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

Monthly Archives: August 2024

Uterine fibroids are a common gynaecological condition often impacting quality of life. While conventional treatment options exist, there is growing interest in so-called alternative Medicine (SCAM) such as homeopathy. The objective of this review paper was to assess the effectiveness of homeopathic medicines in treating uterine fibroids through the analysis of recent clinical trials and observational studies, aiming to provide insights into the potential role of homeopathy as a SCAM for uterine fibroids.

A thorough search of databases such as PubMed, Google Scholar, Scopus, and pertinent medical journals was undertaken to locate recent studies on the efficacy of homeopathic medicines for uterine fibroids. Only studies meeting predefined inclusion criteria, including randomized controlled trials, prospective observational studies, and systematic reviews, were included in the review process.

Recent studies investigating the efficacy of homeopathic medicines in treating uterine fibroids consistently demonstrated positive outcomes, including symptom alleviation, reduction in fibroid size, and improved quality of life. Various remedies showed effectiveness across various potencies. Symptom severity scales, including the Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), and Verbal Multidimensional Scoring System (VMSS), were utilized to assess pelvic pain, menstrual bleeding, and discomfort. Quality of life measures like the WHOQOL-BREF scale provided insights into overall well-being.

The authors concluded that the collective findings from these studies provide robust evidence supporting the efficacy and safety of homeopathic medicines in the management of uterine fibroids. By employing individualized treatment approaches tailored to patient-specific symptoms and characteristics, homeopathy offers a holistic and personalized approach to addressing fibroids and improving the quality of life for affected individuals. Overall, these studies provide robust evidence supporting the efficacy and safety of homeopathic medicines in treating uterine fibroids.

This is a very odd paper:

  • The authors call it a “comprehensive review”, a term that is next to meaningless.
  • It certainly is not a systematic review.
  • The reason for merely including “recent studies” is unclear; it also makes a mockery of the attribute “comprehensive”.
  • The reason for including observational studies, however, seems to be very clear: it is an age-old trick to generate a false-positive result.
  • There was no assessment of the quality of the primary studies.
  • In total, there were just 6 primary studies none of which was anywhere near to being rigorous.
  • The authors never even investigated the safety of homeopathic remedies, yet they draw firm conclusions about it.

My conclusion is that this “comprehensive review” is comprehensive example of how to comprehensively mislead with comprehensively dishonest research. And why would anyone set out to do such a thing? Perhaps the authors’ affiliation provide some hints:

  • Department of Homoeopathic Pharmacy,
  • Homoeopathic Medical College & Research Centre.

I sometimes like to browse through old articles of mine and amaze myself. It is now 15 years ago that I published this paper:

Since 1994 chiropractic has been regulated by statute in the UK. Despite this air of respectability, a range of important problems continue to bedevil this profession. Professional organizations of chiropractic and their members make numerous claims which are not supported by sound evidence. Many chiropractors adhere to concepts which fly in the face of science and most seem to regularly violate important principles of ethical behaviour. The advice chiropractors give to their clients is often dangerously misleading. If chiropractic in the UK is to grow into an established health care profession, the General Chiropractic Council and its members should comply with the accepted standards of today’s health care.

This begs the question: HAVE THINGS IMPROVED AT ALL?

  • Have professional organizations of chiropractic stopped making claims which are not supported by sound evidence?
  • Have their members stopped making claims which are not supported by sound evidence?
  • Do chiropractors no longer adhere to concepts which fly in the face of science?
  • Have they ceased violating important principles of ethical behaviour?
  • Is the advice chiropractors give to their clients no longer dangerously misleading?

Here are my answers to these questions:

  • No.
  • No.
  • No.
  • No.
  • No.

Yes, there are moments when I surprise myself. And there are also those when I ask whether any of my work has ever had any effect. And then, after some reflection, I discover that my job is not nearly as bad as some others.

I only just came across the announcements for two conferences that made me almost speachless:

No 1 Homeopathy in Cancer Care – Aug. 29, 2024

Hosted by the newly formed Special Interest Group (SIG) on Research in Homeopathy in Cancer Care, this webinar aims to shed light on the role of homeopathy in cancer care, focusing on both its research status and practical applications in supportive treatment.

