MD, PhD, FMedSci, FSB, FRCP, FRCPEd

acupuncture

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Acupuncture, like most other alternative therapies, is particular popular for indications that are

  1. chronic,
  2. associated with a high burden of suffering,
  3. not easily treatable with conventional therapies,
  4. are frequently resolved without any intervention.

Infertility or subfertility tick most of these boxes. It is therefore not surprising that acupuncturists the world over claim that acupuncture can cure infertility. But is this claim based on evidence or on wishful thinking?

The objective of this new study was to find out. Specifically, the authors wanted to provide preliminary data to explore whether women with subfertility undergoing a course of acupuncture and lifestyle modification compared with an active control of lifestyle modification alone would demonstrate improved reproductive outcomes, improved menstrual cycles, and increased fertility awareness.

In a pragmatic randomised controlled trial, with the A+B versus B design, sub/infertile women were offered an intervention of acupuncture and lifestyle modification or lifestyle modification only. There was a statistically significant increase in fertility awareness in the acupuncture group (86.4%) compared to 40% of the lifestyle only participants. Changes in menstrual regularity were not statistically significant. There was no statistical difference in the pregnancy rate with seven women achieving pregnancy during the course of the study intervention. Those receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group.

The authors concluded that the acupuncture protocol tested influenced women who received it compared to women who used lifestyle modification alone: their fertility awareness and wellbeing increased, and those who conceived did so in half the time.

The first sentences of the authors’ discussion are, I think, revealing: The main findings were that this acupuncture intervention, compared to lifestyle only, resulted in significant increases in fertility awareness and quality of life measures in relation to wellbeing; it increased the ability of the recipients to engage in desired activities, such as exercise or rest, and it shortened the time to conception by half. The findings provide preliminary evidence that the acupuncture intervention is acceptable and is not inert and that acupuncture dose may have a significant influence on outcomes. 

In my view, the main findings of this study are entirely different. Let me propose alternatives:

  • In alternative medicine, if you did a lousy study, you can just call it a ‘pilot study’ and all is forgiven.
  • The infamous A+B vs B design continues to be popular for those who cannot bring themselves to publishing negative findings.
  • It works perfectly for subjective parameters but less convincingly for objective ones, such as pregnancy rates.
  • Doing such research on infertility is good for the cash flow of acupuncturists.
  • Making women aware of fertility increases (surprise, surprise!) fertility awareness.

No need to be so cynical!, some will think. After all, the results showed that women receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group. True! But there was no statistically significant difference between these two figures. And that means, the difference was a chance finding (which has no place in an abstract) which probably has no relevance whatsoever.

Or perhaps I am wrong?

I am told to always keep an open mind!

So, let’s keep our minds open to some truly alternative explanations. How about this one: regular acupuncture increases the rate of adultery, which, in turn, decreases the time to conception.

Makes sense, doesn’t it? Has anyone a better idea?

Yesterday, I wrote about a new acupuncture trial. Amongst other things, I wanted to find out whether the author who had previously insisted I answer his questions about my view on the new NICE guideline would himself answer a few questions when asked politely. To remind you, this is what I wrote:

This new study was designed as a randomized, sham-controlled trial of acupuncture for persistent allergic rhinitis in adults investigated possible modulation of mucosal immune responses. A total of 151 individuals were randomized into real and sham acupuncture groups (who received twice-weekly treatments for 8 weeks) and a no acupuncture group. Various cytokines, neurotrophins, proinflammatory neuropeptides, and immunoglobulins were measured in saliva or plasma from baseline to 4-week follow-up.

Statistically significant reduction in allergen specific IgE for house dust mite was seen only in the real acupuncture group. A mean (SE) statistically significant down-regulation was also seen in pro-inflammatory neuropeptide substance P (SP) 18 to 24 hours after the first treatment. No significant changes were seen in the other neuropeptides, neurotrophins, or cytokines tested. Nasal obstruction, nasal itch, sneezing, runny nose, eye itch, and unrefreshed sleep improved significantly in the real acupuncture group (post-nasal drip and sinus pain did not) and continued to improve up to 4-week follow-up.

The authors concluded that acupuncture modulated mucosal immune response in the upper airway in adults with persistent allergic rhinitis. This modulation appears to be associated with down-regulation of allergen specific IgE for house dust mite, which this study is the first to report. Improvements in nasal itch, eye itch, and sneezing after acupuncture are suggestive of down-regulation of transient receptor potential vanilloid 1.

