conflict of interest
Research can be defined as the process of discovering new knowledge. There are three somewhat overlapping types of research:
- Exploratory research is research around a problem that has not yet been clearly defined. It aims to gain a better understanding of the nature of the issues involved with a view of conducting more in-depth research at a later stage.
- Descriptive research creates knowledge by describing the issues according to their characteristics and population. It focuses on the ‘how’ and ‘what’, but not on the ‘why’.
- Explanatory research is aimed at determining how variables interact and at identifying cause-and-effect relationships. It deals with the ‘why’ of research questions and is therefore often based on experiments.
The motivation behind doing research in medicine does, of course, vary but essentially it should be to help advance our knowledge and thus create progress.
I have been a researcher in several areas of medicine: physical medicine and rehabilitation, blood rheology, so-called alternative medicine (SCAM). My kind of research was mostly the explanatory type, i.e. formulating a research question and trying to answer it. Looking back at my ~40 years as an active researcher, I find remarkable differences between doing research in SCAM and the other subjects.
The process of discovering new knowledge is rarely contentious. New knowledge may be useful or useless but it should not generate contention. Of course, there can be debates about the reliability of the findings; this is entirely legitimate, helpful, and necessary. We always need to make sure that results are valid, reproducible, and true. And of course, the debates about the quality of the data can generate a certain amount of tension. Such tensions are stimulating and must be welcomed. I have been lucky to have experienced them in all areas of the research I ever touched.
The tension I experienced while doing SCAM research, however, was of an entirely different nature – so much so that I would not even call it ‘tension’; it was outright hostility. While doing non-SCAM research, it had never been in doubt that my research was honestly aimed at creating progress, this issue became the focal point after I had started SCAM research.
- When my research showed that homeopathy might not be effective, I got PERSONALLY attacked by homeopaths.
- When my research showed that homeopathy might not be safe, I got PERSONALLY attacked by homeopaths.
- When my research showed that chiropractic might not be effective, I got PERSONALLY attacked by chiropractors.
- When my research showed that chiropractic might not be safe, I got PERSONALLY attacked by chiropractors.
- When my research showed that acupuncture might not be effective, I got PERSONALLY attacked by acupuncturists.
- When my research showed that acupuncture might not be safe, I got PERSONALLY attacked by acupuncturists.
- When my research showed that herbalism might not be effective, I got PERSONALLY attacked by herbalists.
- When my research showed that herbalism might not be safe, I got PERSONALLY attacked by herbalists.
- Etc., etc.
Essentially, doing SCAM research felt like doing research not FOR but AGAINST the will of those who should have had the most interest in it.
But why?
As I said, one way to describe research is as a process of discovering new knowledge and creating progress. The main difference between doing research in SCAM and non-SCAM areas is perhaps this: in medicine, almost everyone is interested in discovering new knowledge and creating progress, while in SCAM hardly anyone shares this interest. In SCAM, I now tend to feel, research is not understood as a tool for finding the truth, but one for generating more business. To put it even more bluntly: medicine, in general, is open to research and its consequences hoping to make progress; SCAM is mostly anti-science and not interested in progress.
But why?
To me, the answer seems obvious: the truth or progress would be bad for the business of SCAM.
Prince Charles has claimed that people struggling to return to full health after having the coronavirus should practice yoga. This is what the GUARDIAN reported about it on Friday:
In a video statement on Friday to the virtual yoga and healthcare symposium Wellness After Covid, the heir apparent said doctors should work together with “complementary healthcare specialists” to “build a roadmap to hope and healing” after Covid. “This pandemic has emphasised the importance of preparedness, resilience and the need for an approach which addresses the health and welfare of the whole person as part of society, and which does not merely focus on the symptoms alone,” Charles said. “As part of that approach, therapeutic, evidenced-informed yoga can contribute to health and healing. By its very nature, yoga is an accessible practice which provides practitioners with ways to manage stress, build resilience and promote healing…”
… Charles, who has previously espoused the benefits of yoga, is not the only fan in the royal family. His wife, the Duchess of Cornwall, has said “it makes you less stiff” and “more supple”, while Prince William has also been pictured doing yogic poses. In 2019, the Prince of Wales said yoga had “proven beneficial effects on both body and mind”, and delivered “tremendous social benefits” that help build “discipline, self-reliance and self-care”.
