Acupressure is the stimulation of specific points, called acupoints, on the body surface by pressure for therapeutic purposes. The required pressure can be applied manually of by a range of devices. Acupressure is based on the same tradition and assumptions as acupuncture. Like acupuncture, it is often promoted as a panacea, a ‘cure-all’.
Several systematic reviews of the clinical trials of acupressure have been published. An overview published in 2010 included 9 such papers and concluded that the effectiveness of this treatment has not been conclusively demonstrated for any condition.
But since 2010, more trials have become available.
Do they change the overall picture?
The objective of this study was to test the efficacy of acupressure on patient-reported postoperative recovery. The researchers conducted a single centre, three-group, blind, randomised controlled, pragmatic trial assessing acupressure therapy on the PC6, LI4 and HT7 acupoints. Postoperative patients expected to stay in hospital at least 2 days after surgery were included and randomised to three groups:
- In the acupressure group, pressure was applied for 6 min (2 min per acupoint), three times a day after surgery for a maximum of 2 postoperative days during the hospital stay.
- In the sham group, extremely light touch was applied to the acupoints.
- The third group did not receive any such intervention.
All patients also received the normal postoperative treatments.
The primary outcome was the change in the quality of recovery (QoR), using the QoR-15 questionnaire, between postoperative days 1 and 3. Key secondary outcomes included patients’ satisfaction, postoperative nausea and vomiting, pain score and opioid (morphine equivalent) consumption. Assessors for the primary and secondary endpoints were blind to the group allocation.
A total of 163 patients were randomised (acupressure n=55, sham n=53, no intervention n=55). The mean (SD) postoperative change in QoR-15 did not differ statistically (P = 0.27) between the acupressure, sham and no intervention groups: 15.2 (17.8), 14.2 (21.9), 9.2 (21.7), respectively. Patient satisfaction (on a 0 to 10 scale) was statistically different (P = 0.01) among these three groups: 9.1 (1.5), 8.4 (1.6) and 8.2 (2.2), respectively. Changes in pain score and morphine equivalent consumption were not significantly different between the groups.
The authors concluded that two days of postoperative acupressure therapy (up to six treatments) did not significantly improve patient QoR, postoperative nausea and vomiting, pain score or opioid consumption. Acupressure, however, was associated with improved patient satisfaction.
This study is a good example to show why it is so difficult (or even impossible) to use a clinical trial for demonstrating the ineffectiveness of a therapy for any given condition. The above trial fails to show that acupressure had a positive effect on the primary outcome measure. Acupressure fans will, however, claim that:
- there was a positive effect on patient satisfaction,
- the treatment was too intense/long,
- the treatment was not intense/long enough,
- the wrong points were used,
- the sample size was too small,
- the patients were too ill,
- the patients were not ill enough,
- etc., etc.
In the end, such discussions often turn out to be little more than a game of pigeon chess. Perhaps it is best to ask before planning such a trial:
IS THE ASSUMPTION THAT THE TREATMENT WORKS FOR THIS CONDITION PLAUSIBLE?
If the answer is no, why do the study in the first place?
Acupressure is the stimulation of acu-points by using pressure instead of needles, as in acupuncture. The evidence for or against acupressure mirrors that of acupuncture, except there is far less of it. This is why this new trial might be important.
The aim of this RCT was to determine the effect of self-acupressure on fasting blood sugar (FBS) and insulin level in type 2 diabetes patients. A total of 60 diabetic patients were selected from diabetes clinic in Rafsanjan in Iran, and assigned to 2 groups, 30 in the acupressure and 30 in the control-group. The intervention group received acupressure at ST-36, LIV-3, KD-3 and SP-6 points bilaterally for 5 minutes at each point in 10 seconds pressure and 2 seconds rest periods. Subjects in the control group received no intervention. The FBS and insulin levels were measured before and after the intervention for both groups.
There were no significant differences between the acupressure and control group regarding age, sex and level of education. The insulin level significantly increased after treatment in the acupressure group (p=0.001). There were no significant differences between the levels of insulin in study or control groups. Serum FBS level decreased significantly after intervention in the acupressure group compared to the control group (p=0.02).
