MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

methodology

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This systematic review aimed to identify and explore published studies on the health, wellbeing and economic impact of retreat experiences. Three electronic databases were searched for residential retreat studies published in English. Studies were included, if they involved an intervention program in a residential setting of one or more nights, and included before-and-after data related to the health of participants.

A total of 23 studies including 8 randomised controlled trials, 6 non-randomised controlled trials and 9 longitudinal cohort studies met the inclusion criteria. These studies included a total of 2592 participants from diverse geographical and demographic populations and a great heterogeneity of outcome measures, with 7 studies examining objective outcomes such as blood pressure or biological makers of disease, and 16 studies examining subjective outcomes that mostly involved self-reported questionnaires on psychological and spiritual measures.

All studies reported post-retreat health benefits ranging from immediately after to five-years post-retreat. Study populations varied widely and most studies had small sample sizes, poorly described methodology and little follow-up data, and no studies reported on health economic outcomes or adverse effects, making it difficult to make definite conclusions about specific conditions, safety or return on investment.

The authors concluded that health retreat experiences appear to have health benefits that include benefits for people with chronic diseases such as multiple sclerosis, various cancers, HIV/AIDS, heart conditions and mental health. Future research with larger numbers of subjects and longer follow-up periods are needed to investigate the health impact of different retreat experiences and the clinical populations most likely to benefit. Further studies are also needed to determine the economic benefits of retreat experiences for individuals, as well as for businesses, health insurers and policy makers.

In the article, the authors also state that the findings from the reviewed studies suggest there are many positive health benefits from retreat experiences that includes improvements in both subjective and objective measures… The results from the most rigorous studies that used randomized controlled designs were consistent with less rigorous studies and suggest that retreat experiences can produce benefits that include positive changes in metabolic and neurological pathways, loss of weight, blood pressure and abdominal girth, reduction in health symptoms and improvements in quality of life and subjective wellbeing.

As it happens, we have discussed one of their ‘most rigorous’ RCTs on this blog. Here is what I wrote about it when it was first published:

The ‘study‘ in question allegedly examined the effects of a comprehensive residential mind–body program on well-being. The authors describe it as “a quasi-randomized trial comparing the effects of participation in a 6-day Ayurvedic system of medicine-based comprehensive residential program with a 6-day residential vacation at the same retreat location.” They included 69 healthy women and men who received the Ayurvedic intervention addressing physical and emotional well-being through group meditation and yoga, massage, diet, adaptogenic herbs, lectures, and journaling. Key components of the program include physical cleansing through ingestion of herbs, fiber, and oils that support the body’s natural detoxification pathways and facilitate healthy elimination; two Ayurvedic meals daily (breakfast and lunch) that provide a light plant-based diet; daily Ayurvedic oil massage treatments; and heating treatments through the use of sauna and/or steam. The program includes lectures on Ayurvedic principles and lifestyle as well as lectures on meditation and yoga philosophy. The study group also participated in twice-daily group meditation and daily yoga and practiced breathing exercises (pranayama) as well as emotional expression through a process of journaling and emotional support. During the program, participants received a 1-hour integrative medical consultation with a physician and follow-up with an Ayurvedic health educator.

The control group simply had a vacation without any of the above therapies in the same resort. They were asked to do what they would normally do on a resort vacation with the additional following restrictions: they were asked not to engage in more exercise than they would in their normal lifestyle and to refrain from using La Costa Resort spa services. They were also asked not to drink ginger tea or take Gingko biloba during the 2 days before and during the study week.

Recruitment was via email announcements on the University of California San Diego faculty and staff and Chopra Center for Wellbeing list-servers. Study flyers stated that the week-long Self-Directed Biological Transformation Initiative (SBTI) study would be conducted at the Chopra Center for Wellbeing, located at the La Costa Resort in Carlsbad, California, in order to learn more about the psychosocial and physiologic effects of the 6-day Perfect Health (PH) Program compared with a 6-day stay at the La Costa Resort. The study participants were not blinded, and site investigators and study personnel knew to which group participants were assigned.

Participants in the Ayurvedic program showed significant and sustained increases in ratings of spirituality and gratitude compared with the vacation group, which showed no change. The Ayurvedic participants also showed increased ratings for self-compassion as well as less anxiety at the 1-month follow-up.

The authors arrived at the following conclusion: Findings suggest that a short-term intensive program providing holistic instruction and experience in mind–body healing practices can lead to significant and sustained increases in perceived well-being and that relaxation alone is not enough to improve certain aspects of well-being.

This ‘study’ had ethical approval from the University of California San Diego and was supported by the Fred Foundation, the MCJ Amelior Foundation, the National Philanthropic Trust, the Walton Family Foundation, and the Chopra Foundation. The paper’s first author is director of research at the Chopra Foundation… Just for the record, let me formulate a short conclusion that actually fits the data from this ‘study’: Lots of TLC, attention and empathy does make some people feel better… 

END OF QUOTE FROM MY OWN POST

The subject of health retreats could be relevant and important. Educating people and teaching them the essentials about healthy life-styles is potentially a good thing. It could well turn out that health retreats benefit many individuals, while saving money for society.

