MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

methodology

In the realm of so-called alternative medicine (SCAM), we see a lot of papers that are bizarre to the point of being disturbing and often dangerous nonsense. Yesterday, I came across an article that fits this bill well; in fact, I have not seen such misleading BS for quite a while. Let me present to you the abstract of this paper:

Introduction

There has been accumulating interest in the application of biofield therapy as complementary and alternative medicine (CAM) to treat various diseases. The practices include reiki, qigong, blessing, prayer, distant healing, known as biofield therapies. This paper aims to state scientific knowledge on preclinical and clinical studies to validate its potential use as an alternative medicine in the clinic. It also provides a more in-depth context for understanding the potential role of quantum entanglement in the effect of biofield energy therapy.

Content

A comprehensive literature search was performed using the different databases (PubMed, Scopus, Medline, etc.). The published English articles relevant to the scope of this review were considered. The review gathered 45 papers that were considered suitable for the purpose. Based on the results of these papers, it was concluded that biofield energy therapy was effective in treating different disease symptoms in preclinical and clinical studies.

Summary

Biofield therapies offer therapeutic benefits for different human health disorders, and can be used as alternative medicine in clinics for the medically pluralistic world due to the growing interest in CAM worldwide.

Outlook

The effects of the biofield energy therapies are observed due to the healer’s quantum thinking, and transmission of the quantum energy to the subject leads to the healing that occurs spiritually through instantaneous communication at the quantum level via quantum entanglement.

The authors of this article are affiliated with Trivedi Global, an organisation that states this about ‘biofield energy’:

Human Biofield EBnergy has subtle energy that has the capacity to work in an effective manner. This energy can be harnessed and transmitted by the gifted into living and non-living things via the process of a Biofield Energy Healing Treatment or Therapy.

If they aleady know that “Biofield EBnergy has subtle energy that has the capacity to work in an effective manner”, I wonder why they felt the need to conduct this review. Even more wonderous is the fact that their review showed such a positive result.

How did they manage this?

The answer might lie in their methodology: they “gathered 45 papers that were considered suitable”. While scientists gather the totality of the available evidence (and assess it critically), they merely selected what was suitable for the purpose of generating a positive result. This must be the reason our two studies on the subject were discretely omitted:

Our 1st study

Purpose: Distant healing, a treatment that is transmitted by a healer to a patient at another location, is widely used, although good scientific evidence of its efficacy is sparse. This trial was aimed at assessing the efficacy of one form of distant healing on common skin warts.

Subjects and methods: A total of 84 patients with warts were randomly assigned either to a group that received 6 weeks of distant healing by one of 10 experienced healers or to a control group that received a similar preliminary assessment but no distant healing. The primary outcomes were the number of warts and their mean size at the end of the treatment period. Secondary outcomes were the change in Hospital Anxiety and Depression Scale and patients’ subjective experiences. Both the patients and the evaluator were blinded to group assignment.

Results: The baseline characteristics of the patients were similar in the distant healing (n = 41) and control groups (n = 43). The mean number and size of warts per person did not change significantly during the study. The number of warts increased by 0.2 in the healing group and decreased by 1.1 in the control group (difference [healing to control] = -1.3; 95% confidence interval = -1.0 to 3.6, P = 0.25). Six patients in the distant healing group and 8 in the control group reported a subjective improvement (P = 0.63). There were no significant between-group differences in the depression and anxiety scores.

Conclusion: Distant healing from experienced healers had no effect on the number or size of patients’ warts.

