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?
The authors of a recent paper inform us that Reiki is a Japanese system of energy healing that has been used for over 2 500 years. It involves the transfer of energy from the practitioner to the receiver, which promotes healing, and can be done by either contact or non-contact methods. Both the receiver and the practitioner may feel the energy in various forms (warmth, cold, tingling, vibration, pulsations and/or floating sensations). Reiki can also be self-administered if one is a Reiki practitioner. Reiki is mainly used to address stress, anxiety, and pain reduction while also promoting a sense of well-being and improving quality of life.
Such statements should make us weary: what is presented here as fact is nothing more than conjecture – and very, very implausible conjecture too. Anyone who writes stuff like this in the introduction of a scientific paper is, in my view, unlikely to be objective and could be well on the way to present some nasty piece of pseudo-science.
But I am, of course, pre-judging the issue; let’s have a quick look at the article itself.
The purpose of this study was to determine the effects of a 20-week structured self-Reiki program on stress reduction and relaxation in college students. Students were recruited from Stockton University and sessions were conducted in the privacy of their residence. Twenty students completed the entire study consisting of 20 weeks of self-Reiki done twice weekly. Each participant completed a Reiki Baseline Credibility Scale, a Reiki Expectancy Scale, and a Perceived Stress Scale (PSS) after acceptance into the study. The PSS was completed every four weeks once the interventions were initiated. A global assessment questionnaire was completed at the end of the study. Logs summarizing the outcome of each session were submitted at the end of the study.
With the exception of three participants, participants believed that Reiki is a credible technique for reducing stress levels. Except for two participants, participants agreed that Reiki would be effective in reducing stress levels. All participants experienced stress within the month prior to completing the initial PSS. There was a significant reduction in stress levels from pre-study to post-study. There was a correlation between self-rating of improvement and final PSS scores. With one exception, stress levels at 20 weeks did not return to pre-study stress levels.
The authors concluded that this study supports the hypothesis that the calming effect of Reiki may be achieved through the use of self-Reiki.
QED – my suspicions were fully confirmed. This study shows precisely nothing, and it certainly does not support any hypothesis regarding Reiki.
If we recruited 20 volunteers who were sufficiently gullible to believe that watching an ice-cube slowly melting in the kitchen sink, or anything else that we can think of, has profound effects on their vital energy, or chi, or karma, or anything else, we would almost certaily generate similar results.
My conclusion is therefore very different from those of the original authors: THIS STUDY SUPPORTS THE HYPOTHESIS THAT GULLIBLE PEOPLE CAN BE EASILY MISLEAD ABOUT BOGUS THERAPIES WITH PSEUDO-SCIENTIFIC STUDIES BY IRRESPONSIBLE WOULD-BE SCIENTISTS.
Of all alternative treatments, aromatherapy (i.e. the application of essential oils to the body, usually by gentle massage or simply inhalation) seems to be the most popular. This is perhaps understandable because it certainly is an agreeable form of ‘pampering’ for someone in need of come TLC. But is aromatherapy more than that? Is it truly a ‘THERAPY’?
A recent systematic review was aimed at evaluating the existing data on aromatherapy interventions as a means of improving the quality of sleep. Electronic literature searches were performed to identify relevant studies published between 2000 and August 2013. Randomized controlled and quasi-experimental trials that included aromatherapy for the improvement of sleep quality were considered for inclusion. Of the 245 publications identified, 13 studies met the inclusion criteria, and 12 studies could be used for a meta-analysis.
The meta-analysis of the 12 studies revealed that the use of aromatherapy was effective in improving sleep quality. Subgroup analysis showed that inhalation aromatherapy was more effective than aromatherapy applied via massage.
The authors concluded that readily available aromatherapy treatments appear to be effective and promote sleep. Thus, it is essential to develop specific guidelines for the efficient use of aromatherapy.
Perfect! Let’s all rush out and get some essential oils for inhalation to improve our sleep (remarkably, the results imply that aroma therapists are redundant!).
Not so fast! As I see it, there are several important caveats we might want to consider before spending our money this way:
- Why did this review focus on such a small time-frame? (Systematic reviews should include all the available evidence of a pre-defined quality.)
- The quality of the included studies was often very poor, and therefore the overall conclusion cannot be definitive.
