Edzard Ernst

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

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:

  • herbs,
  • other non-vitamin supplements,
  • chiropractic/osteopathic manipulation,
  • acupuncture,
  • 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.

Osteopathic visceral manipulation (VM) is a bizarre so-called alternative medicine (SCAM) that has been featured on this blog with some regularity, e.g.:

Rigorous trials fail to show that it works for anything. So, the obvious solution to this dilemma is to conduct dodgy trials!

This study tested the effects of VM on dysmenorrhea, irregular, delayed, and/or absent menses, and premenstrual symptoms in PCOS patients.

Thirty Egyptian women with polycystic ovary syndrome (PCOS), with menstruation-related complaints and free from systematic diseases and/or adrenal gland abnormalities, participated in a single-blinded, randomized controlled trial. They were recruited from the women’s health outpatient clinic in the faculty of physical therapy at Cairo University, with an age of 20-34 years, and a body mass index (BMI) ≥25, <30 kg/m2. Patients were randomly allocated into two equal groups (15 patients); the control group received a low-calorie diet for 3 months, and the study group that received the same hypocaloric diet added to VM to the pelvic organs and their related structures for eight sessions over 3 months. Evaluations for body weight, BMI, and menstrual problems were done by weight-height scale, and menstruation-domain of Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ), respectively, at baseline and after 3 months from interventions. Data were described as mean, standard deviation, range, and percentage whenever applicable.

Of 60 Egyptian women with PCOS, 30 patients were included, with baseline mean age, weight, BMI, and a menstruation domain score of 27.5 ± 2.2 years, 77.7 ± 4.3 kg, 28.6 ± 0.7 kg/m2, and 3.4 ± 1.0, respectively, for the control group, and 26.2 ± 4.7 years, 74.6 ± 3.5 kg, 28.2 ± 1.1 kg/m2, and 2.9 ± 1.0, respectively, for the study group. Out of the 15 patients in the study group, uterine adhesions were found in 14 patients (93.3%), followed by restricted uterine mobility in 13 patients (86.7%), restricted ovarian/broad ligament mobility (9, 60%), and restricted motility (6, 40%). At baseline, there was no significant difference (p>0.05) in any of the demographics (age, height), or dependent variables (weight, BMI, menstruation domain score) among both groups. Post-study, there was a statistically significant reduction (p=0.000) in weight, and BMI mean values for the diet group (71.2 ± 4.2 kg, and 26.4 ± 0.8 kg/m2, respectively) and the diet + VM group (69.2 ± 3.7 kg; 26.1 ± 0.9 kg/m2, respectively). For the improvement in the menstrual complaints, a significant increase (p<0.05) in the menstruation domain mean score was shown in the diet group (3.9 ± 1.0), and the diet + VM group (4.6 ± 0.5). On comparing both groups post-study, there was a statistically significant improvement (p=0.024) in the severity of menstruation-related problems in favor of the diet + VM group.

The authors concluded that VM yielded greater improvement in menstrual pain, irregularities, and premenstrual symptoms in PCOS patients when added to caloric restriction than utilizing the low-calorie diet alone in treating that condition.

WHERE TO START?

  • Tiny sample size.
  • A trail design (A+B vs B) which will inevitably generate a positive result.
  • Questionable ethics.

VM is a relatively invasive and potentially embarrassing intervention for any woman; I imagine that this is all the more true in Egypt. In such circumstances, it is mandatory to ask whether a planned study is ethically justifiable. I would answer this question related to an implausible treatment like VM with a straight NO!

I realize that there may be people who disagree with me. But even those guys should accept that, at the very minimum, such a study must be designed such that it leads to a clear answer – is VM effective or not? The present trial merely suggests that the placebo effect associated with VM is powerful (which is hardly surprising for a therapy like VM).

Acupuncture is often promoted as a therapeutic option for obesity and weight control. The aim of this study was to investigate the effects of electroacupuncture (EA) on body weight, body mass index (BMI), skin fold thickness, waist circumference and skin temperature of the abdominal region in non-obese women with excessive abdominal subcutaneous fat.

A total of 50 women with excessive abdominal subcutaneous fat (and average BMI of 22) were randomly assigned to one of two groups:

  1. an EA group (n = 25) receiving 10 EA sessions (insertion of needles connected to an electrical stimulator at a frequency of 40 Hz for 40 min),
  2. a control group (n = 25) that received no treatment.

