Several previously published clinical trials have suggested that both acupuncture and sham acupuncture exert significant, non-specific effects on treatment outcomes when compared to no-treatment controls. A recently developed framework (mechanisms in orthodox and complementary and alternative medicine-MOCAM) suggests that the non-specific effects of acupuncture originate from multiple domains (e.g. patient characteristics, acupuncturist skill/technique, the patient-acupuncturist relationship, and the acupuncture environment). However, it remains to be determined precisely how these domains influence the non-specific effects of treatment among patients receiving acupuncture and sham acupuncture in clinical trials.
To address this issue, researchers conducted a systematic review to synthesize existing qualitative evidence on how trial participants randomized to acupuncture and sham acupuncture groups experience non-specific effects, regardless of the types of medical conditions investigated.
This systematic review included primary qualitative studies embedded in randomized controlled trials designed to investigate acupuncture or sham acupuncture interventions. Eligible studies published in English were derived from a search of five international databases. The methodological quality of included studies was evaluated using the Critical Appraisal Skills Programme (CASP) tool. Using a framework synthesis approach, the identified MOCAM framework was adapted based on the synthesis of the available qualitative evidence.
A total of 20 studies of high methodological quality were included. The proposed model indicated that the effects of acupuncture may be increased by:
- maintaining a professional status,
- applying a holistic treatment approach,
- practicing empathy,
- providing patients with an appropriate explanation of the theory behind acupuncture and sham acupuncture.
From the patient’s perspective, the efficacy of treatment can be increased by:
- following the lifestyle modification advice provided by acupuncturists,
- maintaining a positive attitude toward treatment efficacy,
- actively engaging with acupuncturists during the consultation,
- making behavioral changes based on experience gained during the trial.
The authors concluded that the results of this study may provide a basis for improving and standardizing key components of non-specific effects in acupuncture treatment, and for improving the isolation of specific effects in future clinical trials involving acupuncture and sham acupuncture.
The authors also state that having a positive attitude and high expectations regarding treatment efficacy can lead to positive health outcomes, along with a sense of curiosity and altruistic desire to join clinical trials. Indeed, previous clinical trials have reported that higher expectations regarding treatment effects may help to reduce fatigue and alleviate osteoarthritis in both acupuncture and sham acupuncture groups. Similar benefits of positive expectations have also been observed among patients with irritable bowel syndrome in sham acupuncture trials.
SO CLOSE AND YET SO FAR!
So close to admitting that these findings indicate quite strongly that acupuncture is but a theatrical placebo.
My ‘ALTERNATIVE MEDICINE HALL OF FAME’ is filling up nicely. But I noticed that so far we have nobody from Spain. That can be rectified ever so easily. I think I found the ideal candidate to join this group of illustrious experts who never bring themselves to publish a negative conclusion: JORGE VAS.
Jorge Vas works at the ‘Pain Treatment Unit, Doña Mercedes Primary Health Care Center, Dos Hermanas’ in Spain. I have long noticed his research which is focused on ACUPUNCTURE. From memory, I had the impression that his findings are always positive.
But is this true? To find out, I did a Medline search and found 11 clinical trials of acupuncture in his name, published between 2006 and 2019. Here are the conclusions:
- After 2 weeks of treatment, ear acupuncture applied by midwives and associated with standard obstetric care significantly reduces lumbar and pelvic pain in pregnant women, improves quality of life and reduces functional disability.
- Individualised acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualised acupuncture in patients with fibromyalgia is recommended.
- The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services.
- …all 3 modalities of acupuncture were better than conventional treatment alone…
- Moxibustion treatment applied at acupuncture point BL67 can avoid the need for caesarean section and achieve cost savings for the healthcare system in comparison with conventional treatment.
- The application of auriculopressure in patients with non-specific spinal pain in primary healthcare is effective and safe, and therefore should be considered for inclusion in the portfolio of primary healthcare services.
- The degree of pain relief experienced by patients from acupuncture justifies a more rigorous study.
- Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus.
- Single-point acupuncture in association with physiotherapy improves shoulder function and alleviates pain, compared with physiotherapy as the sole treatment. This improvement is accompanied by a reduction in the consumption of analgesic medicaments.
- Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic treatment of osteoarthritis of the knee.
- In the treatment of the intensity of chronic neck pain, acupuncture is more effective than the placebo treatment and presents a safety profile making it suitable for routine use in clinical practice.
Eleven of 11 trials with a positive conclusion!
That surely is a rare feast.
Actually, I cheated a tiny bit. The unabridged sentence from the conclusion of paper N4 was: In the analysis adjusted for the total sample (true acupuncture relative risk 5.04, 95% confidence interval 2.24-11.32; sham acupuncture relative risk 5.02, 95% confidence interval 2.26-11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21-5.46), as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were better than conventional treatment alone, but there was no difference among the 3 acupuncture modalities, which implies that true acupuncture is not better than sham or placebo acupuncture. Thus this (multicentre) study was negative with just a touch of positivity.
But still, look at the range of conditions that respond positively to acupuncture in Vas’ hands. Is there anyone who doubts that Jorge Vas does not deserve to join all these other geniuses in THE ALTERNATIVE MEDICINE HALL OF FAME?
- Andreas Michalsen ( various SCAMs, Germany)
- Jennifer Jacobs (homeopath, US)
- Jenise Pellow (homeopath, South Africa)
- Adrian White (acupuncturist, UK)
- Michael Frass (homeopath, Austria)
- Jens Behnke (research officer, Germany)
- John Weeks (editor of JCAM, US)
- Deepak Chopra (entrepreneur, US)
- Cheryl Hawk (US chiropractor)
- David Peters (osteopathy, homeopathy, UK)
- Nicola Robinson (TCM, UK)
- Peter Fisher (homeopathy, UK)
- Simon Mills (herbal medicine, UK)
- Gustav Dobos (various SCAMs, Germany)
- Claudia Witt (homeopathy, Germany/Switzerland)
- George Lewith (acupuncture, UK)
- John Licciardone (osteopathy, US)
I am sure that Vas has more than merited to join them.
