano
-Homeópata-

jueves, 16 de abril de 2015

Health food expert Joseph E. Pizzorno on toxins and modern diet

(Extraído de theadvocate.com.au)

By Sarah Berry

Takeaway: Dr Joseph E. Pizzorno says salt is a "toxin of choice", along with cigarettes and alcohol.

Toxins are now a major contributor to, and in some cases the cause of, virtually all chronic diseases.

That's what Joseph E. Pizzorno, former advisor to President Clinton on complementary and alternative medicines, says.

"I have become convinced that the toxic load in modern civilisation is now probably even more important than nutritional deficiencies in terms of causing diseases in our patients," says Pizzorno, who is in Sydney to speak at the 3rd BioCeuticals Research Symposium on 17-19 April.

Toxic load and nutrition are closely linked, says Pizzorno.

"How many people think about excessive salt consumption as a toxin in the body," Pizzorno asks. "Did you know that when you eat excessive salt you impair the body's ability to produce glutathione [a substance produced by the liver]?

"And, glutathione is the key molecule required to get rid of chemical toxins. So, the higher the salt intake the less you are able to adequately detoxify and this is a significant factor in keeping toxins in peoples' bodies."

Pizzorno explains that salt is a "toxin of choice" along with cigarettes, alcohol and, depending on genetics, wheat for some people. Other types of toxins are environmental or internal "improperly detoxified hormones such as oestrogen, which if not properly detoxified becomes carcinogenic and microbial chemicals from the gut", for instance.

As far as "choice" toxins go, excessive consumption of certain foods is problematic, but even good foods can be bad for us.

"Pesticides used on the food people eat are a better predictor of type 2 diabetes than any other factor we have today," is the opinion of Pizzorno, who is also the founding president of Bastyr University and the co-author of the Encyclopaedia of Natural Medicine and The Clinician's Handbook of Natural Medicine.

"People in the top 10 per cent of toxic exposure have a 20-fold increase risk for diabetes. These chemicals are insulin receptor site poisons. So, insulin receptors can't respond because they are being poisoned by those persistent organic pollutants."

Harvard biomedical researcher Chirag Patel argues the connections are still murky.

Patel and other researchers have found a link between diabetes and persistent pollutants like the pesticide DDT. "But we still can't pin down the biology behind these correlations," he explains. "Are they biased by other factors such as age, for example, which is a huge risk factor for diabetes and cardiovascular disease?"

Still, pesticides have more than one professional concerned.

Dr. David Bellinger, a professor of neurology at Harvard Medical School, haspreviously estimated that Americans have lost a total of 16.9 million IQ points due to exposure to organophosphates, a common type of pesticide used in agriculture in the US and in Australia.

These pesticides may also be responsible, in part, for the obesity epidemic, Pizzorno says.

"Researchers are now finding such a strong connection between the body load of these chemicals [contaminating the food supply] and diabetes and obesity that they are being called 'diabetoges' and 'obesogens'," he explains.

"These chemical toxins also preferentially convert calories into fat – hence they are being called obesogens. Since they are stored in fat, when a person starts losing weight these are released at higher concentrations making further weight loss even more difficult."

As Robert H. Lustig, a professor of clinical pediatrics at the University of California,says of obesogens, "Even those at the lower end of the BMI [body mass index] curve are gaining weight. Whatever is happening is happening to everyone, suggesting an environmental trigger."

Adding to this difficulty is that the bigger a person is to begin with the more the body struggles to detoxify itself.

"This detoxification capability is also greatly impacted by diet as [it is] dependent on the availability of key nutrients that are often deficient in the diet," Pizzorno adds, noting that fibre, for example, is "critical" to the detoxification process.

"As we have evolved as a species, we had about 100-150g of fibre in our diet every day," he says. "Now in Western civilisations we have about 10-15g of fibre every day."

Professor Ian Rae, an honorary professorial fellow specialising in toxicology and pollutants at the University of Melbourne agrees with Pizzorno's points on fibre and "choice" toxins.

"He makes some good points," Rae says.

"Consuming more fibre, within sensible limits, is good for digestive efficiency."

Rae, however has a different perspective on toxins.

"The chemicals in our blood are gradually accumulated over time and although there is no proof they are harmful at the levels we experience, they are being removed from products and the environment and so blood levels are falling," he says.

"Those concerned to reduce their levels should avoid packaging, especially plastic of all kinds (difficult to manage in western society) and reduce their intake of [too much] fatty foods. Good advice on nutritional grounds, anyway!"

Pizzorno's top tips for reducing our exposure to toxic chemicals

1. Primarily eat organically grown foods. If you can't afford all organic, use websites such as ewg.org to determine which conventionally grown foods are the least contaminated.

2. Only use health and beauty aids which don't have added chemicals such as phthalates. "Products with fragrances have high levels of phthalates," Pizzorno explains. "Phthalates are odourless but they are present in the mixtures to ensure blending of the ingredients and to help with the 'feel' of the product," Rae adds, noting that those concerned about ought to choose phthalate-free products. "It is possible to exert some degree of control but i's not as easy as it sounds, since very few products disclose all their constituents, although some do."

3. Increase dietary fibre as this is a main mechanism for eliminating toxic chemicals and metals. Especially good sources are oat bran, ground flax seeds, beans and lentils.

4. See your healthcare practitioner who may recommend supplementation to promote detoxification. Rae takes issue with this point. "I'll bet there's never been a well-conducted trial of the supposed benefits," he says.

5. Only use dietary supplements which have been tested for quality and contamination. Be especially careful about traditional Ayurvedic combination products. "Really nothing more than hocus pocus," Rae says.

6. Eliminate toxins from your household. You may be surprised to find them in almost all commercial cleaning products as well as most garden products like weed control.

On this point, Rae disagrees. "Eliminating commercial cleaning products and garden products ... because they contain 'toxins' is simplistic and unnecessary," he counters. "Using these products as advised and taking care not to get them on the skin is good advice."

Fasting could help us cope with a number of diseases

(Extraído de stuff.co.nz)

By LIZ HUNT

We usually think of fasting as a weight loss measure, but advocates say it has therapeutic benefits too.

Francoise Wilhelmi de Toledo combines a passion for her subject with a precision one would expect of a doctor and scientist with a raft of publications to her name.

"Real medicine is lifestyle. It is how we live," she says. "Drugs, any drugs, must be complementary to that."

As medical director of the renowned Buchinger Wilhelmi Clinic in Germany, she is an authority on therapeutic fasting and responsible at least in part for the current interest in its role in the management of chronic diseases including obesity, diabetes, high blood pressure, high cholesterol and cancer. And, of course, as a means of weight control made popular by the diet du jour, the 5:2.

The capacity to fast derives from periods when our ancestors ate more than they needed and built up fat reserves for winter when access to food was reduced.

Fasting – as part of a lifestyle – is undoubtedly a good thing, she says, but her focus is on making it part of the armamentarium available to doctors coping with an epidemic of lifestyle diseases in the West that threaten to cripple healthcare systems. 

She says there is strong evidence gathered over many decades to show how it can lower blood pressure, reduce excess fat and glucose in the blood, modulate the immune system, increase the effect of the mood and sleep-regulating neuro-transmitter serotonin, boost protein repair, and reduce inflammation.

Fasting has been likened to a "reset" button that returns the human body to its – healthy – factory settings. A study published last year in the United States, drawing on animal and human trials, concluded that three days of fasting can rejuvenate the immune system, triggering the production of new white blood cells. Other studies show that fasting can enable healthy cells to endure better the toxic impact of chemotherapy while cancer cells die more rapidly. It is a fascinating area of research that draws on the body's evolutionary adaptation.

"Human beings are not programmed for abundance," de Toledo says. "Humans are programmed for loss." The capacity to fast derives from periods when our ancestors ate more than they needed and built up fat reserves and surplus nutrients, such as vitamins and minerals, in summer and autumn.

In winter and spring, when access to food was much reduced, they endured periods of fasting in which their metabolism switched automatically from "external nutrition to nutrition taken from fat reserves".

In the absence of carbohydrates as a source of energy (glucose) for the cells, fatty acids, from fat supplies, were broken down in the liver to produce molecules known as ketone bodies which were used for fuel instead.

Of course we retain this ability to fast and exist on a ketogenic diet but rarely use it in the affluent West because food shortages are largely unknown. Nor is there much incentive to invest in fasting research, despite preliminary evidence that it may help in Parkinson's, multiple sclerosis and Alzheimer's. In Russia, there is a vast, largely unexplored archive built up by a psychiatrist Dr Yuri Nikolayev, who used fasting or "the hunger cure" to treat a range of mental disorders.

This lack of interest frustrates de Toledo.

"Take type 2 diabetes," she says. "This is a disease we know that we can cure [through fasting]. But there is an industry that sells all these drugs and devices. We have a type of medicine [in fasting] that is highly successful but there is no return on investment."

It was as a 17-year-old in Geneva that de Toledo embarked on her first fast with the aid of a book, because she "was at odds with my weight and wanted to match the ideal of the slim beauty". She says it was a revelation, that she felt "buoyant, sometimes euphoric" while fasting.

She says people who turn to fasting include some seeking help for intractable health problems while for others weight loss is the primary goal. Many, however, are seeking respite from stress of work in the "spiritual dimension of fasting" that de Toledo claims is one of its most beneficial side effects. 

She still fasts twice a year, during a 12-day annual retreat, and to counteract a severe seasonal allergy to birch pollen. She says suspicion and cynicism about fasting is still rife among doctors and nutritionists and she is determined to challenge it. "We want to document and show that fasting is therapeutically efficient, safe and enjoyable," she says.

The science, it would seem, is increasingly on her side.

New herbal tea to treat malaria in Africa

(Extraído de news-medical.net)

Malaria is a critical health problem in West Africa, where traditional medicine is commonly used alongside modern healthcare practices. An herbal remedy derived from the roots of a weed, which was traditionally used to alleviate malarial symptoms, was combined with leaves and aerial portions from two other plants with antimalarial activity, formulated as a tea, and eventually licensed and sold as an antimalarial phytomedicine. The fascinating story and challenges behind the development of this plant-based treatment are presented in The Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on The Journal of Alternative and Complementary Medicinewebsite until May 14, 2015.

Dr. Merlin Willcox (University of Oxford, U.K.), Dr. Zéphirin Dakuyo (Phytofla, Banfora, Burkina Faso), and coauthors discuss the antimalarial and pharmacological properties of the herbal medication derived from Cochlospermum planchonii (a shrubby weed known as N'Dribala), Phyllanthus amarus, and Cassia alata. The authors provide a unique historical perspective in describing the early evaluation, development, and production of this phytomedicine. They present the ongoing research and challenges in scaling up cultivation and harvesting of the plants and in production of the final product. The article also describes other traditional uses of the medication, such as to treat hepatitis.

Source:

Mary Ann Liebert, Inc./Genetic Engineering News

domingo, 12 de abril de 2015

7 herbs to relieve kids’ allergy symptoms

(Extraído de foxnews.com)

By Julie Revelant

Most of us may be enjoying the spring weather, but experts agree this year will be a rough one for allergy sufferers. And for parents who are looking to avoid over-the-counter drugs and all their potential side effects, herbal remedies might be a natural, alternative solution that may also be even more effective than conventional medicine.

In fact, a recent report from the Centers for Disease Control and Prevention (CDC) found that the most common complementary health approach for children ages 4 to 17 in 2012 were herbal remedies.

Although herbs are considered safe, they’re not regulated by the Food and Drug Administration (FDA). It’s a good idea to consult with a naturopathic doctor or an herbalist first, especially if your child is taking other medications or could be allergic to the herb itself.

