MD, PhD, FMedSci, FSB, FRCP, FRCPEd

herbal medicine

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I am pleased to report that my ‘ALTERNATIVE MEDICINE HALL OF FAME’ is growing steadily. So far, this elite club includes:

Gustav Dobos

Claudia Witt

George Lewith

John Licciardone

Time, I think, to elect another member. I was fascinated to read what the COLLEGE OF MEDICINE (I have published about this organisation before, for instance, here) writes about a former co-worker of mine, Simon Mills (those who have read my memoir will know more about him and about my struggle to disassociate me and my work from him and his activities):

Simon Mills is a member of the College of Medicine Council. He is a Cambridge graduate in medical sciences who has since 1977 been a herbal practitioner and natural therapist in Exeter. In that time he has led the main organizations for herbal medicine in the UK (the British Herbal Medicine Association, the College of Practitioners of Phytotherapy, and National Institute of Medical Herbalists) and served on Government and House of Lords committees. Since 1997 he has been Secretary of ESCOP, the lead herbal scientific network in Europe, that produces defining monographs on herbal medicines for the European Medicines Agency. He has also written award-winning seminal herbal medicine textbooks, notably with Kerry Bone the two editions of Principles and Practice of Phytotherapy and the Essential Book of Herbal Safety. He has long been involved in academic work having co-founded the world’s first University centre for complementary health in Exeter (1987), the first integrated health course at a UK medical school at the Peninsula Medical School in Exeter (2000) and the first masters degree programme in herbal medicine in the USA (2001). He has published in many peer-reviewed scientific journals including full clinical trials with herbal medicines, and has supervised 10 successful doctorate theses. Simon is currently building a new role for healthcare practitioners as ‘health guides. With health workbooks, training programmes, community projects and websites.

It was new to me that he has ‘published in many peer-reviewed scientific journals’, so I did a Medline search and found a total of 14 articles. Most of these were comments, letters etc. I decided to identify the first 10 papers that drew some sort of conclusions about the value of alternative therapies. This is what I found (as usual, I have copied the conclusions in bold):

Short-term study on the effects of rosemary on cognitive function in an elderly population.

Pengelly A, Snow J, Mills SY, Scholey A, Wesnes K, Butler LR.

J Med Food. 2012 Jan;15(1):10-7. doi: 10.1089/jmf.2011.0005. Epub 2011 Aug 30.

The positive effect of the dose nearest normal culinary consumption points to the value of further work on effects of low doses over the longer term.

Continuous PC6 wristband acupressure for relief of nausea and vomiting associated with acute myocardial infarction: a partially randomised, placebo-controlled trial.

Dent HE, Dewhurst NG, Mills SY, Willoughby M.

Complement Ther Med. 2003 Jun;11(2):72-7.

Continuous 24-h PC6 acupressure therapy as an adjunct to standard antiemetic medication for post-MI nausea and vomiting is feasible and is well accepted and tolerated by patients. In view of its benefits, further studies are worthwhile using earlier onset of treatment.

Effect of a proprietary herbal medicine on the relief of chronic arthritic pain: a double-blind study.

Mills SY, Jacoby RK, Chacksfield M, Willoughby M.

Br J Rheumatol. 1996 Sep;35(9):874-8.

It is concluded that Reumalex has a mild analgesic effect in chronic arthritis at a level appropriate to self-medication.

Yes, there were just three such papers; perhaps the College of Medicine’s description is just a trifle misleading? As all of these arrived at positive conclusions, I think Mr Mills nevertheless deserves a place in my ALTERNATIVE MEDICINE’S HALL OF FAME.

Many cancer patients use some form of alternative therapy. Most of them combine it with conventional oncological treatments which begs the important question whether the two can interact.

The aim of this new investigation was firstly to assess prevalence of interactions between alternative medicines (AMs) and drugs for comorbidities from a large survey on melanoma patients and secondly to classify herb-drug interactions with regard to their potential to harm. Consecutive melanoma outpatients of seven skin cancer centers in Germany were asked to complete a standardized questionnaire including questions about their AM-use and their taken medication for comorbidities and cancer. Each combination of conventional drugs and AMs was evaluated for their potential of interaction.

