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

systematic review

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Practitioners of so-called alternative medicine (SCAM) often argue against treating back problems with drugs. They also frequently defend their own therapy by claiming it is backed by published guidelines. So, what should we think about guidelines for the management of back pain?

This systematic review was aimed at:

  1. systematically evaluating the literature for clinical practice guidelines (CPGs) that included the pharmaceutical management of non-specific LBP;
  2. appraising the methodological quality of the CPGs;
  3. qualitatively synthesizing the recommendations with the intent to inform non-prescribing providers who manage LBP.

The authors searched PubMed, Cochrane Database of Systematic Review, Index to Chiropractic Literature, AMED, CINAHL, and PEDro to identify CPGs that described the management of mechanical LBP in the prior five years. Two investigators independently screened titles and abstracts and potentially relevant full text were considered for eligibility. Four investigators independently applied the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument for critical appraisal. Data were extracted for pharmaceutical intervention, the strength of recommendation, and appropriateness for the duration of LBP.

Only nine guidelines with global representation met the eligibility criteria. These CPGs addressed pharmacological treatments with or without non-pharmacological treatments. All CPGs focused on the management of acute, chronic, or unspecified duration of LBP. The mean overall AGREE II score was 89.3% (SD 3.5%). The lowest domain mean score was for applicability, 80.4% (SD 5.2%), and the highest was Scope and Purpose, 94.0% (SD 2.4%). There were ten classifications of medications described in the included CPGs: acetaminophen, antibiotics, anticonvulsants, antidepressants, benzodiazepines, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, oral corticosteroids, skeletal muscle relaxants (SMRs), and atypical opioids.

The authors concluded that nine CPGs, included ten medication classes for the management of LBP. NSAIDs were the most frequently recommended medication for the treatment of both acute and chronic LBP as a first line pharmacological therapy. Acetaminophen and SMRs were inconsistently recommended for acute LBP. Meanwhile, with less consensus among CPGs, acetaminophen and antidepressants were proposed as second-choice therapies for chronic LBP. There was significant heterogeneity of recommendations within many medication classes, although oral corticosteroids, benzodiazepines, anticonvulsants, and antibiotics were not recommended by any CPGs for acute or chronic LBP.

Oddly, this review was published by chiros in a chiro journal. The authors mention that nearly all guidelines the included CPGs recommended non-pharmacological treatments for non-specific LBP, however it was not always delineated as to precede or be used in conjunction with pharmacological intervention.

I find the review interesting because I think it suggests that:

  1. CPGs are not the most reliable form of evidence. Their guidance depends on how up-to-date they are and on the identity and purpose of the authors.
  2. Guidelines are therefore often contradictory.
  3. Back pain is a symptom for which currently no optimal treatment exists.
  4. The most reliable evidence will rarely come from CPGs but from rigorous, up-to-date, independent systematic reviews such as those from the Cochrane Collaboration.

So, the next time chiropractors osteopaths, acupuncturists, etc. tell you “BUT MY THERAPY IS RECOMMENDED IN THE GUIDELINES”, please take it with a pinch of salt.

This meta-analysis was conducted by researchers affiliated to the Evangelical Clinics Essen-Mitte, Department of Internal and Integrative Medicine, Faculty of Medicine, University of Duisburg-Essen, Germany. (one of its authors is an early member of my ALTERNATIVE MEDICINE HALL OF FAME). The paper assessed the safety of acupuncture in oncological patients.

The PubMed, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from their inception to August 7, 2020. Randomized controlled trials in oncological patients comparing invasive acupuncture with sham acupuncture, treatment as usual (TAU), or any other active control were eligible. Two reviewers independently extracted data on study characteristics and adverse events (AEs). Risk of bias was assessed using the Cochrane Risk of Bias Tool.

Of 4590 screened articles, 65 were included in the analyses. The authors observed that acupuncture was not associated with an increased risk of intervention-related AEs, nonserious AEs, serious AEs, or dropout because of AEs compared with sham acupuncture and active control. Compared with TAU, acupuncture was not associated with an increased risk of intervention-related AEs, serious AEs, or dropout because of AEs but was associated with an increased risk for nonserious AEs (odds ratio, 3.94; 95% confidence interval, 1.16-13.35; P = .03). However, the increased risk of nonserious AEs compared with TAU was not robust against selection bias. The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials.

The authors concluded that the current review indicates that acupuncture is as safe as sham acupuncture and active controls in oncological patients. The authors recommend researchers heed the CONSORT (Consolidated Standards of Reporting Trials) safety and harm extension for reporting to capture the side effects and better investigate the risk profile of acupuncture in oncology.

You might think this article is not too bad. So, why do I feel that this paper is so bad?

One reason is that the authors included evidence up to August 2020. Since then, there must have been hundreds of further papers on acupuncture. The article was therefore out of date before it was published.

But that is by no means my main reason. We know from numerous investigations that acupuncture studies often fail to report AEs (and thus violate publication ethics). This means that this new analysis is merely an amplification of the under-reporting. It is, in other words, a means of perpetuating a wrong message.

Yes, you might say, but the authors acknowledge this; they even state in the abstract that “The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials.” True, but this fact does not erase the mistake, it merely concedes it. At the very minimum, the authors should have phrased their conclusion differently, e.g.: the current review confirms that AEs of acupuncture are under-reported in RCTs. Therefore, a meta-analysis of RCTs is unable to verify whether acupuncture is safe. From other types of research, we know that it can cause serious AEs.