Our 2nd study

Spiritual healing is a popular complementary and alternative therapy; in the UK almost 13000 members are registered in nine separate healing organisations. The present randomized clinical trial was designed to investigate the efficacy of healing in the treatment of chronic pain. One hundred and twenty patients suffering from chronic pain, predominantly of neuropathic and nociceptive origin resistant to conventional treatments, were recruited from a Pain Management Clinic. The trial had two parts: face-to-face healing or simulated face-to-face healing for 30 min per week for 8 weeks (part I); and distant healing or no healing for 30 min per week for 8 weeks (part II). The McGill Pain Questionnaire was pre-defined as the primary outcome measure, and sample size was calculated to detect a difference of 8 units on the total pain rating index of this instrument after 8 weeks of healing. VASs for pain, SF36, HAD scale, MYMOP and patient subjective experiences at week 8 were employed as secondary outcome measures. Data from all patients who reached the pre-defined mid-point of 4 weeks (50 subjects in part I and 55 subjects in part II) were included in the analysis. Two baseline measurements of outcome measures were made, 3 weeks apart, and no significant differences were observed between them. After eight sessions there were significant decreases from baseline in McGill Pain Questionnaire total pain rating index score for both groups in part I and for the control group in part II. However, there were no statistically significant differences between healing and control groups in either part. In part I the primary outcome measure decreased from 32.8 (95% CI 28.5-37.0) to 23.3 (16.8-29.7) in the healing group and from 33.1 (27.2-38.9) to 26.1 (19.3-32.9) in the simulated healing group. In part II it changed from 29.6 (24.8-34.4) to 24.0 (18.7-29.4) in the distant healing group and from 31.0 (25.8-36.2) to 21.0 (15.7-26.2) in the no healing group. Subjects in healing groups in both parts I and II reported significantly more ‘unusual experiences’ during the sessions, but the clinical relevance of this is unclear. It was concluded that a specific effect of face-to-face or distant healing on chronic pain could not be demonstrated over eight treatment sessions in these patients.

In addition, they, of course, also omitted many further studies by other investigators that failed to be positive. Considering this amount of cherry-picking, it is easy to understand how they arrived at their conclusion. It is all a question of chosing the right methodology!

A few decades ago, the cigarette industry employed this technique to show that smoking did not cause cancer! Luckily, we have since moved away from such pseudo-scientific ‘research’ – except, of course, in the realm of SCAM where it is still hughely popular.

Some abstracts of medical papers are so bizarre that they must not be tempered with, I find. This is one of them:

Rationale:

This case report aims to provide clinical evidence on the effectiveness of integrating chiropractic and moxibustion techniques for treating pseudomyopia accompanied by elevated intraocular pressure resulting from cervical spine issues because the application of complementary medicine modalities for managing such vision disorders currently lacks adequate investigations.

Patient concerns:

A 6-year-old patient presented with blurred vision, intermittent ocular discomfort, and upper cervical discomfort.

Diagnoses:

Spine-related increased intraocular pressure and pseudomyopia.

Interventions:

The patient received integrative treatment of chiropractic and walnut-shell moxibustion 3 times a week for a total of 10 treatment sessions.

Outcomes:

The patient exhibited progressive improvements in visual acuity and reductions in intraocular pressure over the treatment period, with unaided vision exceeding 2 lines of improvement in visual acuity charts and normalized intraocular pressure after 10 treatment sessions. These therapeutic effects were sustained at 3-month follow-up.

Lessons:

The integrative use of chiropractic and walnut-shell moxibustion demonstrates considerable potential in alleviating symptoms of pseudomyopia, reducing intraocular pressure, and restoring visual function in spine-related pseudomyopia cases.

Pseudomyopia is a spasm of the ciliary muscle that prevents the eye from focusing in the distance. It differs from myopia which is caused by the eye’s shape or other basic anatomy. Pseudomyopia may be either organic, through stimulation of the parasympathetic nervous system, or functional in origin, through eye strain or fatigue of ocular systems. It is common in young adults after a change in visual requirements, such as students preparing for an exam, or a change in occupation. The condition is often transitory and it is necessary to request psychiatric consultation in each case of pseudomyopia. Comorbidity of anxiety and depressive disorders is more common in pseudomyopia cases. In addition, as the severity of psychiatric symptoms increases, the amount of accommodation also appears to increase.

