MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

critical thinking

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I remember reading this paper entitled ‘Comparison of acupuncture and other drugs for chronic constipation: A network meta-analysis’ when it first came out. I considered discussing it on my blog, but then decided against it for a range of reasons which I shall explain below. The abstract of the original meta-analysis is copied below:

The objective of this study was to compare the efficacy and side effects of acupuncture, sham acupuncture and drugs in the treatment of chronic constipation. Randomized controlled trials (RCTs) assessing the effects of acupuncture and drugs for chronic constipation were comprehensively retrieved from electronic databases (such as PubMed, Cochrane Library, Embase, CNKI, Wanfang Database, VIP Database and CBM) up to December 2017. Additional references were obtained from review articles. With quality evaluations and data extraction, a network meta-analysis (NMA) was performed using a random-effects model under a frequentist framework. A total of 40 studies (n = 11032) were included: 39 were high-quality studies and 1 was a low-quality study. NMA showed that (1) acupuncture improved the symptoms of chronic constipation more effectively than drugs; (2) the ranking of treatments in terms of efficacy in diarrhoea-predominant irritable bowel syndrome was acupuncture, polyethylene glycol, lactulose, linaclotide, lubiprostone, bisacodyl, prucalopride, sham acupuncture, tegaserod, and placebo; (3) the ranking of side effects were as follows: lactulose, lubiprostone, bisacodyl, polyethylene glycol, prucalopride, linaclotide, placebo and tegaserod; and (4) the most commonly used acupuncture point for chronic constipation was ST25. Acupuncture is more effective than drugs in improving chronic constipation and has the least side effects. In the future, large-scale randomized controlled trials are needed to prove this. Sham acupuncture may have curative effects that are greater than the placebo effect. In the future, it is necessary to perform high-quality studies to support this finding. Polyethylene glycol also has acceptable curative effects with fewer side effects than other drugs.

END OF 1st QUOTE

This meta-analysis has now been retracted. Here is what the journal editors have to say about the retraction:

After publication of this article [1], concerns were raised about the scientific validity of the meta-analysis and whether it provided a rigorous and accurate assessment of published clinical studies on the efficacy of acupuncture or drug-based interventions for improving chronic constipation. The PLOS ONE Editors re-assessed the article in collaboration with a member of our Editorial Board and noted several concerns including the following:

  • Acupuncture and related terms are not mentioned in the literature search terms, there are no listed inclusion or exclusion criteria related to acupuncture, and the outcome measures were not clearly defined in terms of reproducible clinical measures.
  • The study included acupuncture and electroacupuncture studies, though this was not clearly discussed or reported in the Title, Methods, or Results.
  • In the “Routine paired meta-analysis” section, both acupuncture and sham acupuncture groups were reported as showing improvement in symptoms compared with placebo. This finding and its implications for the conclusions of the article were not discussed clearly.
  • Several included studies did not meet the reported inclusion criteria requiring that studies use adult participants and assess treatments of >2 weeks in duration.
  • Data extraction errors were identified by comparing the dataset used in the meta-analysis (S1 Table) with details reported in the original research articles. Errors included aspects of the study design such as the experimental groups included in the study, the number of study arms in the trial, number of participants, and treatment duration. There are also several errors in the Reference list.
  • With regard to side effects, 22 out of 40 studies were noted as having reported side effects. It was not made clear whether side effects were assessed as outcome measures for the other 18 studies, i.e. did the authors collect data clarifying that there were no side effects or was this outcome measure not assessed or reported in the original article. Without this clarification the conclusion comparing side effect frequencies is not well supported.
  • The network geometry presented in Fig 5 is not correct and misrepresents some of the study designs, for example showing two-arm studies as three-arm studies.
  • The overall results of the meta-analysis are strongly reliant on the evidence comparing acupuncture versus lactulose treatment. Several of the trials that assessed this comparison were poorly reported, and the meta-analysis dataset pertaining to these trials contained data extraction errors. Furthermore, potential bias in studies assessing lactulose efficacy in acupuncture trials versus lactulose efficacy in other trials was not sufficiently addressed.

While some of the above issues could be addressed with additional clarifications and corrections to the text, the concerns about study inclusion, the accuracy with which the primary studies’ research designs and data were represented in the meta-analysis, and the reporting quality of included studies directly impact the validity and accuracy of the dataset underlying the meta-analysis. As a consequence, we consider that the overall conclusions of the study are not reliable. In light of these issues, the PLOS ONE Editors retract the article. We apologize that these issues were not adequately addressed during pre-publication peer review.