Supportive and palliative care are pivotal components of cancer treatment, offering avenues to enhance quality of life and potentially extend survival rates. Homeopathy emerges as a prominent integrative modality embraced by patients worldwide, notably in Europe, India, and Latin America. Despite varying perspectives on its efficacy, homeopathy’s emphasis on empathic listening and its unique approach to symptom management garner significant attention.

In the United States, homeopathy’s popularity surged during the 1990s, with over 5 million people reported to have used it by 2015. While some attribute its effects to a placebo response, clinical studies suggest tangible benefits in cancer care, particularly in alleviating symptoms like fatigue, anxiety, and hot flashes. Homeopathy is one of the leading integrative oncology modalities in Europe. Observations from France reveal that homeopathy supplements conventional treatments in about 30% of cancer patients, yielding notable improvements in symptomatology. Homeopathy was the most commonly used integrative therapy in cancer care in Belgium and in the top five in six other countries Turkey, Czech Republic, Sweden, Italy, Spain, and Greece. (Molassiotis 2005)

The speakers are:

Dr. Moshe Frenkel is a clinical associate professor at the University of Texas and founder of the Integrative Medicine Clinic, at The University of Texas M. D. Anderson Cancer Center, Houston Texas where he served as a full faculty until he returned to Israel in 2010. Up to 2014 Dr Frenkel was chairing the clinical practice committee of The Society of Integrative Oncology and was acting as the chair of The Israeli Society of Complementary Medicine (A section of The Israel Medical Association) until 2016.  Currently, Dr Frenkel is the medical director of the Integrative Oncology Service in RAMBAM Medical Center Oncology Department, a comprehensive oncology center and the largest in Northern Israel, as well as leading a feasibility study in homeopathy in cancer care.

Elio Rossi, MD will provide a brief overview of his practice and discuss symptom management, particularly focusing on radio dermatitis and leading homeopathic remedies that he utilizes. Director of the homeopathy outpatient clinic at the Campo di Marte public hospital in Lucca Italy, was established in 1998 and to date more than 7,500 patients have been consecutively examined. Of these 1100 are cancer patients who required an ‘integrated’ homeopathic treatment to reduce the adverse effects of anti-cancer therapies and improve their quality of life.  Works as a homeopathic doctor and expert in integrative medicine, collaborating with a local oncologist. Collaborated as Co-Chair, in the organization of many national and international congresses on Integrative Oncology (2017, 2019), specific sessions within other congresses organized in Italy (ECIM 2012 Florence, WCIMH 2023 Rome) and regional workshops, which have been attended by hundreds of CIM experts and oncologists.

Jean Lionel Bagot, MD will share insights from his practice, focusing on homeopathic remedies for fatigue and potential remedies for skin afflictions. A specialist in integrative cancer supportive care treatments in private practice as well as coordinating doctor of the Outpatients Department for Integrative Care in Groupe Hospitalier Saint Vincent Strasbourg, France; President of the International Homeopathic Society of Supportive Care in Oncology (SHISSO); Scientific officer of the French Society for Integrative Oncology (SFOI); Associated Member of the University College of Integrative and Complementary Medicine (CUMIC); Lecturer in the Medicine and Pharmacy Faculty in Strasbourg University.

Elizabeth Thompson, MD will have the opportunity to briefly describe her previous NHS practice and discuss symptom management, specifically addressing hot flushes and leading homeopathic remedies. Homeopathic Physician in NHS, NCIM Founder, CEO & Integrative Medicine Doctor, National Centre for Integrative Medicine (NCIM) www.ncim.org.uk, Chair, Integrative and Personalized Medicine Congress, London, June 2022. Past President ECIM 2021 and Board Member European Society Integrative Medicine, Council Member British Society of Integrative Oncology, Council Member College of Medicine.

No 2: “Pushing the Boundaries” Yes to Life Annual Conference 2024, 28th September

Integrative Medicine is a living, rapidly expanding science, with new understandings and potential being unveiled on a daily basis. This year’s conferences – one online in the Summer, and one in-person in the Autumn – share the title ‘Pushing the Boundaries’, as we have decided to devote them both to looking at the latest developments in Integrative Medicine, across the board. So that includes new techniques, new scientific understandings, and new applications for existing therapies, and you’ll be hearing fresh insights from some of your most trusted clinicians and scientists, and led into unfamiliar territory by pioneering speakers who may be as yet unfamiliar. The conferences are being co-created by Patricia Peat from Cancer Options and the Peat Institute and Yes to Life, with the aim of sending our audiences home with a wealth of resources on which to be able to draw for their own needs. Both events will be priced for accessibility, and the in-person Autumn Conference will include an extensive Exhibition that will offer yet more knowledge and resources to delegates.

