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!
Alan Gaby, the assistant editor of the journal Integr Med has written an interesting commentary about widespread fraud in natural health products research. Here is an excerpt of his article:
During the past 49 years, I have reviewed and analyzed more than 50 000 papers from the biomedical literature, most of which were related to the field of nutritional medicine. Doing this work has given me some understanding of how to assess the reliability of a study. Over the past 10 to 15 years, an uncomfortably large and growing number of published papers related to my area of expertise have left me wondering whether the research was fabricated; that is, whether people were writing papers about research that had not actually been conducted. If the studies were not actually conducted, the publishing of this research is an affront to all who value integrity in science, and it has the potential to harm practitioners and patients who rely on its findings.
The studies that have raised concerns have come primarily from Iran and to a lesser extent from Egypt, China, India, Japan, and a few other countries. Characteristics of these concerning studies typically include one or more of the following:
- The study comes from an investigator or research group that has published an enormous number of randomized clinical trials in a relatively short period of time.
- The number of participants in the trial is unusually large, when considering the resources that appear to be available to the researchers.
- The recruitment period for the trial is unusually short.
- The paper is submitted to a journal unusually rapidly after the study is completed, or in some cases before it would have been possible to have completed the trial.
- A randomized double-blind trial is conducted before there is any preliminary evidence of efficacy in humans (such as case reports or uncontrolled trials). Because double-blind trials are expensive to conduct, such trials are generally reserved for treatments for which there is some evidence of efficacy.
- The magnitude of the reported improvement is much larger than is typically seen in trials using just one or two nutrients.
- No funding source is listed or the study is listed as self-funded. This is of particular concern when the sample size or study design suggests that the study was expensive.
- The design of the study raises ethical issues, such as participants not being permitted to use treatments that are known to be effective.
- One or more baseline characteristics of the study group appear to be implausible.
- The research was conducted by a student as part of a graduate school thesis, and the magnitude of the project seems to have been beyond the capabilities and resources of a student.
What Gaby alludes to is a problem indeed. I have previously posted about the Chinese aspect of this story. What Gaby does not mention is the fact that even many studies of so-called alternative medicine (SCAM) which seem to be not overtly fraudulent are nevertheless highly suspect. I am referring to trials that are fatally flawed and/or studies that draw unwarranted conclusions. These are, of course, the types of studies that are the main target of this blog. Because they are so numerous, I feel that the damage they do is much bigger than that of the more overtly fraudulent papers.
Today, a 3-day conference is starting on ‘INTEGRATIVE MEDICINE’ (IM) in London. Dr. Michael Dixon, claims that it is going to be the biggest such conference ever and said that it ‘will make history’. Dixon is an advisor to Prince Charles, chair of the College of Medicine and Integrated Health (CoMIH, of which Charles is a patron), and joint-chair of the congress. The other co-chair is Elizabeth Thompson. Both have been the subject of several previous posts on this blog.
Dixon advertised the conference by commenting: “I am seeing amongst by younger colleagues, the newly trained GPs, that they have a new attitude towards healthcare. They are not interested in whether something is viewed as conventional, complementary, functional or lifestyle, they are just looking at what works for their patients. Through this conference, we aim to capture that sense of hope, open-mindedness, and patient-centred care”. I believe that this ‘history-making’ event is a good occasion to yet again review the concept of IM.
The term IM sounds appealing, yet it is also confusing and misleading. The confusion starts with the fact that our American friends call it integrative medicine, while we in the UK normally call it integrated medicine, and it ends with different people understanding different things by IM. In conventional healthcare, for instance, people use the term to mean the integration of social and medical care. In the bizarre world of alternative medicine, IM is currently used to signify the parallel use of alternative and conventional therapies on an equal footing.
Today, there are many different definitions of the latter version of IM. Prince Charles, one of the world’s most ardent supporter of IM, used to simply call it ‘the best of both worlds’. A recent, more detailed definition is a ‘healing-oriented medicine that takes account of the whole person, including all aspects of lifestyle. It emphasizes the therapeutic relationship between practitioner and patient, is informed by evidence, and makes use of all appropriate therapies’. This seems to imply that conventional medicine is not healing-orientated, does not account for the whole person, excludes aspects of lifestyle, neglects the therapeutic relationship, is not informed by evidence, and does not employ all appropriate therapies. This, I would argue is a bonanza of strawman fallacies, i.e. the misrepresentation of an opponent’s qualities with a view of defeating him more easily and making one’s own position look superior. Perhaps this is unsurprising – after all, Dixon has been once named ‘a pyromaniac in a field of (integrative) strawmen’.
