Monthly Archives: January 2017
If you want to scientifically investigate this question, it might be a good idea NOT to start with the following sentence: “Auricular acupuncture (AA) is effective in the treatment of preoperative anxiety”. Yet, this is exactly what the authors did in their recent publication.
The aim of this new study was to investigate whether AA can reduce exam anxiety as compared to placebo and no intervention. Forty-four medical students were randomized to receive AA, placebo, or no intervention in a crossover manner. Subsequently they completed three comparable oral anatomy exams with an interval of one month between the exams/interventions.
A licensed acupuncturist with more than five years of experience with this technique applied AA at the acupuncture points MA-IC1 (Lung), MA-TF1 (ear Shenmen), MA-SC (Kidney), MA-AT1 (Subcortex) and MA-TG (Adrenal gland) bilaterally. Indwelling fixed ‘New Pyonex’ needles embedded in a skin-coloured adhesive tape were used for AA. The participants were instructed by the acupuncturist to stimulate the auricular needles for 3–5 minutes, if they felt anxious. For the placebo procedure, ‘New Pyonex’ placebo needles were attached to five sites on the helix of the auricle bilaterally. ‘New Pyonex’ placebo needles have the same appearance as AA needles but consist of self-adhesive tape only. In order to avoid potential physiologic effects of acupressure, the participants were not instructed to stimulate the attached ‘New Pyonex’ placebo needles. AA and placebo needles were left in situ until the next day and were removed out of sight of the participants after the exam by the investigator, who was not involved in acupuncture procedure
Levels of anxiety were measured using a visual analogue scale before and after each intervention as well as before each exam. Additional measures included the State-Trait-Anxiety Inventory, duration of sleep at night, blood pressure, heart rate and the extent of participant blinding.
All included participants finished the study. Anxiety levels were reduced after AA and placebo intervention compared to baseline and the no intervention condition (p < 0.003). Moreover, AA was also better at reducing anxiety than placebo in the evening before the exam (p = 0.018). Participants were able to distinguish between AA and placebo intervention.
The authors concluded that both auricular acupuncture and placebo procedure were shown to be effective in reducing levels of exam anxiety in medical students. The superiority of verum AA over placebo AA and no intervention is considered to be due to stimulation of cranial nerves, but may have been increased in effect by insufficient participant blinding.
Here are just three of the major concerns I have about this study:
- The trial design seems odd: a crossover study can only work well, if there is a stable baseline. This may not be the case with three consecutive exams; the anxiety experienced by students is bound to get less as time goes by. I think anyone who has passed a series of exams will confirm that there is a large degree of habituation.
- It seems inadequate to employ just one acupuncturist; it means that the trial might end up testing not acupuncture per se but the skills of the therapist.
- The placebo used for this study cannot possibly have fooled anyone into believing that it was real AA; volunteers were not even instructed to ‘stimulate’ the placebo devices. The difference to the ‘real thing’ must have been very clear to all involved. This means that the control for placebo-effects was woefully incomplete. In turn, this means that the observed outcomes are most likely due to residual bias.
In view of these concerns, allow me to re-phrase the authors’ conclusions:
THE RESULTS OF THIS POORLY-DESIGNED STUDY ARE DIFFICULT TO INTERPRET. MOST LIKELY THEY SHOW THAT ACUPUNCTURE IS NOT EFFECTIVE BUT MERELY WORKS THROUGH A PLACEBO-RESPONSE.
The WDDTY is not my favourite journal – far from it. The reason for my dislike is simple: far too many of its articles are utterly misleading and a danger to public health. Take this recent one entitled ‘Paleo-type diet reversing Crohn’s and ulcerative colitis’, for instance:
START OF QUOTE
Crohn’s disease and ulcerative colitis are being reversed solely by diet—essentially a Paleo diet. The non-drug approach has been successful in 80 per cent of children who’ve been put on the special diet.
The diet—called the specific carbohydrate diet (SCD)—has been pioneered by Dr David Suskind, a gastroenterologist at Seattle Children’s Hospital. The diet excludes grains, dairy, processed foods and sugars, other than honey, and promotes natural, nutrient-rich foods, including vegetables, fruits, meats and nuts.
Children are going into complete remission after just 12 weeks on the diet, a new study has discovered. Ten children with inflammatory bowel disease (IBD)—an umbrella term for Crohn’s and ulcerative colitis—were put on the diet, and eight were completely symptom-free by the end of the study. Suskind started exploring a dietary approach to IBD because he became convinced that the standard medical treatment of steroids or other medication was inadequate. “For decades, medicine has said diet doesn’t matter, that it doesn’t impact disease. Now we know that diet does have an impact, a strong impact. It works, and now there’s evidence,” he said.