- The effect size of armoatherapy is small. In 2000, we published a similar review and concluded that aromatherapy has a mild, transient anxiolytic effect. Based on a critical assessment of the six studies relating to relaxation, the effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. The hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
- It seems uncertain which essential oil is best suited for this indication.
- Aromatherapy is not always entirely free of risks. Another of our reviews showed that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
- There are several effective ways for improving sleep when needed; we need to know how aromatherapy compares to established treatments for that indication.
All in all, I think stronger evidence is required that aromatherapy is more that pampering.
Reiki is a form of energy healing that evidently has been getting so popular that, according to the ‘Shropshire Star’, even stressed hedgehogs are now being treated with this therapy. In case you argue that this publication is not cutting edge when it comes to reporting of scientific advances, you may have a point. So, let us see what evidence we find on this amazing intervention.
A recent systematic review of the therapeutic effects of Reiki concludes that the serious methodological and reporting limitations of limited existing Reiki studies preclude a definitive conclusion on its effectiveness. High-quality randomized controlled trials are needed to address the effectiveness of Reiki over placebo. Considering that this article was published in the JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE, this is a fairly damming verdict. The notion that Reiki is but a theatrical placebo recently received more support from a new clinical trial.
This pilot study examined the effects of Reiki therapy and companionship on improvements in quality of life, mood, and symptom distress during chemotherapy. Thirty-six breast cancer patients received usual care, Reiki, or a companion during chemotherapy. Data were collected from patients while they were receiving usual care. Subsequently, patients were randomized to either receive Reiki or a companion during chemotherapy. Questionnaires assessing quality of life, mood, symptom distress, and Reiki acceptability were completed at baseline and chemotherapy sessions 1, 2, and 4. Reiki was rated relaxing and caused no side effects. Both Reiki and companion groups reported improvements in quality of life and mood that were greater than those seen in the usual care group.
The authors of this study conclude that interventions during chemotherapy, such as Reiki or companionship, are feasible, acceptable, and may reduce side effects.
This is an odd conclusion, if there ever was one. Clearly the ‘companionship’ group was included to see whether Reiki has effects beyond simply providing sympathetic attention. The results show that this is not the case. It follows, I think, that Reiki is a placebo; its perceived relaxing effects are the result of non-specific phenomena which have nothing to do with Reiki per se. The fact that the authors fail to spell this out more clearly makes me wonder whether they are researchers or promoters of Reiki.
Some people will feel that it does not matter how Reiki works, the main thing is that it does work. I beg to differ!
If its effects are due to nothing else than attention and companionship, we do not need ‘trained’ Reiki masters to do the treatment; anyone who has time, compassion and sympathy can do it. More importantly, if Reiki is a placebo, we should not mislead people that some super-natural energy is at work. This only promotes irrationality – and, as Voltaire once said: those who make you believe in absurdities can make you commit atrocities.
A special issue of Medical Care has just been published; it was sponsored by the Veterans Health Administration’s Office of Patient Centered Care and Cultural Transformation. A press release made the following statement about it:
Complementary and alternative medicine therapies are increasingly available, used, and appreciated by military patients, according to Drs Taylor and Elwy. They cite statistics showing that CAM programs are now offered at nearly 90 percent of VA medical facilities. Use CAM modalities by veterans and active military personnel is as at least as high as in the general population.
If you smell a bit of the old ad populum fallacy here, you may be right. But let’s look at the actual contents of the special issue. The most interesting article is about a study testing acupuncture for posttraumatic stress disorder (PTSD).
Fifty-five service members meeting research diagnostic criteria for PTSD were randomized to usual PTSD care (UPC) plus eight 60-minute sessions of acupuncture conducted twice weekly or to UPC alone. Outcomes were assessed at baseline and 4, 8, and 12 weeks postrandomization. The primary study outcomes were difference in PTSD symptom improvement on the PTSD Checklist (PCL) and the Clinician-administered PTSD Scale (CAPS) from baseline to 12-week follow-up between the two treatment groups. Secondary outcomes were depression, pain severity, and mental and physical health functioning. Mixed model regression and t test analyses were applied to the data.
The results show that the mean improvement in PTSD severity was significantly greater among those receiving acupuncture than in those receiving UPC. Acupuncture was also associated with significantly greater improvements in depression, pain, and physical and mental health functioning. Pre-post effect-sizes for these outcomes were large and robust.
