Polycystic ovarian syndrome (PCOS) is a common condition characterised by oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Some studies have suggested that acupuncture might be helpful but the evidence is often flawed and the results are mixed. What is needed in such a situation is, of course, a systematic review.
The aim of this new Cochrane review was to assess the effectiveness and safety of acupuncture treatment of oligo/anovulatory women with polycystic ovarian syndrome (PCOS). The authors identified relevant studies from databases including the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, EMBASE, PsycINFO, CNKI and trial registries. The data are current to 19 October 2015.
They included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs. Primary outcomes were live birth and ovulation (primary outcomes), and secondary outcomes were clinical pregnancy, restoration of menstruation, multiple pregnancy, miscarriage and adverse events. We assessed the quality of the evidence using GRADE methods.
Two review authors independently selected the studies, extracted data and assessed risk of bias. They calculated Mantel-Haenszel odds ratios (ORs) and mean difference (MD) and 95% confidence intervals (CIs).
Five RCTs with 413 women were included. They compared true acupuncture versus sham acupuncture (two RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT) and electroacupuncture versus physical exercise (one RCT). Four of the studies were at high risk of bias in at least one domain. No study reported live birth rate. Two studies reported clinical pregnancy and found no evidence of a difference between true acupuncture and sham acupuncture (OR 2.72, 95% CI 0.69 to 10.77, two RCTs, 191 women, very low quality evidence). Three studies reported ovulation. One RCT reported number of women who had three ovulations during three months of treatment but not ovulation rate. One RCT found no evidence of a difference in mean ovulation rate between true and sham acupuncture (MD -0.03, 95% CI -0.14 to 0.08, one RCT, 84 women, very low quality evidence). However, one other RCT reported very low quality evidence to suggest that true acupuncture might be associated with higher ovulation frequency than relaxation (MD 0.35, 95% CI 0.14 to 0.56, one RCT, 28 women). Two studies reported menstrual frequency. One RCT reported true acupuncture reduced days between menstruation more than sham acupuncture (MD 220.35, 95% CI 252.85 to 187.85, 146 women). One RCT reported electroacupuncture increased menstrual frequency more than no intervention (0.37, 95% CI 0.21 to 0.53, 31 women). There was no evidence of a difference between the groups in adverse events. Evidence was very low quality with very wide CIs and very low event rates. Overall evidence was low or very low quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.
The authors concluded that, thus far, only a limited number of RCTs have been reported. At present, there is insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS.
This is, in my view, a rigorous assessment of the evidence leading to a clear conclusion. Foremost, I applaud the authors from the Faculty of Science, University of Technology Sydney for using such clear language. Such clarity seems to be getting a rare event in reviews of alternative medicine. To demonstrated this point, here are the most recent 5 systematic reviews which came up on my screen when I searched today Medline for ‘complementary alternative medicine, systematic review’.
The combination of TGP and LEF in treatment of RA presented the characteristics of notably decreasing the levels of laboratory indexes and higher safety in terms of liver function. However, this conclusion should be further investigated based on a larger sample size.
CHM as an adjunctive therapy is associated with a decreased risk of in-hospital mortality compared with WT in patients with AKI. Further studies with high quality and large sample size are needed to verify our conclusions.
As an important supplementary treatment, TCM may provide benefits in repair of injured spinal cord. With a general consensus that future clinical approaches will be diversified and a combination of multiple strategies, TCM is likely to attract greater attention in SCI treatment.
I think the phenomenon is fairly obvious: authors of such papers are far too often not able or willing to express the bottom line of their work openly. As systematic reviews are supposed to be the ultimate type of evidence, this trend is very worrying, I think. In my view, such conclusions merely display the bias of the authors. If the evidence is not convincingly positive (which it very rarely is), authors have an ethical obligation to clearly say so.
If they don’t do it, journal editors have the duty to correct the error. If neither of these actions happen, funding agencies should make sure that such teams get no further research money until they can demonstrate that they have learnt the lesson.
