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

clinical trial

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Medical Acupuncture is the name of a quarterly journal published for the ‘American Academy of Medical Acupuncture’ that publishes around 60 pro-acupuncture articles every year. Its editor is Richard C. Niemtzow, M.D., Ph.D., M.P.H. Richard is a retired US Air Force colonel who was the first full-time physician acupuncturist in the US Armed Forces. He is probably best known for his invention called ‘BATTLE FIELD ACUPUNCTURE’, a form of ear-acupuncture allegedly reducing pain in emergency situations.

Medline lists 79 papers (mostly published in 3rd class journals such as ‘Medical Acupuncture’) in Niemtzow’s name. Only one of them – 21 years ago – was a clinical trial. Here it is:

Purpose: We performed a pilot trial to assess the response of lower urinary tract symptoms and prostate specific antigen (PSA) to acupuncture in a population of patients biopsy negative for prostate cancer.

Materials and methods: A total of 30 patients were randomly assigned to 1 of 3 study groups, including observation for 3 months with 6 blood samples for PSA at set intervals, 9 sessions of acupuncture in 3 months to points of the kidney-bladder distinct meridian expected to treat the prostate with 6 blood samples for PSA at set intervals and 9 sessions of acupuncture in 3 months to points not expected to treat the prostate with 6 blood samples for PSA at set intervals. The effect of acupuncture on lower urinary tract symptoms was assessed monthly using the International Prostate Symptom Score.

Results: Trend analysis (repeated measures ANOVA) revealed no significant changes in the 3-month period in the randomized arms. Statistical analysis showed p = 0.063 for the International Prostate Symptom Score, p = 0.945 for PSA and p = 0.37 for the free-to-total PSA ratio.

Conclusions: Acupuncture to the kidney-bladder distinct meridian neither relieves lower urinary tract symptoms nor impacts PSA.

Yes, an acupuncture study with a negative result!

Niemtzow has, as far as I can see, never himself conducted a study of ‘battle field acupuncture’. In fact, there only very few trials of ‘battle field acupuncture‘. The most recent (albeit lousy) study even suggest that it is less effective than electroacupuncture (EA): EA was more effective than ‘battle field auricular acupuncture’ at reducing pain severity, but both similarly improved physical and mental health scores.

This does not stop Niemtzow to continue praising acupuncture in dozens of papers, particularly his ‘battle field’ version and especially in his ‘own’ journal. The most recent example has just been published; allow me to present an excerpt to you:

In December of 2023, I had the opportunity to visit the Van Gogh Museum in Amsterdam. The only day I had for this visit was characterized by a pouring and chilling rain. This did not stop the crowds of people visiting this famous exhibition. I reminded myself that Van Gogh was a troubled spirit. He lived a short tumultuous life characterized by cutting off his left ear lobe and he spent a sojourn in an asylum. Yet, his art emerged in all its beauty and splendor to become famous in the world. Despite all his troubles, he contributed a precious collection of magnificent art. Many individuals would not have surfaced out of personal disorders to produce such a wonderful gift to society. However, history tells us that many sensational contributions originated from people embroiled in mental health illnesses.

Medical Acupuncture published more than 13 years ago the acupuncture ‘‘diagnosis’’ of Vincent Van Gogh. The article, which is worth rereading, discussed the Five-Element pattern associated with the artist’s hallucinations, alcoholism, severe depression, insomnia, anxiety, dizziness, headaches, nightmares, etc. The author, Vera Kaikobad, LAc, stated: ‘‘It is poignant to realize that a few needles in the hands of a skilled acupuncturist may have spared this great artist such torment and perhaps saved his life.’’ Feasibly, in 2024 we should not only examine our patients for their physical complaints; we should venture into their mental health status as well. A back or neck pain is important, but so is anxiety, insomnia, etc. In promoting mental health, we may assist many patients who are perhaps capable of contributing to the well-being of the world. It is our responsibility as acupuncturists not to think of our patients as a neck or back pain, etc.; instead, we must see them as whole persons having spiritual and physical needs that must be addressed.