Here, are 7 herbal remedies to help ease your child’s allergies.

1. Stinging nettle
A perennial wild plant, stinging nettle reduces inflammation and histamine production and is one of the best herbs for allergies, Dr. Patrick Fratellone, an integrative physician and an herbalist in New York City, said. Once the leaves are dried, simply soak them in boiling water to make a tea.

2. Quercetin
Quercetin is a bioflavonoid that reduces histamine from being released in the body and controls a running nose and itchy eyes. Quercetin is available as a supplement but one of the best ways to get it is through foods that have a white substance on the peel like oranges, tangerines and grapefruit.

“When a child has more allergies or allergy season is coming up, you want to give them more fruit that has those types of peels on it,” said Dr. Susanne Bennett, a holistic chiropractic physician in Santa Monica, Calif., best-selling author of "The 7-Day Allergy Makeover" and host of “Wellness for Life Radio” on RadioMD/iHeart Radio.

3. Ginger
Ginger is a powerful antioxidant and one of the most effective remedies to reduce inflammation in the respiratory tract caused by allergies. Try ginger candy or ginger root tea with some honey to make it more palatable.

4. Black currant
Black currant is a type of herbal medicine known as gemmotherapy, which uses plant stem cells to treat a condition and also acts as a natural cortisone to help alleviate inflammation and allergies, Bennett said.

5. Black elderberry
Black elderberry flowers can help to prevent viral infections and boost the immune system against viruses.

“Once your body is loaded with mucus and you’re congested all the time, that’s when all the bugs like to get there,” Bennett said.

Black elderberry is also effective at relieving coughs. Steep the flowers in boiling water and raw honey for three minutes.

6. Bilberry
The fruit and leaves of the bilberry plant, a perennial shrub that contains plant pigments, have super antioxidants as well as quercetin.

7. Pycnogenol
A pine bark extract, pycnogenol has antioxidant and anti-inflammatory properties and heals the mucus tissues in the eyes, nose, mouth and lungs.

Like the quercetin found in fruit, there are other foods that can relieve allergies. One is pineapple, because of the enzyme bromelain, which is anti-inflammatory.

“When you eat it— especially on an empty stomach— it cuts down the inflammation in the nose, lungs and eyes,” Bennett said.

Another food is bone broth because it soothes gut inflammation that can lead to allergies and boosts the immune system.

“Bone broth works to heal the actual membrane of the intestines because it is so high in calcium, phosphorus and many minerals, and because it is a ready source of collagen and gelatin, which are hard to get in supplements or food,” said Dr. Shauna Young, a certified traditional naturopath in Durango, Colo. and Chief Medical Advisor for The No Harm Foundation.

Homeopathy is not a placebo science

(Extraído de dnaindia.com)

Scientists discuss research to address medication and vaccines for diseases like cancer, AIDS, swine flu and MDR-TB at world summit

Contrary to popular belief, homeopathy is not a placebo science, said a group of eminent scientists at the World Homeopathy Summit being held in the city this weekend. It has been long believed that consuming homeopathic medicine has a psychological effect on the patient which leads to some of them getting cured. Busting this and other myths, scientists from Haffkine Institute in Parel, Bhabha Atomic Research Centre (BARC) at Chembur, Indian Institute of Technology (IIT-B) in Powai, and the Tata Institute of Fundamental Research (TIFR) shared their research at the summit, which has attracted scientists and doctors from different parts of the world including Italy, Brazil and Austria.

Critic claim that because homeopathy medicines are very highly diluted, they are merely believed to have a placebo effect. However, research by Dr Jayesh Bellare, head of department, Chemical Engineering, at IIT-B, and his team has proved that they do contain nano-particles of medicinal molecules. "While earlier it was thought that homeopathic medicines do not contain medicinal molecules, high resolution microscopes used in the IIT-B lab to observe the medicines found that the molecules do exist in nano sizes," said Dr Bellare.

Physicists at TIFR and BARC have detected the effect of energy particles in homeopathy using laser beams and electrical devices. Former BARC scientist and physicist, Dr Akalpita Paranjpe talked about an electrical device called 'Medical Analyser' which measures the effects of homeopathy medicines on a person's physiology. "We measured the heart rate of a person before and after administering homeopathic medicine Sulphur 200. We noticed that the body reacts to Sulphur 200 and that the ill person goes back to being normal after being administered the medicine," said Dr Paranjpe.

Dr Kanjaksha Ghosh, director, National Institute of Immunohaematology (NII) vouches for homeopathytherapy to cure bleeding disorder in haemophilia patients. "In a study conducted in Surat, Mumbai and Nasik, in 500 cases of haemophilic patients, internal bleeding has been stalled by administering homeopathic drugs," said Dr Ghosh. "There have been cases when the Factor 8 and 9 injections for haemophilia management have been unavailable or very expensive, one-year treatment can cost lakhs of rupees. Homeopathy drugs have proven effective in saving their lives," said Dr Ghosh.

Virologist Dr Abhay Chowdhury at Haffkine Institute said they are working on a homeopathy-based drug or a nosode, which is sourced from tuberculosis germs of multi-drug resistant TB patients. The nosode, which is hoped to improve the condition of TB patients, will undergo animal trials in the near future, said Dr Chowdhury.

Where is global research in homeopathy headed?
Austrian molecular biologist Dr Michael Frass and Indian scientist Dr Gaurisankar Sa have proved anti-cancer activities of homeopathy in laboratory experiments on cell lines extracted from the human body. Dr Gaurisankar also demonstrated the regression of cancer in rats after giving homeopathy medicines.

Swine flu may have preventive homeopathy, a Brazil researcher has found. Scientist from Brazil University conducted a study and proved the role of homeopathy medicine sourced from influenza virus itself to prevent the disease.

"Homeopathy is personalised medicine and homeopaths are the first technocrats in medicine in terms of use of computer software in early times for their analysis. MUHS is going to volunteer for meta-analysis in homeopathy. Human genes have a memory of health and diseases. Homeopathy helps to decode this information. Allopathy has scope only for curing only 40 per cent of diseases, which are mostly infectious and nutritional diseases," says Dr Arun Jamkar, Maharashtra University of Health Sciences (MUHS).

viernes, 10 de abril de 2015

Arts, Crafts, Socializing May Buoy the Aging Brain

(Extraído de medlineplus.gov)

Those participating in these activities or using computers half as likely to develop mild dementia, study found

WEDNESDAY, April 8, 2015 (HealthDay News) -- Adults who pursue artistic, craft and social activities may stay mentally sharp longer, a new study suggests.

Researchers found that older adults involved in these activities or those who used a computer later in life were about half as likely to experience mild dementia over the next four years.

"Engaging in cognitively stimulating activities has beneficial long-term effects on cognitive [thinking] function," said study author Rosebud Roberts, chair of the division of epidemiology at the Mayo Clinic in Rochester, Minn.

The study could not show that these activities actually prevented declines in thinking, but it found the risk was lower among those participating in them. The findings were published in the April 8 online edition of the journal Neurology.

The researchers tracked 256 adults, aged 85 and older, over four years. Nearly half developed mild dementia during that time.

Aside from differences in sex and education, those who took part in artistic pursuits throughout midlife and late life were 73 percent less likely to experience mild dementia.

Similarly, those involved in crafts and social activities both in midlife and later life were about half as likely to experience mild dementia. So were those who used computers in later life, the investigators found.

It's possible that sharper adults are more likely to seek out these activities in the first place, but the findings still suggest the participation contributes to brain health, Roberts said.

"We found that if you were engaged in these activities in midlife, regardless of late life, or in both midlife and late life, your risk of cognitive [thinking] decline was reduced," she said. "In the few people who only began these activities in late life, there was also a benefit, but this was not statistically different from those who never participated in these activities."

Dr. Anton Porsteinsson, director of Alzheimer's Disease Care at the University of Rochester School of Medicine in New York, said the findings fit with past research showing that artistic and social activities appear to help protect against mental decline.

"It's hard to say what's the chicken and what's the egg, but there's emerging data that some kinds of creative, artistic activity may stimulate certain parts of your brain that are more vulnerable to damage through the aging process," he said.

The researchers also found risk factors linked to a higher risk of mental decline.

Those with depressive symptoms were almost twice as likely to develop mild cognitive impairment as those without symptoms. These symptoms may be part of the degenerative processes of the brain or a response to a person's awareness that their memory is failing, Roberts said, but the reason for the association between depression and dementia isn't clear.

Further, those who developed high blood pressure (hypertension) in midlife were more than twice as likely to develop thinking problems, the study found. Having vascular diseases increased risk of mild dementia 13 percent, and having other chronic conditions increased the risk by 8 percent.

However, the study could only show an association between these risk factors and dementia, not a cause-and-effect.

"Hypertension and vascular diseases can have an effect on small blood vessels that supply the brain tissue, gradually reducing the transport of oxygen and fuel to those brain cells, and eventually resulting in death of larger and larger portions of the brain," said Dr. Vernon Williams, a neurologist and director of the Center for Sports Neurology and Pain Medicine at Kerlan-Jobe Orthopaedic Clinic in Los Angeles.

Past research has found that other factors that may protect against mental decline include exercise, a healthy diet and engagement in group activities such as book clubs, Bible studies and organized discussion groups, Roberts said. Participants in the new study who exercised three to four times a week had lower risks of thinking impairment, but those results were not statistically significant, she added.

Williams said the study highlights important strategies for potentially improving neurologic health and function throughout life. The currently aging population is already at risk for mental decline, needing assistance and reduced quality of life, he added.

"We should look at this as another example of the importance of promoting neurologic health across the life span," Williams said. "It's not all doom and gloom. Optimistic and positive outcomes can be used to encourage and promote positive behavioral changes at every stage of life."

SOURCES: Rosebud Roberts, M.B., Ch.B., M.S., professor and chair, division of epidemiology, department of health sciences research, Mayo Clinic, Rochester, Minn.; Anton Porsteinsson, M.D., professor, psychiatry, and director, Alzheimer's Disease Care, Research and Education Program, University of Rochester School of Medicine, Rochester, N.Y.; Vernon Williams, M.D., neurologist and director, Center for Sports Neurology and Pain Medicine, Kerlan-Jobe Orthopaedic Clinic, Los Angeles; April, 8, 2015, Neurology, online

jueves, 9 de abril de 2015

El colectivo homeópata pide formar parte de la sanidad pública

(Extraído de elperiodico.com)

La presidenta de la Academia Médico Homeopática de Barcelona, Maite Bravo, defiende la inclusión con la reducción del gasto que puede suponer y el aumento de la investigación

La presidenta de la Academia Médico Homeopática de Barcelona (AMHB), Maite Bravo, ha pedido este jueves en una rueda de prensa para conmemorar el Día Mundial de la Homeopatía que se celebra mañana 10 de abril que el colectivo homeópata pueda formar parte de la sanidad pública.

Bravo ha defendido su inclusión dentro del sistema sanitario público, ya que "puede ayudar a reducir gasto en la sanidad pública" y ha recordado que ya forma parte de la Seguridad Social de diferentes países europeos como el Reino Unido o Francia. Según Bravo, unamayor presencia en las instituciones les permitiría "hacer más investigación" y ha sostenido que, aunque la homeopatía está dentro del Colegio de Médicos de Barcelona, "aún no está considerada una especialidad médica".

Bravo ha recordado que, según el "I Estudio sobre conocimiento y uso de la homeopatía" hecho por el laboratorio homeopático Boiron, el 44 % de los catalanes ha usado alguna vez homeopatía y el 38 % la utilizan de forma habitual para tratar sus dolencias. Bravo también sostiene que gran parte de los ataques del colectivo médico están "basados en el desconocimiento de la homeopatía".