The authors concluded that self-acupressure as a complementary alternative medicine can be a helpful complementary method in reducing FBS and increasing insulin levels in type 2 diabetic patients.
I do not want to go into the methodological details of this study; suffice to say that it was less than rigorous and that its findings are therefore not trustworthy (never mind the fact that the results are biologically implausible). Even if that had not been the case, a single study would certainly not be sufficient reason to reach the conclusion that acupressure is helpful to control diabetes. For that, I am sure, we would need at least half a dozen independent replications.
Like most people, I have several non-medical friends who suffer from diabetes. They would love nothing better than having a simple, safe and effective method applying pressure to their skin in order to manage their disease. If they read this paper, some of them might conclude that acupressure is the answer to their problems and use it to control their condition. One does not need all that much imagination to see that this could seriously harm them, or even cost several lives.
Acupressure might be virtually free of risks, but with a bit of ill advice, even seemingly harmless treatments can kill.
Often referred to as “Psychological acupressure”, the emotional freedom technique (EFT) works by releasing blockages within the energy system which are the source of emotional intensity and discomfort. These blockages in our energy system, in addition to challenging us emotionally, often lead to limiting beliefs and behaviours and an inability to live life harmoniously. Resulting symptoms are either emotional and/ or physical and include lack of confidence and self esteem, feeling stuck anxious or depressed, or the emergence of compulsive and addictive behaviours. It is also now finally widely accepted that emotional disharmony is a key factor in physical symptoms and dis-ease and for this reason these techniques are being extensively used on physical issues, including chronic illness with often astounding results. As such these techniques are being accepted more and more in medical and psychiatric circles as well as in the range of psychotherapies and healing disciplines.
An EFT treatment involves the use of fingertips rather than needles to tap on the end points of energy meridians that are situated just beneath the surface of the skin. The treatment is non-invasive and works on the ethos of making change as simple and as pain free as possible.
EFT is a common sense approach that draws its power from Eastern discoveries that have been around for over 5,000 years. In fact Albert Einstein also told us back in the 1920’s that everything (including our bodies) is composed of energy. These ideas have been largely ignored by Western Healing Practices and as they are unveiled in our current times, human process is reopening itself to the forgotten truth that everything is Energy and the potential that this offers us.
END OF QUOTE
If you ask me, this sounds as though EFT combines pseudo-psychological with acupuncture-BS.
But I may be wrong.
What does the evidence tell us?
A systematic review included 14 RCTs of EFT with a total of 658 patients. The pre-post effect size for the EFT treatment group was 1.23 (95% confidence interval, 0.82-1.64; p < 0.001), whereas the effect size for combined controls was 0.41 (95% confidence interval, 0.17-0.67; p = 0.001). Emotional freedom technique treatment demonstrated a significant decrease in anxiety scores, even when accounting for the effect size of control treatment. However, there were too few data available comparing EFT to standard-of-care treatments such as cognitive behavioural therapy, and further research is needed to establish the relative efficacy of EFT to established protocols. Meta-analyses indicate large effect sizes for posttraumatic stress disorder, depression, and anxiety; however, treatment effects may be due to components EFT shares with other therapies.
Another, more recent analysis reviewed whether EFTs acupressure component was an active ingredient. Six studies of adults with diagnosed or self-identified psychological or physical symptoms were compared (n = 403), and three (n = 102) were identified. Pretest vs. posttest EFT treatment showed a large effect size, Cohen’s d = 1.28 (95% confidence interval [CI], 0.56 to 2.00) and Hedges’ g = 1.25 (95% CI, 0.54 to 1.96). Acupressure groups demonstrated moderately stronger outcomes than controls, with weighted posttreatment effect sizes of d = -0.47 (95% CI, -0.94 to 0.0) and g = -0.45 (95% CI, -0.91 to 0.0). Meta-analysis indicated that the acupressure component was an active ingredient and outcomes were not due solely to placebo, nonspecific effects of any therapy, or non-acupressure components.
From these and other reviews, one could easily get the impression that my above-mentioned suspicion is erroneous and EFT is an effective therapy. But I still do have my doubts.
These reviews conveniently forget to mention that the primary studies tend to be of poor or even very poor quality. The most common flaws include tiny sample sizes, wrong statistical approach, lack of blinding, lack of control of placebo and other nonspecific effects. Reviews of such studies thus turn out to be a confirmation of the ‘rubbish in, rubbish out’ principle: any summary of flawed studies are likely to produce a flawed result.