END OF QUOTE
“For decades, medicine has said diet doesn’t matter, that it doesn’t impact disease”.
Really?
In this case, I must have studied an entirely different subject all these years ago at university – I had been told it was medicine but perhaps…???…!!!
It took me some time to find the original paper – they cited a wrong reference (2017 instead of 2016). But eventually I located it. Here is its abstract:
GOAL:
To determine the effect of the specific carbohydrate diet (SCD) on active inflammatory bowel disease (IBD).
BACKGROUND:
IBD is a chronic idiopathic inflammatory intestinal disorder associated with fecal dysbiosis. Diet is a potential therapeutic option for IBD based on the hypothesis that changing the fecal dysbiosis could decrease intestinal inflammation.
STUDY:
Pediatric patients with mild to moderate IBD defined by pediatric Crohn’s disease activity index (PCDAI 10-45) or pediatric ulcerative colitis activity index (PUCAI 10-65) were enrolled into a prospective study of the SCD. Patients started SCD with follow-up evaluations at 2, 4, 8, and 12 weeks. PCDAI/PUCAI, laboratory studies were assessed.
RESULTS:
Twelve patients, ages 10 to 17 years, were enrolled. Mean PCDAI decreased from 28.1±8.8 to 4.6±10.3 at 12 weeks. Mean PUCAI decreased from 28.3±23.1 to 6.7±11.6 at 12 weeks. Dietary therapy was ineffective for 2 patients while 2 individuals were unable to maintain the diet. Mean C-reactive protein decreased from 24.1±22.3 to 7.1±0.4 mg/L at 12 weeks in Seattle Cohort (nL<8.0 mg/L) and decreased from 20.7±10.9 to 4.8±4.5 mg/L at 12 weeks in Atlanta Cohort (nL<4.9 mg/L). Stool microbiome analysis showed a distinctive dysbiosis for each individual in most prediet microbiomes with significant changes in microbial composition after dietary change.
CONCLUSIONS:
SCD therapy in IBD is associated with clinical and laboratory improvements as well as concomitant changes in the fecal microbiome. Further prospective studies are required to fully assess the safety and efficacy of dietary therapy in patients with IBD.
What does this mean?
The WDDTY report bears very little resemblance to the journal article (let alone with the title of their article or any other published research by David Suskind).
How come?
I cannot be sure, but I would not be surprised to hear that the latter was ‘egged up’ to make the former appear more interesting.
If that is so, WDDTY are (once again) guilty of misleading the public to the point of endangering lives of vulnerable patients.
SHAME ON EVERY OUTLET THAT SELLS WDDTY, I’d say.
The ACUPUNCTURE NOW FOUNDATION (ANF) has featured on this blog before. Today I want to re-introduce them because I just came across one of their articles which I found remarkable. In it, they define what many of us have often wondered about: the most important myth about acupuncture.
Is it acupuncture’s current popularity, its long history, its mode of action, its efficacy, its safety?
No, here is the answer directly from the ANF:
The most important myth that needs to be put to rest is the idea promoted by a small group of vocal critics that acupuncture is nothing more than a placebo. Many cite the fact that studies showing acupuncture to be highly effective were of low quality and that several higher quality studies show that, while acupuncture was clinically effective, it usually does not outperform “sham” acupuncture. But those studies are dominated by the first quality issue cited above; studies with higher methodological rigor where the “real” acupuncture was so poorly done as to not be a legitimate comparison. Yet despite the tendency toward poor quality acupuncture in studies with higher methodological standards, a benchmark study was done that showed “real” acupuncture clearly outperforming “sham” acupuncture in four different chronic pain conditions.3 When you add this study together with the fact veterinary acupuncture is used successfully in many different animals, the idea of acupuncture only being placebo must now be considered finally disproven. This is further supported by studies which show that the underlying physiological pathways activated by acupuncture sometimes overlap, but can be clearly differentiated from, those activated by placebo responses.
Disappointed?
Yes, I was too.
The myth, according to the ANF, essentially is that sceptics do not understand the scientific evidence. And these blinkered sceptics even go as far as ignoring the findings from what the ANF consider to be a ‘benchmark study’! Ghosh, that’s nasty of them!!!
