Updated Edition!
The objective of the present double-blind, randomized, placebo-controlled, feasibility trial was to identify the effects of individualized homeopathic medicinal products (IHMPs) against placebos in post-COVID-19 conditions. Sixty participants with post-COVID-19 conditions were randomised into either:
- group verum (n = 30; IHMPs plus concomitant care),
- group control (n = 30; placebos plus concomitant care).
Feasibility issues; primary—post-COVID-19 symptoms checklist; secondary—Measure Yourself Medical Outcomes Profile version 2 (MYMOP-2); all of them were measured at baseline, and monthly intervals, up to 3 months. The intention-to-treat sample was analyzed; group differences were reported using descriptive statistics: means, 95% confidence intervals (CIs), and between group effect sizes (Cohen’s d).
Feasibility concerns showed promise; recruitment, retention, and attrition rates were 34.2%, 95%, and 5%, respectively. Group differences in both primary and secondary outcomes favored IHMPs against placebos: symptoms checklist score mean difference after 3 months: −4.2, 95% CI −4.9 to −3.4, d = 2.854 and MYMOP-2 mean difference after 3 months: −2.2, 95% CI −2.8 to −1.7, d = 2.082, respectively. Natrum muriaticum (11.7%), Pulsatilla nigricans (10%), Rhus toxicodendron (8.3%), and Calcarea carbonica (8.3%) were the most frequently prescribed remedies.
The authors concluded that IHMPs produced better results than placebos in reducing symptoms checklist scores and MYMOP-2 scores in the treatment of post-COVID-19 conditions. Definitive trials are warranted to confirm the findings.
A feasibility study (the authors employ this term repeatedly) has – as I have often pointed out – the purpose of testing whether a trial disign, set-up, etc. is FEASIBLE. It is not meant to report other outcome data.
Why?
Mainly because such studies are far too underpowered for generating reliable results!
This means that the present findings can be ignored. They are most likely caused by chance.
Why are they published anyway, and why could the authors find a journal that goes along with such nonsense?
Are they too stupid or are they biased or both?
The nature of the journal might provide a hint for answering these questions (J Integr Complement Med), and so does the list of authors and their affiliations:
- 1Department of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
- 2Department of Pathology and Microbiology, D. N. De Homoeopathic Medical College & Hospital, Govt. of West Bengal, Kolkata, India.
- 3Department of Practice of Medicine, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
- 4Department of Homeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, Department of Health & Family Welfare, Govt. of West, Kolkata, India.
- 5Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
- 6Department of Community Medicine, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, India.
I rest my case.
Although acupuncture is widely used by patients with chronic sciatica, the evidence of its efficacy is scarce. The objective of this multicenter 2-arm randomized clinical trial, conducted in 6 tertiary-level hospitals in China, was to investigate the efficacy and safety of acupuncture compared with sham acupuncture in patients with chronic sciatica from herniated disk. Participants were recruited from March 25, 2021, to September 23, 2021, with a final follow-up through September 22, 2022. Data analyses were performed from December 2022 to March 2023.
Participants were randomly assigned to receive:
- 10 sessions of acupuncture (n = 110) or
- 10 sessions of sham acupuncture (n = 110) over 4 weeks.
Participants, outcome assessors, and statisticians were blinded.
The 2 primary outcomes were changes in visual analog scale (VAS) for leg pain and Oswestry Disability Index (ODI) from baseline to week 4. Secondary outcomes were adverse events.
A total of 216 patients (mean [SD] age, 51.3 [15.2] years; 147 females [68.1%] and 69 males [31.9%]) were included in the analyses. The VAS for leg pain decreased:
- 30.8 mm in the acupuncture group,
- 14.9 mm in the sham acupuncture group at week 4 (mean difference,
−16.0; 95% CI, −21.3 to −10.6; P < .001).
The ODI decreased:
- 13.0 points in the acupuncture group,
- 4.9 points in the sham acupuncture group at week 4 (mean difference, −8.1; 95%
CI, −11.1 to −5.1; P < .001).