Until I have good quality trials to convince me otherwise, EFT is in my view:
- implausible and
- not of proven effectiveness for any condition.
I have to admit that I had little hope it would come. But after sending my ‘open letter’ twice to their email address, I have just received this:
As you might remember, the AACMA had accused me of an pecuniary undeclared link with the pharmaceutical industry. Their claim was based on me having been the editor of a journal, FACT, which was co-published by the British Pharmaceutical Society (BPS). When I complained and the AACMA learnt that the journal had been discontinued, they retracted their claim but carried on distributing the allegation that I had formerly had an undeclared conflict of interest. When they finally understood that the BPS was not the pharmaceutical industry (all it takes is a simple Google search), and after me complaining again and again, they sent me the above email.
So, the AACMA have done the right thing?
Yes and no!
The have retracted their repeated lies.
But they have not done this publicly as requested (this is partly the reason for me writing this post to make their retraction public).
More importantly, they have not apologised !!!
Why should they, you might ask.
- Because they have (tried to) damage my reputation as an independent scientist.
- Because they have not done their research before making and insisting on a far-reaching claim.
- Because they have shown themselves too stupid to grasp even the most elementary issues.
By not apologising, they have, I find, shown how unprofessional they really are, and how much they lack simple human decency. On their website, the AACMA state that “since 1973, AACMA has represented the profession and values high standards in ethical and professional practice.” Personally, I think that their standards in ethical and professional practice are appalling.
The aim of this three-armed, parallel, randomized exploratory study was to determine, if two types of acupuncture (auricular acupuncture [AA] and traditional Chinese acupuncture [TCA]) were feasible and more effective than usual care (UC) alone for TBI–related headache. The subjects were previously deployed Service members (18–69 years old) with mild-to-moderate TBI and headaches. The interventions explored were UC alone or with the addition of AA or TCA. The primary outcome was the Headache Impact Test (HIT). Secondary outcomes were the Numerical Rating Scale (NRS), Pittsburgh Sleep Quality Index, Post-Traumatic Stress Checklist, Symptom Checklist-90-R, Medical Outcome Study Quality of Life (QoL), Beck Depression Inventory, State-Trait Anxiety Inventory, the Automated Neuropsychological Assessment Metrics, and expectancy of outcome and acupuncture efficacy.
Mean HIT scores decreased in the AA and TCA groups but increased slightly in the UC-only group from baseline to week 6 [AA, −10.2% (−6.4 points); TCA, −4.6% (−2.9 points); UC, +0.8% (+0.6 points)]. Both acupuncture groups had sizable decreases in NRS (Pain Best), compared to UC (TCA versus UC: P = 0.0008, d = 1.70; AA versus UC: P = 0.0127, d = 1.6). No statistically significant results were found for any other secondary outcome measures.
The authors concluded that both AA and TCA improved headache-related QoL more than UC did in Service members with TBI.
The stated aim of this study (to determine whether AA or TCA both with UC are more effective than UC alone) does not make sense and should therefore never have passed ethics review, in my view. The RCT followed a design which essentially is the much-lamented ‘A+B versus B’ protocol (except that a further groups ‘C+B’ was added). The nature of such designs is that there is no control for placebo effects, the extra time and attention, etc. Therefore, such studies cannot fail but generate positive results, even if the tested intervention is a placebo. In such trials, it is impossible to attribute any outcome to the experimental treatment. This means that the positive results are known before the first patient has been enrolled; hence they are an unethical waste of resources which can only serve one purpose: to mislead us. It also means that the conclusions drawn above are not correct.
An alternative and in my view more accurate conclusion would be this one: both AA and TCA had probably no effect; the improved headache-related QoL was due to the additional attention and expectation in the two experimental groups and is unrelated to the interventions tested in this study.
In our new book, MORE HARM THAN GOOD, we discuss that such trials are deceptive to the point of being unethical. Considering the prominence and experience of Wayne Jonas, the 1st author of this paper, such obvious transgression is more than a little disappointing – I would argue that is amounts to overt scientific misconduct.
