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

systematic review

In 2007, we published a systematic review summarizing the efficacy of homeopathic remedies used as a sole or additional therapy in cancer care. We have searched the literature using the databases: Amed (from 1985); CINHAL (from 1982); EMBASE (from 1974); Medline (from 1951); and CAMbase (from 1998). Randomized and non-randomized controlled clinical trials including patients with cancer or past experience of cancer receiving single or combined homeopathic interventions were included. The methodological quality of the trials was assessed by Jadad score. Six studies met our inclusion criteria (five were randomized clinical trials and one was a non-randomized study); but the methodological quality was variable including some high-standard studies. Our analysis of published literature on homeopathy thus found insufficient evidence to support the clinical efficacy of homeopathic therapy in cancer care.

Meanwhile, more trials have emerged, not least a dubious study by Frass et al which is currently under investigation. This means that a new evaluation of the totality of the available evidence might be called for. I am pleased to report that such an assessment has just been published.

In this systematic review, the researchers included clinical studies from 1800 until 2020 to evaluate evidence of the effectiveness of homeopathy on physical and mental conditions in patients during oncological treatment.

In February 2021 a systematic search was conducted searching five electronic databases (Embase, Cochrane, PsychInfo, CINAHL, and Medline) to find studies concerning the use, effectiveness, and potential harm of homeopathy in cancer patients.

From all 1352 search results, 18 studies with 2016 patients were included in this SR. The patients treated with homeopathy were mainly diagnosed with breast cancer. The therapy concepts include single and combination homeopathic remedies (used systemically or as mouth rinses) of various dilutions. Outcomes assessed were the influence on toxicity of cancer treatment (mostly hot flashes and menopausal symptoms), time to drain-removal in breast cancer patients after mastectomy, survival, quality of life, global health and subjective well-being, anxiety, and depression as well as safety and tolerance.

The included studies reported heterogeneous results: some studies described significant differences in quality of life or toxicity of cancer treatment favoring homeopathy, whereas others did not find an effect or reported significant differences to the disadvantage of homeopathy or side effects caused by homeopathy. The majority of the studies have low methodological quality.

The authors concluded that, for homeopathy, there is neither a scientifically based hypothesis of its mode of action nor conclusive evidence from clinical studies in cancer care.

I predict that, if we wait another 15 years, we will have even more studies. I also predict that some of them will be less than reliable or even fake. Finally, I predict that the overall result will still be mixed and unconvincing.

Why can I be so sure?

  1. Because homeopathy lacks biological plausibility as a treatment of cancer (or any other condition).
  2. Because highly diluted homeopathic remedies are pure placebos.
  3. Because homeopathy has developed into a cult where one is no longer surprised to see studies emerging that are too good to be true.

A study by an international team of researchers estimated the proportion of healthcare interventions tested within Cochrane Reviews that are effective according to high-quality evidence.

They selected a random sample of 2428 (35%) of all Cochrane Reviews published between 1 January 2008 and 5 March 2021 and extracted data about interventions within these reviews that were compared with placebo, or no treatment, and whose outcome quality was rated using Grading of Recommendations Assessment, Development and Evaluation (GRADE). They then calculated the proportion of interventions whose effectiveness was based on high-quality evidence according to GRADE, had statistically significant positive effects and were judged as beneficial by the review authors. They also calculated the proportion of interventions that suggested harm.

Of 1567 eligible interventions, 87 (5.6%) had high-quality evidence on first-listed primary outcomes, positive, statistically significant results, and were rated by review authors as beneficial. Harms were measured for 577 (36.8%) interventions, 127 of which (8.1%) had statistically significant evidence of harm. Our dependence on the reliability of Cochrane author assessments (including their GRADE assessments) was a potential limitation of our study.

The authors drew the following conclusions: While many healthcare interventions may be beneficial, very few have high-quality evidence to support their effectiveness and safety. This problem can be remedied by high-quality studies in priority areas. These studies should measure harms more frequently and more rigorously. Practitioners and the public should be aware that many frequently used interventions are not supported by high-quality evidence.

Proponents of so-called alternative medicine (SCAM) are fond of the ‘strawman’ fallacy; meaning they like to present a picture of conventional medicine that is overtly negative in order for SCAM to appear more convincing (Prince Charles, for instance, uses this trick every single time he speaks about SCAM). Therefore I am amazed that this paper has not been exploited in that way by them. I was expecting headlines such as

Evidence-based medicine is not supported by evidence

or

Less than 6% of all conventional treatments are supported by sound evidence.

etc.