A few question, if I may:

  • Walnut-shell moxibustion? Yes, it exists! Moxibustion with walnut shell spectacles is a characteristic therapy of Guang’anmen Hospital, developed on the basis of walnut shell moxibustion, and mainly composed of an eye moxibustion frame, a walnut shell soaked with wolfberry and chrysanthemum liquid, and moxibustion strips. Moxibustion with a walnut shell was first recorded by Shicheng Gu for treating surgical ulcers in the Qing dynasty. Then, moxibustion with walnut shell spectacles was reformed by us, combining Shicheng Gu’s experience with our clinical practice, and is mainly used for the treatment of optic nerve atrophy and myopia.
  • The authors state that, “based on traditional Chinese medicine principles, moxibustion is known to warm meridians, dredge collaterals, relax tendons, and enhance blood circulation”. Is this true? Well, based on TCM, anything goes, but it does not make it true.
  • How can we know whether chiropractic or walnut-shell moxibustion or both caused the outcome? We can’t!
  • Can we be sure what caused the child’s problem? No!
  • Do we know whether the outcome was not a spontaneous recovery? No!
  • The authors claim that “cervical spine imbalance leads to visual impairment”. Is that correct? Not as far as I know.
  • The authors state that “the patient in this case, presenting with pseudomyopia, elevated intraocular pressure, and neck pain, likely had a cervical spine-derived condition. Currently, such spine-derived vision disorders lack sufficient clinical recognition.” Is this true? No, I’d say such spine-derived vision disorders might not even exist.
  • Why would anyone publish a paper about the case? Search me!

 

This study aims to assess the feasibility of a pragmatic prospective study aiming to report the immediate and delayed (48-hours post-treatment) AEs associated with manual therapies in children aged 5 or younger and to report preliminary data on AEs frequency.

Between July 2021 and March 2022, chiropractors were recruited through purposive sampling and via a dedicated Facebook group for Quebec chiropractors interested in pediatrics. Legal guardians of patients aged 5 or younger were invited to fill out an online information and consent form. AEs were collected using the SafetyNET reporting system, which had been previously translated by the research team. Immediate AEs were collected through a questionnaire filled out by the legal guardian immediately after the treatment, while delayed AEs were collected through a questionnaire sent by email to the legal guardian 48 h after the treatment. Feasibility was assessed qualitatively through feedback from chiropractors and quantitatively through recruitment data.

Overall, a total of 28 chiropractors expressed interest following the Facebook publication, and 5 participated. An additional two chiropractors were enrolled through purposive sampling. In total, 80 legal guardians consented to their child’s participation, and data from 73 children were included for the analysis of AEs. At least one AE was reported in 30% of children (22/73), and AEs were mainly observed immediately following the treatment (16/22). The most common AEs were irritability/crying (11 children) or fatigue/tiredness (11 children). Feasibility analysis demonstrated that regular communication between the research team and clinicians, as well as targeting clinicians who showed great interest in pediatrics, were key factors for successful research.

The authors concluded that their results suggest that it is feasible to conduct a prospective pragmatic study evaluating AEs associated with manual therapies in private practices. Direct communication with the clinicians, a strategic clinicians’ recruitment plan, and the resulting administrative burden should be considered in future studies. A larger study is required to confirm the frequency of AEs reported in the current study.

It is hardly surprising that such a study is ‘feasible’. I could have told the authors that and saved them the trouble of doing the study. What is surprising, in my view, that chiropractors, after ~120 years of existence of the profession, ask whether it is feasible.

I suggest to do the definitive study on a much larger sample, extend the observation period, and recruit a representative rather than self-selected sample of chiros … or – much better – forget about the study and establich a functioning post-marketing surveillance system.

According to its authors, this study‘s objective was to demonstrate that acupuncture is beneficial for decreasing the risk of ischaemic stroke in patients with rheumatoid arthritis (RA).