1089 questionnaires were eligible for evaluation. From these, 61.6 % of patients reported taking drugs regularly from which 34.4 % used biological-based AMs. Risk evaluation for interaction was possible for 180 AM users who listed the names or substances they took for comorbidities. From those patients, we found 37.2 % at risk of interaction of their co-consumption of conventional drugs and AMs. Almost all patients using Chinese herbs were at risk (88.6 %).

The authors concluded that with a high rate of AM usage at risk of interactions between AMs and drugs taken for comorbidities, implementation of a regular assessment of AM usage and drugs for comorbidities is mandatory in cancer care.

On this blog, I have mentioned this problem repeatedly. For instance, I reported about a survey of 1,500 members of the German non-medically trained practitioner (NMP) associations. Its results showed that the treatments employed by NMPs were heterogeneous. Homeopathy was used by 45% of the NMPs, and 10% believed it to be a treatment directly against cancer. Herbal therapy, vitamins, orthomolecular medicine, ordinal therapy, mistletoe preparations, acupuncture, and cancer diets were used by more than 10% of the NMPs. None of the treatments were discussed with the respective physician on a regular basis. The authors concluded from these findings that many therapies provided by NMPs are biologically based and therefore may interfere with conventional cancer therapy. Thus, patients are at risk of interactions, especially as most NMPs do not adjust their therapies to those of the oncologist. Moreover, risks may arise from these CAM methods as NMPs partly believe them to be useful anticancer treatments. This may lead to the delay or even omission of effective therapies.

One problem regarding herb-drug interactions is that we currently have to rely more on speculations than on facts. The only exception is the issue of interactions with St John’s Wort (SJW). Some time ago, I reported on this blog about a study assessing how often SJW is prescribed with medications that interact dangerously with it. The researchers conducted a retrospective analysis of nationally representative data from the National Ambulatory Medical Care Survey. Twenty-eight percent of SJW visits involved a drug that has a potentially dangerous interaction with SJW. These included selective serotonin reuptake inhibitors, benzodiazepines, warfarin, statins, verapamil, digoxin, and oral contraceptives. The authors concluded that SJW is frequently used in potentially dangerous combinations. Physicians should be aware of these common interactions and warn patients appropriately.

My conclusion at the time is as true and important today: physicians ought to know about the potential of herbal remedies to interact with drugs but, considering the frequency of self-prescription of such treatments, raising  consumers’ awareness of the risks associated with herbal medicines is at least as important.

The ‘ALTERNATIVE MEDICINE SOCIETY’ claims to be a ‘a global network of medical practitioners and contributors who scour the best research and findings from around the world to provide the best advice on alternative, holistic, natural and integrative medicines and treatments for free.’

Sounds great!

They even give advice on ‘7 common diseases you can treat through natural medicine.’ This headline fascinated me, and I decided to have a closer look at what is being recommended there. The following is copied from the website which looks to me as though it was written by a naturopath. My comments appear dispersed in the original text and are in bold.

Despite an exponential research advancement in recent years, we’re finding more and more problems with conventional medicine – from reports of fraud, to terrible medicinal side effects, to bacterial tolerance to antibiotics. Thus, it’s no surprise that more and more people are looking towards more natural medicine for disease management. Many people are seeking solutions which are not only inexpensive, but are also less harmful. Did you know that a lot of the medical conditions suffered by patients today can be adequately treated with natural medicine? Here are seven diseases you can treat through natural medicine:

  1. High blood pressure/hypertension

High blood pressure, or hypertension, is a condition most of us are really familiar with. It’s a risk factor, not a ‘disease’. Defined as the elevation of blood pressure in systemic arteries, hypertension left untreated could lead to serious, possibly fatal complications such as strokes and heart attacks. Conventional treatments for hypertension usually include a cocktail of several drugs (no, good conventional doctors start with life-style advice, if that is not successful, one adds a diruretic, and only if that does not work, one adds a further drug) consisting of vasodilators, alpha/beta blockers, and enzyme inhibitors. However, hypertension can be managed, and altogether avoided with the use of natural medicine. Alternative treatments involve lifestyle changes (e.g. intentionally working out, alcohol intake moderation), dietary measures (e.g. lowering salt intake, choosing healthier food options), and natural medicine (e.g. garlic). As pointed out already, this is the conventional approach! Unfortunately, it often does not work because it is either not sufficiently effective or the patient is non-compliant. Altogether alternative treatments play only a very minor (many experts would say no) role in the management of hypertension.

