A comprehensive review of the evidence relating to acupuncture entitled “The Acupuncture Evidence Project: A Comparative Literature Review” has just been published. The document aims to provide “an updated review of the literature with greater rigour than was possible in the past.” That sounds great! Let’s see just how rigorous the assessment is.
The review was conducted by John McDonald who no stranger to this blog; we have mentioned him here, for instance. To call him an unbiased, experienced, or expert researcher would, in my view, be more than a little optimistic.
The review was financed by the ‘Australian Acupuncture and Chinese Medicine Association Ltd.’ – call me a pessimist, but I do wonder whether this bodes well for the objectivity of the findings.
The research seems to have been assisted by a range of experts: Professor Caroline Smith, National Institute of Complementary Medicine, Western Sydney University, provided advice regarding evidence levels for assisted reproduction trials; Associate Professor Zhen Zheng, RMIT University identified the evidence levels for postoperative nausea and vomiting and post-operative pain; Dr Suzanne Cochrane, Western Sydney University; Associate Professor Chris Zaslawski, University of Technology Sydney; and Associate Professor Zhen Zheng, RMIT University provided prepublication commentary and advice. I fail to see anyone in this list who is an expert in EBM or who is even mildly critical of acupuncture and the many claims that are being made for it.
The review has not been published in a journal. This means, it has not been peer-reviewed. As we will see shortly, there is reason to doubt that it could pass the peer-review process of any serious journal.
There is an intriguing declaration of conflicts of interest: “Dr John McDonald was a co-author of three of the research papers referenced in this review. Professor Caroline Smith was a co-author of six of the research papers referenced in this review, and Associate Professor Zhen Zheng was co-author of one of the research papers in this review. There were no other conflicts of interest.” Did they all forget to mention that they earn their livelihoods through acupuncture? Or is that not a conflict?
I do love the disclaimer: “The authors and the Australian Acupuncture and Chinese Medicine Association Ltd (AACMA) give no warranty that the information contained in this publication and within any online updates available on the AACMA website are correct or complete.” I think they have a point here.
But let’s not be petty, let’s look at the actual review and how well it was done!
Systematic reviews must first formulate a precise research question, then disclose the exact methodology, reveal the results and finally discuss them critically. I am afraid, I miss almost all of these essential elements in the document in question.
The methods section includes statements which puzzle me (my comments are in bold):
- A total of 136 systematic reviews, including 27 Cochrane systematic reviews were included in this review, along with three network meta-analyses, nine reviews of reviews and 20 other reviews. Does that indicate that non-systematic reviews were included too? Yes, it does – but only, if they reported a positive result, I presume.
- Some of the included systematic reviews included studies which were not randomised controlled trials. In this case, they should have not been included at all, in my view.
- … evidence from individual randomised controlled trials has been included occasionally where new high quality randomised trials may have changed the conclusions from the most recent systematic review. ‘Occasionally’ is the antithesis of systematic. This discloses the present review as being non-systematic and therefore worthless.
- Some systematic reviews have not reported an assessment of quality of evidence of included trials, and due to time constraints, this review has not attempted to make such an assessment. Say no more!
It is almost needless to mention that the findings (presented in a host of hardly understandable tables) suggest that acupuncture is of proven or possible effectiveness/efficacy for a very wide array of conditions. It also goes without saying that there is no critical discussion, for instance, of the fact that most of the included evidence originated from China, and that it has been shown over and over again that Chinese acupuncture research never seems to produce negative results.
So, what might we conclude from all this?
I don’t know about you, but for me this new review is nothing but an orgy in deceit and wishful thinking!
A new acupuncture study puzzles me a great deal. It is a “randomized, double-blind, placebo-controlled pilot trial” evaluating acupuncture for cancer-related fatigue (CRF) in lung cancer patients. Twenty-eight patients presenting with CRF were randomly assigned to active acupuncture or placebo acupuncture groups to receive acupoint stimulation at LI-4, Ren-6, St-36, KI-3, and Sp-6 twice weekly for 4 weeks, followed by 2 weeks of follow-up. The primary outcome measure was the change in intensity of CFR based on the Chinese version of the Brief Fatigue Inventory (BFI-C). The secondary endpoint was the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS). Adverse events were monitored throughout the trial.
A significant reduction in the BFI-C score was observed at 2 weeks in the 14 participants who received active acupuncture compared with those receiving the placebo. At week 6, symptoms further improved. There were no significant differences in the incidence of adverse events of the two group.