Why did they not have a field day with this new paper then?

As the article is behind a paywall, it took me a while to get the full paper (thanks Paul). Now that I have read it, I think I understand the reason.

In the article, the authors provide figures for specific types of treatments. Let me show you some of the percentages of interventions that met the primary outcome (high quality, statistically significant effect, and authors interpret as effective):

  • pharmacological 73.8%
  • surgical 4.6%
  • exercise 5.8%
  • diet 1.2%
  • alternative 0.0%
  • manual therapies 0.0%

So, maybe the headlines should not be any of the above but:

No good evidence to support SCAM?

or

SCAM is destroying the evidence base of medicine.

 

If you have been following my blog for a while, you probably know the answer to this question. A recent article published in JAMA re-emphasizes it in an exemplary fashion:

According to National Health and Nutrition Examination Survey data, 52% of surveyed US adults reported using at least 1 dietary supplement in the prior 30 days and 31% reported using a multivitamin-mineral supplement. The most commonly cited reason for using supplements is for overall health and wellness and to fill nutrient gaps in the diet. Cardiovascular disease and cancer are the 2 leading causes of death and combined account for approximately half of all deaths in the US annually. Inflammation and oxidative stress have been shown to have a role in both cardiovascular disease and cancer, and dietary supplements may have anti-inflammatory and antioxidative effects.

Objective  To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a review of the evidence on the efficacy of supplementation with single nutrients, functionally related nutrient pairs, or multivitamins for reducing the risk of cardiovascular disease, cancer, and mortality in the general adult population, as well as the harms of supplementation.

Population  Community-dwelling, nonpregnant adults.

Evidence Assessment  The USPSTF concludes with moderate certainty that the harms of beta carotene supplementation outweigh the benefits for the prevention of cardiovascular disease or cancer. The USPSTF also concludes with moderate certainty that there is no net benefit of supplementation with vitamin E for the prevention of cardiovascular disease or cancer. The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of supplementation with multivitamins for the prevention of cardiovascular disease or cancer. Evidence is lacking and the balance of benefits and harms cannot be determined. The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of supplementation with single or paired nutrients (other than beta carotene and vitamin E) for the prevention of cardiovascular disease or cancer. Evidence is lacking and the balance of benefits and harms cannot be determined.

Recommendation  The USPSTF recommends against the use of beta carotene or vitamin E supplements for the prevention of cardiovascular disease or cancer. (D recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of multivitamin supplements for the prevention of cardiovascular disease or cancer. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of single- or paired-nutrient supplements (other than beta carotene and vitamin E) for the prevention of cardiovascular disease or cancer. (I statement)

The report also elaborates on potential harms:

For many of the vitamins and nutrients reviewed, there was little evidence of serious harms. However, an important harm of increased lung cancer incidence was reported with the use of beta carotene by persons who smoke tobacco or have occupational exposure to asbestos.

Excessive doses of vitamin supplements can cause several known adverse effects; for example, moderate doses of vitamin A supplements may reduce bone mineral density, and high doses may be hepatotoxic or teratogenic. Vitamin D has potential harms, such as a risk of hypercalcemia and kidney stones, when given at high doses. The potential for harm from other supplements at high doses should be carefully considered.

There is nothing new here, of course. I (and others) have been trying to get these points across for many years. But it is nevertheless most gratifying to see the message repeated by a top journal such as JAMA. I hope JAMA is more successful than I was in changing the behavior of the often all too gullible public!

Nausea and vomiting are common symptoms of patients with advanced cancer. While there is some evidence for acupuncture point stimulation in the treatment of these symptoms for patients having anticancer treatment, there is little for when they are not related to such treatment.

This study aimed to determine whether acupressure at the pericardium 6 sites can help treat nausea and vomiting suffered by palliative care patients with advanced cancer. The researchers conducted a double-blind randomized controlled trial-active versus placebo acupressure wristbands. In-patients with advanced cancer in two specialist palliative care units who fitted either or both of the following criteria were approached: nausea that was at least of moderate severity; vomiting daily on average for the prior 3 days.

A total of 57 patients were randomized to have either active or placebo acupressure wristbands. There was no difference in any of the outcome measures between the two groups:

  • change from the baseline number of vomits;
  • Visual Analogue Scale for ‘did acupressure wristbands help you to feel better?’;
  • the total number of doses of antiemetic medication;
  • the need for escalation of antiemetics.