Yet, do we need all sorts of quackery for achieving this aim?

No, we don’t!

A rational programme would need to teach and motivate people about diet, weight control, smoking cessation, regular sleep, relaxation, exercise, etc. It could prevent disease and save funds. This approach has existed in Europe long before the US ‘New Agers’ with their flimflam jumped on this bandwagon. Health education is a good idea, but it does not require the use of alternative therapies or luxury retreats.

As it turns out, the new systematic review is a disappointment. It fails to stress that no firm conclusions can be drawn from flimsy data and degenerates into little more than an embarrassing advertisement for Deepak Chopra’s and similar entrepreneurs’ money-making retreats. It totally ignores the sizable body of Non-English literature on the subject, and is focussed on promoting fashionable retreats and wellness centres in the US and Australia.

To be fair to the authors, they almost admit as much when they state: “Competing interests: MC is a board member of the Global Wellness Summit and has previously been a paid presenter at the Gwinganna Health Retreat. RMIT University has received donations from Danubius Hotel Group, Lapinha, Sunswept Resorts, Sheenjoy and The Golden Door for ongoing retreat research.”

I rest my case.

Can conventional therapy (CT) be combined with herbal therapy (CT + H) in the management of Alzheimer’s disease (AD) to the benefit of patients? This was the question investigated by Chinese researchers in a recent retrospective cohort study funded by grants from China Ministry of Education, National Natural Science Foundation of China, Beijing Municipal Science and Technology Commission, and Beijing Municipal Commission of Health and Family Planning.

In total, 344 outpatients diagnosed as probable dementia due to AD were collected, who had received either CT + H or CT alone. The GRAPE formula was prescribed for AD patients after every visit according to TCM theory. It consisted mainly (what does ‘mainly’ mean as a description of a trial intervention?) of Ren shen (Panax ginseng, 10 g/d), Di huang (Rehmannia glutinosa, 30 g/d), Cang pu (Acorus tatarinowii, 10 g/d), Yuan zhi (Polygala tenuifolia, 10 g/d), Yin yanghuo (Epimedium brevicornu, 10 g/d), Shan zhuyu (Cornus officinalis, 10 g/d), Rou congrong (Cistanche deserticola, 10 g/d), Yu jin (Curcuma aromatica, 10 g/d), Dan shen (Salvia miltiorrhiza, 10 g/d), Dang gui (Angelica sinensis, 10 g/d), Tian ma (Gastrodia elata, 10 g/d), and Huang lian (Coptis chinensis, 10 g/d), supplied by Beijing Tcmages Pharmaceutical Co., LTD. Daily dose was taken twice and dissolved in 150 ml hot water each time. Cognitive function was quantified by the mini-mental state examination (MMSE) every 3 months for 24 months.

The results show that most of the patients were initially diagnosed with mild (MMSE = 21-26, n = 177) and moderate (MMSE = 10-20, n = 137) dementia. At 18 months, CT+ H patients scored on average 1.76 (P = 0.002) better than CT patients, and at 24 months, patients scored on average 2.52 (P < 0.001) better. At 24 months, the patients with improved cognitive function (△MMSE ≥ 0) in CT + H was more than CT alone (33.33% vs 7.69%, P = 0.020). Interestingly, patients with mild AD received the most robust benefit from CT + H therapy. The deterioration of the cognitive function was largely prevented at 24 months (ΔMMSE = -0.06), a significant improvement from CT alone (ΔMMSE = -2.66, P = 0.005).

 

The authors concluded that, compared to CT alone, CT + H significantly benefited AD patients. A symptomatic effect of CT + H was more pronounced with time. Cognitive decline was substantially decelerated in patients with moderate severity, while the cognitive function was largely stabilized in patients with mild severity over two years. These results imply that Chinese herbal medicines may provide an alternative and additive treatment for AD.

Conclusions like these render me speechless – well, almost speechless. This was nothing more than a retrospective chart analysis. It is not possible to draw causal conclusions from such data.

Why?

Because of a whole host of reasons. Most crucially, the CT+H patients were almost certainly a different and therefore non-comparable population to the CT patients. This flaw is so elementary that I need to ask, who are the reviewers letting such utter nonsense pass, and which journal would publish such rubbish? In fact, I can be used for teaching students why randomisation is essential, if we aim to find out about cause and effect.

Ahhh, it’s the ! I think the funders, editors, reviewers, and authors of this paper should all go and hide in shame.

We have discussed the NHMRC report on homeopathy several times – see, for instance, here, here and here. Perhaps understandably, homeopaths have great difficulties accepting its negative findings, and have complained about it ever since it was published. Now, a very detailed and well-researched analysis has become available of both the report and its criticism. Here I take the liberty to copy and (clumsily) translate its conclusions; if you can read German, I highly recommend studying the full document.