But, no – the benchmark study (actually, it was not a ‘study’ but a meta-analysis of studies) has been discussed fully on this blog (and in many other places too). Here is what I wrote in 2012 when it was first published:
An international team of acupuncture trialists published a meta-analysed of individual patient data to determine the analgesic effect of acupuncture compared to sham or non-acupuncture control for the following 4 chronic pain conditions: back and neck pain, osteoarthritis, headache, and shoulder pain. Data from 29 RCTs, with an impressive total of 17 922 patients, were included.
The results of this new evaluation suggest that acupuncture is superior to both sham and no-acupuncture controls for each of these conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than those of sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs.
Based on these findings, the authors reached the conclusion that “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture”.
… even the enthusiastic authors of this article admit that, when compared to sham, the effect size of real acupuncture is too small to be clinically relevant. Therefore one might argue that this meta-analysis confirms what critics have suggested all along: acupuncture is not a useful treatment for clinical routine.
Unsurprisingly, the authors of the meta-analysis do their very best to play down this aspect. They reason that, for clinical routine, the comparison between acupuncture and non-acupuncture controls is more relevant than the one between acupuncture and sham. But this comparison, of course, includes placebo- and other non-specific effects masquerading as effects of acupuncture – and with this little trick (which, by the way is very popular in alternative medicine), we can, of course, show that even sugar pills are effective.
I do not doubt that context effects are important in patient care; yet I do doubt that we need a placebo treatment for generating such benefit in our patients. If we administer treatments which are effective beyond placebo with kindness, time, compassion and empathy, our patients will benefit from both specific and non-specific effects. In other words, purely generating non-specific effects with acupuncture is far from optimal and certainly not in the interest of our patients. In my view, it cannot be regarded as not good medicine, and the authors’ conclusion referring to a “reasonable referral option” is more than a little surprising in my view.
Acupuncture-fans might argue that, at the very minimum, the new meta-analysis does demonstrate acupuncture to be statistically significantly better than a placebo. Yet I am not convinced that this notion holds water: the small residual effect-size in the comparison of acupuncture with sham might not be the result of a specific effect of acupuncture; it could be (and most likely is) due to residual bias in the analysed studies.
The meta-analysis is strongly driven by the large German trials which, for good reasons, were heavily and frequently criticised when first published. One of the most important potential drawbacks was that many participating patients were almost certainly de-blinded through the significant media coverage of the study while it was being conducted. Moreover, in none of these trials was the therapist blinded (the often-voiced notion that therapist-blinding is impossible is demonstrably false). Thus it is likely that patient-unblinding and the absence of therapist-blinding importantly influenced the clinical outcome of these trials thus generating false positive findings. As the German studies constitute by far the largest volume of patients in the meta-analysis, any of their flaws would strongly impact on the overall result of the meta-analysis.
So, has this new meta-analysis finally solved the decades-old question about the effectiveness of acupuncture? It might not have solved it, but we have certainly moved closer to a solution, particularly if we employ our faculties of critical thinking. In my view, this meta-analysis is the most compelling evidence yet to demonstrate the ineffectiveness of acupuncture for chronic pain.
END OF QUOTE
The ANF-text then goes from bad to worse. First they cite the evidence from veterinary acupuncture as further proof of the efficacy of their therapy. Well, the only systematic review in this are is, I think, by my team; and it concluded that 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.
Lastly, the ANF mentions acupuncture’s mode of action which they seem to understand clearly and fully. Congratulations ANF! In this case, you are much better than the many experts in basic science or neurology who almost unanimously view these ‘explanations’ of how acupuncture might work as highly adventurous hypotheses or speculations.
So, what IS the most important myth about acupuncture? I am not sure and – unlike the ANF – I do not feel that I can speak for the rest of the world, but one of the biggest myths FOR ME is how acupuncture fans constantly manage to mislead the public.
Can intercessory prayer improve the symptoms of sick people?
Why should it? It’s utterly implausible!
Because the clinical evidence says so?
No, the current Cochrane review concluded that [the] findings are equivocal and, although some of the results of individual studies suggest a positive effect of intercessory prayer, the majority do not and the evidence does not support a recommendation either in favour or against the use of intercessory prayer. We are not convinced that further trials of this intervention should be undertaken and would prefer to see any resources available for such a trial used to investigate other questions in health care.
Yet, not all seem to agree with this; and some even continue to investigate prayer as a medical therpy.
For this new study (published in EBCAM), the Iranian investigators randomly assigned 92 patients in 2 groups to receive either 40 mg of propranolol twice a day for 2 month (group “A”) or 40 mg of propranolol twice a day for 2 months with prayer (group “B”). At the beginning of study and 3 months after intervention, patients’ pain was measured using the visual analogue scale.