…Anyway, the trial itself raises a number of questions – unfortunately I have no access to the full paper – which I will post here in the hope that my acupuncture friend, who are clearly impressed by this paper, might provide the answers in the comments section below:

  1. Which was the primary outcome measure of this trial?
  2. What was the power of the study, and how was it calculated?
  3. For which outcome measures was the power calculated?
  4. How were the subjective endpoints quantified?
  5. Were validated instruments used for the subjective endpoints?
  6. What type of sham was used?
  7. Are the reported results the findings of comparisons between verum and sham, or verum and no acupuncture, or intra-group changes in the verum group?
  8. What other treatments did each group of patients receive?
  9. Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?

In the comments section, the author wrote: “after you have read the full text and answered most of your questions for yourself, it might then be a more appropriate time to engage in any meaningful discussion, if that is in fact your intent”, and I asked him to send me his paper. As he does not seem to have the intention to do so, I will answer the questions myself and encourage everyone to have a close look at the full paper [which I can supply on request].

  1. The myriad of lab tests were defined as primary outcome measures.
  2. Two sentences are offered, but they do not allow me to reconstruct how this was done.
  3. No details are provided.
  4. Most were quantified with a 3 point scale.
  5. Mostly not.
  6. Needle insertion at non-acupoints.
  7. The results are a mixture of inter- and intra-group differences.
  8. Patients were allowed to use conventional treatments and the frequency of this use was reported in patient diaries.
  9. I don’t think so.

So, here is my interpretation of this study:

  • It lacked power for many outcome measures, certainly the clinical ones.
  • There were hardly any differences between the real and the sham acupuncture group.
  • Most of the relevant results were based on intra-group changes, rather than comparing sham with real acupuncture, a fact, which is obfuscated in the abstract.
  • In a controlled trial fluctuations within one group must never be interpreted as caused by the treatment.
  • There were dozens of tests for statistical significance, and there seems to be no correction for multiple testing.
  • Thus the few significant results that emerged when comparing sham with real acupuncture might easily be false positives.
  • Patient-blinding seems questionable.
  • McDonald as the only therapist of the study might be suspected to have influenced his patients through verbal and non-verbal communications.

I am sure there are many more flaws, particularly in the stats, and I leave it to others to identify them. The ones I found are, however, already serious enough, in my view, to call for a withdrawal of this paper. Essentially, the authors seem to have presented a study with largely negative findings as a trial with positive results showing that acupuncture is an effective therapy for allergic rhinitis. Subsequently, McDonald went on social media to inflate his findings even more. One might easily ask: is this scientific misconduct or just poor science?

I would be most interested to hear what you think about it [if you want to see the full article, please send me an email].

While looking up an acupuncturist who has recently commented on this blog trying to teach me how to do science and understand research methodology, I was impressed that he, Dr John McDonald, PhD, has just published a clinical trial. Not many acupuncturists do that, you know, and I very much applaud this action, which even seems to have earned him his PhD! McDonald is understandably proud of his achievement – all the more because the study arrived at positive conclusions. This is what he wrote about it:

…So, in a nutshell, acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis which produces lasting changes in the immune system and hence improvements in symptoms and quality of life.    Dr John McDonald

Fascinating! I quickly looked up the paper. Here it is:

This new study was designed as a randomized, sham-controlled trial of acupuncture for persistent allergic rhinitis in adults investigated possible modulation of mucosal immune responses. A total of 151 individuals were randomized into real and sham acupuncture groups (who received twice-weekly treatments for 8 weeks) and a no acupuncture group. Various cytokines, neurotrophins, proinflammatory neuropeptides, and immunoglobulins were measured in saliva or plasma from baseline to 4-week follow-up.

Statistically significant reduction in allergen specific IgE for house dust mite was seen only in the real acupuncture group. A mean (SE) statistically significant down-regulation was also seen in pro-inflammatory neuropeptide substance P (SP) 18 to 24 hours after the first treatment. No significant changes were seen in the other neuropeptides, neurotrophins, or cytokines tested. Nasal obstruction, nasal itch, sneezing, runny nose, eye itch, and unrefreshed sleep improved significantly in the real acupuncture group (post-nasal drip and sinus pain did not) and continued to improve up to 4-week follow-up.

The authors concluded that acupuncture modulated mucosal immune response in the upper airway in adults with persistent allergic rhinitis. This modulation appears to be associated with down-regulation of allergen specific IgE for house dust mite, which this study is the first to report. Improvements in nasal itch, eye itch, and sneezing after acupuncture are suggestive of down-regulation of transient receptor potential vanilloid 1.

