Back pain is a huge problem: it affects many people, causes much suffering and leads to extraordinary high cost for all of us. Considering these facts, it would be excellent to identify a treatment that truly works. However, at present, we do not have found the ideal therapy; instead we have dozens of different approaches that are similarly effective/ineffective. Two of these therapies are massage and acupuncture.
Is one better than the other?
This study compared the efficacy of classical massage (KMT, n = 66) with acupuncture therapy (AKU, n = 66) in patients with chronic back pain. The primary endpoint was the non-inferiority of classical massage compared with the acupuncture treatment in respect of the impairment in everyday life, with the help of the Hannover function questionnaire (HFAQ) and the reduction in pain (“Von Korff”-Questionnaire) at the follow-up after one month.
In the per-protocol analysis during the period between enrollment in the study and follow-up, the responder rate of the KMT was 56.5% and thus tended to be inferior to the responder rate of the AKU with 62.5% (Δ = - 6%; KIΔ: - 23.5 to + 11.4%).
The authors concluded that classical massage therapy is not significantly inferior to acupuncture therapy in the period from admission to follow-up. Thus, the non-inferiority of the KMT to the AKU cannot be proven in the context of the defined irrelevance area.
I find such studies oddly useless.
To conduct a controlled trial, one needs an experimental treatment (the therapy that is not understood) and compare it with an intervention that is understood (such as a placebo that has no specific effects, or a treatment that has been shown to work). In comparative studies like the one above, one compares one unknown with another unknown. I do not see how such a comparison can ever produce a meaningful result.
In a way, it is like an equation with two unknowns: x + 5 = y. It is simply not possible to define either x nor y, and the equation is unsolvable.
For comparative studies of two back-pain treatments to make sense, we would need one of which the effect size is well-established. I do not think that we currently have identified such a therapy. Certainly, we cannot say that we know it for massage or acupuncture.
In other words, comparative studies like the one above are a waste of resources that cannot possibly make a meaningful contribution to our knowledge.
To put it even more bluntly: we ought to stop such pseudo-research.
Acupuncture is a branch of alternative medicine where pseudo-science abounds. Here is yet another example of this deplorable phenomenon.
This study was conducted to evaluate the efficacy of acupuncture in the management of primary dysmenorrhea.
Sixty females aged 17-23 years were randomly assigned to either a study group or a control group.
- The study group received acupuncture for the duration of 20 minutes/day, for 15 days/month, for the period of 90 days.
- The control group did not receive acupuncture for the same period.
Both groups were assessed on day 1; day 30 and day 60; and day 90. The results showed a significant reduction in all the variables such as the visual analogue scale score for pain, menstrual cramps, headache, dizziness, diarrhoea, faint, mood changes, tiredness, nausea, and vomiting in the study group compared with those in the control group.
The authors concluded that acupuncture could be considered as an effective treatment modality for the management of primary dysmenorrhea.
These findings contradict those of a recent Cochrane review (authored by known acupuncture-proponents) which included 42 RCTs and concluded that there is insufficient evidence to demonstrate whether or not acupuncture or acupressure are effective in treating primary dysmenorrhoea, and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias.
The question that I ask myself is this: why do researchers bother to conduct studies that contribute NOTHING to our knowledge and progress? The new study had a no-treatment control group which means it cannot control for the effects of placebo, the extra attention, social desirability etc. In view of the fact that already 42 poor quality trials exist, it is not just useless to add a 43rd but, in my view, it is scandalous! A 43rd useless trial:
- tells us nothing of value;
- misleads the public;
- pollutes the medical literature;
- is a waste of resources;
- undermines the trust in clinical research;
- is deeply unethical.
It is high time to stop such redundant, foolish, wasteful and unethical pseudo-science.
According to the 2014 European Social Survey, Spain is relatively modest when it comes to using alternative therapies. While countries such as Austria, Denmark, Estonia, Finland, France, Germany, Lithuania, Sweden and Switzerland all have 1-year prevalence figures of over 30%, Spain only boasts a meagre 17%. Yet, its opposition to bogus treatments has recently become acute.