For both VAS and ODI, the between-group difference became apparent starting in week 2 (mean difference, −7.8; 95% CI, −13.0 to −2.5; P = .004 and −5.3; 95% CI, −8.4 to −2.3; P = .001, respectively) and persisted through week 52 (mean difference, −10.8; [95% CI, −16.3 to −5.2; P < .001; and −4.8; 95% CI, −7.8 to −1.7; P = .003, respectively). No serious adverse events occurred.
The authors concluded that this randomized clinical trial found that in patients with chronic sciatica from herniated disk, acupuncture resulted in less pain and better function compared with sham acupuncture at week 4, and these benefits persisted through week 52.
Acupuncture should be considered as a potential treatment option for patients with chronic sciatica from a herniated disk.
At first glance, this certainly looks like a rigorous and well-reported study. Yet, at a second glance, multiple concerns emerge about its reliability. Here are some of my reasons:
- The study was started 3 years ago and concluded in 2022; I am wondering why it took 2 years to get it published.
- A clinical trial with ~200 patients cannot reasonably assume to “investigate the safety” of a therapy.
- I am amazed that the trialists found >200 patients with severe chronic sciatica who did not take any medication (In my experience, 100% of these patients take something against their pain). Those who did were told to stop them and renter the trial after a washout phase; I am wondering whether this would pass an ethics committee in a Western country.
- The authors state that all verum patients experienced de qi. It is not my experience that 100% of patients excerience this sensation during acupuncture.
- The therapists were told to follow a standardised protocol. Yet I doubt that they were not able to influece patients by their verbal or non-verbal communication – after all, they had a poweful vested interest to generate a positive result.
- The authors state that blinding the therapist is not possible in trials of acupuncture. I disagree.
- The authors report that they tested the degree to which patients were unblinded and state “patients were unaware of assigned treatments”. I find this utterly implausible. There are several reasons for my disbelief: 1) sham patients did not experience de qi, according to the authors., while the verum patients are said to have experienced this sensation with each of the 5 needles inserted at each of the 10 session. 2) While in the verum group the needles were manipulated and left in place for 30 minutes, this did not happen in the sham group. I cannot believe that these differences did not prompt a large degree of de-blinding.
We have often reported that acupuncture trials from China invariably report positive results. We have also repeatedly mentioned that >80% of Chinese clinical trials are said to be fabricated. If I consider all of this and look at the results of this study critically, I have to say that I find them far too good to be true.
An article entitled “The use of ayurvedic medicine in the management of hypertension” was recently published in the ‘Journal of Ayurveda and Naturopathy’ (no, I did not know either that this journal existed). Here I show you merely its conclusion, but encourage you to read the entire paper.
Hypertension, a significant risk factor for cardiovascular diseases, necessitates effective and sustainable management strategies. Ayurveda, with its holistic approach, offers a comprehensive framework for managing hypertension by addressing the underlying dosha imbalances through dietary and lifestyle modifications, herbal formulations, and therapeutic procedures. This review has highlighted the
efficacy of various Ayurvedic interventions, including the use of specific herbs like Ashwagandha, Arjuna, Brahmi, Gokshura, and Sarpagandha, which have demonstrated significant benefits in reducing blood pressure and improving overall health. Panchakarma therapies such as Virechana, Basti, Nasya, and Shirodhara have also been shown to detoxify the body, restore balance, and promote
long-term well-being.
Integrating Ayurvedic practices with modern medical approaches can enhance treatment outcomes, offering a more personalized and holistic approach to hypertension management. This synergy can potentially reduce the reliance on pharmaceuticals, minimize side effects, and improve patient compliance and quality of life. Future research should focus on rigorous clinical trials and the standardization of Ayurvedic formulations to further validate their efficacy and facilitate their integration into mainstream healthcare.
By embracing the principles of Ayurveda, individuals can achieve better control over hypertension, reduce the risk of associated complications, and enhance their overall health and well-being. This comprehensive approach not only addresses the symptoms but also tackles the root causes, promoting a sustainable and balanced lifestyle.
END OF QUOTE
Not only does the author, Dr. Zafar Siddiqa (from the Faculty of Natural Medicine and Holistic Sciences, Rajshahi Holistic Health College, Rajshahi, Bangladesh) re-write the current knowledge of hypertonology, he also provides no evidence for any of the far-reaching statements he makes in this paper. In particular, he cites no rigorous studies that “highlighted the efficacy of various Ayurvedic interventions” (most likely because such studies do not exist).