All patients who participate in present study were Muslim. At the beginning of study and before intervention, the mean score of pain in patients in groups A and B were 5.7 ± 1.6 and 6.5 ± 1.9, respectively. According to results of independent t test, mean score of pain intensity at the beginning of study were similar between patients in 2 groups (P > .05). Three month after intervention, mean score of pain intensity decreased in patients in both groups. At this time, the mean scores of pain intensity were 5.4 ± 1.1 and 4.2 ± 2.3 in patients in groups A and B, respectively. This difference between groups was statistically significant (P < .001).
The above figure shows the pain score in patients before and after the intervention.
The authors concluded that the present study revealed that prayer can be used as a nonpharmacologic pain coping strategy in addition to pharmacologic intervention for this group of patients.
Extraordinary claims require extraordinary proof. This study is, in fact, extraordinary – but only in the sense of being extraordinarily poor, or at least it is extraordinary in its quality of reporting. For instance, all we learn in the full text article about the two treatments applied to the patient groups is this: “The prayer group participated in an 8-week, weekly, intercessory prayer program with each session lasting 45 minutes. Pain reduction was measured at baseline and after 3 months, by registered nurses who were specialist in pain management and did not know which patients were in which groups (control or intervention), using a visual analogue scale.”
Intercessory prayer is the act of praying on behalf of others. This mans that the patients receiving prayer might have been unaware of being ‘treated’. In this case, the patients could have been adequately blinded. But this is not made clear in the article.
More importantly perhaps, the authors fail to provide any numeric results. All that we are given is the above figure. It is not possible therefore to run any type of check on the data. We are simply asked to believe what the authors have written. I for one have great difficulties in doing so. All I do believe in relation to this article is that
- the journal EBCAM is utter trash,
- constantly publishing rubbish is unethical and a disservice to everyone,
- prayer does not need further research of this nature,
- and poor studies often generate false-positive findings.
Is acupuncture a pseudoscience? An interesting question! It was used as the title of a recent article. Knowing who authored it, the question unfortunately promised to be rhetorical. Dr Mike Cummings is (or was?) the ‘Medical Director at British Medical Acupuncture Society’ – hardly a source of critical or sceptical thinking about acupuncture, I’d say. The vast majority of his recent publications are in ‘ACUPUNCTURE IN MEDICINE’ and his blog post too is for that journal. Nevertheless, his thoughts might be worth considering, and therefore I present the essence of his post below [the footnotes refer to my comments following Cummings’ article]:
…Wikipedia has branded acupuncture as pseudoscience and its benefits as placebo [1]. ‘Acupuncture’ is clearly is not pseudoscience; however, the way in which it is used or portrayed by some may on occasion meet that definition. Acupuncture is a technique that predates the development of the scientific method [2] … so it is hardly fair to classify this ancient medical technique within that framework [3]. It would be better to use a less pejorative classification within the bracket of history when referring to acupuncture and other ancient East Asian medical techniques [4]. The contemporary use of acupuncture within modern healthcare is another matter entirely, and the fact that it can be associated with pre-scientific medicine does not make it a pseudoscience.
The Wikipedia acupuncture page is extensive and currently runs to 302 references. But how do we judge the quality or reliability of a text or its references? … I would generally look down on blogs, such as this, because they lack … hurdles prior to publication [5]. Open peer review was introduced relatively recently associated with immediate publication. But all this involves researchers and senior academics publishing and reviewing within their own fields of expertise. Wikipedia has a slightly different model built on five pillars. The second of those pillars reads:
Wikipedia is written from a neutral point of view: We strive for articles that document and explain major points of view, giving due weight with respect to their prominence in an impartial tone. We avoid advocacy and we characterize information and issues rather than debate them. In some areas there may be just one well-recognized point of view; in others, we describe multiple points of view, presenting each accurately and in context rather than as “the truth” or “the best view”. All articles must strive for verifiable accuracy, citing reliable, authoritative sources, especially when the topic is controversial or is on living persons. Editors’ personal experiences, interpretations, or opinions do not belong.
Experts within a field may be seen to have a certain POV (point of view), and are discouraged from editing pages directly because they cannot have the desired NPOV (neutral POV). This is a rather unique publication model in my experience, although the editing and comments are all visible and traceable, so there is no hiding… apart from the fact that editors are allowed to be entirely anonymous. Have a look at the talk page behind the main acupuncture page on Wikipedia. You may be shocked by the tone of much of the commentary. It certainly does not seem to comply with the fourth of the five pillars, which urges respect and civility, and in my opinion results primarily from the security of anonymity. I object to the latter, but there is always a balance to be found between freedom of expression (enhanced for some by the safety of anonymity) and cyber bullying (almost certainly fuelled in part by anonymity). That balance requires good moderation, and whilst there was some evidence of moderation on the talk page, it was inadequate to my mind… I might move to drop anonymity from Wikipedia if moderation is wanting.