WELCOME JORGE VAS!
The state of acupuncture research has long puzzled me. The first thing that would strike who looks at it is its phenomenal increase:
- Until around the year 2000, Medline listed about 200 papers per year on the subject.
- From 2005, there was a steep, near-linear increase.
- It peaked in 2020 when we had a record-breaking 20515 acupuncture papers currently listed in Medline.
Which this amount of research, one would expect to get somewhere. In particular, one would hope to slowly know whether acupuncture works and, if so, for which conditions. But this is not the case.
On the contrary, the acupuncture literature is a complete mess in which it gets more and more difficult to differentiate the reliable from the unreliable, the useful from the redundant, and the truth from the lies. Because of this profound confusion, acupuncture fans are able to claim that their pet-therapy is demonstrably effective for a wide range of conditions, while skeptics insist it is a theatrical placebo. The consumer might listen in bewilderment.
Yesterday (18/1/2021), I had a quick (actually, it was not that quick after all) look into what Medline currently lists in terms of new acupuncture research published in 2021 and found a few other things that are remarkable:
- There were already 100 papers dated 2021 (today, there were even 118); that corresponds to about 5 new articles per day and makes acupuncture one of the most research-active areas of so-called alternative medicine (SCAM).
- Of these 100 papers, only 7 were clinical trials (CTs). In my view, clinical trials would be more important than any other type of research on acupuncture. To see that they amount to just 7% of the total is therefore disappointing.
- Twelve papers were systematic reviews (SRs). It is odd, I find, to see almost twice the amount of SRs than CTs.
- Eighteen papers referred to protocols of studies of SRs. In particular protocols of SRs are useless in my view. It seems to me that the explanation for this plethora of published protocols might be the fact that Chinese researchers are extremely keen to get papers into Western journals; it is an essential boost to their careers.
- Seven papers were surveys. This multitude of survey research is typical for all types of SCAM.
- Twenty-four articles were on basic research. I find basic research into an ancient therapy of questionable clinical use more than a bit strange.
- The rest of the articles were other types of publications and a few were misclassified.
- The vast majority (n = 81) of the 100 papers were authored exclusively by Chinese researchers (and a few Korean). In view of the fact that it has been shown repeatedly that practically all acupuncture studies from China report positive results and that data fabrication seems rife in China, this dominance of China could be concerning indeed.
Yes, I find all this quite concerning. I feel that we are swamped with plenty of pseudo-research on acupuncture that is of doubtful (in many cases very doubtful) reliability. Eventually, this will create an overall picture for the public that is misleading to the extreme (to check the validity of the original research is a monster task and way beyond what even an interested layperson can do).
And what might be the solution? I am not sure I have one. But for starters, I think, that journal editors should get a lot more discerning when it comes to article submissions from (Chinese) acupuncture researchers. My advice to them and everyone else:
if it sounds too good to be true, it probably is!
So-called alternative medicine (SCAM) is, as we all know, an umbrella term. Under this umbrella, we find hundreds of different modalities that have little in common with each other. Here I often focus on:
- herbal medicine.
There are uncounted others, and in my recent book, I published critical evaluations 150 of them. But for the moment, let’s keep to the 4 SCAMs listed above.
What strikes me regularly is that many SCAM enthusiasts do seem to appreciate my critical assessments of SCAM; for instance:
- When I point out that the assumptions of homeopathy fly in the face of science, most SCAM enthusiasts agree.
- When I point out that chiropractic spinal manipulations might not be safe, most SCAM enthusiasts agree.
- When I point out that acupuncture is not a panacea, most SCAM enthusiasts agree.
- When I point out that herbal remedies can interact with prescribed drugs, most SCAM enthusiasts agree.
Most but not all!
- Those who find my criticism of homeopathy unfair are the homeopaths and their proponents.
- Those who find my criticism of chiropractic unfair are the chiropractors and their proponents.
- Those who find my criticism of acupuncture unfair are the acupuncturists and their proponents.
- Those who find my criticism of herbal medicine unfair are the herbalists and their proponents.
Hardly ever does a herbalist defend homeopathy’s weird assumptions; rarely does an acupuncturist tell me that I am too harsh with the chiropractors; never have I heard a chiropractor complain that my criticism of acupuncture is unjustified.
But I find it nevertheless curious, because my critical stance is always the same. I do not change it for this or that form of SCAM (I would also not change it for conventional medicine, but I leave it to those who have more specific expertise to do the criticising). I have no axe to grind against any particular SCAM. All I do is point out flaws in their logic, limitations in their studies, gaps in the evidence. All I do is provide my honest interpretation of the evidence.
It really seems to me that everyone appreciates my honesty, until I start being honest with them.
And this is why I find it curious. Homeopaths, chiropractors, acupuncturists, herbalists and all the other types of SCAM practitioners like to be seen on the side of science, evidence, critical thinking and progress. This, I suppose, is good for the (self) image; it might even help the delusion that they are all evidence-based. But as soon as someone applies science, evidence, critical thinking and progress to their very own little niche within SCAM, they stop liking it and start aggressing the critic.
I suppose this is entirely obvious as well?
But it also exposes the double standard that is so deeply ingrained in SCAM.
This is an analysis that I have long hesitated to conduct. The reason for my hesitation is simple: some people might think it is vindictive, revengeful or ad hominem. After reflecting about it for years, I have now decided to go ahead with it (sorry, it’s a bit lengthy). This case study is not meant to be vindictive, but offers an important insight into the power of conflicts of interest in SCAM that are not financial but ideological. I think it is crucial that people are aware of and consider such conflicts carefully, and I can’t see how else I might demonstrate my point so plainly.