  1. Arthritis

Arthritis literally translated from Greek, means joint (arthro-) inflammation (-itis). There are two main categories of arthritis: inflammatory and degenerative, and they need to be managed differently. This condition is common in old patients, due to prior dietary choices (diet is not important enough to be mentioned on 1st place), and the natural wearing out of joint structures. Doctors typically prescribe anti-inflammatory drugs (e.g. steroids) to reduce irritation, and pain relievers (e.g. analgesics) for managing the pain. On the other hand, natural medicine could do an equally effective job in treating arthritis, through the use of several herbs such as willow, turmeric, ginger, and capsicum. It is not true that these herbs have been shown to be of equal effectiveness. Research has also shown that lifestyle measures such as weight loss (that would be the advice of conventional doctors), and other natural treatments such as acupuncture (not very effective for degenerative arthritis and ineffective for inflammatory arthritis) and physical therapy (that is conventional medicine), also lessen pain and inflammation in patients. Altogether alternative treatments play only a very minor role in the management of arthritis.

  1. Bronchitis

Bronchitis may be defined as the irritation, or swelling of the bronchial tubes connecting our nasal cavity to our lungs commonly cause by infections or certain allergens (that would be asthma, not bronchitis). Patients with bronchitis typically deal with breathing difficulties, coughing spells, nasal congestion, and fever. There are usual prescriptions for bronchitis, but there are also very effective natural medicine available. Natural medicine include garlic, ginger, turmeric, eucalyptus, Echinacea, and honey. None of these have been shown by good evidence to be ‘very effective’! These herbs may be prepared at home as tonics, tea, or taken as is, acting as anti-microbial agents for fighting off the infections. Altogether alternative treatments play only a very minor role in the management of bronchitis.

  1. Boils

Boils are skin infections which occur as pus-filled pimples in various parts of the body. Despite being highly contagious and painful, boils can easily be treated with natural medicine. Some of the herbs proven to be effective in treating boils include Echinacea, turmeric, garlic, and tea tree oil, due to the presence of natural chemicals which have antibiotic capacities. There is no good evidence to support this claim. Repeated exposure to topical application of these natural medicine is guaranteed to cure your boils in no time. Altogether alternative treatments play only a very minor role in the management of boils.

  1. Eczema

Eczema is also a skin condition resulting from allergic reactions which are typically observed as persistent rashes. The rashes are usually incredibly itchy, showing up in the most awkward places such as the inside of the knees and thighs. Thankfully, eczema can be managed by lifestyle measures (such as avoiding certain foods which elicit allergies – these measures would be entirely conventional and require conventional allergy testing to be effective), and natural medicine. These includes herbal components such as sunflower seed oil, coconut oil, evening primrose oil and chamomile. There is no good evidence to show that these therapies are effective. These natural medicine contain different active ingredients which are not only able to moisturize the affected skin, but are also able to reduce inflammation and soothe itchiness. Altogether alternative treatments play only a very minor role in the management of eczema.

  1. Constipation

Constipation is a normal (??? why should it be normal???) medical condition in which patients are unable to empty bowels at ease. It may be caused by a wide variety of reasons such as bowel stricture, hyperparathyroidism, or simply a case of terrible (???) food choices. However, it can very easily be treated with natural medicine. Some common remedies are molasses, sesame seeds, fiber, ginger or mint tea, lemon water, prunes, castor oil (an old-fashioned and largely obsolete conventional treatment) and coffee (for none of the other treatments is there good evidence). The action of these natural medicine involves laxative effects which stimulate contractions along the colon which incidentally moves your bowels along. Conventional doctors would recommend life-style changes and would warn patients NOT to use laxatives long-term. Altogether alternative treatments play only a very minor role in the management of constipation.

  1. Hay Fever

Allergic rhinitis, as hay fever is also known, are allergic reactions to certain particles like dust or pollen which incite coughing sprees, sneezing spells, and congested sinuses. There are very good natural medicine options for treating hay fever, which contain ingredients which act the same way as your conventional anti-histamine drugs. If they act the same way, what would be their advantage? Some of the natural medicine used to treat hay fever include chamomile, ginger, green, and peppermint teas, as well as butterbur, calendula, and grapefruit. Butterbur is the only one in this list that is supported by some evidence. Altogether alternative treatments play only a very minor role in the management of hay fever.