Anyway my impression, for what it’s worth, is that the acupuncture page on Wikipedia is not written from an NPOV, but rather it appears to be controlled by semi professional anti-CAM pseudosceptics [6]. I have come across these characters [6] regularly since I was introduced to the value of needling in military general practice. I have a stereotypical mental image: plain or scary looking bespectacled geeks and science nuts [6], the worst are often particle physicists … Interacting with them is at first intense, but rapidly becomes tedious as they know little of the subject detail [6], fall back on the same rather simplistic arguments [6] and ultimately appear to be motivated by eristic discourse rather than the truth [6].
I am not surprised that they prefer to close the comments, because I imagine that some people might object rather strongly to many of the statements made in this text.
Here are my short comments:
[1] I should perhaps stress that I am not the author of nor a contributor to this Wiki (or any other) page. [2] Is this an attempt to employ the ‘appeal to tradition’ fallacy? [3] The Wiki page does by no means classify the ancient history of acupuncture as pseudoscience. [4] I have always felt that classification of science or medicine according to geography is nonsensical; they should not be classified as Western or Asian but as sound or not, effective or not, etc. [5] As we have often seen on this blog, the ‘hurdles’ (peer-review) are often laughable, particularly in the realm of alternative medicine. [6] This article is essentially trying to show that the Wiki page is biased. Yet it ends with a bonanza of insults which essentially reveal the profound bias of the author.IS ACUPUNCTURE PSEUDOSCIENCE? Cummings’ article promised to address this question. Sadly it did nothing of the sort. It turned out to be an incompetent rant about a Wiki page. If anything, Cummings contributed to the neutral reader of his text getting convinced that, indeed, acupuncture IS a pseudoscience! At least Wiki used facts, arguments, evidence etc. and it went a lot further in finding a rational answer to this intriguing question.
‘How to convince someone when facts fail’ – this is the title of a very good and ‘must read’ article by Michael Shermer recently published in SCIENTIFIC AMERICAN. The issue is clearly relevant to numerous discussions we have on this blog. Therefore, I will repeat Shermer’s conclusions here:
If corrective facts only make matters worse, what can we do to convince people of the error of their beliefs? From my experience,
1. keep emotions out of the exchange,
2. discuss, don’t attack (no ad hominem and no ad Hitlerum),
3. listen carefully and try to articulate the other position accurately,
4. show respect,
5. acknowledge that you understand why someone might hold that opinion, and
6. try to show how changing facts does not necessarily mean changing worldviews.
These strategies may not always work to change people’s minds, but now that the nation has just been put through a political fact-check wringer, they may help reduce unnecessary divisiveness.
Wise words and good strategies! But, as Shermer himself admits, they unfortunately don’t always work. This blog and the comments made by its readers provide ample examples of failures in this respect.
By and large, I try my very best to adhere to Shermer’s principles. Yet, I do not pretend that I always succeed brilliantly – on the contrary, far too often, I lose my rag. I am not particularly proud of it, but neither am I all that deeply ashamed.
The thing is that any attempt at a respectful and constructive dialogue requires the co-operation of both sides. If the opponent is continually disrespectful, offensive, dishonest, unable to grasp even the simplest concepts, etc., I often just stop the dialogue. If that does not prevent my opponent from being a belligerent nuisance, I have been known to get impatient or even rude. TO ALL WHO I OFFENDED IN 2016, I CAN ONLY SAY THIS: THERE PROBABLY WAS A GOOD REASON FOR MY BEHAVIOUR.
I know, this is not good enough, particularly as I should set an example for others. How can I expect all the commentators on this blog to be respectful and constructive, if I too loose my temper from time to time? The answer is I cannot (by the way, this is one reason why I have passed other people’s outbursts and ,so far, published them largely uncensored; as long as I cannot fully control myself, I must not censor others with the same predicament).
So, here is my resolution for 2017:
I will continue to be provocative (this is part of the ‘raison d’etre’ of this blog) but, at the same time, I will try harder to show respect, politeness and understanding. Crucially, I am herewith asking everyone to PLEASE do likewise. Failing this, I will start censoring those sections of the comments that I consider abusive; and [I almost forgot] I will ban those commentators who repeatedly need censoring.