This double-blind RCT aimed to test the efficacy of self-administered acupressure for pain and physical function in adults with knee osteoarthritis (KOA).
150 patients with symptomatic KOA participated and were randomized to
- verum acupressure,
- sham acupressure,
- or usual care.
Verum and sham, but not usual care, participants were taught to self-apply acupressure once daily, five days/week for eight weeks. Assessments were collected at baseline, 4 and 8 weeks. The numeric rating scale (NRS) for pain was administered during weekly phone calls. Outcomes included the WOMAC pain subscale (primary), the NRS and physical function measures (secondary). Linear mixed regression was conducted to test between group differences in mean changes from baseline for the outcomes at eight weeks.
Compared with usual care, both verum and sham participants experienced significant improvements in WOMAC pain, NRS pain and WOMAC function at 8 weeks. There were no significant differences between verum and sham acupressure groups in any of the outcomes.
The authors concluded that self-administered acupressure is superior to usual care in pain and physical function improvement for older people with KOA. The reason for the benefits is unclear and placebo effects may have played a role.
Another very odd conclusion!
The authors’ stated aim was to TEST THE EFFICACY OF ACUPRESSURE. To achieve this aim, they rightly compared it to a placebo (sham) intervention. This comparison did not show any differences between the two. Ergo, the only correct conclusion is that acupressure is a placebo.
I know, the authors (sort of) try to say this in their conclusions: placebo effects may have played a role. But surely, this is more than a little confusing. Placebo effects were quite evidently the sole cause of the observed outcomes. Is it ethical to confuse the public in this way, I wonder.
You may recall, we have dealt with the JCAM many times before; for instance here, here, here and here. Now they have come out with another remarkable paper. This study – no, the authors called it a ‘pilot study’ – was to compare the efficacy of Emotional Freedom Techniques (EFT) with that of Cognitive-Behavioral Therapy (CBT) in reducing adolescent anxiety. Sixty-three American high-ability students in grades 6–12, ages 10–18 years, who scored in the moderate to high ranges for anxiety on the Revised Children’s Manifest Anxiety Scale-2 (RCMAS-2) were randomly assigned to one of three groups:
- CBT (n = 21),
- EFT (n = 21),
- or waitlist control (n = 21).
EFT is an alternative therapy that incorporates acupoint stimulation. Students assigned to the CBT or EFT treatment groups received three individual sessions of the identified protocols from trained graduate counseling, psychology, or social work students enrolled at a large northeastern research university. The RCMAS-2 was used to assess preintervention and postintervention anxiety levels in participants.
EFT participants showed significant reduction in anxiety levels compared with the waitlist control group with a moderate to large effect size. CBT participants did not differ significantly from the EFT or control.
The authors concluded that EFT is an efficacious intervention to significantly reduce anxiety for high-ability adolescents.
They also state in their abstract that EFT is an evidence-based treatment for anxiety…
Are you happy with these conclusions?
Are you convinced that this trial lends itself to establish efficacy of anything?
Are you impressed with the trial design, the sample size, etc?
Are you sure that EFT is plausible, credible or evidence-based in any way?
If you look up EFT, you will find that there is a surprising amount of papers on it. Most of them have one thing in common: they were published in highly dubious journals. The field does not inspire trust or competence. The authors of the study state that EFT is an easily implemented strategy that uses such techniques as awareness building, exposure, reframing of interpretation, and systematic desensitization, while teaching the participant to self-stimulate protocol-identified acupoints (i.e., acupuncture points) by tapping. The effectiveness of acupuncture for treating anxiety has been well documented. Rather than using acupuncture needles, EFT relies on the manual stimulation of the acupoints. A recent meta-analysis indicated that interventions using acupoint stimulation had a moderate effect size (Hedge’s g = −0.66 95% CI [−0.99, −0.33]) in reducing symptoms. In EFT, the client stimulates the protocol-identified acupoints by tapping on them. Preliminary studies have suggested that tapping and other alternative ways of stimulating acupuncture points to be as effective as acupuncture needling. The EFT protocol and identified acupoints that were used in this study are the ones recommended for research purposes by the Association for Comprehensive Energy Psychology…
Wikipedia tells us that “Emotional Freedom Techniques (EFT) is a form of counseling intervention that draws on various theories of alternative medicine including acupuncture, neuro-linguistic programming, energy medicine, and Thought Field Therapy (TFT). It is best known through Gary Craig’s EFT Handbook, published in the late 1990s, and related books and workshops by a variety of teachers. EFT and similar techniques are often discussed under the umbrella term “energy psychology”. Advocates claim that the technique may be used to treat a wide variety of physical and psychological disorders, and as a simple form of self-administered therapy. The Skeptical Inquirer describes the foundations of EFT as “a hodgepodge of concepts derived from a variety of sources, [primarily] the ancient Chinese philosophy of chi, which is thought to be the ‘life force’ that flows throughout the body.” The existence of this life force is “not empirically supported”. EFT has no benefit as a therapy beyond the placebo effect or any known-effective psychological techniques that may be provided in addition to the purported “energy” technique. It is generally characterized as pseudoscience and it has not garnered significant support in clinical psychology.”