An even better solution would have been to abandon or modify the research project when they first came across the mountain of evidence showing that RCTs often fail to mention AEs.

As it stands, the conclusion that acupuncture is as safe as sham acupuncture is simply not true. Since the article probably looks sound to naive readers, I feel that is a particularly good candidate for the WORST PAPER OF 2022 COMPETITION.

 

PS

For those who are interested, here are 4 of my own peer-reviewed articles on the safety of acupuncture (much more can, of course, be found on this blog):

  1. Patient safety incidents from acupuncture treatments: a review of reports to the National Patient Safety Agency – PubMed (nih.gov)
  2. Acupuncture–a critical analysis – PubMed (nih.gov)
  3. Prospective studies of the safety of acupuncture: a systematic review – PubMed (nih.gov)
  4. The risks of acupuncture – PubMed (nih.gov)

I know, transcutaneous electrical nerve stimulation (TENS) is not really a so-called alternative medicine (SCAM) but it is used by many SCAM practitioners and pain patients. It is, therefore, worth knowing whether it works.

This systematic review investigated the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for the relief of pain in adults. All randomized clinical trials (RCTs) were considered which compared strong non-painful TENS at or close to the site of pain versus placebo or other treatments in adults with pain, irrespective of diagnosis.

Reviewers independently screened, extracted data, and assessed the risk of bias (RoB, Cochrane tool) and certainty of evidence (Grading and Recommendations, Assessment, Development, and Evaluation). The outcome measures were the mean pain intensity and the proportions of participants achieving reductions of pain intensity (≥30% or >50%) during or immediately after TENS. Random effect models were used to calculate standardized mean differences (SMD) and risk ratios. Subgroup analyses were related to trial methodology and characteristics of pain.

The review included 381 RCTs (24 532 participants). Pain intensity was lower during or immediately after TENS compared with placebo (91 RCTs, 92 samples, n=4841, SMD=-0·96 (95% CI -1·14 to -0·78), moderate-certainty evidence). Methodological (eg, RoB, sample size) and pain characteristics (eg, acute vs chronic, diagnosis) did not modify the effect. Pain intensity was lower during or immediately after TENS compared with pharmacological and non-pharmacological treatments used as part of standard of care (61 RCTs, 61 samples, n=3155, SMD = -0·72 (95% CI -0·95 to -0·50], low-certainty evidence). Levels of evidence were downgraded because of small-sized trials contributing to imprecision in magnitude estimates. Data were limited for other outcomes including adverse events which were poorly reported, generally mild, and not different from comparators.

The authors concluded that there was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.

This is an impressive review, not least because of its rigorous methodology and the large number of included trials. Its results are clear and convincing. In the words of the authors: “TENS should be considered in a similar manner to rubbing, cooling or warming the skin to provide symptomatic relief of pain via neuromodulation. One advantage of TENS is that users can adjust electrical characteristics to produce a wide variety of TENS sensations such as pulsate and paraesthesiae to combat the dynamic nature of pain. Consequently, patients need to learn how to use a systematic process of trial and error to select electrode positions and electrical characteristics to optimise benefits and minimise problems on a moment to moment basis.”

There are many patients in general practice with health complaints that cannot be medically explained. Some of these patients attribute their problems to dental amalgam.

This study examined the cost-effectiveness of the removal of amalgam fillings in patients with medically unexplained physical symptoms (MUPS) attributed to amalgam compared to usual care, based on a prospective cohort study in Norway.

Costs were determined using a micro-costing approach at the individual level. Health outcomes were documented at baseline and approximately two years later for both the intervention and the usual care using EQ-5D-5L. Quality-adjusted life year (QALY) was used as the main outcome measure. A decision analytical model was developed to estimate the incremental cost-effectiveness of the intervention. Both probabilistic and one-way sensitivity analyses were conducted to assess the impact of uncertainty on costs and effectiveness.

In patients who attributed health complaints to dental amalgam and fulfilled the inclusion and exclusion criteria, amalgam removal was associated with a modest increase in costs at the societal level as well as improved health outcomes. In the base-case analysis, the mean incremental cost per patient in the amalgam group was NOK 19 416 compared to the MUPS group, while the mean incremental QALY was 0.119 with a time horizon of two years. Thus, the incremental costs per QALY of the intervention were NOK 162 680, which is usually considered to be cost-effective in Norway. The estimated incremental cost per QALY decreased with increasing time horizons, and amalgam removal was found to be cost-saving over both 5 and 10 years.

The authors concluded that this study provides insight into the costs and health outcomes associated with the removal of amalgam restorations in patients who attribute health complaints to dental amalgam fillings, which are appropriate instruments to inform health care priorities.

The group sizes were 32 and 28 respectively. This study was thus almost laughably small and therefore cannot lead to firm conclusions of any type. In this contest, a recent systematic review might be relevant; it concluded as follows:

On the basis of the available RCTs, amalgam restorations, if compared with resin-based fillings, do not show an increased risk for systemic diseases. There is still insufficient evidence to exclude or demonstrate any direct influence on general health. The removal of old amalgam restorations and their substitution with more modern adhesive restorations should be performed only when clinically necessary and not just for material concerns. In order to better evaluate the safety of dental amalgam compared to other more modern restorative materials, further RCTs that consider important parameters such as long and uniform follow up periods, number of restorations per patient, and sample populations representative of chronic or degenerative diseases are needed.