The authors concluded that, in contrast to a previously published feasibility study, active acupressure wristbands were no better than placebo for specialist palliative care in patients with advanced cancer and nausea and vomiting.

When the research into acupuncture for nausea and vomiting began some 20 years ago, the evidence turned out to be encouraging. Later, as the studies became more and more rigorous, many trials failed to confirm the initial findings. Today, the totality of the evidence is far less convincing than it seemed years ago.

This is a phenomenon that can be observed not just in acupuncture research but in many types of treatment:

  • Initially, over-enthusiastic researchers become victims of their own optimism.
  • These investigators are less into testing hypotheses than into confirming their own wishful thinking.
  • Thus, several positive trials emerge.
  • These, however, turn out to be methodologically flawed.
  • Eventually, the subject might be picked up by real scientists who truly test hypotheses.
  • More and more negative studies thus emerge.
  • Depending on how many flawed studies were initially published and how critical the authors of systematic reviews are, it can take years until the totality of the evidence depicts the true picture which discloses the initial findings as false-positive.

The message is, I think, clear: poor quality studies have the potential to mislead us for many years. Eventually, however, the self-cleansing ability of science should generate the truth about the value of any treatment. In other words:

poor-quality science is not just useless, it causes long-term harm

and

critical thinking prevents harm

 

This systematic review evaluated individualized homeopathy as a treatment for children with attention deficit and hyperactivity disorder (ADHD) when compared to placebo or usual care alone.

Thirty-seven online sources were searched up to March 2021. Studies investigating the effects of individualized homeopathy against any control in ADHD were eligible. Data were extracted to a predefined excel sheet independently by two reviewers.

Six studies were analyzed:

  • 5 were RCTs
  • 2 were controlled against standard treatments;
  • 4 were placebo-controlled and double-blinded.

The meta-analysis revealed a significant effect size across studies of Hedges’ g = 0.542 (95% CI 0.311-0.772; z = 4,61; p < 0.001) against any control and of g = 0.605 (95% CI 0.05-1.16; z = 2.16, p = 0.03) against placebo. The effect estimations are based on studies with an average sample size of 52 participants.

The authors concluded that individualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD.

This is a counter-intuitive result (to put it mildly), and it is, therefore, wise to have a look at the 6 included studies:

1.Frei, H. et al. Homeopathic treatment of children with attention deficit hyperactivity disorder: a randomised, double blind, placebo controlled crossover trial. Eur. J. Pediatr. 164, 758–767 (2005).

This was a trial with just 62 patients who had previously responded to homeopathy. The study was conducted by known proponents of homeopathy and had a highly unusual design. The results suggested that homeopathy was better than placebo.

2. Oberai, P. et al. Homoeopathic management of attention deficit hyperactivity disorder: a randomised placebo-controlled pilot trial. Indian J. Res. Homoeopathy 7, 158–167 (2013).

This one was published in an obscure journal that I could not access.

3. Jacobs, J., Williams, A. L., Girard, C., Njike, V. Y. & Katz, D. Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial. J. Altern. Complement. Med. 11, 799–806 (2005)

This study showed that there were no statistically significant differences between homeopathic remedy and placebo groups on the primary or secondary outcome variables.

4. Jones, M. The efficacy of homoeopathic simillimum in the treatment of attention-deficit/hyperactivity disorder (AD/HD) in schoolgoing children aged 6-11 years (2009).

This was a small unpublished (and not peer-reviewed) thesis. Its results showed no statistically significant effect of treatment.

5. Lamont, J. Homoeopathic treatment of attention deficit hyperactivity disorder. Br. Homeopathic J. 86, 196–200 (1997)

This was a small (n=46) trial with an unusual design. Its results suggested that homeopathy was better than placebo.

6. von Ammon, K. et al. Homeopathic RCT embedded in a long-term observational study of children with ADHD—a successful model of whole systems CAM research. Eur. J. Integr. Med. 1, 27 (2008).

Even though the journal is Medline-listed, I was unable to find this paper. I did, however, find a paper by the same authors with the same title. It turned out to be a duplication of the paper by Frei et al listed above.