Perhaps definitions are too theoretical and it is more productive to look at what IM stands for in real life. If you surf the Internet, you can find thousands of clinics that carry the name IM. It will take you just minutes to discover that there is not a single alternative therapy, however ridiculous, that they don’t offer. What is more, there is evidence to show that doctors who are into IM are also often against public health measures such as vaccinations.
The UK ‘Integrated Medicine Alliance’, a grouping within the CoMIH, offers information sheets on all of the following treatments: Acupuncture, Alexander Technique, Aromatherapy, Herbal Medicine, Homeopathy, Hypnotherapy, Massage, ,Naturopathy, Reflexology, Reiki, Tai Chi, Yoga Therapy. The one on homeopathy, for example, tells us that “homeopathy … can be used for almost any condition either alone or in a complementary manner.” Compare this to what the NHS says about it: “homeopathic remedies perform no better than placebos (dummy treatments)”.
This evidently grates with the politically correct definition above: IM is not well-informed about the evidence, and it does use inappropriate treatments. In fact, it is little more than a clumsy attempt to smuggle unproven and disproven alternative therapies into the mainstream of healthcare. It does render medicine not better but will inevitably make it worse, and this is surely not in the best interest of vulnerable patients who, I would argue, have a right to be treated with the most effective therapies currently available.
The conference can perhaps be characterized best by having a look at its sponsors. ‘Gold sponsor’ is WELEDA, and amongst the many further funders of the meeting are several other manufacturers of mistletoe medications for cancer. I just hope that the speakers at this meeting – Dixon has managed to persuade several reputable UK contributors – do not feel too embarrassed when they pass their exhibitions.
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. 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”. 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.’.
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.’.
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”.  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. 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. 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. 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. 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.
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.
During their cancer treatment path, cancer patients use numerous drugs,e.g.:
- anticancer medications,
- supportive drugs,
- other prescribed medications,
- herbal remedies,
- other OTC products.
This puts them at risk of significant drug interactions (DIs).
This study describes potential DIs in cancer patients and their prevalence and predictors.
A cross-sectional study was carried out in two centers in the northern West Bank, Palestine. The Lexicomp® Drug Interactions tool (Lexi-Comp, Hudson OH, USA) was applied to check the potential DIs. In addition, the Statistical Package for the Social Sciences (SPSS) was used to show the results and find the associations.
The final analysis included 327 patients. Most of the participants were older than 50 years (61.2%), female (68.5%), and had a solid tumor (74.6%). The total number of potential DIs was 1753, including 1510 drug-drug interactions (DDIs), 24 drug-herb interactions, and 219 drug-food interactions. Importantly, the prevalence of DDIs was 88.1%. In multivariate analysis, the number of potential DDIs significantly decreased with the duration of treatment (p = 0.007), while it increased with the number of comorbidities (p < 0.001) and the number of drugs used (p < 0.001).
The authors concluded that they found a high prevalence of DIs among cancer patients. This required health care providers to develop a comprehensive protocol to monitor and evaluate DIs by improving doctor-pharmacist communication and supporting the role of clinical pharmacists.
What the investigators did not study was the possibility of herb-herb and herb-non-herbal supplement interactions. The reason for this is probably simple: we know too little about these areas to make reasonable judgments. But even in the absence of such considerations, the prevalence of DDIs among cancer patients was high (88.1%). This means that the vast majority of cancer patients had at least one potential DDI. Over half of them were classified as moderately severe or worse.
The lessons seem to be to:
- use only truly necessary drugs and omit all remedies that are of doubtful value,
- educate the public about the risks of interactions,
- be skeptical about the messages of integrative medicine,
- consult a healthcare professional who is competent to make such judgments,
- conduct more rigorous research to increase our knowledge in this complex area.