START OF MY TRANSLATION

The criticism of the NHMRC review is very voluminous and highlights many different aspects of the background, the methodology, the execution and the unwanted results from a homeopathic perspective. The very engaging discussions in the general public about this document and its flaws are, however, relatively meaningless: the NHMRC arrives at exactly the same conclusions as the employee of the Homeopathic Research Institute (HRI), Mathie, in his reviews of 2014 and 2017.

In both reviews, Mathie evaluated a total of 107 primary studies and found only 2 trials that could be rated as qualitatively good, that is to say constituting reliable evidence. Mathie did upgrade 2 further studies to the category of reliable evidence, however, this was in violation of the procedures proscribed in the study protocol.

The criticism of the NHMRC review was not able to make a single valid rebuttal. No condition could be identified for which homeopathy is clearly superior to placebo. This is all the more important, as Mathie avoided the mistakes that constituted the most prominent alleged criticisms of the NHMRC report.

  • Since Mathie and most of his co-authors are affiliated with organisations of homeopathy, an anti-homeopathy bias can be excluded.
  • Mathie conducted classic reviews and even differentiated between individualised and non-individualised homeopathy.
  • Mathie did not exclude studies below a certain sample size.

Yet, in both reviews, he draws the same conclusion.

In view of the truly independent replications of an employee of the HRI, we can be sure that there are, in fact, no solid proofs for the effectiveness of homeopathy. The claim of a  strong efficacy, equivalent to conventional medicines, that is made by homeopathy’s advocates is therefore not true.

END OF MY TRANSLATION

And here is the original German text:

Die Kritik an dem Review des NHMRC ist sehr umfangreich und beleuchtet sehr viele verschiedene Facetten über das Umfeld, die Methodik und die Durchführung sowie das aus Sicht der Homöopathen unerwünschte Ergebnis selbst. Die in der Öffentlichkeit sehr engagierte Diskussion um diese Arbeit und ihre möglichen Unzulänglichkeiten sind jedoch relativ bedeutungslos: Das NHMRC kommt zu genau dem gleichen Ergebnis wie Mathie als Mitarbeiter des HRI in seinen in 2014 und 2017 veröffentlichten systematischen Reviews:

Insgesamt hat Mathie in beiden Reviews 107 Einzelstudien untersucht und fand nur zwei Studien, die als qualitativ gut („low risk of bias“), also als zuverlässige Evidenz betrachtet werden können. Mathie hat zwar vier weitere Studien zur zuverlässigen Evidenz aufgewertet, was allerdings im Widerspruch zu den üblichen Vorgehensweisen steht und im Studienprotokoll nicht vorgesehen war.

Die Kritik am Review des NHMRC hat keinen einzigen Punkt fundiert widerlegen können. Man konnte keine Indikation finden, bei der sich die Homöopathie als klar über Placebo hinaus wirksam erwiesen hätte. Diese Punkte sind umso bedeutsamer, weil Mathie die am NHMRC hauptsächlich kritisierten Fehler nicht gemacht hat:

  • Als Mitarbeiter des HRI und mit Autoren, die überwiegend für Homöopathie-affine Organisationen arbeiten, ist eine Voreingenommenheit gegen die Homöopathie auszuschließen.
  • Mathie hat klassische Reviews ausgeführt, sogar getrennt zwischen einzelnen Ausprägungen (individualisierte Homöopathie und nicht-individualisierte Homöopathie).
  • Mathie hat keine Größenbeschränkung der Studien berücksichtigt.

Er kommt aber dennoch zweimal zum gleichen Ergebnis wie das NHMRC.

Angesichts der wirklich als unabhängig anzusehenden Bestätigung der Ergebnisse des NHMRC durch einen Mitarbeiter des Homeopathy Research Institute kann man sicher davon ausgehen, dass es tatsächlich keine belastbaren Wirkungsnachweise für die Homöopathie gibt und dass die von ihren Anhängern behauptete starke, der konventionellen Medizin gleichwertige oder gar überlegene Wirksamkeit der Homöopathie nicht gegeben ist.

I do apologise for my clumsy translation and once again encourage those who can to study the detailed original in full.

My conclusion of this (and indeed of virtually all criticism of homeopathy) is that homeopaths are just as unable to accept criticism as an evangelic believer is going to accept any rational argument against his belief. In other words, regardless of how convincing the evidence, homeopaths will always dismiss it – or, to put it in a nutshell: HOMEOPATHY IS A CULT.

In 2017, Medline listed just over 1800 articles on ‘complementary alternative medicine’. If you find this number impressively high, consider that, for ‘surgery’ (a subject that has often been branded as less that active in conducting research), there were almost 18 000 Medline-listed papers.