In essence, none of the 7 ‘diseases’ can be treated effectively with any of the alternative treatments recommended here. ‘The best advice on alternative, holistic, natural and integrative medicines and treatments’, it seems to me, is therefore: AVOID CHARLATANS WHO TELL YOU THAT ALTERNATIVE TREATMENTS ARE MORE EFFECTIVE THAN CONVENTIONAL MEDICINE. 

On this blog, I have repeatedly tried to alert consumers and patients to the risks of herbal medicine. The risks include:

A new paper throws more light on the latter issue which has been not well-studies so far.

The objective of this study was to investigate the relationship between the use of medicinal plants and medication adherence in elderly people. The authors conducted an observational, cross-sectional study of elderly residents in Cuité-PB, Northeastern Brazil, through a household survey. A stratified proportional and systematic random sample of 240 elders was interviewed in their homes and the use of pharmaceutical medicines and of medicinal plants was assessed by direct examination. The association of medication adherence with socio-demographic, clinical, medication and use of medicinal plants was analysed with multiple logistic regression.

The results showed that medication non-adherence increases with use of herbal medicines (adjusted odds ratio 2.022, 95% CI 1.059–3.862, p = 0.03), as well as with the number of different medicinal plants used (adjusted odds ratio 1.937, 95% CI 1.265–2.965, p = 0.002).

The authors concluded that this study provides first-hand evidence that the use of herbal medicines is associated with poor medication adherence. Given the high frequency of the use of herbal medicines, further research into the mechanisms of this association is justified.

This conclusion is well-put, I think. If these findings are confirmed in other populations, we are confronted with a somewhat paradoxical situation: combining herbal and synthetic medicines can reduce adherence to the synthetic drugs and, in cases where adherence is not affected, it could increase the risk of herb/drug interactions.

Don’t get me wrong, I have nothing against systematic reviews. Quite to the contrary, I am sure they are an important source of information for patients, doctors, scientists, policy makers and others – after all, I have published more than 300 of such papers!

Having said that, I do dislike a certain type of systematic review, namely systematic reviews by Chinese authors evaluating TCM therapies and arriving at misleading conclusions. Such papers are currently swamping the marked.

At first glance, they look fine. On closer scrutiny, however, most turn out to be stereotypically useless, boring and promotional. The type of article I mean starts by stating its objective which usually is to evaluate the evidence for a traditional Chinese therapy as a treatment of a condition which few people in their right mind would treat with any form of TCM. It continues with details about the methodologies employed and then, in the results section, informs the reader that x studies were included in the review which mostly reported encouraging results but were wide open to bias. And then comes the crucial bit: THE CONCLUSIONS.

They are as predictable as they are misleading. let me give you two examples only published in the last few days.

The first review drew the following conclusions: This systematic review suggests that Chinese Herbal Medicine as an adjunctive therapy can improve cognitive impairment and enhance immediate response and quality of life in Senile Vascular Dementia patients. However, because of limitations of methodological quality in the included studies, further research of rigorous design is needed.

The second review concluded that the evidence that external application of traditional Chinese medicine is an effective treatment for venous ulcers is encouraging, but not conclusive due to the low methodological quality of the RCTs. Therefore, more high-quality RCTs with larger sample sizes are required.

Why does that sort of thing frustrate me so much? Because it is utterly meaningless and potentially harmful:

  • I don’t know what treatments the authors are talking about.
  • Even if I managed to dig deeper, I cannot get the information because practically all the primary studies are published in obscure journals in Chinese language.
  • Even if I  did read Chinese, I do not feel motivated to assess the primary studies because we know they are all of very poor quality – too flimsy to bother.
  • Even if they were formally of good quality, I would have my doubts about their reliability; remember: 100% of these trials report positive findings!
  • Most crucially, I am frustrated because conclusions of this nature are deeply misleading and potentially harmful. They give the impression that there might be ‘something in it’, and that it (whatever ‘it’ might be) could be well worth trying. This may give false hope to patients and can send the rest of us on a wild goose chase.