This study used a US nationally representative 11-year sample of office-based visits to physicians from the National Ambulatory Medical Care Survey (NAMCS), to examine a comprehensive list of factors believed to be associated with visits where complementary health approaches were recommended or provided.
NAMCS is a national health care survey designed to collect data on the provision and use of ambulatory medical care services provided by office-based physicians in the United States. Patient medical records were abstracted from a random sample of office-based physician visits. The investigators examined several visit characteristics, including patient demographics, physician specialty, documented health conditions, and reasons for a health visit. They ran chi-square analyses to test bivariate associations between visit factors and whether complementary health approaches were recommended or provided to guide the development of logistic regression models.
Of the 550,114 office visits abstracted, 4.43% contained a report that complementary health approaches were ordered, supplied, administered, or continued. Among complementary health visits, 87% of patient charts mentioned nonvitamin nonmineral dietary supplements. The prevalence of complementary health visits significantly increased from 2% in 2005 to almost 8% in 2015. Returning patient status, survey year, physician specialty and degree, menopause, cardiovascular, and musculoskeletal diagnoses were significantly associated with complementary health visits, as was seeking preventative care or care for a chronic problem.
The authors concluded that these data confirm the growing popularity of complementary health approaches in the United States, provide a baseline for further studies, and inform subsequent investigations of integrative health care.
The authors used the same dataset for a 2nd paper which examined the reasons why office-based physicians do or do not recommend four selected complementary health approaches to their patients in the context of the Andersen Behavioral Model. Descriptive estimates were employed of physician-level data from the 2012 National Ambulatory Medical Care Survey (NAMCS) Physician Induction Interview, a nationally representative survey of office-based physicians (N = 5622, weighted response rate = 59.7%). The endpoints were the reasons for the recommendation or lack thereof to patients for:
- other non-vitamin supplements,
- chiropractic/osteopathic manipulation,
- mind-body therapies (including meditation, guided imagery, and progressive relaxation).
Differences by physician sex and medical specialty were described.
For each of the four complementary health approaches, more than half of the physicians who made recommendations indicated that they were influenced by scientific evidence in peer-reviewed journals (ranging from 52.0% for chiropractic/osteopathic manipulation [95% confidence interval, CI = 47.6-56.3] to 71.3% for herbs and other non-vitamin supplements [95% CI = 66.9-75.4]). More than 60% of all physicians recommended each of the four complementary health approaches because of patient requests. A higher percentage of female physicians reported evidence in peer-reviewed journals as a rationale for recommending herbs and non-vitamin supplements or chiropractic/osteopathic manipulation when compared with male physicians (herbs and non-vitamin supplements: 78.8% [95% CI = 72.4-84.3] vs. 66.6% [95% CI = 60.8-72.2]; chiropractic/osteopathic manipulation: 62.3% [95% CI = 54.7-69.4] vs. 47.5% [95% CI = 42.3-52.7]).
For each of the four complementary health approaches, a lack of perceived benefit was the most frequently reported reason by both sexes for not recommending. Lack of information sources was reported more often by female versus male physicians as a reason to not recommend herbs and non-vitamin supplements (31.4% [95% CI = 26.8-36.3] vs. 23.4% [95% CI = 21.0-25.9]).
The authors concluded that there are limited nationally representative data on the reasons as to why office-based physicians decide to recommend complementary health approaches to patients. Developing a more nuanced understanding of influencing factors in physicians’ decision making regarding complementary health approaches may better inform researchers and educators, and aid physicians in making evidence-based recommendations for patients.
I am not sure what these papers really offer in terms of information that is not obvious or that makes a meaningful contribution to progress. It almost seems that, because the data of such surveys are available, such analyses get done and published. The far better reason for doing research is, of course, the desire to answer a burning and relevant research question.
A problem then arises when researchers, who perceive the use of so-called alternative medicine (SCAM) as a fundamentally good thing, write a paper that smells more of SCAM promotion than meaningful science. Having said that, I find it encouraging to read in the two papers that
- the prevalence of SCAM remains quite low,
- more than 60% of all physicians recommended SCAM not because they were convinced of its value but because of patient requests,
- the lack of perceived benefit was the most frequently reported reason for not recommending it.
Ayush-64 is an Ayurvedic formulation, developed by the Central Council for Research in Ayurvedic Sciences (CCRAS), the apex body for research in Ayurveda under the Ministry of Ayush. Originally developed in 1980 for the management of Malaria, this drug has now been repurposed for COVID-19 as its ingredients showed notable antiviral, immune-modulator, and antipyretic properties. Its ingredients are:
|Alstonia scholaris R. Br. Aqueous extract of (Saptaparna)||Bark-1 part|
|Picrorhiza Kurroa Royle Aqueous extract of (Kutki)||Rhizome-1 part|
|Swertia chirata Buch-Ham. Aqueous extract of (Chirata)||Whole plant-1 part|
|Caesalphinia crista, Linn. Fine powder of seed (Kuberaksha)||Pulp-2 parts|
The crucial question, of course, is does AYUSH-64 work?
An open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India with 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone.
The outcome measures were:
- the proportion of participants who attained clinical recovery on days 7, 15, 23, and 30,
- the proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point,
- change in pro-inflammatory markers,
- metabolic functions,
- HRCT chest (CO-RADS category),
- the incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE).
Out of 80 participants, 74 (37 in each group) contributed to the final analysis. A significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. The mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG.
The authors concluded that AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.
I do object to these conclusions for several reasons:
- The study cannot possibly determine the safety of AYUSH-64.
- Even for assessing its efficacy, it was too small.
- The trial design followed the often-discussed A+B vs B concept and is thus prone to generate false-positive results.
I believe that it is highly irresponsible, during a medical crisis like ours, to conduct studies that can only produce unreliable findings. If there is a real possibility that a therapy might work, we do need to test it, but we should take great care that the test is rigorous enough to generate reliable results. This, I think, is all the more true, if – like in the present case – the study was done with governmental support.
Today is WORLD ASTHMA DAY, a good opportunity perhaps to revisit a few of our own evaluations of so-called alternative medicine (SCAM) for asthma. Here are the abstracts of some of our systematic reviews on the subject:
Objective: The objective of this systematic review was to assess the effectiveness of yoga as a treatment option for asthma.
Method: Seven databases were searched from their inception to October 2010. Randomized clinical trials (RCTs) and non-randomized clinical trials (NRCTs) were considered, if they investigated any type of yoga in patients with asthma. The selection of studies, data extraction, and validation were performed independently by two reviewers.
Results: Six RCTs and one NRCT met the inclusion criteria. Their methodological quality was mostly poor. Three RCTs and one NRCT suggested that yoga leads to a significantly greater reduction in spirometric measures, airway hyperresponsivity, dose of histamine needed to provoke a 20% reduction in forced expiratory volume in the first second, weekly number of asthma attacks, and need for drug treatment. Three RCTs showed no positive effects compared to various control interventions.
Conclusions: The belief that yoga alleviates asthma is not supported by sound evidence. Further, more rigorous trials are warranted.
Some clinicians believe that spinal manipulation is an effective treatment for asthma. The aim of this systematic review was to critically evaluate the evidence for or against this claim. Four electronic databases were searched without language restrictions from their inceptions to September 2008. Bibliographies and departmental files were hand-searched. The methodological quality of all included studies was assessed with the Jadad score. Only randomised clinical trials of spinal manipulation as a treatment of asthma were included. Three studies met these criteria. All of them were of excellent methodological quality (Jadad score 5) and all used sham-manipulation as the control intervention. None of the studies showed that real manipulation was more effective than sham-manipulation in improving lung function or subjective symptoms. It is concluded that, according to the evidence of the most rigorous studies available to date, spinal manipulation is not an effective treatment for asthma.