Dr Adrian White was a co-worker of mine for about 10 years. He became a trusted colleague, my ‘right hand’ man and even my deputy at my Exeter department. When I discovered that my trust had been misplaced, I did not prolong his contract (I will not dwell on this episode, those who are interested find it in my memoir). Adrian then got a senior research fellowship with Prof John Campbell (not my favourite colleague at Exeter) at the department of general practice where he continued his research on acupuncture for about 10 more years largely unsupervised.
Adrian had been an acupuncturist body and soul (in fact, I had never before met anyone so utterly convinced of the value of this therapy). When he joined my team, he was scientifically naive, and we spent many month trying to teach him how to think like a scientist. Initially, he found it very difficult to think critically about acupuncture. Later, I thought the problem was under control. Yet, most of his research in my department was guided by me and tightly supervised (i.e. I made sure that out studies were testing rather than promoting SCAM, and that our reviews were critical assessments of the existing evidence).
Thus there exist two separate and well-documented periods of a pro-acupuncture researcher:
- 10 years guided by me and members of my team;
- 10 years largely unsupervised.
What could be more tempting than to compare Adrian’s output during these two periods?
To do this, I looked up all of Adrian’s 120 publications on acupuncture and selected those 52 articles that generated factual new data (mostly clinical trials or systematic reviews). As it happens, they are numerically distributed almost equally within the two periods. The endpoints for my analysis were the directions of the conclusions of his papers. I therefore extracted, dated, and rated the 52 articles as follows:
- P = positive from the point of view of an acupuncture advocate,
- N = negative from the point of view of an acupuncture advocate.
- P/N = not clearly pointing in either direction.
To render this exercise transparent (occasionally, I was not entirely sure about my ratings), I copied all the 52 conclusions and provided links to the original papers so that anyone inferested is able to check easily.
Here are my findings. Articles 1 – 27 were published AFTER Adrian had left my department; articles 28 – 52 are his papers from the time while he worked with me.
- A definitive three-arm trial is feasible. Further follow-up reminders, minimum data collection and incentives should be considered to improve participant retention in the follow-up processes in the standardised advice and exercise booklet arm. (2016) P/N
- The available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking. (2016) P
- The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials – particularly comparing acupuncture with other treatment options – are needed. (2016) P
- Acupuncture during pregnancy appears to be associated with few AEs when correctly applied. (2014) P
- Although pooled estimates suggest possible short-term effects there is no consistent, bias-free evidence that acupuncture, acupressure, or laser therapy have a sustained benefit on smoking cessation for six months or more. However, lack of evidence and methodological problems mean that no firm conclusions can be drawn. Electrostimulation is not effective for smoking cessation. Well-designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions. (2014) P
- The current evidence suggests that acupuncture may have some effects on drug dependence that have been missed because of choice of outcome in many previous studies, and future studies should use outcomes suggested by clinical experience. Body points and electroacupuncture, used in the original clinical observation, justify further research. (2013) P
- Acceptability is very high and may be maximised by taking a number of factors into account: full information should be provided before treatment begins; flexibility should be maintained in the appointment system and different levels of contact between fellow patients should be fostered; sufficient space and staffing should be provided and single-sex groups used wherever possible. (2012) P
- This is the first evaluation of nurse-led group (multibed) acupuncture clinics for patients with knee osteoarthritis to include a 2 year follow-up. It shows the practicability of offering a low-cost acupuncture service as an alternative to knee surgery and the service’s success in providing long-term symptom relief in about a third of patients. Using realistic assumptions, the cost consequences for the local commissioning group are an estimated saving of £100 000 a year. Sensitivity analyses are presented using different assumptions. (2012) P
- There is no consistent, bias-free evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation, but lack of evidence and methodological problems mean that no firm conclusions can be drawn. Further, well designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions. (2011) P/N
- Eight (8) of 10 international acupuncture experts were able to reach consensus on the syndromes, symptoms, and treatment of postmenopausal women with hot flashes. The syndromes were similar to those used by practitioners in the ACUFLASH clinical trial, but there were considerable differences between the acupuncture points. This difference is likely to be the result of differences in approach of training schools, and whether it is relevant for clinical outcomes is not well understood. (2011) P
- 70% of those patients eligible to participate volunteered to do so; all participants had clinically identified MTrPs; a 100% completion rate was achieved for recorded self-assessment data; no serious adverse events were reported as a result of either intervention; and the end of treatment attrition rate was 17%. A phase III study is both feasible and clinically relevant. This study is currently being planned. (2010) P
- In conclusion, the results from all studies are in agreement with the hypothesis that acupuncture needling relieves hot flushes. There are few data however supporting the hypothesis that the effect of acupuncture is point specific. Future research should investigate whether there is a biological effect of needling on hot flushes or not, whether tailored treatment is superior to standardised treatment, and ways of delivering treatment that causes least discomfort and least cost. (2010) P
- Acupuncture can contribute to a more rapid reduction in vasomotor symptoms and increase in health-related quality of life in postmenopausal women but probably has no long-term effects. (2010) P
- within the context of this pilot study, the sham acupuncture intervention was found to be a credible control for acupuncture. This supports its use in a planned, definitive, randomised controlled trial on a similar whiplash injured population. (2009) N/P
- factors other than the TCM syndrome diagnoses and the point selection may be of importance regarding the outcome of the treatment. (2009) N/P
- Acupuncture plus self-care can contribute to a clinically relevant reduction in hot flashes and increased health-related quality of life in postmenopausal women. (2009) P