_________________________

All in all, this brief analysis of the available abstracts (most full papers are behind paywalls) leaves many questions as to the trustworthiness of this systematic review unanswered. The fact that H. Walach (and other apologists of homeopathy) is its senior author does not inspire me with overwhelming confidence. In any case, I very much doubt that the authors’ conclusion is correct. I therefore would encourage someone with access to all full papers to initiate a more thorough analysis; the abstracts obviously leave many questions unanswered. For instance, it would be crucial to know how many of the trials followed an A+B versus B design (I suspect most studies did, and this would completely invalidate the review’s conclusion). I am more than happy to co-operate with such an evaluation.

Guest post by Derk P. Kooi

Political lobbying is not only restricted to major companies, even quackery lobbies extensively in Dutch politics as well as at a European and global level. The EUROpean Complementary and Alternative Medicine Stakeholder Group (EUROCAM) has been active in Europe for some time. EUROCAM recently attracted attention with a statement on antibiotic resistance during the European Antibiotics Awareness Day.[1] EUROCAM claims that Complementary and Alternative Medicine (CAM) could enhance the immune system and could therefore contribute to the fight against antibiotic resistance. An early study conducted by the anthroposophist Erik Baars was referenced, inter alia. However, this medical claim turns out to be pure nonsense.

EUROCAM regularly publishes so-called ‘position papers’ on the contribution CAM could provide to the European health care system. EUROCAM is currently cautious with its medical claims, and rightly so, as it has seriously overstepped the mark in the past. For example, claims about the efficacy of CAM for infections referred to research by Erik Baars, doctor, anthroposophical healthcare lector at the University of Applied Sciences Leiden and researcher at the Louis Bolk Institute. Baars is an associate of the society due to his misleading statements in his publications on the usefulness of CAM, more specifically of the anthroposophical variant.

Where does this fairly unknown club actually come from, what does it do and how seriously should we take it? Well, EUROCAM is an umbrella organisation for various alternative therapists and their patients. We are talking about Ayurveda, homeopathy, osteopathy, anthroposophy, herbal medicine, traditional (Chinese) medicine, Reiki and acupuncture. The Dutch Registry of Complementary Care Professionals (RBCZ) is also affiliated with EUROCAM. Classical homeopath Annemieke Boelsma is the contact person of the RBCZ at EUROCAM.

It is unclear precisely when EUROCAM was created, the LinkedIn page says 2009. The figurehead of the club is “secretary general” Ton Nicolaï. This homeopathic doctor is also well known to Vereniging tegen de Kwakzalverij, (www.kwakzalverij.nl) the Dutch Society against Quackery. The treasurer of EUROCAM is business administrator Wim Menkveld. Menkveld is on the Advisory Board of the Hortus Botanicus of Leiden. He is also active on the board of the European Patients’ Federation of Homeopathy. EUROCAM thus seems to have originated mainly from Dutch homeopathic circles.

Furthermore, TV producer Miranda Eilert-Ruchtie from Hilversum sits on the EUROCAM board. According to the EUROCAM website, she acts as their “operations manager” and communications advisor. The German Heilprakterin Sonja Maric, an anthropologist and “specialist in Tibetan medicine”, also acts as a communications consultant.

The European Transparency Register shows that in 2020 the total budget of the organisation was 40,498 euros; no more recent data is available. In the year 2018, 5,000 euros were reserved as an honorarium for Mr Nicolaï, for the 0.5 FTE that he works for the organisation. Miranda Eilert-Ruchtie works a number of hours a week for EUROCAM, as a freelancer. Sonja Maric does this on a voluntary basis.

EUROCAM is a member of the European Public Health Alliance (EPHA), the European Union Health Policy Platform. The World Health Organisation (WHO) recognises the organisation as a non-state actor, which means that both the EU and the WHO consider EUROCAM to be a serious legal entity. In the past, EUROCAM has intervened in public EU consultations in the fields of aging, pharmaceutical strategy, cancer, and digital data and services.

EUROCAM provides the secretariat of the MEP Interest Group on Integrative Medicine and Health, a group of five European parliamentarians who have set themselves the goal of promoting integrative medicine at the European level. Co-chairs are Finish Sirpa Pietikäinen, a European parliamentarian for the Christian Democrats, and French Michèle Rivasi, a European parliamentarian for the Greens. The other members are Luxembourg’s Tilly Metz, the Italian Eleonara Evi, and the Danish Margrete Auken. It is noteworthy that they are European parliamentarians for the Greens. They are all members of the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). Eleonara Evi was part of the illustrious Five Star Movement until 2020, known for its anti-vaccination stance. The Member of European Parliament (MEP) Interest Group organises annual events with speakers who are the same people who perform at EUROCAM symposia. These include the aforementioned anthroposophist Erik Baars. Baars worked closely with EUROCAM boss Ton Nicolaï in a European research project on CAM alternatives to antibiotics. More about his bad science later.