Contradictory results from randomised controlled trials of acupuncture in asthma suggest both a beneficial and detrimental effect. The authors conducted a formal systematic review and meta-analysis of all randomised clinical trials in the published literature that have compared acupuncture at real and placebo points in asthma patients. The authors searched for trials published in the period 1970-2000. Trials had to measure at least one of the following objective outcomes: peak expiratory flow rate, forced expiratory volume in one second (FEV1) and forced vital capacity. Estimates of the standarised mean difference, between acupuncture and placebo were computed for each trial and combined to estimate the overall effect. Hetereogeneity was investigated in terms of the characteristics of the individual studies. Twelve trials met the inclusion criteria but data from one could not be obtained. Individual patient data were available in only three. Standardised differences between means ranging from 0.071 to 0.133, in favour of acupuncture, were obtained. The overall effect was not conventionally significant and it corresponds to an approximate difference in FEV1 means of 1.7. After exploring hetereogenenity, it was found that studies where bronchoconstriction was induced during the experiment showed a conventionally significant effect. This meta-analysis did not find evidence of an effect of acupuncture in reducing asthma. However, the meta-analysis was limited by shortcomings of the individual trials, in terms of sample size, missing information, adjustment of baseline characteristics and a possible bias against acupuncture introduced by the use of placebo points that may not be completely inactive. There was a suggestion of preferential publication of trials in favour of acupuncture. There is an obvious need to conduct a full-scale randomised clinical trial addressing these limitations and the prognostic value of the aetiology of the disease.
Background: Emotional stress can either precipitate or exacerbate both acute and chronic asthma. There is a large body of literature available on the use of relaxation techniques for the treatment of asthma symptoms. The aim of this systematic review was to determine if there is any evidence for or against the clinical efficacy of such interventions.
Methods: Four independent literature searches were performed on Medline, Cochrane Library, CISCOM, and Embase. Only randomised clinical trials (RCTs) were included. There were no restrictions on the language of publication. The data from trials that statistically compared the treatment group with that of the control were extracted in a standardised predefined manner and assessed critically by two independent reviewers.
Results: Fifteen trials were identified, of which nine compared the treatment group with the control group appropriately. Five RCTs tested progressive muscle relaxation or mental and muscular relaxation, two of which showed significant effects of therapy. One RCT investigating hypnotherapy, one of autogenic training, and two of biofeedback techniques revealed no therapeutic effects. Overall, the methodological quality of the studies was poor.
Conclusions: There is a lack of evidence for the efficacy of relaxation therapies in the management of asthma. This deficiency is due to the poor methodology of the studies as well as the inherent problems of conducting such trials. There is some evidence that muscular relaxation improves lung function of patients with asthma but no evidence for any other relaxation technique.
Background: Asthma is one of the most common chronic diseases in modern society and there is increasing evidence to suggest that its incidence and severity are increasing. There is a high prevalence of usage of complementary medicine for asthma. Herbal preparations have been cited as the third most popular complementary treatment modality by British asthma sufferers. This study was undertaken to determine if there is any evidence for the clinical efficacy of herbal preparations for the treatment of asthma symptoms.
Methods: Four independent literature searches were performed on Medline, Pubmed, Cochrane Library, and Embase. Only randomised clinical trials were included. There were no restrictions on the language of publication. The data were extracted in a standardised, predefined manner and assessed critically.
Results: Seventeen randomised clinical trials were found, six of which concerned the use of traditional Chinese herbal medicine and eight described traditional Indian medicine, of which five investigated Tylophora indica. Three other randomised trials tested a Japanese Kampo medicine, marihuana, and dried ivy leaf extract. Nine of the 17 trials reported a clinically relevant improvement in lung function and/or symptom scores.
Conclusions: No definitive evidence for any of the herbal preparations emerged. Considering the popularity of herbal medicine with asthma patients, there is urgent need for stringently designed clinically relevant randomised clinical trials for herbal preparations in the treatment of asthma.
Breathing techniques are used by a large proportion of asthma sufferers. This systematic review was aimed at determining whether or not these interventions are effective. Four independent literature searches identified six randomized controlled trials. The results of these studies are not uniform. Collectively the data imply that physiotherapeutic breathing techniques may have some potential in benefiting patients with asthma. The safety issue has so far not been addressed satisfactorily. It is concluded that too few studies have been carried out to warrant firm judgements. Further rigorous trials should be carried out in order to redress this situation.