This may sound a bit drastic but I think such steps would be both necessary and urgent. The problem is now extremely common, and if we do not quickly implement some effective preventative measures, our scientific literature will become contaminated to the point of becoming useless. This surely would be a disaster that affects us all.
There can, of course, be several reasons for the evidence being not positive:
- there can be a paucity of data
- the results might be contradictory
- the trials might be open to bias
- some of the primary data might look suspicious
In all of these cases, the evidence would be not convincingly positive, and it would be wrong and unhelpful not to be frank about it. Beating about the bush, like so many authors nowadays do, is misleading, unhelpful, unethical and borderline fraudulent. Therefore it constitutes a disservice to everyone concerned.
On this blog, I have repeatedly pleaded for a change of the 2010 NICE guidelines for low back pain (LBP). My reason was that it had become quite clear that their recommendation to use spinal manipulation and acupuncture for recurrent LBP was no longer supported by sound evidence.
Two years ago, a systematic review (authored by a chiropractor and published in a chiro-journal) concluded that “there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP.” A the time, I wrote a blog explaining that “whenever two treatments are equally effective (or, in this case, perhaps equally ineffective?), we must consider other important criteria such as safety and cost. Regular chiropractic care (chiropractors use spinal manipulation on almost every patient, while osteopaths and physiotherapists employ it less frequently) is neither cheap nor free of serious adverse effects such as strokes; regular exercise has none of these disadvantages. In view of these undeniable facts, it is hard not to come up with anything other than the following recommendation: until new and compelling evidence becomes available, exercise ought to be preferred over spinal manipulation as a treatment of chronic LBP – and consequently consulting a chiropractor should not be the first choice for chronic LBP patients.”
Three years ago, a systematic review of acupuncture for LBP (published in a TCM-journal) concluded that the effect of acupuncture “is likely to be produced by the nonspecific effects of manipulation.” At that time I concluded my blog-post with this question: Should NICE be recommending placebo-treatments and have the tax payer foot the bill? Now NICE have provided an answer.
The new draft guideline by NICE recommends various forms of exercise as the first step in managing low back pain. Massage and manipulation by a physiotherapist should only be used alongside exercise; there is not enough evidence to show they are of benefit when used alone. Moreover, patients should be encouraged to continue with normal activities as far as possible. Crucially, the draft guideline no longer recommends acupuncture for treating low back pain.
NICE concluded that the evidence shows that acupuncture is not better than sham treatment. Paracetamol on its own is no longer recommended either, instead non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or aspirin should be tried first. Talking therapies are recommended in combination with physical therapies for patients who had no improvement on previous treatments or who have significant psychological and social barriers to recovery.
Professor Mark Baker, clinical practice director for NICE, was quoted stating “Regrettably there is a lack of convincing evidence of effectiveness for some widely used treatments. For example acupuncture is no longer recommended for managing low back pain with or without sciatica. This is because there is not enough evidence to show that it is more effective than sham treatment.”
Good news for us all, I would say:
- good news for patients who now hear from an accepted authority what to do when they suffer from LBP,
- good news for society who does no longer need to spend vast amounts of money on questionable therapies,
- good news for responsible clinicians who now have clear guidance which they can show and explain to their patients.
Not so good news, I admit, for acupuncturists, chiropractors and osteopaths who just had a major source of their income scrapped. I have tried to find some first reactions from these groups but, for the moment, they seemed to be stunned into silence – nobody seems to have yet objected to the new guideline. Instead, I found a very recent website where chiropractic is not just recommended for LBP therapy but where patients are instructed that, even in the absence of pain, they need to see their chiropractor regularly: “Maintenance chiropractic care is well supported in studies for controlling chronic LBP.”
NEVER LET THE TRUTH GET IN THE WAY OF YOUR CASH-FLOW…they seem to conclude.