The texts EUROCAM produces nowadays (on its website) are carefully written, and the medical claims are carefully formulated. The texts are larded with synonyms for “possible”, known in linguistics as hedging. For example “Several CAM methods have shown high potential to reduce cancer pain”.[2] Generic health claims are also often used to suggest medical benefits, for example in the context of COVID-19, ‘In building and maintaining resistance to infectious illness, CAM modalities as a part of Integrative Medicine & Health can play an important role because they mobilise and stimulate people’s self-regulating capacity, thus increasing their resilience, their immune system.’.[3]

Furthermore, claims are put in the mouths of others, which can be read, for example, in quoting patient expectations: ‘While improving quality of life is the major rationale for CAM use, there is a definite undercurrent of expectation, particularly among the younger patients, that some therapies might have an anticancer effect (prolongation of remission periods) and slow/stagnate tumour growth (prolongation of survival periods), boost the immune system, making it easier to overcome the disease.’.[4]

The educated reader will immediately see through these strategies, but the question is whether the lobbied politicians targeted by EUROCAM understand these subtleties. EUROCAM has not always been so cautious, by the way. In an undated (presumably 2013) interview with the Dutch Association for Classical Homeopathy, “secretary general” Ton Nicolaï made a number of remarkable statements. For example, he claimed at the time that research shows “that for a number of herbal medicines there is a reasonable amount of evidence that scientifically confirms their effectiveness in respiratory infection treatments”. [5] Nicolaï bases his assertion on recent research by Erik Baars conducted as part of a European research programme that aimed to find CAM alternatives to antibiotics.

The report of this project, which ended in 2018, can be found on the EUROCAM website.[6] The authors of this report are, not surprisingly, Erik Baars and Ton Nicolaï. The report contains practically no hard science. Sub-studies focus on, for example, the frequency of antibiotic prescribing among alternative-working GPs and on the best practice of CAM believers. A so-called systematic review of systematic reviews offers good starting points to evaluate Mr Nicolaï’s claim: ‘A systematic review of systematic reviews demonstrates that there are specific, evidence-supported, promising CAM treatments for acute, uncomplicated RTIs [uncomplicated respiratory tract infections, ed.] and that they are safe.’

Here, a medical claim is made, which is weakened by the use of the hedge term “promising”. The conclusion can be summarised with “There would be ‘promising’ CAM treatments for respiratory infections, and they would be safe”. However, surprisingly, the project report does not refer to this “systematic review of systematic reviews”, nor to any of the other concrete results of the project!

Due to the lack of references, we cannot but conclude that the claim is based on a 2019 article by Erik Baars. One of the co-authors is Ton Nicolaï.[7] The article was published in the journal Evidence Based Complementary and Alternative Medicine (EBCAM), which has a shady reputation. Even one of the founders of EBCAM states that the peer-review system is a farce, and therefore the majority of the articles published in it are useless nonsense.[8] In this article, besides a large amount of vagueness about the “worldview differences” between CAM and medicine, systematic reviews are discussed about the effectiveness and safety of CAM treatments. From this systematic review of systematic reviews, it is concluded that there are promising CAM treatments for respiratory, urinary tract and skin infections and that there is even evidence that some CAM treatments are effective for respiratory infections, but what is this based on?

The reviews that were looked at were split into Cochrane and non-Cochrane reviews. Among the Cochrane reviews, there is one that would demonstrate the efficacy of CAM. It is a review on the use of immunostimulants for the prevention of respiratory tract infections in children.[9] Of the 35 studies that were analysed, six involve small molecules, such as isoprinosine, levamisole and pidotimod. In other words, regular medicine, if it turns out to work, but describing it as being experimental would be more appropriate. Baars’ article states that the review also contains herbal medicine. This is somewhat exaggerated: only one of the 35 studies deals with herbs. Of the remaining 28 studies, 25 cover bacterial extracts and three thymus extracts. Again: Baars does not make clear what this has to do with the CAM that EUROCAM represents.