Outcome measures evaluated included waist circumference, supra-iliac and abdominal skinfolds, body composition and superficial skin temperature (measured by cutaneous thermography) before and after treatment.

Compared with the untreated group, women in the EA group exhibited decreased supra-iliac and abdominal skin folds (p < 0.001), waist circumference (p < 0.001), percentage body fat (p = 0.001) and percentage abdominal fat (p < 0.001). In addition, the EA group showed an elevated skin temperature at the site of the treatment. However, EA did not significantly impact body weight (p = 0.01) or BMI (p = 0.2).

The authors concluded that EA promoted a reduction in abdominal waist circumference, supra-iliac and abdominal skin folds, and percentage body and abdominal fat in women of normal BMI with excessive abdominal subcutaneous fat, as well as an increase in the superficial skin temperature of the abdominal region.

If we did not know that acupuncture researchers were all honest investigators testing hypotheses the best they can, we could almost assume that some are trying to fool us. The set-up of this study is ideally suited to introduce a proper placebo treatment. All one has to do is to not switch on the electrical stimulator in the control group. Why did the researchers not do that? Surely not because they wanted to increase the chances of generating a positive result; that would have been dishonest!!!

So, as it stands, what does the study tell us? I think it shows that, compared to patients who receive no treatment, patients who do receive the ritual of EA are better motivated to adhere to calorie restrictions and dietary advice. Thus, I suggest to re-phrase the conclusions of this trial as follows:

The extra attention of the EA treatment motivated obese patients to eat less which caused a reduction in abdominal waist circumference, supra-iliac and abdominal skin folds, and percentage body and abdominal fat in women of normal BMI with excessive abdominal subcutaneous fat.

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

This systematic review was aimed at:

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

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

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

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

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

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

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

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

I have previously reported about the ‘Havelhöhe Community Hospital’ in Berlin and its medical director, Prof Harald Matthes. He made headlines two years ago when he claimed that anthroposophical remedies were effective for treating COVID. More recently, Matthes made headlines again when he went on TV claiming that serious adverse effects of COVID vaccinations were 40 times more frequent than generally accepted.

Now a German newspaper reports more about the ‘Havelhöhe Community Hospital’ and its medical director. Here are a few (translated) passages from this remarkable article:

At the Havelhöhe Community Hospital in Berlin, there are considerable shortcomings in the handling of the Corona pandemic … basic protective measures are in part neither adhered to nor monitored. In addition, employees of the anthroposophical clinic are recommended a vaccination regimen for which there is no approval, i.e. the option of “dose splitting with frequency increase,” in which the vaccine usually administered at one time is to be divided among several injections.

However, there is no official basis for this vaccination scheme. “There is no vaccine approved for it, and it does not correspond in any way to the Stiko recommendation,” said Gudrun Widders, the public health officer responsible. “My hair stands on end when I hear that,” says the head of the Berlin-Spandau health department, who is also a member of the Standing Commission on Vaccination.

Visitors of the hospital Havelhöhe can enter buildings and wards without control of the inoculation status or a daily updated test result which is against current regulations in Germany. While other Berlin hospitals such as the Charité imposed bans on visitors, a public concert took place at Havelhöhe Hospital, where the audience did not wear a mask, contrary to the valid Corona protection regulation. Employees of the hospital also report to the taz that many of the hospital staff are lax about wearing masks, even when on duty.

“I can only say something when I see someone,” said hospital director Harald Matthes. “And I don’t see anyone with me in the hospital who walks around without a mask.” Matthes had publicly criticized corona measures as excessive on several occasions.

________________________________

I have said it before and I say it again: in my view, Matthes’ behavior amounts to serious professional misconduct. I, therefore, suggest that his professional body, the Aerztekammer, look into it with a view of preventing further harm.

 

 

 

I was alerted to the following conference announcement:

The MEP Interest Group on Integrative Medicine and Health is delighted to invite you to the event ‘Integrative Medicine and Health in prevention and management of COVID-19 and long COVID’ on Thursday 2 June 16.0018.00 CEST.

This event will give you in-depth information about:

Expert speakers will share their knowledge and insights about how:

• Complementary and Integrative Medicine and Health interventions can improve resilience to COVID-19 infection.

• Promoting resilience and health restoration can reduce the risk of severe COVID-19 or development of Long COVID.

• These interventions can improve the recovery from Long COVID.

Key speakers and topics:

Therapeutic strategies of complementary medicines in the COVID 19 pandemic and Long COVID in addition to conventional medicine

Dr Joanna Dietzel, MD Neurologist, Acupuncturist. Department for integrative & complementary medicine, Institute of social medicine, epidemiology and health economics, Charité – Universitätsmedizin Berlin, Germany.