A recent systematic review of EFT concluded that “there were too few data available comparing EFT to standard-of-care treatments such as cognitive behavioral therapy, and further research is needed to establish the relative efficacy of EFT to established protocols.”
Notwithstanding these and many other verdicts on EFT, we now are asked to agree with the new study that EFT IS EFFICACIOUS.
Is this a joke?
They want us to believe this on the basis of a PILOT STUDY? Such studies are not even supposed to test efficacy! (Yet the authors of the trial state that this study was designed to meet the American Psychological Association (APA) Division 12 quality control criteria and the Consolidated Standards for Reporting Trials (CONSORT) criteria. I have to admit, they could have fooled me!)
No, it is not a joke, it is yet another nonsense from the ‘The Journal of Complementary and Alternative Medicine’ which, in my view, should henceforth be called THE JOURNAL OF ALTERNATIVE FACTS (JAF).
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’?
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.
Blinding patients in clinical trials is a key methodological procedure for minimizing bias and thus making sure that the results are reliable. In alternative medicine, blinding is not always straight forward, and many studies are therefore not patient-blinded. We all know that this can introduce bias into a trial, but how large is its effect on study outcomes?
This was the research question addressed by a recent systematic review of randomized clinical trials with one sub-study (i.e. experimental vs control) involving blinded patients and another, otherwise identical, sub-study involving non-blinded patients. Within each trial, the researchers compared the difference in effect sizes (i.e. standardized mean differences) between the two sub-studies. A difference <0 indicates that non-blinded patients generated a more optimistic effect estimate. The researchers then pooled the differences with random-effects inverse variance meta-analysis, and explored reasons for heterogeneity.
The main analysis included 12 trials with a total of 3869 patients. Ten of these RCTs were studies of acupuncture. The average difference in effect size for patient-reported outcomes was -0.56 (95% confidence interval -0.71 to -0.41), (I(2 )= 60%, P = 0.004), indicating that non-blinded patients exaggerated the effect size by an average of 0.56 standard deviation, but with considerable variation. Two of the 12 trials also used observer-reported outcomes, showing no indication of exaggerated effects due lack of patient blinding.
There was an even larger effect size difference in the 10 acupuncture trials [-0.63 (-0.77 to -0.49)], than in the two non-acupuncture trials [-0.17 (-0.41 to 0.07)]. Lack of patient blinding was also associated with increased attrition rates and the use of co-interventions: ratio of control group attrition risk 1.79 (1.18 to 2.70), and ratio of control group co-intervention risk 1.55 (0.99 to 2.43).
The authors conclude that this study provides empirical evidence of pronounced bias due to lack of patient blinding in complementary/alternative randomized clinical trials with patient-reported outcomes.
This is a timely, rigorous and important analysis. In alternative medicine, we currently see a proliferation of trials that are not patient-blinded. We always suspected that they are at a high risk of generating false-positive results – now we know that this is, in fact, the case.
What should we do with this insight? In my view, the following steps would be wise:
- Take the findings from the existing trials that are devoid of patient-blinding with more than just a pinch of salt.
- Discourage the funding of future studies that fail to include patient-blinding.
- If patient-blinding is truly and demonstrably impossible – which is not often the case – make sure that the trialists at least include blinding of the assessors of the primary outcome measures.