The speakers are:

  • Dr Penny Kechagioglou MBBS (Honours), MRCP, CCT (Clin Onc), MPH, MBA Clinical oncologist
  • Dr Britt Cordi PhD
  • Dr Robert Verkerk MSc DIC PhD FACN​
  • Robin Daly Yes to Life Founder and Chairman
  • Patricia Peat Founder of Cancer Options
  • Mark Sean Taylor  Patient Led Oncology Founder

_____________________________

Yes, you remembered correctly: some of the speakers have in the past featured on this blog, e.g.:

Crucially, we have encountered the YES TO LIFE charity:

But please do not let me spoil your enthusiasm of attending these meetings!

I do mean it: can someone please attend?

I offter a guest post to any critical thinker who wants to write up his/her experience.

GOOD LUCK

The American Society of Clinical Oncology (ASCO) and the Society for Integrative Oncology have collaborated to develop guidelines for the application of integrative approaches in the management of:

  • anxiety,
  • depression,
  • fatigue,
  • use of cannabinoids and cannabis in patients with cancer.

These guidelines provide evidence-based recommendations to improve outcomes and quality of life by enhancing conventional cancer treatment with integrative modalities.

All studies that informed the guideline recommendations were reviewed by an Expert Panel which was made up of a patient advocate, an ASCO methodologist, oncology providers, and integrative medicine experts. Panel members reviewed each trial for quality of evidence, determined a grade quality assessment label, and concluded strength of recommendations.

The findings show:

  • Strong recommendations for management of cancer fatigue during treatment were given to both in-person or web-based mindfulness-based stress reduction, mindfulness-based cognitive therapy, and tai chi or qigong.
  • Strong recommendations for management of cancer fatigue after cancer treatment were given to mindfulness-based programs.
  • Clinicians should recommend against using cannabis or cannabinoids as a cancer-directed treatment unless within the context of a clinical trial.
  • The recommended modalities for managing anxiety included Mindfulness-Based Interventions (MBIs), yoga, hypnosis, relaxation therapies, music therapy, reflexology, acupuncture, tai chi, and lavender essential oils.
  • The strongest recommendation in the guideline is that MBIs should be offered to people with cancer, both during active treatment and post-treatment, to address depression.

The authors concluded that the evidence for integrative interventions in cancer care is growing, with research now supporting benefits of integrative interventions across the cancer care continuum.

I am sorry, but I find these guidelines of poor quality and totally inadequate for the purpose of providing responsible guidance to cancer patients and carers. Here are some of my reasons:

  • I know that this is a petty point, particularly for me as a non-native English speaker, but what on earth is an INTEGRATIVE THERAPY? I know integrative care or integrative medicine, but what could possibly be integrative with a therapy?
  • I can vouch for the fact that the assertion “all studies that informed the guideline recommendations were reviewed” is NOT  true. The authors seem to have selected the studies they wanted. Crucially, they do not reveal their selection criteria. I have the impression that they selected positive studies and omitted those that were negative.
  • The panel of experts conducting the research should be mentioned; one can put together a panel to show just about anything simply by choosing the right individuals.
  • The authors claim that they assessed the quality of the evidence, yet they fail to tell us what it was. I know that many of the trials are of low quality and their results therefore less than reliable. And guidance based on poor-quality studies is misguidance.
  • The guidelines say nothing about the risks of the various treatments. In my view, this would be essential for any decent guideline. I know that some of the mentioned therapies are not free of adverse effects.
  • They also say nothing about the absolute and relative effect sizes of the treatments they recommend. Such information would ne necessary for making informed decisions about the optimal therapeutic choices.
  • The entire guideline is bar any critical thinking.

Overall, these guidelines provide more an exercise in promotion of dubious therapies than a reliable guide for cancer patients and their carers. The ASCO and the Society for Integrative Oncology should be ashamed to have given their names to such a poor-quality document.