La Academia Médico Homeopática de Barcelona (AMHB), que actualmente cuenta con 250 socios, celebra este año el 125 aniversario desde su fundación en 1890. La AMHB tuvo una importante actividad profesional, académica y científica en sus primeros años y contó con una publicación mensual, la 'Revista Homeopática", hasta que, a partir de 1929, gran parte de sus miembros se exiliaron debido a la situación política.

Desde finales de los 70 se produjo un resurgimiento de la asociación y se volvió a editar la revista. En 1990 se conmemoró el centenario de la AMHB y se celebró en Barcelona el Congreso de la Liga Médica Homeopática Internacional y, 14 años después, en el 2004, se inició el Máster en Medicina Homeopática de la Universidad de Barcelona.

Database of Homeopathy Research Trials

(Correo recibido de Manish Bhatia, gestor de www.hpathy.com)

Dear,

Our homeopathic colleague and friend, Robert Medhurst, has been compiling positive research studies related to homeopathy since last several years. He initially shared a compilation of positive homeopathic research studies with us in 2010 and since December 2013, he has been sharing his findings with the community every month through Hpathy.com.

To help people find all the scientific research studies related to homeopathy at one place, we are providing links to all his articles at one place. The posts below list a huge volume of human trials, in-vitro and in-vivo research studies, animal trials, as well as plant trials. Huge evidence base that is difficult to refute. Use these links to study homeopathic research and to convince others about homeopathy’s efficacy and scientific base. Click on the link below
http://hpathy.com/scientific-research/database-of-positive-homeopathy-research-studies/


Please do give us your feedback at mail@hpathy.com or post your comments below any article through the comment box.


Best wishes,
Dr. Manish Bhatia
Editor, Homeopathy 4 Everyone


Estimado,

Nuestro colega y amigo homeopática, Robert Medhurst, ha estado recopilando estudios de investigación positivos relacionados con la homeopatía desde hace varios años. Inicialmente compartió una compilación de estudios de investigación homeopática positivas con nosotros en 2010 y desde diciembre de 2013, ha estado compartiendo sus descubrimientos con la comunidad todos los meses a través Hpathy.com.

Para ayudar a la gente a encontrar todos los estudios de investigación científica relacionados con la homeopatía en un solo lugar, estamos proporcionando enlaces a todos sus artículos en un solo lugar. Los mensajes que figuran a continuación enumeran un enorme volumen de ensayos en humanos, in vitro e in vivo estudios de investigación, ensayos con animales, así como ensayos de plantas. Base de evidencias es tan enorme que es difícil de refutar. Utilice estos enlaces para estudiar la investigación en homeopatía y para convencer a los demás acerca de la eficacia de la homeopatía y la base científica.

Haga clic en el enlace de abajo
http://hpathy.com/scientific- investigación / base de datos-de-positiva homeopatía-estudios e investigación /

Por favor dénos su opinión en mail@hpathy.com o envíe sus comentarios a continuación cualquier artículo por medio del cuadro de comentarios.

Mis mejores deseos,
Dr. Manish Bhatia
Editor, Homeopatía 4 Everyone

Doctors defend relevance of homeopathy

(Extraído de en-maktoob.news.yahoo.com)

Refute claims that it is ineffective ahead of World Homeopathy Day

Doctors in the UAE have come out in strong defence of homeopathy, weeks after Australia’s top body for medical research concluded that it is not effective in treating any medical condition.

Speaking to XPRESS ahead of World Homeopathy Day on April 10, they refuted the claims of Australia’s National Health and Medical Research Council which concluded that there are no health conditions for which there is reliable evidence that homeopathy is effective.

Dr Mukesh Batra of Dr Batra’s homeopathy clinic in Dubai said: “We hear about such studies time and again, especially around World Homeopathy Day. But I refute the claims. There have been more than 300 studies conducted with double blind trials all over the world to establish the efficacy of homeopathy in treating various problems like asthma, allergies, diabetes, hypertension, insomnia etc.”

Holistic method

Dr Rajshree Rele, a Dubai-based homeopath, said the belief that homeopathy is slow to impact is misplaced. “It is a misconception that homeopathy cannot cure,” she said. “It is based on the principle of like cures like (similia similibus curentur) - where a substance that causes the symptoms of a disease in a healthy person can cure similar symptoms in a sick person.”

Dr Rajkumar Nair, Director of the Unicare Medical Center, which has two homeopaths on board, said: “A high percentage of healing is based on faith. To debunk any form of medicine is wrong because it is an evolving science. We cannot dismiss what we practised hundreds of years ago, by that logic what we practise today cannot also be called quackery many years hence.”

He said: “Complementary forms of medicine treat patients in a holistic way and cannot be scientifically researched.”

Homeopathy drugs for AIDS from snake venom, HIV Virus

(Extraído de en-maktoob.news.yahoo.com)

(IANS) Scientific research into possible medicines for the dreaded AIDS disease from the human immunodeficiency virus (HIV) itself and even snake venom and drugs for MDR-TB from the tuberculosis germs will be in sharp focus at the two-day World Homeopathic Summit to be held in Mumbai this weekend.

A homeopathic experiment with snake venom on the HIV virus has given rise to excitement among scientists to work on a possible relief to AIDS and Ebola patients as well.

Research by doctors at the Hyderabad-based JSPS Government Homeopathic Medical College and the Indian Institute of Chemical Technology (IICT) Hyderabad indicates that homeopathic medicine from snake venom - Crotalus Horridus - can positively arrest the HIV spread.

In another pioneering study, Mumbai-based homeopath Dr Rajesh Shah has developed a new medicine for AIDS patients, sourced from the human immunodeficiency virus (HIV) itself. During the two-year study, the drug has been tested on humans for safety and efficacy and the results are encouraging, said Shah.

His scientific paper for debate was recently published in the online edition of Indian Journal of Research in Homoeopathy (IJRH), the official publication of the Central Council for Research in Homeopathy (CCRH).

The Global Homeopathy Foundation (GHF), an NGO, has invited scientists and conventional doctors from across the world for the Mumbai summit. Over 25 scientists have already confirmed their presentations, said Shah, who is also the organising secretary of the foundation.

The Central Council for Research in Homeopathy (CCRH), a premier government agency under AYUSH, is collaborating with GHF for the summit. Scientists from eminent institutes of pure science such as IIT-B, ICMR, TIFR, BARC, Haffkine, ICT, and Bose are to present their research in homeopathy at the summit.

Pioneering researches at Kottayam's MG University and Bangalore's Indian Institute of Science (IIS) have proved that homeopathic dilutions contain nano-particles that are so vital for medical treatment, thus debunking the critics' view that homeopathy medicines do not have anything worthwhile.

The studies by Dr E.S. Rajendran Aurum Metallicum (6C to CM potency) and Carbo Vegetabilis 6C to CM potencies have conclusively proved that homeopathy dilutions contain nano-particles.

The dilutions were studied under high resolution transmission electronic microscope (HRTEM) and energy dispersive spectrometer (EDS) and "we are in a position to conclusively prove the presence of nanoparticles in all the high dilutions of Homeopathic drugs", Rajendran said.

On his own research into AIDS, Shah said: "The study has showed that the blood count (CD4 cells) of HIV patients has improved on administering the drug and this is a very positive and hopeful sign... This may encourage advanced research into the subject."

Shah, in a separate research, teamed up with noted virologist Abhay Chowdhury at the premier Haffkine Institute and developed a drug sourced from TB germs of MDR-TB patients.

In yet another study, conducted in coordination with CCRH, noted homeopath Dr Kusum Chand of New Delhi demonstrated that homeopathic medicines together with the conventional anti-TB medicine produced better results than only the allopathic medicines for TB. The study was conducted on 120 patients.

The homeopathy summit will also focus on the need to integrate both the systems of medicine to meet challenges posed by various diseases because mono-therapy may not work for all patients.

Homeopathy is heading towards scientist facelift and in this context that the Mumbai summit assumes significance as some eminent scientists from Austria, Brazil, Italy, Holland, Britain and the US, who have also done path-breaking research in the field will showcase their studies.

Homeopathy is gaining popularity and there is a resurgence of interest in many developed countries, while the system is also being criticised for inadequate clinical evidences, in spite of considerable and encouraging research work. The practitioners, students and the followers of homeopathy often are unaware about the scientific advances in the field due to inadequate exposure.

The summit will aim at allaying fears and setting facts straight, Shah said.

Among those who will share their research experiences at the summit are Dr Paulo Bellavite (Italy - Dipartimento di Patologia e Diagnostica, University di Verona), Dr Eswara Das (India - ex-director, National Institute of Homoeopathy, Kolkata), Dr Gustav Brucha (Cuba - researcher at Finlay Institute), Dr Alexander Tournier (Britain - Homeopathy Research Institute, London), and Dr Carla Holandino, (Brazil - professor of pharmacy at Federal University of Rio de Janeiro).

GHF, founded by a group of homeopathic activists with the mission to spread the benefits of homeopathy to the masses is a non-government non-profit group. Its objectives include: to work for the growth of the science so that homeopathy could benefit those suffering from various ailments, and to support the professionals to be able to serve the society well.

lunes, 6 de abril de 2015

Combinar lo mejor de cada medicina

(Extraído de republica.com.uy)

“PANDEMIA DE CÁNCER” EN URUGUAY

Acerca de los expositores, señaló que “si bien todos son médicos egresados de universidades de medicina ortodoxa, todos ellos han dedicado gran parte de su vida a la investigación y en el caso de las doctoras cubanas, conjuntamente con laboratorios mundialmente reconocidos, en la búsqueda de nuevos tratamientos, que hoy se llaman complementarios, porque aún no se han integrado a la medicina convencional”, y aseveró que “la existencia de la medicina natural es tan antigua como el hombre mismo y nadie se atreve a negar su efectividad.

El mismísimo fundador de la medicina occidental, el sabio griego Hipócrates, reconoció incluso la vis medicatix natura (fuerza curativa de la naturaleza), concepto que ha trascendido como principio confortante del Corpus Hipocratium hasta la actualidad.

Lo más sabio sería combinar lo mejor de cada una de ellas. No soy médico ni mucho menos, pero creo que si hay alguien que te diga alguna vez que no ha tomado un té de yuyos, por ejemplo, parecería que es mentira”.

Consultada sobre qué la motivó a organizar esta actividad, sostuvo que “me ha movido la inmensa pandemia de cáncer que se extiende por el Uruguay, y el ver que hay mucha gente que no conoce o no accede a diversos tratamientos, ya sea por prejuicios o por desconocimiento, cuando en realidad quienes están impartiendo estos tratamientos son médicos”.

“Los tratamientos complementarios potencian resultados contra el cáncer”

(Extraído de republica.com.uy)

ESPECIALISTAS CONVENCIONALES DEFIENDEN LA INVESTIGACIÓN EN EL TEMA Y FOMENTAN EL ABORDAJE INTEGRAL

Por Marcelo Hernández

Cuatro médicos especialistas en los tratamientos oncológicos de todo tipo estarán en nuestro país en los próximos días para participar del 1er. Coloquio sobre Medicina Complementaria para el cáncer.

