Monthly Archives: October 2018
Twenty years ago (5 years into my post at Exeter), I published this little article (BJGP, Sept 1998). It was meant as a sort of warning – sadly, as far as I can see, it has not been heeded. Oddly, the article is unavailable on Medline, I therefore take the liberty of re-publishing it here without alterations (if I had to re-write it today, I would not change much) or comment:
Once the omnipotent heroes in white, physicians today are at risk of losing the trust of their patients. Medicine, some would say, is in a deep crisis. Shouldn’t we start to worry?
The patient-doctor relationship, it seems, is at the heart of this argument. Many patients are deeply dissatisfied with this aspect of medicine. A recent survey on patients consulting GPs and complementary practitioners in parallel and for the same problem suggested that most patients are markedly more happy with all facets of the therapeutic encounter as offered by complementary practitioners. This could explain the extraordinary rise of complementary medicine during recent years. The neglect of the doctor-patient relationship might be the gap in which complementary treatments build their nest.
Poor relationships could be due to poor communication. Many books have been written about communications skills with patients. But never mind the theory, the practice of all this may be less optimal than we care to believe. Much of this may simply relate to the usage of language. Common terms such as ‘stomach’, ‘palpitations’, ‘lungs’, for instance, are interpreted in different ways by lay and professional people. Words like ‘anxiety’, ‘depression’, and ‘irritability’ are well defined for doctors, while patients view them as more or less interchangeable. At a deeper level, communication also relates to concepts and meanings of disease and illness. For instance, the belief that a ‘blockage of the bowel’ or an ‘imbalance of life forces’ lead to disease is as prevalent with patients as it is alien to doctors. Even on the most obvious level of interaction with patients, physicians tend to fail. Doctors often express themselves unclearly about the nature, aim or treatment schedule of their prescriptions.
Patients want to be understood as whole persons. Yet modern medicine is often seen as emphazising a reductionistic and mechanistic approach, merely treating a symptom or replacing a faulty part, or treating a ‘case’ rather than an individual. In the view of some, modern medicine has become an industrial behemoth shifted from attending the sick to guarding the economic bottom line, putting itself on a collision course with personal doctoring. This has created a deeply felt need which complementary medicine is all too ready to fill. Those who claim to know the reason for a particular complaint (and therefore its ultimate cure) will succeed in satisfying this need. Modern medicine has identified the causes of many diseases while complementary medicine has promoted simplistic (and often wrong) ideas about the genesis of health and disease. The seductive message usually is as follows: treating an illness allopathically is not enough, the disease will simply re-appear in a different guise at a later stage. One has to tackle the question – why the patient has fallen ill in the first place. Cutting off the dry leaves of a plant dying of desiccation won’t help. Only attending the source of the problem, in the way complementary medicine does, by pouring water on to the suffering plant, will secure a cure. This logic is obviously lop-sided and misleading, but it creates trust because it is seen as holistic, it can be understood by even the simplest of minds, and it generates a meaning for the patient’s otherwise meaningless suffering.
Doctors, it is said, treat diseases but patients suffer from illnesses. Disease is something an organ has; illness is something an individual has. An illness has more dimensions than disease. Modern medicine has developed a clear emphasis on the physical side of disease but tends to underrate aspects like the patient’s personality, beliefs and socioeconomic environment. The body/mind dualism is (often unfairly) seen as a doctrine of mainstream medicine. Trust, it seems, will be given to those who adopt a more ‘holistic’ approach without dissecting the body from the mind and spirit.
Empathy is a much neglected aspect in today’s medicine. While it has become less and less important to doctors, it has grown more and more relevant to patients. The literature on empathy is written predominantly by nurses and psychologists. Is the medical profession about to delegate empathy to others? Does modern, scientific medicine lead us to neglect the empathic attitude towards our patients? Many of us are not even sure what empathy means and confuse empathy with sympathy. Sympathy with the patient can be described as a feeling of ‘I want to help you’. Empathy, on these terms, means ‘I am (or could be) you’; it is therefore some sort of an emotional resonance. Empathy has remained somewhat of a white spot on the map of medical science. We should investigate it properly. Re-integrating empathy into our daily practice can be taught and learned. This might help our patients as well as us.
Lack of time is another important cause for patients’ (and doctors’) dissatisfaction. Most patients think that their doctor does not have enough time for them. They also know from experience that complementary medicine offers more time. Consultations with complementary practitioners are appreciated, not least because they may spend one hour or so with each patient. Obviously, in mainstream medicine, we cannot create more time where there is none. But we could at least give our patients the feeling that, during the little time available, we give them all the attention they require.