In January 2024, this remarkable paper was published in a top journal:

Macrophages are associated with innate immune response and M1-polarized macrophages exhibit pro-inflammatory functions. Nanoparticles of natural or synthetic compounds are potential triggers of innate immunity. As2O3 is the major component of the homeopathic drug, Arsenic album 30C.This has been claimed to have immune-boosting activities, however, has not been validated experimentally. Here we elucidated the underlying mechanism of Ars. alb 30C-mediated immune priming in murine macrophage cell line. Transmission Electron Microscopy (TEM) and X-ray diffraction (XRD) used for the structural analysis of the drug reveals the presence of crystalline As2O3 nanoparticles of cubic structure. Similarly, signatures of M1-macrophage polarization were observed by surface enhanced Raman scattering (SERS) in RAW 264.7 cells with concomitant over expression of M1 cell surface marker, CD80 and transcription factor, NF-κB, respectively. We also observed a significant increase in pro-inflammatory cytokines like iNOS, TNF-α, IL-6, and COX-2 expression with unaltered ROS and apoptosis in drug-treated cells. Enhanced expression of Toll-like receptors 3 and 7 were observed both in transcriptional and translational levels after the drug treatment. In sum, our findings for the first time indicated the presence of crystalline As2O3 cubic nanostructure in Ars. alb 30C which facilitates modulation of innate immunity by activating macrophage polarization.

On 21 August 2024, this paper was retracted; here is the retraction notice:

After publication, concerns were raised about the reagents used in this study, in particular that the arsenic trioxide solution is diluted beyond the point at which any active molecules are expected to be present. Post-publication peer review confirmed that the nature of the particles detected in the study is unclear. This means that without further corroborative evidence, the data presented in the paper are not sufficient to attribute the effects observed after treating cells with the compound. The Editors therefore no longer have confidence in the results reported in this Article.

Swift retractions of sloppy science, errors, fraud, scientific misconduct, misinterpretaton of results, etc. are necessary to prevent the harm caused by such unfortunate publications. The editors of SCIENTIFIC REPORTS should be congratulated to have achieved this so quickly and elegantly. This is in sharp contrast to similar events like the protracted hoo-hah that occurred until THE LANCET finally retracted the fraudulent study of Andrew Wakefield or the deplorable ongoing saga of  THE ONCOLOGIST, the editor of which has still not retracted the fraudulent paper by Michael Frass et al claiming that homeopathy could prolong the survival of cancer patients.

 

Pharmacists often advise patients on the use of over-the counter (OTC) medications, including homeopathics. Yet, little is known about student pharmacist education about homeopathy. The objectives of this study were to:

  1. describe homeopathic topics being taught in pharmacy schools,
  2. evaluate faculty views about pharmacists’ roles in counseling patients about homeopathic products.

An explanatory sequential mixed methods approach was used. Online surveys were distributed to 3,300 pharmacy practice faculty members representing all schools accredited in the US. Frequencies were calculated to describe faculty characteristics and their responses. Moreover, 18 interviews of faculty involved with teaching homeopathy were conducted to learn about homeopathy teaching and expectations about roles of pharmacists in counseling patients.

Survey data were collected from 365 respondents. Over half (84 of 137) of the responding pharmacy schools reported teaching
homeopathy to pharmacy students. In addition, the responses from most of the interviewed faculty were summarized into two themes
which emphasized that pharmacists should be knowledgeable and able to counsel patients effectively to ensure they benefit from
taking homeopathic products.

The authors concluded that over half of US pharmacy schools are teaching students about homeopathy topics. Further, there was support for pharmacists being able to counsel effectively about homeopathic products.

Oh, dear!

The sampling method of “3,300 pharmacy practice faculty members representing all schools accredited in the US” seems nonsensical. It means, if I understand it correctly, that some schools will be represented multiple times, while others are not represented at all. The response rate (~11%) is dismal which means that the data allow no generalisable conclusion whatsoever.

If we forget about these fatal flaws for just a minute and take the findings of the survey seriously, we are perhaps surprised that over half of the schools teach homeopathy. This fact in itself might, however, not necessarily be a bad thing. The students could simply learn that (and why) homeopathy is an obsolete therapy. What makes me shudder is this statement: “pharmacists should be knowledgeable and able to counsel patients effectively to ensure they benefit from taking homeopathic products”.

How can you teach students to counsel patients in such a way that they benefit from an ineffective therapy?, I wonder.