In 2016, it was reported that a master’s degree in homeopathic medicine at one of Spain’s top universities has been scrapped. Remarkably, the reason was “lack of scientific basis”. A university spokesman confirmed the course was being discontinued and gave three main reasons: “Firstly, the university’s Faculty of Medicine recommended scrapping the master’s because of the doubt that exists in the scientific community. Secondly, a lot of people within the university – professors and students across different faculties – had shown their opposition to the course. Thirdly, the postgraduate degree in homeopathic medicine is no longer approved by Spain’s Health Ministry.”
A few weeks ago, I had the great pleasure of being invited to a science festival in Bilbao and was impressed by the buoyant sceptic movement in Spain. At the time, two of my books were published in Spanish and received keen interest by the Spanish press.
And now, it has been reported that Spain’s Ministry of Health has released a list of only 2,008 homeopathic products whose manufacturers will have to apply for an official government license for if they wish to continue selling them. The homeopathic producers have until April 2019 to prove that their remedies actually work, which may very well completely slash homeopathic products in Spain.
It’s the latest blow for Spain’s homeopathy industry, once worth an estimated €100 million but which has seen a drop in public trust and therefore sales of around 30 percent in the last five years. Spain’s Health Ministry stopped allowing homeopathy treatments from being prescribed as part of people’s social security benefits, along with acupuncture, herbal medicine and body-based practices such as osteopathy, shiatsu or aromatherapy.
“Homeopathy is an alternative therapy that has not shown any scientific evidence that it works” Spanish Minister of Health Maria Luisa Carcedo is quoted as saying in La Vanguardia in response to the homeopathic blacklist. “I’m committed to combatting all forms of pseudoscience.”
Mini-scalpel acupuncture or acupotomy is a relatively new type of non-invasive acupuncture/ micro surgery using a small needle-scalpel invented by Professor Zhu Hanzhang around 30 years ago in China. It is a slightly thicker and more blunt instrument that gets under the skin and is able to break apart adhesions and muscle knots more effectively than a regular acupuncture needle would.
Never mind, the question is does it work!
A systematic review showed that almost all studies reported an effect of acupotomy on joint pain compared to a variety of controls. On reflection, this is hardly surprising:
- all the trials were from China;
- all had major methodological flaws.
This means that we need better studies to decide the efficacy question.
This new study investigated the efficacy and safety of mini-scalpel acupuncture (MA) for knee osteoarthritis (KOA) in an assessor-blinded randomized controlled pilot trial; this would provide information for a large-scale randomized controlled trial.
Participants (n = 24) were recruited and randomly allocated to the MA group (experimental) or acupuncture group (control). The MA group received treatment once a week for 3 weeks (total of 3 treatments), while the acupuncture group received treatment two times per week for 3 weeks (total of 6 treatments). The primary outcome was pain as assessed by a visual analogue scale (VAS). The secondary outcomes (intensity of current pain, stiffness, and physical function) were assessed using the short-form McGill Pain Questionnaire (SF-MPQ) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Assessments were performed at baseline, 1, 2, and 3 during treatment and at week 5 (2 weeks after the end of treatment).
Of the 24 participants, 23 completed the study. Both groups showed significant improvements in VAS, SF-MPQ, and WOMAC. There were no significant differences between the MA and acupuncture groups. No serious adverse event occurred and blood test results were within normal limits.
The authors concluded that although both MA and acupuncture provide similar effects with regard to pain control in patients with KOA, MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments. A large-scale clinical study is warranted to further clarify these findings.
I can recommend this article to anyone who wants a quick introduction into the critical analysis of clinical trials. It is a veritable treasure trove of mistakes, flaws, errors, fallacies etc. Here are just a few:
- The authors aim of investigating the safety of MA is unobtainable. It would require not 24 but probably 24 000 patients.
- The authors aim of investigating the efficacy of MA is equally unobtainable. It would require a much larger sample than 24, a sham control arm, identical treatment schedules, patient-blinding, etc.
- Calling the trial a ‘pilot’ is endearing but, except for the title and the insufficient sample size, this study has none of the characteristics of a pilot study.
- In their ‘introduction’, the authors state that miniscalpel acupuncture (MA) is a new subtype of acupuncture that is effective in treating chronic soft tissue injuries such as adhesions and contractures. This is clearly wrong but discloses their bias very plainly.
- The authors statement that both MA and acupuncture provide similar effects with regard to pain control in patients with KOA is misleading. It implies that both interventions had specific effects. Without a sham control arm, this is pure speculation.
- Similarly their assumption that MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments, is pure fantasy.
- In fact, as MA requires injections of local anaesthetics, any outcome is heavily confounded by this addition.
- In the discussion section, the authors state that because MA is invasive and provides a strong stimulus, some participants complained of stiff and dull pain for few days after treatment. Yet, when reporting adverse effects in the results section, this was not mentioned.
- The way this study was designed, it should have been clear from the start that it would not produce any meaningful findings. Seen from this perspective, running the trial could even be seen as a breach of research ethics.
- According to the aims of a pilot study and the authors hope that their study would provide information for a large-scale randomized controlled trial, all reporting of outcomes is misplaced and should be replaced by information as to how a definitive trial should be conducted.
The following footnote is worth mentioning: This study is supported by a grant from the Ministry of Health & Welfare, Korea. It suggests to me that this ministry should urgently re-think its funding strategy and recruit some reviewers who are capable of critical analysis.
In my view, this is a lousy study which the authors decides to call ‘a pilot’ in order to get it published in a lousy journal.
One theory as to how acupuncture works is that it increases endorphin levels in the brain. These ‘feel-good’ chemicals could theoretically be helpful for weaning alcohol-dependent people off alcohol. So, for once, we might have a (semi-) plausible mechanism as to how acupuncture could be clinically effective. But a ‘beautiful hypothesis’ does not necessarily mean acupuncture works for alcohol dependence. To answer this question, we need clinical trials or systematic reviews of clinical trials.
A new systematic review assessed the effects and safety of acupuncture for alcohol withdrawal syndrome (AWS). All RCTs of drug plus acupuncture or acupuncture alone for the treatment of AWS were included. Eleven RCTs with a total of 875 participants were included. In the acute phase, two trials reported no difference between drug plus acupuncture and drug plus sham acupuncture in the reduction of craving for alcohol; however, two positive trials reported that drug plus acupuncture was superior to drug alone in the alleviation of psychological symptoms. In the protracted phase, one trial reported acupuncture was superior to sham acupuncture in reducing the craving for alcohol, one trial reported no difference between acupuncture and drug (disulfiram), and one trial reported acupuncture was superior to sham acupuncture for the alleviation of psychological symptoms. Adverse effects were tolerable and not severe.
The authors concluded that there was no significant difference between acupuncture (plus drug) and sham acupuncture (plus drug) with respect to the primary outcome measure of craving for alcohol among participants with AWS, and no difference in completion rates (pooled results). There was limited evidence from individual trials that acupuncture may reduce alcohol craving in the protracted phase and help alleviate psychological symptoms; however, given concerns about the quantity and quality of included studies, further large-scale and well-conducted RCTs are needed.
There is little to add here. Perhaps just two short points:
1. The quality of the trials was poor; only one study of the 11 trials was of acceptable rigor. Here is its abstract:
We report clinical data on the efficacy of acupuncture for alcohol dependence. 503 patients whose primary substance of abuse was alcohol participated in this randomized, single blind, placebo controlled trial. Patients were assigned to either specific acupuncture, nonspecific acupuncture, symptom based acupuncture or convention treatment alone. Alcohol use was assessed, along with depression, anxiety, functional status, and preference for therapy. This article will focus on results pertaining to alcohol use. Significant improvement was shown on nearly all measures. There were few differences associated with treatment assignment and there were no treatment differences on alcohol use measures, although 49% of subjects reported acupuncture reduced their desire for alcohol. The placebo and preference for treatment measures did not materially effect the results. Generally, acupuncture was not found to make a significant contribution over and above that achieved by conventional treatment alone in reduction of alcohol use.
To me, this does not sound all that encouraging.
2. Of the 11 RCTs, 8 failed to report on adverse effects of acupuncture. In my book, this means these trials were in violation with basic research ethics.
My conclusion of all this: another ugly fact kills a beautiful hypothesis.
Acupuncture research does not have a good name; if it originates from China, even less so.
And this note in ‘ACUPUNCTURE IN MEDICINE’ is not likely to change this image:
Fang J, Keller CL, Chen L, et al. Effect of acupuncture and Chinese herbal medicine on subacute stroke outcomes: a single-centre randomised controlled trial. Acupuncture in Medicine Published online first 10 November 2017. doi: 10.1136/acupmed-2016-011167.
This article is retracted by the Editor-in-Chief on grounds of redundant publication.
The above article reports that a trial originally planned to be carried out at three hospitals was reduced to a single centre for reasons of cost. This is incorrect. The full three-centre trial was run and reported elsewhere (Scientific Reports 6, Article number: 25850 (2016) DOI: 10.1038/srep25850).
The Scientific Reports paper was accepted for publication prior to submission of the above paper to Acupuncture in Medicine. The third author takes responsibility for the mistake. All authors have agreed to this retraction.
The abstract of the paper in SCIENTIFIC REPORTS is here:
To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton’s Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation.
I find all this odd in several ways:
- The publication of the ACUPUNCTURE IN MEDICINE article does not seem to have been a ‘mistake‘ but plain scientific fraud, in my view.
- The paper in SCIENTIFIC REPORTS (SR) was published in May 2016. Therefore the reviewers and editor of AIM could and should have spotted the fraud.
- In the SR paper, the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. As the authors were affiliated to three different departments of acupuncture, I feel this to be debatable.
What do you think?
Bee venom acupuncture is a form of acupuncture in which bee venom is applied to the tips of acupuncture needles, stingers are extracted from bees, or bees are held with an instrument exposing the stinger, and applied to acupoints on the skin.
Bee venom consisting of multiple anti-inflammatory compounds such as melittin, adolapin, apamin. Other substances such as phospholipase A2 can be anti-inflammatory in low concentrations and pro-inflammatory in others. However, bee venom also contains proinflammatory substances, melittin, mast cell degranulation peptide 401, and histamine.
Bee venom acupuncture has been used to treat a number of conditions such as lumbar disc disease, osteoarthritis of the knee, rheumatoid arthritis, adhesive capsulitis, lateral epicondylitis, peripheral neuropathies, stroke and Parkinson’s Disease. The quality of these studies tends to be so poor that any verdict on the effectiveness of bee venom acupuncture would be premature.
A new clinical trial of bee-venom acupuncture for rheumatoid arthritis (RA) might change this situation. A total of 120 cases of RA patients were randomized into bee-sting acupuncture group (treatment) and western medicine group (control). The patients of the control group were treated by oral administration of Methotrexate (10 mg, once a week) and Celecoxlb (0.2 g, once a day). Those of the treatment group received 5 to 15 bee stings of Ashi-points or acupoints according to different conditions and corporeity, and with the bee-sting retained for about 5 min every time, once every other day. The treatment lasted for 8 weeks. The therapeutic effect was assessed by examining:
- symptoms and signs of the affected joints as morning stiffness duration,
- swollen/tender joint counts (indexes),
- handgrip strength,
- 15 m-walking time,
- visual analogue scale (VAS),
- Disease Activity Score including a 28-joint count (DAS 28),
- rheumatoid factor (RF),
- erythrocyte sedimentation rate (ESR),
- C-reactive protein (CRP),
- anti-cyclic citrullinated peptide antibody (ACCPA).
For assessing the safety of bee-venom acupuncture, the patients’ responses of fever, enlargement of lymph nodes, regional red and swollen, itching, blood and urine tests for routine were examined.
Findings of DAS 28 responses displayed that of the two 60 cases in the control and bee-venom acupuncture groups, 15 and 18 experienced marked improvement, 33 and 32 were effective, 12 and 10 ineffective, with the effective rates being 80% and 83. 33%, respectively. No significant difference was found between the two groups in the effective rate (P>0.05). After the treatment, both groups have witnessed a marked decrease in the levels of morning stiffness duration, arthralgia index, swollen joint count index, joint tenderness index, 15 m walking time, VAS, RF, ESR, CRP and ACCPA, and an obvious increase of handgrip strength relevant to their own levels of pre-treatment in each group (P<0.05). There were no significant differences between the two groups in the abovementioned indexes (P>0.05). The routine blood test, routine urine test, routine stool test, electrocardiogram result, the function of liver and kidney and other security index were within the normal range, without any significant adverse effects found after bee-stinging treatment.