Similarly, a review of the evidence might be informative:

Since more than 100 years amalgam is successfully used for the functional restoration of decayed teeth. During the early 1990s the use of amalgam has been discredited by a not very objective discussion about small amounts of quicksilver that can evaporate from the material. Recent studies and reviews, however, found little to no correlation between systemic or local diseases and amalgam restorations in man. Allergic reactions are extremely rare. Most quicksilver evaporates during placement and removal of amalgam restorations. Hence it is not recommended to make extensive rehabilitations with amalgam in pregnant or nursing women. To date, there is no dental material, which can fully substitute amalgam as a restorative material. According to present scientific evidence the use of amalgam is not a health hazard.

Furthermore, there is evidence that the removal of amalgam fillings is not such a good idea. One study, for instance, showed that the mercury released by the physical action of the drill, the replacement material and especially the final destination of the amalgam waste can increase contamination levels that can be a risk for human and environment health.

As dental amalgam removal does not seem risk-free, it is perhaps unwise to remove these fillings at all. Patients who are convinced that their amalgam fillings make them ill might simply benefit from assurance. After all, we also do not re-lay electric cables because some people feel they are the cause of their ill-health.

Today is WORLD ASTHMA DAY, a good opportunity perhaps to revisit a few of our own evaluations of so-called alternative medicine (SCAM) for asthma. Here are the abstracts of some of our systematic reviews on the subject:

YOGA

Objective: The objective of this systematic review was to assess the effectiveness of yoga as a treatment option for asthma.

Method: Seven databases were searched from their inception to October 2010. Randomized clinical trials (RCTs) and non-randomized clinical trials (NRCTs) were considered, if they investigated any type of yoga in patients with asthma. The selection of studies, data extraction, and validation were performed independently by two reviewers.

Results: Six RCTs and one NRCT met the inclusion criteria. Their methodological quality was mostly poor. Three RCTs and one NRCT suggested that yoga leads to a significantly greater reduction in spirometric measures, airway hyperresponsivity, dose of histamine needed to provoke a 20% reduction in forced expiratory volume in the first second, weekly number of asthma attacks, and need for drug treatment. Three RCTs showed no positive effects compared to various control interventions.

Conclusions: The belief that yoga alleviates asthma is not supported by sound evidence. Further, more rigorous trials are warranted.

SPINAL MANIPULATION

Some clinicians believe that spinal manipulation is an effective treatment for asthma. The aim of this systematic review was to critically evaluate the evidence for or against this claim. Four electronic databases were searched without language restrictions from their inceptions to September 2008. Bibliographies and departmental files were hand-searched. The methodological quality of all included studies was assessed with the Jadad score. Only randomised clinical trials of spinal manipulation as a treatment of asthma were included. Three studies met these criteria. All of them were of excellent methodological quality (Jadad score 5) and all used sham-manipulation as the control intervention. None of the studies showed that real manipulation was more effective than sham-manipulation in improving lung function or subjective symptoms. It is concluded that, according to the evidence of the most rigorous studies available to date, spinal manipulation is not an effective treatment for asthma.

ACUPUNCTURE

Contradictory results from randomised controlled trials of acupuncture in asthma suggest both a beneficial and detrimental effect. The authors conducted a formal systematic review and meta-analysis of all randomised clinical trials in the published literature that have compared acupuncture at real and placebo points in asthma patients. The authors searched for trials published in the period 1970-2000. Trials had to measure at least one of the following objective outcomes: peak expiratory flow rate, forced expiratory volume in one second (FEV1) and forced vital capacity. Estimates of the standarised mean difference, between acupuncture and placebo were computed for each trial and combined to estimate the overall effect. Hetereogeneity was investigated in terms of the characteristics of the individual studies. Twelve trials met the inclusion criteria but data from one could not be obtained. Individual patient data were available in only three. Standardised differences between means ranging from 0.071 to 0.133, in favour of acupuncture, were obtained. The overall effect was not conventionally significant and it corresponds to an approximate difference in FEV1 means of 1.7. After exploring hetereogenenity, it was found that studies where bronchoconstriction was induced during the experiment showed a conventionally significant effect. This meta-analysis did not find evidence of an effect of acupuncture in reducing asthma. However, the meta-analysis was limited by shortcomings of the individual trials, in terms of sample size, missing information, adjustment of baseline characteristics and a possible bias against acupuncture introduced by the use of placebo points that may not be completely inactive. There was a suggestion of preferential publication of trials in favour of acupuncture. There is an obvious need to conduct a full-scale randomised clinical trial addressing these limitations and the prognostic value of the aetiology of the disease.

RELAXATION THERAPIES

Background: Emotional stress can either precipitate or exacerbate both acute and chronic asthma. There is a large body of literature available on the use of relaxation techniques for the treatment of asthma symptoms. The aim of this systematic review was to determine if there is any evidence for or against the clinical efficacy of such interventions.

Methods: Four independent literature searches were performed on Medline, Cochrane Library, CISCOM, and Embase. Only randomised clinical trials (RCTs) were included. There were no restrictions on the language of publication. The data from trials that statistically compared the treatment group with that of the control were extracted in a standardised predefined manner and assessed critically by two independent reviewers.

Results: Fifteen trials were identified, of which nine compared the treatment group with the control group appropriately. Five RCTs tested progressive muscle relaxation or mental and muscular relaxation, two of which showed significant effects of therapy. One RCT investigating hypnotherapy, one of autogenic training, and two of biofeedback techniques revealed no therapeutic effects. Overall, the methodological quality of the studies was poor.