This paper employs a governmentality framework to explore resistance by sceptics to homeopathy’s partial settlement in the public health systems of England and France, resulting in its defunding in both countries in 2018 and 2021, respectively. While partly dependent upon long-standing problematisations – namely, that homeopathy’s ability to heal is unproven, its mechanisms implausible, and its consequences for patients potentially dangerous – the defunding of homeopathy was also driven by the conduct of  sceptics towards so-called alternative medicine (SCAM), who undermined homeopathy’s position in strikingly different ways in both contexts. This difference, we suggest, is a consequence of the diverging regulatory arrangements surrounding homeopathy (and SCAMs more generally) in England and France—and the ambivalent effects of SCAM’s regulation. If law and regulation have been a key component of SCAM’s integration and (partial) acceptance over the past four decades, the fortunes of homeopathy in England and France highlight their unpredictability as techniques of governmentality: just as the formal regulatory systems in England and France have helped to normalise homeopathy in different ways, they have also incited and galvanised opposition, providing specific anchor-points for resistance by SCAM sceptics.

The authors state that they approach the sceptics’ actions as a form of resistance to the normalising power of governmentality—a resistance that is also shaped by the possibilities and spaces offered by legal orderings. From a Foucauldian perspective, resistance is immanent to relations of power: the two presuppose one another. If regimes of governmentality have increasingly let SCAMs ‘in’ as a means of normalising them, then this paper attends to some of the resistances the modes of SCAM’s regulation have incited and shaped, and how resistance to SCAM has taken different forms in different regulatory contexts. At times, resistance has emanated from some SCAM healers themselves, who regard their practice as inimical to the standardisation and bureaucratisation required by formal regulation. In the case of homeopathy, much resistance has come from those outside of the SCAM professions. Such resistance seemingly rejects per se the notion that ‘good’ homeopathy (or SCAMs more generally) can be distinguished from ‘bad’—and, hence, the idea that state institutions should grant any form of legitimacy to such practices. By grounding our analysis in a governmentality perspective, we invite a closer consideration of the means by which homeopathy’s regulation (and its conditional acceptance by formal institutions)—a core component of its normalisation—has incited irritations, aggravations and resistances which have paradoxically helped to challenge its place in the national healthcare systems of England and France.

The authors further explain that SCAM sceptics’ initial resistance to homeopathy began to emerge in a coordinated fashion in the mid 2000s, and can best be described as a cumulative build-up of dispersed sceptic activism and campaigning on the part of a loose coalition of prominent non-state, non-official individuals, often, but not always, from outside the medical profession itself. It included high profile scientists and academics such as Edzard Ernst and David Colquhoun, and sceptic campaigning groups, such as Sense About Science (SAS), which was founded in 2002. In other words, the multifaceted nature of their campaigning and the dispersal of their targets appeared to be a reaction to the diffuse, decentred provision and regulation of homeopathy in England and the involvement of a broad range of actors ‘beyond the state’.

__________________________

I find this version of events interesting (I encourage you to read the full text of the paper) and somewhat amusing, as I hardly recognise it. The way I experienced and recall this story is roughly as follows:

  • In the 1970/80s EBM had become the generally accepted norm and logic  in healthcare. It had begun to generate significant, tangible advantages for the fate of suffering patients.
  • Thus many areas of medicine came under scrutiny and those that were non-compliant with EBM were rightly criticised.
  • From the early 1990s, I and others started to apply the principles of EBM to homeopathy (and other SCAMs).
  • This soon made it obvious that homeopathy was lacking convincing evidence of efficacy.
  • Now, it was merely a question of time that the regulators had to act accordingly.
  • England and France happened to do this first, but, in my view, it is virtually inevitable that other countries will follow – not because of any organised activism but because ethical medicine must always follow the evidence and cannot tolerate quackery.

I disagree with the authors of the above paper; there was no coordinated resistance, cumulative build-up, activism, coalition of individuals, multifacetet campaigning to speak of. The actions that occurred were merely the inevitable consequence of the scientific evidence that emerged from the 1990s onwards. In other words, the principles of EBM were simply taking their course. The defunding is thus not unique to homeopathy but has happened (and will continue to happen) in many other areas of healthcare that do not demonstrably generate more good than harm.

The authors of the above article mention my name repeatedly and seem to imply that I assumed the role of a key activist. Interestingly, they do not cite a single of my papers, presumably because none of them can demonstrate the points they are trying to make. The truth is that, until my retirement from academia in 2012/13, my role was merely that of a researcher. The activism that did happen consisted mostly of diverse and unfunded actions of rationalists who felt that homeopathy was making a mockery of EBM.