The authors, researchers from Shanghai, concluded that fatigue is a common symptom experienced by lung cancer patients. Acupuncture may be a safe and feasible optional method for adjunctive treatment in cancer palliative care, and appropriately powered trials are warranted to evaluate the effects of acupuncture.
And why would this be puzzling?
There are several minor oddities here, I think:
- The first sentence of the conclusion is not based on the data presented.
- The notion that acupuncture ‘may be safe’ is not warranted from the study of 14 patients.
- The authors call their trial a ‘pilot study’ in the abstract, but refer to it as an ‘efficacy study’ in the text of the article.
But let’s not be nit-picking; these are minor concerns compared to the fact that, even in the title of the paper, the authors call their trial ‘double-blind’.
How can an acupuncture-trial be double-blind?
The authors used the non-penetrating Park needle, developed by my team, as a placebo. We have shown that, indeed, patients can be properly blinded, i. e. they don’t know whether they receive real or placebo acupuncture. But the acupuncturist clearly cannot be blinded. So, the study is clearly NOT double-blind!
As though this were not puzzling enough, there is something even more odd here. In the methods section of the paper the authors explain that they used our placebo-needle (without referencing our research on the needle development) which is depicted below.
Then they state that “the device is placed on the skin. The needle is then gently tapped to insert approximately 5 mm, and the guide tube is then removed to allow sufficient exposure of the handle for needle manipulation.” No further explanations are offered thereafter as to the procedure used.
Removing the guide tube while using our device is only possible in the real acupuncture arm. In the placebo arm, the needle telescopes thus giving the impression it has penetrated the skin; but in fact it does not penetrate at all. If one would remove the guide tube, the non-penetrating placebo needle would simply fall off. This means that, by removing the guide tube for ease of manipulation, the researchers disclose to their patients that they are in the real acupuncture group. And this, in turn, means that the trial was not even single-blind. Patients would have seen whether they received real or placebo acupuncture.
It follows that all the outcomes noted in this trial are most likely due to patient and therapist expectations, i. e. they were caused by a placebo effect.
Now that we have solved this question, here is the next one: IS THIS A MISUNDERSTANDING, CLUMSINESS, STUPIDITY, SCIENTIFIC MISCONDUCT OR FRAUD?
During Voltaire’s time, this famous quote was largely correct. But today, things are very different, and I often think this ‘bon mot’ ought to be re-phrased into ‘The art of alternative medicine consists in amusing the patient, while medics cure the disease’.
To illustrate this point, I shall schematically outline the story of a patient seeking care from a range of clinicians. The story is invented but nevertheless based on many real experiences of a similar nature.
Tom is in his mid 50s, happily married, mildly over-weight and under plenty of stress. In addition to holding a demanding job, he has recently moved home and, as a consequence of lots of heavy lifting, his whole body aches. He had previous episodes of back trouble and re-starts the exercises a physio once taught him. A few days later, the back-pain has improved and most other pains have subsided as well. Yet a dull and nagging pain around his left shoulder and arm persists.
He is tempted to see his GP, but his wife is fiercely alternative. She was also the one who dissuaded Tom from taking Statins for his high cholesterol and put him on Garlic pills instead. Now she gives Tom a bottle of her Rescue Remedy, but after a week of taking it Tom’s condition is unchanged. His wife therefore persuades him to consult alternative practitioners for his ‘shoulder problem’. Thus he sees a succession of her favourite clinicians.
THE CHIROPRACTOR examines Tom’s spine and diagnoses subluxations to be the root cause of his problem. Tom thus receives a series of spinal manipulations and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE ENERGY HEALER diagnoses a problem with Tom’s vital energy as the root cause of his persistent pain. Tom thus receives a series of healing sessions and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE REFLEXOLOGIST examines Tom’s foot and diagnoses knots on the sole of his foot to cause energy blockages which are the root cause of his problem. Tom thus receives a series of most agreeable foot massages and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE ACUPUNCTURIST examines Tom’s pulse and tongue and diagnoses a chi deficiency to be the root cause of his problem. Tom thus receives a series of acupuncture treatments and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE NATUROPATH examines Tom and diagnoses some form of auto-intoxication as the root cause of his problem. Tom thus receives a full program of detox and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE HOMEOPATH takes a long and detailed history and diagnoses a problem with Tom’s vital force to be the root cause of his pain. Tom thus receives a homeopathic remedy tailor-made for his needs and feels a little improved after taking it for a few days. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore tries to make another appointment for him.