These conclusions seem to be based on the data of the study. But they are oddly out of line with the above statement made by McDonald about his trial. What could be the reason for this discrepancy? Could it be that he behaves ‘scientifically’ correct when under the watchful eye of numerous co-authors from the School of Medicine, Menzies Health Institute, Griffith University, Queensland, Australia, the School of Medicine, Menzies Health Institute, Griffith University, Queensland, Australia, the National Institute of Complementary Medicine, Western Sydney University, Sydney, Australia, the Health Innovations Research Institute and School of Health Sciences, RMIT University, Melbourne, Victoria, Australia, and the Stanford University, Palo Alto, California? And could it be that he is a little more ‘liberal’ when on his own? A mere speculation, of course, but it would be nice to know.

Anyway, the trial itself raises a number of questions – unfortunately I have no access to the full paper – which I will post here in the hope that my acupuncture friend, who are clearly impressed by this paper, might provide the answers in the comments section below:

  1. Which was the primary outcome measure of this trial?
  2. What was the power of the study, and how was it calculated?
  3. For which outcome measures was the power calculated?
  4. How were the subjective endpoints quantified?
  5. Were validated instruments used for the subjective endpoints?
  6. What type of sham was used?
  7. Are the reported results the findings of comparisons between verum and sham, or verum and no acupuncture, or intra-group changes in the verum group?
  8. Was the success of patient-blinding checked, quantified and successful?
  9. What other treatments did each group of patients receive?
  10. Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?

“Conflicts of interest should always be disclosed.”

This is what I wrote in the ‘RULES’ of this blog when I first started it almost 4 years ago. Sadly, very few people writing comments observe this rule. Perhaps, I just thought, I did not observe it either? So, here are my conflicts of interest: none.

Not true!!! I hear some people say. But it is!

I have no financial interest in any ‘Big Pharma’ or  ‘TINY CAM’, and I get not a penny for writing this blog.

How do I pay for my living? Mind your own business… well, on second thought, even that must not be a secret: I get a small pension and have some savings.

Still not convinced?

Perhaps it’s time to define what ‘conflicts of interests’ are. According to Wikipedia, they can be defined as  situations in which a person or organization is involved in multiple interests, financial interest, or otherwise, one of which could possibly corrupt the motivation of the individual or organization.

So, not having financial benefits from my current work does not necessarily mean that I have no conflicts of interest. The above definitions vaguely mentions ‘or otherwise’ – and that could be important. What could this mean in the context of this blog?

Well, I might have very strong beliefs, for instance (for instance, very strong beliefs that acupuncture is by definition nonsense [see below]). We all know that strong beliefs can corrupt motivation (and a lot more). And if I ask myself, do you have strong beliefs?, I have to say: Yes, absolutely!

I believe that:

  • good evidence is a prerequisite for progress in healthcare,
  • good evidence must be established by rigorous research,
  • we should not tolerate double standards in healthcare,
  • patients deserve to be treated with the best available treatments,
  • making therapeutic claims that are not supported by sound evidence is wrong.

These strong beliefs might make me biased in the eyes of many who comment on this blog. In Particular, we recently had a bunch of acupuncturists who went on the rampage attacking me personally the best they could. However, a rational analysis of my beliefs can hardly produce evidence for bias against anything other than the promotion of unproven therapies to the unsuspecting public.

The above mentioned acupuncturists seem to think that I have always been against acupuncture for the sake of being against acupuncture. However, this is not true. The proof for this statement is very simple: I have published quite a bit of articles that concluded positively – even (WOULD YOU BELIEVE IT?) about acupuncture for back pain! A prominently published meta-analysis of 2005 (with me as senior author) concluded:  “Acupuncture effectively relieves chronic low back pain.” (This of course was 11 years ago when the evidence was, in fact, positive; today, this seems to have changed – just like the NICE guidelines [probably not a coincidence!])

Conflicts of interest? No, not on my side, I think.

But what about the ‘other side’?

The unruly horde of acupuncturists (no, this is not an ad hominem attack, it’s a fact) who recently made dozens of ad hominem attacks against me, what about them?

  • They earn their money with acupuncture.
  • They have invested in acupuncture training often for long periods of time.
  • They have invested in practice equipment etc.
  • Some of them sell books on acupuncture.
  • Others run courses.
  • And all of them very clearly and demonstrably  have strong beliefs about acupuncture.