Recently, I came across the ‘Clinical Practice Guidelines on the Use of Integrative Therapies as Supportive Care in Patients Treated for Breast Cancer’ published by the ‘Society for Integrative Oncology (SIO) Guidelines Working Group’. The mission of the SIO is to “advance evidence-based, comprehensive, integrative healthcare to improve the lives of people affected by cancer. The SIO has consistently encouraged rigorous scientific evaluation of both pre-clinical and clinical science, while advocating for the transformation of oncology care to integrate evidence-based complementary approaches. The vision of SIO is to have research inform the true integration of complementary modalities into oncology care, so that evidence-based complementary care is accessible and part of standard cancer care for all patients across the cancer continuum. As an interdisciplinary and inter-professional society, SIO is uniquely poised to lead the “bench to bedside” efforts in integrative cancer care.”
The aim of the ‘Clinical Practice Guidelines’ was to “inform clinicians and patients about the evidence supporting or discouraging the use of specific complementary and integrative therapies for defined outcomes during and beyond breast cancer treatment, including symptom management.”
This sounds like a most laudable aim. Therefore I studied the document carefully and was surprised to read their conclusions: “Specific integrative therapies can be recommended as evidence-based supportive care options during breast cancer treatment.”
How can this be? On this blog, we have repeatedly seen evidence to suggest that integrative medicine is little more than the admission of quackery into evidence-based healthcare. This got me wondering how their conclusion had been reached, and I checked the document even closer.
On the surface, it seemed well-made. A team of researchers first defined the treatments they wanted to look at, then they searched for RCTs, evaluated their quality, extracted their results, combined them into an overall verdict and wrote the whole thing up. In a word, they conducted what seems a proper systematic review.
Based on the findings of their review, they then issued recommendations which I thought were baffling in several respects. Let me just focus on three of the SIO’s recommendations dealing with acupuncture:
- “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
- “Acupuncture can be considered for improving depressive symptoms in women suffering from hot flashes…” [RCTs (1 and 2) cited in support]
- “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
The actual RCT (1) cited in support of all three recommendations stated that the authors “randomly assigned 75 patients to usual care and 227 patients to acupuncture plus usual care…” As we have discussed often before on this blog and elsewhere, such a ‘A+B versus B study design’ will never generate a negative result, does not control for placebo-effects and is certainly not a valid test for the effectiveness of the treatment in question. Nevertheless, the authors of this study concluded that: “Acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life.”
RCT (2) cited in support of recommendation number 2 seems to be a citation error; the study in question is not an acupuncture-trial and does not back the statement in question. I suspect they meant to cite their reference number 87 (instead of 88). This trial is an equivalence study where 50 patients were randomly assigned to receive 12 weeks of acupuncture (n = 25) or venlafaxine (n = 25) treatment for cancer-related hot flushes. Its results indicate that the two treatments generated the similar results. As the two therapies could also have been equally ineffective, it is impossible, in my view, to conclude that acupuncture is effective.
Finally, RCT (1) does in no way support recommendation number two. Yet RCT (1) and RCT (2) were both cited in support of this recommendation.
I have not systematically checked any other claims made in this document, but I get the impression that many other recommendations made here are based on similarly ‘liberal’ interpretations of the evidence. How can the ‘Society for Integrative Oncology’ use such dodgy pseudo-science for formulating potentially far-reaching guidelines?