But this time, Tom had enough. His pain has not really improved and he is increasingly feeling unwell.
At the risk of a marital dispute, he consults his GP. The doctor looks up Tom’s history, asks a few questions, conducts a brief physical examination, and arranges for Tom to see a specialist. A cardiologist diagnoses Tom to suffer from coronary heart disease due to a stenosis in one of his coronary arteries. She explains that Tom’s dull pain in the left shoulder and arm is a rather typical symptom of this condition.
Tom has to have a stent put into the affected coronary artery, receives several medications to lower his cholesterol and blood pressure, and is told to take up regular exercise, lose weight and make several other changes to his stressful life-style. Tom’s wife is told in no uncertain terms to stop dissuading her husband from taking his prescribed medicines, and the couple are both sent to see a dietician who offers advice and recommends a course on healthy cooking. Nobody leaves any doubt that not following this complex (holistic!) package of treatments and advice would be a serious risk to Tom’s life.
It has taken a while, but finally Tom is pain-free. More importantly, his prognosis has dramatically improved. The team who now look after him have no doubt that a major heart attack had been imminent, and Tom could easily have died had he continued to listen to the advice of multiple non-medically trained clinicians.
The root cause of his condition was misdiagnosed by all of them. In fact, the root cause was the atherosclerotic degeneration in his arteries. This may not be fully reversible, but even if the atherosclerotic process cannot be halted completely, it can be significantly slowed down such that he can live a full life.
My advice based on this invented and many real stories of a very similar nature is this:
- alternative practitioners are often good at pampering their patients;
- this may contribute to some perceived clinical improvements;
- in turn, this perceived benefit can motivate patients to continue their treatment despite residual symptoms;
- alternative practitioner’s claims about ‘root causes’ and holistic care are usually pure nonsense;
- their pampering may be agreeable, but it can undoubtedly cost lives.
It was based on a design-based logistic regression analysis of the European Social Survey (ESS), Round 7. The researchers distinguished 4 modalities: manual therapies, alternative medicinal systems, traditional Asian medical systems and mind-body therapies.
In total, 25.9% of the general population had used at least one of these therapies during the last 12 months which was around one-third of the proportion of those who had visited a general practitioner (76.3%). Typically, only one treatment had been used, and it was used more often as complementary rather than alternative treatment. The usage varied greatly by country (see Table 1 below). Compared to those in good health, the use of CAM was two to fourfold greater among those with health problems. The health profiles of users of different CAM modalities varied. For example, back or neck pain was associated with all types of CAM, whereas depression was associated only with the use of mind-body therapies. Individuals with difficult to diagnose health conditions were more inclined to utilize CAM, and CAM use was more common among women and those with a higher education. Lower income was associated with the use of mind-body therapies, whereas the other three CAM modalities were associated with higher income.
The authors concluded that help-seeking differed according to the health problem, something that should be acknowledged by clinical professionals to ensure safe care. The findings also point towards possible socioeconomic inequalities in health service use.
As I said, this is one of the rare surveys that is worth studying in some detail. This is mainly because it is rigorous and its results are clearly presented. Much of what it reports has been known before (for instance, we showed that the use of CAM in the UK was 26% which ties in perfectly with the 21% figure considering that here only 4 CAMs were included), but it is undoubtedly valuable to see it confirmed based on sound methodology.
Apart of what the abstract tells us, there are some hidden gems from this paper:
- 8% of CAM users had used CAM exclusively (alternative use), without any visits to biomedical professionals in the last 12 months. This may look like a low figure, but I would argue that it is worryingly high considering that alternative usage of CAM has the potential to hasten patients’ deaths.
- The most frequently used CAM treatment was massage therapy, used by 11.9% of the population, followed by homeopathy (5.7%), osteopathy (5.2%), herbal treatments (4.6%), acupuncture (3.6%), chiropractic (2.3%), reflexology (1.7%) and spiritual healing (1.3%). Other modalities (Chinese medicine, acupressure and hypnotherapy) were used by around by 1% or less. The figure for homeopathy is MUCH smaller that the ones homeopaths want us to believe.
- About 9% of healthy survey-participants had used at least one of the CAM modalities during the last 12 months. One can assume that this usage was mostly for disease-prevention. But there is no good evidence for CAM to be effective for this purpose.