LZ disagreed with the retraction. YM and XD did not respond.

END OF 2nd QUOTE

Let me start by explaining why I initially decided not to discuss this paper on my blog. Already the first sentence of the abstract put me off, and an entire chorus of alarm-bells started ringing once I read further.

  • A meta-analysis is not a ‘study’ in my book, and I am somewhat weary of researchers who employ odd or unprecise language.
  • We all know (and I have discussed it repeatedly) that studies of acupuncture frequently fail to report adverse effects (in doing this, their authors violate research ethics!). So, how can it be a credible aim of a meta-analysis to compare side-effects in the absence of adequate reporting?
  • The methodology of a network meta-analysis is complex and I know not a lot about it.
  • Several things seemed ‘too good to be true’, for instance, the funnel-plot and the overall finding that acupuncture is the best of all therapeutic options.
  • Looking at the references, I quickly confirmed my suspicion that most of the primary studies were in Chinese.

In retrospect, I am glad I did not tackle the task of criticising this paper; I would probably have made not nearly such a good job of it as PLOS ONE eventually did. But it was only after someone raised concerns that the paper was re-reviewed and all the defects outlined above came to light.

While some of my concerns listed above may have been trivial, my last point is the one that troubles me a lot. As it also related to dozens of Cochrane reviews which currently come out of China, it is worth our attention, I think. The problem, as I see it, is as follows:

  • Chinese (acupuncture, TCM and perhaps also other) trials are almost invariably reporting positive findings, as we have discussed ad nauseam on this blog.
  • Data fabrication seems to be rife in China.
  • This means that there is good reason to be suspicious of such trials.
  • Many of the reviews that currently flood the literature are based predominantly on primary studies published in Chinese.
  • Unless one is able to read Chinese, there is no way of evaluating these papers.
  • Therefore reviewers of journal submissions tend to rely on what the Chinese review authors write about the primary studies.
  • As data fabrication seems to be rife in China, this trust might often not be justified.
  • At the same time, Chinese researchers are VERY keen to publish in top Western journals (this is considered a great boost to their career).
  • The consequence of all this is that reviews of this nature might be misleading, even if they are published in top journals.

I have been struggling with this problem for many years and have tried my best to alert people to it. However, it does not seem that my efforts had even the slightest success. The stream of such reviews has only increased and is now a true worry (at least for me). My suspicion – and I stress that it is merely that – is that, if one would rigorously re-evaluate these reviews, their majority would need to be retracted just as the above paper. That would mean that hundreds of papers would disappear because they are misleading, a thought that should give everyone interested in reliable evidence sleepless nights!

So, what can be done?

Personally, I now distrust all of these papers, but I admit, that is not a good, constructive solution. It would be better if Journal editors (including, of course, those at the Cochrane Collaboration) would allocate such submissions to reviewers who:

  • are demonstrably able to conduct a CRITICAL analysis of the paper in question,
  • can read Chinese,
  • have no conflicts of interest.

In the case of an acupuncture review, this would narrow it down to perhaps just a handful of experts worldwide. This probably means that my suggestion is simply not feasible.

But what other choice do we have?

One could oblige the authors of all submissions to include full and authorised English translations of non-English articles. I think this might work, but it is, of course, tedious and expensive. In view of the size of the problem (I estimate that there must be around 1 000 reviews out there to which the problem applies), I do not see a better solution.

(I would truly be thankful, if someone had a better one and would tell us)

For years, Margaret McCartney, a GP from Scotland, wrote a weekly column in the BMJ. It was invariably well-worth reading. Recently, she regrettably ended it by publishing her last article entitled  A summary of four and a half years of columns in one column. In it, she makes 36 short points. They are all poignant, but the one that made me think most (probably because it is relevant to my work and this blog) reads as follows:

Many people seek to make money from those who don’t understand science. Doctors should call out bollocksology when they see it.

On this blog, I have often discussed people who make money from consumers and patients who are unable to detect the quackery they are being sold. No doubt, the most famous case of me doing this was when, in 2009, I criticised Prince Charles and his ‘Dodgy Originals Detox Tincture’. It made many headlines; the BBC, for instance, reported:

Edzard Ernst, the UK’s first professor of complementary medicine, said the Duchy Originals detox tincture was based on “outright quackery”.

There was no scientific evidence to show that detox products work, he said.

Duchy Originals says the product is a “natural aid to digestion and supports the body’s elimination processes”.

But Professor Ernst of Peninsula Medical School said Prince Charles and his advisers appeared to be deliberately ignoring science, preferring “to rely on ‘make-believe’ and superstition”.