The authors conclude from these data that acupuncture was effective for reducing PTSD symptoms. Limitations included small sample size and inability to parse specific treatment mechanisms. Larger multisite trials with longer follow-up, comparisons to standard PTSD treatments, and assessments of treatment acceptability are needed. Acupuncture is a novel therapeutic option that may help to improve population reach of PTSD treatment.
What shall we make of this?
I know I must sound like a broken record to some, but I have strong reservations that the interpretation provided here is correct. One does not even need to be a ‘devil’s advocate’ to point out that the observed outcomes may have nothing at all to do with acupuncture per se. A much more rational interpretation of the findings would be that the 8 times 60 minutes of TLC and attention have positive effects on the subjective symptoms of soldiers suffering from PTSD. No needles required for this to happen; and no mystical chi, meridians, life forces etc.
It would, of course, have been quite easy to design the study such that the extra attention is controlled for. But the investigators evidently did not want to do that. They seemed to have the desire to conduct a study where the outcome was clear even before the first patient had been recruited. That some if not most experts would call this poor science or even unethical may not have been their primary concern.
The question I ask myself is, why did the authors of this study fail to express the painfully obvious fact that the results are most likely unrelated to acupuncture? Is it because, in military circles, Occam’s razor is not on the curriculum? Is it because critical thinking has gone out of fashion ( – no, it is not even critical thinking to point out something that is more than obvious)? Is it then because, in the present climate, it is ‘politically’ correct to introduce a bit of ‘holistic touchy feely’ stuff into military medicine?
I would love to hear what my readers think.
The Alexander Technique is a method aimed at re-educating people to do everyday tasks with less muscular and mental tension. According to the ‘Complete Guide to the Alexander Technique’, this method can help you if:
- You suffer from repetitive strain injury or carpal tunnel syndrome.
- You have a backache or stiff neck and shoulders.
- You become uncomfortable when sitting at your computer for long periods of time.
- You are a singer, musician, actor, dancer or athlete and feel you are not performing at your full potential.
Sounds good!? But which of these claims are actually supported by sound evidence.
Our own systematic review from 2003 of the Alexander Technique (AT) found just 4 clinical studies. Only two of these trials were methodologically sound and clinically relevant. Their results were promising and implied that AT is effective in reducing the disability of patients suffering from Parkinson’s disease and in improving pain behaviour and disability in patients with back pain. A more recent review concluded as follows: Strong evidence exists for the effectiveness of Alexander Technique lessons for chronic back pain and moderate evidence in Parkinson’s-associated disability. Preliminary evidence suggests that Alexander Technique lessons may lead to improvements in balance skills in the elderly, in general chronic pain, posture, respiratory function and stuttering, but there is insufficient evidence to support recommendations in these areas.
This suggests that the ‘Complete Guide’ is based more on wishful thinking than on evidence. But what about the value of AT for performers – after all, it is for this purpose that Alexander developed his method?
A recent systematic review aimed to evaluate the evidence for the effectiveness of AT sessions on musicians’ performance, anxiety, respiratory function and posture. The following electronic databases were searched up to February 2014 for relevant publications: PUBMED, Google Scholar, CINAHL, EMBASE, AMED, PsycINFO and RILM. The search criteria were “Alexander Technique” AND “music*”. References were searched, and experts and societies of AT or musicians’ medicine contacted for further publications.
In total, 237 citations were assessed. 12 studies were included for further analysis, 5 of which were randomised controlled trials (RCTs), 5 controlled but not randomised (CTs), and 2 mixed methods studies. Main outcome measures in RCTs and CTs were music performance, respiratory function, performance anxiety, body use and posture. Music performance was judged by external experts and found to be improved by AT in 1 of 3 RCTs; in 1 RCT comparing neurofeedback (NF) to AT, only NF caused improvements. Respiratory function was investigated in 2 RCTs, but not improved by AT training. Performance anxiety was mostly assessed by questionnaires and decreased by AT in 2 of 2 RCTs and in 2 of 2 CTs.
From this evidence, the authors drew the following conclusion: A variety of outcome measures have been used to investigate the effectiveness of AT sessions in musicians. Evidence from RCTs and CTs suggests that AT sessions may improve performance anxiety in musicians. Effects on music performance, respiratory function and posture yet remain inconclusive. Future trials with well-established study designs are warranted to further and more reliably explore the potential of AT in the interest of musicians.