Looking back, I am still surprised that these actions were achieved almost entirely by altruistic amateurs. I even feel a little ashamed that the vast majority of doctors seemed to care so little (and were put to shame by the amateurs) about upolding the values of EBM, the best interest of patients and the importance of medical ethics.

 

 

Cancer often causes reduced resilience, quality of life (QoL) and poorer overall well-being. To mitigate these problems, so-called alternative medicine (SCAM) is often advocated for patients with cancer. This study aimed to evaluate the long-term effects of an interdisciplinary integrative oncology group-based program (IO-GP) on the resilience and use of SCAM in patients with cancer.

This was a prospective, observational, single-center study. Resilience (RS-13), SCAM usage (I-CAM-G), QoL (SF-12) and health-related lifestyle factor (nutrition, smoking, alcohol consumption and physical exercise) data were collected for 70 patients who participated in a 10-week IO-GP between January 2019 and June 2022 due to cancer. The IO-GP was offered at the setting of a university hospital and was open to adult patients with cancer. It contained elements from mind-body medicine and positive psychology, as well as recommendations on healthy diet, exercise and SCAM approaches. Patients who completed the IO-GP at least 12months prior (1-4.5years ago) were included in this study. Statistical analysis included descriptive analysis and parametric and nonparametric tests to identify significant differences (P<.05).

Resilience increased significantly ≥12months after participation in the IO-GP (n=44, P=.006, F=8.274) and had a medium effect size (r=.410). The time since the IO-GP was completed (“12-24months,” “24-36months,” and “>36months”) showed no statistically significant interaction with changes in resilience (P=.226, F=1.544). The most frequently used SCAM modalities within the past 12months were vitamins/minerals (85.7%), relaxation techniques (54.3%), herbs and plant medicine (41.1%), yoga (41.4%) and meditation (41.4%). The IO-GP was the most common source informing study participants about relaxation techniques (n=24, 64.9%), meditation (n=21, 72.4%) and taking vitamin D (n=16, 40.0%). Significantly greater levels of resilience were found in those practicing meditation (P=.010, d=−.642) or visualization (P=.003, d=−.805) compared to non-practitioners.

The authors concluded that IO-GPs have the potential to empower patients with cancer to continue using SCAM practices—especially from mind-body medicine—even 1 to 4.5 years after completing the program. Additionally, resilience levels increased. These findings provide notable insight into the long-term effects of integrative oncology interventions on resilience and the use of SCAM, especially in patients with breast cancer.

Really?

Long-term effects of integrative oncology interventions”?

I am sorry, but I see no effects here at all. All I do see are correlations.

For all we know, the outcomes might have even been better if no SCAMs had been offered.

For all we know, the main reason for the observed changes is simply the passage of time.

CORRELATION IS NOT CAUSATION!

There is, of course, little wrong with conductiong studies of this nature – even though they are never really informative, in my view – but there is much wrong when the bias of the authors kicks in and they imply (in the title and throughout the text of their paper) that their interventions were the cause of the observed outcome. This does not provide “notable insight”, it merely misleads some people who are less able to think critically.

WISHFUL THINKING IS NOT SCIENCE!

Sadly, this simple lesson seems to be ever so hard to comprehend by SCAM researchers. One does not need to look far to find hundreds of SCAM studies that are plagued by the same or similar biases. As a result, SCAM research is gradually becoming the laughing stock of real scientists.

This prospective, community-based, active surveillance study aimed to report the incidence of moderate, severe, and serious adverse events (AEs) after chiropractic (n = 100) / physiotherapist (n = 50) visit in offices throughout North America between October-2015 and December-2017.

Three content-validated questionnaires were used to collect AE information: two completed by the patient (pre-treatment [T0] and 2-7 days post-treatment [T2]) and one completed by the provider immediately post-treatment [T1]. Any new or worsened symptom was considered an AE and further classified as mild, moderate, severe or serious.

From the 42 participating providers (31 chiropractors; 11 physiotherapists), 3819 patient visits had complete T0 and T1 assessments. The patients were on average 50±18 years of age and 62.5% females. Neck/back pain was the most common presenting condition (70.0%) with 24.3% of patients reporting no condition/preventative care.