He added: “Prince Charles thus financially exploits a gullible public in a time of financial hardship.”

Marketed as Duchy Herbals’ Detox Tincture, the artichoke and dandelion mix is described as “a food supplement to help eliminate toxins and aid digestion”.

It costs £10 for a 50ml bottle…

At the time, I got a right blocking from my dean, Prof John Tooke, for my audacity. As far as I could see, there was almost no support from the UK medical profession. Since then, the exploitation of the public by quacks has not diminished; on the contrary, I have the feeling that it is thriving. And are doctors calling out bollocksology left right and centre? No, they are not!

Of course, some do occasionally raise their voices (and some do it even regularly). But mostly, it is the group of non-medical sceptics who open their mouths and try their best to prevent harm. Yet, I wholly agree with my friend Margret: doctors have a responsibility and must do more.

And why don’t they?

I think, there are several reasons for their inactivity:

  • doctors are frightfully busy,
  • doctors often don’t know how much bollocksology is out there,
  • doctors don’t (want to) see how dangerous much of this bollocksology is,
  • doctors fail to realise that it would be their ethical responsibility to speak out against bollocksology,
  • some doctors do not seem to understand science either,
  • some doctors are active bollocksologists themselves,
  • some doctors simply don’t care.

This clearly is a depressing state of affairs! But, at the same time, it also is a cheerful occasion for me to thank all those doctors who are the laudable exceptions, who do care, who do think critically, who see their ethical responsibility, and who do something about the never-ending flood of bollocksology endangering their patients’ health and wealth.

“Physiotherapy generally offers a highly science based approach to clinical practice.” This was a recent comment by someone (I presume a physiotherapist) on this blog. It got me thinking – is it true or false? I am in no position to review the entire field of physiotherapy in a blog post. What I will do instead, is list a few alternative therapies often used by physiotherapists.

  1. Acupuncture: many physiotherapists seem to love acupuncture. In the UK, for example, they have their own organisations. The AACP is the largest professional body for acupuncture in the UK with a membership of around 6000 chartered physiotherapists, practising medical acupuncture. They state that there is an increasing number of research publications in the UK and worldwide proving the treatment effectiveness of acupuncture when compared to (chemical) medication for example.
  2. Applied kinesiology: some physiotherapists offer applied kinesiology. This clinic, for instance, states that applied Kinesiology combines a system of muscle tests with acupuncture, reflex points emotion and nutrition to find any imbalances present in the whole person.
  3. Bowen technique: many physiotherapists use the Bowen technique. This practice advertises it as follows. If you’re looking for a way to treat tightness in your upper back, neck or shoulders or are suffering from respiratory pain or headaches, The Bowen Technique could be the answer you’re searching for. Achieving all these things as well as being a great way to treat sports injuries and enhance sporting performance, this therapy also promotes emotional wellbeing. A non-invasive therapy, it is equally suited for the treatment of acute (short-term) and chronic (long-term) conditions.
  4. Craniosacral therapy: some physios also employ craniosacral therapy. Here is an example. Craniosacral therapy as experienced by thousands of babies and people all around the country, has a proven track record at easing and relieving what makes babies upset. If your baby suffers from:
    • Colic
    • Wind
    • Digestive issues
    • Reflux
    • Unsettledness
    • Sleep problems
    • Ongoing crying
    • Difficulty with breast feeding/latch/suck
    • Other problems