The investigation was designed as a propensity score-matched cohort nationwide population-based study. Patients with RA diagnosed between 1 January 1997 and 31 December 2010, through the National Health Insurance Research Database in Taiwan. Patients who were administered acupuncture therapy from the initial date of RA diagnosis to 31 December 2010 were included in the acupuncture cohort. Patients who did not receive acupuncture treatment during the same time interval constituted the no-acupuncture cohort. A Cox regression model was used to adjust for age, sex, comorbidities, and types of drugs used. The researchers compared the subhazard ratios (SHRs) of ischaemic stroke between these two cohorts through competing-risks regression models.

After 1:1 propensity score matching, a total of 23 226 patients with newly diagnosed RA were equally subgrouped into acupuncture cohort or no-acupuncture cohort according to their use of acupuncture. The basic characteristics of these patients were similar. A lower cumulative incidence of ischaemic stroke was found in the acupuncture cohort (log-rank test, p<0.001; immortal time (period from initial diagnosis of RA to index date) 1065 days; mean number of acupuncture visits 9.83. In the end, 341 patients in the acupuncture cohort (5.95 per 1000 person-years) and 605 patients in the no-acupuncture cohort (12.4 per 1000 person-years) experienced ischaemic stroke (adjusted SHR 0.57, 95% CI 0.50 to 0.65). The advantage of lowering ischaemic stroke incidence through acupuncture therapy in RA patients was independent of sex, age, types of drugs used, and comorbidities.

The authors concluded that this study showed the beneficial effect of acupuncture in reducing the incidence of ischaemic stroke in patients with RA.

It seems obvious that the editors of ‘BMJ Open’, the peer reviewers of the study and the authors are unaware of the fact that the objective of such an investigeation is not to to demonstrate that acupuncture is beneficial but to test whether acupuncture is beneficial. Starting a study with the intention to to show that my pet therapy works is akin to saying: “I am intending to mislead you about the value of my intervention”.

One needs therefore not be surprised that the authors of the present study draw very definitive conclusions, such as “acupuncture therapy is beneficial for ischaemic stroke prevention”. But every 1st year medical or science student should know that correlation is not the same as causation. What the study does, in fact, show is an association between acupuncture and stroke. This association might be due to dozens of factors that the ‘propensity score matching’ could not control. To conclude that the results prove a cause effect relationship is naive bordering on scientific misconduct. I find it most disappointing that such a paper can pass all the hurdles to get published in what pretends to be a respectable journal.

Personally, I intend to use this study as a good example for drawing the wrong conclusions on seemingly rigorous research.

 

 

There are many variations of acupuncture. Electroacupuncture (EA) and Laseracupuncture (LA) are but two examples both of which are commonly used. However, it remains uncertain whether LA is as effective as EA. This study aimed to compare EA and LA head to head in dysmenorrhea.

A crossover, randomized clinical trial was conducted. EA or LA was applied to selected acupuncture points. Participants were randomized into two sequence treatment groups who received either EA or LA twice per week in luteal phase for 3 months followed by 2-month washout, then shifted to other groups (sequence 1: EA > LA; sequence 2: LA > EA). Outcome measures were heart rate variability (HRV), prostaglandins (PGs), pain, and quality-of-life (QoL) assessment (QoL-SF12). We also compared the effect of EA and LA in low and high LF/HF (low frequency/high frequency) status.

43 participants completed all treatments. Both EA and LA significantly improved HRV activity and were effective in reducing pain (Visual Analog Scale [VAS]; EA: p < 0.001 and LA: p = 0.010) and improving QoL (SF12: EA: p < 0.001, LA, p = 0.017); although without intergroup difference. EA reduced PGs significantly (p < 0.001; δ p = 0.068). In low LF/HF, EA had stronger effects than LA in increasing parasympathetic tone in respect of percentage of successive RR intervals that differ by more than 50 ms (pNN50; p = 0.053) and very low-frequency band (VLF; p = 0.035).