Other reasons for patients’ frustration lie in the nature of modern medicine and biomedical research. Patients want certainty but statistics provides probabilities at best. Some patients may be irritated to hear of a 70% chance that a given treatment will work; or they feel uncomfortable with the notion that their cholesterol level is associated with a 60% chance of suffering a heart attack within the next decade. Many patients long for reassurance that they will be helped in their suffering. It may be ‘politically correct’ to present patients with probability frequencies of adverse effects and numbers needed to treat, but anybody who (rightly or wrongly) promises certainty will create trust and have a following.
Many patients have become wary of the fact that ‘therapy’ has become synonymous with ‘pharmacotherapy’ and that many drugs are associated with severe adverse reactions. The hope of being treated with ‘side-effect-free’ remedies is a prime motivator for turning to complementary medicine.
Complementary treatments are by no means devoid of adverse reactions, but this fact is rarely reported and therefore largely unknown to patients. Physicians are regularly attacked for being in league with the pharmaceutical industry and the establishment in general. Power and money are said to be gained at the expense of the patient’s well-being. The system almost seems to invite dishonesty. The ‘conspiracy theory’ goes as far as claiming that ‘scientific medicine is destructive, extremely costly and solves nothing. Beware of the octopus’. Spectacular cases could be cited which apparently support it. Orthodox medicine is described as trying to ‘inhibit the development of unorthodox medicine’, in order to enhance its own ‘power, status and income’. Salvation, it is claimed, comes from the alternative movement which represents ‘… the most effective assault yet on scientific biomedicine’. Whether any of this is true or not, it is perceived as the truth by many patients and amounts to a serious criticism of what is happening in mainstream medicine today.
In view of such criticism, strategies for overcoming problems and rectifying misrepresentations are necessary. Mainstream medicine might consider discovering how patients view the origin, significance, and prognosis of the disease. Furthermore, measures should be considered to improve communication with patients. A diagnosis and its treatment have to make sense to the patient as much as to the doctor – if only to enhance adherence to therapy. Both disease and illness must be understood in their socio-economic context. Important decisions, e.g. about treatments, must be based on a consensus between the patient and the doctor. Scientists must get better in promoting their own messages, which could easily be far more attractive, seductive, and convincing than those of pseudo-science.These goals are by no means easy to reach. But if we don’t try, trust and adherence will inevitably deteriorate further. I submit that today’s unprecedented popularity of complementary medicine reflects a poignant criticism of many aspects of modern medicine. We should take it seriously
Even though illegal and unethical, many remedies used in Traditional Chinese Medicine (TCM) still contain animal parts. This fact has long concerned critics. Not only is there no evidence that these ingredients have any positive health effects, they also endanger the survival of endangered species. In the past, China has paid lip service to conservation and evidence. However, even these half-hearted pronouncements seem to be a thing of the past.
China’s State Council is now replacing its 1993 ban on the trade of tiger bones and rhino horn. Horns of rhinos or bones of tigers that were bred in captivity can hence force be used “for medical research or clinical treatment of critical illnesses” under the new rules. The fact that no critical illness responds to either of these remedies seems to matter little. Grave concern has therefore been voiced by the World Wildlife Fund (WWF) over China’s announcement.
“It is deeply concerning that China has reversed its 25 year old tiger bone and rhino horn ban, allowing a trade that will have devastating consequences globally”, said Margaret Kinnaird, WWF Wildlife Practice Leader. “Trade in tiger bone and rhino horn was banned in 1993. The resumption of a legal market for these products is an enormous setback to efforts to protect tigers and rhinos in the wild. China’s experience with the domestic ivory trade has clearly shown the difficulties of trying to control parallel legal and illegal markets for ivory. Not only could this lead to the risk of legal trade providing cover to illegal trade, this policy will also stimulate demand that had otherwise declined since the ban was put in place.”
Both tiger bone and rhino horn were removed from the TCM pharmacopeia in 1993, and the World Federation of Chinese Medicine Societies released a statement in 2010 urging members not to use tiger bone or any other parts from endangered species. Even if restricted to antiques and use in hospitals, the WWF argue, this trade would increase confusion by consumers and law enforcers as to which products are and are not legal, and would likely expand the markets for other tiger and rhino products. “With wild tiger and rhino populations at such low levels and facing numerous threats, legalized trade in their parts is simply too great a gamble for China to take. This decision seems to contradict the leadership China has shown recently in tackling the illegal wildlife trade, including the closure of their domestic ivory market, a game changer for elephants warmly welcomed by the global community,” Kinnaird added.
WWF calls on China to set a clear plan and timeline to close existing captive tiger breeding facilities used for commercial purposes. Such tiger farms pose a high risk to wild tiger conservation by complicating enforcement and increasing demand in tiger products.
China’s announcement comes at the precise moment when we learnt from the 2018 edition of the Living Planet Report that, between 1970 and 2014, there was 60% decline, on average, among 16,700 wildlife populations around the world. The Living Planet report, issued every two years to track global biodiversity, is based on the Living Planet Index, put out every two years since 1998 in collaboration with the Zoological Society of London and based on international databases of wildlife populations. The two previous reports, in 2014 and 2016, found wildlife population declines of 50% and 58%, respectively, since 1970.