    then call…

  5. Cupping: One physio writes this about cupping. It was good to see the public (Western cultures) exposed more to cupping therapy practice thanks to the recent Olympics in Rio 2016. Last Olympics in London 2012,  the Chinese and Japanese Athletes, amongst neighbouring nations, were readily seen to use and advocate the practice, along with the approval no doubt of their large team of Medical and Physiotherapy related support staff. This time however it has bridged to divide to Western World Athletes, such as Michael Phelps (he of 23 Olympic Golds fame). This advocacy of the practice and again the presumed support from his Medical and Sports science entourage with team USA, is a good barometer of the progress and acceptance within Western Medicine, for Cupping Therapy.
  6. Massage therapy: in many countries, massage and related techniques therapy always have been an integral part of physiotherapy.
  7. Feldenkrais method: The same applies to The Feldenkrais Method® is based on principles of physics, biomechanics, neuroscience, and the study of human motor development. Feldenkrais recognized the capability of the human brain to learn and relearn at any age – neuroplasticity. The method utilizes slow, gentle movements, and awareness of subtle differences to optimize learning, improve movement, and make changes in the brain.
  8. Kinesiology tape: If you have suffered an injury or illness that causes a problem with your functional mobility or normal activity, you may benefit from the skilled services of a physical therapist to help you return to your previous level of mobility.  Your physical therapist may use various exercises and modalities to help treat your specific problem.
  9. Reflexology: Here is what the UK Chartered Society of Physiotherapists writes about reflexology: Developed centuries ago in countries such as China, Egypt and India, reflexology is often referred to as a ‘gentle’ and ‘holistic’ therapy that benefits both mind and body. It centres on the feet because these are said by practitioners to be a mirror, or topographical map, for the rest of the body. Manipulation of certain pressure, or reflex, points is claimed to have an effect on corresponding zones in the body. The impact, say reflexologists, extends throughout – to bones, muscles, organs, glands, circulatory and neural pathways. The head and hands can also be massaged in some cases. The treatment is perhaps best known for use in connection with relaxation and relief from stress, anxiety, pain, sleep disorders, headaches, migraine, menstrual and digestive problems. But advocates say it can be used to great effect far more widely, often in conjunction with other treatments…
  10. Spinal manipulation: Physiotherapists learn spinal manipulation as part of continuing education courses in Canada. The Orthopaedic Division of the Canadian Physiotherapy Association is responsible for the standards of education and supervises exams required to meet the standards of the International Federation of Manipulative Physiotherapists (IFOMPT). In many other countries, the situation is similar.

These 10 therapies have all been discussed on this blog before. They lack

  • plausibility or
  • proof of efficacy or
  • proof of safety or
  • all of the above

In other words, they are NOT highly science-based.

QED

It has been reported that the faculty of medicine of Lille unversity in France has suspended its degree in homeopathy for the 2018-19 academic year. The university announced its decision on Twitter, and the faculty of medicine’s dean, Didier Gosset, confirmed it to the AFP news agency: “It has to be said that we teach medicine based on proof – we insist on absolute scientific rigour – and it has to be said that homeopathy has not evolved in the same direction, that it is a doctrine that has remained on the margins of the scientific movement, that studies on homeopathy are rare, that they are not very substantial,” he explained. “Continuing to teach it would be to endorse it.”

The decision is, of course, long overdue and must be welcomed. Personally, however, I wonder why defenders of reason like Prof Gosset often employ such unclear lines of argument. Would it not be clearer to make (some of) these simple points?

  1. The assumptions on which homeopathy is based are obsolete and implausible.
  2. It is not that we do not understand homeopathy’s mode of action, but we understand that there cannot be one that does not fly in the face of science.
  3. The clinical evidence fails to show that highly diluted homeopathic remedies are more than placebos.
  4. Homeopathy can cause significant harm, e. g. through neglect.
  5. Homeopathy costs millions which would be much better used for evidence-based treatments.
  6. The practice of homeopathy hinders progress and does not provide benefit for the public.
  7. Teaching homeopathy at university-level is unscientific, unethical and nonsensical.

The French are among the world’s largest consumers of homeopathic remedies. The French social security system does normally reimburse homeopathic therapy. A group of doctors challenged this situation in an open letter in Le Figaro newspaper in March 2018. They called practitioners of homeopathy and other alternative medicines “charlatans”, pointing to a 2017 report by the European Academies Science Advisory Council that stressed, like a plethora of previous reports, the “absence of proof of homeopathy’s efficacy”. They challenged the French medical council to stop allowing doctors to practice homeopathy and asked the social security system to stop paying for it. Subsequently, a group of French homeopaths filed a formal complaint with the medical council against the signatories of this letter.

France’s health ministry has asked France’s National Health Authority to prepare and publish a report on whether homeopathy works and should be paid for by the public purse. It is due to be delivered in February 2019.

WATCH THIS SPACE

Psoriasis is one of those conditions that is

  • chronic,
  • not curable,
  • irritating to the point where it reduces quality of life.

In other words, it is a disease for which virtually all alternative treatments on the planet are claimed to be effective. But which therapies do demonstrably alleviate the symptoms?

This review (published in JAMA Dermatology) compiled the evidence on the efficacy of the most studied complementary and alternative medicine (CAM) modalities for treatment of patients with plaque psoriasis and discusses those therapies with the most robust available evidence.

PubMed, Embase, and ClinicalTrials.gov searches (1950-2017) were used to identify all documented CAM psoriasis interventions in the literature. The criteria were further refined to focus on those treatments identified in the first step that had the highest level of evidence for plaque psoriasis with more than one randomized clinical trial (RCT) supporting their use. This excluded therapies lacking RCT data or showing consistent inefficacy.