The authors concluded that there is no significant difference between EA and LA in improving autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea. EA is prominent in PGs changing and preserving vagus tone in low LF/HF; yet LA is noninvasive for those who have needle phobia. Whether LA is equivalent with EA and the mechanism warrants further study.

Looking at the affiliations of the authors, one might expect that they should be able to design a meaningful study:

  • 1Division of Hemato-Oncology, Department of Internal Medicine, Branch of Zhong-Zhou, Taipei City Hospital, Taipei, Taiwan.
  • 2Institute of Traditional Medicine, National Yang-Ming Chiao Tung University, Taipei, Taiwan.
  • 3Department of Traditional Medicine, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
  • 4Department of Traditional Medicine, Branch of Kunming, Taipei City Hospital, Taipei, Taiwan.
  • 5Department of Gynecology and Obstetrics, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.

Sadly, this assumption is evidently mistaken.

The trial certainly does not show what they claim and neither had it ever the chance to show anything relevent. A clinical trial is comparable to a mathematical equation. It can be solved, if it has one unkown; it cannot produce a result, if it has two unknowns.

The efficacy of EA and LA for dysmenorrhea are both unknown. A comparative study with two unknowns cannot produce a meaningful result. EA and LA did not both improve autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea but most likely they both had no effect. What caused the improvement was not the treatment per se but the ritual, the placebo effect, the TLC or other non-specific factors. The maginal differences in other parameters are meaningless; they are due to the fact that – as an equivalence trial – the study was woefully underpowered and thus open to coincidental differences.

Clinical trials should be about contributing to our knowledge and not about contributing to confusion.

Acute Otitis Media (AOM) is one of the most common acute infections in children and often injudiciously treated by antibiotics. Homeopathy has been claimed to work but is it really effective?

This open label, randomized, controlled, parallel arm trial was conducted on children (aged 0–12 years), suffering from AOM. The primary outcome was changes in Tympanic Membrane Examination scale (TMES) and Acute Otitis Media-Severity of Symptoms (AOM-SOS) scale, time to improvement in pain through Facial Pain Scale-Revised (FPS-R) over 10 days. The need for antibiotics in both groups and the recurrence of subsequent episodes of AOM over 12 months were also compared.

Intention-to-treat analysis was performed on 222 children; Homeopathy (n = 117) (H-group), Allopathy (A-group) (n = 105). There was a statistically significant reduction of scores in H-group compared with A-group at each time point: at day 3 (mean diff. ± sd: 1.71 ± 0.19; 95% CI: 1.34 to 2.07; p = 0.0001), at day 7 (mean diff. ± sd: 1.29 ± 0.24; 95% CI: 0.82 to 1.76; p = 0.0001) and at day 10 (mean diff. ± sd: 1.23 ± 0.25; 95% CI = 0.74 to 1.71; p = 0.0001) favoring homeopathy. Clinical failure by the third day of treatment was observed in 11% and 24% of children in H-group vs A-group (OR: 0.03; 95% CI: 0.001 to 0.52; p = 0.03). None of the children in the H-group required antibiotics, whereas 14 children in the A-group did.

The authors concluded that both therapies seemed to produce comparable effects and appeared safe. The study consolidated the findings observed during a pilot study, i.e., homeopathy is non-inferior to allopathy in managing AOM in children and antibiotics in children can be avoided.

This study was published in the journal ‘Homeopathy’ and originates from the Central Council for Research in Homeopathy, New Delhi, India. Sadly, I do not have the full text of the paper and cannot therefore scrutinize it adequately.

Let me just mention these three facts:

  1.  The journal ‘Homeopathy’ never publishes negative results.
  2. Indian researchers of homeopathy publish as good as no negative results.
  3. As far as I can see, the Central Council for Research in Homeopathy, New Delhi, has never published a negative result.