- the authors conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches. (2009) P
- there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of ‘true’ acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment. (2009) P
- We have conducted the first survey of the effects of provision of acupuncture in UK general practice, using data provided by the NHS, and uncovered a wide variation in the availability of the service in different areas. We have been unable to demonstrate any consistent differences in the prescribing or referral rates that could be due to the use of acupuncture in these practices. The wide variation in the data means that if such a trend exists, a very large survey would be needed to identify it. However, we discovered inaccuracies and variations in presentation of data by the PCTs which have made the numerical input, and hence our results, unreliable. Thus the practicalities of access to data and the problems with data accuracy would preclude a nationwide survey. (2008) P
- In conclusion, there is limited evidence deriving from one study that deep needling directly into myofascial trigger points has an overall treatment effect when compared with standardised care. Whilst the result of the meta-analysis of needling compared with placebo controls does not attain statistically significant, the overall direction could be compatible with a treatment effect of dry needling on myofascial trigger point pain. However, the limited sample size and poor quality of these studies highlights and supports the need for large scale, good quality placebo controlled trials in this area. (2009) P
- We conclude that limited evidence supports acupuncture use in treating pregnancy-related pelvic and back pain. Additional high-quality trials are needed to test the existing promising evidence for this relatively safe and popular complementary therapy. (2008) P
- Acupuncture appears to offer symptomatic improvement to some patients with fibromyalgia in a tertiary clinic who have failed to respond to other treatments. In view of its safety, further acupuncture research is justified in this population. (2007) P
- It is speculated that optimal results from acupuncture treatment for osteoarthritis of the knee may involve: climatic factors, particularly high temperature; high expectations of patients; minimum of four needles; electroacupuncture rather than manual acupuncture, and particularly, strong electrical stimulation to needles placed in muscle; and a course of at least 10 treatments. These factors offer some support to criteria for adequate acupuncture used in the recent review. In addition, ethnic and cultural factors may influence patients’ reporting of their symptoms, and different versions of an outcome measure are likely to differ in their sensitivity – both factors which may lead to apparent rather than real differences between studies. The many variables in a study are likely to be more tightly controlled in a single centre study than in multicentre studies. (2007) P
- Any effects of acupressure on smoking withdrawal, as an adjunct to the use of NRT and behavioural intervention, are unlikely to be detectable by the methods used here and further preliminary studies are required before the hypothesis can be tested. (2007) P
- Auricular acupuncture appears to be effective for smoking cessation, but the effect may not depend on point location. This calls into question the somatotopic model underlying auricular acupuncture and suggests a need to re-evaluate sham controlled studies which have used ‘incorrect’ points. Further experiments are necessary to confirm or refute these observational conclusions. (2006) P
- Acupuncture that meets criteria for adequate treatment is significantly superior to sham acupuncture and to no additional intervention in improving pain and function in patients with chronic knee pain. Due to the heterogeneity in the results, however, further research is required to confirm these findings and provide more information on long-term effects. (2007) P
- There is no consistent evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation, but methodological problems mean that no firm conclusions can be drawn. Further research using frequent or continuous stimulation is justified. (2006) N/P
- Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients. (2005) N
- The evidence from controlled trials is insufficient to conclude whether acupuncture is an effective treatment for depression, but justifies further trials of electroacupuncture. (2005) N
- Acupuncture effectively relieves chronic low back pain. No evidence suggests that acupuncture is more effective than other active therapies. (2005) N/P
- In view of the small number of studies and their variable quality, doubt remains about the effectiveness of acupuncture for gynaecological conditions. Acupuncture and acupressure appear promising for dysmenorrhoea, and acupuncture for infertility, and further studies are justified. (2003) N
- In conclusion, the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects, and is inactive, where the specific needle sensation (de qi) is taken as a surrogate measure of activity. It is therefore a valid control for acupuncture trials. The findings also lend support to the existence of de qi, a major concept underlying traditional Chinese acupuncture. (2002) N/P
- There is no clear evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation. (2002) N
- Collectively, these data imply that acupuncture is superior to various control interventions, although there is insufficient evidence to state whether it is superior to placebo. (2002) N/P
- In conclusion, the incidence of adverse events following acupuncture performed by doctors and physiotherapists can be classified as minimal; some avoidable events do occur. Acupuncture seems, in skilled hands, one of the safer forms of medical intervention. (2001) N/P
- Based on the evidence of rigorous randomised controlled trials, there is no compelling evidence to show that acupuncture is effective in stroke rehabilitation. Further, better-designed studies are warranted. (2001) N
- Although it has already been demonstrated that severe adverse events seem to be uncommon in standard practice, many serious cases of negligence have been found in the present review, suggesting that training system for acupuncturists (including medical doctors) should be improved and that unsupervised self-treatment should be discouraged. (2001) N
- Direct needling of myofascial trigger points appears to be an effective treatment, but the hypothesis that needling therapies have efficacy beyond placebo is neither supported nor refuted by the evidence from clinical trials. Any effect of these therapies is likely because of the needle or placebo rather than the injection of either saline or active drug. Controlled trials are needed to investigate whether needling has an effect beyond placebo on myofascial trigger point pain. (2001) N/P
- Although the incidence of minor adverse events associated with acupuncture may be considerable, serious adverse events are rare. Those responsible for establishing competence in acupuncture should consider how to reduce these risks. (2001) N