So, to ease the task of future authors of such papers, I decided give them a text for a proper EVIDENCE-BASED conclusion which they can adapt to fit every review. This will save them time and, more importantly perhaps, it will save everyone who might be tempted to read such futile articles the effort to study them in detail. Here is my suggestion for a conclusion soundly based on the evidence, not matter what TCM subject the review is about:

OUR SYSTEMATIC REVIEW HAS SHOWN THAT THERAPY ‘X’ AS A TREATMENT OF CONDITION ‘Y’ IS CURRENTLY NOT SUPPORTED BY SOUND EVIDENCE.

The search for an effective treatment of obesity is understandably intense. Many scientists are looking in the plant kingdom for a solution, but so far none has been forthcoming – as we have already discussed on this blog before (e. g. here, and here). One herbal slimming aid is currently becoming popular: Yerba Mate also called Ilex paraguariensis, a plant many of us know from teas and other beverages. Our review concluded that the evidence for it was unconvincing but that it merited further study. This was 10 years ago, and meanwhile the evidence has moved on.

The aim of a recent study was to investigate the efficacy of Yerba Mate supplementation in subjects with obesity. For this purpose, a randomized, double-blind, placebo-controlled trial was conducted. Korean subjects with obesity (body mass index (BMI) ≥ 25 but < 35 kg/m(2) and waist-hip ratio (WHR) ≥ 0.90 for men and ≥ 0.85 for women) were given oral supplements of Yerba Mate capsules (n = 15) or placebos (n = 15) for 12 weeks. They took three capsules per each meal, total three times in a day (3 g/day). Outcome measures were efficacy (abdominal fat distribution, anthropometric parameters and blood lipid profiles) and safety (adverse events, laboratory test results and vital signs).

During 12 weeks of Yerba Mate supplementation, statistically significant decreases in body fat mass and percent body fat compared to the placebo group were noted significant. The WHR was significantly also decreased in the Yerba Mate group compared to the placebo group. No clinically significant changes in any safety parameters were observed.

The authors concluded that Yerba Mate supplementation decreased body fat mass, percent body fat and WHR. Yerba Mate was a potent anti-obesity reagent that did not produce significant adverse effects. These results suggested that Yerba Mate supplementation may be effective for treating obese individuals.

These are encouraging results, but the conclusions go way too far, for my taste. The study was tiny and does therefore not lend itself to far-reaching generalisations. What would be helpful, is a review of other evidence. As it happens, such a paper has just become available. Its authors evaluated the impact of yerba maté on obesity and obesity-related inflammation and demonstrate that yerba maté suppresses adipocyte differentiation as well as triglyceride accumulation and reduces inflammation. Animal studies show that yerba maté modulates signaling pathways that regulate adipogenesis, antioxidant, anti-inflammatory and insulin signaling responses.

The review authors concluded that the use of yerba maté might be useful against obesity, improving the lipid parameters in humans and animal models. In addition, yerba maté modulates the expression of genes that are changed in the obese state and restores them to more normal levels of expression. In doing so, it addresses several of the abnormal and disease-causing factors associated with obesity. Protective and ameliorative effects on insulin resistance were also observed… it seems that yerba maté beverages and supplements might be helpful in the battle against obesity.

I am still not fully convinced that this dietary supplement is the solution to the current obesity epidemic. But the evidence is encouraging – more so than for most of the many other ‘natural’ slimming aids that are presently being promoted for this condition by gurus like Dr Oz.

What we needed now is not the ill-informed, self-interested voice of charlatans; what we need is well-designed research to define efficacy, effect size and risks.

The Nobel Prize committee has just awarded this year’s prize to a Chinese researcher from the Chinese Academy of Traditional Chinese Medicine (TCM) in Beijing. To be precise, the 2015 Nobel Prize in Physiology or Medicine was given jointly to three scientists from three different institutions, William C. Campbell, Satoshi Ōmura and Youyou Tu, for their work on new anti-malaria drugs. A small excerpt from the press-release of the committee tells us more about the possibility of a TCM connection:

Malaria was traditionally treated by chloroquine or quinine, but with declining success. By the late 1960s, efforts to eradicate Malaria had failed and the disease was on the rise. At that time, Youyou Tu in China turned to traditional herbal medicine to tackle the challenge of developing novel Malaria therapies. From a large-scale screen of herbal remedies in Malaria-infected animals, an extract from the plant Artemisia annua emerged as an interesting candidate. However, the results were inconsistent, so Tu revisited the ancient literature and discovered clues that guided her in her quest to successfully extract the active component from Artemisia annua. Tu was the first to show that this component, later called Artemisinin, was highly effective against the Malaria parasite, both in infected animals and in humans (Figure 4). Artemisinin represents a new class of antimalarial agents that rapidly kill the Malaria parasites at an early stage of their development, which explains its unprecedented potency in the treatment of severe Malaria.