Chinese herbal medicine treatment in cases of infections with SARS-CoV-2 – therapeutic strategies for COVID-19 and Long COVID

Dr Christian Thede, MD, General practitioner, specialised in Acupuncture and Chinese Medicine. Former lecturer in Chinese medicine, University of Witten-Herdecke, Germany

Instructor for Acupuncture and Chinese Medicine at International Society of Chinese Medicine (SMS).

Traditional and Complementary Medicine contributions to health system resilience during COVID-19 – the WHO perspective

Dr Geetha Kopalakrishna, MD, Bachelor of Ayurvedic Medicine & Surgery

Technical Officer at Traditional, Complementary & Integrative Medicine, Department of Service Delivery and Safety, World Health Organization, Geneva, Switzerland

Key member of the AYUSH-based COVID-19 response Task Force for the Government of India.

Research programme into integrative medicine’s contribution to improving resilience to COVID-19 infection and reducing the risk of severe COVID-19 or development of Long COVID

Dr Helene M. Langevin, Director at National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, Maryland (MD), USA. Previously, Director of the Harvard Osher Center for Integrative Medicine and professor of medicine at Harvard Medical School, Boston (MA) and professor of neurological sciences at the Larner College of Medicine at the University of Vermont (VT).

Q&A sessions after the presentations.

Resilience to infections: a solution for COVID-19 and other infectious illnesses

Studies show that certain common medical conditions put people at higher risk for severe illness and death from COVID-19. Nearly two-thirds of COVID-19 hospitalizations could be attributed to obesity, diabetes, hypertension, and heart failure. There is increasing awareness that a health system that focuses on improving health could prevent all these conditions to a large extent.

Long COVID

More than 40% of people who have or had COVID-19 get long COVID, and among people who needed hospitalization, the statistics go up to 57%. The recovery from such post viral syndromes will be greatly helped by offering patients access to complementary and integrative medicine interventions that aim at restoring their health balance.

MEP Interest Group on Integrative Medicine and Health

The event is hosted by the members of the MEP Interest Group on Integrative Medicine & Health:

Michèle Rivasi, Greens/EFA, France

Sirpa Pietikäinen, EPP, Finland

Tilly Metz, Greens/EFA, Luxembourg

Margrete Auken, Greens/EFA, Denmark

Romana Jerković, S&D, Croatia

Manuela Ripa, Greens/EFA, Germany

I had not been aware of the ‘MEP Interest Group on Integrative Medicine & Health‘. Therefore, I looked it up and found this:

The newly established Interest Group on Integrative Medicine & Health continues the work of the former MEP Interest Group on CAM. This group brings together MEPs who work collectively to promote the inclusion of CAM as part of Integrative Medicine & Health in all possible European Parliament public health policy.

Why an Interest Group in the European Parliament?

One in two EU citizens uses complementary medicine either alongside or as an alternative to conventional biomedical care. This high demand is not yet reflected in EU or national health policy or provision. In addition, there is diversity in complementary medicine regulation across the EU. There are differences in who can practice complementary medicine, what qualifications are required and how services are offered and financed. These discrepancies mean that citizens experience practical and attitudinal barriers that limit their access to and use of TCIM.

The health sector in the EU Member States is facing considerable challenges, such as antimicrobial resistance (AMR), increasing prevalence of Non-Communicable Diseases (NCDs) and soaring costs. Complementary medicine can offer a significant contribution to meet these challenges. These modalities are “integrative”, offering patient-centered healthcare, based on evidence-informed integration of conventional biomedicine and complementary medicine. Integrative Medicine and Health focuses on the whole person and considers the individual in its physical, psychological, spiritual, social and environmental context. It is inclusive of all professions and practices that use this approach and meets the demand of EU citizens for a more holistic, patient-centered approach in medicine. At the same time, TCIM is at the center of political and scientific debate. In this context, a forum for discussion on Integrative and Complementary Medicine’s contribution to EU health systems will bring clarity and rationality to this debate.

Aims and objectives of the Interest Group on Integrative Medicine & Health

  • Establish and maintain a forum for discussion and action with all stakeholders regarding Integrative Medicine and Health.
  • Raise awareness of Integrative Medicine and its contribution to more sustainable healthcare systems in the EU and a more holistic approach to health.
  • Focus on the integration of complementary modalities into the health systems of the EU Member States.
  • Protect and promote citizens’ right to choose their own healthcare while providing access to Integrative Medicine and Health information.
  • Advocate for EU involvement in setting unified standards to regulation of Integrative Medicine and Health.