The autor is correct in the 1st sentence of his conclusion: “Hypertension, a significant risk factor for cardiovascular diseases, necessitates effective and sustainable management strategies”. But he is wrong in almost everything else! Because hypertension is such an important risk factor for stroke and ischaemic heart disease, we MUST treat it effectively.
Today, we fortunately have many conventional treatments that control hypertension well and with no or just minimal adverse effects. Advocating quackary or unproven therapies for managing hypertension is thus deeply unethical. It could contribute to the premature deaths of millions. I thus fear that the ‘Faculty of Natural Medicine and Holistic Sciences, Rajshahi Holistic Health College’ is in urgent need of taking a few courses in proper science and medical ethics.
- mind-body medicine (32.0%),
- massage (16.1%),
- chiropractic (14.4%),
- acupuncture (3.4%),
- naturopathy (2.2%),
- art and/or music therapy (2.1%).
Reporting post-COVID-19 was associated with an increased likelihood of using any SCAM in the last 12 months (AOR = 1.18, 95% CI [1.03, 1.34], p = 0.014) and specifically to visit an art and/or music therapist (AOR = 2.56, 95% CI [1.58, 4.41], p < 0.001). The overall use of any SCAM was more likely among post-COVID-19 respondents under 65 years old, females, those with an ethnical background other than Hispanic, African-American, Asian or Non-Hispanic Whites, having a higher educational level, living in large metropolitan areas and having a private health insurance.
If I remember correctly, I was – some 20 years ago – a founding member of the editorial board of the journal Evidence-Based Complementary and Alternative Medicine (EBCAM). I also published several papers there, but eventually I became concerned about what seemed to be going on at the journal (it seemed a money-making scam to me) and withdrew my cooperation. Since then, I have repeatedly posted on this blog about this strange journal, e.g.:
- EBCAM: an alt med journal that puzzles me a great deal
- Some alternative medicine journals should be de-listed
- Fraud and greed can cause enormous harm
Yesterday,I came across this announcement by John Wiley & Sons, now the publisher of EBCAM:
Evidence-Based Complementary and Alternative Medicine ceased publishing as of September 2024.
Trying to find out more about this surprising action, I found this little note:
John Wiley & Sons, a global publication house with revenues north of $2 billion, announced on May 19, 2024, that it was closing 19 journals it acquired as part of its 2021 purchase of Egypt-based Hindawi publishing company, citing large-scale research fraud.
Next, I went on to Medline and saw that EBCAM had to retract 1 497 (!) of its papers.
That amount of retractions must be a world record!
I thus understand that the journal was no longer tenable. But what exactly did happen? What brought about the decision to cease publication?
I have no idea (various searches for answers were unsuccessful) and would be most grateful, if someone in the know could fill me in.
- complement conventional and supportive care,
- be complemented with other supportive therapies,
- substitute for supportive drugs,
- replace other supportive therapies,
- not be suitable to replace all supportive therapies,
- be the only supportive option available in some situations.
While the evidence base on web-based cancer misinformation continues to develop, relatively little is known about the extent of such information on the world’s largest e-commerce website, Amazon. Multiple media reports indicate that Amazon may host on its platform questionable cancer-related products for sale, such as books on purported cancer cures. This context suggests an urgent need to evaluate Amazon.com for cancer misinformation.
This study sought to
- (1) examine to what extent are misleading cancer cure books for sale on Amazon.com’
- (2) determine how cancer cure books on Amazon.com provide misleading cancer information.
The investigators searched “cancer cure” on Amazon.com and retrieved the top 1000 English-language book search results. They reviewed the books’ descriptions and titles to determine whether the books provided misleading cancer cure or treatment information. They considered a book to be misleading if it suggested scientifically unsupported cancer treatment approaches to cure or meaningfully treat cancer. Among books coded as misleading, they conducted an inductive latent thematic analysis to determine the informational value the books sought to offer.
Nearly half (494/1000, 49.4%) of the sampled “cancer cure” books for sale on Amazon.com appeared to contain misleading cancer treatment and cure information. Overall, 17 (51.5%) out of 33 Amazon.com results pages had 50% or more of the books coded as misleading. The first search result page had the highest percentage of misleading books (23/33, 69.7%). Misleading books (n=494) contained eight themes:
- (1) claims of efficacious cancer cure strategies (n=451, 91.3%),
- (2) oversimplifying cancer and cancer treatment (n=194, 39.3%),
- (3) falsely justifying ineffective treatments as science based (n=189, 38.3%),
- (4) discrediting conventional cancer treatments (n=169, 34.2%),
- (5) finding the true cause of cancer (n=133, 26.9%),
- (6) homogenizing cancer (n=132, 26.7%),
- (7) discovery of new cancer treatments (n=119, 24.1%),
- (8) cancer cure suppression (n=82, 16.6%).
The authors concluded that the results demonstrate that misleading cancer cure books are for sale, visible, and prevalent on Amazon.com, with prominence in initial search hits. These misleading books for sale on Amazon can be conceived of as forming part of a wider, cross-platform, web-based information environment in which misleading cancer cures are often given prominence. Our results suggest that greater enforcement is needed from Amazon and that cancer-focused organizations should engage in preemptive misinformation debunking.
This is an excellent paper that is long overdue. The plethora of dangerous books on so-called alternative medicine (SCAM) targeted at lay people is nothing short of a scandal. It was high time that we expose it, because it kills vulnerable patients. It is difficult, if not impossible, to quantify the damage done by such books but I am sure it runs in the thousands.
I have been aware of this scandal for a long time, in fact, it was the main motivation for publishing my own book on the subject. Obviously, it is not much more than a drop in the ocean.
Tragically, this scandal is not confined to just cancer. It relates to all potentially serious conditions. What could be more despicable and unethical than earning money through making desperately ill patients suffer? As the authors point out, Amazon urgently needs to address this problem. Failing this, Amazon should be legally held responsible, in my view.
Approximately 30% of children diagnosed with attention-deficit/hyperactivity disorder (ADHD), the most prevalent mental health disorder in children worldwide, do not respond to conventional pharmaceutical treatments. Previous studies of homeopathic treatment for ADHD have been inconclusive. The objectives of this randomized double-blind placebo-controlled clinical trial were to determine if there
- (a) is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD;
- (b) are any specific effects the homeopathic consultation alone in the treatment of ADHD;
- (c) are any specific effects of homeopathic medicines in the treatment of ADHD.
Children aged 6-16 years diagnosed with ADHD were randomized to one of three arms:
- Arm 1 (Remedy and Consultation);
- Arm 2 (Placebo and Consultation);
- Arm 3 (Usual Care).
The primary outcome was the change of CGI-P T score between baseline and 28 weeks.
There was an improvement in ADHD symptoms as measured by the Conner 3 Global Index-Parent T-score in the two groups (Arms 1 and 2) that received consultations with a homeopathic practitioner when compared with the usual care control group (Arm 3). Parents of the children in the study who received homeopathic consultations (Arms 1 and 2) also reported greater coping efficacy compared with those receiving usual care (Arm 3). There was no difference in adverse events among the three study arms.
The authors concluded that, in this study, homeopathic consultations provided over 8 months with the use of homeopathic remedy was associated with a decrease in ADHD symptoms in children aging 6-16 years when compared with usual treatment alone. Children treated with homeopathic consultations and placebo experienced a similar decrease in ADHD symptoms; however, this finding did not reach statistical significance when correcting for multiple comparisons. Homeopathic remedies in and of themselves were not associated with any change in ADHD symptoms.
This is an interesting study. It – yet again! – confirms that the effects observed after homeopathic treatments are not due to the remedie but are caused by the interaction with the homeopath. To put it more clearly:
HOMEOPATHIC REMEDIES HAVE NO SPECIFIC EFFECTS; ANY BENEFITS ARE DUE TO THE EFFECTS OF THE THERAPEUTIC ENCOUNTER AND OTHER NON-SPECIFIC EFFECTS.
Nearly every time that I talk to proponents of so-called alternative medicine (SCAM) I hear a lot about diet. Diet is a central theme to almost all of them, it seems. In such conversations, several issues often emerge and frequently take the form of accusations, e.g.:
- Conventional medicine neglects the importance of diet for our health.
- Medical students learn next to nothing about the subject.
- In conventional medicine, hardly any research is focussed on diet.
- By contrast, practitioners of SCAM know a lot about diet.
- Many are experts in the subject.
- Patients are well-advised to consult SCAM practitioners if they want to learn how to eat healthily.
- SCAM practitioners have developed a wide range of diets that keep their patients fit and healthy.
I usually try to object to some of these points. The truth is that medical students do learn about diet, that doctors are aware of its importance, and that research into diets is highly active.
Particularly about the last point, I can get rather irritated. Sadly, this impresses the SCAM fans very little. They have their opinion and rarely budge.
After one such conversation, I decided to go on Medline and produce some figures. Here they are:
- As of 6 October, there are 1 453 clinical trials listed on Medline as published in 2024.*
- Between 1957 and today, around 57 000 such trials have been published.
- Their number shows an almost exponential growth during this period.
- The diets tested range widely and include, for instance, the Mediteranean diet, the ketogenic diet, intermittent fasting, vegetarian diet, energy restricted diet, gluten-free diet.
- There are as good as no trials on any of the SCAM diets.
- The researchers doing the diet trials are almost exclusively conventional medics or nutritionist.
- I did not find any SCAM practitioners in the list of authors.
So, the next time a SCAM proponent bullshits you about diet, you can tell him or her to get lost!
*Not all are, in fact, clinical trials
RAND claims to be “a research organization that develops solutions to public policy challenges to help make communities throughout the world safer and more secure, healthier and more prosperous. RAND is nonprofit, nonpartisan, and committed to the public interest.” Recently, RAND has published an extensive report entitled ‘THE STATE OF HOMEOPATHIC RESEARCH“. Here I show you a few interesting passages from this document [the number in square brackets refer to short comments of mine that I appended at the end]:
In this report on the state of homeopathic research, we encapsulate the outcomes of our comprehensive review and the deliberations of our expert panel. These findings and recommendations can guide the homeopathic research community, governmental agencies, and philanthropic organizations in how to best allocate research effort and fund quality and pertinent clinical research endeavors in the field of homeopathy [1].
This research was funded by the Samueli Foundation [2] and carried out by the RAND Research Across Complementary and Integrative Health Institutions (REACH) Center within the Quality Measurement and Improvement Program in RAND Health Care. The RAND REACH Center is a collaboration of researchers across institutions that educate complementary and integrative health practitioners in the United States (www.rand.org/reachcenter); several of these researchers and their students participated in this project…
We examined the state of homeopathic research by critically [3] assessing the overall quality of homeopathic clinical research literature and convening an expert panel to identify gaps in research quality [4] and in areas studied. Our assessment of research quality used a sample of studies from the most comprehensive database of published research on homeopathic research…
There were many areas in which the quality of the studies could be improved. About two-thirds of the 85 controlled trials had either high (42 percent) or unclear (24 percent) risk of bias according to internationally recognized standards for internal validity. Trials with a placebo arm were less likely than those with other comparators to have high risk of bias (29 percent versus 73 percent), primarily because of the ease of blinding patients and outcome assessors. Of the 14 observational (cohort) studies included in our sample, more than one-third did not control for important confounders in the outcome analyses. Regarding external validity, adherence was reported in less than one-third of the studies. Homeopathic consultations took place in 44 studies (the others were studies of routine homeopathy in which all patients received the same remedy [5]); almost half did not describe the experience and training of the practitioners. Forty percent of all studies did not report on safety; 79 percent of observational studies did not. Regarding model validity, which is essential for replicability and interpretability, fewer than two-thirds of the reviewed studies were consistent with homeopathic principles…
Recommendations
Drawing from the outcomes of our homeopathic clinical research literature review and the deliberations of our expert panel, we and the panelists developed the following six recommendations:
1. Funders, researchers, and journal editors and reviewers should require authors to follow the Consolidated Standards of Reporting Trials (CONSORT) and guidelines specific to reporting homeopathic studies, such as the Reporting Data on Homeopathic Treatments (RedHot) criteria for trials, and develop guidelines, as needed. In addition, training institutions should include training on the early use and reference to these guidelines in homeopathic research curricula.