- The highest ORs for the use of Traditional Asian Medical Systems were found in Denmark, Switzerland and Israel, followed by Austria, Norway and Sweden. The highest OR for the use of Alternative Medical Systems was found in Lithuania, while manual therapies were most commonly used in Finland, Austria, Switzerland, Germany and Denmark. Moreover, Denmark, Ireland, Slovenia and Lithuania had the highest ORs for using mind-body therapies. France, Spain and Germany presented a common pattern, with relatively similar use of the different modalities. Poland and Hungary had low ORs for use of the different CAM modalities.
But by far the nicest gem, however, comes from my favourite source of misinformation on matters of health, WDDTY. They review the new survey and state this: The patients are turning to alternatives for a range of chronic conditions because they consider the conventional therapy to be inadequate, the researchers say. Needless to point out that this is not a theme that was addressed by the new survey, and therefore its authors also do not draw this conclusion.
Remember Oetzi? Well, he was (almost) Bavarian. He had acupuncture points tattooed all over his body, and he lived more than 5000 years ago. And now the Chinese have the chutzpa to claim having invented acupuncture 3 000 ago. No, they have nicked it from the Bavarians! It’s obvious!
But it gets better.
You must admit this is convincing evidence, if there ever was one.
What does this Bavarian slapping therapy cure?
It is a holistic form of energy healing to cure foremost thirst. You have to drink 1 litre of beer (a herbal infusion of hops and a few other ingredients – also Bavarian, of course) before you start and 2 when it’s over (perfect detox as well!). Moreover it is a better workout than Tai Chi, and it re-balances your vital energies more effectively than any acupuncture needle.
Trust me – I am a (Bavarian) doctor!
Gastro-oesophageal reflux disease (GORD) is a common, benign condition. It can be treated by changing eating habits or drugs. Many alternative therapies are also on offer, for instance, acupuncture. But does it work? Let’s find out.
The objective of this meta-analysis was to explore the effectiveness of acupuncture for the treatment of gastro-oesophageal reflux disease (GORD). Four English and four Chinese databases were searched through June 2016. Randomised controlled trials investigating the effectiveness of manual acupuncture or electroacupuncture (MA/EA) for GORD versus or as an adjunct to Western medicine (WM) were selected.
A total of 12 trials involving 1235 patients were included. The results demonstrated that patients receiving MA/EA combined with WM had a superior global symptom improvement compared with those receiving WM alone with no significant heterogeneity. Recurrence rates of those receiving MA/EA alone were lower than those receiving WM with low heterogeneity, while global symptom improvement (six studies) and symptom scores (three studies) were similar. Descriptive analyses suggested that acupuncture also improves quality of life in patients with GORD.
The authors concluded that this meta-analysis suggests that acupuncture is an effective and safe treatment for GORD. However, due to the small sample size and poor methodological quality of the included trials, further studies are required to validate our conclusions.
I am glad the authors used the verb ‘suggest’ in their conclusions. In fact, even this cautious terminology is too strong, in my view. Here are 9 reasons why:
- The hypothesis that acupuncture is effective for GORD lacks plausibility.
- All the studies were of poor or very poor methodological quality.
- All but one were from China, and we know that all acupuncture trials from this country are positive, thus casting serious doubt on their validity.
- Six trials had the infamous ‘A+B versus B’ design which never generates a negative result.
- There was evidence of publication bias, i. e. negative trials had disappeared and were thus not included in the meta-analysis.
- None of the trials made an attempt to control for placebo effects by using a sham-control procedure.
- None used patient-blinding.
- The safety of a therapy cannot be assessed on the basis of 12 trials
- Seven studies failed to report adverse effects, thus violating research ethics.
Considering these facts, I think that a different conclusion would have been more appropriate: this meta-analysis provides no good evidence for the assumption that acupuncture is an effective and safe treatment for GORD.
The purpose of the study was to compare utilization of conventional psychotropic drugs among patients seeking care for anxiety and depression disorders (ADDs) from general practitioners (GPs) who
- strictly prescribe conventional medicines (GP-CM),
- regularly prescribe homeopathy in a mixed practice (GP-Mx),
- or are certified homeopathic GPs (GP-Ho).
The investigation was an epidemiological cohort study of general practice in France, which included GPs and their patients consulting for ADDs (scoring 9 or more in the Hospital Anxiety and Depression Scale, HADS). Information on all medication utilization was obtained by a standardised telephone interview at inclusion, 1, 3 and 12 months.