I feel that, overall, this remarkable effort justifies Niemtzow’s admission to my ALTERNATIVE MEDICINE HALL OF FAME.

WELCOME, RICHARD!

And let me introduce you to the rest of the 24 laureates:

  1. Helmut Kiene (anthroposophical medicine)
  2. Helge Franke (osteopathy, Germany)
  3. Tery Oleson (acupressure , US)
  4. Jorge Vas (acupuncture, Spain)
  5. Wane Jonas (homeopathy, US)
  6. Harald Walach (various SCAMs, Germany)
  7. Andreas Michalsen ( various SCAMs, Germany)
  8. Jennifer Jacobs (homeopath, US)
  9. Jenise Pellow (homeopath, South Africa)
  10. Adrian White (acupuncturist, UK)
  11. Michael Frass (homeopath, Austria)
  12. Jens Behnke (research officer, Germany)
  13. John Weeks (editor of JCAM, US)
  14. Deepak Chopra (entrepreneur, US)
  15. Cheryl Hawk (chiropractor, US)
  16. David Peters (osteopathy, homeopathy, UK)
  17. Nicola Robinson (TCM, UK)
  18. Peter Fisher (homeopathy, UK)
  19. Simon Mills (herbal medicine, UK)
  20. Gustav Dobos (various SCAMs, Germany)
  21. Claudia Witt (homeopathy, Germany/Switzerland)
  22. George Lewith (acupuncture, UK)
  23. John Licciardone (osteopathy, US)

This study tested whether trigger point acupuncture (TrPA) is beneficial for office workers who have reduced job performance (presenteeism) due to chronic neck and shoulder pain (katakori).

A 4-week single-center randomized clinical trial was conducted on 20 eligible female office workers with chronic neck and shoulder pain of at least 3-month duration. The control group implemented only workplace-recommended presenteeism measures, whereas the intervention group received TrPA up to 4 times per month in addition to the presenteeism measures recommended by each workplace. The major outcome measure was the relative presenteeism score on the World Health Organization Health and Work Performance (WHO-HPQ). The secondary outcome measures were pain intensity (numerical rating scale), absolute presenteeism (WHO-HPQ), anxiety and depression (Hospital Anxiety and Depression Scale; HADS), catastrophic thoughts related to pain (Pain Catastrophizing Scale; PCS), and sleep (Athens Insomnia Scale; AIS).

All 9 cases in the intervention group and 11 cases in the control group were analyzed. TrPA up to 4 times per month reduced the intensity of neck and shoulder pain by 20% (P < .01, d = 1.65) and improved labor productivity (relative presenteeism value) by 0.25 (P < .01, d = 1.33) compared with the control group over 1 month. No significant differences were observed between the 2 groups in terms of absolute presenteeism score, HADS, PCS, or AIS.

The authors concluded that these results suggest that regular intervention with TrPA may be effective in the relative presenteeism score before and after the intervention and the degree of neck and shoulder pain over 28 days compared with the control group.

Sure, TrPA may be effective.

But is it?

I thought the trial was aimed at answering that question!

But it didn’t!

Why not?

Because, as we have discussed ad nauseam on this blog, the A+B versus B study design cannot answer it. On the contrary, it will always generate a positive result without determining whether the treatment or a nonspecific (placebo) effect caused the outcome (which, of course, is the reason why this study design is so popular in SCAM research).

In view of this, I suggest to re-formulate the conclusions as follows:

The study suggests that the researchers were ill-informed when designing it. Therefore, the findings show nothing of value.

The Buteyko techniques (known in Russia as ‘Voluntary Elimination of Deep Breathing’) are treatments to control respiration developed by the Russian Konstantin Buteyko (1923–2003). Inspired by the methods of respiratory control in yoga, the original Buteyko technique was specifically aimed at easing the symptoms of respiratory conditions, particularly asthma. Konstantin Buteyko postulated that there is a connection between hyperventilation and asthma and that it should be possible to reduce asthma symptoms by deliberate breath control.