One does not have to be a clairvoyant to predict that this event will now be celebrated by TCM fans as a vindication of TCM. But is this justified?

The antifebrile effect of the Chinese herb Artemisia annua (qinghaosu 青蒿素), or sweet wormwood, has been known 1,700 years ago. Tu was the first to extract the biologically active component of the herb, Artemisinin, and discover how it worked. As a result, Artemisinin could be studied and tested for efficacy. Fortunately these tests turned out positive, and subsequently Artemisinin could be produced on a large scale and made available for those who needed it.

Tu’s achievements are huge, and I do unreservedly and enthusiastically applaud her for getting this prestigious award. But is it an award for TCM?

No!

One could even argue that Tu showed how insufficient TCM can be. Artemisia was not used for malaria in TCM, it was used to lower fever. In fact, the whole plant extract shows not enough activity to be effective for malaria. It was not employed to treat a disease but to ease a symptom. TCM physicians had no idea what malaria was, what its cause was, or how it should be treated effectively. It needed a skilled scientist, modern scientific tools and systematic research to make these discoveries.

So, what does this episode really tell us?

Amongst other things,I think, it shows that medicine is open to discoveries regardless where they come from, that experience alone is normally insufficient to make progress, that China has some good scientists who can do amazing work, that plants contain millions of interesting molecules of which some might be therapeutic, that tenacity and skill is usually required to make an important break-through… WHAT IS DOES NOT SHOW, HOWEVER, IS THAT THE MERITS OF TCM HAVE BEEN AKNOWLEDGED BY A NOBEL PRIZE.

Proponents of alternative medicine regularly stress the notion that their treatments are either risk-free or much safer than conventional medicine. This assumption may be excellent for marketing bogus treatments, however, it neglects that even a relatively harmless therapy can become dangerous, if it is ineffective. Here is yet again a tragic reminder of this undeniable fact.

Japanese doctors reported the case of 2-year-old girl who died of precursor B-cell acute lymphoblastic leukaemia (ALL), the most common cancer in children.

She had no remarkable medical history. She was transferred to a hospital because of respiratory distress and died 4 hours after arrival. Two weeks before her death, she had developed a fever of 39 degrees C, which subsided after the administration of a naturopathic herbal remedy. One week before death, she developed jaundice, and her condition worsened on the day of death.

Laboratory test results on admission to hospital showed a markedly elevated white blood cell count. Accordingly, the cause of death was suspected to be acute leukaemia. Forensic autopsy revealed the cause of death to be precursor B-cell ALL.

With the current advancements in medical technology, the 5-year survival rate of children with ALL is nearly 90%. However, in this case, the child’s parents had opted for naturopathy instead of evidence-based medicine. They had not taken her to a hospital for a medical check-up or immunisation since she was an infant. If the child had received routine medical care, she would have a more than 60% chance of being alive 5 years after diagnosis of ALL.

The authors of this case-report concluded that the parents should be accused of medical neglect regardless of their motives.

Such cases are tragic and infuriating in equal measure. There is no way of knowing how often this sort of thing happens; we rely entirely on anecdotes because systematic research is hardly feasible.

While anecdotes of this nature have their obvious limitations, they are nevertheless important. They can serve as poignant reminders that alternative remedies might be relatively harmless, but this does not necessarily apply to all alternative practitioners. Moreover, they should make us redouble our efforts to inform the public responsibly about the all too often trivialized risks of alternative medicine.

This post is dedicated to all homeopathic character assassins.

Some ardent homeopathy fans have reminded me that, some 25  years ago, I published (OH, WHAT A SCANDAL!!!) a positive trial of homeopathy; I even found a website that proudly announces this fact. Homeopaths seem jubilant about this discovery (not because they now need to revise their allegations that I never did any trials; or the other, equally popular claim, that I have always been squarely against their trade but) because the implication is that even I have to concede that homeopathic remedies are better than placebo. In their view, this seems to beg the following important and embarrassing questions:

  • Why did I change my mind?
  • Am I not contradicting myself?
  • Who has bribed me?
  • Am I in the pocket of Big Pharma?
  • Does this ‘skeleton in my closet’ discredit me for all times?