Of 1562 eligible patients consulting for ADDs, 710 (45.5 %) agreed to participate. Adjusted multivariate analyses showed that GP-Ho and GP-Mx patients were less likely to use psychotropic drugs over 12 months, compared to GP-CM patients. The rate of clinical improvement (HADS <9) was marginally superior for the GP-Ho group as compared to the GP-CM group, but not for the GP-Mx group.
The authors concluded that patients with ADD, who chose to consult GPs prescribing homeopathy reported less use of psychotropic drugs, and were marginally more likely to experience clinical improvement, than patients managed with conventional care. Results may reflect differences in physicians’ management and patients’ preferences as well as statistical regression to the mean.
Aren’t we glad they added the last sentence to their conclusion!!!
Without it, one might have thought that the observed differences were due to the homeopathic remedies. In fact, the finding amounts to a self-fulfilling prophecy: Homeopaths tend to be against prescribing conventional drugs. This means that patients consulting homeopaths are bound to use less drugs than patients who consult conventional doctors. In that sense, the study was like monitoring whether consumers who go to the butchers buy more meat than those shopping in a shop for vegetarians.
The only result that requires a more serious consideration is that homeopathically treated patients experienced more clinical improvement than those treated conventionally. But even this difference is not hard to explain: firstly, the difference was merely marginal; secondly, patients with ADD are bound to respond particularly well to the empathetic and long therapeutic encounter most homeopaths offer. In other words, the difference had nothing to do with the alleged effectiveness of the homeopathic remedies.
Insomnia is a ‘gold standard’ indication for alternative therapies of all types. In fact, it is difficult to find a single of these treatments that are not being touted for this indication. Consequently, it has become a nice little earner for alternative therapists (hence ‘gold standard’).
But how good is the evidence suggesting that any alternative therapy is effective for insomnia?
Whenever I have discussed this issue on my blog, the conclusion was that the evidence is less than convincing or even negative. Similarly, whenever I conducted proper systematic reviews in this area, the evidence turned out to be weak or negative. Here are four of the conclusions we drew at the time:
- The evidence for acupuncture as a treatment of insomnia is plagued by important limitations, e.g. the poor quality of most primary studies and some systematic reviews. Those that are sensitive to such limitations, fail to arrive at a positive verdict about the effectiveness of acupuncture.
- We conclude that, because of the paucity and of the poor quality of the data, the evidence for the effectiveness of auricular acupuncture for the symptomatic treatment of insomnia is limited. Further, rigorously designed trials are warranted to confirm these results.
- The evidence for valerian as a treatment for insomnia is inconclusive.
- Evidence from RCTs does not show homeopathy to be an effective treatment for insomnia and sleep-related disorders. (FACT, 2011, 16:195-99)
“But this ERNST fellow cannot be trusted, he is not objective!”, I hear some of my detractors shout.
But is he really?
Would an independent, high-level panel of experts arrive at more positive conclusions?
Let’s find out!
This European guideline for the diagnosis and treatment of insomnia recently provided recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to grade the evidence and guide recommendations.
The findings and recommendations are as follows:
- Cognitive behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (strong recommendation, high-quality evidence).
- A pharmacological intervention can be offered if cognitive behavioural therapy for insomnia is not sufficiently effective or not available. Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4 weeks; weak recommendation, moderate-quality evidence). Antihistamines, antipsychotics, melatonin and phytotherapeutics are not recommended for insomnia treatment (strong to weak recommendations, low- to very-low-quality evidence).
- Light therapy and exercise need to be further evaluated to judge their usefulness in the treatment of insomnia (weak recommendation, low-quality evidence).
- Complementary and alternative treatments (e.g. homeopathy, acupuncture) are not recommended for insomnia treatment (weak recommendation, very-low-quality evidence).
I think, I can rest my case.
The goal of this study was to assess clinical outcomes observed among adult patients who received acupuncture treatments at a United States Air Force medical center.
This retrospective chart review was performed at the Nellis Family Medicine Residency in the Mike O’Callaghan Military Medical Center at Nellis Air Force Base in Las Vegas, NV. The charts were from 172 consecutive patients who had at least 4 acupuncture treatments within 1 year. These patients were suffering from a wide range of symptoms, including pain, anxiety and sleep problems. The main outcome measures were prescriptions for opioid medications, muscle relaxants, benzodiazepines, and nonsteroidal anti-inflammatory drugs (NSAIDS) in the 60 days prior to the first acupuncture session and in the corresponding 60 days 1 year later; and Measure Yourself Medical Outcome Profile (MYMOP2) values for symptoms, ability to perform activities, and quality of life.