Conclusions: There is a lack of evidence for the efficacy of relaxation therapies in the management of asthma. This deficiency is due to the poor methodology of the studies as well as the inherent problems of conducting such trials. There is some evidence that muscular relaxation improves lung function of patients with asthma but no evidence for any other relaxation technique.

HERBAL MEDICINE

Background: Asthma is one of the most common chronic diseases in modern society and there is increasing evidence to suggest that its incidence and severity are increasing. There is a high prevalence of usage of complementary medicine for asthma. Herbal preparations have been cited as the third most popular complementary treatment modality by British asthma sufferers. This study was undertaken to determine if there is any evidence for the clinical efficacy of herbal preparations for the treatment of asthma symptoms.

Methods: Four independent literature searches were performed on Medline, Pubmed, Cochrane Library, and Embase. Only randomised clinical trials were included. There were no restrictions on the language of publication. The data were extracted in a standardised, predefined manner and assessed critically.

Results: Seventeen randomised clinical trials were found, six of which concerned the use of traditional Chinese herbal medicine and eight described traditional Indian medicine, of which five investigated Tylophora indica. Three other randomised trials tested a Japanese Kampo medicine, marihuana, and dried ivy leaf extract. Nine of the 17 trials reported a clinically relevant improvement in lung function and/or symptom scores.

Conclusions: No definitive evidence for any of the herbal preparations emerged. Considering the popularity of herbal medicine with asthma patients, there is urgent need for stringently designed clinically relevant randomised clinical trials for herbal preparations in the treatment of asthma.

BREATHING TECHNIQUES

Breathing techniques are used by a large proportion of asthma sufferers. This systematic review was aimed at determining whether or not these interventions are effective. Four independent literature searches identified six randomized controlled trials. The results of these studies are not uniform. Collectively the data imply that physiotherapeutic breathing techniques may have some potential in benefiting patients with asthma. The safety issue has so far not been addressed satisfactorily. It is concluded that too few studies have been carried out to warrant firm judgements. Further rigorous trials should be carried out in order to redress this situation.

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So, if you suffer from asthma, my advice is to stay away from SCAM. This might be easier said than done because SCAM practitioners are only too willing to lure asthma patients into their cult. In 2003, we have demonstrated this phenomenon by conducting a survey with chiropractors. Here is our short paper in full:

Classic chiropractic theory claims that vertebral subluxation blocks the flow of ‘‘innate intelligence’’ which, in turn, affects the health of asthma patients (1). Chiropractictors often use spinal manipulation (SM) to correct such malalignments and treat asthma (2). Several clinical trials of chiropractic SM exist, but the most rigorous ones are clearly negative (3,4). Chronic medication with corticosteroids can lead to osteoporosis, a condition, which is a contra-indication to chiropractic SM (5). Given this background, we aimed to determine whether chiropractors would advise an asthma patient on long-term corticosteroids (5 years) to try chiropractic as a treatment for this condition.

All 350 e-mail addresses listed at www.interadcom.com/chiro/html were randomised into two groups. A (deceptive) letter from a (fictitious) patient was sent to group A while group B was asked for advice on chiropractic treatment for asthma as part of a research project. Thus, groups A and B were asked the same question in di¡erent contexts: is chiropractic safe and e¡ective for an asthma patient on long-term steroids. After data collection, respondents from group A were informed that the e-mail had been part of a research project.

Of 97 e-mails in group A, we received 31 responses (response rate = 32% (95% CI, 0.23^ 0.41)). Seventy-four per cent (23 respondents) recommended visiting a chiropractor (95% CI, 0.59^ 0.89). Thirty-five per cent (11 respondents) mentioned minimal or no adverse effects of SM (95% CI, 0.18 ^ 0.52). Three chiropractors responded that some adverse e¡ects exist, e.g. risk of bone fracture, or stroke. Two respondents noted that other investigations (X-rays, spinal and neurological examination) were required before chiropractic treatment. Three respondents suggested additional treatments and one warned about a possible connection between asthma and the measles vaccine. Of 77 e-mails sent to group B, we received 16 responses (response rate = 21% (95% CI, 0.17^ 0.25)). Eleven respondents (69%) recommended visiting a chiropractor (95% CI, 0.46 ^ 0.91). Ten respondents mentioned minimal or no adverse effects of SM (95% CI, 0.39^ 0.87). Five chiropractors responded that adverse effects of SM exist (e.g. bone fracture). Five respondents suggested pre-testing the patient to check bone density, allergy, diet, exercise level, hydration and blood. Additional treatments were recommended by three respondents. The pooled results of groups A and B suggested that the majority of chiropractors recommend chiropractic treatment for asthma and the minority mention any adverse effects.

Our results demonstrate that chiropractic advice on asthma therapy is as readily available over the Internet as it is likely to be misleading. The majority of respondents from both groups (72%) recommended chiropractic treatment. This usually entails SM, a treatment modality which has been demonstrated to be ineffective in rigorous clinical trials (3,4,6). The advice may also be dangerous: the minority of the respondents of both groups (17%) caution of the risk of bone fracture. Our findings also suggest that, for the research question asked, a degree of deception is necessary. The response rate in group B was 12% lower than that of group A, and the answers received differed considerably between groups. In group A, 10% acknowledged the possibility of adverse e¡ects, this figure was 33% in group B. In conclusion, chiropractors readily provide advice regarding asthma treatment, which is often not evidence-based and has the potential to put patients at risk.