I think the latter point constitutes by far the most important conflict of interest in this context.

And this is where the somewhat trivial story has an unexpected twist and gets truly bizarre:

I have just leant that the same group of conflicted acupuncturists are now planning to publicly attack the panel of experts responsible for drafting the NICE guidelines. The reason? They feel that this panel had significant conflicts of interest that led them to come out against acupuncture.

Perhaps I should mention that I was not a member of this group, but I suspect that some of its members might have links to the pharmaceutical industry. It is almost impossible to find top experts in any area of medicine who do not have such links. You either gather experts with potential conflicts of interest, or you get non-experts without them. Would that bias them against acupuncture or any other alternative therapy? I very much doubt it.

What I do not doubt for a minute is that conflicts of interest are of major importance in these discussions. And by that I mean the more than obvious (but nevertheless undeclared) conflicts of interest of the acupuncturists. It seems that those with the strongest conflicts of interest shout the loudest about the non-existent or irrelevant conflict of interest of those who do not happen to share their quasi-religious belief in acupuncture.

Ad hominem attacks, I have previously pointed out, are victories of reason over unreason. And they are used frequently by supporters of alternative medicine!

If you doubt it, see for yourself.

I recently posted a comment on new Nice guidelines. It generated lots of comments, and mostly they were rational discussions of the issues involved. This changed abruptly when, on 16 May, Mel’s comment started a new, concerted wave of discussion at a time when the usual debate had already subsided. In the course of this new and heated debate, I was repeatedly accused of being rude.

As I have stated repeatedly on this blog, I try to keep rudeness out of the comments as much as I can. Therefore, the claim surprised me and today I reviewed the entire comment section selecting all potential ad hominem attacks. Here are the results:

ACTUAL OR POTENTIAL AD HOMINEM ATTACKS AGAINST ME

Peter Deadman on Tuesday 17 May 2016 at 12:55 Edward Ernst, I always thought you were a bully and a fraud. You’re very macho when it comes to slapping down people who may have experiential reasons for supporting acupuncture and other therapies but don’t have the skill to challenge you on the clinical evidence. Now as soon as somebody does, you back off, cry ‘enough’, say you can’t possibly comment till some undetermined future date and generally act like a wuss. I say put up or shut up. I’d prefer the former because it would be good to see you eat crow but I lean towards the latter because of the substantial harm you are causing and the beautiful silence that would ensue if you did indeed go quiet.

tonto on Tuesday 17 May 2016 at 13:19 You appear as weak in your arguments, as some pendulum swinging, new age dowser, who vainly holds sticks to their guns, not because they can back their position up with scientific evidence, but because it is what they “believe”.

Jill Onyett on Tuesday 17 May 2016 at 14:29 …an unfortunate creature too keen on the sound of his own voice.

Tracey Phillips on Tuesday 17 May 2016 at 13:16 …to date you have been fairly opinionated …

Peter Deadman on Tuesday 17 May 2016 at 16:34  I made an ad hominem response because your blog is all about you as a person. You are constantly rude to others and bypass or ignore responses that you don’t like. It’s you who makes it hominem.

Peter Deadman on Tuesday 17 May 2016 at 16:52 You are hyper-emotional, extremely biased, hostile and contemptuous of anyone you think ‘beneath you’. You gloat over people’s real or imagined inconsistencies and generally come across as a nasty piece of work.

Peter Deadman on Tuesday 17 May 2016 at 19:30 How can such a childish provocateur remain in his post. It demeans the University and it’s time they let him go.

Kylee Junghans on Wednesday 18 May 2016 at 08:42 …you, kind Sir, with your rhetoric and tantrums, are exhibiting a prime example of confirmation bias.

Peter Deadman on Wednesday 18 May 2016 at 08:48 [Ernst] professes a scholarly detachment, a commitment to evidence and an open mind, but in fact is deeply biased… He clearly loves his childish provocative stance and is as far from a disinterested observer as it’s possible to be. I wouldn’t waste my time or breath on him if he didn’t have an influence that far exceeds his worth.

Carol Cooke on Wednesday 18 May 2016 at 09:27 I have followed this discussion with interest. Some of the rudest and most discourteous posts I can see are from Mr Ernst himself. But I get that, I imagine you seek to maintain a bold and authoritative tone simply by dismissing others. Being a bit controversial in your discourse has obviously served you well in that you have built a media profile on it.

ACTUAL OR POTENTIAL AD HOMINEM ATTACKS BY MYSELF

Edzard on Wednesday 18 May 2016 at 09:18 “it is also difficult to get a man to read something, when he is foaming from his mouth”.

I know, this is not really ‘ad hominem’ but I could not find anything more dramatic. Surely, some will disagree this me here, and I do invite them to cite my rudeness from this threat, if they spot it. You are more than welcome!

CONCLUSION

You may think this is a bit trivial, but I disagree. The main reason I did this little exercise is to demonstrate a point which I think is important and carries a relevant lesson for future comments and discussions:

  • WHEN I OR ANYONE ELSE DEFENDING RATIONALITY GET AGGRESSED, WE NATURALLY TEND TO RESPOND SLIGHTLY MORE FORCEFULLY.
  • SUBSEQUENTLY, THE OTHER SIDE OFTEN REACTS BY ATTACKING US PERSONALLY.
  • THIS OFTEN LEADS TO AN ESCALATION OF TONE.
  • EVENTUALLY THE OTHER SIDE CLAIMS WITH INDIGNATION THAT WE ARE THE ONES DOING THE PERSONAL ATTACKS.
  • IT IS A TACTIC THAT IS EFFECTIVE BUT DISHONEST, IN MY VIEW.
  • THE LESSON IS SIMPLE: DO NOT LET YOURSELF GET PROVOKED INTO ISSUING AD HOMINEM ATTACKS, BE POLITE AND PATIENT.

I know this sounds simpler than it is, and I am far from being immune to the problem, but we owe it to reason to give it a try.

 

While over on my post about the new NICE GUIDELINES on acupuncture for back pain, the acupuncturists’ assassination attempts of my character, competence, integrity and personality are in full swing, I have decided to employ my time more fruitfully and briefly comment on a new piece of acupuncture research.

This new Italian study was to determine the effectiveness of acupuncture for the management of hot flashes in women with breast cancer.

A total of 190 women with breast cancer were randomly assigned to two groups. Random assignment was performed with stratification for hormonal therapy; the allocation ratio was 1:1. Both groups received a booklet with information about climacteric syndrome and its management to be followed for at least 12 weeks. In addition, the acupuncture group received 10 traditional acupuncture treatment sessions involving needling of predefined acupoints.

The primary outcome was hot flash score at the end of treatment (week 12), calculated as the frequency multiplied by the average severity of hot flashes. The secondary outcomes were climacteric symptoms and quality of life, measured by the Greene Climacteric and Menopause Quality of Life scales. Health outcomes were measured for up to 6 months after treatment. Expectation and satisfaction of treatment effect and safety were also evaluated. We used intention-to-treat analyses.

Of the participants, 105 were randomly assigned to enhanced self-care and 85 to acupuncture plus enhanced self-care. Acupuncture plus enhanced self-care was associated with a significantly lower hot flash score than enhanced self-care at the end of treatment (P < .001) and at 3- and 6-month post-treatment follow-up visits (P = .0028 and .001, respectively). Acupuncture was also associated with fewer climacteric symptoms and higher quality of life in the vasomotor, physical, and psychosocial dimensions (P < .05).

The authors concluded that acupuncture in association with enhanced self-care is an effective integrative intervention for managing hot flashes and improving quality of life in women with breast cancer.

This hardly needs a comment, as I have been going on about this study design many times before: the ‘A+B versus B’ design can only produce positive findings. Any such study concluding that ‘acupuncture (or whatever other intervention) is effective’ can therefore not be a legitimate test of a hypothesis and ought to be categorised as pseudo-science. Sadly, this problem seems more the rule than the exception in the realm of acupuncture research. That’s a pity really… because, if there is potential in acupuncture at all, this sort of thing can only distract from it.

I think the JOURNAL OF CLINICAL ONCOLOGY, its editors and reviewers, should be ashamed of having published such misleading rubbish.

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.

Compared to control groups, both MA and EA were more effective in improving AHI and mean SaO2. In addition, MA could further improve apnea index and hypopnea index compared to control.

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.

clinicians may consider Tai Chi as a viable complementary and alternative medicine for chronic pain conditions.

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:

  1. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
  2. “Acupuncture can be considered for improving depressive symptoms in women suffering from hot flashes…” [RCTs (1 and 2) cited in support] 
  3. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
One or two studies as a basis for far-reaching guidelines? Yes, that would normally be a concern! But, at closer scrutiny, my worries about these recommendation turn out to be much more serious than this.

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?

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