A total of 457 articles were found, of which 107 articles were retrieved for closer examination. Of those articles, 54 were excluded because the CAM therapy did not have more than 1 RCT on the subject or showed consistent lack of efficacy. An additional 7 articles were found using references of the included studies, resulting in a total of 44 RCTs (17 double-blind, 13 single-blind, and 14 nonblind), 10 uncontrolled trials, 2 open-label nonrandomized controlled trials, 1 prospective controlled trial, and 3 meta-analyses.

Compared with placebo, application of topical indigo naturalis, studied in 5 RCTs with 215 participants, showed significant improvements in the treatment of psoriasis. Treatment with curcumin, examined in 3 RCTs (with a total of 118 participants), 1 nonrandomized controlled study, and 1 uncontrolled study, conferred statistically and clinically significant improvements in psoriasis plaques. Fish oil treatment was evaluated in 20 studies (12 RCTs, 1 open-label nonrandomized controlled trial, and 7 uncontrolled studies); most of the RCTs showed no significant improvement in psoriasis, whereas most of the uncontrolled studies showed benefit when fish oil was used daily. Meditation and guided imagery therapies were studied in 3 single-blind RCTs (with a total of 112 patients) and showed modest efficacy in treatment of psoriasis. One meta-analysis of 13 RCTs examined the association of acupuncture with improvement in psoriasis and showed significant improvement with acupuncture compared with placebo.

The authors concluded that CAM therapies with the most robust evidence of efficacy for treatment of psoriasis are indigo naturalis, curcumin, dietary modification, fish oil, meditation, and acupuncture. This review will aid practitioners in advising patients seeking unconventional approaches for treatment of psoriasis.

I am sorry to say so, but this review smells fishy! And not just because of the fish oil. But the fish oil data are a good case in point: the authors found 12 RCTs of fish oil. These details are provided by the review authors in relation to oral fish oil trials: Two double-blind RCTs (one of which evaluated EPA, 1.8g, and DHA, 1.2g, consumed daily for 12 weeks, and the other evaluated EPA, 3.6g, and DHA, 2.4g, consumed daily for 15 weeks) found evidence supporting the use of oral fish oil. One open-label RCT and 1 open-label non-randomized controlled trial also showed statistically significant benefit. Seven other RCTs found lack of efficacy for daily EPA (216mgto5.4g)or DHA (132mgto3.6g) treatment. The remainder of the data supporting efficacy of oral fish oil treatment were based on uncontrolled trials, of which 6 of the 7 studies found significant benefit of oral fish oil. This seems to support their conclusion. However, the authors also state that fish oil was not shown to be effective at several examined doses and duration. Confused? Yes, me too!

Even more confusing is their failure to mention a single trial of Mahonia aquifolium. A 2013 meta-analysis published in the British Journal of Dermatology included 5 RCTs of Mahonia aquifolium which, according to these authors, provided ‘limited support’ for its effectivenessHow could they miss that?

More importantly, how could the reviewers miss to conduct a proper evaluation of the quality of the studies they included in their review (even in their abstract, they twice speak of ‘robust evidence’ – but how can they without assessing its robustness? [quantity is not remotely the same as quality!!!]). Without a transparent evaluation of the rigour of the primary studies, any review is nearly worthless.

Take the 12 acupuncture trials, for instance, which the review authors included based not on an assessment of the studies but on a dodgy review published in a dodgy journal. Had they critically assessed the quality of the primary studies, they could have not stated that CAM therapies with the most robust evidence of efficacy for treatment of psoriasis …[include]… acupuncture. Instead they would have had to admit that these studies are too dubious for any firm conclusion. Had they even bothered to read them, they would have found that many are in Chinese (which would have meant they had to be excluded in their review [as many pseudo-systematic reviewers, the authors only considered English papers]).

There might be a lesson in all this – well, actually I can think of at least two:

  1. Systematic reviews might well be the ‘Rolls Royce’ of clinical evidence. But even a Rolls Royce needs to be assembled correctly, otherwise it is just a heap of useless material.
  2. Even top journals do occasionally publish poor-quality and thus misleading reviews.

Yesterday, I was interviewed and filmed by a Canadian TV-journalist. Even though the subject was osteopathy (apparently, in Canada, osteopathy is strong and full of woo), we found ourselves talking about ‘oil pulling’. I knew next to nothing about this alternative therapy, but learnt that it was big in North America. When the TV-crew had left my home, I therefore read up about it. I must admit, I was more than a little sceptical about the therapy – not least because I soon found articles by fellow sceptics that were less than complimentary – but, as I studied the original research on oil pulling, my scepticism somewhat waned.