So, if you suffer from asthma, my advice is to stay away from SCAM. This might be easier said than done because SCAM practitioners are only too willing to lure asthma patients into their cult. In 2003, we have demonstrated this phenomenon by conducting a survey with chiropractors. Here is our short paper in full:
Classic chiropractic theory claims that vertebral subluxation blocks the flow of ‘‘innate intelligence’’ which, in turn, affects the health of asthma patients (1). Chiropractictors often use spinal manipulation (SM) to correct such malalignments and treat asthma (2). Several clinical trials of chiropractic SM exist, but the most rigorous ones are clearly negative (3,4). Chronic medication with corticosteroids can lead to osteoporosis, a condition, which is a contra-indication to chiropractic SM (5). Given this background, we aimed to determine whether chiropractors would advise an asthma patient on long-term corticosteroids (5 years) to try chiropractic as a treatment for this condition.
All 350 e-mail addresses listed at www.interadcom.com/chiro/html were randomised into two groups. A (deceptive) letter from a (fictitious) patient was sent to group A while group B was asked for advice on chiropractic treatment for asthma as part of a research project. Thus, groups A and B were asked the same question in di¡erent contexts: is chiropractic safe and e¡ective for an asthma patient on long-term steroids. After data collection, respondents from group A were informed that the e-mail had been part of a research project.
Of 97 e-mails in group A, we received 31 responses (response rate = 32% (95% CI, 0.23^ 0.41)). Seventy-four per cent (23 respondents) recommended visiting a chiropractor (95% CI, 0.59^ 0.89). Thirty-five per cent (11 respondents) mentioned minimal or no adverse effects of SM (95% CI, 0.18 ^ 0.52). Three chiropractors responded that some adverse e¡ects exist, e.g. risk of bone fracture, or stroke. Two respondents noted that other investigations (X-rays, spinal and neurological examination) were required before chiropractic treatment. Three respondents suggested additional treatments and one warned about a possible connection between asthma and the measles vaccine. Of 77 e-mails sent to group B, we received 16 responses (response rate = 21% (95% CI, 0.17^ 0.25)). Eleven respondents (69%) recommended visiting a chiropractor (95% CI, 0.46 ^ 0.91). Ten respondents mentioned minimal or no adverse effects of SM (95% CI, 0.39^ 0.87). Five chiropractors responded that adverse effects of SM exist (e.g. bone fracture). Five respondents suggested pre-testing the patient to check bone density, allergy, diet, exercise level, hydration and blood. Additional treatments were recommended by three respondents. The pooled results of groups A and B suggested that the majority of chiropractors recommend chiropractic treatment for asthma and the minority mention any adverse effects.
Our results demonstrate that chiropractic advice on asthma therapy is as readily available over the Internet as it is likely to be misleading. The majority of respondents from both groups (72%) recommended chiropractic treatment. This usually entails SM, a treatment modality which has been demonstrated to be ineffective in rigorous clinical trials (3,4,6). The advice may also be dangerous: the minority of the respondents of both groups (17%) caution of the risk of bone fracture. Our findings also suggest that, for the research question asked, a degree of deception is necessary. The response rate in group B was 12% lower than that of group A, and the answers received differed considerably between groups. In group A, 10% acknowledged the possibility of adverse e¡ects, this figure was 33% in group B. In conclusion, chiropractors readily provide advice regarding asthma treatment, which is often not evidence-based and has the potential to put patients at risk.
As I stated above: if you suffer from asthma, my advice is to
stay away from SCAM.
This systematic review and meta-analysis of clinical trials were performed to summarize the evidence of the effects of Urtica dioica (UD) consumption on metabolic profiles in patients with type 2 diabetes mellitus (T2DM).
Eligible studies were retrieved from searches of PubMed, Embase, Scopus, Web of Science, Cochrane Library, and Google Scholar databases until December 2019. Cochran (Q) and I-square statistics were used to examine heterogeneity across included clinical trials. Data were pooled using a fixed-effect or random-effects model and expressed as weighted mean difference (WMD) and 95% confidence interval (CI).