The Eucapnic Buteyko method is an adaptation of Buteyko’s original technique which was first introduced in Australia and is now used worldwide. It includes the same focus on ventilation control, but the approach has been re-designed with the aim of achieving better patient-compliance. Both treatments and further variations depend crucially on the cooperation of the patient who has to attend long sessions of learning the technique and must follow the somewhat tedious programme rigorously.

A Cochrane review of Buteyko and similar breathing techniques concluded that “there is no credible evidence regarding the effectiveness of breathing exercises for the clinical symptoms of dysfunctional breathing/hyperventilation syndrome. It is currently unknown whether these interventions offer any added value in this patient group or whether specific types of breathing exercise demonstrate superiority over others.”

Now, a new study adds to this knowledge. This randomized clinical trial included two groups (n = 30 each) of patients with asthma. They received either:

  • Buteyko breathing technique (BBT) together with usual therapy (UT)
  • or UT alone over a period of 3 months.

The primary outcome comprised the voluntary control pause (CP) after 3 months, secondary outcomes an additional breathhold parameter, forced expiratory volume in 1 s (FEV1), capnovolumetry, exhaled nitric oxide (FeNO), Asthma Control Questionnaire (ACQ) and Nijmegen Questionnaire (NQ), and the use of medication (β2-agonists; inhaled corticosteroids, ICS).

CP showed significant time-by-group interaction [F(1,58.09) = 28.70, p < 0.001] as well as main effects for study group [F(1,58.27) = 5.91, p = 0.018] and time [F(1,58.36) = 17.67, p < 0.001]. ACQ and NQ scores were significantly (p < 0.05 each) improved with BBT. This was associated with reductions in the use of β2-agonists and ICS (p < 0.05 each) by about 20% each. None of these effects occurred in the UT group. While FEV1 and the slopes of the capnovolumetric expiratory phases 2 and 3 did not significantly change, the capnovolumetric threshold volume at tidal breathing increased (p < 0.05) with BBT by about 10 mL or 10%, compared to baseline, suggesting a larger volume of the central airways. No significant changes were seen for FeNO.

The authors concluded that BBT was clinically effective, as indicated by the fact that the improvement in symptom scores and the small increase in bronchial volume occurred despite the significant reduction of respiratory pharmacotherapy. As the self-controlled Buteyko breathing therapy was well-accepted by the participants, it could be considered as supporting tool in asthma therapy being worth of wider attention in clinical practice.

I disagree with this conclusion and think it ought to be changed to:

BBT or a placebo effect was clinically effective.

The reason is that, as many readers have heard me say before, the infamous A+B versus B design does not control for placebo effects and thus is guaranteed to produce a positive result.

The research was conducted by an international team evidently led by the relatively new ARCIM Institute which claims on its website:

The acronym ARCIM stands for Academic Research in Complementary and Integrative Medicine.

The bridging between different treatment and research approaches, disciplines and ways of thinking achieved by the research work of the ARCIM Institute can be symbolized by our logo’s bridge arch. ARCIM integrates this bridge-building metaphor within its name since the Latin term “arcus” means “arch” or “bridge.”

The aim of the ARCIM research institute, founded in 2010, is to research complementary and integrative medicine, in particular anthroposophic medicine, on a scientific basis according to rigorous scientific standards established by the Equator Network criteria (http://www.equator-network.org/).
______________________
“rigorous scientific standards”?
… … …
You could have fooled me!

Getting old is not nice – but think of the alternative!

I think it was Woody Allen who said something to that extent. But there is a third way, at least this is waht Tai Chi advocates want us to believe.

Utilizing a hybrid design, this study aimed to test whether both long-term and short-term Tai Chi (TC) training are associated with age-related decline in physical function in healthy older adults.