- In conclusion, this study does not provide evidence that this form of acupuncture is effective in the prevention of episodic tension-type headache. (2000) N
- The present study provides no strong evidence to support the hypothesis that the acupuncture point SP6 is more tender in women and in men. Recommendations for further investigations are discussed. (2000) N
- Acupuncture has not been demonstrated to be efficacious as a treatment for tinnitus on the evidence of rigorous randomized controlled trials. (2000) N
- We conclude that acupuncture continues to be associated with occasional, serious adverse events and fatalities. These events have no geographical limits. Most of these events are due to negligence. Everyone concerned with setting standards, delivering training, and maintaining competence in acupuncture should familiarise themselves with the lessons to be learnt from these untoward events. (2000) N
- Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurrent headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions. (1999) N/P
- While the frequency of adverse effects of acupuncture is unknown and they may be rare, knowledge of normal anatomy and anatomical variations is essential for safe practice and should be reviewed by regulatory bodies and those responsible for training courses. (1999) N
- In conclusion, the hypothesis that acupuncture is efficacious in the treatment of neck pain is not based on the available evidence from sound clinical trials. Further studies are justified. (1999) N
- Even though all studies are in accordance with the notion that acupuncture is effective for temporomandibular joint dysfunction, this hypothesis requires confirmation through more rigorous investigations. (1999) N
- Acupuncture is not free of risks. All adverse events reported in 1997 would have been avoidable. The absolute number of cases is small, but the degree of underreporting remains unknown. (1999) N
- This form of electroacupuncture is no more effective than placebo in reducing nicotine withdrawal symptoms. (1998) N
- Acupuncture was shown to be superior to various control interventions, although there is insufficient evidence to state whether it is superior to placebo. (1998) N/P
- Considerable variation was observed in the scores awarded by the acupuncture experts. (1998) N
- It is therefore concluded that, according to the data published to date, the evidence that acupuncture is a useful adjunct for stroke rehabilitation is encouraging but not compelling. More and better trials are required to clarify this highly relevant issue. (1996) N
The results are remarkable (particularly considering that one would not expect unbiased studies or reviews of acupuncture to generate plenty of positive conclusions):
0 times N, 5 times N/P, 22 times P – after Adrian had left my department,
17 times N, 7 times N/P, 0 times P – while Adrian worked in my department.
From these figures, it is tempting to calculate the ratios for both periods of negative : positive conclusions:
zero versus infinite
If that is not impressive, I don’t know what is!
Looking just at the positive and the negative papers over the years:
One could discuss these papers in more detail, but I think this is hardly necessary. Just a few highlights perhaps: look at articles No 5, 20 and 27 for examples of turning an essentially negative finding into a positive conclusion. Notice that Adrian conducted a clinical trial of acupuncture for smoking cessation (No 49) while working with me and later published uncritical positive reviews on the subject. Does this not indicate that he distrusted his own study because it had not generated the result he had hoped for?
Of course, my analysis is merely a case study and therefore my findings are not generalisable. However, in my personal experience, the described phenomenon is by no means an exception in SCAM research. I have observed similar phenomena over and over again. Just look at the ALTERNATIVE MEDICINE HALL OF FAME that I created for this blog:
- John Weeks (editor of JCAM)
- Deepak Chopra (US entrepreneur)
- Cheryl Hawk (US chiropractor)
- David Peters (osteopathy, homeopathy, UK)
- Nicola Robinson (TCM, UK)
- Peter Fisher (homeopathy, UK)
- Simon Mills (herbal medicine, UK)
- Gustav Dobos (various, Germany)
- Claudia Witt (homeopathy, Germany and Switzerland)
- George Lewith (acupuncture, UK)
- John Licciardone (osteopathy, US)
But Adrian’s case might be unique because it allows us to make a longitudinal observation over two decades. And it suggests to me that an ideological bias can (and often is) so strong and indistructable that is re-emerges as soon as it is no longer kept under strict control.
I have long suspected that ideological conflicts of interest have a much more powerful influence in SCAM research than financial ones. Such an overpowering influence might even be characteristic to much of SCAM research. And because it can be so dominant, it seems important to know about. People reading research need to be aware that it originates from a biased source, and funders who finance research would be wise to think twice about supporting researchers who are likely to generate findings that are biased and therefore false-positive. In the final analysis, such research is worse than no research at all.
This systematic review and meta-analysis was aimed at investigating the effect and safety of acupuncture for the treatment of chronic spinal pain.
The authors included 22 randomized controlled trials (RCTs) involving patients with chronic spinal pain treated by acupuncture versus sham acupuncture, no treatment, or another treatment were included. Chronic spinal pain was defined as:
- chronic neck pain,
- chronic low back pain,
- or sciatica for more than 3 months.
Fourteen studies had a high risk of bias, 5 studies had a low risk of bias, and 5 studies had an unclear risk of bias. Pooled analysis revealed that:
- acupuncture can reduce chronic spinal pain compared to sham acupuncture (weighted mean difference [WMD] -12.05, 95% confidence interval [CI] -15.86 to -8.24),
- acupuncture can reduce chronic spinal pain compared to mediation control (WMD -18.27, 95% CI -28.18 to -8.37),
- acupuncture can reduce chronic spinal pain compared to usual care control (WMD -9.57, 95% CI -13.48 to -9.44),
- acupuncture can reduce chronic spinal pain compared to no treatment control (WMD -17.10, 95% CI -24.83 to -9.37).
In terms of functional disability, acupuncture can improve physical function at
- immediate-term follow-up (standardized mean difference [SMD] -1.74, 95% CI -2.04 to -1.44),
- short-term follow-up (SMD -0.89, 95% CI -1.15 to -0.62),
- long-term follow-up (SMD -1.25, 95% CI -1.48 to -1.03).
Trials assessed as having a high risk of bias (WMD −13.45, 95% CI −17.23 to −9.66, I 2 96.2%, moderate-quality evidence, including 14 studies and 1379 patients) found greater effects of acupuncture treatment than trials assessed as having a low risk of bias (WMD −11.99, 95% CI −13.94 to −10.03, I 2 44.6%, high-quality evidence, including 4 studies and 432 patients), but smaller effects than trials assessed as having an unclear risk of bias (WMD −14.51, 95% CI −17.25 to −11.78, I 2 0%, high-quality evidence, including 3 studies and 190 patients).