Among 1485 citations, thirteen clinical trials were found to be eligible for the current metaanalysis. UD consumption significantly decreased levels of fasting blood glucose (FBG) (WMD = – 17.17 mg/dl, 95% CI: -26.60, -7.73, I2 = 93.2%), hemoglobin A1c (HbA1c) (WMD = -0.93, 95% CI: – 1.66, -0.17, I2 = 75.0%), C-reactive protein (CRP) (WMD = -1.09 mg/dl, 95% CI: -1.64, -0.53, I2 = 0.0%), triglycerides (WMD = -26.94 mg/dl, 95 % CI = [-52.07, -1.82], P = 0.03, I2 = 90.0%), systolic blood pressure (SBP) (WMD = -5.03 mmHg, 95% CI = -8.15, -1.91, I2 = 0.0%) in comparison to the control groups. UD consumption did not significantly change serum levels of insulin (WMD = 1.07 μU/ml, 95% CI: -1.59, 3.73, I2 = 63.5%), total-cholesterol (WMD = -6.39 mg/dl, 95% CI: -13.84, 1.05, I2 = 0.0%), LDL-cholesterol (LDL-C) (WMD = -1.30 mg/dl, 95% CI: -9.95, 7.35, I2 = 66.1%), HDL-cholesterol (HDL-C) (WMD = 6.95 mg/dl, 95% CI: -0.14, 14.03, I2 = 95.4%), body max index (BMI) (WMD = -0.16 kg/m2, 95% CI: -1.77, 1.44, I2 = 0.0%), and diastolic blood pressure (DBP) (WMD = -1.35 mmHg, 95% CI: -2.86, 0.17, I2= 0.0%) among patients with T2DM.
The authors concluded that UD consumption may result in an improvement in levels of FBS, HbA1c, CRP, triglycerides, and SBP, but did not affect levels of insulin, total-, LDL-, and HDL-cholesterol, BMI, and DBP in patients with T2DM.
Several plants have been reported to affect the parameters of diabetes. Whenever I read such results, I cannot stop wondering whether this is a good or a bad thing. It seems to be positive at first glance, yet I can imagine at least two scenarios where such effects might be detrimental:
- A patient reads about the antidiabetic effects and decides to swap his medication for the herbal remedy which is far less effective. Consequently, the patient’s metabolic control is insufficient.
- A patient adds the herbal remedy to his therapy. Consequently, his blood sugar drops too far and he suffers a hypoglycemic episode.
My advice to diabetics is therefore this: if you want to try herbal antidiabetic treatments, please think twice. And if you persist, do it only under the close supervision of your doctor.
This study describes the use of so-called alternative medicine (SCAM) among older adults who report being hampered in daily activities due to musculoskeletal pain. The characteristics of older adults with debilitating musculoskeletal pain who report SCAM use is also examined. For this purpose, the cross-sectional European Social Survey Round 7 from 21 countries was employed. It examined participants aged 55 years and older, who reported musculoskeletal pain that hampered daily activities in the past 12 months.
Of the 4950 older adult participants, the majority (63.5%) were from the West of Europe, reported secondary education or less (78.2%), and reported at least one other health-related problem (74.6%). In total, 1657 (33.5%) reported using at least one SCAM treatment in the previous year.
The most commonly used SCAMs were:
- manual body-based therapies (MBBTs) including massage therapy (17.9%),
- osteopathy (7.0%),
- homeopathy (6.5%)
- herbal treatments (5.3%).
SCAM use was positively associated with:
- younger age,
- physiotherapy use,
- female gender,
- higher levels of education,
- being in employment,
- living in West Europe,
- multiple health problems.
(Many years ago, I have summarized the most consistent determinants of SCAM use with the acronym ‘FAME‘ [female, affluent, middle-aged, educated])
The authors concluded that a third of older Europeans with musculoskeletal pain report SCAM use in the previous 12 months. Certain subgroups with higher rates of SCAM use could be identified. Clinicians should comprehensively and routinely assess SCAM use among older adults with musculoskeletal pain.
I often mutter about the plethora of SCAM surveys that report nothing meaningful. This one is better than most. Yet, much of what it shows has been demonstrated before.
I think what this survey confirms foremost is the fact that the popularity of a particular SCAM and the evidence that it is effective are two factors that are largely unrelated. In my view, this means that more, much more, needs to be done to inform the public responsibly. This would entail making it much clearer:
- which forms of SCAM are effective for which condition or symptom,
- which are not effective,
- which are dangerous,
- and which treatment (SCAM or conventional) has the best risk/benefit balance.
Such information could help prevent unnecessary suffering (the use of ineffective SCAMs must inevitably lead to fewer symptoms being optimally treated) as well as reduce the evidently huge waste of money spent on useless SCAMs.