I remember the trial in question quite well. We conducted it during my time in Vienna, and I am proud of several innovative ideas that went into it. Here is the abstract in full:

The aim of this study was to test the effectiveness of a combined homeopathic medication in primary varicosity. A well-defined population of 61 patients was randomized into active medication (Poikiven®) or placebo. Both were given for 24 d. At the start of the trial, after 12 d medication and at the end of the study, objective and subjective parameters were recorded: venous filling time, leg volume, calf circumference, haemorheological measurements and patients’ symptoms such as cramps, itching, leg heaviness, pain during standing and the need to elevate the legs. The results show that venous filling time is changed by 44% towards normal in the actively-treated group. The average leg volume fell significantly more in this group, but calf circumferences did not change significantly and blood rheology was not altered in any relevant way. None of the patients reported side-effects. Subjective complaints were relieved significantly more by Poikiven than by placebo. These results suggest that the oral treatment of primary varicosity using Poikiven is feasible.

So, there we have it: a homeopathic remedy (as tested by me) is clearly better than placebo normalising important objective parameters as well as subjective symptoms of varicose veins. Is that not a contradiction of what I keep saying today, namely that homeopathy is a placebo therapy?

YES AND NO! (But much more NO than YES)

Yes, because that was clearly our result, and I never tried to deny it.

No, because our verum was far from being a homeopathic, highly diluted remedy. It contained Aesculus D1 12,5 ml, Arnica D1 2,5 ml, Carduus marianus D1 5 ml, Hamamelis D1 10 ml, Lachesis D6 5 ml, Lycopodium D4 5 ml, Melilotus officinalis D1 10 ml. Take just the first of these ingredients, Aesculus or horse chestnut. This is a herbal medicine that has been well documented (even via a Cochrane review) to be effective for the symptoms of varicose veins, and it contains Aesculus in the D1 potency. This means that it is diluted merely by a factor of 1:10. So, for all intents and purposes, our verum was herbal by nature, and there is no surprise at all that we found it to be effective.

[Here is a little ‘aside’: Aesculus is a proven treatment for varicose veins. Homeopathy must always rely on the ‘like cures like’ principle. Therefore, if Aesculus had been used in the homeopathic way, would it not, according to homeopathic dogma, had to worsen the symptoms of our patients rather than alleviating them?]

All of this would be trivial to the extreme, if it did not touch upon an important and confusing point which is often used as an ‘escape route’ by homeopaths when they find themselves between a rock and a hard place. Some trials of homeopathy are positive because they use medications which are homeopathic only by name. This regularly creates considerable confusion. In the recent BMJ debate I tried to address this issue head on by stating at the outset: ” Nobody questions, of course, that some substances used in homeopathy, such as arsenic or strychnine, can be pharmacologically active, but homeopathic medicines are typically far too dilute to have any effect.”

And that’s the point: homeopathic remedies beyond a C12 potency contain nothing, less dilute ones contain little to very little, and D1 potencies are hardy diluted at all and thus contain substantial amounts of active ingredients. Such low potencies are rarely used by homeopaths and should be called PSEUDO-HOMEOPATHIC, in my view. Homeopaths tend to use this confusing complexity to wriggle out of difficult arguments, and often they rely on systematic reviews of homeopathic trials which can generate somewhat confusing overall findings because of such PSEUDO-HOMEOPATHIC remedies.

To make it perfectly clear: the typical homeopathic remedy is far too dilute to have any effect. When scientists or the public at large speak of homeopathic remedies, we don’t mean extracts of Aesculus or potent poisons like Arsenic D1 (has anyone heard of someone claiming to have killed rats with homeopathy?); we refer to the vast majority of remedies which are highly dilute and contain no or very few active molecules – even when we do not explain this somewhat complicated and rather tedious circumstance each and every time. I therefore declare once and for all that, unless I indicate otherwise, I do NOT mean potencies below C6 when I speak of a ‘homeopathic remedy’ (sorry homeopathy fans, perhaps I should have done this when I started this blog).

What if our Vienna study all those years ago had tested not the pseudo-homeopathic ‘Poikiven’ but a highly dilute, real homeopathic remedy and had still come up with a positive finding? Would that make me inconsistent, dishonest, untrustworthy or corrupt? Certainly not!