The most common 10 acupuncture treatments in descending order were: (1) the Auricular Trauma Protocol; (2) Battlefield Auricular Acupuncture; (3) Chinese scalp acupuncture, using the upper one-fifth of the sensory area and the Foot Motor Sensory Area; (4) the Koffman Cocktail; (5) lumbar percutaneous electrical nerve stimulation (PENS); (6) various auricular functional points; (7) Chinese scalp acupuncture, using the frontal triangle pattern; (8) cervical PENS; (9) the Great American Malady treatment; and (10) tendinomuscular meridian treatment with surface release.
The results show that opioid prescriptions decreased by 45%, muscle relaxants by 34%, NSAIDs by 42%, and benzodiazepines by 14%. MYMOP2 values decreased 3.50–3.11 (P < 0.002) for question 1, 4.18–3.46 (P < 0.00001) for question 3, and 2.73–2.43 (P < 0.006) for question 4.
The authors concluded that in this military patient population, the number of opioid prescriptions decreased and patients reported improved symptom control, ability to function, and sense of well-being after receiving courses of acupuncture by their primary care physicians.
The phraseology used by the authors is intriguing; they imply that the clinical outcomes were the result of the acupuncture treatment without actually stating it. This is perhaps most obvious in the title of the paper: Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Association is not causation! But the implication of a cause effect relationship is clearly there. Once we realise who is behind this research we understand why: This study was funded by the ACUS Foundation as part of a Cooperative Research and Development Agreement with the 99th Medical Group, at Nellis Air Force Base.
The mission of Acus Foundation is to educate military physicians in the science and art of medical acupuncture, and to facilitate its integration into conventional military care… we are the most experienced team of physician teachers and practitioners of acupuncture in the United States. If they are so experienced, they surely also know that there are many explanations for the observed outcomes which are totally unrelated to acupuncture, e. g.:
- the natural history of the conditions that were being treated;
- the conventional therapies the soldiers received;
- the regression to the mean;
- social desirability;
- placebo effects.
In fact the results could even indicate that acupuncture caused a delay of clinical improvement; without a control group, we cannot know either way. All we can safely assume from this study is that it is yet another example of promotion masquerading as research.
This new RCT by researchers from the National Institute of Complementary Medicine in Sydney, Australia was aimed at ‘examining the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea’. It had four arms:
- low frequency manual acupuncture (LF-MA),
- high frequency manual acupuncture (HF-MA),
- low frequency electro acupuncture (LF-EA)
- and high frequency electro acupuncture (HF-EA).
A total of 74 women were given 12 treatments over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry.
During the treatment period and 9 month follow-up all groups showed statistically significant reductions in peak and average menstrual pain compared to baseline. However, there were no differences between groups. Health related quality of life increased significantly in 6 domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups. HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups.
The authors concluded that acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.
If I were not used to reading rubbish research of alternative medicine in general and acupuncture in particular, this RCT would amaze me – not so much because of its design, execution, or write-up, but primarily because of its conclusion (why, oh why, I ask myself, did PLOS ONE publish this paper?). They are, I think, utterly barmy.
Let me explain:
- “acupuncture treatment reduced menstrual pain intensity” – oh no, it didn’t; at least this is not what the study proves; the fact that pain was perceived as less could be due to a host of factors, for instance regression towards the mean, or social desirability; as there was no proper control group, nobody can tell;
- the lack of difference between treatments “may be due to a lack of power”. Yes, but more likely it is due to the fact that all versions of a placebo therapy generate similar outcomes.
- “acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials”. Why? Because the authors have a quasi-religious belief in acupuncture? And if they have, why did they not design their study ‘appropriately’?
The best conclusion I can suggest for this daft trial is this: IN THIS STUDY, THE PRIMARY ENDPOINT SHOWED NO DIFFERENCE BETWEEN THE 4 TREATMENT GROUPS. THE RESULTS ARE THEREFORE FULLY COMPATIBLE WITH THE NOTION THAT ACUPUNCTURE IS A PLACEBO THERAPY.
Something along these lines would, in my view, have been honest and scientific. Sadly, in acupuncture research, we very rarely get such honest science and the ‘National Institute of Complementary Medicine in Sydney, Australia’ has no track record of being the laudable exception to this rule.