Los exponentes serán la Dra. Maricela Espronceda Pérez (Cuba), que es doctora en Medicina, científica, docente instructora e investigadora; la Dra. María Isabel Bermúdez Domínguez (Cuba), doctora en Medicina, especialista en Inmunología, investigadora y especialista en varias ramas de la Oncología; el Dr. Jorge Juan Schulte (Argentina), doctor en Medicina, cirujano, urólogo y investigador de la Medicina Antroposófica; el Dr. Jesús Costa (Uruguay), doctor en Medicina, posgrado en Cardiología, fundador y director de la Clínica de Medicina Biológica Vitalista e investigador Método Hansi.

Dicho evento se efectuará en el Ballroom del Radisson Victoria Plaza el sábado 11 de abril, a las 10.30 hs. y a las 19 hs., y el domingo 12 de abril, a las 18.30 hs.

Las entradas para este evento están a la venta en la Red UTS, Red Pagos y Tienda Inglesa.

“Este coloquio tiene como finalidad de que pacientes oncológicos, así como todas aquellas personas y/o profesionales que quieran participar, puedan informarse más sobre medicina complementaria, pero sobre todo es una instancia de la medicina integrativa, poniendo al alcance de los pacientes todos los instrumentos posibles para su curación, sin despreciar el enorme aporte que la medicina convencional ha tenido, y tiene, sobre el desarrollo y sanación de la población mundial”, manifestó a LA REPÚBLICA su organizadora, la licenciada Graciela De León.

Ella decidió realizar este evento basada en que “el cáncer tiene muchas formas, sus tratamientos también”, agregando que “el abordaje integral, combinando tratamientos convencionales con alternativas terapéuticas complementarias, potencia los resultados enormemente”.

La organizadora explicó la metodología de trabajo durante el coloquio, al indicar que “los médicos expondrán los diferentes métodos utilizados y aprobados como medicina complementaria, pero también bajo la convicción de que las enfermedades oncológicas se pueden prevenir a través de diferentes mecanismos”.

Cada médico realizará una exposición individual, y luego de un intervalo (coffee break), los profesionales responderán todas las consultas que el público asistente quiera realizarles.

Este evento es dirigido a todo público, pacientes, familiares, profesionales que quieran conocer más sobre tratamientos no convencionales que luchan contra las enfermedades oncológicas.

Lo natural

Añadió De León que “el tema es que aún, lamentablemente, y si bien la OMS habla de medicina integrativa, no hay un método de trabajo conjunto entre la medicina convencional y la medicina natural, que hasta suena un poco absurdo, porque no existen varias medicinas, si vamos a qué es natural y que no, estaríamos viendo que lo natural es mucho más de lo que pensamos en el avance para la curación de diferentes dolencias o enfermedades, un grupo importante de fármacos son obtenidos a partir de la sustracción de principios activos de plantas medicinales, por ejemplo: la aspirina es derivada del sauce, la digoxina de la digitalis purpúrea, la morfina de la amapola y la penicilina, que en su momento revolucionó la medicina, es obtenida del hongo penicilinum”.

La organizadora también dijo que “quizá si ya hubiese existido un químico en el momento en que Fleming descubrió la penicilina, habríamos dicho, ¿se podrá usar esta medicina natural, se podrá usar esta medicina complementaria para no intoxicarnos con tantos químicos?

Me atrevo a decir, como ser humano, que buscar, investigar y descubrir nuevos tratamientos es científico y derive de plantas, de animales o de minerales, lo más importante a tener en cuenta es que curen las enfermedades, si fuera posible sin producir daño, o produciendo el menor daño y el menor sufrimiento posible a los pacientes”, puntualizó.

Visón integral e integradora

Uno de los especialistas que estará en el coloquio, el doctor uruguayo Jesús Costa, dijo a LA REPÚBLICA que “la humanidad vive una epidemia de enfermedad, donde lo ‘extraordinario’ se ha transformado en lo ‘habitual’. Debemos urgentemente promover una ‘revolución de conciencia’ de salud.

La ciencia sin espíritu ha demostrado ser limitada; por eso necesitamos generar una visión integral e integradora de la Medicina, donde no solo debemos ver al individuo de una forma multidimensional sino además integrar al Medio Ambiente también en su multidimensionalidad como un organismo vivo”.

La Naturopatía para combatir el cáncer?

(Extraído de presspeople.com)

Investigadores canadienses y estadounidenses estudiarán el impacto de la Naturopatía en la lucha contra el cáncer en una etapa avanzada.
Este gran estudio observacional diseñado para evaluar el impacto de la oncología integrativa en pacientes con cáncer avanzado.
La Oncología Integrativa pretende conciliar lo mejor de la atención convencional y los cuidados Naturopática holístico para mejorar la supervivencia y calidad de vida, reducir los efectos secundarios del tratamiento convencional y ayudar a prevenir la recurrencia del cáncer.
Un total de 400 personas con cáncer de mama avanzado, colon, páncreas y ovario participan en este estudio que se llevará a cabo en siete clínicas a través de América del Norte en los próximos tres años.
"Los resultados de esta investigación proporcionarán información valiosa sobre el papel de la Naturopatía en el tratamiento contra el cáncer y dará lugar a la realización de ensayos clínicos aleatorios más rigurosos", dijo Dugald Seely, director gerente del Centro de Cáncer Integradora de Ottawa y principal investigador canadiense para este estudio.
"Vamos a recoger los resultados en la tasa de supervivencia de los pacientes con cáncer avanzado apoyado por varias clínicas oncológicas Naturopática en América del Norte en un intento de responder a la pregunta fundamental de si la oncología Integrativa Avanzada tiene o no un efecto positivo sobre la supervivencia ", dijo Leanna Standish, profesor en el Instituto de Investigación de la Universidad Bastyr e investigadora principal de este estudio en los Estados Unidos.
Fuente: canoe.ca

Veterinaria UdeC valida innovador antiparasitario ovino homeopático

(Extraído de ladiscusion.cl)

A buen puerto llegó el proyecto “Desarrollo y evaluación técnica, económica y comercial de una estrategia homeopática para el control de parásitos gastrointestinales en ovinos”, desarrollado en parte en la provincia de Ñuble desde 2013, por el Centro de Investigación en Medicina y Agroecología (Cimasur), según se dio a conocer en un seminario en el Campus Chillán de la Universidad de Concepción.

El objetivo de la iniciativa fue diseñar y evaluar técnica, económica y comercialmente una estrategia homeopática para el control de parásitos gastrointestinales en ovinos.

Los resultados fueron exitosos, según explicó el coordinador de la iniciativa, Alejandro Montero. “Permitió elaborar productos homeopáticos que trabajan mecanismos inmunitarios y metabólicos que hacen al animal resistente a los parásitos”.Agregó que por el origen de los compuestos, “no se producen efectos de toxicidad, ni efectos colaterales, por lo que se puede utilizar en los distintos estados productivos, no siendo necesario los periodos de carencia. Esto abre la posibilidad de obtener un valor agregado a la producción ovina por concepto de producto limpio, natural, ecológico u orgánico”. 

Los impulsores de la iniciativa hicieron hincapié en que los hallazgos de esta investigación fueron el resultado de un trabajo de investigación colaborativo, que contó con la participación de la Facultad de Ciencias Veterinarias de la Universidad de Concepción, el Centro de Innovación y Transferencia Tecnológica (Citta) de la Universidad Católica de la Santísima Concepción, la Federación de Sindicatos de Trabajadores Agrícolas Campesinos de Ñuble, el municipio de San Nicolás, la empresa de certificación orgánica Bioaudita, además de la asesoría del Centro CIMA Colombia.

En este aspecto, Montero destacó que “el perfil de los actores involucrados garantiza y agrega valor a la homeopatía en los procesos de validación en el campo de las ciencias y abre las puertas al desarrollo de una ganadería ecológica en nuestro país, dado que la terapéutica homeopática tiene la capacidad de elaborar soluciones frente a todas las patologías presentes en la producción animal de una manera limpia y natural”.

TRASCENDENCIA

La importancia de la iniciativa es contar con una alternativa a los productos convencionales que se utilizan en la actualidad, que presentan algunos problemas que se expresan en pérdida de efectividad, resistencia en los animales y toxicidad.

A inicios de la investigación se había consignado que los problemas señalados producen pérdidas productivas del orden de un 10% y también que la demanada anual en el país de tratamientos antiparasitarios ovinos asciende a US$ 3,3 millones, mercado dominado principalmente por transnacionales.

Se explicó que “los productos homeopáticos, diseñados y elaborados durante la investigación, lograron controlar de manera efectiva los parásitos gastrointestinales en ovinos, durante todas las fases del sistema productivo, lo que fue demostrado estadísticamente. Del mismo modo y como consecuencia de la aparición de un brote de coccidias durante la investigación, se amplió la formulación para dar respuesta y dados los aprendizajes, se obtuvo como resultado el control homeopático en esta patología”.

También el proyecto abordó conceptos relacionados con el enfoque territorial, el paradigma agroecológico y el paradigma homeopático, diseñando indicaciones que buscan estabilizar los sistemas productivos durante el primer año de intervención, permitiendo reducir la carga parasitaria del animal y también en la pradera, y en el segundo año sólo mantener las condiciones apropiadas del sistema y enfrentar oscilaciones ocasionadas por manejos que provocan estrés.

“La efectividad de este remedio homeopático, que se logró probar en este proyecto, demostró que es tan efectivo como los productos químicos, entonces estamos frente a la posibilidad de poder entregar y ofrecer al sector de ganadería ovina productos naturales, siendo ésta la principal fortaleza y resultado de la iniciativa”, dijo el ejecutivo de Innovación Agraria de FIA, Ignacio Briones Arregui.

Los productos también quiebran otros esquemas en el sentido que el proceso se puede comenzar en cualquier momento del año, privilegiando la indicación asociada a manejos propios del sistema de producción ovina.

También se destacó que la reiteración en el uso del producto permite mayor efectividad en los resultados, pudiendo ser administrado vía oral, en el alimento o inyectable vía subcutánea, permitiendo generar en el animal estados de resistencia a parásitos o resiliencia.

“Este producto no genera efectos adversos en hembras durante la gestación ni en la lactancia. No requiere periodos de carencia.

Su aplicación no compromete el ambiente o los recursos naturales y es un producto seguro para quien lo aplica, y se calcula va a estar disponible a mediados de abril para ser comercializado en las cadenas de distribución de los productos veterinarios”, concluyó Briones.

A homeopathic experiment gives hope for treatment of AIDS

(Extraído de bussiness-standart.com)

Various research studies will be presented at the two-day World Homeopathy Summit to be held at Mumbai from April 11

A homeopathic experiment with snake venom on human immunodeficiency virus (HIV) has given rise to excitement among scientists to work on a possible relief to AIDS and Ebola patients, according to Global Homeopathy Foundation (GHF) managing trustee Sreevalsa Menon.
GHF, founded by a group of homeopathic activists, is a non-government non-profit making organisation.
Research by doctors at the Hyderabad-based JSPS Government Homeopathic Medical College and Indian Institute of Chemical Technology (IICT), it is stated to have shown that homeopathic medicine from snake venom, Crotalus Horridus, can arrest the multiplication of HIV.
In another two-year long study, Mumbai-based homeopathRajesh Shah has developed a new medicine for AIDS patients, sourced from HIV itself. The drug has been tested on humans for safety and efficacy and the results are encouraging. Shah’s scientific paper for debate has just been published in Indian Journal of Research in Homeopathy (IJRH), the official publication of the Central Council for Research in Homeopathy (CCRH) in its online edition.
These and other research studies will be presented at the two-day World Homeopathy Summit to be held at Mumbai from April 11. Scientists and doctors from across 25 countries have confirmed their participation at the summit being organised by GHF, Menon stated in a press release here on Thursday.
“Our experiment entails that the homeopathic drug has the capacity to act on HIV, etc,” said Praveen Kumar, head of Department of Practice of Medicine at JSPS College. He, however, pointed out that “it is too early to declare anything big, but our work has certainly opened the floodgates of advanced research and clinical testing.”
Prathama S Mainkar, fellow QRS Division of Natural Products Chemistry at IICT, said her team experimented with homeopathic dilutions as well but found that the medicine made out of snake venom was the most useful.
For years, homeopathy is stated to have been using the process of converting snake venom and poison from scorpions, spiders and wild bees into medicinal substances by transforming them into nano-particles that have proved safe and effective for patients.
GHF has invited conventional doctors as well to participate in the meet and update themselves on the “significant” research that has been going on for the past 15 years, Menon said.
The summit will also focus on the need to integrate both the systems of medicine to meet challenges posed by various diseases because mono-therapy may not work for all patients, he added.

miércoles, 1 de abril de 2015

Individualized Homeopathic Treatment and Fluoxetine for Moderate to Severe Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP Study): A Randomized, Double-Dummy, Double-Blind, Placebo-Controlled Trial

(Extraído de http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4359147/)

Emma del Carmen Macías-Cortés,1,2,* Lidia Llanes-González,3 Leopoldo Aguilar-Faisal,1 and Juan Asbun-Bojalil1

Yiru Fang, Academic Editor

Background

Perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression.