From the patients visits with a complete T2 assessment (n = 2136 patient visits, 55.9%), 21.3% reported an AE, of which:

  • 7.9% were mild,
  • 6.2% moderate,
  • 3.7% severe,
  • 1.5% serious,
  • 2.0% had missing severity rating.

The most common symptoms reported with moderate or higher severity were:

  • discomfort/pain,
  • stiffness,
  • difficulty walking,
  • headache.

 

The authors concluded that this study provides valuable information for patients and providers regarding incidence and severity of AEs following patient visits in multiple community-based professions. These findings can be used to inform patients of what AEs may occur and future research opportunities can focus on mitigating common AEs.

They also note that:

  • The incidence of AEs reported in their study was lower than the 30%-50% reported in a recent scoping review of 250 observational and experimental studies of manual treatments of the spine.
  • A similar prospective clinic-based survey collected data from 4712 encounters from Norwegian chiropractors found that 55% of these encounters had an AE.
  • A clinical trial of chiropractic care for patients with neck pain found that 30% reported an AE.
  • The Scandinavian College of Naprapathic Manual Medicine collected AE information from 767 patients and found that 51% of those who had at least 3 SMT treatments reported an AE.

The authors did not mention our systematic review:

The aim of this systematic review was to summarize the evidence about the risks of spinal manipulation. Articles were located through searching three electronic databases (MEDLINE, EMBASE, Cochrane Library), contacting experts (n =9), scanning reference lists of relevant articles, and searching departmental files. Reports in any language containing data relating to risks associated with spinal manipulation were included, irrespective of the profession of the therapist. Where available, systematic reviews were used as the basis of this article. All papers were evaluated independently by the authors. Data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.

Whatever the true rate of AEs turns out to be, one thing is very clear: it is unacceptably high, particularly if we consider that the benefits of spinal manipulations are doubtful and at best small.

Irregular menstrual cycle is a common complaint. Recent research suggested that homeopathy is one of the most popular choices for women with various gynecological disorders. This randomised, double-blind, placebo-controlled trial was aimed at differentiating individualized homeopathic medicinal products (IHMPs) from identical-looking placebos in the treatment of menstrual irregularities in early reproductive women.

Group verum (n = 46) received IHMPs plus concomitant care. The control group (n = 46) received placebos plus concomitant care. The proportion patients in whom menstrual irregularities were corrected for consecutive three cycles was the primary outcome measure. The secondary outcome measure was the Menstrual Distress Questionnaire (MDQ) total score. Both endpoints were measured at baseline and then monthly for up to 4 months.

The intention-to-treat sample (n = 92) was analyzed. Group differences were examined by chi-squared tests with categorical outcomes, two-way repeated measure analysis of variance accounting for the time–effect interactions, and unpaired t-tests comparing the mean estimates obtained individually every month. The level of significance was set at p < 0.05 two-tailed.

The results show that:
  • After 4 months of intervention, the group difference in the primary outcome was nonsignificant—IHMPs: 22/46 v/s placebo: 24/46, chi-square (Yates corrected) = 0.043, p = 0.835.
  • The improvement observed in the MDQ total score (F1,90 = 0.054, p = 0.816) and subscales scores were also not significant in most of the occasions, except for the behavioral change subscale (F1,90 = 0.029, p < 0.001).
  • Pulsatilla nigricans was the most frequently prescribed medicine.
  • Kent’s Repertory and Zandvoort’s Complete Repertory were the most frequently used repertories.
  • No harm or serious adverse events were reported from either group.

The authors concluded that the analysis failed to demonstrate clearly that IHMPs were effective beyond placebos in all but one of the outcomes. More appropriate outcome measures may be sought for future trials.

I have just four short comments:

  1. I’d like to congratulate the authors for their courage in reporting a squarely negative result.
  2. I should nevertheless correct their conclusion regarding the statement “in all but one of the outcomes”; according to their own admission, the subscale of the MDQ was not even a secondary outcome measure.
  3. The sentence “More appropriate outcome measures may be sought for future trials”  seems to imply that the negative result was due to having chosen the wrong endpoints for this study. This would be mistaken: the negative result was due to the ineffectiveness of homeopathy.
  4. And because of the ineffectiveness of homeopathy, the entire concept of the study was a mistake and arguably not even ethical. To put it bluntly, this trial should have never been conducted in the first place.
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