The authors first conducted cross-sectional comparisons among TC-naïve older adults (n = 60, 64.2 ± 7.7 years), TC-expert older adults (n = 27, 62.8 ± 7.6 years, 24.5 ± 12 years experience), and TC-naïve younger adults (n = 15, 28.7 ± 3.2 years) to inform long-term effects of TC training on physical function, including single leg stance time with eyes closed, grip strength, Timed Up and Go, maximum walking speed, functional reach, and vertical jump for lower-extremity power. There were significant differences among the three groups on all the six tests. For most functional tests, TC-experts performed better than age-matched TC-naïve controls and were statistically indistinguishable from young healthy adult controls. Long-term TC training was associated with higher levels of physical function in older adults, suggesting a potential preventative healthy aging effect.

In the randomized longitudinal trial, TC-naïve subjects were randomized (n = 31 to Tai Chi group, n = 29 to usual care control group) to evaluate the short-term effects of TC over 6 months on all outcomes. TC’s short-term impacts on physical function were small and not statistically significant. The impact of short-term training in healthy adults is less clear.

The authors concluded that both potential longer-term preventive effects and shorter-term restorative effects warrant further research with rigorous, adequately powered controlled clinical trials.

Even though the authors imply that their cross-sectional comparison points to a causal effect, this is clearly not true. For instance, it could easily be that people who are somehow destined to keep fit and agile are the ones who keep up Tai Chi. So, rather than being the result of Tai Chi, the proneness to fitness and agility could be the cause for doing Tai Chi.

The authors laudably were aware of these problems and therefore also did an RCT. Sadly this RCT did not yield significant findings. Essentially this means that eitherTai Chi did not work, or the study was naively inadequate, e.g. too small and too short-term.

Thus the authors finish with the usual statement that MORE RESEARCH IS NEEDED. This might be true, but is a definitive RCT likely?

I don’t think so.

A long time ago I had designed such a definitive study. It needed to be very large considering that many participants might drop out. Crucially, it also had to be long- term, i.e. years, not months.

And what happened to my study?

I never managed to get it funded, mainly because the costs would have been astronomical.

Supportive care is often assumed to be beneficial in managing the anxiety symptoms common in patients in sterile hematology unit. The authors of this study hypothesize that personal massage can help the patient, particularly in this isolated setting where physical contact is extremely limited.

The main objective of this study therefore was to show that anxiety could be reduced after a touch-massage performed by a nurse trained in this therapy.

A single-center, randomized, unblinded controlled study in the sterile hematology unit of a French university hospital, validated by an ethics committee. The patients, aged between 18 and 65 years old, and suffering from a serious and progressive hematological pathology, were hospitalized in sterile hematology unit for a minimum of three weeks. They were randomized into either a group receiving 15-minute touch-massage sessions or a control group receiving an equivalent amount of quiet time once a week for three weeks.

In the treated group, anxiety was assessed before and after each touch-massage session, using the State-Trait Anxiety Inventory questionnaire with subscale state (STAI-State). In the control group, anxiety was assessed before and after a 15-minute quiet period. For each patient, the difference in the STAI-State score before and after each session (or period) was calculated, the primary endpoint was based on the average of these three differences. Each patient completed the Rosenberg Self-Esteem Questionnaire before the first session and after the last session.

Sixty-two patients were randomized. Touch-massage significantly decreased patient anxiety: a mean decrease in STAI-State scale score of 10.6 [7.65-13.54] was obtained for the massage group (p ≤ 0.001) compared with the control group. The improvement in self-esteem score was not significant.

The authors concluded that this study provides convincing evidence for integrating touch-massage in the treatment of patients in sterile hematology unit.

I find this conclusion almost touching (pun intended). The wishful thinking of the amateur researchers is almost palpable.

Yes, I mean AMATEUR, despite the fact that, embarrassingly, the authors are affiliated with prestigeous institutions:

  • 1Nantes Université, CHU Nantes, Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, UIC 22, Nantes, F-44000, France.
  • 2Université Paris Est, EA4391 Therapeutic and Nervous Excitability, Creteil, F-93000, France.
  • 3Nantes Université, CHU Nantes, Hematology Department, Nantes, F-44000, France.
  • 4Nantes Université, CHU Nantes, CRCI2NA – INSERM UMR1307, CNRS UMR 6075, Equipe 12, Nantes, F-44000, France.
  • 5Institut Curie, Paris, France.
  • 6Université Paris Versailles Saint-Quentin, Versailles, France.
  • 7Nantes Université, CHU Nantes, Direction de la Recherche et l’Innovation, Coordination Générale des Soins, Nantes, F-44000, France.
  • 8Methodology and Biostatistics Unit, DRCI CHU Nantes CHD Vendée, La Roche Sur Yon, F-85000, France.
  • 9Nantes Université, CHU Nantes, Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, UIC 22, Nantes, F-44000, France. [email protected].

So, why do I feel that they must be amateurs?

  • Because, if they were not amateurs, they would know that a clinical trial should not aim to show something, but to test something.
  • Also, if they were not amateurs, they would know that perhaps the touch-massage itself had nothing to do with the outcome, but that the attention, sympathy and empathy of a therapist or a placebo effect can generate the observed effect.
  • Lastly, if they were not amateurs, they would not speak of convincing evidence based on a single, small, and flawed study.
The objective of this study is to evaluate the efficacy of an OMT intervention for reducing pain and disability in patients with chronic low back pain (LBP). It was designed as a single-blinded, crossover, randomized trial (RCT) and conducted at a university-based health system. Participants were adults, 21–65 years old, with non-specific LBP. Eligible participants (n=80) were randomized to two trial arms:
  • an immediate osteopathic manipulative therapy (OMT) intervention group,
  • a delayed OMT (waiting period) group.

The intervention consisted of three to four OMT sessions over 4–6 weeks, after which the participants switched (crossed-over) groups. The OMT techniques included a mandatory HVLA thrust technique to the lumbar spine region and any (or none) combination of the following four techniques: (i) soft tissue, (ii) muscle energy, (iii) myofascial, and (iv) articulatory. For patients who could not tolerate the HVLA treatment, a physician had to attempt this technique, minimally by attempting to place the patient in the position to perform this maneuver.

The primary clinical outcomes were average pain, current pain, Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v1.0 pain interference and physical function, and modified Oswestry Disability Index (ODI). Secondary outcomes included the remaining PROMIS health domains and the Fear Avoidance Beliefs Questionnaire (FABQ). These measures were taken at baseline (T0), after one OMT session (T1), at the crossover point (T2), and at the end of the trial (T3). Due to the carryover effects of OMT intervention, only the outcomes obtained prior to T2 were evaluated utilizing mixed-effects models and after adjusting for baseline values.

Totals of 35 and 36 participants with chronic LBP were available for the analysis at T1 in the immediate OMT and waiting period groups, respectively, whereas 31 and 33 participants were available for the analysis at T2 in the immediate OMT and waiting period groups, respectively.
After one session of OMT (T1), the analysis showed a significant reduction in the secondary outcomes of sleep disturbance and anxiety compared to the waiting period group. Following the entire intervention period (T2), the immediate OMT group demonstrated a significantly better average pain outcome. The effect size was a 0.8 standard deviation (SD), rendering the reduction in pain clinically significant. Further, the improvement in anxiety remained statistically significant. No study-related serious adverse events (AEs) were reported.
The authors concluded that OMT intervention is safe and effective in reducing pain along with improving sleep and anxiety profiles in patients with chronic LBP.The authors stared their abstract by stating that “the evidence for the efficacy of osteopathic manipulative treatment (OMT) in the management of low back pain (LBP) is considered weak … because it is generally based on low-quality studies.” This is undoubtedly true – but why then did they add one more low-quality study?, I ask myself. To mention just some of the most obvious flaws:

  • This study is far too small to allow conclusions about safety.
  • The trial compared OMT with no therapy; it is likely that the observed outcomes have little to do with OMT but are due to a placebo response.
  • The primary outcome measure showed no effect which essentially means that the study finding was that OMT is ineffective.

My conclusion:

a poor study conducted by wishful thinkers.

 

Motor aphasia is common among patients with stroke. Acupuncture is recommended by TCM enthusiasts as a so-called alternative medicine (SCAM) for poststroke aphasia, but its efficacy remains uncertain.

JAMA just published a study that investigated the effects of acupuncture on language function, neurological function, and quality of life in patients with poststroke motor aphasia.
The study was designed as a multicenter, sham-controlled, randomized clinical trial. It was conducted in 3 tertiary hospitals in China from October 21, 2019, to November 13, 2021. Adult patients with poststroke motor aphasia were enrolled. Data analysis was performed from February to April 2023.

Eligible participants were randomly allocated (1:1) to manual acupuncture (MA) or sham acupuncture (SA) groups. Both groups underwent language training and conventional treatments.
The primary outcomes were the aphasia quotient (AQ) of the Western Aphasia Battery (WAB) and scores on the Chinese Functional Communication Profile (CFCP) at 6 weeks. Secondary outcomes included WAB subitems, Boston Diagnostic Aphasia Examination, National Institutes of Health Stroke Scale, Stroke-Specific Quality of Life Scale, Stroke and Aphasia Quality of Life Scale–39, and Health Scale of Traditional Chinese Medicine scores at 6 weeks and 6 months after onset. All statistical analyses were performed according to the intention-to-treat principle.

Among 252 randomized patients (198 men [78.6%]; mean [SD] age, 60.7 [7.5] years), 231 were included in the modified intention-to-treat analysis (115 in the MA group and 116 in the SA group). Compared with the SA group, the MA group had significant increases in AQ (difference, 7.99 points; 95% CI, 3.42-12.55 points; P = .001) and CFCP (difference, 23.51 points; 95% CI, 11.10-35.93 points; P < .001) scores at week 6 and showed significant improvements in AQ (difference, 10.34; 95% CI, 5.75-14.93; P < .001) and CFCP (difference, 27.43; 95% CI, 14.75-40.10; P < .001) scores at the end of follow-up.

The authors concluded that in this randomized clinical trial, patients with poststroke motor
aphasia who received 6 weeks of MA compared with those who received SA demonstrated
statistically significant improvements in language function, quality of life, and neurological
impairment from week 6 of treatment to the end of follow-up at 6 months after onset.

I was asked by the SCIENCE MEDIC CENTRE to provide a short comment. This is what I stated:

Superficially, this looks like a rigorous trial. We should remember, however, that several groups, including mine, have shown that very nearly all Chinese acupuncture studies report positive results. This suggests that the reliability of these trials is less than encouraging. Moreover, the authors state that real acupuncture induced ‘de chi’, while sham acupuncture did not. This shows that the patients were not blinded and the outcomes might easily be due to a placebo response.

Here, I’d like to add two further points:

The WHO has just released guidelines for non-surgical management of chronic primary low back pain (CPLBP). The guideline considers 37 types of interventions across five intervention classes. With the guidelines, WHO recommends non-surgical interventions to help people experiencing CPLBP. These interventions include:

  • education programs that support knowledge and self-care strategies;
  • exercise programs;
  • some physical therapies, such as spinal manipulative therapy (SMT) and massage;
  • psychological therapies, such as cognitive behavioural therapy; and
  • medicines, such as non-steroidal anti-inflammatory medicines.

The guidelines also outline 14 interventions that are not recommended for most people in most contexts. These interventions should not be routinely offered, as WHO evaluation of the available evidence indicate that potential harms likely outweigh the benefits. WHO advises against interventions such as:

  • lumbar braces, belts and/or supports;
  • some physical therapies, such as traction;
  • and some medicines, such as opioid pain killers, which can be associated with overdose and dependence.

As you probably guessed, I am particularly intrigued by the WHO’s positive recommendation for SMT. Here is what the guideline tells us about this specific topic:

Considering all adults, the guideline development group (GDG) judged overall net benefits [of spinal manipulation] across outcomes to range from trivial to moderate while, for older people the benefit was judged to be largely uncertain given the few trials and uncertainty of evidence in this group. Overall, harms were judged to be trivial to small for all adults and uncertain for older people due to lack of evidence.

The GDG commented that while rare, serious adverse events might occur with SMT, particularly in older people (e.g. fragility fracture in people with bone loss), and highlighted that appropriate training and clinical vigilance concerning potential harms are important. The GDG also acknowledged that rare serious adverse events were unlikely to be detected in trials. Some GDG members considered that the balance of benefits to harms favoured SMT due to small to moderate benefits while others felt the balance did not favour SMT, mainly due to the very low certainty evidence for some of the observed benefits.

The GDG judged the overall certainty of evidence to be very low for all adults, and very low for older people, consistent with the systematic review team’s assessment. The GDG judged that there was likely to be important uncertainty or variability among people with CPLBP with respect to their values and preferences, with GDG members noting that some people might prefer manual
therapies such as SMT, due to its “hands-on” nature, while others might not prefer such an approach.

Based on their experience and the evidence presented from the included trials which offered an average of eight treatment sessions, the GDG judged that SMT was likely to be associated with moderate costs, while acknowledging that such costs and the equity impacts from out-of-pocket costs would vary by setting.

The GDG noted that the cost-effectiveness of SMT might not be favourable when patients do not experience symptom improvements early in the treatment course. The GDG judged that in most settings, delivery of SMT would be feasible, although its acceptability was likely to vary across
health workers and people with CPLBP.

The GDG reached a consensus conditional recommendation in favour of SMT on the basis of small to moderate benefits for critical outcomes, predominantly pain and function, and the likelihood of rare adverse events.

The GDG concluded by consensus that the likely short-term benefits outweighed potential harms, and that delivery was feasible in most settings. The conditional nature of the recommendation was informed by variability in acceptability, possible moderate costs, and concerns that equity might be negatively impacted in a user-pays model of financing.

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This clearly is not a glowing endorsement or recommendation of SMT. Yet, in my view, it is still too positive. In particular, the assessment of harm is woefully deficient. Looking into the finer details, we find how the GDG assessed harms:

WHO commissioned quantitative systematic evidence syntheses of randomized controlled
trials (RCTs) to evaluate the benefits and harms (as reported in included trials) of each of the
prioritized interventions compared with no care (including trials where the effect of an
intervention could be isolated), placebo or usual care for each of the critical outcomes (refer to Table 2 for the PICO criteria for selecting evidence). Research designs other than RCTs
were not considered.

That explains a lot!

It is not possible to establish the harms of SMT (or any other therapy) on the basis of just a few RCTs, particularly because the RCTs in question often fail to report adverse events. I can be sure of this phenomenon because we investigated it via a systematic review:

Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.

Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.

Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.

Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

The GDG did not cite our review (or any other of our articles on the subject) but, as it was published in a very well-known journal, they must have been aware of it. I am afraid that this wilfull ignorance caused the WHO guideline to underestimate the level of harm of SMT. As there is no post-marketing surveillance system for SMT, a realistic assessment of the harm is far from easy and needs to include a carefully weighted summary of all the published reports (such as this one).

The GDG seems to have been aware of (some of) these problems, yet they ignored them and simply assumed (based on wishful thinking?) that the harms were small or trivial.

Why?

Even the most cursory look at the composition of the GDG, begs the question: could it be that the GDG was highjacked by chiropractors and other experts biased towards SMT?