These points do, of course, not necessarily mean that the study is false-positive, but they do not inspire me with confidence. In any case, it seems wise to insist on better evidence. To render it credible, we would need:

  1. Several rigorous RCTs that test homeopathy for AOM against placebo.
  2. If (and only then) they show that homeopathy is better than placebo, at least one independent replication of the present study.

As the biological plausibility of all this is close to zero, the chances that this will happen are also zero.

Jennifer Jacobs started publishing peer-reviewed papers on homeopathy in the early 1990s. This happens to be around the same time as I did. So, we both have about 30 years of research into homeopathy behind us.

Jennifer just authored a paper entitled “Thirty Years of Homeopathic Research – Lessons Learned“. Here is its abstract:

Conducting double-blind randomized controlled trials is difficult, even in the allopathic medical system. Doing so within the paradigm of classical homeopathy is even more challenging. More than thirty years of experience in carrying out such trials has taught me much about the pitfalls to avoid as well as the factors that can lead to success. The initial steps of putting together a research protocol, securing funding, and obtaining human subjects’ approval can be daunting. After that comes developing questionnaires and surveys, hiring study personnel, and recruitment of subjects. The actual implementation of the research comes with its own set of possible missteps. Sample size determination, entry criteria, as well as type, frequency and duration of treatment are all crucial. Finally, statistical analysis must be performed to a high standard and a manuscript prepared to submit for publication. Even then there can be one or more manuscript revisions to make, based on feedback from reviewers, before a study is actually published. The entire process can take at least two years and is usually much longer.

Mistakes at any one of these steps can damage the outcome, as well as the impact of the study. With examples from my body of research, I will discuss some of the things that I wish I had done differently, as well as those that turned out to be correct. Homeopathic research is held to a much higher standard than conventional trials. Any flaws in study design, implementation, and analysis can be used by critics to negate the results. I am hopeful that the next generation of homeopathic researchers will learn from my experiences and carry on with great success.

Jennifer’s example motivated me to follow suit and contribute some very brief thoughts about my 30 years of homeopathy research and the lessons I have learnt:

  Conducting double-blind randomized controlled trials is difficult in any area of medicine. Yet these types of studies are by far the best way to find out which treatments work and which don’t. Therefore, they need doing, regardless of the obstacles they may pose.

In homeopathy, we now have a large body of such trials. Sadly, not all of them are reliable. Those that are, according to accepted criteria, tend to fail to show that homeopathy works better than a placebo. Understandably, homeopaths are disappointed with this overall result and have made numerous attempts to invalidate it.

The main problem with research into homeopathy is not the research methodology. It is well established for clinical trials and can be easily modified to fit all the demands made by individualised treatment or other pecularities that may apply to homeopathy. The main problem is the homeopath who finds it impossible to accept the truth, namely that highly diluted homeopathic remedies are pure placebos and any observed benefits of homeopathy are due to non-specific effects such as the empathetic encounter or a placebo response.

The lesson to be learned from the past is that, in medicine, even the most obsessive belief, conviction or wishful thinking will eventually have to give way to the scientific evidence. In the case of homeopathy, this process has taken an extraordinary amount of time and effort but, finally, we are almost there and the writing is on the wall for everyone to see.

Two resumes of 30 years of work, research and experience!

And what a difference between them!

Who do you think gets closer to the truth,

Jennifer or I?

Of all the forms of so-called alternative medicine (SCAM), Reiki is amongst the least plausible. It is a form of paranormal or ‘energy healing’ popularised by Japanese Mikao Usui (1865–1926). Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that is assumed to determine our health.

Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.

Despite its implausibility, Reiki is used for a very wide range of conditions. Some people are even convinced that it has positive effects on sexuality. But is that really so?