In summary, EUROCAM is a small European lobbying organisation with perhaps some influence at both European and WHO level. One keeps coming across the same names. The organisation is currently using woolly, disguising language to mask medical claims and to fend off criticism. In the past, this was different when EUROCAM, by means of Ton Nicolaï among others, made very reprehensible statements about the role of CAM in (respiratory tract) infections. For the time being, this little club does not seem to pose much of a threat, but European politicians should, of course, ignore this hobby club.

 

References

1. ‘Improving patient resilience to reduce the need to rely on anti-infection treatment: the role of Integrative Medicine’. EUROCAM. https://cam-europe.eu/statement-on-amr-2021/ (visited on 28 December 2021) 2. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021) 3. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021) 4. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021)

5. Miranda Ruchtie. In gesprek met Ton Nicolaï, CAM integreren in de Europese gezondheidszorg. [In discussion with Ton Nicolaï, integrating CAM into the European health care system]. Nederlandse Vereniging van Klassiek Homeopaten. [Dutch Association of Classical Homeopaths] https://www.nvkh.nl/nieuwsbrieven-nvkh/interview-met-ton-nicolai (visited on 3 October 2021)

6. Erik Baars, et al. Reducing the need for antibiotics, the contribution of Complementary and Alternative Medicine. EUROCAM, 2018. https://cam-europe.eu/wp-content/uploads/2019/01/CAM-AMR-EUROCAM-Post-Conference-Paper-2018.pdf (visited on 3 October 2021)

7. Erik W. Baars et al. The Contribution of Complementary and Alternative Medicine to Reduce Antibiotic Use: A Narrative Review of Health Concepts, Prevention, and Treatment Strategies. Evid. Based Complement. Alternat. Med., 2019:5365608. DOI: 10.1155/2019/5365608

8. Edzard Ernst. “EBCAM: an alt med journal that puzzles me a great deal”, URL: http://edzardernst.com/2016/05/ebcam-an-alt-med-journal-that-puzzles-me-a-great-deal/ (visited on 8 January 2022)

9. B. E. Del-Rio-Navarro, F. J. Espinosa-Rosales, V. Flenady, and J. J. Sienra-Monge, “Cochrane Review: Immunostimulants for preventing respiratory tract infection in children,” Evidence-Based Child Health: A Cochrane Review Journal, 2012, 7 (2), 629–717.

Many systematic reviews have summarized the evidence on spinal manipulative therapy (SMT) for low back pain (LBP) in adults. Much less is known about the older population regarding the effects of SMT. This paper assessed the effects of SMT on pain and function in older adults with chronic LBP in an individual participant data (IPD) meta-analysis.

Electronic databases were searched from 2000 until June 2020; reference lists of eligible trials and related reviews were also searched. Randomized controlled trials (RCTs) were considered if they examined the effects of SMT in adults with chronic LBP compared to interventions recommended in international LBP guidelines. The authors of trials eligible for the IPD meta-analysis were contacted and invited to share data. Two review authors conducted a risk of bias assessment. Primary results were examined in a one-stage mixed model, and a two-stage analysis was conducted in order to confirm the findings. The main outcomes and measures were pain and functional status examined at 4, 13, 26, and 52 weeks.

A total of 10 studies were retrieved, including 786 individuals; 261 were between 65 and 91 years of age. There was moderate-quality evidence that SMT results in similar outcomes at 4 weeks (pain: mean difference [MD] – 2.56, 95% confidence interval [CI] – 5.78 to 0.66; functional status: standardized mean difference [SMD] – 0.18, 95% CI – 0.41 to 0.05). Second-stage and sensitivity analysis confirmed these findings.

The authors concluded that SMT provides similar outcomes to recommended interventions for pain and functional status in the older adult with chronic LBP. SMT should be considered a treatment for this patient population.

This is a fine analysis. Unfortunately, its results are less than fine. Its results confirm what I have been saying ad nauseam: we do not currently have a truly effective therapy for back pain, and most options are as good or as bad as the rest. This is most frustrating for everyone concerned, but it is certainly no reason to promote SMT as usually done by chiropractors or osteopaths.

The only logical solution, in my view, is to use those options that:

  • are associated with the least risks,
  • are the least expensive,
  • are widely available.

However you twist and turn the existing evidence, the application of these criteria does not come up with chiropractic or osteopathy as an optimal solution. The best treatment is therapeutic exercise initially taught by a physiotherapist and subsequently performed as a long-term self-treatment by the patient at home.

 

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.”

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