So, there you are: if you are a performing artist, AT seems to be useful for you. If you have health problems (other than perhaps back pain), I would look elsewhere for help.
A reader of this blog recently sent me the following message: “Looks like this group followed you recent post about how to perform a CAM RCT!” A link directed me to a new trial of ear-acupressure. Today is ‘national acupuncture and oriental medicine day’ in the US, a good occasion perhaps to have a critical look at it.
The aim of this study was to assess the effectiveness of ear acupressure and massage vs. control in the improvement of pain, anxiety and depression in persons diagnosed with dementia.
For this purpose, the researchers recruited a total of 120 elderly dementia patients institutionalized in residential homes. The participants were randomly allocated, to three groups:
- Control group – they continued with their routine activities;
- Ear acupressure intervention group – they received ear acupressure treatment (pressure was applied to acupressure points on the ear);
- Massage therapy intervention group – they received relaxing massage therapy.
Pain, anxiety and depression were assessed with the Doloplus2, Cornell and Campbell scales. The study was carried out during 5 months; three months of experimental treatment and two months with no treatment. The assessments were done at baseline, each month during the treatment and at one and two months of follow-up.
A total of 111 participants completed the study. The ear acupressure intervention group showed better improvements than the two other groups in relation to pain and depression during the treatment period and at one month of follow-up. The best improvement in pain was achieved in the last (3rd) month of ear acupressure treatment. The best results regarding anxiety were also observed in the last month of treatment.
The authors concluded that ear acupressure and massage therapy showed better results than the control group in relation to pain, anxiety and depression. However, ear acupressure achieved more improvements.
The question is: IS THIS A RIGOROUS TRIAL?
My answer would be NO.
Now I better explain why, don’t I?
If we look at them critically, the results of this trial might merely prove that spending some time with a patient, being nice to her, administering a treatment that involves time and touch, etc. yields positive changes in subjective experiences of pain, anxiety and depression. Thus the results of this study might have nothing to do with the therapies per se.
And why would acupressure be more successful than massage therapy? Massage therapy is an ‘old hat’ for many patients; by contrast, acupressure is exotic and relates to mystical life forces etc. Features like that have the potential to maximise the placebo-response. Therefore it is conceivable that they have contributed to the superiority of acupressure over massage.
What I am saying is that the results of this trial can be interpreted in not just one but several ways. The main reason for that is the fact that the control group were not given an acceptable placebo, one that was indistinguishable from the real treatment. Patients were fully aware of what type of intervention they were getting. Therefore their expectations, possibly heightened by the therapists, determined the outcomes. Consequently there were factors at work which were totally beyond the control of the researchers and a clear causal link between the therapy and the outcome cannot be established.
An RCT that is aimed to test the effectiveness of a therapy but fails to establish such a causal link beyond reasonable doubt cannot be characterised as a rigorous study, I am afraid.
Sorry! Did I spoil your ‘national acupuncture and oriental medicine day’?
Many experts have warned us that, when we opt for dietary supplements, we might get more than we bargained for. A recent article reminded us that the increased availability and use of botanical dietary supplements and herbal remedies among consumers has been accompanied by an increased frequency of adulteration of these products with synthetic pharmaceuticals. Unscrupulous producers may add drugs and analogues of various classes, such as phosphodiesterase type 5 (PDE-5) inhibitors, weight loss, hypoglycemic, antihypertensive and anti-inflammatory agents, or anabolic steroids, to develop or intensify biological effects of dietary supplements or herbal remedies. The presence of such adulterated products in the marketplace is a worldwide problem and their consumption poses health risks to consumers.
Other authors recently warned that these products are often ineffective, adulterated, mislabeled, or have unclear dosing recommendations, and consumers have suffered injury and death as a consequence. When Congress passed the Dietary Supplement Health and Education Act, it stripped the Food and Drug Administration of its premarket authority, rendering regulatory controls too weak to adequately protect consumers. State government intervention is thus warranted. This article reviews studies reporting on Americans’ use of dietary supplements marketed for weight loss or muscle building, notes the particular dangers these products pose to the youth, and suggests that states can build on their historical enactment of regulatory controls for products with potential health consequences to protect the public and especially young people from unsafe and mislabeled dietary supplements.