The researcher who proves that highly diluted homeopathics work beyond placebo might be in for a Nobel Prize. The scientist who finds a cure for addictions probably also deserves one. The investigator who does both might get two Nobels. The question is, do these Brazilian homeopaths fulfil these criteria?
Their study investigated the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting. A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence. The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group). The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were recorded in both groups.
The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% compared to 29.8% in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients’ appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group.
The authors concluded that a psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention.
I am glad that the authors mention the high dropout rate which clearly is a serious limitation of this fascinating trial. Had they analysed the data according to an intention to treat analysis – which, I think, would have been a better statistical approach – the results would almost certainly have been negative.
But there are other puzzling issues about this study:
- The authors say they used homeopathic remedies. I think, however, that this is not the case. Homeopathy is defined as a therapy that follows the ‘like cures like’ principle. If the remedy is based on the causative agent, as in the case of the present study, it follows a different principle (identical cures identical) and is not called homeopathy but isopathy (here an explanation from my book: “Isopathy is the use of potentised remedies which are derived from the causative agent of the disease that is being treated. It thus does not follow the supreme law of homeopathy; instead of ‘like cures like’, instead it postulates that identical cures identical. An example of isopathy is the use of potentised grass pollen to treat patients suffering from hay fever. Some of the methodologically best trials that generated a positive result were done using isopathy; they therefore did not test homeopathy and its principal assumption, the ‘like cures like’ theory. They are nevertheless regularly used by proponents of homeopathy to argue that homeopathy is effective”). This means that the above trial does, in fact, NOT test the defining principle of homeopathy.
- Moreover, I fail to understand why the authors called their trial a PILOT study. It does not explore the feasibility of a more definitive trial, but tests the effectiveness of the intervention. It is thus NOT a pilot study.
- I cannot help being suspicious of authors who, based on an extremely implausible, such as homeopathy, publish one paper after the next with positive or encouraging results.
- I am also puzzled by the fact that, in 2012 and 2013, the authors have published two previous studies along the same lines that produced encouraging results. Surely 6/5 years are a long enough period for INDEPENDENT replications to be carried out and published. And surely, a finding like this would have been replicated several times by now.
- I furthermore find it odd that the authors chose to publish their findings in the JOURNAL OF INTEGRATIVE MEDICINE. This is a 3rd class journal read only by those who promote alternative therapies. The notion that a treatment of addiction has finally be found should appear in journals like SCIENCE, NATURE, NEJM, etc.
- Considering the extremely low prior probability of their hypothesis, the authors should perhaps have not used the conventional 5% probability threshold, but one two dimensions lower.
- I have not found a statement regarding informed consent of the study participants.
So, are these Brazilian homeopaths likely to be on the next list of Nobel laureates?
I have my doubts.
What do you think?
Homeopathy for depression? A previous review concluded that the evidence for the effectiveness of homeopathy in depression is limited due to lack of clinical trials of high quality. But that was 13 years ago. Perhaps the evidence has changed?
A new review aimed to assess the efficacy, effectiveness and safety of homeopathy in depression. Eighteen studies assessing homeopathy in depression were included. 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 and 8 weeks.
- The second trial (N = 133), with low risk of bias, found HMPs was comparable to fluoxetine and superior to placebo 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.
I beg to differ!
What these data really show amounts to far less than the authors imply:
- The two ‘double-blind’ trials are next to meaningless. As equivalence studies they were far too small to produce meaningful results. Any decent review should discuss this fact in full detail. Moreover, these studies cannot have been double-blind, because the typical adverse-effects of anti-depressants would have ‘de-blinded’ the trial participants. Therefore, these results are almost certainly false-positive.
- The other studies are even less rigorous and therefore do also not allow positive conclusions.
This review was authored by known proponents of homeopathy. It is, in my view, an exercise in promotion rather than a piece of research. I very much doubt that a decent journal with a responsible peer-review system would have ever published such a biased paper – it had to appear in the infamous EUROPEAN JOURNAL OF INTEGRATIVE MEDICINE.
Who cares? No harm done!
Again, I beg to differ.
The conclusion that homeopathy has a ‘promising risk/benefit profile’ is frightfully dangerous and irresponsible. If seriously depressed patients follow it, many lives might be lost.
Yet again, we see that poor research has the potential to kill vulnerable individuals.
In this RCT tested the effectiveness of foot reflexology and slow stroke back massage on the severity of fatigue in 52 patients treated with hemodialysis. Foot massage and slow stroke back massage were performed during three weeks, two sessions each week, 5 sessions in total. At the end of intervention, data of two groups were collected and compared.