__________________________________

Unified standards? But what about high or perhaps just scientific standards? What about first doing the research and then making claims about CAM or TCIM or however you decide to call it? Has common sense gone out of fashion?

Yes, you guessed it: I am seriously underwhelmed by all this. To show you why, let me list just a few claims from the above two statements that are based purely on wishful thinking:

  • Complementary and Integrative Medicine and Health interventions can improve resilience to COVID-19 infection.
  • These interventions can improve the recovery from Long COVID.
  • Studies show that certain common medical conditions put people at higher risk for severe illness and death from COVID-19.
  • The recovery from such post viral syndromes will be greatly helped by offering patients access to complementary and integrative medicine interventions that aim at restoring their health balance.
  • One in two EU citizens uses complementary medicine either alongside or as an alternative to conventional biomedical care.
  • The health sector in the EU Member States is facing considerable challenges, such as antimicrobial resistance (AMR), increasing prevalence of Non-Communicable Diseases (NCDs) and soaring costs. Complementary medicine can offer a significant contribution to meet these challenges.
  • These modalities are “integrative”, offering patient-centered healthcare, based on evidence-informed integration of conventional biomedicine and complementary medicine.
  • Integrative medicine … meets the demand of EU citizens for a more holistic, patient-centered approach in medicine.

I find all this confusing and concerning in equal measure. I also seriously doubt that the forum for discussion on Integrative and Complementary Medicine will bring clarity and rationality to this debate. If they really wanted a debate, they would need to include a few critical thinkers; can anyone recognize one on the list of speakers? I cannot!

I fear the aim of the group and their meeting is to mislead us all into thinking that CAM, TCIM, etc. generate more good than harm without ever delivering the evidence for that assumption. Therefore, I suggest they rename both the conference as well as their group:

Wishful thinking in prevention and management of COVID-19 and long COVID

and

MEP Interest Group on Wishful Thinking and Promotion of Quackery

 

 

PS

As an antidote to wishful thinking, I recommend reading some proper science papers on the subject. Here are the conclusions of an up-to-date and wishful-thinking-free review on the subject of post-acute infection syndrome:

Unexplained post-acute infection syndromes (PAISs) appear to be an under-recognized feature of a spectrum of infectious diseases in a minority of patients. At present, our understanding of the underlying pathophysiologic mechanisms and etiologic factors is poor and there are no known objective markers or effective therapeutic options. More basic biomedical research is needed. The overlap of symptoms, signs, and general features of the individual PAISs suggests the involvement of shared pathological pathways and the possibility that common diagnostic markers, or even a unified etiological model, might be established.

However, some symptoms or clinical characteristics seem to be trigger-specific or more prevalent in one PAIS than in others, emphasizing the need for cohorts with a well-documented infectious trigger. The overall clinical picture of many PAISs often overlaps with the presentation of post-infectious ME/CFS or fibromyalgia, or resembles other fatiguing, neurological, or rheumatic disorders. Exploiting existing knowledge of these conditions might help guide future scientific discovery and progress in clinical care.

The SARS-CoV-2 pandemic uncovered a significant gap in knowledge about post-acute sequelae of infectious diseases and identified the need for better diagnostic care and clinical infrastructure for patients experiencing these long-term effects. In addition to basic biomedical research, more needs to be done to refine diagnostic criteria and obtain more reliable estimates of the prevalence and societal burden of these disorders to help shape health-policy decisions. Moreover, we call for unified nomenclature and better conceptualization of post-acute infection symptoms.

There is much to be done, but the unprecedented amount of attention and resources that have recently been allocated to the study of COVID-19-related pathology brings a promise of much-needed progress in the wider field of unexplained infection-associated chronic disability.

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:

  1. The study cannot possibly determine the safety of AYUSH-64.
  2. Even for assessing its efficacy, it was too small.
  3. 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.