Methods/Design

A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoctest).

Results

After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale.

Conclusion

Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale.

Trial Registration

ClinicalTrials.gov NCT01635218

Protocol Publication

http://www.trialsjournal.com/content/14/1/105.

 

Introduction

Major depression disorder (MDD) is a chronic and frequently disabling disorder. The risk for MDD is approximately 1.5 to 3 times higher in women than in men, with an estimated lifetime prevalence in women of 21.3% [1,2]. It is characterized by sadness, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or appetite, feelings of tiredness, and poor concentration. The perimenopausal period refers to the interval when women's menstrual cycles become irregular, which generally occurs above 40. It is typically marked by intense hormonal fluctuations with a rising concentration of the pituitary gonadotropin follicle-stimulating hormone (FSH) [3,4]. The rising FSH concentration is probably caused by an exponential decline of gonadotropin-sensitive ovarian follicles as menopause approaches [4]. For some women the menopause is a largely uneventful part of life. However, for others is a period of biological vulnerability with remarkable physiologic, psychological, and somatic symptoms such as vasomotor symptoms (hot flashes, night sweats), changes in sexual function, sleep disturbance, among others [57]. According to the Stages of Reproductive Aging Workshop (STRAW), transition to menopause is the period that precedes menopause and it is characterized by variations in cycle length (> 7 days different from baseline or two or more skipped cycles and an interval of amenorrhea of sixty or more days). Postmenopausal stage is the period that continues after twelve months or more of amenorrhea [8].

Recent studies have demonstrated a significant association between menopausal transition and a higher risk for developing depression, with risk rising from early to late perimenopause and decreasing during postmenopause. It has been postulated that during perimenopause the risk for mood disorders may be increased for women with sensitivity to normal hormonal fluctuations [9]. A number of cross-sectional and longitudinal studies have evaluated the relationship between the menopausal transition and an increased risk of depression [10]. The Study of Women's Health Across the Nation found correlation between the menopausal transition and depressive symptoms [11]. The risk for recurrence of MDD during the perimenopausal period in women with a history of depression has been well documented [12]. Women with a history of depression are up to five times more likely to have a MDD during this time period. Other recent studies have independently demonstrated that transition to menopause was indeed associated with an increased risk for the development of depression, even among women with no previous history of depression [13,14]. Moreover, there are other risk factors that can contribute to worsen depressive symptoms, such as marital concerns, stressful life events, unhealthy lifestyle, among others [9].

The Diagnostic and Statistical Manual of Mental Disorders, abbreviated as DSM, is the diagnostic tool that serves as a universal authority for psychiatric diagnosis. The DSM-5 was recently published on 2013 [15]. Depression severity can be assessed by the Hamilton Rating Scale of Depression (HRSD) and Beck Depression Inventory (BDI), two well known standardized scales used in trials worldwide. Spanish versions of both scales have been validated [1619]. Greene Climacteric Scale (GS) is also a standardized scale used in Mexican population [17]. Spanish version has also been validated [16]. It is intended specifically to be a brief and standard measure of core climacteric symptoms or complaints to be used for comparative and replicative purposes across different types of studies whether they are medical, psychological, sociological or epidemiological in nature. Three separate sub-scales measure vasomotor symptoms, somatic symptoms, psychological symptoms, and an additional probe related to sexual function. Psychological symptoms can be further sub-divided to measure anxiety and depression [20, 21].

A number of meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment. Specifically, Kirsch et al published a meta-analyses of clinical trial data submitted to the US Food and Drug Administration (FDA) and revealed a mean drug-placebo difference in improvement scores of 1.8 points, whereas the National Institute for Clinical Excellence (NICE) used a drug-placebo difference of 3 points as a criterion for clinical significance [22]. Moreover, another meta-analyses found that only studies with higher average baseline severity achieved the clinically significant 3-point difference in HRSD scores [23]. By contrast, Gibbons et al published a detailed research synthesis using patient-level longitudinal data from available youth, adult and geriatric placebo controlled RCTs of fluoxetine. The results revealed consistent statistically benefits of treatment, the magnitude of which was greatest in youth and smallest in geriatric subpopulations. Baseline severity did not moderate the effect of treatment [24].

Homeopathy is delivered across Mexico via public and private healthcare systems to treat menopausal symptoms and depression, among many others diseases. Homeopathy is based on the 'principle of similars'. Highly diluted preparations of substances that cause symptoms in healthy individuals are used to stimulate healing in patients who have similar symptoms when ill [25]. Individualized homeopathic treatment (IHT) consists of a prescription of an individually selected homeopathic remedy based on the totality of symptoms ascertained after a complete clinical examination of the patient [26]. Nowadays, homeopathic medicines are produced by a standardized methodology. Homeopathic medicines in Centesimal (C) potencies are produced through sequential agitated dilutions. A drop of a parent substance is diluted in 99 drops of ethanol followed by agitation of the solution (1 C). This procedure is repeated in consecutive agitated dilutions (2 C, 3 C, 4 C, and so on).

Observational studies of homeopathic treatment for menopausal symptoms have been conducted. The evidence demonstrates an association between homeopathic treatment and improvement in fatigue, hot flushes, anxiety, depression and quality of life for menopausal women and breast cancer survivors. More homeopathic research is needed specially in the menopausal time period where there is a lack of well-designed RCTs [27, 28]. At moment, although homeopathy is frequently prescribed for psychiatric conditions, the need for more high-quality RCTs has been identified [29, 30]. Meta-analyses and systematic reviews have drawn mixed conclusions as to whether homeopathy is more effective than placebo in general medicine [26, 2335]. Few RCTs of homeopathy and placebo in psychiatry have been performed. The results are very limited, but do not preclude the possibility of some benefit, as it was found for fibromyalgia [36].

Adler et al conducted a RCT of individualized homeopathic Q-potencies for moderate to severe depression and found that IHT was non-inferior to fluoxetine, but because of ethical reasons the study did not include a placebo group [37]. Most importantly, although mood symptoms are one of the most common complaints during transition to menopause, to date, there is a lack of RCTs of homeopathic treatment for depression in women at this stage.

The main objective of the HOMDEP-MENOP study was to assess the efficacy and safety of IHT in C-potencies vs placebo; the secondary objective was to assess the efficacy and safety of fluoxetine vs placebo, for moderate to severe depression in women in peri- and postmenopuase.

 

Methods

Ethics statement

The protocol was reviewed and approved by Research and Ethics Committee of Hospital Juárez de México (JMH) (Comisión de Ética e Investigación del Hospital Juárez de México) (Approval Number: HJM 2030/12-A), registered in ClinicalTrials.gov (ID: NCT01635218) and published [38] inhttp://www.trialsjournal.com/content/14/1/105. This study is in compliance with Helsinki Declaration and with the International Conference of Harmonisation ICH—Good Clinical Practice. Prior to undertaking any study procedures each participant received a verbal and written explanation about study aims, methods, potential hazards, and benefits from investigators. Participants signed a written informed consent at the time of their enrollment. The trial process was reviewed every three months by the institutional board. Participant's study information was not released outside of the study without written permission of the participant.

Design

A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a six week follow-up study was conducted.

Study setting

The study was conducted in a public, academic and research hospital in Mexico City, the Hospital Juárez de México (JMH), which belongs to the Ministry of Health (MoH), central authority in charge of the health policies and design programs. The MoH provides health care to people without social security. JMH is a highly academic specialized hospital. Homeopathy is part of the National Health System regularized by the MoH. The outpatient service of homeopathy was established in JMH since 2004 and provides health care for climacteric stage women daily.

Patients

The recruitment methods included advertisements through internet, community groups and liaisons with health professionals. Posters with information about the study protocol were pasted at the study site; brochures were distributed among hospital population. Participants were recruited since March 2012 until December 2013.

Five hundred thirty four women seeking care for menopausal complaints or feeling depressive were screened at study site. Participants were recruited from this sample; one hundred thirty three women diagnosed with MDD according to DSM-IV who met the inclusion criteria agreed to participate. The entry criteria included: (1) 40 to 65 years; (2) diagnosed with major depression according to DSM-IV; (3) moderate to severe depression according with 17-item HRSD (14–24 score); (4) no current use of homeopathic treatment for depression or antidepressants or anxiolytic drugs three months prior to study entry; (5) not be currently taking psychotherapy for at least three months before screening; (6) no current use of estrogens or other medications known to affect ovarian function for at least three months before screening; (7) early transition to menopause, defined by a change in cycle length of seven days or longer in either direction from the participant's own baseline for at least two cycles, or late transition to menopause, defined as three to eleven months of amenorrhea; (8) postmenopausal stage defined by twelve months or more of amenorrhea; (9) capability and willingness to give informed consent and to comply with the study procedures.

Exclusion criteria included: (1) pregnancy or breastfeeding; (2) other psychiatric disorders different from moderate to severe depression (severe depression, schizophrenia, psychotic disorders, bipolar affective disorders, suicide attempt); (3) alcohol or other substance abuse; (4) known allergy to fluoxetine; (5) cancer or hepatic diseases.

Plans to promote participant retention and complete follow-up included: scheduling appointments and contacting patients by telephone calls.

Study medications

After inclusion, patients were randomly assigned to either one of three groups: (1) individualized homeopathic treatment (IHT) plus fluoxetine dummy-loaded; (2) fluoxetine (20 mg/d) plus IHT dummy-loaded; (3) fluoxetine placebo plus IHT placebo.

The selection of the individualized remedy was carried out after the case history by a certified medical doctor, specialized in homeopathy with 18 years experience in classical homeopathy based on Hahnemann's methodology described in paragraphs 83–104 of the Organon of Medicine, 6th edition. A complete medical history with clinical examination was done. All patients no matter the group assigned, had a full homeopathic case-taking including the collection of all the facts pertaining to the patient which may help in reaching the totality of the symptoms: past and present physical and emotional symptoms, family environment since childhood, stressful life events, marital satisfaction. The symptoms were organized by hierarchy: mental, general and physical. In first place, the strategy to choose the individualized remedy was based on the most characteristic and clear mental symptoms. Secondly, general symptoms were taken into account. Computerized version of Synthesis Homeopathic Repertory 9.1 (Radar version 10) was used to facilitate the prescription. Only one remedy was prescribed at a time but it could be changed at every follow-up according to patient's symptoms.