I know none of the authors (Heather Greenlee, Lynda G. Balneaves, Linda E. Carlson, Misha Cohen, Gary Deng, Dawn Hershman, Matthew Mumber, Jane Perlmutter, Dugald Seely, Ananda Sen, Suzanna M. Zick, Debu Tripathy) of the document personally. They made the following collective statement about their conflicts of interest: “There are no financial conflicts of interest to disclose. We note that some authors have conducted/authored some of the studies included in the review.” I am a little puzzled to hear that they have no financial conflicts of interest (do not most of them earn their living by practising integrative medicine? Yes they do! The article informs us that: “A multidisciplinary panel of experts in oncology and integrative medicine was assembled to prepare these clinical practice guidelines. Panel members have expertise in medical oncology, radiation oncology, nursing, psychology, naturopathic medicine, traditional Chinese medicine, acupuncture, epidemiology, biostatistics, and patient advocacy.”). I also suspect they have other, potentially much stronger conflicts of interest. They belong to a group of people who seem to religiously believe in the largely nonsensical concept of integrative medicine. Integrating unproven treatments into healthcare must affect its quality in much the same way as the integration of cow pie into apple pie would affect the taste of the latter.
After considering all this carefully, I cannot help wondering whether these ‘Clinical Practice Guidelines’ by the ‘Society for Integrative Oncology’ are just full of honest errors or whether they amount to fraud and scientific misconduct.
WHATEVER THE ANSWER, THE GUIDELINES MUST BE RETRACTED, IF THIS SOCIETY WANTS TO AVOID LOSING ALL CREDIBILITY.
In recent blogs, I have written much about acupuncture and particularly about the unscientific notions of traditional acupuncturists. I was therefore surprised to see that a UK charity is teaming up with traditional acupuncturists in an exercise that looks as though it is designed to mislead the public.
The website of ‘Anxiety UK’ informs us that this charity and the British Acupuncture Council (BAcC) have launched a ‘pilot project’ which will see members of Anxiety UK being able to access traditional acupuncture through this new partnership. Throughout the pilot project, they proudly proclaim, data will be collected to “determine the effectiveness of traditional acupuncture for treating those living with anxiety and anxiety based depression.”
This, they believe, will enable both parties to continue to build a body of evidence to measure the success rate of this type of treatment. Anxiety UK’s Chief Executive Nicky Lidbetter said: “This is an exciting project and will provide us with valuable data and outcomes for those members who take part in the pilot and allow us to assess the benefits of extending the pilot to a regular service for those living with anxiety. “We know anecdotally that many people find complementary therapies used to support conventional care can provide enormous benefit, although it should be remembered they are used in addition to and not instead of seeking medical advice from a doctor or taking prescribed medication. This supports our strategic aim to ensure that we continue to make therapies and services that are of benefit to those with anxiety and anxiety based depression, accessible.”
And what is wrong with that, you might ask.
What is NOT wrong with it, would be my response.
To start with, traditional acupuncture relies of obsolete assumptions like yin and yang, meridians, energy flow, acupuncture points etc. They have one thing in common: they fly in the face of science and evidence. But this might just be a triviality. More important is, I believe, the fact that a pilot project cannot determine the effectiveness of a therapy. Therefore the whole exercise smells very much like a promotional activity for pure quackery.
And what about the hint in the direction of anecdotal evidence in support of the study? Are they not able to do a simple Medline search? Because, if they had done one, they would have found a plethora of articles on the subject. Most of them show that there are plenty of studies but their majority is too flawed to draw firm conclusions.
A review by someone who certainly cannot be accused of being biased against alternative medicine, for instance, informs us that “trials in depression, anxiety disorders and short-term acute anxiety have been conducted but acupuncture interventions employed in trials vary as do the controls against which these are compared. Many trials also suffer from small sample sizes. Consequently, it has not proved possible to accurately assess the effectiveness of acupuncture for these conditions or the relative effectiveness of different treatment regimens. The results of studies showing similar effects of needling at specific and non-specific points have further complicated the interpretation of results. In addition to measuring clinical response, several clinical studies have assessed changes in levels of neurotransmitters and other biological response modifiers in an attempt to elucidate the specific biological actions of acupuncture. The findings offer some preliminary data requiring further investigation.”