A new study has shown that these problems are not just theoretical but are real and common.
Twenty-four products suspected of containing anabolic steroids and sold in fitness equipment shops in the UK were analyzed for their qualitative and semi-quantitative content using full scan gas chromatography-mass spectrometry (GC-MS), accurate mass liquid chromatography-mass spectrometry (LC-MS), high pressure liquid chromatography with diode array detection (HPLC-DAD), UV-Vis, and nuclear magnetic resonance (NMR) spectroscopy. In addition, X-ray crystallography enabled the identification of one of the compounds, where reference standard was not available.
Of the 24 products tested, 23 contained steroids including known anabolic agents; 16 of these contained steroids that were different to those indicated on the packaging and one product contained no steroid at all. Overall, 13 different steroids were identified; 12 of these are controlled in the UK under the Misuse of Drugs Act 1971. Several of the products contained steroids that may be considered to have considerable pharmacological activity, based on their chemical structures and the amounts present.
The authors concluded that such adulteration could unwittingly expose users to a significant risk to their health, which is of particular concern for naïve users.
The Internet offers thousands of supplements for sale; specifically for bodybuilders there are hundreds of supplements all claiming things that are untrue or untested. The lax regulations that exist in this area seem to be often ignored completely. I think it is important to inform customers that most supplements are a waste of money and some even a waste of health.
One of the most commonly ‘accepted’ indications for acupuncture is anxiety. Many trials have suggested that it is effective for that condition. But is this really true? To find out, we need someone to conduct a systematic review or meta-analysis.
Korean researchers have just published such a paper; they wanted to assess the preoperative anxiolytic efficacy of acupuncture therapy and therefore conducted a meta-analysis of all RCTs on the subject. Four electronic databases were searched up to February 2014. Data were included in the meta-analysis from RCTs in which groups receiving preoperative acupuncture treatment were compared with control groups receiving a placebo for anxiety.
Fourteen publications with a total of 1,034 patients were included. Six RCTs, using the State-Trait Anxiety Inventory-State (STAI-S), reported that acupuncture interventions led to greater reductions in preoperative anxiety relative to sham acupuncture. A further eight publications, employing visual analogue scales, also indicated significant differences in preoperative anxiety amelioration between acupuncture and sham acupuncture.
The authors concluded that aacupuncture therapy aiming at reducing preoperative anxiety has a statistically significant effect relative to placebo or nontreatment conditions. Well-designed and rigorous studies that employ large sample sizes are necessary to corroborate this finding.
From these conclusions most casual readers might get the impression that acupuncture is indeed effective. One has to dig a bit deeper to realise that is perhaps not so.
Why? Because the quality of the primary studies was often dismally poor. Most did not even mention adverse effects which, in my view, is a clear breach of publication ethics. What is more, all the studies were wide open to bias. The authors of the meta-analysis include in their results section the following short paragraph:
The 14 included studies exhibited various degrees of bias susceptibility (Figure 2 and Figure 3). The agreement rate, as measured using Cohen’s kappa, was 0.8 . Only six studies reported concealed allocation; the other six described a method of adequate randomization, although the word “randomization” appeared in all of the articles. Thirteen studies prevented blinding of the participants. Participants in these studies had no previous experience of acupuncture. According to STRICTA, two studies enquired after patients’ beliefs as a group: there were no significant differences [20, 24].
There is a saying amongst experts about such meta-analyses: RUBBISH IN, RUBBISH OUT. It describes the fact that several poor studies, pooled meta-analytically, can never give a reliable result.
This does, however, not mean that such meta-analyses are necessarily useless. If the authors prominently (in the abstract) stress that the quality of the primary studies was wanting and that therefore the overall result is unreliable, they might inspire future researchers to conduct more rigorous trials and thus generate progress. Most importantly, by insisting on pointing out these limitations and by not drawing positive conclusions from flawed data, they would avoid misleading those health care professionals – and let’s face it, they are the majority – who merely read the abstract or even just the conclusions of such articles.
The authors of this review have failed to do any of this; they and the journal EBCAM have thus done a disservice to us all by contributing to the constant drip of misleading and false-positive information about the value of acupuncture.