C-potencies were provided by Laboratorio Similia (Mexico City) and were manufactured according to Mexican Homeopathic Pharmacopoeia and Hahnemann's methodology. Homeopathic medicines are produced through sequential agitated dilutions in Decimal (D), Centesimal (C) or Quinquagintamillesimal (Q or LM) potencies. C-potencies are prepared by diluting a drop of a parent substance in 99 drops of ethanol followed by agitation of the solution (1 C). Then one drop of this solution is diluted in 99 drops of ethanol followed by agitation of the solution (2 C). This procedure is repeated in consecutive agitated dilutions (3 C, 4 C, and so on). In the HOMDEP-MENOP study each individualized homeopathic remedy was prescribed in C-potencies.

Higher initial potencies were tried, only 30 C and 200 C were prescribed. The factors that influenced the selection of the potency included: clarity of mental symptoms, patient's vitality and sensitivity, nature and kingdom (source) of medicine, chronicity, presence of any pathological disorder. As previously stated, in an IHT the homeopathic doctor selects a remedy based on the specific and most important symptoms the patient has. This individualized prescription also includes the selection of the appropriate potency based on the factors mentioned. Thus, the prescription is individualized in the selection of the remedy and in the appropriate potency required by the patient.

In the HOMDEP-MENOP study, a single dose of the individualized homeopathic remedy selected was dissolved in a 60 ml bottle of 30% alcohol-distilled water. Patients received 10 drops PO two times per day following agitation plus fluoxetine-dummy loaded prescribed PO daily. A double-dummy technique with matching placebos for each active treatment was applied, thus both placebos seemed identical to their corresponding verum formulations. Follow-up visits were at weeks 4 and 6 after the first clinical interview.

Patients in fluoxetine group received 20 mg/d PO plus IHT-dummy loaded. IHT-dummy loaded was repeated at week 4. Capsules of a generic fluoxetine were provided by Laboratorio Similia (Mexico City). Placebo capsules contained sucrose micro globules. Homeopathic placebo bottles were filled with the same amount of 30% alcohol-distilled water. Patients received 10 drops PO of this solution two times per day following agitation. Homeopathic placebo was repeated at week 4. The third group received both fluoxetine and IHT placebos, as previously described.

Concomitant medications

Some medications were prohibited during the trial: triptans, tramadol, anxiolytic drugs and other serotonergic agents or antidepressants, as well as hormone replacement therapy. Medication for diabetes and hypertension was allowed. Psychotherapy was also forbidden during study duration. Rescue intervention in case of lack of efficacy in the IHT group was fluoxetine 20 mg per day and, in case of placebo, an IHT was prescribed.

Criteria for discontinuing or modifying allocated medications

In case of emergency interventions, clinical worsening or serious adverse events, the pharmacist informed the homeopathic doctor if the individual patient was taking homeopathy, fluoxetine or placebo, without disclosing the code. In these circumstances, the homeopathic doctor reported the adverse events as serious, examined again the patient and suspended the medication. After medication was interrupted, if placebo was taken, an IHT was prescribed for this patient; if the patient was taken IHT, a new IHT was given. Only in case of lack of efficacy in the IHT group, fluoxetine 20 mg per day was prescribed. In case of serious events during fluoxetine treatment, medication was interrupted and an IHT was also prescribed. The participant did not continue furthermore in the original allocated intervention in placebo or fluoxetine groups.

The criteria for discontinuing or modifying allocated interventions included the presence of serious adverse effects observed during fluoxetine treatment. Some adverse events reported in fluoxetine treatment are: lack of interest in sex, sexual dysfunction, nausea, insomnia, somnolence, anorexia, anxiety, asthenia, tremor, allergic skin reactions. If they resulted in interruption of treatment, this was reported.

In case of IHT, if the participant underwent a severe 'homeopathic aggravation' (temporary intensification of symptoms before a condition improves), the homeopathic medicine was interrupted and the reaction was lessened by using frequent doses of the same remedy in lower potency. If the participant experimented the appearance of new symptoms different from those which prescription was based, the homeopathic medicine was interrupted, a full homeopathic case-taking was taken again with a new individualized remedy prescription, and these symptoms were reported as adverse events.

Each participant received a report form that enabled to write daily any adverse event or stressful event observed during trial duration. Study participants were retained in the trial whenever possible to enable follow-up data collection and prevent missing data.

Adherence to study medications

To enhance validity data, participants returned the unused capsules and bottles at each follow-up visit. Unused capsules were counted and recorded on the appropriate case report form. Participants were asked about any problems they had taking their study treatment.

Outcome measures

The following three measures were used. The primary efficacy outcome was the change from baseline in mean total depression score using the 17-item version of the HRSD at week 4 and 6. Severity of symptoms was assessed by a blinded investigator (clinical psychologist) from the JMH. The secondary outcomes were: change from baseline in mean total depression score using BDI and GS at week 4 and 6; responder rates (response rate: decrease of 50% or more from baseline score; remission rate: 7 or less points in HRSD score). Number and severity of all adverse events and homeopathic aggravations during the study period and fifteen days after final dose were collected in determining the safety of fluoxetine and homeopathic medicines.

Adverse events were defined as any untoward medical occurrence in a subject without regard to the possibility of a causal relationship. Adverse events were collected after participants consent and enrolled in the study and fifteen days after study completion.

Randomization

Participants were simple randomized in a 1:1:1 ratio using a computer-generated random allocation sequence, by a statistician not further involved in the study. Participants were assigned in sequential order to the treatment groups. The randomization list was kept strictly confidential.

Allocation
Concealment mechanism and implementation

The principal investigator enrolled participants. Following inclusion, all patients went through a full homeopathic case-taking and received a prescription of the individualized homeopathic medicine. Only third of them actually received it. The research pharmacist randomly delivered the treatment according the allocation sequence in one of the three groups previously described. The randomization list was sent to the research pharmacist at the beginning of the study.

Blinding

Participants, the homeopathic doctor, the psychologist, and the statistician remained blinded from the identity of the three treatment groups until the end of the study. The psychologist assessed the severity of the symptoms and kept the HRSD scores strictly confidential in a close envelope every follow-up until the end of the study.

Sample size calculation

Sample size calculation was estimated using G*Power (available at University of Dusseldorf:http://www.psycho.uni-dusseldorf.de/aap/projects/gpower/). The sample size calculation was based on a previous study protocol for a randomized controlled trial of homeopathy for depression published by Adler et al [37]. We assumed that verum treatment is better than placebo by 2.7 (6.0) [(mean (standard deviation)] HRSD score points after six weeks, corresponding an effect size = 0.45 (largest difference between any two groups to be detected/expected within group standard deviation = diff/de). To detect an effect size = 0.45, in a 3-group design (1:1:1), using F-Test, with a 5% risk of type 1 error, and 83% power, 63 patients per group were expected to be required considering also a 10% drop-out rate.

Data collection

Study data were collected at baseline and every follow-up during the study duration. Data were collected from different sources: medical records, questionnaires (HRSD, BDI, GS) and report forms where participants wrote daily any adverse event.

Data management

All data were entered electronically on data sheets designed for the study. Original study forms were entered and kept on files at the JMH. Participants files were stored in numerical order in a secure and accessible place and manner. Participants files will be maintained in storage for a period of five years after completion of the study. All forms related to the study data were kept in locked cabinets. Access to the study data was restricted.

Statistical analysis

All patients under randomization were included in the primary efficacy population (intention-to-treat population), regardless whether or not they adhered to the treatment protocol or provided complete data sets. Only patients who withdrew their consent to use their personal data were excluded from the analysis. The flow of participants through the trial is presented in a CONSORT diagram.

First, the three groups were compared in order to verify that there are not significant differences among them at baseline to confirm they are comparable after randomization. Demographic characteristics were summarized using means and standard deviation for continuous data (i.e., age) and relative frequencies for qualitative data (i.e., marital status, occupation, menopausal status). The baseline demographic characteristics among groups were compared with the use of chi square test or by one-way independent measures of analysis of variance (ANOVA) as required. Continuous data were represented by means and standard deviation, whereas categorical data were represented by a frequency table.

Data were analyzed with SPSS statistical software (version 17.0). We compared: (1) IHT versus placebo; (2) fluoxetine versus placebo. The main statistical analysis compared primary and secondary outcomes measurements among groups at weeks 4 and 6. The primary outcome (change in mean HRSD score) and secondary outcomes (change in mean BDI and GS scores) among groups at baseline and weeks 4 and 6, were analyzed by one-way ANOVA to provide a statistical test of whether or not the means of the three groups are all equal. The statistical significant ANOVA result (p<0.05) suggests rejecting the global null hypothesis H0 (the means are the same across IHT, fluoxetine and placebo groups). Owing to the study is a three-arm trial, adjustment for multiple comparisons was accomplished with Bonferroni method which requires that the p-value for each comparison be less than or equal to 0.05 divided by the total number of study comparisons. This guarantees that the probability of at least one type I error is less than 0.05.

Eta squared [between-groups sum of squares/total sum of squares] was calculated by hand to determine effect size. Responder rates were compared among groups using chi square test. Relative risk and odds ratio with 95% CI, and number needed to treat (NNT) were also determined. Statistical significance was set at p<0.05 level for all analysis. Steps taken in the design and data collection stages were observed carefully in order to prevent missing data, but this was difficult to completely achieve. Missing data were as a result of loss to follow-up and were handled by sensitivity analysis (SA). A multiple imputation technique (MI) was performed using multiple imputed datasets which yield unbiased estimates, and also accounts for the within and between dataset variability. Five imputations were performed in SPSS (version 17.0).

Statistical analysis for repeated measurements was not prespecified in the study protocol. A mixed effect model analysis with random intercept and slope was used to assess the rate of change in HRSD, BDI and GS scores, among groups over the 6-week treatment interval.

All patients who received at least one dose of study drugs were considered in the safety analysis. Adverse events were translated to Medical Dictionary for Regulatory Activities terms (MeDRa terms), quantified, and compared among groups using chi square test.

 

Results

Fig. 1 describes the CONSORT diagram of women through the study. Five hundred thirty-four women seeking medical care for menopausal complaints were interviewed. Four hundred and one women did not meet inclusion criteria and were excluded. One hundred thirty-three women (24.9%) met inclusion criteria, accepted to participate in the study and were randomized as previously described.

Fig 1

Fig 1

CONSORT flow diagram of study participants through the trial.

Baseline characteristics of participants are summarized in Table 1. There were no significant differences among the three groups with respect to demographic characteristics (age, marital status, occupation, education) and menopausal status. The mean age (SD) in all groups was approximately 49 (5.8) years (p = 0.944). Most of the women included in the three groups were married (65%), housewives (61%), and the highest level of education was elementary school (80%). Fifty-five percent were postmenopausal, whereas 22% were in early transition to menopause and 23% in late transition (p = 0.474).

Table 1

Table 1

Baseline demographic characteristics and menopausal status of participants.

There were no significant differences among groups with respect to risk factors for depression (Table 2). Sixty-four percent of women had a history of depression (p = 0.857), 73% reported domestic violence (emotional, physical or economic) (p = 0.883), 36% history of sexual abuse in infancy (p = 0.748) and 53% marital dissatisfaction (p = 0.397).

Table 2

Table 2

Baseline prevalence of risk factors for depression among groups.