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As I stated above: if you suffer from asthma, my advice is to

stay away from SCAM.

Acupuncture for animals has a long history in China. In the West, it was introduced in the 1970s when acupuncture became popular for humans. A recent article sums up our current knowledge on the subject. Here is an excerpt:

Acupuncture is used mainly for functional problems such as those involving noninfectious inflammation, paralysis, or pain. For small animals, acupuncture has been used for treating arthritis, hip dysplasia, lick granuloma, feline asthma, diarrhea, and certain reproductive problems. For larger animals, acupuncture has been used for treating downer cow syndrome, facial nerve paralysis, allergic dermatitis, respiratory problems, nonsurgical colic, and certain reproductive disorders.Acupuncture has also been used on competitive animals. There are veterinarians who use acupuncture along with herbs to treat muscle injuries in dogs and cats. Veterinarians charge around $85 for each acupuncture session.[8]Veterinary acupuncture has also recently been used on more exotic animals, such as chimpanzees (Pan troglodytes)[9] and an alligator with scoliosis,[10] though this is still quite rare.

In 2001, a review found insufficient evidence to support equine acupuncture. The review found uniformly negative results in the highest quality studies.[11] In 2006, a systematic review of veterinary acupuncture found “no compelling evidence to recommend or reject acupuncture for any condition in domestic animals”, citing trials with, on average, low methodological quality or trials that are in need of independent replication.[1] In 2009, a review on canine arthritis found “weak or no evidence in support of” various treatments, including acupuncture.[12]

To put it in a nutshell: acupuncture for animals is not evidence-based.

How can I be so sure?

Because ref 1 in the text above refers to our paper. Here is its abstract:

Acupuncture is a popular complementary treatment option in human medicine. Increasingly, owners also seek acupuncture for their animals. The aim of the systematic review reported here was to summarize and assess the clinical evidence for or against the effectiveness of acupuncture in veterinary medicine. Systematic searches were conducted on Medline, Embase, Amed, Cinahl, Japana Centra Revuo Medicina and Chikusan Bunken Kensaku. Hand-searches included conference proceedings, bibliographies, and contact with experts and veterinary acupuncture associations. There were no restrictions regarding the language of publication. All controlled clinical trials testing acupuncture in any condition of domestic animals were included. Studies using laboratory animals were excluded. Titles and abstracts of identified articles were read, and hard copies were obtained. Inclusion and exclusion of studies, data extraction, and validation were performed independently by two reviewers. Methodologic quality was evaluated by means of the Jadad score. Fourteen randomized controlled trials and 17 nonrandomized controlled trials met our criteria and were, therefore, included. The methodologic quality of these trials was variable but, on average, was low. For cutaneous pain and diarrhea, encouraging evidence exists that warrants further investigation in rigorous trials. Single studies reported some positive intergroup differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. These trials require independent replication. On the basis of the findings of this systematic review, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.

This evidence is in sharp contrast to the misinformation published by the ‘IVAS’ (International Veterinary Acupuncture Society). Under the heading “For Which Conditions is Acupuncture Indicated?“, they propagate the following myth:

Acupuncture is indicated for functional problems such as those that involve paralysis, noninfectious inflammation (such as allergies), and pain. For small animals, the following are some of the general conditions which may be treated with acupuncture:

  • Musculoskeletal problems, such as arthritis, intervertebral disk disease, or traumatic nerve injury
  • Respiratory problems, such as feline asthma
  • Skin problems such as lick granulomas and allergic dermatitis
  • Gastrointestinal problems such as diarrhea
  • Selected reproductive problems

For large animals, acupuncture is again commonly used for functional problems. Some of the general conditions where it might be applied are the following:

  • Musculoskeletal problems such as sore backs or downer cow syndrome
  • Neurological problems such as facial paralysis
  • Skin problems such as allergic dermatitis
  • Respiratory problems such as heaves and “bleeders”
  • Gastrointestinal problems such as nonsurgical colic
  • Selected reproductive problems

In addition, regular acupuncture treatment can treat minor sports injuries as they occur and help to keep muscles and tendons resistant to injury. World-class professional and amateur athletes often use acupuncture as a routine part of their training. If your animals are involved in any athletic endeavor, such as racing, jumping, or showing, acupuncture can help them keep in top physical condition.

And what is the conclusion?

Perhaps this?

Never trust the promotional rubbish produced by SCAM organizations.

There is hardly a form of therapy under the SCAM umbrella that is not promoted for back pain. None of them is backed by convincing evidence. This might be because back problems are mostly viewed in SCAM as mechanical by nature, and psychological elements are thus often neglected.

This systematic review with network meta-analysis determined the comparative effectiveness and safety of psychological interventions for chronic low back pain. Randomised controlled trials comparing psychological interventions with any comparison intervention in adults with chronic, non-specific low back pain were included.