2. All homeopathic studies should proactively monitor and report on adverse events as recommended in CONSORT and several other guidelines for the study of homeopathy [6].
3. Organizations with credibility and acceptability within the homeopathic research community [7] should identify methodological exemplar studies and make them known to researchers, so that these studies can be used to guide future research.
4. Training and support for homeopathic researchers should be increased, and where possible, research teams examining homeopathy should include experienced medical researchers who have an excellent track record for high-quality research. [7]
5. Funders and researchers should consider studies determining the validity of the Critical Appraisal Tool for Homeopathic Intervention Studies (CATHIS) tool as a quality measure for studies of homeopathy.
6. An organization with credibility and acceptability within the homeopathic research community [7] should assemble representative panels of stakeholders to obtain agreement about a small number of areas of focus for future research, with each area reflecting a specific population, treatment or prevention of a condition, and type of homeopathy in a particular country. These stakeholder panels could also address such research quality issues as determining the level of quality sufficient for making clinical decisions and setting policy guidelines, weighting the relative importance of different aspects of external and model validity, and establishing how to describe homeopathic practice [8]…
Conclusion
The goal of this project was to develop recommendations for the future of homeopathic research to ensure higher-quality evidence on the most relevant uses of homeopathy [9]. We accomplished this goal through a review of recent homeopathic clinical research literature, input from an expert panel, and a synthesis of results from both. We found that the state of homeopathic research could be greatly improved in terms of internal, external, and model validity. Strict adherence to reporting guidelines, with attention to quality criteria during study design, would likely result in most of the needed improvement. However, there is also a need for the homeopathic community to decide where to focus future research in terms of conditions, populations, and types of homeopathy studied. These focus areas could take many forms and should align with the community’s research goals. An appropriate focus (or set of focuses) should also balance answering questions to improve homeopathic treatment with the requirements for coverage by payers and desired inclusion in the broader health care system. [10]
We are grateful for the important feedback from members of our expert panel:
- Iris Bell, M.D., Ph.D., University of Arizona College of Medicine (Retired) and Sonoran University of Health
Sciences; - Dan Cherkin, Ph.D., Osher Center for Integrative Health, Department of Family Medicine, University of Washington;
- Roger Chou, M.D., Department of Medical Informatics & Clinical Epidemiology and Department of Medicine, Oregon Health & Science University;
- Katharina Gaertner, MBBS, Research Faculty of Health, University Witten/Herdecke;
- Klaus Linde, M.D., Ph.D., Scientific Coordinator, Technische Universität München, Institute of General Practice and Health Services Research;
- Alexander Tournier, Ph.D., Homeopathy Research Institute and Institute of Complementary and Integrative Medicine, University of Bern;
- Esther van der Werf, M.Sc., Ph.D., Clinical Research Lead, Homeopathy Research Institute, and Honorary Senior Lecturer, Primary
Care Infection, Bristol Medical School, University of Bristol; - Harald Walach, Ph.D., CHS Institute. [11]
The project’s steering committee: Wayne B. Jonas, M.D., President, Healing Works Foundation [11]; and Jennifer Jacobs, M.D., M.P.H., Clinical Assistant Professor, Epidemiology, University of Washington School of Public Health [11].
_______________________________
- The fundamentally important question whether more research of homeopathy is required was studiously ignored.
- Not exactly an organisation that is known to be impartial.
- After reading the entire document, I found very little critical input.
- I am not sure what “gaps in research quality” are; do they mean deficits?
- I think that’s normally called ‘clinical homeopathy’.
- Failure to do so is not merely a little lapse but a violation of research ethics!
- They do not exist.
- This is not realistic.
- There is a wide consensus that “relevant uses of homeopathy” do not exist.
- The crucial question was avoided, whether it is ethical to waste money and effort on researching something that, by a general consensus, is nonsense.
- Member of our ALTERNATIVE MEDICINE HALL OF FAME!
My final comment: imagine the ‘Flat Earth Society’ convenes an expert panel to decide about the shape of our planet …