So, the research activity in CAM is relatively small. Vis a vis the plethora of open questions, this inactivity is perhaps lamentable. What I find much more regrettable, however, is the near total lack of investigations into the ethical issues in CAM. In 2017, there were just 11 articles on Medline on ‘ethics and CAM’ (24393 articles on ‘ethics and surgery’).

One of the 11 papers that tackled the ethics directly and that was (in my opinion) one of the best is this article. Here is its concluding paragraph:

When we encounter patients who use or consider the use of complementary and/or alternative medicine, we should respect their autonomy while also fulfilling our obligations of beneficence and nonmaleficence. Physicians should become more knowledgeable about research on CAM therapies and approach discussions in an open, nonjudgmental manner to enhance patient trust. In situations where there is little risk of harm and the possibility of benefit, supporting a patient in their interest in complementary therapies can strengthen the patient-physician relationship. However, when a patient’s desire to utilize alternative therapies poses a health risk, physicians have the ethical obligation to skillfully counsel the patient toward those therapies that are medically appropriate.

I have had a long-lasting and keen interest in the ethics of CAM which resulted in the publication of many papers. Here is a selection:

Problems with ethical approval and how to fix them: lessons from three trials in rheumatoid arthritis.

‘Complementary & Alternative Medicine’ (CAM): Ethical And Policy Issues.

Pharmacists and homeopathic remedies.

No obligation to report adverse effects in British complementary and alternative medicine: evidence for double standards.

Homeopathy, a “helpful placebo” or an unethical intervention?

Advice offered by practitioners of complementary/ alternative medicine: an important ethical issue.

The ethics of British professional homoeopaths.

Evidence-based practice in British complementary and alternative medicine: double standards?

Ethics of complementary medicine: practical issues.

The ethics of chiropractic.

Reporting of ethical standards: differences between complementary and orthodox medicine journals?

Informed consent: a potential dilemma for complementary medicine.

Ethical problems arising in evidence based complementary and alternative medicine.

Complementary medicine: implications for informed consent in general practice.

Ethics and complementary and alternative medicine.

Research ethics questioned in Qigong study.

Informed consent in complementary and alternative medicine.

The ethics of complementary medicine.

For most of the time conducting this research, I felt that I was almost alone in realising the importance of this topic. And all this time, I was convinced that the subject needed more attention and recognition. Therefore, I teamed up with with the excellent ethicist Kevin Smith from the University of Dundee, and together we spent the best part of 2017 writing about it.

Our book is entitled ‘MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE’ and will be published shortly by Springer.

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It is an attempt to highlight some of the most important topics in this broad and under-researched area. While working on it, I was continually struck by the fact that most of the issues we have been struggling with on this blog are, in the final analysis, ethical by nature.

My hope is that, in 2018, we will see many more high quality papers filling the almost total void of ethical perspectives on CAM. In my view, it is unquestionably an area that needs to be addressed with some urgency.

A comprehensive review of the evidence relating to acupuncture entitled “The Acupuncture Evidence Project: A Comparative Literature Review” has just been published. The document aims to provide “an updated review of the literature with greater rigour than was possible in the past.” That sounds great! Let’s see just how rigorous the assessment is.

The review was conducted by John McDonald who no stranger to this blog; we have mentioned him here, for instance. To call him an unbiased, experienced, or expert researcher would, in my view, be more than a little optimistic.

The review was financed by the ‘Australian Acupuncture and Chinese Medicine Association Ltd.’ – call me a pessimist, but I do wonder whether this bodes well for the objectivity of the findings.

The research seems to have been assisted by a range of experts: Professor Caroline Smith, National Institute of Complementary Medicine, Western Sydney University, provided advice regarding evidence levels for assisted reproduction trials; Associate Professor Zhen Zheng, RMIT University identified the evidence levels for postoperative nausea and vomiting and post-operative pain; Dr Suzanne Cochrane, Western Sydney University; Associate Professor Chris Zaslawski, University of Technology Sydney; and Associate Professor Zhen Zheng, RMIT University provided prepublication commentary and advice. I fail to see anyone in this list who is an expert in EBM or who is even mildly critical of acupuncture and the many claims that are being made for it.

The review has not been published in a journal. This means, it has not been peer-reviewed. As we will see shortly, there is reason to doubt that it could pass the peer-review process of any serious journal.

There is an intriguing declaration of conflicts of interest: “Dr John McDonald was a co-author of three of the research papers referenced in this review. Professor Caroline Smith was a co-author of six of the research papers referenced in this review, and Associate Professor Zhen Zheng was co-author of one of the research papers in this review. There were no other conflicts of interest.” Did they all forget to mention that they earn their livelihoods through acupuncture? Or is that not a conflict?

I do love the disclaimer: “The authors and the Australian Acupuncture and Chinese Medicine Association Ltd (AACMA) give no warranty that the information contained in this publication and within any online updates available on the AACMA website are correct or complete.” I think they have a point here.

But let’s not be petty, let’s look at the actual review and how well it was done!