The results show that the fatigue in the group receiving foot reflexology massage decreased significantly more compared to slow stroke back massage group.
The authors concluded that reflexology massage is a safe and economical nursing intervention for decreasing fatigue in hemodialysis patients.
At first glance, this might be a fairly straight forward study comparing two different interventions. One treatment yields better results than the other one, and therefore, this therapy is deemed to be the more effective one.
So far, so good.
The problem is, however, that the authors did not draw the conclusion. Instead they stated that:
- Reflexology is safe.
- Reflexology is economical.
The first point is perhaps true but cannot be concluded from the data presented. Adverse effects were not mentioned; and even if they had been noted, 52 patients is a wholly inadequate size to say anything about safety.
The second point might also be correct, but cannot be named as a conclusion, because the study was not a cost evaluation.
All of this would be hardly worth mentioning – except for the fact that such sloppy errors and illogical conclusions happen with such embarrassing regularity in the realm of alternative medicine. I feel strongly that the ‘Journal of Complementary and Integrative Medicine‘ and all similar publications must get their act together. Publishing articles such as the one discussed here only makes them the laughing stock of real scientists.
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.
Chiropractic is a therapy that has been in search for an indication ever since it was invented some 120 years ago. So far, this search seems to have been unsuccessful.
Perhaps it could be promoted as a means of enhancing athletic performance?
That would be excellent news for chiropractic cash-flow!
The authors of this study wanted to analyse the acute effects of spinal manipulative therapy (SMT) on performance and autonomic modulation. A total of 37 male recreational athletes who had never received SMT were assigned to a sham (n = 19) or actual SMT group (n = 18). Study endpoints included autonomic modulation (heart rate variability), handgrip strength, jumping ability and cycling performance (8-minute time trial [TT]). Differences in custom effects between interventions were determined using magnitude-based inferences.
A significant and very likely lower value of a marker of sympathetic modulation, the stress score, was observed in response to actual compared to sham SMT (p = 0.007; effect size [ES] = -0.97). A trend towards a significant and likely lower sympathetic:parasympathetic ratio (p = 0.055; ES = -0.96) and a likely higher natural logarithm of the root-mean-square differences of successive heartbeat intervals ([LnRMSSD], p = 0.12; ES = 0.36) was also found with actual SMT. Moreover, a significantly lower mean power output was observed during the TT with actual compared with sham SMT (p = 0.035; ES = -0.28). Non-significant (p > 0.05) and unclear or likely trivial differences (ES < 0.2) were found for the rest of endpoints, including handgrip strength, heart rate during the TT, and jump loss thereafter.
A single pre-exercise SMT session induced an acute shift towards parasympathetic dominance and slightly impaired performance in recreational healthy athletes.
The search was unsuccessful yet again!
SMT impaired performance; this might not convince athletes to become fans of chiropractic.
What indication should the desperate chiros try next?
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?
The authors of this paper wanted to establish and compare the effectiveness of Healing Touch (HT) and Oncology Massage (OM) therapies on cancer patients’ pain. They conducted pre-test/post-test, observational, retrospective study. A total of 572 outpatient oncology were recruited and asked to report pain before and after receiving a single session of either HT or OM from a certified practitioner.
Both HT and OM significantly reduced pain. Unadjusted rates of clinically significant pain improvement (defined as ≥2-point reduction in pain score) were 0.68 HT and 0.71 OM. Adjusted for pre-therapy pain, OM was associated with increased odds of pain improvement. For patients with severe pre-therapy pain, OM was not more effective in yielding clinically significant pain reduction when adjusting for pre-therapy pain score.
The authors concluded that both HT and OM provided immediate pain relief. Future research should explore the duration of pain relief, patient attitudes about HT compared with OM, and how this may differ among patients with varied pretherapy pain levels.
This paper made me laugh out loud; no, not because of the ‘certified’ practitioners (in the UK, we use this term to indicate that someone is not quite sane), but because of the admission that the authors aimed at establishing the effectiveness of their therapies. Most researchers of alternative medicine have exactly this motivation, but few make the mistake to write it into the abstract of their papers. Little do they know that this admission discloses a fatal amount of bias. Science is supposed to test hypotheses, and researchers who aim at establishing the effectiveness of their pet-therapy oust themselves as pseudo-researchers.
It comes therefore as no surprise that the study turns out to be a pseudo-study. As there was no adequate control group, these outcomes cannot be attributed to the interventions administered. The results could therefore be due to:
- the time that has passed;
- regression to the mean;
- the attention provided by the therapists;
- the expectation of the patient;
- social desirability;
- all of the above.
It follows that – just as with the study discussed in the previous post – the conclusion is wholly misleading. In fact, the data are consistent with the hypothesis that HT and OM both aggravated the pain (the results might have been better without HT and OM). The devils advocate concludes that both HT and OM provided an immediate increase in pain.