Only 6 trials provided information on adverse events. No trial reported data on serious adverse events during acupuncture treatment. The most frequent adverse events were temporarily worsened pain and needle pain at the acupuncture site, which can decrease quickly after a short period of rest.
The authors concluded that compared to no treatment, sham acupuncture, or conventional therapy such as medication, massage, and physical exercise, acupuncture has a significantly superior effect on the reduction in chronic spinal pain and function improvement. Acupuncture might be an effective treatment for patients with chronic spinal pain and it is a safe therapy.
I think this is a thorough review which produced interesting findings. I agree with most of what the authors report, except with their conclusions which I find too optimistic. In view of the facts that
- only 5 RCTs had a low risk of bias,
- collectively, the rigorous trials reported smaller effect sizes,
- the majority of trials failed to mention adverse effects which, in my view, casts considerable doubt on their quality and ethical standard,
I would have phrased the conclusion differently: compared to no treatment, sham acupuncture, or conventional therapies, acupuncture seems to have a significantly superior effect on pain and function. Due to the lack rigour of most studies, these effects are less certain than one would have wished. Many trials fail to report adverse effects which reflects poorly on their quality and ethics and prevents conclusions about the safety of acupuncture. In essence, this means that the effectiveness and safety of acupuncture as a treatment of chronic spinal pain remains uncertain.
Bloodletting has been used for centuries in many cultures. Its principle, it was assumed, consisted in re-balancing the body’s four humours. Bloodletting had a detrimental effect on most diseases and must have killed millions. It is a good historical example of the harm that ensues, if healthcare adheres to dogma. Today, we know that bloodletting is useful only in rare conditions such as polycythaemia vera or haemochromatosis (and some 30 years ago, a variation of bloodletting, isovolaemic haemodilution, was being discussed as a treatment for circulatory diseases such as intermittent claudication or stroke).
Yet, in so-called alternative medicine (SCAM), there are some practitioners who seem to find it hard to concede that ancient treatments might be not as good as they think. Thus, bloodletting has survived in this realm as a therapy for a wide range of conditions. This study assessed the efficacy of bloodletting therapy (acupoint pricking and cupping) in patients with chronic idiopathic urticaria (CIU) in a randomized, control, parallel-group trial.
A total of 174 patients with CIU were randomized into three groups:
- group A was treated with bloodletting therapy and ebastine (an anti-histamine),
- group B was treated with placebo treatment (acupoint pseudopricking and cupping) and ebastine,
- group C was treated with ebastine only.
The treatment period lasted 4 weeks. An intention-to-treat analysis was conducted, and the primary outcome was the effective rate of UAS7 score being reduced to 7 or below after treatment phase.
The effective rates at the end of treatment phase were different among the three groups, which were
- 73.7% in group A,
- 45.6% in group B,
- and 42.9% in group C.
Multiple analysis indicated differences between groups A and B (P < 0.0125) and groups A and C (P < 0.0125) and no difference between groups B and C (P > 0.0125). No severe bloodletting therapy-related adverse events were observed.
The authors concluded that one month of bloodletting therapy combined with ebastine is clinically beneficial compared with placebo treatment combined with ebastine and treatment with ebastine only. Thus, bloodletting therapy can be an effective complementary treatment in CIU.
How on earth might bloodletting help for CIU? Luckily, the authors have an answer to this question:
The clinical feature of urticaria with wheals and pruritus coming and going quickly is the manifestation of wind-evil that lurks in and circulates with blood. Hence, in the treatment of urticaria, dispersing wind is the one of the principle methods, and treating blood before wind is an important procedure because when blood flows fluently , wind-evil will resolve spontaneously. Bloodletting therapy is a direct and effective way of regulating blood.
You see, it’s all perfectly clear!
In this case, the results must be true. And the argument that patients might have known in which treatment group they had ended up (and were thus not blinded) can be discarded.
Acupuncture-moxibustion therapy (AMT) is a so-called alternative medicine (SCAM) that has been used for centuries in treatment of numerous diseases. Some enthusiasts even seem to advocate it for chemotherapy-induced leukopenia (CIL) The purpose of this review was to evaluate the efficacy and safety of acupuncture-moxibustion therapy in treating CIL.
Relevant studies were searched in 9 databases up to September 19, 2020. Two reviewers independently screened the studies for eligibility, extracted data, and assessed the methodological quality of selected studies. Meta-analysis of the pooled mean difference (MD) and risk ratio (RR) with their respective 95% confidence intervals (CI) were calculated.
Seventeen studies (1206 patients) were included, and the overall quality of the included studies was moderate. In comparison with medical therapy, AMT has a better clinical efficacy for CIL (RR, 1.24; 95% CI, 1.17-1.32; P < 0.00001) and presents advantages in increasing leukocyte count (MD, 1.10; 95% CI, 0.67-1.53; P < 0.00001). Also, the statistical results show that AMT performs better in improving the CIL patients’ Karnofsky performance score (MD, 5.92; 95% CI, 3.03-8.81; P < 0.00001).
The authors concluded that this systematic review and meta-analysis provides updated evidence that AMT is a safe and effective alternative for the patients who suffered from CIL.
A CIL is a serious complication. If I ever were afflicted by it, I would swiftly send any acupuncturist approaching my sickbed packing.
But this is not an evidence-based attitude!!!, I hear some TCM-fans mutter. What more do you want that a systematic review showing it works?
I beg to differ. Why? Because the ‘evidence’ is hardly what critical thinkers can accept as evidence. Have a look at the list of the primary studies included in this review:
- Lin Z. T., Wang Q., Yu Y. N., Lu J. S. Clinical observation of post-chemotherapy-leukopenia treated with ShenMai injectionon ST36. World Journal of Integrated Traditional and Western Medicine. 2010;5(10):873–876. [Google Scholar]
- Wang H. Clinical Observation of Acupoint Moxibustion on Leukopenia Caused by Chemotherapy. Beijing, China: Beijing University of Chinese Medicine; 2011. [Google Scholar]
- Fan J. Y. Coupling of Yin and Yang between Ginger Moxibustion Improve the Clinical Effect of the Treatment of Chemotherapy Adverse Reaction. Henan, China: Henan University of Chinese Medicine; 2013. [Google Scholar]
- Lu D. R., Lu D. X., Wei M., et al. Acupoint injection with addie injection for patients of nausea and vomiting with cisplatin induced by chemotherapy. Journal of Clinical Acupuncture and Moxibustion. 2013;29(10):33–38. [Google Scholar]
- Yang J. E. The Clinical Observation on Treatment of Leukopenia after Chemotherapy with Needle Warming Moxibustion. Hubei, China: Hubei University of Chinese Medicine; 2013. [Google Scholar]
- Fu Y. H., Chi C. Y., Zhang C. Y. Clinical effect of acupuncture and moxibustion on leukopenia after chemotherapy of malignant tumor. Guide of China Medicine. 2014;12(12) [Google Scholar]
- Wang J. N., Zhang W. X., Gu Q. H., Jiao J. P., Liu L., Wei P. K. Protection of herb-partitioned moxibustion on bone marrow suppression of gastric cancer patients in chemotherapy period. Chinese Archives of Traditional Chinese Medicine. 2014;32(12):110–113. [Google Scholar]
- Zhang J. The Clinical Research on Myelosuppression and Quality of Life after Chemotherapy Treated by Grain-Sized Moxibustion. Nanjing, China: Nanjing University of Chinese Medicine; 2014. [Google Scholar]
- Tian H., Lin H., Zhang L., Fan Z. N., Zhang Z. L. Effective research on treating leukopenia following chemotherapy by moxibustion. Clinical Journal of Chinese Medicine. 2015;7(10):35–38. [Google Scholar]
- Hu G. W., Wang J. D., Zhao C. Y. Effect of acupuncture on the first WBC reduction after chemotherapy for breast cancer. Beijing Journal of Traditional Chinese Medicine. 2016;35(8):777–779. [Google Scholar]
- Zhu D. L., Lu H. Y., Lu Y. Y., Wu L. J. Clinical observation of Qi-blood-supplementing needling for leukopenia after chemotherapy for breast cancer. Shanghai Journal of Acupuncture and Moxibustion. 2016;35(8):964–966. [Google Scholar]
- Chen L, Xu G. Y. Observation on the prevention and treatment of chemotherapy-induced leukopenia by moxibustion therapy. Zhejiang Journal of Traditional Chinese Medicine. 2016;51(8):p. 600. [Google Scholar]
- Mo T., Tian H., Yue S. B., Fan Z. N., Zhang Z. L. Clinical observation of acupoint moxibustion on leukocytopenia caused by tumor chemotherapy. World Chinese Medicine. 2016;11(10):2120–2122. [Google Scholar]
- Nie C. M. Nursing observation of acupoint moxibustion in the treatment of leucopenia after chemotherapy. Today Nurse. 2017;4:93–95. [Google Scholar]
- Wang D. Y. Clinical Research on Post-chemotherapy-leukopenia with Spleen-Kidney Yang Deficiency in Colorectal Cancer Treated with Point-Injection. Yunnan, China: Yunnan University of Chinese Medicine; 2017. [Google Scholar]
- Gong Y. Q, Zhang M. Q, Zhang B. C. Prevention and treatment of leucocytopenia after chemotherapy in patients with malignant tumor with ginger partitioned moxibustion. Chinese Medicine Modern Distance Education of China. 2018;16(21):135–137. [Google Scholar]
- Li Z. C., Lian M. J., Miao F. G. Clinical observation of fuzheng moxibustion combined with wenyang shengbai decoction in the treatment of 80 cases of leukopenia after chemotherapy. Hunan Journal of Traditional Chinese Medicine. 2019;35(3):64–66. [Google Scholar]
Notice anything peculiar?
- The studies are all from China where data fabrication was reported to be rife.
- They are mostly unavailable for checking (why the published adds links that go nowhere is beyond me).
- Many do not look at all like randomised clinical trials (which, according to the authors, was an inclusion criterion).
- Many do not look as though their primary endpoint was the leukocyte count (which, according to the authors, was another inclusion criterion).
Intriguingly, the authors conclude that AMT is not just effective but also ‘safe’. How do they know? According to their own data extraction table, most studies failed to mention adverse effects. And how exactly is acupuncture supposed to increase my leukocyte count? Here is what the authors offer as a mode of action:
I think it is high time that we stop tolerating that the medical literature gets polluted with such nonsense (helped, of course, by journals that are beyond the pale) – someone might actually believe it, in which case it would surely hasten the death of vulnerable patients.
Many experts doubt that acupuncture generates the many positive health effects that are being claimed by enthusiasts. Yet, few consider that acupuncture might not be merely useless but could even make things worse. Here is a trial that seems to suggest exactly that.
This study evaluated whether combining two so-called alternative medicines (SCAMs), acupuncture and massage, reduce postoperative stress, pain, anxiety, muscle tension, and fatigue more than massage alone.
Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative SCAMs for three consecutive days. All participants were observed for up to 3 months. Forty-two participants were recruited from January 29, 2016 to July 11, 2018. Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture. Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0-10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated.
Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment. After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes.
The authors concluded tha no additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.
I recently went to the supermarket to find out whether combining two bank notes (£10 + £5) can buy more goods than one £10 note alone. What I found was interesting: the former did indeed purchase more than the latter. Because I am a scientist, I did not stop there; I went to a total of 10 shops and my initial finding was confirmed each time: A+B results in more than A alone.