So, what is oil pulling? It is the use of oil for swishing it around your mouth for alleged health benefits. Here are several short points that might explain it more fully:

  • Oil pulling is said to have roots that reach back to ancient Hindu texts. Coconut or sesame oils are usually employed for this therapy.
  • The mechanism of action (if there is one at all) is poorly understood, and several theories have been put forward:

Alkali hydrolysis of fat results in saponification or “soap making” process. Since the oils used for oil pulling contain fat, the alkali hydrolysis process emulsifies the fat into bicarbonate ions, normally found in the saliva. Soaps then blend in the oil, increase the surface area of the oil, and thus cleanse the teeth and gums.

A second theory suggests that the viscous nature of the oil inhibits plaque accumulation and adhesion of bacteria.

A third theory holds that the antioxidants present in the oil prevent lipid peroxidation, resulting in an antibiotic-like effect helping in the destruction of microorganisms.

  • Oil pulling is recommended to be carried out in the morning on an empty stomach. About 10 ml of oil is swished between the teeth for a duration of approximately 15-20 min and spat out. This ritual should be followed by rinsing and tooth brushing. The practice should be repeated regularly, even three times daily for acute diseases.
  • To my surprise, oil pulling has been tested in clinical trials. Some of these investigations seem reasonably sound and suggest that coconut oil pulling reduces potentially harmful bacteria in the mouth.[1] This effect has been shown to lead to a reduction in dental plaque formation[2] , halitosis (bad breath) [3] and gingivitis. [4]
  • The evidence for these oral effects is by no means strong, but I have not found studies that show negative results.
  • Dentists – even the bizarre species of ‘holistic dentists‘ – do not seem to be balled over by oil pulling (some malicious minds might speculate that this is so because they cannot earn much money with it).
  • The claimed benefits of oil pulling are, however, not limited to the oral cavity. It is advocated also for the prevention and treatment of conditions such as headaches, migraines, thrombosis, eczema, diabetes and asthma.[5] Some proponents also claim that oil pulling is a detox therapy. Unsurprisingly, none of these claims are supported by good evidence.
  • As long as you don’t swallow the oil, there are no serious risks associated with oil pulling.

So, what is the conclusion? To me, the evidence looks promising as far as oral health is concerned. For all other indication, oil pulling is neither plausible nor evidence-based.

[1] https://www.ncbi.nlm.nih.gov/pubmed/27891311

[2] https://www.ncbi.nlm.nih.gov/pubmed/18408265

[3] https://www.ncbi.nlm.nih.gov/pubmed/21911944

[4] https://www.ncbi.nlm.nih.gov/pubmed/19336860

[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5654187/

This systematic review included 18 studies assessing homeopathy in depression. Two double-blind placebo-controlled trials of homeopathic medicinal products (HMPs) for depression were assessed. The first trial (N = 91) with high risk of bias found HMPs were non-inferior to fluoxetine at 4 (p = 0.654) and 8 weeks (p = 0.965); whereas the second trial (N = 133), with low risk of bias, found HMPs was comparable to fluoxetine (p = 0.082) and superior to placebo (p < 0.005) at 6 weeks.

The remaining research had unclear/high risk of bias. A non-placebo-controlled RCT found standardised treatment by homeopaths comparable to fluvoxamine; a cohort study of patients receiving treatment provided by GPs practising homeopathy reported significantly lower consumption of psychotropic drugs and improved depression; and patient-reported outcomes showed at least moderate improvement in 10 of 12 uncontrolled studies. Fourteen trials provided safety data. All adverse events were mild or moderate, and transient. No evidence suggested treatment was unsafe.

The authors concluded that limited evidence from two placebo-controlled double-blinded trials suggests HMPs might be comparable to antidepressants and superior to placebo in depression, and patients treated by homeopaths report improvement in depression. Overall, the evidence gives a potentially promising risk benefit ratio. There is a need for additional high quality studies.

It is worth having a look at these two studies, I think.

The 1st (2011) study is from Brazil

Here is its abstract:

Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression.