A total of 97 randomised controlled trials involving 13 136 participants and 17 treatment nodes were included. Inconsistency was detected at short term and mid-term follow-up for physical function, and short term follow-up for pain intensity, and were resolved through sensitivity analyses. For physical function, cognitive behavioural therapy (standardised mean difference 1.01, 95% confidence interval 0.58 to 1.44), and pain education (0.62, 0.08 to 1.17), delivered with physiotherapy care, resulted in clinically important improvements at post-intervention (moderate-quality evidence). The most sustainable effects of treatment for improving physical function were reported with pain education delivered with physiotherapy care, at least until mid-term follow-up (0.63, 0.25 to 1.00; low-quality evidence). No studies investigated the long term effectiveness of pain education delivered with physiotherapy care. For pain intensity, behavioural therapy (1.08, 0.22 to 1.94), cognitive behavioural therapy (0.92, 0.43 to 1.42), and pain education (0.91, 0.37 to 1.45), delivered with physiotherapy care, resulted in clinically important effects at post-intervention (low to moderate-quality evidence). Only behavioural therapy delivered with physiotherapy care maintained clinically important effects on reducing pain intensity until mid-term follow-up (1.01, 0.41 to 1.60; high-quality evidence).

Forest plot of network meta-analysis results for physical function at post-intervention. *Denotes significance at p<0.05. BT=behavioural therapy; CBT=cognitive behavioural therapy; Comb psych=combined psychological approaches; Csl=counselling; GP care=general practitioner care; PE=pain education; SMD=standardised mean difference. Physiotherapy care was the reference comparison group

 

The authors concluded that for people with chronic, non-specific low back pain, psychological interventions are most effective when delivered in conjunction with physiotherapy care (mainly structured exercise). Pain education programmes (low to moderate-quality evidence) and behavioural therapy (low to high-quality evidence) result in the most sustainable effects of treatment; however, uncertainty remains as to their long term effectiveness. Although inconsistency was detected, potential sources were identified and resolved.

The authors’ further comment that their review has identified that pain education, behavioural therapy, and cognitive behavioural therapy are the most effective psychological interventions for people with chronic, non-specific LBP post-intervention when delivered with physiotherapy care. The most sustainable effects of treatment for physical function and fear avoidance are achieved with pain education programmes, and for pain intensity, they are achieved with behavioural therapy. Although their clinical effectiveness diminishes over time, particularly in the long term (≥12 months post-intervention), evidence supports the clinical benefits of combining physiotherapy care with these specific types of psychological interventions at the onset of treatment. The small total sample size at long term follow-up (eg, for physical function, n=6986 at post-intervention v n=2469 for long term follow-up; for pain intensity, n=6963 v n=2272) has resulted in wide confidence intervals at this time point; however, the magnitude and direction of the pooled effects seemed to consistently favour the psychological interventions delivered with physiotherapy care, compared with physiotherapy care alone.

Commenting on their paper, two of the authors, Ferriera and Ho, said they would like to see the guidelines on LBP therapy updated to provide more specific recommendations, the “whole idea” is to inform patients, so they can have conversations with their GP or physiotherapist. Patients should not come to consultations with a passive attitude of just receiving whatever people tell them because unfortunately people still receive the wrong care for chronic back pain,” Ferreira says. “Clinicians prescribe anti-inflammatories or paracetamol. We need to educate patients and clinicians about options and more effective ways of managing pain.”

Is there a lesson here for patients consulting SCAM practitioners for their back pain? Perhaps it is this: it is wise to choose the therapy that has been demonstrated to be effective while having the least potential for harm! And this is not chiropractic or any other form of SCAM. It could, however, well be a combination of physiotherapeutic exercise and psychological therapy.

The Lancet is a top medical journal, no doubt. But even such journals can make mistakes, even big ones, as the Wakefield story illustrates. But sometimes, the mistakes are seemingly minor and so well hidden that the casual reader is unlikely to find them. Such mistakes can nevertheless be equally pernicious, as they might propagate untruths or misunderstandings that have far-reaching consequences.

A recent Lancet paper might be an example of this phenomenon. It is entitled “Management of common clinical problems experienced by survivors of cancer“, unquestionably an important subject. Its abstract reads as follows:

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Improvements in early detection and treatment have led to a growing prevalence of survivors of cancer worldwide.
Models of care fail to address adequately the breadth of physical, psychosocial, and supportive care needs of those who survive cancer. In this Series paper, we summarise the evidence around the management of common clinical problems experienced by survivors of adult cancers and how to cover these issues in a consultation. Reviewing the patient’s history of cancer and treatments highlights potential long-term or late effects to consider, and recommended surveillance for recurrence. Physical consequences of specific treatments to identify include cardiac dysfunction, metabolic syndrome, lymphoedema, peripheral neuropathy, and osteoporosis. Immunotherapies can cause specific immune-related effects most commonly in the gastrointestinal tract, endocrine system, skin, and liver. Pain should be screened for and requires assessment of potential causes and non-pharmacological and pharmacological approaches to management. Common psychosocial issues, for which there are effective psychological therapies, include fear of recurrence, fatigue, altered sleep and cognition, and effects on sex and intimacy, finances, and employment. Review of lifestyle factors including smoking, obesity, and alcohol is necessary to reduce the risk of recurrence and second cancers. Exercise can improve quality of life and might improve cancer survival; it can also contribute to the management of fatigue, pain, metabolic syndrome, osteoporosis, and cognitive impairment. Using a supportive care screening tool, such as the Distress Thermometer, can identify specific areas of concern and help prioritise areas to cover in a consultation.

_____________________________

You can see nothing wrong? Me neither! We need to dig deeper into the paper to find what concerns me.