Spondyloptosis is a grade V spondylolisthesis – a vertebra having slipped so far with respect to the vertebra below that the two endplates are no longer congruent. It is usually seen in the lower lumbar spine but rarely can be seen in other spinal regions as well. Spondyloptosis is most commonly caused by trauma. It is defined as the dislocation of the spinal column in which the spondyloptotic vertebral body is either anteriorly or posteriorly displaced (>100%) on the adjacent vertebral body. Only a few cases of cervical spondyloptosis have been reported. The cervical cord injury in most patients is complete and irreversible. In most cases of cervical spondyloptosis, regardless of whether there is a neurologic deficit or not, reduction and stabilization of the fracture-dislocation is the management of choice

The case of a 16-year-old boy was reported who had been diagnosed with spondyloptosis of the cervical spine at the C5-6 level with a neurologic deficit following cervical manipulation by a traditional massage therapist. He could not move his upper and lower extremities, but the sensory and autonomic function was spared. The pre-operative American Spinal Cord Injury Association (ASIA) Score was B with SF-36 at 25%, and Karnofsky’s score was 40%. The patient was disabled and required special care and assistance.

The surgeons performed anterior decompression, cervical corpectomy at the level of C6 and lower part of C5, deformity correction, cage insertion, bone grafting, and stabilization with an anterior cervical plate. The patient’s objective functional score had increased after six months of follow-up and assessed objectively with the ASIA Impairment Scale (AIS) E or (excellent), an SF-36 score of 94%, and a Karnofsky score of 90%. The patient could carry on his regular activity with only minor signs or symptoms of the condition.

The authors concluded that this case report highlights severe complications following cervical manipulation, a summary of the clinical presentation, surgical treatment choices, and a review of the relevant literature. In addition, the sequential improvement of the patient’s functional outcome after surgical correction will be discussed.

This is a dramatic and interesting case. Looking at the above pre-operative CT scan, I am not sure how the patient could have survived. I am also not aware of previous similar cases. This does, however, not mean they don’t exist. Perhaps most affected patients simply died without being diagnosed. So, do we need to add spondyloptosis to the (hopefully) rare but severe complications of spinal manipulation?

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

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

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

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

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

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

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

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

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

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

 

PS

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

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

Anyone who has followed this blog for a while will know that advocates of so-called alternative medicine (SCAM) are either in complete denial about the risks of SCAM or they do anything to trivialize them. Here is a dialogue between a SCAM proponent (P) and a scientist (S) that is aimed at depicting this situation. The conversation is fictitious, of course, but it is nevertheless based on years of experience in discussing these issues with practitioners of various types of SCAM. As we shall see, the arguments turn out to be perfectly circular.

P: My therapy is virtually free of risks.

S: How can you be so sure?

P: I am practicing it for decades and have never seen a single problem.

S: That could have several reasons; perhaps the patients who experience problems did simply not come back.

P: I find this unlikely.

S: I don’t, and I know of reports where patients had serious complications after the type of SCAM you practice.

P: These are isolated case reports. They do not amount to evidence.

S: How do you know they are isolated?

P: They must be isolated because, in the many clinical trials of my therapy available to date, you will not find any evidence of serious adverse effects.

S: That is true, but it has been repeatedly shown that these trials regularly fail to mention side effects altogether.

P: That’s because there aren’t any.

S: Not quite, clinical trials should always mention adverse effects, and if there were none, they should mention this too.

P: So, you admit that you have no evidence that my therapy causes adverse effects.

S: The thing is, I don’t need such evidence. It is you, the practitioners of this therapy, who should provide evidence that your treatments are safe.

P: We did! The complete absence of reports of side effects constitutes that evidence.

S: Except, there is some evidence. I already told you that there are several case reports of serious problems.

P: But case reports are anecdotes; they are no evidence.

S: Look, here is a systematic review of all the case reports. You cannot possibly deny that this is a concern.

P: It’s still merely a bunch of anecdotes, nothing more.

S: Only because your profession does nothing about it.

P: What do you think we need to do about it?

S: Like other professions, you need to systematically record adverse effects.

P: How would that help?

S: It would give us a rough indication of the size and severity of the problem.

P: This sounds expensive and complicated to organize.

S: Perhaps, but it is necessary if you want to be sure that your therapy is safe.

P: But we are sure already!

S: No, you believe it, but you don’t know it.

P: You are getting on my nerves with your obsession. Don’t you know that the true danger in healthcare is the adverse effects of pharmaceutical drugs?

S: But these drugs are also effective.

P: Are you saying my therapy isn’t?

S: What I am saying is that the drugs you claim to be dangerous do more good than harm, while this is not at all clear with your SCAM.

P: To me, that is very clear. My therapy helps many and harms nobody!

S: How do you know that it harms nobody?

 

 

… At this point, we have gone full circle and we can re-start this conversation from its beginning.

 

 

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