The more I think of it, the more I feel that this might actually be the case. One committee even listed an expert, Scott Haldeman, as a ‘neurologist’ without disclosing that he foremost is a chiropractor who, for most of his professional life, has promoted SMT in one form or another.

Altogether, the WHO guideline is, in my view, a shameful example of pro-chiropractic bias and an unethical disservice to evidence-based medicine.

 

Due to the common adverse effects of motion sickness pharmaceuticals (e.g., drowsiness), medication options to treat the condition are limited. Thus many non-pharmacological therapies are being advocated for it. One of them is osteopathy.

The purpose of this study was to explore the potential utility of a nonpharmaceutical method for motion sickness prevention, specifically an osteopathic manipulative technique (OMT). A novel OMT protocol for the reduction of motion sickness symptoms and severity was evaluated using a sham-controlled, counterbalanced, between-subjects study design. The independent variable was OMT treatment administered prior to the motion sickness-inducing procedure (rotating chair). The primary dependent measures were total and subscale scores from the Motion Sickness Assessment Questionnaire.

The OMT treatment group experienced significantly fewer gastrointestinal (mean scores postprocedure, treatment M = 20.42, sham M = 41.67) and sopite-related (mean scores postprocedure, treatment M = 12.81, sham M = 20.68) symptoms than the sham group while controlling for motion sickness susceptibility. There were no differences between groups with respect to peripheral and central symptoms.

The authors concluded that the results suggest that the treatment may prevent gastrointestinal (nausea) and sopite-related symptoms (sleepiness). These preliminary findings support further exploration of OMT for the prevention of motion sickness. A more precise evaluation of the mechanism of action is needed. Additionally, the duration of the effects needs to be investigated to determine the usefulness of this technique in training and operational settings.

Motion sickness is one of those conditions for which many forms of so-called alternative medicine (SCAM) have been tried and found in dodgy studies to be promissing, e.g.:

And now even OMT!

But before we rush into doing further research on this topic, we should perhaps ask whether the trial really does show OMT to be effective. Unfortunately, the article is behind a paywall, and I can therefore only speculate and ask whether the sham procedure was credible. Was the success of patient-blinding tested? I suspect it wasn’t. If that is so, it could mean that the OMT itself was not the reason for the results but that patient expectation caused the reported outcomes.

In any case, if nothing else, this paper shows yet again that the notion of OMT being an option purely for spinal problems is fantasy. Its advocates try everything to get it accepted as a cure all.

 

Despite effective vaccines, there is still a need for effective treatments for COVID, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. This study tested whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc would improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19.

Participants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 μg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality.

A total of 90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes.

The authors concluded that, in this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility.

In several ways I am puzzled by this study. On the other hand, I should congratulate the naturopathic authors for honestly reporting such a squarely negative result. One could, of course, argue that the study was under-powered and that thus the findings are not conclusive. However, the actual survival curve depicting the results show clearly that there was not even the tiniest trend for the supplement to show any effect. In other words, a larger sample would have most likely yielded the same result.

Participants randomised to the treatment arm received:

  1. Vitamin D3 50 000 units orally once on day 1 of the study (capsule).
  2. Vitamin K2/D3 120 μg/500 units orally two times per day for 21 days (liquid).
  3. Vitamin C/Zinc acetate 2 g/25 mg orally three times daily for 21 days (capsule).

I fail to understand why the researchers might have conceived the hypothesis that such a mixture would be effective. Only 90 of a planned 200 participants were enrolled in this study which ran between September 2021 and April 2022. I fail to understand why recruitment was so poor that the study eventually had to be aborted. My speculation is that the naturopaths in charge of running the trial were too inexperienced in conducting such research to make it a success.

The study was supported by the Ottawa Integrative Cancer Centre Foundation and by Mavis and Martin Sacher. All investigational products for this study were provided in-kind by New Roots Herbal. Perhaps in future these sponsors should think again before they support amateurs pretending to be scientists?

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