I have always urged people to not go by the results of single trials. There are numerous reasons why a single study can produce a misleading result. We should therefore, wherever possible, rely on systematic reviews that critically evaluate the totality of the evidence (I would always mistrust even my own trial data, if it contradicted the totality of the reliable evidence) – and such analyses clearly fail to show that homeopathy is more than a placebo.

And even, if none of this had happened, and I had just changed my mind about homeopathy because

  • the evidence changed,
  • I had become wiser,
  • I had learnt how to think like a scientist,
  • I had managed to see behind the smokescreen many homeopaths put up to hide the truth?

Would that discredit me? I don’t think so! As someone once said, being able to change one’s mind is a sign of intelligence.

I am sure that the weird world of homeopathic character assassination will soon find something else to discredit me – but for now…

I REST MY CASE.

Lots of alternative therapies are advocated for migraine. Few of them are supported by good evidence. An exception could be the herbal remedy FEVERFEW.

This review is an update of a previously published review in the Cochrane Database of Systematic Reviews on ‘Feverfew for preventing migraine’. Feverfew (Tanacetum parthenium L.) extract is a herbal remedy, which has been used for preventing attacks of migraine. Our aim was to systematically review the evidence from double-blind, randomised, clinical trials (RCTs) assessing the clinical efficacy and safety of feverfew monopreparations versus placebo for preventing migraine.

For this updated version of the review we searched CENTRAL, MEDLINE, EMBASE and AMED to January 2015. We contacted manufacturers of feverfew and checked the bibliographies of identified articles for further trials.

We included randomised, placebo-controlled, double-blind trials assessing the efficacy of feverfew monopreparations for preventing migraine in migraine sufferers of any age. We included trials using clinical outcome measures, while we excluded trials focusing exclusively on physiological parameters. There were no restrictions regarding the language of publication.

We systematically extracted data on patients, interventions, methods, outcome measures, results and adverse events. We assessed risk of bias using the Cochrane ‘Risk of bias’ tool and evaluated methodological quality using the Oxford Quality Scale developed by Jadad and colleagues. Two review authors independently selected studies, assessed methodological quality and extracted data. We resolved disagreements concerning evaluation of individual trials through discussion.

We identified one new study for this update, resulting in a total of 6 trials (561 patients) meeting the inclusion criteria. Five of the 6 trials reported on the main outcome measure which was migraine frequency. Although 5 of the trials were generally of good methodological quality, all studies were either of unclear or high risk of bias with regards to sample size. Pooled analysis of the results was not possible due to the lack of common outcome measures and heterogeneity between studies in terms of participants, interventions and designs. The most recent trial added to this update was rigorous and larger (n = 218) than previous studies. It used a stable feverfew extract at a dose determined by a previous dose-finding trial. It reported that feverfew reduced migraine frequency by 1.9 attacks from 4.8 to 2.9 and placebo by 1.3 from to 4.8 to 3.5 per month. This difference in effect between feverfew and placebo was thus 0.6 attacks per month. For the secondary outcome measures such as intensity and duration of migraine attacks, incidence and severity of nausea and vomiting, and global assessment no statistically significant differences between feverfew and placebo were reported.

The results of previous trials were not convincing: three trials reporting positive effects of feverfew were all of small sample size (17 to 60 participants), while two rigorous trials (n = 50, 147) did not find significant differences between feverfew and placebo.

Only mild and transient adverse events of feverfew, most commonly gastrointestinal complaints and mouth ulcers, were reported in the included trials.

We concluded that, since the last version of this review, one larger rigorous study has been included, reporting a difference in effect between feverfew and placebo of 0.6 attacks per month. This adds some positive evidence to the mixed and inconclusive findings of the previous review. However, this constitutes low quality evidence, which needs to be confirmed in larger rigorous trials with stable feverfew extracts and clearly defined migraine populations before firm conclusions can be drawn. It appears from the data reviewed that feverfew is not associated with any major safety concerns.

So, good or bad news for migraine sufferers? I suppose it depends on whether you are an optimist or a pessimist. I would say that, considering the mostly bad news about alternative medicine for migraine, it is relative good news: patients who want to try something ‘natural’ could do so, particularly in view of the lack of serious risks.

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