Systematic reviews must first formulate a precise research question, then disclose the exact methodology, reveal the results and finally discuss them critically. I am afraid, I miss almost all of these essential elements in the document in question.

The methods section includes statements which puzzle me (my comments are in bold):

  • A total of 136 systematic reviews, including 27 Cochrane systematic reviews were included in this review, along with three network meta-analyses, nine reviews of reviews and 20 other reviews. Does that indicate that non-systematic reviews were included too? Yes, it does – but only, if they reported a positive result, I presume.
  • Some of the included systematic reviews included studies which were not randomised controlled trials. In this case, they should have not been included at all, in my view.
  • … evidence from individual randomised controlled trials has been included occasionally where new high quality randomised trials may have changed the conclusions from the most recent systematic review. ‘Occasionally’ is the antithesis of systematic. This discloses the present review as being non-systematic and therefore worthless.
  • Some systematic reviews have not reported an assessment of quality of evidence of included trials, and due to time constraints, this review has not attempted to make such an assessment. Say no more!

It is almost needless to mention that the findings (presented in a host of hardly understandable tables) suggest that acupuncture is of proven or possible effectiveness/efficacy for a very wide array of conditions. It also goes without saying that there is no critical discussion, for instance, of the fact that most of the included evidence originated from China, and that it has been shown over and over again that Chinese acupuncture research never seems to produce negative results.

So, what might we conclude from all this?

I don’t know about you, but for me this new review is nothing but an orgy in deceit and wishful thinking!

A new acupuncture study puzzles me a great deal. It is a “randomized, double-blind, placebo-controlled pilot trial” evaluating acupuncture for cancer-related fatigue (CRF) in lung cancer patients. Twenty-eight patients presenting with CRF were randomly assigned to active acupuncture or placebo acupuncture groups to receive acupoint stimulation at LI-4, Ren-6, St-36, KI-3, and Sp-6 twice weekly for 4 weeks, followed by 2 weeks of follow-up. The primary outcome measure was the change in intensity of CFR based on the Chinese version of the Brief Fatigue Inventory (BFI-C). The secondary endpoint was the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS). Adverse events were monitored throughout the trial.

A significant reduction in the BFI-C score was observed at 2 weeks in the 14 participants who received active acupuncture compared with those receiving the placebo. At week 6, symptoms further improved. There were no significant differences in the incidence of adverse events of the two group.

The authors, researchers from Shanghai, concluded that fatigue is a common symptom experienced by lung cancer patients. Acupuncture may be a safe and feasible optional method for adjunctive treatment in cancer palliative care, and appropriately powered trials are warranted to evaluate the effects of acupuncture.

And why would this be puzzling?

There are several minor oddities here, I think:

  • The first sentence of the conclusion is not based on the data presented.
  • The notion that acupuncture ‘may be safe’ is not warranted from the study of 14 patients.
  • The authors call their trial a ‘pilot study’ in the abstract, but refer to it as an ‘efficacy study’ in the text of the article.

But let’s not be nit-picking; these are minor concerns compared to the fact that, even in the title of the paper, the authors call their trial ‘double-blind’.

How can an acupuncture-trial be double-blind?

The authors used the non-penetrating Park needle, developed by my team, as a placebo. We have shown that, indeed, patients can be properly blinded, i. e. they don’t know whether they receive real or placebo acupuncture. But the acupuncturist clearly cannot be blinded. So, the study is clearly NOT double-blind!

As though this were not puzzling enough, there is something even more odd here. In the methods section of the paper the authors explain that they used our placebo-needle (without referencing our research on the needle development) which is depicted below.

Park Sham Device Set

Then they state that “the device is placed on the skin. The needle is then gently tapped to insert approximately 5 mm, and the guide tube is then removed to allow sufficient exposure of the handle for needle manipulation.” No further explanations are offered thereafter as to the procedure used.

Removing the guide tube while using our device is only possible in the real acupuncture arm. In the placebo arm, the needle telescopes thus giving the impression it has penetrated the skin; but in fact it does not penetrate at all. If one would remove the guide tube, the non-penetrating placebo needle would simply fall off. This means that, by removing the guide tube for ease of manipulation, the researchers disclose to their patients that they are in the real acupuncture group. And this, in turn, means that the trial was not even single-blind. Patients would have seen whether they received real or placebo acupuncture.

It follows that all the outcomes noted in this trial are most likely due to patient and therapist expectations, i. e. they were caused by a placebo effect.

Now that we have solved this question, here is the next one: IS THIS A MISUNDERSTANDING, CLUMSINESS, STUPIDITY, SCIENTIFIC MISCONDUCT OR FRAUD?

This randomized controlled trial was aimed to investigate the effect of aromatherapy massage on anxiety, depression, and physiologic parameters in older patients with acute coronary syndrome. It was conducted on 90 older women with acute coronary syndrome. The participants were randomly assigned into the intervention and control groups. The intervention group received reflexology with lavender essential oil plus routine care and the control group only received routine care. Physiologic parameters, the levels of anxiety and depression in the hospital were evaluated using a checklist and the Hospital’s Anxiety and Depression Scale, respectively, before and immediately after the intervention.