In the actual article, the authors state that “there is good evidence of benefit for … acupuncture …”[1]; the same message was conveyed in one of the tables. In support of these categorical statements, the authors quote the current Cochrane review entitled “Acupuncture for cancer pain in adults”. Its abstract reads as follows:

Background: Forty per cent of individuals with early or intermediate stage cancer and 90% with advanced cancer have moderate to severe pain and up to 70% of patients with cancer pain do not receive adequate pain relief. It has been claimed that acupuncture has a role in management of cancer pain and guidelines exist for treatment of cancer pain with acupuncture. This is an updated version of a Cochrane Review published in Issue 1, 2011, on acupuncture for cancer pain in adults.

Objectives: To evaluate efficacy of acupuncture for relief of cancer-related pain in adults.

Search methods: For this update CENTRAL, MEDLINE, EMBASE, PsycINFO, AMED, and SPORTDiscus were searched up to July 2015 including non-English language papers.

Selection criteria: Randomised controlled trials (RCTs) that evaluated any type of invasive acupuncture for pain directly related to cancer in adults aged 18 years or over.

Data collection and analysis: We planned to pool data to provide an overall measure of effect and to calculate the number needed to treat to benefit, but this was not possible due to heterogeneity. Two review authors (CP, OT) independently extracted data adding it to data extraction sheets. Data sheets were compared and discussed with a third review author (MJ) who acted as arbiter. Data analysis was conducted by CP, OT and MJ.

Main results: We included five RCTs (285 participants). Three studies were included in the original review and two more in the update. The authors of the included studies reported benefits of acupuncture in managing pancreatic cancer pain; no difference between real and sham electroacupuncture for pain associated with ovarian cancer; benefits of acupuncture over conventional medication for late stage unspecified cancer; benefits for auricular (ear) acupuncture over placebo for chronic neuropathic pain related to cancer; and no differences between conventional analgesia and acupuncture within the first 10 days of treatment for stomach carcinoma. All studies had a high risk of bias from inadequate sample size and a low risk of bias associated with random sequence generation. Only three studies had low risk of bias associated with incomplete outcome data, while two studies had low risk of bias associated with allocation concealment and one study had low risk of bias associated with inadequate blinding. The heterogeneity of methodologies, cancer populations and techniques used in the included studies precluded pooling of data and therefore meta-analysis was not carried out. A subgroup analysis on acupuncture for cancer-induced bone pain was not conducted because none of the studies made any reference to bone pain. Studies either reported that there were no adverse events as a result of treatment, or did not report adverse events at all.

Authors’ conclusions: There is insufficient evidence to judge whether acupuncture is effective in treating cancer pain in adults.

This conclusion is undoubtedly in stark contrast to the categorical statement of the Lancet authors: “there is good evidence of benefit for … acupuncture …

What should be done to prevent people from getting misled in this way?

  1. The Lancet should correct the error. It might be tempting to do this by simply exchanging the term ‘good’ with ‘some’. However, this would still be misleading, as there is some evidence for almost any type of bogus therapy.
  2. Authors, reviewers, and editors should do their job properly and check the original sources of their quotes.

 

PS

In case someone argued that the Cochrane review is just one of many, here is the conclusion of an overview of 15 systematic reviews on the subject: The … findings emphasized that acupuncture and related therapies alone did not have clinically significant effects at cancer-related pain reduction as compared with analgesic administration alone.

 

Today, several UK dailies report about a review of osteopathy just published in BMJ-online. The aim of this paper was to summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different conditions. The authors conducted an overview of systematic reviews (SRs) and meta-analyses (MAs). SRs and MAs of randomised controlled trials evaluating the efficacy and safety of OMT for any condition were included.

The literature searches revealed nine SRs or MAs conducted between 2013 and 2020 with 55 primary trials involving 3740 participants. The SRs covered a wide range of conditions including

  • acute and chronic non-specific low back pain (NSLBP, four SRs),
  • chronic non-specific neck pain (CNSNP, one SR),
  • chronic non-cancer pain (CNCP, one SR),
  • paediatric (one SR),
  • neurological (primary headache, one SR),
  • irritable bowel syndrome (IBS, one SR).

Although with different effect sizes and quality of evidence, MAs reported that OMT is more effective than comparators in reducing pain and improving the functional status in acute/chronic NSLBP, CNSNP and CNCP. Due
to the small sample size, presence of conflicting results and high heterogeneity, questionable evidence existed on OMT efficacy for paediatric conditions, primary headaches and IBS. No adverse events were reported in most SRs. The methodological quality of the included SRs was rated low or critically low.

The authors concluded that based on the currently available SRs and MAs, promising evidence suggests the possible effectiveness of OMT for musculoskeletal disorders. Limited and inconclusive evidence occurs for paediatric conditions, primary headache and IBS. Further well-conducted SRs and MAs are needed to confirm and extend the efficacy and safety of OMT.