This randomised clinical trial was aimed at finding out. Specifically, its authors wanted to determine the effect of Reiki on sexual function and sexual self-confidence in women with sexual distress*. It was was conducted with women between the ages of 15–49 years who were registered at a family health center in the eastern region of Turkey and had sexual distress.

The sample of the study consisted of 106 women, 53 in the experimental group and 53 in the control group. Women in the experimental group received Reiki once a week for four weeks, while no intervention was applied to those in the control group. Data were collected using the Female Sexual Distress Scale-Revised (FSDS-R), the Arizona Sexual Experiences Scale (ASEX), and the Sexual Self-confidence Scale (SSS).

The levels of sexual distress, sexual function, and sexual self-confidence of women in both groups were similar before the intervention, and the difference between the groups was not statistically significant (p > 0.05). After the Reiki application, the FSDS-R and ASEX mean scores of women in the experimental group significantly decreased, while their SSS mean score significantly increased, and the difference between the groups was statistically significant (p < 0.05).

The authors concluded that Reiki was associated with reduced sexual distress, positive outcomes in sexual functions, and increase sexual self-confidence in women with sexual distress. Healthcare professionals may find Reiki to positively enhance women’s sexuality.

Convinced?

I hope not!

The study has the most obvious of all design flaws: it does not control for a placebo effect, nor the effect of empaty/sympathy received from the therapist, nor the negative impact of learning that you are in the control group and will thus not receive any treatment or attention.

To me, it is obvious that these three factors combined must be able to bring about the observed outcomes. Therefore, I suggest to re-write the conclusions as follows:

The intervention was associated with reduced sexual distress, positive outcomes in sexual functions, and increase sexual self-confidence in women with sexual distress. Considering the biological plausibility of a specific effect of Reiki, the most likely cause for the outcome are non-specific effects of the ritual.

*[Sexual distress refers to persistent, recurrent problems with sexual response, desire, orgasm or pain that distress you or strain your relationship with your partner. Yes, I had to look up the definition of that diagnosis.]

 

Yes, I often moan about the abundance of poor-quality prevalence surveys that we are confronted with when scanning the literaturee on so-called alternative medicine (SCAM), e.g.:

Here is another example that recently appeared on my screen and that allows me to explain (yet again) why these surveys are such a waste of space:

The Use of Traditional and Complementary Medicine Among Patients With Multiple Sclerosis in Morocco

Let’s assume the survey is done perfectly (a condition that most are very far from meeting). If the information generated by such a perfect survey were worthwhile, we would also need to consider possible mutations that would be just as relevant:

  • We have just over 200 nations (other than Morocco) on the planet.
  • I assume there are about 1000 conditions (other than multiple sclerosis) for which SCAM is used.
  • There are, I estimate, 100 different definitions of SCAM (other than ‘traditional and complementary medicine’) that all include different modalities.

So, this alone would make 20 000 000 surveys that would be important enough to get published. But that’s not all. The usage and nature of SCAM change fairly quickly. That means we would need these 20 million surveys to be repeated every 2 to 3 years to be up-to-date.

For all this, we would need, I estimate, 200 000 research groups doing the work and about 20 000 SCAM journals to publish their results.

I think we can agree that this would be a nonsensical effort for producing millions of papers reaching dramatic conclusions that read something like this:

Our survey shows that patients suffering from xy  living in yz use much SCAM. This level of popularity suggests that SCAM is much appreciated and needs to be made available more widely and free of charge. 

I rest my case.

Current interventions for posttraumatic stress disorder (PTSD) are efficacious, yet effectiveness may be limited by adverse effects and high withdrawal rates. Acupuncture is an intervention with some positive preliminary but methodologically flawed data for PTSD.  Therefore a new study compared verum acupuncture with sham acupuncture (minimal needling) on clinical and physiological outcomes.