The authors (from the Department of Acupuncture and Moxibustion, Bao’an Hospital of Traditional Chinese Medicine, Shenzhen, China) concluded that bee-venom acupuncture therapy for RA patients is safe and effective, worthy of popularization and application in clinical practice.
Where to start? There is so much – perhaps I just comment on the conclusion:
- Safety cannot be assessed on the basis of such a small sample. Bee venom can cause anaphylaxis, and several deaths have been reported in patients who successfully received the therapy prior to the adverse event. Because there is no adverse-effect monitoring system, the incidence of adverse events is unknown. Stating that it is safe, is therefore a big mistake.
- The trial was a non-superiority study. As such, it needs a much larger sample to be able to make claims about effectiveness.
- From the above two points, it follows that popularization and application in clinical practice would be a stupid exercise.
So, what is left over from this seemingly rigorous RCT?
(except perhaps a re-affirmation of my often-voiced fear that we must take TCM-studies from China with more than just one pinch of salt)
Traditional Chinese Medicine (TCM) is the umbrella term for modalities historically used in ancient China. TCM includes many therapeutic and some diagnostic modalities. Even though, these modalities differ in many respects, they are claimed to have in common that they are based on assumptions most of which originate from Taoist philosophy:
- The human body is a miniature version of the universe.
- Harmony between the two opposing forces, yin and yang, means health.
- Disease is caused by an imbalance between these forces.
- Five elements—fire, earth, wood, metal, and water—symbolically represent all phenomena, including the stages of human life, and explain the functioning of the body and how it changes during disease.
- The vital energy, qi or chi, flows through the body in meridians, is essential for maintaining health.
TCM is a construct of Mao Zedong who lumped all historical Chinese treatments together under this umbrella and created the ‘barefoot doctor’ to practice TCM nationwide – not because he believed in TCM, but because China was desperately short of real doctors and needed at least a semblance of healthcare.
Over the past few years, China has been aggressively promoting TCM for expanding its global influence and for a share of the estimated US$50-billion global market (of products of dubious quality). A recent article in ‘Nature’ explains that the WHO’s governing body, the World Health Assembly, is set to adopt the 11th version of the organization’s global compendium — known as the International Statistical Classification of Diseases and Related Health Problems (ICD). For the first time, the ICD will include information about TCM. Chapter 26 of the ICD will feature a classification system on TCM, largely based not on science or facts, but on obsolete nonsense.
The WHO’s support applies to all traditional medicines, but its relationship with Chinese medicine, and with China, has grown especially close, in particular during the tenure of Margaret Chan, who ran the organization from 2006 to 2017 and made sure that several documents favourable to TCM were passed. The WHO’s declarations about traditional medicine are puzzling. Various of these WHO documents call for the integration of “traditional medicine, of proven quality, safety and efficacy”, while being silent as to which traditional medicines and diagnostics are proven. Wu Linlin, a WHO representative in the Beijing office, told Nature that the “WHO does not endorse particular traditional and complementary medicine procedures or remedies”.
But this is evidently not the case and in sharp contrast to the WHO’s actions in other areas. The agency provides, for instance, specific advice on what vaccines and drugs to use and what foods to avoid. With traditional medicines, however, such specifics are missing. The message therefore can only be that the WHO endorses TCM as safe and effective.
The evidence, however, tells us a different story. On this blog, we have repeatedly discussed that:
- the clinical trials of TCM are often of poor quality,
- there are several good reasons why one has to be very sceptical about research coming out of China,
- critics are silenced,
- in general, the evidence on TCM is neither positive nor trustworthy.
China’s drug regulator gets more than 230,000 reports of adverse effects from TCM each year, and Chinese herbal medicines carry multiple direct risks:
- one or more ingredients can be toxic,
- some have been shown to be contaminated with toxic materials such as heavy metals,
- others are adulterated with synthetic drugs such as steroids,
- others again can interact with prescription drugs taken concomitantly,
- and not to forget, the risk for endangered species.
To this, we have to add the indirect risk of employing useless treatments for otherwise treatable conditions.
In view of all this, the WHO’s endorsement of TCM and its obsolete concepts is not just not understandable, it is a dangerous step backwards and, in my view, even intolerable.
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 , 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)
Psoriasis is one of those conditions that is
- 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 effectiveness. How 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:
- 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.
- Even top journals do occasionally publish poor-quality and thus misleading reviews.