This paper raises several questions. Here a just the two that bothered me most:

  1. If the authors had truly wanted to evaluate the SAFETY of OMT (as they state in the abstract), they would have needed to look beyond SRs, MAs or RCTs. We know – and the authors of the overview confirm this – that clinical trials of so-called alternative medicine (SCAM) often fail to mention adverse effects. This means that, in order to obtain a more realistic picture, we need to look at case reports, case series and other observational studies. It also means that the positive message about safety generated here is most likely misleading.
  2. The authors (the lead author is an osteopath) might have noticed that most – if not all – of the positive SRs were published by osteopaths. Their assessments might thus have been less than objective. The authors did not include one of our SRs (because it fell outside their inclusion period). Yet, I do believe that it is one of the few reviews of OMT for musculoskeletal problems that was not done by osteopaths. Therefore, it is worth showing you its abstract here:

The objective of this systematic review was to assess the effectiveness of osteopathy as a treatment option for musculoskeletal pain. Six databases were searched from their inception to August 2010. Only randomized clinical trials (RCTs) were considered if they tested osteopathic manipulation/mobilization against any control intervention or no therapy in human with any musculoskeletal pain in any anatomical location, and if they assessed pain as an outcome measure. The selection of studies, data extraction, and validation were performed independently by two reviewers. Studies of chiropractic manipulations were excluded. Sixteen RCTs met the inclusion criteria. Their methodological quality ranged between 1 and 4 on the Jadad scale (max = 5). Five RCTs suggested that osteopathy compared to various control interventions leads to a significantly stronger reduction of musculoskeletal pain. Eleven RCTs indicated that osteopathy compared to controls generates no change in musculoskeletal pain. Collectively, these data fail to produce compelling evidence for the effectiveness of osteopathy as a treatment of musculoskeletal pain.

It was published 11 years ago. But I have so far not seen compelling evidence that would make me change our conclusion. As I state in the newspapers:

OSTEOPATHY SHOULD BE TAKEN WITH A SIZABLE PINCH OF SALT.

 

 

The Anglo-European College of Chiropractic (AECC) has been promoting pediatric chiropractic for some time, and I have posted about the subject before  (see, for instance, here). Now the AECC has gone one decisive step further. On the website, the AECC announced an MSc ‘Musculoskeletal Paediatric Health‘:

The MSc Musculoskeletal Paediatric Health degree is designed to develop your knowledge and skills in the safe and competent care of children of all ages. Our part-time, distance-based course blends live online classes with ready to use resources through our virtual learning environment. In addition, you will have the opportunity to observe in the AECC University College clinical services at our Bournemouth campus. The course covers topics in paediatric musculoskeletal practice with specific units on paediatric development, paediatric musculoskeletal examination, paediatric musculoskeletal interventions, and paediatric musculoskeletal management. You will address issues such as risk factors and public health, including breastfeeding, supine sleep in infancy, physical activity in children and conditions affecting the musculoskeletal health of children from birth. The paediatric specific topics are completed by other optional units such as professional development, evidence-based practice, and leadership and inter-professional collaboration. In the dissertation unit you will conduct a study relevant to musculoskeletal paediatric health.

Your learning will happen through a mix of live and recorded lectures, access to online reading materials, and access to the literature through our learning services. You will also engage with the contents taught through guided activities with your peers and staff. Clinical paediatric experience is recommended to fully engage with the course. For students with limited access to a suitable clinical environment to support their studies, or for student who wants to add to their clinical experience, we are able to offer a limited number of opportunities to observe and work alongside our clinical educators within the AECC University College clinical services. Assessments are tailor made to each unit and may include a variety of methods such as critical reviews, reflective accounts, portfolios and in the last year a research dissertation.

___________________________

The AECC emphasizes its commitment to being a leading higher education institution in healthcare disciplines, nationally and internationally recognised for quality and excellence. Therefore, it seems only fair to have another look at the science behind pediatric chiropractic. Specifically, is there any good science to show that would justify a Master of Science in ‘Musculoskeletal Paediatric Health’?

So, let’s have a look and see whether there are any good review articles supporting such a degree. Here is what I found with several Medline searches (date of the review on chiropractic for any pediatric conditions, followed by its conclusion + link [so that the reader can look up the evidence]):

2008

I am unable to find convincing evidence for any of the above-named conditions. 

2009

Previous research has shown that professional chiropractic organisations ‘make claims for the clinical art of chiropractic that are not currently available scientific evidence…’. The claim to effectively treat otitis seems to
be one of them. It is time now, I think, that chiropractors either produce the evidence or abandon the claim.

2009

The … evidence is neither complete nor, in my view, “substantial.”

2010

Although the major reason for pediatric patients to attend a chiropractor is spinal pain, no adequate studies have been performed in this area. It is time for the chiropractic profession to take responsibility and systematically investigate the efficiency of joint manipulation of problems relating to the developing musculoskeletal system.

2018

Some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

What seems to emerge is rather disappointing:

  1. There are no really new reviews.
  2. Most of the existing reviews are not on musculoskeletal conditions.
  3. All of the reviews cast considerable doubt on the notion that chiropractors should go anywhere near children.

But perhaps I was too ambitious. Perhaps there are some new rigorous clinical trials of chiropractic for musculoskeletal conditions. A few further searches found this (again year and conclusion):

2019

We found that children with long duration of spinal pain or co-occurring musculoskeletal pain prior to inclusion as well as low quality of life at baseline tended to benefit from manipulative therapy over non-manipulative therapy, whereas the opposite was seen for children reporting high intensity of pain. However, most results were statistically insignificant.

2018

Adding manipulative therapy to other conservative care in school children with spinal pain did not result in fewer recurrent episodes. The choice of treatment-if any-for spinal pain in children therefore relies on personal preferences, and could include conservative care with and without manipulative therapy. Participants in this trial may differ from a normal care-seeking population.

I might have missed one or two trials because I only conducted rather ‘rough and ready’ searches, but even if I did: would this amount to convincing evidence? Would it be good science?

No! and No!

So, why does the AECC offer a Master of Science in ‘Musculoskeletal Paediatric Health’?

Search me!

It wouldn’t have something to do with the notion that it is good for business?

Or perhaps they just want to give science a bad name?

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