Significant differences in the levels of anxiety and depression were reported between the groups after the intervention. The analysis of physiological parameters revealed a statistically significant reduction in systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. However, no significant difference was observed in the respiratory rate.

The authors concluded that aromatherapy massage can be considered by clinical nurses an efficient therapy for alleviating psychological and physiological responses among older women suffering from acute coronary syndrome.

WRONG!

This trial does not show remotely what the authors think. It demonstrates that A+B is always more than B. We have discussed this phenomenon so often that I hesitate to mention it again. Any study with the ‘A+B versus B’ design can only produce a positive result. The danger that this result is false-positive is so high that it is best to forget about such investigations altogether.

Ethics committees should not accept such protocols.

Researchers should stop running such studies.

Reviewers should not pass them for publication.

Editors should not publish such trials.

THEY MISLEAD ALL OF US AND GIVE CLINICAL RESEARCH A BAD NAME.

George Vithoulkas * (GV) is one of today’s most influential lay-homeopaths, a real ‘super guru’. He has many bizarre ideas; one of the most peculiar one was recently outlined in his article entitled ‘An innovative proposal for scientific alternative medical journals’. Here are a few excerpts from it:

…the only evidence that homeopathy can present to the scientific world at this moment are these thousands of cured cases. It is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.

… the international “scientific” community, which has neither direct perception nor personal experience of the beneficial effects of homeopathy, is forced to repeat the same old mantra: “Where is the evidence? Show us the evidence!” … the successes of homeopathy have remained hidden in the offices of hardworking homeopaths – and thus go largely ignored by the world’s medical authorities, governments, and the whole international scientific community…

… simple questions that are usually asked by the “gnorant”, for example, “Can homeopathy cure cancer, multiple sclerosis, ulcerative colitis, etc.?” are invalid and cannot elicit a direct answer because the reality is that many such cases can be ameliorated significantly, and a number can be cured…

A journal could invite a selected number of good prescribers from all over the world as a start to this project and let them contribute to their honest experience and results, as well as their failures. The possibilities and limitations would soon be revealed…

I admit that an argument against accepting cases is that it is possible that false or unreliable information could be provided. This risk could be minimized by preselecting a well-known group of good prescribers, who could be asked to submit their cases, at least in the first phase of such a radical change in the policy of the journals…

This way, instead of rejecting important homeopathic case studies, in the name of a dry intellectualism and conservatism, homeopathy journals (including alternative and complementary journals) could become lively and interesting: initiating debates and discussions on real issues of therapeutics in medicine…

Our own “Evidence Based Medicine” lies in the multitude of chronic cases treated with homeopathy that we can present to the world and on the better quality of life that such cures offer.

END OF QUOTES

So, GV wants homeopathy to thrive by means of publishing lots of case reports of patients who benefitted from homeopathy. And he believes that this suggestion is ‘innovative’? It is not! Case reports were all the rage 150 years ago before medicine started to become a little more scientific. And today, there are several journals specialising in the publication of case-reports, hundreds of journals that like accepting them, as well as dozens of websites that do little else but publishing case reports of homeopathy.

But case reports essentially are anecdotes. Medicine finally managed to progress from its dark ages when we realised how unreliable case reports truly are. To state it yet again (especially for GV who seems to be a bit slow on the uptake): THE PLURAL OF ANECDOTE IS ANECDOTES, NOT EVIDENCE!

In the above article, GV claims that ‘it is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.’ That is most puzzling because, only a few years ago, he did publish this:

Alternative therapies in general, and homeopathy in particular, lack clear scientific evaluation of efficacy. Controlled clinical trials are urgently needed, especially for conditions that are not helped by conventional methods. The objective of this work was to assess the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome (PMS). It was a randomised controlled double-blind clinical trial. Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel 1992-1994. The subjects were 20 women, aged 20-48, suffering from PMS. Homeopathic intervention was chosen individually for each patient, according to a model of symptom clusters. Recruited volunteers with PMS were treated randomly with one oral dose of a homeopathic medication or placebo. The main outcome measure was scores of a daily menstrual distress questionnaire (MDQ) before and after treatment. Psychological tests for suggestibility were used to examine the possible effects of suggestion. Mean MDQ scores fell from 0.44 to 0.13 (P<0.05) with active treatment, and from 0.38 to 0.34 with placebo (NS). (Between group P=0.057). Improvement >30% was observed in 90% of patients receiving active treatment and 37.5% receiving placebo (P=0.048). Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.

I find this intriguing, particularly because the ‘further research’ mentioned prominently in the conclusions never did surface! Perhaps its results turned out to be unfavourable to homeopathy? Perhaps this is why GV dislikes RCTs these days? Perhaps this is why he prefers case reports such as this one which he recently published:

START OF QUOTE

An 81-year-old female patient was admitted in July 2015 to the Cardiovascular Surgery Department of a hospital in Bucharest for an aortic valve replacement surgery.