There are many important points to make about this trial:

  1. Contrary to what the reviewers claim, the trial had no placebo group.
  2. It was a double-dummy equivalence study comparing individualised homeopathy with the antidepressant fluoxetine.
  3. Fluoxetine might have been under-dosed (see below).
  4. Equivalence studies require large sample sizes, and with just 91 patients (only 55 of whom finished the study), this trial was underpowered which means the finding of equivalence is false positive.
  5. The authors noted that a higher percentage of troublesome adverse effects reported by patients receiving fluoxetine. This means that the trial was not double-blind; patients were able to tell by their side-effects which group they were in.
  6. The authors also state that more patients randomized to homeopathy than to fluoxetine were excluded due to worsening of their depressive symptoms. I think this confirms that homeopathy was ineffective.

The 2nd (2015) study is from Mexico

Here is its abstract:

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-hoc test).

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.

And here are my critical remarks about this trial:

  1. The aim of a small study like this cannot be to assess or draw conclusions about the safety of the interventions used; for this purpose, we need sample sizes that are at least one dimension bigger.
  2. Fluoxetine might have been under-dosed (see below).
  3. The blinding of patients might have been jeopardized by patients experiencing the specific side-effects of fluoxetine. The authors reported adverse effects in all three groups. However, the characteristic and most common side-effects of fluoxetine (such as hives, itching, skin rash, restlessness, inability to sit still) were not included.

________________________________________________

Usual Adult Dose for Depression

Immediate-release oral formulations:
Initial dose: 20 mg orally once a day in the morning, increased after several weeks if sufficient clinical improvement is not observed
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 80 mg orally per day

Delayed release oral capsules:
Initial dose: 90 mg orally once a week, commenced 7 days after the last daily dose of immediate-release fluoxetine 20 mg formulations.

_________________________________________________

Considering all this, I feel that the conclusions of the above review are far too optimistic and not justified. In fact, I find them misleading, dangerous, unethical and depressing.

If you thought that Chinese herbal medicine is just for oral use, you were wrong. This article explains it all in some detail: Injections of traditional Chinese herbal medicines are also referred to as TCM injections. This approach has evolved during the last 70 years as a treatment modality that, according to the authors, parallels injections of pharmaceutical products.

The researchers from China try to provide a descriptive analysis of various aspects of TCM injections. They used the the following data sources: (1) information retrieved from website of drug registration system of China, and (2) regulatory documents, annual reports and ADR Information Bulletins issued by drug regulatory authority.

As of December 31, 2017, 134 generic names for TCM injections from 224 manufacturers were approved for sale. Only 5 of the 134 TCM injections are documented in the present version of Ch.P (2015). Most TCM injections are documented in drug standards other than Ch.P. The formulation, ingredients and routes of administration of TCM injections are more complex than conventional chemical injections. Ten TCM injections are covered by national lists of essential medicine and 58 are covered by China’s basic insurance program of 2017. Adverse drug reactions (ADR) reports related to TCM injections account for  over 50% of all ADR reports related to TCMs, and the percentages have been rising annually.

The authors concluded that making traditional medicine injectable might be a promising way to develop traditional medicines. However, many practical challenges need to be overcome by further development before a brighter future for injectable traditional medicines can reasonably be expected.

I have to admit that TCM injections frighten the hell out of me. I feel that before we inject any type of substance into patients, we ought to know as a bare minimum:

  • for what conditions, if any, they have been proven to be efficacious,
  • what adverse effects each active ingredient can cause,
  • with what other drugs they might interact,
  • how reliable the quality control for these injections is.

I somehow doubt that these issues have been fully addressed in China. Therefore, I can only hope the Chinese manufacturers are not planning to export their dubious TCM injections.

It’s been often said that we live in the age of information.  Everyone can get tons of it at the click of a button. This is undoubtedly true. Sadly, it also means that we are exposed to tons of misinformation, and sometimes it seems to me that we now live in THE AGE OF MISINFORMATION.

Here I will explain the consequences of this phenomenon on two examples that, at first glance, seem to have nothing in common at all (other than being close to my heart):

  • Homeopathy
  • Brexit

With homeopathy, the public are confronted by a steady flood of misinformation from the powerful homeopathy lobby who tell us quite incredible untruths about it:

  • Homeopathy is effective
  • Homeopathy is harmless
  • Homeopathy is natural
  • Homeopathy is holistic
  • Homeopathy is supported by many of the brightest people
  • Homeopathy is an important contribution to public health
  • Homeopathy prevents epidemics
  • Homeopathy works through quantum effects
  • Homeopathy is nano-medicine
  • Homeopathy is energy medicine
  • Homeopathy works for infants
  • Homeopathy works in animals
  • Homeopathy works for plants
  • Homeopathy is the victim of a propaganda campaign against it

Those who put out this multi-level misinformation pretend that they inform the public. Of course, the public must be informed – how else could they possibly make informed choices? (If this important aim requires a bit of cheating here and there, so be it!)