This was a 2-arm, parallel-group, prospective blinded randomized clinical trial hypothesizing superiority of verum to sham acupuncture. The study was conducted at a single outpatient-based site, the Tibor Rubin VA Medical Center in Long Beach, California, with recruitment from April 2018 to May 2022, followed by a 15-week treatment period. Following exclusion for characteristics that are known PTSD treatment confounds, might affect biological assessment, indicate past nonadherence or treatment resistance, or indicate risk of harm, 93 treatment-seeking combat veterans with PTSD aged 18 to 55 years were allocated to group by adaptive randomization and 71 participants completed the intervention protocols.

Verum and sham were provided as 1-hour sessions, twice weekly, and participants were given 15 weeks to complete up to 24 sessions. The primary outcome was pretreatment to posttreatment change in PTSD symptom severity on the Clinician-Administered PTSD Scale-5 (CAPS-5). The secondary outcome was pretreatment to posttreatment change in fear-conditioned extinction, assessed by fear-potentiated startle response. Outcomes were assessed at pretreatment, midtreatment, and posttreatment. General linear models comparing within- and between-group were analyzed in both intention-to-treat (ITT) and treatment-completed models.

A total of 85 male and 8 female veterans (mean [SD] age, 39.2 [8.5] years) were randomized. There was a large treatment effect of verum (Cohen d, 1.17), a moderate effect of sham (d, 0.67), and a moderate between-group effect favoring verum (mean [SD] Δ, 7.1 [11.8]; t90 = 2.87, d, 0.63; P = .005) in the intention-to-treat analysis. The effect pattern was similar in the treatment-completed analysis: verum d, 1.53; sham d, 0.86; between-group mean (SD) Δ, 7.4 (11.7); t69 = 2.64; d, 0.63; P = .01). There was a significant pretreatment to posttreatment reduction of fear-potentiated startle during extinction (ie, better fear extinction) in the verum but not the sham group and a significant correlation (r = 0.31) between symptom reduction and fear extinction. Withdrawal rates were low.

The authors concluded that the acupuncture intervention used in this study was clinically efficacious and favorably affected the psychobiology of PTSD in combat veterans. These data build on extant literature and suggest that clinical implementation of acupuncture for PTSD, along with further research about comparative efficacy, durability, and mechanisms of effects, is warranted.

I am not sure that the authors’ enthusiastic verdict is correct. Its lead author was even quoted stating that his study, which used improved controls, was needed to “definitively” support acupuncture for PTSD. He noted that “acupuncture ought to be considered a potential first-line treatment for PTSD.”

While the study is an improvement on the previous research in this area, it is by no means compelling. My main point of criticism is the nature of the sham acupuncture. Such controls are used to account for placebo effects which, of course, can be considerable in the case of acupuncture.

For this concept to work adequately, the patient and the therapist need to be blinded. In the case of acupuncture, therapist blinding is difficult (but not impossible). In this study, therepists were not blinded. Thus they could have influenced the outcome by verbal and non-verbal clues given to the patient. As acupuncturists inevitably have an interest in the positive result of their study, this effect seems inevitable to me.

More important, however, is the adequate blinding of the patient. In this study, it was attempted by using shallow needling as a sham intervention. Yet, shallow needling can easily distinguished from real acupuncture by the patient. At the very least, patients should be asked what treatment – sham or real – they thought they had received. This did not happen, and we therefore might assume that the effect of patient de-blinding – combined with the confounder described above – was sufficient to bring about the relatively small effect sizes observed by the authors.

One might argue that this does not really matter; all that counts is to alleviate the suffering of the patients, never mind by what mechanism. I think, this would be erroneous. It matters because, if acupuncture itself is ineffective (which I suggest), settling for acupuncture as a first line therapy for PTSD is in nobody’s interest and a disservice to severely suffering patients. It would inhibit meaningful research aimed at finding an optimal therapy (one that works beyond placebo) and be a waste of resources.

 

Subscribe via email

Enter your email address to receive notifications of new blog posts by email.

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories