Edzard Ernst

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

Neuropathic pain is difficult to treat. Luckily, we have acupuncture! Acupuncturists leave us in no doubt that their needles are the solution. But are they correct or perhaps victims of wishful thinking?

This review was aimed at determining the proportion of patients with neuropathic pain who achieve a clinically meaningful improvement in their pain with the use of different pharmacologic and nonpharmacologic treatments.

Randomized controlled trials were included that reported a responder analysis of adults with neuropathic pain-specifically diabetic neuropathy, postherpetic neuralgia, or trigeminal neuralgia-treated with any of the following 8 treatments: exercise, acupuncture, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), topical rubefacients, opioids, anticonvulsant medications, and topical lidocaine.

A total of 67 randomized controlled trials were included. There was moderate certainty of evidence that anticonvulsant medications (risk ratio of 1.54; 95% CI 1.45 to 1.63; number needed to treat [NNT] of 7) and SNRIs (risk ratio of 1.45; 95% CI 1.33 to 1.59; NNT = 7) might provide a clinically meaningful benefit to patients with neuropathic pain. There was low certainty of evidence for a clinically meaningful benefit for rubefacients (ie, capsaicin; NNT = 7) and opioids (NNT = 8), and very low certainty of evidence for TCAs. Very low-quality evidence demonstrated that acupuncture was ineffective. All drug classes, except TCAs, had a greater likelihood of deriving a clinically meaningful benefit than having withdrawals due to adverse events (number needed to harm between 12 and 15). No trials met the inclusion criteria for exercise or lidocaine, nor were any trials identified for trigeminal neuralgia.

The authors concluded that there is moderate certainty of evidence that anticonvulsant medications and SNRIs provide a clinically meaningful reduction in pain in those with neuropathic pain, with lower certainty of evidence for rubefacients and opioids, and very low certainty of evidence for TCAs. Owing to low-quality evidence for many interventions, future high-quality trials that report responder analyses will be important to strengthen understanding of the relative benefits and harms of treatments in patients with neuropathic pain.

This review was published in a respected mainstream journal and conducted by a multidisciplinary team with the following titles and affiliations:

  • Associate Professor in the College of Pharmacy at the University of Manitoba in Winnipeg.
  • Pharmacist in Edmonton, Alta, and Clinical Evidence Expert for the College of Family Physicians of Canada.
  • Family physician and Assistant Professor at the University of Alberta.
  • Family physician and Associate Professor in the Department of Family Medicine at the University of Alberta.
  • Pharmacist, Clinical Evidence Expert Lead for the College of Family Physicians of Canada, and Associate Clinical Professor in the Department of Family Medicine at the University of Alberta.
  • Pharmacist in Edmonton and Clinical Evidence Expert for the College of Family Physicians of Canada.
  • Pharmacist and Clinical Evidence Expert at the College of Family Physicians of Canada.
  • Family physician, Director of Programs and Practice Support at the College of Family Physicians of Canada, and Adjunct Professor in the Department of Family Medicine at the University of Alberta.
  • Professor in the Faculty of Pharmaceutical Sciences at the University of British Columbia in Vancouver.
  • Pharmacist at the CIUSSS du Nord-de-l’lle-de-Montréal and Clinical Associate Professor in the Faculty of Pharmacy at the University of Montreal in Quebec.
  • Care of the elderly physician and Assistant Professor in the Department of Family Medicine at the University of Alberta.
  • Family physician and Professor in the Department of Family Medicine at the University of Alberta.
  • Assistant Professor in the Department of Family Medicine at Queen’s University in Kingston, Ont.
  • Research assistant at the University of Alberta.
  • Medical student at the University of Alberta.
  • Nurse in Edmonton and Clinical Evidence Expert for the College of Family Physicians of Canada.

As far as I can see, the review is of sound methodology, it minimizes bias, and its conclusions are therefore trustworthy. They suggest that acupuncture is not effective for neuropathic pain.

But how can this be? Do the authors not know about all the positive evidence on acupuncture? A quick search found positive recent reviews of acupuncture for all of the three indications in question:

  1. Diabetic neuropathy: Acupuncture alone and vitamin B combined with acupuncture are more effective in treating DPN compared to vitamin B.
  2. Herpes zoster: Acupuncture may be effective for patients with HZ.
  3. Trigeminal neuralgia: Acupuncture appears more effective than pharmacotherapy or surgery.

How can we explain this obvious contradiction?

Which result should we trust?

Do we believe pro-acupuncture researchers who published their papers in pro-acupuncture journals, or do we believe the findings of researchers who could not care less whether their work proves or disproves the effectiveness of acupuncture?

I think that these papers offer an exemplary opportunity for us to study how powerful the biases of researchers can be. They also remind us that, in the realm of so-called alternative medicine (SCAM), we should always be very cautious and not accept every conclusion that has been published in supposedly peer-reviewed medical journals.

The purpose of this study was to describe changes in opioid-therapy prescription rates after a family medicine practice included on-site chiropractic services. It was designed as a retrospective analysis of opioid prescription data. The database included opioid prescriptions written for patients seeking care at the family medicine practice from April 2015 to September 2018. In June 2016, the practice reviewed and changed its opioid medication practices. In April 2017, the practice included on-site chiropractic services. Opiod-therapy use was defined as the average rate of opioid prescriptions overall medical providers at the practice.

There was a significant decrease of 22% in the average monthly rate of opioid prescriptions after the inclusion of chiropractic services (F1,40 = 10.69; P < .05). There was a significant decrease of 32% in the prescribing rate of schedule II opioids after the inclusion of chiropractic services (F2,80 = 6.07 for the Group × Schedule interaction; P < .05). The likelihood of writing schedule II opioid prescriptions decreased by 27% after the inclusion of chiropractic services (odds ratio, 0.73; 95% confidence interval, 0.59-0.90). Changes in opioid medication practices by the medical providers included prescribing a schedule III or IV opioid rather than a schedule II opioid (F6,76 = 29.81; P < .05) and a 30% decrease in the daily doses of opioid prescriptions (odds ratio, 0.70; 95% confidence interval, 0.50-0.98).

The authors concluded that this study demonstrates that there were decreases in opioid-therapy prescribing rates after a family medicine practice included on-site chiropractic services. This suggests that inclusion of chiropractic services may have had a positive effect on prescribing behaviors of medical physicians, as they may have been able to offer their patients additional nonpharmaceutical options for pain management.

The authors are correct in concluding the inclusion of chiropractic services MAY have had a positive effect. And then again, it may not!

Cause and effect cannot be established by correlation alone.

CORRELATION IS NOT CAUSATION!

And even if the inclusion of chiropractic services caused the positive effect, it would not prove that chiropractic is effective in the management of pain. It would only mean that the physicians had an option that helped them to write fewer opioid prescriptions. Had they hired a crystal healer or a homeopath or a faith healer or any other practitioner of an ineffective therapy, the findings might have been very similar.

The long and short of it is this: if we want to use fewer opioids, there is only one way to achieve it: we must prescribe less.

 

The objective of this systematic review was to examine whether back pain is associated with increased mortality risk and, if so, whether this association varies by age, sex, and back pain severity.

A systematic search of published literature was conducted and English-language prospective cohort studies evaluating the association of back pain with all-cause mortality with follow-up periods >5 years were included. Three reviewers independently screened studies, abstracted data, and appraised risk of bias using the Quality in Prognosis Studies (QUIPS) tool. A random-effects meta-analysis estimated combined odds ratios (OR) and 95% confidence intervals (CI), using the most adjusted model from each study. Potential effect modification by a priori hypothesized factors (age, sex, and back pain severity) was evaluated with meta-regression and stratified estimates.

Eleven studies with a total of 81,337 participants were included. Follow-up periods ranged from 5 to 23 years. The presence of any back pain, compared to none, was not associated with an increase in mortality (OR, 1.06; 95% CI, 0.97 to 1.16). However, back pain was associated with mortality in studies of women (OR, 1.22; 95% CI, 1.02 to 1.46) and among adults with more severe back pain (OR, 1.26; 95% CI, 1.14 to 1.40).

The authors concluded that back pain was associated with a modest increase in all-cause mortality among women and those with more severe back pain.

I bet that back pain is associated with hundreds of things. The question is whether there might be a causal association; could it be that people die earlier BECAUSE of back pain?

Unless someone’s back pain is so unbearable that she commits suicide, I cannot see how the two can be directly linked in a cause/effect relationship. But there could be indirect causal links. For instance, certain cancers can cause both back pain and death. Or someone’s back pain might make him take treatment against a life-threatening condition less seriously and thus hasten his death.

It has also occurred to me that chiropractors might jump on the bandwagon and use the association between back pain and mortality for boosting their business. Something like this:

Back pain is a risk factor for premature death.

Come to us, and we treat your back pain.

This will make you live longer.

Chiropractic prolongs life!

That would, of course, be daft. Firstly, chiropractic is not all that effective for back pain (or anything else). Secondly, getting rid of back pain is unlikely to prolong your life.

Correlation is not causation!

 

Mind-body interventions (MBIs) are one of the top ten so-called alternative medicine (SCAM) approaches utilized in pediatrics, but there is limited knowledge on associated adverse events (AE). The objective of this review was to systematically review AEs reported in association with MBIs in children.

Electronic databases MEDLINE, Embase, CINAHL, CDSR, and CCRCT were searched from inception to August 2018. The authors included primary studies on participants ≤ 21 years of age that used an MBI. Experimental studies were assessed for whether AEs were reported on or not, and all other study designs were included only if they reported an AE.

A total of 441 were included as primary pediatric MBI studies. Of these, 377 (85.5%) did not explicitly report the presence/absence of AEs or a safety assessment. In total, there were 64 included studies: 43 experimental studies reported that no AE occurred, and 21 studies reported AEs. A total of 37 AEs were found, of which the most serious were grade 3. Most of the studies reporting AEs did not report on severity (81.0%) or duration of AEs (52.4%).

The authors concluded that MBIs are popularly used in children; however associated harms are often not reported and lack important information for meaningful assessment.

SCAM is far too often considered to be risk-free. This phenomenon is particularly stark if the SCAM in question does not involve physical or pharmacological treatments. Thus MBIs are seen and often waved through as especially safe. Consequently, many researchers do not even bother to monitor AEs in their clinical trials. This might be understandable, but it is nevertheless a violation of research ethics.

This new review is important in that it highlights these issues. It is high time that we stop giving researchers in SCAM the benefit of the doubt. They may or may not make honest mistakes when not reporting AEs. In any case, it is clear that they are not properly trained and supervised. All too often, we still see clinical trials run by amateurs who have little idea of methodology and even less of ethics. The harm this phenomenon does is difficult to quantify, but I fear it is huge.

The objective of this study was to assess a new treatment, Medi-Taping, which aims at reducing complaints by treating pelvic obliquity with a combination of manual treatment of trigger points and kinesio taping in a pragmatic RCT with pilot character.

One hundred ten patients were randomized at two study centers either to Medi-Taping or to a standard treatment consisting of patient education and physiotherapy as control. Treatment duration was 3 weeks. Measures were taken at baseline, end of treatment and at follow-up after 2 months. Main outcome criteria were low back pain measured with VAS, the Chronic Pain Grade Scale (CPGS) and the Oswestry Low Back Pain Disability Questionnaire (ODQ).

Patients of both groups benefited from the treatment by medium to large effect sizes. All effects were pointing towards the intended direction. While Medi-Taping showed slightly better improvement rates, there were no significant differences for the primary endpoints between groups at the end of treatment (VAS: mean difference in change 0.38, 95-CI [- 0.45; 1.21] p = 0.10; ODQ 2.35 [- 0.77; 5.48] p = 0.14; CPGS – 0.19 [- 0.46; 0.08] p = 0.64) and at follow-up. Health-related quality of life was significantly higher (p = .004) in patients receiving Medi-Taping compared to controls.

The authors concluded that Medi-Taping, a purported way of correcting pelvic obliquity and chronic tension resulting from it, is a treatment modality similar in effectiveness to complex physiotherapy and patient education.

This conclusion is obviously nonsense! The authors stated that their trial has ‘pilot character’. The study was not designed as an equivalence trial. Thus it is improper to draw conclusions about the comparative effectiveness of Medi-Taping.