Elsewhere, the same author, together with other pro-acupuncture researchers, wrote this: “Positive findings are reported for acupuncture in the treatment of generalised anxiety disorder or anxiety neurosis but there is currently insufficient research evidence for firm conclusions to be drawn. No trials of acupuncture for other anxiety disorders were located. There is some limited evidence in favour of auricular acupuncture in perioperative anxiety. Overall, the promising findings indicate that further research is warranted in the form of well designed, adequately powered studies.”
What does this mean in the context of the charity’s project?
I think, it tells us that acupuncture for anxiety is not exactly the most promising approach to further investigate. Even in the realm of alternative medicine, there are several interventions which are supported by more encouraging evidence. And even if one disagrees with this statement, one cannot possibly disagree with the fact that more flimsy research is not required. If we do need more studies, they must be rigorous and not promotion thinly disguised as science.
I guess the ultimate question here is one of ethics. Do charities not have an ethical and moral duty to spend our donations wisely and productively? When does such ill-conceived pseudo-research cross the line to become offensive or even fraudulent?
You have to admit, quacks had a difficult time recently:
- homeopathy has been disclosed as humbug,
- chiropractic is not much better,
- ‘acupuncture awareness week’ left acupuncturists bruised…
Need I go on?
One has to pity these guys; their income is dwindling; they have no pensions, no unions to protect them etc., they know nothing other than quackery…what can they do? They are clearly fighting for survival.
I suggest we all focus, use our imagination and come up with come constructive ideas to help them.
Alright, I start: HOLISTIC DOPING
The fate of the poor (not in a monetary sense, of course) tennis star Sharapova gave me that brainwave.
Our elite athletes are in a pickle: they feel the need to enhance their performance but more and more ways of achieving this with cleverly administered drugs are becoming illegal. Their livelihood is at stake almost as much as that of our dear quacks.
What if the two groups jointed forces?
What if they decided to help solve each others’ problems?
This could be a classical win/win situation!
I am sure homeopaths, chiropractors, acupuncturists etc. could design holistic program for improving athletic performance. It would be highly individualised and embrace body, mind, spirit, sole and anything else they can think of. It could include the newest concepts in quantum healing, energy field, qi, vital force, etc. The advantages are obvious, I think:
- none of these interventions will ever be found on a list of forbidden drugs,
- the program will work perfectly well because it will generate large placebo responses,
- performance will therefore increase (as always in alternative medicine, anecdotal ‘evidence’ will suffice) ,
- and so will the quacks’ cash flow.
Is there a downside? Not really…oh, hold on…yes there is!
My idea is not that original; others have had it already. In fact, there are quite a few quacks offering alternatives to good old-fashioned doping.
THAT’S THE AWFUL THING ABOUT QUACKERY: ALL THE GOOD IDEAS TURN OUT TO BE ALREADY TAKEN!
As if to celebrate the end of ‘Acupuncture Awareness Week’, I am off today to give a few lectures in Oslo. One title is most fitting: ACUPUNCTURE: FACTS AND FALLACIES. Here are some of the fallacies I intend to discuss:
- Appeal to popularity
- Appeal to tradition
- Science can explain how it works
- Acupuncture is a ‘cure-all’
- It worked for me, my aunt, etc.
- Acupuncture even works for animals
- Even if it’s just a placebo, it helps patients.
- It defies scientific testing.
- Acupuncture research is productive
- Acupuncture is by definition rubbish
- Acupuncture is risk-free
- Its benefits outweigh its risks
None of these themes need much by way of explanation for the readers of this blog, I think.
So, why do I mention them at all?
The answer is simple: I was hoping to get a few inspirations and tips from you for further subjects that I might include.
WHAT DO YOU THINK ARE THE MAIN FALLACIES IN THE REALM OF ACUPUNCTURE?