And the public reacts as directed: they buy homeopathic preparations in droves. The result is that the promoters of homeopathy can claim that THE PUBLIC IS VOTING WITH THEIR FEET! The people have decided, they say, homeopathy is a good thing!

_______________________________________________________________

With Brexit, the public is confronted by a steady flood of misinformation from the powerful Brexit lobby who tell us quite incredible untruths about it:

  • Brexit is going to give us our country back
  • Brexit is good for the economy
  • Brexit will mean more money for the NHS
  • Brexit will be easy
  • Brexit will allow us to trade with the rest of the world
  • Brexit will keep foreigners out
  • Brexit is going to create jobs
  • Brexit is good for our industry
  • Brexit is good for farmers
  • Brexit is good for the environment
  • Brexit will free us from the shackles of the EU
  • Brexit will strengthen our alliance with the US

Those who put out this multi-level misinformation pretend that they inform the public. Of course, the public must be informed – how else could they possibly make informed choices? (If this important aim requires a bit of cheating here and there, so be it!)

And the public reacts as directed: they buy into the lies of the Brexiteers in droves. The result is that the promoters of Brexit can claim that THE PUBLIC HAS VOTED WITH THEIR FEET! The people have decided, they say, Brexit is a good thing!

_____________________________________________________________

Yes, I know, this is a bit simplistic. But the point I am trying to make is surely valid: misinformation not only leads to wrong and often dangerous decision, it is also the way charlatans try to fool us with their circular arguments and justify their blatant lies.

This could (and perhaps should) be a very short post:

I HAVE NO QUALIFICATIONS IN HOMEOPATHY!

NONE!!!

[the end]

The reason why it is not quite as short as that lies in the the fact that homeopathy-fans regularly start foaming from the mouth when they state, and re-state, and re-state, and re-state this simple, undeniable fact.

The latest example is by our friend Barry Trestain who recently commented on this blog no less than three times about the issue:

  1. Falsified? You didn’t have any qualifications falsified or otherwise according to this. In quotes as well lol. Perhaps you could enlighten us all on this. Edzard Ernst, Professor of Complementary and Alternative Medicine (CAM) at Exeter University, is the most frequently cited „expert‟ by critics of homeopathy, but a recent interview has revealed the astounding fact that he “never completed any courses” and has no qualifications in homeopathy. What is more his principal experience in the field was when “After my state exam I worked under Dr Zimmermann at the Münchner Krankenhaus für Naturheilweisen” (Munich Hospital for Natural Healing Methods). Asked if it is true that he only worked there “for half a year”, he responded that “I am not sure … it is some time ago”!
  2. I don’t know what you got. I’m only going by your quotes above. You didn’t pass ANY exams. “Never completed any courses and has no qualifications in Homeopathy.” Those aren’t my words.
  3. LOL qualification for their cat? You didn’t even get a psuedo qualification and on top of that you practiced Homeopathy for 20 years eremember. With no qualifications. You are a fumbling and bumbling Proffessor of Cam? LOL. In fact I think I’ll make my cat a proffessor of Cam. Why not? He’ll be as qualified as you.

Often, these foaming (and in their apoplectic fury badly-spelling) defenders of homeopathy state or imply that I lied about all this. Yet, it is they who are lying, if they say so. I never claimed that I got any qualifications in homeopathy; I was trained in homeopathy by doctors of considerable standing in their field just like I was trained in many other clinical skills (what is more, I published a memoir where all this is explained in full detail).

In my bewilderment, I sometimes ask my accusers why they think I should have got a qualification in homeopathy. Sadly, so far, I  have not received a logical answer (most of the time not even an illogical one).

So, today I ask the question again: WHY SHOULD I HAVE NEEDED ANY QUALIFICATION IN HOMEOPATHY?

My answers are here:

  1. I consider such qualifications as laughable.  A proper qualification in nonsense is just nonsense!
  2. For practising homeopathy (which I did for a while), I did not need such qualifications; as a licensed physician, I was at liberty to use the treatments I felt to be adequate.
  3. For researching homeopathy (which I did too and published ~120 Medline-listed papers as a result of it), I do not need them either. Anyone can research homeopathy, and some of the most celebrated heroes of homeopathy research (e. g. Klaus Linde and Robert Mathie) do also have no such qualifications.

I am therefore truly puzzled and write this post to give everyone the chance to name the reasons why they feel I needed qualifications in homeopathy.

Please do tell me!

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