Having clarified this crucial point, we might ask, what is this new therapy called Medi-Taping? This is how the authors of the above paper describe the technique:

…sessions started with an assessment of leg length difference. Patients were asked to lie on their back and the legs were slightly stretched by a soft pull at the ankles. Next, a continuous horizontal line was drawn on the inside of both calves indicating the position of the calves relative to each other. Then the patient was asked to sit up with the legs remaining outstretched. This procedure results in a shift of the line between the two calves for most people. This shift was measured in millimeters as leg length difference.

The patient was then asked to stretch out, lying supine, and the therapist palpated any myogeloses (areas of abnormal hardening in a muscle) and tense muscles areas that could be found next to the cervical spine between the base of the skull and seventh cervical vertebra on both sides. After this treatment the leg length difference assessment was repeated. If there was still a substantial difference. The same treatment was also performed on the thoracic and lumbar spine. Also, the mandibular joint was assessed for tense muscles and, if necessary, treated by palpation.

Next, the leg length difference was assessed again and several tapes were applied as follows: First, two parallel tapes were fixed on both sides of the spine above the erector spinae muscles ranging from the base of the skull to the sacrum. For the application patients were asked to bend forward and to lean on a bench. This position stretches the back and its anatomical structure before applying the tape and thus provides the tape with tension before fixing it. Next a star-shaped pattern of tape (three stripes meeting in one point) was placed on the lower back while the patient was still in the same bent position. Thus, the star tape covered the area of the patient’s maximum pain and additionally stabilized the sacroiliac joint. This tape was placed with maximum tension in the middle section by stretching the tape before application, with the ends (approx. 5 cm) applied without tension. If after this procedure there was still residual pain, a third tape was placed at the gluteus maximus muscle. This tape was first fixed distally from the greater trochanter then stretched up to approx. 80% of the possible tension before the other end was placed on the sacrum. On average six tapes were applied for the gluteus tape.

Patients were instructed to keep the tapes on as long as they stuck to the skin. If the patients had recurring low back pain (LBP) within the same week, they were asked to see the therapist again immediately. Otherwise, the second and the third treatment were scheduled once a week for the following 2 weeks, respectively.

(Elsewhere MEDI-Taping is described differently as a technique using an elastic tape. The tape comes in different colors that are used depending on the patient’s need. The fabric and adhesive are made from cotton and other all natural materials. The tape can be ‘stretched’ in order to better support a given joint or muscle. Through the stretch, the underlying areas are relieved of tension, circulation is improved, and as a result injuries are healing faster. While it is applied to the skin, the tape gently massages the affected area as the body is moving. As the tape is applied, an improvement in motor function and pain relief should be felt immediately.)

Considering the above, I think that the most likely explanation of the outcome of this study (if it ever got confirmed in a properly designed equivalence trial) is that Medi-Taping itself is fairly useless. The fact that it did as well as (more precisely perhaps not worse than) standard physiotherapy is due to its exotic and novel flair which raised expectations and thus contributed to a large placebo response.

Whether my speculation is true or not, I don’t feel that Medi-Taping is the solution to back or any other problems.

 

PS

The senior author of this study is Harad Walach who has been a regular feature on this blog, and I could not help but notice that he now has 4 affiliations:

“Time to say good-bye? Homeopathy, skeptics and thoughts on how to proceed” is the title of an article by two Swiss homeopaths which is almost touchingly naive. Here is its abstract:

Although homeopathy is frequently used by many health professionals, there are ongoing debates concerning its effectiveness. Currently no unifying explanation how homeopathy works exists. Homeopaths are frequently challenged by skeptics, and in public opinion, the swan song for homeopathy is frequently sung.

Content: Regarding the efficacy of homeopathy, several well-designed RCTs, observational studies, case studies, and case reports, have been published, demonstrating its clinical efficacy. Regarding its mode of action, the discovery of the working principle of homeopathy would be a major advance towards a thorough scientific recognition of homeopathy. Basic research has already discovered some milestones, e.g., significant and reproducible effects of homeopathic preparations in plants.

Summary: To overcome the distrust of skeptics and public opinion, the support of basic research is indispensable. Second, homeopaths should continue to design prospective randomized clinical studies in order to create robust clinical evidence for the efficacy of homeopathy. Third, they should continue to publish their treatment outcomes, as these publications document clinical effectiveness beyond doubts about its mode of action.

Outlook: These measures will not only support homeopaths in continuing their clinical work, but may lead to a better recognition of this treatment in both the scientific world and the public.

To this, I might add the following comments:

  • “ongoing debates concerning its effectiveness”: this debate has been ongoing for 200 years but it has now come to a conclusion, namely that homeopathy is a placebo therapy.
  • “no unifying explanation how homeopathy works exists”: we do know, however, that the laws of nature, as we understand them today, must be wrong if homeopathy did work.
  • “Homeopaths are frequently challenged by skeptics”: the main challenges currently come not from skeptics but from health experts who rightly insist on sound evidence.
  • “several well-designed RCTs, observational studies, case studies, and case reports, have been published, demonstrating its clinical efficacy”: arguably, this might be correct but misses the crucial point that the totality of the reliable evidence fails to show that homeopathy is efficacious for any condition of humans or animals.
  • “the discovery of the working principle of homeopathy would be a major advance”: yes, so much so that it would require rewriting whole sections of the textbooks of physics and chemistry.
  • “Basic research has already discovered some milestones”: these ‘milestones’ are so imposing that nobody outside the realm of homeopathy has ever recognized them.
  • “the support of basic research is indispensable”: not so much indispensable as non-existent, I would say.
  • “design prospective randomized clinical studies in order to create robust clinical evidence for the efficacy of homeopathy”: homeopaths believe research to be a tool for creating evidence that supports their creed; I have often tried to remind them that it is a tool for testing hypotheses – to no avail, it seems.
  • “publish their treatment outcomes, as these publications document clinical effectiveness”: I have also often tried to explain to them that treatment outcomes can be due to many factors other than the specific effect of the applied therapy – again to no avail.
  • “These measures will not only support homeopaths in continuing their clinical work, but may lead to a better recognition of this treatment in both the scientific world and the public”: these measures, if applied rigorously, will merely confirm what we already know, namely that homeopathy does not work beyond placebo.

A low intake of selenium has been associated with increased cardiovascular mortality in some epidemiological studies. This could be reduced by supplementation with selenium and coenzyme Q10. D-dimer, a fragment of fibrin mirroring fibrinolysis, is a biomarker of thromboembolism, increased inflammation, endothelial dysfunction and is associated with cardiovascular mortality in ischemic heart disease.

The objective of this trial was to examine the impact of selenium and coenzyme Q10 on the level of D-dimer, and its relationship to cardiovascular mortality. D-dimer was measured in 213 individuals at the start and after 48 months of a randomised double-blind placebo-controlled trial with selenium yeast (200 µg/day) and coenzyme Q10 (200 mg/day) (n = 106) or placebo (n = 107). The follow-up time was 4.9 years.

All included individuals were low in selenium (mean 67 μg/L, SD 16.8). The differences in D-dimer concentration were evaluated by the use of T-tests, repeated measures of variance, and ANCOVA analyses. At the end, a significantly lower D-dimer concentration was observed in the active treatment group in comparison with those on placebo (p = 0.006). Although D-dimer values at baseline were weakly associated with high-sensitive CRP, while being more strongly associated with soluble tumour necrosis factor receptor 1 and sP-selectin, controlling for these in the analysis there was an independent effect on D-dimer.

In participants with a D-dimer level above median at baseline, the supplementation resulted in significantly lower cardiovascular mortality compared to those on placebo (p = 0.014). All results were validated with a persisting significant difference between the two groups.

The authors concluded that supplementation with selenium and coenzyme Q10 in a group of elderly low in selenium and coenzyme Q10 prevented an increase in D-dimer and reduced the risk of cardiovascular mortality in comparison with the placebo group. The obtained results also illustrate important associations between inflammation, endothelial function and cardiovascular risk.

These results are interesting and potentially important. The authors agree that their study is not fully conclusive: “Even if the size of the study population is small, we regard the results as being interesting from a scientific point of view, and for hypothesis-generating. The included participants represented a relatively narrow age stratum, so it is not possible to extrapolate the results to other age groups without uncertainty. Finally, as the evaluated population consisted of Caucasians who were low in selenium and coenzyme Q10, it is not necessarily true that the obtained results could be extrapolated to another population.” It might furthermore be of interest to note that part of the analysis cost was supported by grants from Pharma Nord Aps, Denmark, the County Council of Östergötland, Linköping University.