It stands to reason that the same thing happens with clinical trials. We even tested this hypothesis in a systematic review entitled ‘A trial design that generates only ”positive” results‘. Here is our abstract:
In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.
But why is this not so with the above-mentioned study?
Why is, in this instance, A even more that A+B?
There are, of course, several possible answers. To use my supermarket example again, the most obvious one is that B is not a £5 note but a negative amount, a dept note, in other words: A + B can only be less than A alone, if B is a minus number. In the context of the clinical trail, this means acupuncture must have caused a negative effect.
But is that possible? Evidently yes! Many patients don’t like needles and experience stress at the idea of a therapist sticking one into their body. Thus acupuncture would cause stress, and stress would have a negative effect on all the other parameters quantified in the study (pain, anxiety, muscle tension, and fatigue).
My conclusion: in certain situations, acupuncture is more than just useless; it makes things worse.
Some of us got used to the idea that acupuncture might be effective for pain. But could it work for infections? Unlikely! Well, let’s not rely on gut feelings; let’s have a fair and critical look at the evidence.
This systematic review assessed the evidence for acupuncture for uncomplicated recurrent urinary tract infections (rUTI) women. Five randomised controlled trials (RCTs) evaluating the effects of acupuncture and related therapies for prophylaxis or treatment of uncomplicated rUTI in women were included. The methodological quality of the studies and the strength of the evidence were low to moderate. The chance of achieving a composite cure with acupuncture therapies was greater than that with antibiotics (three studies, 170 participants, RR 1.92, 95% CI 1.31‐2.81, I2 = 38%). The risk of UTI recurrence was lower with acupuncture than with no treatment (two studies, 135 participants, RR 0.39, 95% CI 0.26–0.58, I2 = 0%) and sham acupuncture (one study, 53 participants, RR 0.45, 95% CI 0.22–0.92).
The authors concluded that acupuncture showed promising results compared to no treatment and sham acupuncture in reducing recurrence, based on low to moderate certainty evidence. Low certainty evidence found acupuncture increased the chance of achieving a composite cure compared to antibiotics. Findings from this review should be interpreted with caution, taking into consideration the biases identified and small sample size of the included trials. Included studies suggest acupuncture has a good safety profile for women with UTI, and may be considered as a therapeutic option in the treatment and prevention of rUTI in women, particularly those who are unresponsive to, or intolerant of, antibiotics. Rigorously designed research is needed to inform clinical decisionmaking about the use of acupuncture for women with UTIs.
The authors of this review are affiliated to the Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangdong Provincial Academy of Chinese Medical Sciences and The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China and the China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Melbourne, VIC, Australia. The review was funded by the China-Australia International Research Centre for Chinese Medicine (CAIRCCM) (International Cooperation Project, Grant Number 2012DFA31760), and the National Natural Science Foundation of China (NSFC) (Grant Number 81873261). In view of these facts, it is strange, I think, that the authors declared no conflicts of interest.
The 5 primary studies included in this review are the following:
- Alraek T, Soedal LI, Fagerheim SU, Digranes A, Baerheim A. Acupuncture treatment in the
prevention of uncomplicated recurrent lower urinary tract infections in adult women. American journal of
public health. 2002;92(10):1609-11.
- Aune A, Alraek T, LiHua H, Baerheim A. Acupuncture in the prophylaxis of recurrent lower urinary
tract infection in adult women. Scandinavian journal of primary health care. 1998;16(1):37-9.
- Hong JY, Li F, Liang XQ, Hou Z. [Efficacy observation on female chronic pyelonephritis treated with
abdominal cluster-needling therapy]. Zhongguo zhen jiu = Chinese acupuncture & moxibustion.
- Yu SM, Guo DD. Moxibustion combined with antibiotics was used to treat 30 cases of chronic
urinary tract infection in adult women. Shandong Journal of Traditional Chinese Medicine.
- Liu JL, Luo Q, Liu XH, Lin L. Observation on the clinical effect of external treatment of strong renal
moxibustion on recurrent urinary tract infection. China Modern Doctor. 2018;56(29):116-8.
- Alraek T, Soedal LI, Fagerheim SU, Digranes A, Baerheim A. Acupuncture treatment in the
As always, it is worth checking these studies for reliability.
In the trial by Alraek et al patients were randomised patients to receive either acupuncture or no treatment. Is anyone surprised that the former group fared better than the latter? (I am not!)
The trial by Aune et al is the only study that attempted to control for placebo effects by using a sham control group. This is what they used as a sham treatment: Sham acupuncture was given using six needles superficially inserted in the calves, thighs or abdomen outside known acupuncture points or meridians. Needles were not manipulated in the sham group. Sham controls have the purpose of rendering patients unaware whether they receive the real or the sham treatment. The method used here cannot achieve this aim; patients were easily able to determine that they were in the control group.
The last three trials are all not Medline-listed studies authored by Chinese investigators published in inaccessible journals in Chinese. We know that such studies invariably report positive outcomes which are often fabricated and thus have a reliability close to zero. But even if we ignore these facts for a moment, from what I see in the results table of the review, these studies are invalid. All three are equivalence trials of acupuncture versus antibiotics; with a sample size of merely around 30, they must be woefully underpowered and thus unable to generate a reliable result.
The authors of this review claim that the risk of bias of trials was generally high or unclear. This is an understatement to put it mildly. In fact, the quality of the studies was mostly dismal.
In view of all this, I take the liberty to re-formulate the conclusions drawn by the review authors as follows:
Due to the lack of reliable RCTs, the effectiveness of acupuncture as a treatment or prevention of rUTIs remains unproven. Due to the implausibility of the therapy, its effectiveness seems highly unlikely.
The BJOG should never have published such a deeply misleading paper.