The current ‘Acupuncture Awareness Week’ is perhaps a good occasion to look beyond acupuncture for humans. The ‘Chi Institute’ is an organisation that teaches TCM for animals. There you can specialise in all sorts of intriguing things that a critical mind would have never thought about. Take acupuncture for horses, for instance; on their website, the Institute informs us that:
The Equine Acupuncture Program…certifies students in veterinary acupuncture with an emphasis on horses. The program begins with an overview of fundamental aspects of Chinese Medicine, including Ying-Yang and Five Elements theory, which serve as a foundation for case diagnosis and treatment presented later in the class. A variety of acupuncture techniques are taught, including electro-acupuncture and moxibustion, in addition to conventional “dry” needling. Students of the program learn acupuncture points on large animals only, and horses are used for practice in the wet labs.
The program is presented in five sessions (two online and three on-site) over a period of six months. Online sessions are composed of lectures that students can stream at their own convenience. Afternoon wet-labs of on-site sessions give students the opportunity to learn acupuncture points on live animals in small lab groups of five to six students per instructor. A spring class and a fall class are held each year. Equine Acupuncture is offered to licensed veterinarians and veterinary school junior/senior students only.
- Traditional Chinese Veterinary Medicine (TCVM) Principles: Five Elements, Yin-Yang, Eight Principles, Zang-Fu Physiology and Pathology, Meridians and Channels
- Scientific Basis of Acupuncture
- 200 Transpositional Equine Acupuncture Points (hands-on, wet-lab demos)
- 70 Classical Equine Acupuncture Points (hands-on, wet-lab demos)
- How to needle acupuncture points in horses
- TCVM Diagnostic Systems, including Tongue and Pulse Diagnosis
- How to integrate acupuncture into your practice
- How to use veterinary acupuncture to diagnose and treat:
- Musculoskeletal conditions, lameness and neurological disorders
- Cardiovascular diseases and respiratory disorders
- Gastrointestinal disorders and behavioral problems
- Dermatological problems and immune-mediated diseases
- Renal & urinary disorders and reproductive disorders
- Dry needle (conventional needling)
- Aqua-acupuncture (point injection)
But is there not something missing, I asked myself when I read this. What about the evidence? What about the question whether there is any proof that any of this works?
As it happens, some time ago, we looked into this by conducting a systematic review. Here is our abstract ( I should mention that the first author of this paper was a vet who was very fond of acupuncture):
Acupuncture is a popular complementary treatment option in human medicine. Increasingly, owners also seek acupuncture for their animals. The aim of the systematic review reported here was to summarize and assess the clinical evidence for or against the effectiveness of acupuncture in veterinary medicine. Systematic searches were conducted on Medline, Embase, Amed, Cinahl, Japana Centra Revuo Medicina and Chikusan Bunken Kensaku. Hand-searches included conference proceedings, bibliographies, and contact with experts and veterinary acupuncture associations. There were no restrictions regarding the language of publication. All controlled clinical trials testing acupuncture in any condition of domestic animals were included. Studies using laboratory animals were excluded. Titles and abstracts of identified articles were read, and hard copies were obtained. Inclusion and exclusion of studies, data extraction, and validation were performed independently by two reviewers. Methodologic quality was evaluated by means of the Jadad score. Fourteen randomized controlled trials and 17 nonrandomized controlled trials met our criteria and were, therefore, included. The methodologic quality of these trials was variable but, on average, was low. For cutaneous pain and diarrhea, encouraging evidence exists that warrants further investigation in rigorous trials. Single studies reported some positive intergroup differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. These trials require independent replication. On the basis of the findings of this systematic review, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.
What a pity that the pupils of the above course are not being told that THERE IS NO COMPELLING EVIDENCE that any of the tings they are about to learn has any value…but that would be bad for business, wouldn’t it? And we cannot have a bit of evidence jeopardize a nice little earner, can we?
Yes, we discussed this study on a previous blog post. But, as it is ‘ACUPUNCTURE AWARENESS WEEK’ in the UK, and because of another reason (which will become clear in a minute) I decided to revisit the trial.
In case you have forgotten, here is its abstract once again:
Background: Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting.
Objective: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs.