What is needed next, I think, are independent replications. Also of interest would be to determine whether the effects are due to the selenium, or the Q10, or both. And finally, one must caution consumers to not overdose on selenium which could have a host of negative effects on health.

The UK ‘Advertising Standards Authority‘ (ASA) received a complaint about an advertisement that stated:

“Homeopathy is used throughout the world to keep healthy … People in the UK have been using it to successfully help with migraine, anxiety, chronic pain, woman’s [sic] health issues, depression, eczema, chronic fatigue, asthma, IBS, rheumatoid arthritis, and many other conditions”.

The ‘Good Thinking Society‘ had challenged whether:

  1. the ad discouraged essential treatment for conditions for which medical supervision should be sought, namely migraines, chronic pain, women’s health issues, depression, asthma, rheumatoid arthritis; and
  2. the claim “People in the UK have been using [homeopathy] to successfully help with anxiety, chronic pain … eczema, chronic fatigue syndrome … IBS” was misleading and could be substantiated.

The response of the ASA has just been published. Here are the key excerpts from the ASA’s assessment:

1. Upheld

The CAP Code required that marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis or treatment for such conditions unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified medical professional. Among other conditions, the ad referred to “migraines”, “chronic pain”, “woman’s [sic] health issues”, “depression”, “asthma”, and “rheumatoid arthritis”, which we considered were conditions for which medical supervision should be sought, and therefore advice, diagnosis or treatment must be conducted under the supervision of a suitably qualified medical professional. We noted that the practice was run by a GMC-registered GP, who we considered was a suitably qualified health professional. However, the individual homeopaths were not registered and did not hold the same qualifications. Therefore, Homeopathy UK had not shown that all treatment and diagnoses conducted at the practice would be conducted under the supervision of a suitably qualified medical professional. Because Homeopathy UK had not supplied evidence that treatment would always be carried out by a suitably qualified health professional, and because reference to the conditions listed in the ad could discourage consumers from seeking essential treatment under the supervision of a suitably qualified health professional, we concluded that the ad had breached the Code.

On that point the ad breached CAP Code (Edition 12) rule 12.2 (Medicines, medical devices, health-related products and beauty products).

2. Upheld

We considered that consumers would understand the claim “People in the UK have been using [homeopathy] to successfully help with anxiety, chronic pain … eczema, chronic fatigue syndrome … IBS” to mean that homeopathy could be used to successfully treat those conditions … when we reviewed the evidence provided by Homeopathy UK, we considered that the studies provided did not meet the standard of evidence we required for the types of claims being made, both in terms of adequacy and relevance…

On that point the ad breached CAP Code (Edition) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1  (Medicines, medical devices, health-related products and beauty products).

Action

The ad must not appear again in the form complained about. We told Homeopathy UK to ensure their future marketing communications did not to refer to conditions for which advice should be sought from suitably qualified health professionals. We also told them to ensure they did not make claims for homeopathy unless they were supported with robust evidence.

_____________________________

Am I reading this correctly?

The ASA seems to be saying that homeopaths are not suitably qualified health professionals and, as no therapeutic claims are supported by robust evidence, that claims for homeopathy are improper.

Qigong is a branch of Traditional Chinese Medicine using meditation, exercise, deep breathing, and other techniques with a view of strengthening the assumed life force ‘qi’ and thus improving health and prolong life. There are several distinct forms of qigong which can be categorized into two main groups, internal qigong, and external qigong. Internal qigong refers to a physical and mental training method for the cultivation of oneself to achieve optimal health in both mind and body. Internal qigong is not dissimilar to tai chi but it also employs the coordination of different breathing patterns and meditation. External qigong refers to a treatment where qigong practitioners direct their qi-energy to the patient with the intention to clear qi-blockages or balance the flow of qi within that patient. According to Taoist and Buddhist beliefs, qigong allows access to higher realms of awareness. The assumptions of qigong are not scientifically plausible and its clinical effectiveness remains unproven.

The aim of this study was to investigate the effects of internal Qigong for the management of a symptom cluster comprising fatigue, dyspnea, and anxiety in patients with lung cancer.