The patient had a history of mild hypertension, insulin-dependent type 2 diabetes, coronary artery disease, congestive heart failure NYHA 2, severe aortic stenosis, moderate mitral regurgitation, mild pulmonary hypertension, bilateral carotid atheromatosis with a 50% stenosis of the left internal carotid artery, complete right mastectomy for breast cancer (at that moment in remission).

After a preoperative evaluation and preparation, the surgery was completed with the replacement of the aortic valve with a bioprosthesis (Medtronic Hancock II Ultra no. 23) and myocardial revascularization by using a double aortic-coronary bypass.

The post-operatory evolution was a good one in terms of the heart disease. However, the patient did not regain consciousness after the anaesthesia, maintaining a deep comatose state (GCS 7 points – E1V2M4).

A brain CT was performed the third day postoperatively, showing no recent ischemic or haemorrhagic cerebral lesions, moderate diffuse cerebral atrophy and carotid atheromatosis.

After the surgery, the patient was admitted to the Intensive Care Unit and was treated by using a multidisciplinary approach. The patient was treated with inotropic, antiarrhythmic, and diuretic drugs, insulin and antidiabetic drugs were used in order to keep the blood sugar levels under control. The patient was kept hydrated and the electrolytes balanced by using an i.v. line, prophylaxis for deep vein thrombosis, and pulmonary thromboembolism was performed by using low molecular weight heparin. Prophylaxis for bedsores was also performed by using a pressure relieve air mattress.

The patient went into acute respiratory distress, needing mechanical ventilation in order to maintain oxygenation.

Despite these complex and correctly performed therapeutic efforts, the patient did not regain consciousness and was still in a deep coma in the fourteenth day post-operatory (GCS 7 points – E1V2M4), without having a confirmed medical explanation.

At that point, the patient’s family requested a consult from a homeopathic specialist.

The homeopathic examination, which was performed in the fourteenth day postoperatively, revealed the following: old, comatose, tranquil patient, with pale and cold skin, with the need to uncover herself (the few movements that she made with her hands were to remove her blanket and clothes, as if she wanted more air – “thirst for air”), abdominal distension, and bloating.

The thorough evaluation of the patient and the analysis of her symptoms led us to the remedy most appropriate for this critical situation – Carbo Vegetabilis.

Homeopathic treatment was initiated the same day, by using Carbo Vegetabilis 200CH 7 granules twice a day, administered diluted in 20ml of water by using a nasogastric tube.

The patient’s evolution was spectacular. The next day after the initiation of the treatment (fifteenth day postoperatively) the patient was in a superficial coma (GCS 11 points – E2V4M5), and the following day she regained consciousness. Carbo Vegetabilis was administered in the same dose for a total of five days (including the nineteenth day postoperatively).

After these five days, the case was reassessed from a homeopathically point of view and the second evaluation revealed the following: severely dyspnoeic patient (even talking caused exhaustion) with pale skin, severe fatigue aggravated by the slightest movements, a weakness sensation located in the chest area, extreme lack of energy, the wish “to be left alone”.

Considering the state of general exhaustion the patient was in at that moment and her lack of energy, the homeopathic treatment was changed to a new remedy: Stanum metallicum 30CH 7 granules administered sublingually twice a day for a week.

After the administration of the second remedy, the patient’s general condition improved dramatically: she started eating, she was able to get up in a sitting position with only little help, her fatigue diminished significantly.

The patient was then transferred to a recovery clinic in Cluj-Napoca in order to continue the cardiovascular recovery treatment. During her three-week admission in the clinic, she followed an individualized cardiovascular recovery program, which led to her ability to walk short distances with minimal support and has was released from the hospital in September 2015.

The following weeks after release, the patient recovered almost entirely, both physically and mentally. She was able to retake her place in her family and in society in general.

END OF QUOTE

One has to be a homeopath (one who is ignorant of the ‘post hoc propter hoc fallacy’) to believe in a causal link between the intake of the homeopathic remedy and the recovery of this patient. Thankfully, comatose patients do re-gain consciousness all the time! Even without homeopathy! But GV seems to not know that. In the discussion of this paper, he even states this: “ even after a well-conducted therapy, this condition leads to the death of the patient.” Is it ethical to publish such falsehoods, I wonder?

As far as the case report goes, the homeopathic remedy might even have delayed the process – perhaps the patient would have re-gained consciousness quicker and more completely without it! My hypothesis (homeopathy cased harm) is exactly as strong and silly as the one (homeopathy cased benefit) of GV. Anecdotes will never be able to answer the question as to who is correct.

One has to be a homeopath (and a daft one at that) to believe that this sort of evidence will lead to the acceptance of homeopathy by the scientific community. No journal will take GV seriously. No editor can be that stupid!

Oooops! Hold on, I might be wrong here.