Table 3 shows HRSD, BDI and GS scores at baseline, 4 and 6 weeks. No significant differences among the three groups were observed with respect to baseline mean (SD) scores in HRSD, BDI and GS. Mean (SD) baseline score in HRSD was 21.2 (2.7) [95% CI (20.4–22)] in IHT group vs 20.6 (2.9) [95% CI (19.7–21.5)] in fluoxetine group vs 20.7 (3.1) [95% CI (19.8–21.7)] in placebo group [F (2,130) = 0.506, p = 0.604]. Mean (SD) baseline score in BDI was 26.3 (7.2) [95% CI (24.1–28.4)] in IHT group vs 25 (7.8) [95% CI (22.7–27.3)] in fluoxetine group vs 27 (9.0) [95% CI (24.2–29.8)] in placebo group [F (2,130) = 0.692, p = 0.502]. Mean (SD) baseline score in GS was 35.3 (8.5) [95% CI (32.7–37.9)] in IHT group vs 33.2 (10.1) [95% CI (30.5–36.5)] in fluoxetine group vs 37.9 (11.5) [95% CI (34.3–41.4)] in placebo group [F (2,130) = 2.11, p = 0.125].

Table 3

Table 3

Mean change in 17-item Hamilton Depression Rating Scale, Beck Depression Inventory and Greene Climacteric Scale among groups after six weeks of treatment.

After six weeks follow-up, there were significant differences among groups in HRSD. Mean (SD) score in HRSD was 9.9 (3.0) [95% CI (9.0–10.9)] in IHT group vs 11.7 (3.7) [95% CI (10.5–12.9)] in fluoxetine group vs 15.0 (3.7) [95% CI (15.9–18.3)] in placebo group [F (2,115) = 20.2, p = 0.0, eta squared = 0.26]. Bonferroni post hoc test determined that means differed in IHT group vs placebo group (p = 0.0) and fluoxetine group vs placebo group (p = 0.0). IHT group was better than placebo in 5.0 points (p = 0.00); fluoxetine group was better than placebo in 3.2 points (p = 0.00). Means did not differ in IHT group vsfluoxetine group (p = 0.082).

With respect to BDI, after six weeks of treatment, there were no significant differences among the three groups [F (2,116) = 2.08, p = 0.130, eta squared = 0.03]. In the IHT group baseline score decreased from 26.3 (7.2) [95% CI (24.1–28.4)] to 12 (6.1) [95% CI (10.1–13.9)], fluoxetine group decreased from 25.0 (7.8) [95% CI (22.7–27.3)] to 14.2 (7.8) [95% CI (11.7–16.7)] and placebo group, from 27.0 (9.0) [95% CI (24.2–29.8)] (Table 3).

By contrast, after six weeks there were significant differences in GS. Mean (SD) score in GS was 18.1 (7.8) [95% CI (15.7–20.6)] in IHT group vs 23.1 (12.3) [95% CI (19.2–27.1)] in fluoxetine group vs 26.8 (11.7) [95% CI (22.8–30.7)] in placebo group [F (2,116) = 6.41, p = 0.002, eta squared = 0.09]. Bonferroni post hoc test showed that IHT was better than placebo in 8.6 points (p = 0.02). Means did not differ in fluoxetine group vs placebo group (p = 0.424). Also, there were no differences in fluoxetine group vs IHT group (p = 0.115) (Table 3).

The improvements in the three treatment groups in HRSD, BDI and GS are shown in Figs. ​Figs.22 to ​to4.4. Mixed effect model analysis results indicated that the average rate of change in HRSD score was −5.70 points (p = 0.00) for each subsequent measurement (week 4 and 6) in IHT during the 6-week treatment interval (Fig. 2). The placebo group had 2.78 points higher than IHT in HRSD score [(t = 6.44, p = 0.00, 95% CI (1.93–3.63)] and the fluoxetine group had 1.31 points higher than IHT in HRSD score [(t = 3.083, p = 0.02, 95% CI (0.47–2.149)].

Fig 2

Fig 2

Mean change in 17-item Hamilton Rating Scale for Depression score after six weeks of treatment according to the study group.

Fig 4

Fig 4

Mean change in Greene Climacteric Scale score after six weeks of treatment according to the study group.

The rate of change in BDI score was −7.17 points (p = 0.00) for IHT during the 6-week treatment interval. The placebo group had 1.21 points higher than IHT in BDI score [(t = 1.13, p = 0.258, 95% CI (−0.894–3.32)] and the fluoxetine group had 1.82 points higher than IHT in BDI score [(t = 1.73, p = 0.084, 95% CI (−0.245–3.88)] (Fig. 3).

Fig 3

Fig 3

Mean change in Beck Depression Inventory score after six weeks of treatment according to the study group.

The rate of change in GS score was −8.65 points (p = 0.00) for IHT during the 6-week treatment interval. The placebo group had 3.28 points higher than IHT in GS score [(t = 2.49, p = 0.03, 95% CI (0.689–5.78)]; the fluoxetine group had 3.62 points higher than IHT in GS score [(t = 2.80, p = 0.005, 95% CI (1.08–6.168)] (Fig. 4).

Table 4 summarizes response rates according to HRSD. In IHT group, 54.5% had a response to treatment (decrease of 50% or more on baseline score), 41.3% in fluoxetine group and 11.6% in placebo group (chi2 = 18.1, 2 df, p = 0.00). Neither IHT nor fluoxetine group differed from placebo group on the remission definition (7 or less points in HRSD). Only 15.9% had remission of depression after six weeks of treatment in IHT group, 15.2% in fluoxetine group and 4.7% in placebo group (chi2 = 3.28, p = 0.194).

Table 4

Table 4

Response rates among groups according to 17-item Hamilton Rating Scale for Depression.

Two patients need to be treated for one to benefit (decrease of 50% or more on HRSD baseline score) in an IHT compared to placebo after a 6-week treatment. Thus IHT is protective for depression after 6-week treatment [OR = 0.11, 95% CI (0.04–0.33), p = 0.0001], but no statistical significance was found in benefit from a 6-week IHT according to remission definition (7 or less points in HRSD) [OR = 0.26, 95% CI (0.05–1.32), p = 0.103] (Table 5). In case of fluoxetine, number needed to treat (NNT) is 3, [OR = 0.19, 95% CI (0.06–0.56), p = 0.0029], but the same as IHT, there is no statistical significance according to remission definition [OR = 0.27, 95% CI (0.05–1.39), p = 0.11] (Table 6).

Table 5

Table 5

Benefit of 6-weeks individualized homeopathic treatment in patients who responded to treatment and who had remission according 17-item Hamilton Rating Scale for Depression.

Table 6

Table 6

Benefit of 6-weeks fluoxetine treatment in patients who responded to treatment and who had remission according 17-item Hamilton Rating Scale for Depression.

With respect to adverse events, Table 7 summarizes percentage of patients in each group reporting any adverse symptom during treatment and after 15 days. There were no severe adverse events in either of the three groups. Nine mild adverse events were reported in study participants (nausea, constipation, diarrhea, dyspepsia, anxiety, headache, insomnia, dizziness, fatigue). There were no significant differences among groups in the safety outcome.

Table 7

Table 7

Percentage of patients in each group reporting adverse events.

Only one patient taking fluoxetine had increased anxiety and insomnia, so it was necessary to interrupt the medication and prescribe an IHT. This reaction did not threaten patient's life. This was the only case that the pharmacist told the homeopathic doctor the medication the patient was taken (fluoxetine). Then it was necessary to prescribed an IHT and the patient did not continue in the previously allocated intervention. In the rest of participants, all the adverse events were very mild and tolerable and medication was not interrupted. In the IHT group, 11.4% felt a mild homeopathic aggravation followed by clinical improvement. It was not necessary to stop study medication.

In compliance with RedHot Guidelines, S1 Table shows the homeopathic medication prescribed in this study.

The results were assessed for robustness through sensitivity analysis. Missing data were handled using a multiple imputation technique. The primary efficacy outcome and the two secondary outcomes were analyzed by this technique. Five imputations were performed and results remained unchangeable with respect to the primary analysis in all imputations.

 

Discussion

The results of this study indicate that both IHT and fluoxetine are effective antidepressant treatments for women in peri- and posmenopausal stage. This clinical trial is based on: (1) CONSORT guidelines for reporting randomized trials with parallel groups [39]; (2) Reporting data on homeopathic treatments (RedHot) supplement to CONSORT [40]; and (3) the SPIRIT 2013 guidance for protocols of clinical trials [41].

Some RCTs had failed to prove antidepressants efficacy, but other reports and meta-analysis had already shown that fluoxetine improves depression with a drug-placebo difference of 3 points in HRSD considered as a criterion of clinical significance [22]. Our results showed a fluoxetine-placebo difference of 3.2 points. In case of homeopathy, this is the first RCT of IHT in peri- and posmenopausal women with moderate to severe depression using C-potencies with three treatment groups. Previously, Adler et al reported improvement in depression in outpatient patients with moderate to severe depression using individualized homeopathic Q-potencies. They conducted a non-inferiority trial comparing homeopathy with fluoxetine, but a placebo group was not included due to ethical reasons [37]. The HOMDEP-MENOP study included a three arm design, so the placebo group allowed to rule out the placebo effect.

IHT-placebo difference in HRSD score was higher (5 points) than fluoxetine-placebo difference. This result deserves a comment. Although the three groups had the same case history, in case of IHT group, participants received an individualized homeopathic prescription, which matched with the specific symptoms the patient had, whereas, all participants in fluoxetine group received the same antidepressant and dosage, fluoxetine 20 mg per day. The dosing protocol for fluoxetine was below the approved maximum (60–80 mg/d) [42]. For this reason, efficacy of fluoxetine relative to placebo could had been underestimated. In addition, Pinto-Mezaet al concluded that menopause seems to negatively affect selective serotonin reuptake inhibitors (SSRIs) treatment response of depressed women treated in primary care. It might be possible that female gonadal hormones could augment response to SSRIs, so endocrine changes of menopause could be modifying the pharmacodynamic effects of the SSRIs [43]. It has been found that estrogen enhances serotonergic activity. By contrast, Kornstein et al investigated the influence of sex and menopausal status on response and remission in patients treated with venlafaxine extended release or fluoxetine and concluded that treatment outcomes with these two antidepressants did not differ on the basis of sex or menopausal status [44]. However, the confidence in these findings is limited by the lack of a placebo arm and by the small sample sizes for subgroup analysis.

The results of the analysis of the primary outcome (HRSD) were statistical significant (p<0.05). It is known that there are several limitations with the null hypothesis testing because it is highly dependent of the sample size [45], so in the HOMDEP-MENOP study the effect size, which is an estimation of the magnitud of the effect independently of sample size, was calculated (eta squared = 0.262).This magnitude corresponds to a moderate to strong effect and supports our results. In addition, the sensitivity analysis by a multiple imputation technique contribute to support the robustness of the HOMDEP-MENOP study results in all outcomes.

Although we did not include all the participants that were initially planned, we found statistically significant differences among groups in the primary outcome (HRSD) and in GS after four and six weeks. We calculated the achieved statistic power of the study using G*Power program. Taking into account an effect size (eta squared) = 0.262, a sample size = 133, a three-groups design, with a 5% risk of type 1 error, the result is 77%. Although we did not achieve a statistic power of >80% with this sample size (133 participants), we found statistically significant differences for both, IHT and fluoxetine, in HRSD and for IHT in GS. If not, we should have included more participants, in order to increase the statistic power of the study to detect a difference, if the difference in reality exists. Furthermore, for both IHT and fluoxetine, we found statistically significant differences versus placebo in response rates and statistical significance was found in benefit from a 6-week IHT or fluoxetine treatment according to response definition.