Design: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954)
Setting: Community in Australia.
Participants: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency.
Interventions: 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture.
Measurements: The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.
Results: 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, −1.87 to 2.52]; P = 0.77). No serious adverse events were reported.
Limitation: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause.
Conclusion: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.
When I first discussed this trial, I commented that the trial has several strengths: it includes a large sample size and the patients were adequately blinded to eliminate the effects of expectations. It was published in a top journal, and we can therefore assume that it was properly peer-reviewed. Combined with the evidence from our previous systematic review, this indicates that acupuncture has no effect beyond placebo.
The reason for bringing it up again is that a comment about the study has recently appeared, not just any old comment but one from the British Medical Acupuncture Society. It is, in my view, gratifying and interesting. It was published on ‘facebook’ and is therefore in danger of getting forgotten. I hope to preserve it by citing it in full.
Here it is:
A large rigorous trial published in a prestigious general medical journal, and the usual mantra rings out – acupuncture is no better than sham. In this case there was not a fraction of difference from a non-penetrating sham in a two-armed trial with over 300 women. Ok,…so we have known for some time that we really need 400 in each arm to demonstrate the usual difference over sham seen in meta-analysis in pain conditions, but there really was not even a sniff of a difference here. So is that it for acupuncture in hot flushes? Well, we have a 40% symptom reduction in both groups, and a strong conviction from some practitioners that it really seems to work. Is 40% enough for a strong conviction? I have heard some dramatic stories from medical acupuncturist colleagues that really would be hard to dismiss as non-specific effects, and from others I have heard relative ambivalence about the effects in hot flushes.
Personally I always try to consider mechanisms, and I wish researchers in the field would do the same before embarking on their trials. That is not intended as a criticism of this trial, but some consideration of mechanisms might allow us to explain all our data, including the contribution of this trial.
Acupuncture has recognised effects that are local to the needle, in the spinal cord (mainly in the segments stimulated) and in the brain (as well as humoral effects in CSF and blood). The latter are probably the mildest of the three categories, and require the best group of patient responders for them to be observable in clinical practice.
Menopausal hot flushes are explained by the effects of reduced oestrogens on the thermoregulatory centre in the anterior hypothalamus. It is certainly plausible that the neuro-inhibitory effects of endogenous opioids such as beta-endorphin, which we know can be released by acupuncture stimulation in experimental settings, could stablise neurones in the anterior hypothalamus that have become irritable due to a sudden drop in oestrogens.
So are endogenous opioids always released by acupuncture? Well, they and their effects seem to be measurable in experiments that use what I call proper acupuncture. That is, strong stimulation to deep somatic tissue. In the laboratory, and indeed in my clinic, this is only usually achieved in a palatable manner by electroacupuncture to muscle, although repeated manual stimulation every few minutes may have similar effects.
Ee et al used a relatively gentle acupuncture protocol, so they may have only generated measurable effects, based on mechanistic speculation, in the most responsive patients, perhaps less than 10%.
What does all this tell us? Well this trial clearly demonstrates that gentle acupuncture protocols generate effects in women with hot flushes via context rather than penetrating needling. In conditions that rely on central effects, I think we still need to consider stronger stimulation protocols and enriched enrollment in trials, ie preselecting responders before randomisation.
In my original comment I also predicted: “One does not need to be a clairvoyant to predict that acupuncturists will now find what they perceive as a flaw in the new study and claim that its results were false-negative.”
I am so glad Mike Cummings and the BMAS rushed to prove me right.
It’s so nice to know one can rely on someone in these uncertain times!
As it is ‘ACUPUNCTURE AWARENESS WEEK’, I thought I make a constructive contribution to this field by assessing what is currently being published on the subject. For this purpose, I looked at the first 100 Medline-listed articles of 2016. This has the advantage, of course, that all the numbers thus generated can be seen as absolute and as percentage figures at the same time. I categorised the articles according to where they were published and what their subject was.