Dr Peter Fisher, editor of the journal ‘Homeopathy’ just published an editorial ( Fisher P, Homeopathy and intellectual honesty, Homeopathy (2017), see also my previous post) stating that, in future, ‘we will increase publication of well-documented case-reports’.

Did I just claim that no editor can be that stupid?

 

 

 

  • I should declare a conflict of interest: when he got his ‘Right Livelihood Award’, GV sent me (and other prominent homeopathy-researchers) some of the prize money (I think it was around £ 1000) to support my research in homeopathy. I used it for exactly that purpose.

 

Gastro-oesophageal reflux disease (GORD) is a common, benign condition. It can be treated by changing eating habits or drugs. Many alternative therapies are also on offer, for instance, acupuncture. But does it work? Let’s find out.

The objective of this meta-analysis was to explore the effectiveness of acupuncture for the treatment of gastro-oesophageal reflux disease (GORD). Four English and four Chinese databases were searched through June 2016. Randomised controlled trials investigating the effectiveness of manual acupuncture or electroacupuncture (MA/EA) for GORD versus or as an adjunct to Western medicine (WM) were selected.

A total of 12 trials involving 1235 patients were included. The results demonstrated that patients receiving MA/EA combined with WM had a superior global symptom improvement compared with those receiving WM alone  with no significant heterogeneity. Recurrence rates of those receiving MA/EA alone were lower than those receiving WM  with low heterogeneity, while global symptom improvement (six studies) and symptom scores (three studies) were similar. Descriptive analyses suggested that acupuncture also improves quality of life in patients with GORD.

The authors concluded that this meta-analysis suggests that acupuncture is an effective and safe treatment for GORD. However, due to the small sample size and poor methodological quality of the included trials, further studies are required to validate our conclusions.

I am glad the authors used the verb ‘suggest’ in their conclusions. In fact, even this cautious terminology is too strong, in my view. Here are 9 reasons why:

  1. The hypothesis that acupuncture is effective for GORD lacks plausibility.
  2. All the studies were of poor or very poor methodological quality.
  3. All but one were from China, and we know that all acupuncture trials from this country are positive, thus casting serious doubt on their validity.
  4. Six trials had the infamous ‘A+B versus B’ design which never generates a negative result.
  5. There was evidence of publication bias, i. e. negative trials had disappeared and were thus not included in the meta-analysis.
  6. None of the trials made an attempt to control for placebo effects by using a sham-control procedure.
  7. None used patient-blinding.
  8. The safety of a therapy cannot be assessed on the basis of 12 trials
  9. Seven studies failed to report adverse effects, thus violating research ethics.

Considering these facts, I think that a different conclusion would have been more appropriate:  this meta-analysis provides no good evidence for the assumption that acupuncture is an effective and safe treatment for GORD.

The purpose of the study was to compare utilization of conventional psychotropic drugs among patients seeking care for anxiety and depression disorders (ADDs) from general practitioners (GPs) who

  • strictly prescribe conventional medicines (GP-CM),
  • regularly prescribe homeopathy in a mixed practice (GP-Mx),
  • or are certified homeopathic GPs (GP-Ho).

The investigation was an epidemiological cohort study of general practice in France, which included GPs and their patients consulting for ADDs (scoring 9 or more in the Hospital Anxiety and Depression Scale, HADS). Information on all medication utilization was obtained by a standardised telephone interview at inclusion, 1, 3 and 12 months.

Of 1562 eligible patients consulting for ADDs, 710 (45.5 %) agreed to participate. Adjusted multivariate analyses showed that GP-Ho and GP-Mx patients were less likely to use psychotropic drugs over 12 months, compared to GP-CM patients. The rate of clinical improvement (HADS <9) was marginally superior for the GP-Ho group as compared to the GP-CM group, but not for the GP-Mx group.

The authors concluded that patients with ADD, who chose to consult GPs prescribing homeopathy reported less use of psychotropic drugs, and were marginally more likely to experience clinical improvement, than patients managed with conventional care. Results may reflect differences in physicians’ management and patients’ preferences as well as statistical regression to the mean.

Aren’t we glad they added the last sentence to their conclusion!!!

Without it, one might have thought that the observed differences were due to the homeopathic remedies. In fact, the finding amounts to a self-fulfilling prophecy: Homeopaths tend to be against prescribing conventional drugs. This means that patients consulting homeopaths are bound to use less drugs than patients who consult conventional doctors. In that sense, the study was like monitoring whether consumers who go to the butchers buy more meat than those shopping in a shop for vegetarians.

The only result that requires a more serious consideration is that homeopathically treated patients experienced more clinical improvement than those treated conventionally. But even this difference is not hard to explain: firstly, the difference was merely marginal; secondly, patients with ADD are bound to respond particularly well to the empathetic and long therapeutic encounter most homeopaths offer. In other words, the difference had nothing to do with the alleged effectiveness of the homeopathic remedies.

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