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Yoga is a complex subject because it entails a host of different techniques, attitudes, and life-styles. There have been numerous clinical trials of various yoga techniques. They tend to suffer from poor study design as well as incomplete reporting and are thus no always reliable. Several systematic reviews have summarised the findings of these studies. A 2010 overview included 21 systematic reviews relating to a wide range of conditions. Nine systematic reviews arrived at positive conclusions, but many were associated with a high risk of bias. Unanimously positive evidence emerged only for depression and cardiovascular risk reduction.[1] There is no evidence that yoga speeds the recovery after COVID-19 or any other severe infectious disease, as Charles suggested.
Yoga is generally considered to be safe. However, a large-scale survey found that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that patients with chronic diseases were more likely to experience adverse events.[2] It, therefore, seems unlikely that yoga is suited for many patients recovering from a COVID-19 infection.
The warning by the Vatican’s chief exorcist that yoga leads to ‘demonic possession’[3] might not be taken seriously by rational thinkers. Yet, experts have long warned that many yoga teachers try to recruit their clients into the more cult-like aspects of yoga.[4]
Perhaps the most remarkable expression in Charles’ quotes is the term ‘EVIDENCE-INFORMED‘. It crops up regularly when Charles (or his advisor Dr. Michael Dixon) speaks or writes about so-called alternative medicine (SCAM). It is a clever term that sounds almost like ‘evidence-based’ but means something entirely different. If a SCAM is not evidence-based, it can still be legitimately put under the umbrella of ‘evidence-informed’: we know the evidence is not positive, we were well-informed of this fact, we nevertheless conclude that yoga (or any other SCAM) might be a good idea!
In my view, the regular use of the term ‘evidence-informed’ in the realm of SCAM discloses a lack of clarity that suits all snake-oil salesmen very well.
[1] Ernst E, Lee MS: Focus on Alternative and Complementary Therapies Volume 15(4) December 2010 274–27
[2] Matsushita T, Oka T. A large-scale survey of adverse events experienced in yoga classes. Biopsychosoc Med. 2015 Mar 18;9:9. doi: 10.1186/s13030-015-0037-1. PMID: 25844090; PMCID: PMC4384376.
[3] https://www.social-consciousness.com/2017/06/vaticans-chief-exorcist-warns-that-yoga-causes-demonic-possession.html
[4] https://www.theguardian.com/lifeandstyle/2020/jun/26/experience-my-yoga-class-turned-out-to-be-a-cult
The Indian AYUSH ministry has a track record of doing irresponsible stuff. Now they have published guidelines for treating Mucormycosis (black fungus) with homeopathy. Allow me to show you the crucial passages of their announcement:
… With the increasing cases of special variety of fungal infection, Mucormycosis (black fungus) the present information have been prepared with experience of senior clinicians in treating specific fungal infections and researchers of the system, for efficient treatment of suspected and diagnosed cases of Mucormycosis with Homoeopathy. This condition requires hospital based treatment under supervision and Homoeopathic medicines can be prescribed in an integrated manner. Since mostly immune compromised patients get this infection, strict monitoring of blood sugar and other vitals is required…
As a system with holistic approach, homoeopathy medicines may be selected based on the presenting signs and symptoms of each patient(4). Fungal infections are amenable to homoeopathic treatment. Various research studies undertaken on various fungi in-vitro model showed that homoeopathy medicine could prevent the growth of the fungus(5-8). Clinical studies have shown encouraging results on fungal infections (9-10). The medicines given here are suggestive based on their clinical use.
Symptomatic Homoeopathy management of Suspected and Diagnosed cases of Mucormycosis-
Note: -Apart from these lists of medicines any other medicine and any other potency may be
prescribed based on the symptom similarity in each case.
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Mucormycosis (black fungus) is a disease of immunocompromised patients. Five types can be differentiated:
- rhinocerebral (most common),
- pulmonary,
- cutaneous,
- disseminated,
- gastrointestinal (rare).