A total of 156 lung cancer patients participated in this trial, and they were randomized to a Qigong group (6 weeks of intervention) or a waitlist control group receiving usual care. A professional coach with 12 years of experience in teaching Qigong was employed to guide the participants’ training. The training protocol was developed according to the “Qigong Standard” enacted by the Chulalongkorn University, Thailand. The training involved a series of simple, repeated practices including body posture/movement, breathing practice, and meditation performed in synchrony. It mainly consisted of gentle movements designed to bring about a deep state of relaxation and included 7 postures. The symptom cluster was assessed at baseline, at the end of treatment (primary outcome), and at 12 weeks, alongside measures of cough and quality of life (QOL).

The results showed no significant interaction effect between group and time for the symptom cluster, the primary outcome measure of this study, overall and for fatigue and anxiety. However, a significant trend towards improvement was observed on fatigue (P = .004), dyspnea (P = .002), and anxiety (P = .049) in the Qigong group from baseline assessment to the end of intervention at the 6th week (within-group changes). Improvements in dyspnea and in the secondary outcomes of cough, global health status, functional well-being and QOL symptom scales were statistically significant between the 2 groups (P = .001, .014, .021, .001, and .002, respectively).

The authors concluded that Qigong did not alleviate the symptom cluster experience. Nevertheless, this intervention was effective in reducing dyspnea and cough, and improving QOL. More than 6 weeks were needed, however, for detecting the effect of Qigong on improving dyspnea. Furthermore, men benefited more than women. It may not be beneficial to use Qigong to manage the symptom cluster consisting of fatigue, dyspnea, and anxiety, but it may be effective in managing respiratory symptoms (secondary outcomes needing further verification in future research). Future studies targeting symptom clusters should ensure the appropriateness of the combination of symptoms.

I am getting very tired of negative trials getting published as (almost) positive ones. The primary outcome measure of this study did not yield a positive result. The fact that some other endpoints suggested a positive might provide an impetus for further study but does not demonstrate Qigong to be effective. I know the first author of this study is a fan of so-called alternative medicine (SCAM), but this should not stop him from doing proper science.

If you thought that osteopathy is for spinal problems, think again. This study aimed to determine whether osteopathic manipulation of the T9-T10 vertebrae improves the evolution of tonsillitis. A randomized, stratified, controlled clinical trial with blinded patients, evaluator, and data analyst was performed.

The patients in the control group (CG) received a “sham” manipulation consisting of a 150° passive flexion of the shoulders, with a gentle contact of the osteopath’s knees in the middle thoracic vertebrae, without impulse or causing tension. A high-speed, low-amplitude technique was applied to the T9-T10 vertebrae in the osteopathic manipulative group (OMG) patients.

The number of days needed to resolve the tonsillitis was significantly lower (p = 0.025) in the OMG (2.03 ± 0.95 days) than the CG (2.39 ± 0.82 days). Additionally, the number of episodes of tonsillitis after the treatment decreased significantly more in the OMG (0.8 ± 1.88 episodes/year in total) than the CG (2 ± 2.12) (p = 0.005). In the OMG, 60.8% had no recurrences of tonsillitis, compared to 22.5% of the CG, in the following year (χ2 (1) = 15.57, p < 0.001). No patients reported adverse effects.

The authors concluded that during an episode of tonsillitis, the number of days to resolution was significantly lower after the application of an osteopathic manipulation of the T9-T10 vertebrae, compared to a sham manipulation. The number of subsequent year tonsillitis episodes was greatly reduced in both groups, significantly more in the OMG than in the CG patients.

This is an interesting study. Its exceptional feature is that it is sham-controlled. This must mean that the results are reliable and that osteopathic manipulation is indeed an effective treatment of tonsillitis.

Or perhaps not?

It is, of course, most laudable to introduce a sham control group into such a study. But let us for a moment reflect on what purpose it serves. Its main purpose, no doubt, is to render patients unaware of which treatment they received, sham or verum. This is only possible if the sham is indistinguishable from the verum. In this study, this was clearly not the case. Patients in the verum group felt that they received the verum, and patients in the sham group felt that they had the placebo. Thus the former expect to get better, while the latter don’t.

So, we are left with two very different interpretations of the findings:

  1. Osteopathic manipulations are effective for tonsillitis.
  2. Osteopathic manipulations are not effective for tonsillitis, but the patients’ expectations determined the outcomes.

Which is more likely?

What do you think?

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