My results show that, of the first 100 articles,
- 33 were published in CAM journals,
- 67 were published in mainstream medical journals,
- 6 were RCTs,
- 6 were other clinical studies,
- 30 were pre-clinical investigations,
- 27 were systematic reviews,
- 8 were surveys,
- 23 were other types of papers.
I have to admit, these results are not as bad as I had feared. What seems impressive is foremost the notion that acupuncture research has entered the mainstream journals. But there are issues that might be of concern; in my view these results suggest that:
- Too little research is focussed on the two big questions: efficacy and safety.
- In relation to the meagre output in RCTs, there are too many systematic reviews.
- As long as we cannot be sure that acupuncture is more than a placebo, all these pre-clinical studies seem a bit out of place.
- The vast majority of the articles were in low or very low impact journals.
- There was only one paper that I would consider outstanding (my next post will discuss it).
So, what conclusions can one draw from these data?
Not many, I fear.
My little exploration does not lend itself to grand, generalizable or far-reaching conclusions. Acupuncture fans might proudly say: LOOK HOW FAR WE HAVE COME! Less enthusiastic experts, however, might think: LOOK HOW FAR YOU HAVE TO GO!
It’s acupuncture awareness week in the UK, and therefore, I will focus on this treatment for a few days.
Yesterday, the ‘HALE CLINIC’, London happened to be in the papers for making unsubstantiated claims. It seems to be THE place where the super-rich take their money when they feel a little off colour.
This institution has for many years been a great promoter of acupuncture. On their website, which seems to have changed significantly since the press report about bogus claims made there, they even advertise acupuncture for children and little babies:
Acupuncture has been a normal part of the healthcare system in China for thousands of years, ever since ancient times, being used on babies and children as well as adults. Paediatric acupuncture is a specialist branch of traditional acupuncture, fundamentally the traditional theory is no different, the difference comes with how we assess the children and the way we use the needles. A child’s vital energy or Qi is abundant and much easier to access as it is young. This often means results can be very dramatic and sustained in a positive way, enabling the child to grow into adulthood without conditions that may have stayed throughout their lives.
Acupuncture involves using very short, fine sterile needles which are inserted using a very gentle needle technique specifically for babies. The needles do not stay in so the consultation is relatively quick and the child feels very little. Moxa is often used which is a herb called mugwart that has been rolled into a cigar shape. This is lit and then it smoulders producing a gentle heat which is held over the skin of the child creating a delightful warming sensation. This therapy is very popular with the children as it is very relaxing.
Acupuncture is an extremely effective therapy for babies and children and they are very receptive to it. Once their initial natural anxieties have been overcome, children often find the whole experience enjoyable and look forward to coming for their appointments.
In the interest of promoting awareness of the truth about acupuncture, I think, one ought to point out a few things here:
- The history of acupuncture was not at all as simple as implied above. Acupuncture was even banned in China. Mao re-introduced it, not because he thought it was effective but because he needed to offer some sort of healthcare to the masses.
- The concept of vital energy is a pre-scientific myth which has no basis in reality.
- To claim that children can grow into adulthood without conditions that may have stayed throughout their lives, implies that acupuncture effectively prevents certain diseases. I am not aware of any good evidence for this claim and would therefore classify it as bogus.
- The claim that acupuncture is an extremely effective therapy for babies and children is not supported by good evidence.
What does that tell us about the honesty of the claims made for acupuncture?
You are not surprised?
Considering that the HALE CLINIC now had many hours to ‘clean up’ their website after the allegations in the press, I have to admit that I am a little shocked. They seem to make unsubstantiated claims in order to take parents’ money for sticking useless and potentially harmful needles into their tiny infants.
I am shocked that such misleading information seems to be deemed to be inoffensive.
I am shocked to think that some parents might be sufficiently gullible to do this sort of thing to their infants.
And I am shocked that some people seem to earn their living doing such things.