We found that the three groups improved in HRSD scores during the 6-week treatment interval. The administration of IHT during six weeks in climacteric women with moderate to severe depression significantly improved the rate of depression recovery over the treatment interval, as compared to placebo. The fluoxetine group also improved, but the rate of recovery was a little more rapid in the IHT. In case of BDI, the rate of change in scores did not differ significantly among groups.

Nevertheless, there is an impact if the results are analyzed with different cut-off points in HRSD. In spite of the overall results of this study which indicate that both, IHT and fluoxetine improve depression in climacteric women, IHT and fluoxetine were significantly more effective than placebo according to the HRSD definition of response only. Response rates of IHT and fluoxetine are similar to those published in other studies [42]. Neither IHT nor fluoxetine were different from placebo in remission definition. Only 15.9% attained remission in IHT group, 15.2% in fluoxetine group and 4.7% in placebo group (p = 0.194). Nemeroff et al conducted a RCT comparing fluoxetine, venlafaxine and placebo in depression and reported similar results in response rates and higher remission rates for fluoxetine (28%) and placebo (22%), but as in HOMDEP-MENOP study, Nemeroff did not found statistical significance in the remission definition [42]. Translating into a clinical scenario, these results indicate that a 6-week treatment is a short period of time to treat depression in climacteric women. Probably, it is required more time with fluoxetine or IHT to attain remission. A 6-weeks treatment only improves depression, and it may be possible that an amount of patients would still have mild depression after that period of time. Gibbons et al reported remission rates of 45.8% vs30.2% for fluoxetine and placebo respectively [OR = 1.96, 95% CI (1.66–2.31), p < 0.001, NNT = 6.40] in a synthesis of RCTs. They concluded that few well-controlled studies, have documented response rates for extended treatment with a single effective antidepressant. In the Gibbons' study remission rate was 82%, with 75% achieving remission by 140 days (twenty weeks). For fluoxetine, 23% of patients who were unimproved at eight weeks showed full remission at twelve weeks [24]. Therefore, further studies of IHT for depression should be conducted to prove if a longer treatment is effective to attain remission of depressive symptoms in climacteric women.

Different results were published by Adler et al. They reported the highest remission rates (47.2 and 55.3%, for fluoxetine and homeopathy, respectively) after a 4-week follow-up; 76.9 and 72.4% for fluoxetine and homeopathy, respectively, after eight weeks of treatment [37]. Low remission rates in HOMDEP-MENOP study may be due to different factors. First, although there were no statistical differences among groups, maybe the increased baseline prevalence of domestic violence and marital dissatisfaction, could contribute to lessen antidepressant response. Second, the hormonal fluctuations that are characteristic of transition to menopause could also contribute somehow to a lower remission rate compared to other populations of adults. Pinto-Meza et al, reported that menopause is related to a worse antidepressant treatment response [43]. As previously explained, estrogen enhances serotonergic activity, and it is unknown if the fluctuations in this hormone may affect IHT response also. Third, the HOMDEP-MENOP study included only moderate to severe depression. Some meta-analysis have reported that medication versus placebo differences vary substantially as a function of baseline severity. They suggest that the magnitude of benefit of antidepressant treatment compared with placebo increases with severity of depression symptoms and may be minimal or nonexistent, on average, in patients with mild or moderate symptoms [22, 46]. However, Gibbons et alconcluded that baseline severity do not affect antidepressant response.

Otherwise, an important point to consider is NNT. From a public health perspective this is an enormous difference and indicates that for every two treated patients with IHT during six weeks, an additional patient treated will respond. So IHT could be a proven and low cost treatment that improves depression in many women in climacteric stage. Mexico has a big population of low-income women without social security that cannot buy antidepressant medication. Homeopathy could be considered as a health care option for these women. In case of fluoxetine, for every three treated patients during six weeks, an additional patient treated will respond.

Although in the HOMDEP-MENOP study there was no statistical difference between IHT and fluoxetine, this study was not designed to prove if IHT is not worse or equivalent to fluoxetine. It is important to take into account the relative futility of trying to compare the efficacy of active antidepressants in a conventional study. Snappin explains that it is fundamentally impossible to prove that two treatments have exactly equivalent effects. Therefore, equivalence trials aim to show that the effects differ by no more than a specific amount (equivalence margin) [47]. If two treatments differ in their effects by more than the equivalence margin in either direction, then equivalence does not hold. Snappin also explains that non-inferiority trials aim to show that an experimental treatment is not worse than an active control by more than the equivalence margin [47]. In our case, we conducted a superiority trial focused in comparing IHT vs placebo. Further studies with an adequate study design and sample size are needed to confirm whether IHT is equivalent or non-inferior to fluoxetine in climacteric depressive women.

Besides the positive results in HRSD, no statistical differences were found among groups in BDI score. Both, HRSD and BDI are standardized instruments that assessed depression severity, but BDI is self-administered. Participants received instructions to respond correctly. BDI requires elementary school as a minimum to be able to answer the test, and although all participants studied elementary school, some difficulties to understand and answer the test were observed with this instrument, so maybe this could biased the results. BDI has been used in Mexican population in other diseases such as rheumatoid arthritis. Dawes et al investigated the demographic influences for BDI in a non-clinical Spanish speaking population and found that those with lower education tended to report higher severity of individual symptoms [48].

It is well known that there is an association between domestic violence or abuse and mental health problems [49]. The present study found that most of the study participants have low educational level (elementary school) with high prevalence of domestic violence. This may affect the generalizability of the results. According to two national surveys published in Mexico [Encuesta Nacional sobre la Dinámica de las Relaciones en los Hogares (ENDIREH) 2006 and 2011, and Encuesta Nacional de Victimización y Percepción de la Seguridad Pública (ENVIPE) 2012] in 2011, 47% of women above 15 years experienced intimate partner violence. But specifically, in women who had once an intimate partner (and now are widows, divorced, or separated) this increases up to 64% [50]. Overall results of HOMDEP study found that 73% of women in climacteric stage suffer or have recently suffered domestic violence. This higher prevalence may be due to the presence of low educational level and the employment status (most of them did not have a formal job), so they economically depend on their partners. Higher education levels and employment status are probably protective factors against violence exposure, hence these participants had higher risk of suffering domestic violence and depression [5153]. Further studies in other women with other educational level and employment status are required to assess the effect of IHT.

Although individual prescriptions are necessary in classical homeopathy, they have been considered as an obstacle for a double-blind trial in homeopathy [37]. Adler et al stated that 'a study design in which the selection of a suitable, individualized homeopathic medicine occurs during the double-blind randomized phase evaluates not only the efficacy of homeopathy, but also the efficiency of the homeopath in selecting and managing that medicine' [37]. The HOMDEP-MENOP study confirmed the efficacy of 'individualized homeopathic treatment' as a whole, that is, an individualized prescription means selecting an individualized remedy in the appropriate potency. One medicine for each patient was prescribed depending on the symptoms she experienced at the moment of the history case. Many homeopathic RCTs had failed when the same medicine was prescribed for all participants, due to individual differences in symptoms, so although an individualized prescription evaluates the efficiency of the homeopath in selecting the medicine, it can also contribute to resolve a methodological obstacle in homeopathic clinical trials in classical homeopathy.

With respect to climacteric complaints, results from GS score showed that IHT is effective for improving symptoms of women at this stage. Despite the main objective of this study was to prove efficacy of IHT for depression, other climacteric symptoms which are frequently associated with this condition were evaluated. Many observational studies have confirmed the effectiveness of homeopathic treatment for climacteric women [26]. The effectiveness gap remains for women with menopausal symptoms, so it has been necessary to conduct well-designed RCTs. Few RCTs have evaluated the use of homeopathy for menopause, and have failed to demonstrate its efficacy because a single homeopathic medicine for a whole population was prescribed and, as it was previously discussed, that is not the gold standard of homeopathic care, or sample size was too small to obtain meaningful results [26]. Thompson proposed that pragmatic trials in homeopathy could be conducted for menopausal symptoms. Anyway, it might be difficult to elucidate if there is an improvement because of homeopathic medicines effectiveness or due to the whole package of care [26].

The HOMDEP-MENOP study demonstrated the efficacy of IHT for climacteric complaints associated with moderate to severe depression in a RCT. Many women that cannot use hormonal replacement therapy could benefit from homeopathy. However, there are some limitations that require consideration. For example, the HOMDEP-MENOP study did not evaluate the frequency and severity of vasomotor symptoms separately. Hot flushes are one of the most common symptoms in peri- and postmenopause. Approximately, 70% of women could experience them without being depressive, as well as depression could be experienced without vasomotor symptoms [54]. A variety of trial designs in other clinical settings may help capture the value of homeopathic care in this condition, so it could be provide a safe and low cost treatment as part of an integrated approach to managing symptoms of the menopause. In addition, climacteric stage requires a complete study that includes an evaluation of metabolic parameters, cardiovascular symptoms [55], changes in thyroid hormones, among others. Thus, well-designed RCTs should be conducted to prove if homeopathy is also effective for these other disturbances characteristic of peri- and postmenopause.

Fluoxetine was not different from placebo in GS score. This finding also deserves a possible explanation. Because norepinephrine and serotonin are both involved in the development of menopausal symptoms, it is plausible to expect that an agent that is designed to modulate these systems might be effective in reducing the frequency and severity of these symptoms [54]. Carroll et al reported that a growing evidence suggests that SSRIs are effective in the management of hot flushes [56]. Although the SSRIs share a common primary pharmacology, namely the inhibition of serotonin reuptake, their secondary pharmacology is remarkably heterogeneous [57]. Thus, this offers more opportunities to tailor the choice of treatment to the particular circumstances of each woman. Carroll et al concluded that venlafaxine and paroxetine are more consistent in effectively reducing the frequency and severity of vasomotor symptoms based on many studies, and fluoxetine should be considered second or third-line option if patients fail therapy with or cannot tolerate first-line medication [56]. Fluoxetine is a more potent inhibitor of 5-HT2C receptors, which modulate brain norepinephrine and dopamine systems. Therefore, fluoxetine causes activation and weight loss. Fluoxetine has activating properties, and this can lead to problems, such as insomnia and agitation [57]. GS evaluates anxiety in climacteric women, including insomnia, excitability, among other symptoms that are common during menopause. It could be possible that even if fluoxetine improved depression, anxiety, insomnia, agitation, and excitability continued or increased impacting the overall GS score.

In conclusion, IHT and fluoxetine are effective antidepressants for improving depression in climacteric women after a 6-weeks treatment. In the remission definition, IHT and fluoxetine were not different from placebo, so further studies are necessary to prove the effectiveness of IHT in a longer period of time. IHT also improves menopause symptoms according to GS, but well-designed RCTs are required to deeply study the efficacy of homeopathy specifically in climacteric symptoms.

 

Supporting Information

S1 CONSORT Checklist
CONSORT checklist.

(PDF)

Click here for additional data file.(57K, pdf)

S1 Protocol
Trial protocol.

(PDF)

Click here for additional data file.(413K, pdf)

S1 Table
Homeopathic medicines.

(DOCX)

Click here for additional data file.(27K, docx)

Go to:

Acknowledgments

We thank Laboratorio Similia for donating kindly and unconditionally C-potencies, fluoxetine and placebos. Imelda Hernández-Marín, MD, Department of Biology of Reproduction, JMH, who provided technical and medical advice in the study design. We thank Fermin Olivares for the posters and brochure designs; Antonia Herrera-Rivera and Patricia Yañez-Aguilar for helping in the recruitment process. We also thank María Elena Monterde-Coronel, MSc, who provided advertising in the website www.homeopatía.com.

 

Funding Statement

The authors have no support or funding to report.

 

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