Rhinocerebral mucormycosis commonly causes headaches, visual changes, sinusitis, and proptosis. Pulmonary mucormycosis commonly presents as a cough. Late diagnosis may result in dissemination, leading to high mortality. Treatment consists of amphotericin B, surgery, and immune restoration.
It is believed that the current surge of mucormycosis in India has an overall mortality rate of 50% and is triggered by the use of steroids which are often life-saving for critically ill Covid-19 patients. It almost goes without saying that homeopathy has not been shown to be effective against this (or any other) condition. As to the AYUSH ministry, the less they interfere with public health in India, the better for the survival of patients, I fear.
Vertebral artery dissections (VAD) are a rare but important cause of ischemic stroke, especially in younger patients. Many etiologies have been identified, including motor vehicle accidents, cervical fractures, falls, physical exercise, and, as I have often discussed on this blog, cervical chiropractic manipulation. The goal of this study was to investigate the subgroup of patients who suffered a chiropractor-associated injury and determine how their prognosis compared to other-cause VAD.
The researchers, neurosurgeons from Chicago, conducted a retrospective chart review of 310 patients with vertebral artery dissections who presented at their institution between January 2004 and December 2018. Variables included demographic data, event characteristics, treatment, radiographic outcomes, and clinical outcomes measured using the modified Rankin Scale.
Overall, 34 out of our 310 patients suffered a chiropractor-associated injury. These patients tended to be younger (p = 0.01), female (p = 0.003), and have fewer comorbidities (p = 0.005) compared to patients with other-cause VADs. The characteristics of the injuries were similar, but chiropractor-associated injuries appeared to be milder at discharge and at follow-up. A higher proportion of the chiropractor-associated group had injuries in the 0-2 mRS range at discharge and at 3 months (p = 0.05, p = 0.04) and no patients suffered severe long-term neurologic consequences or death (0% vs. 9.8%, p = 0.05). However, when a multivariate binomial regression was performed, these effects dissipated and the only independent predictor of a worse injury at discharge was the presence of a cervical spine fracture (p < 0.001).
The authors concluded that chiropractor-associated injuries are similar to VADs of other causes, and apparent differences in the severity of the injury are likely due to demographic differences between the two populations.
The authors of the present paper are clear: “chiropractic manipulations are a risk factor for vertebral artery dissections.” This fact is further supported by a host of other investigations. For instance, the Canadian Stroke Consortium found that 28% of strokes following cervical artery dissection were preceded by chiropractic neck manipulation. Dziewas et al. obtained a similar rate in patients with vertebral artery dissections. Many chiropractors are in denial; however, this is merely due to their overt conflicts of interest.
My conclusions from the accumulated evidence are this:
Spinal manipulations of the upper spine should not be routinely used for any condition. Patients who nevertheless insist on having them must be made aware of the risks and give informed consent.
I have not often seen a paper reporting a small case series with such an impressively long list of authors from so many different institutions:
- Hospital of Lienz, Lienz, Austria.
- WissHom: Scientific Society for Homeopathy, Koethen, Germany; Umbrella Organization for Medical Holistic Medicine, Vienna, Austria; Vienna International Academy for Holistic Medicine (GAMED), Otto Wagner Hospital Vienna, Austria; Professor Emeritus, Medical University of Vienna, Department of Medicine I, Vienna, Austria. Electronic address: [email protected].
- Resident Specialist in Hygiene, Medical Microbiology and Infectious Diseases, Außervillgraten, Austria.
- St Mary’s University, London, UK.
- Umbrella Organization for Medical Holistic Medicine, Vienna, Austria.
- Shaare Zedek Medical Center, The Center for Integrative Complementary Medicine, Jerusalem, Israel.
- Apotheke Zum Weißen Engel – Homeocur, Retz, Austria.
- Reeshabh Homeo Consultancy, Nagpur, India.
- Umbrella Organization for Medical Holistic Medicine, Vienna, Austria; Vienna International Academy for Holistic Medicine (GAMED), Otto Wagner Hospital Vienna, Austria; Chair of Complementary Medicine, Medical Faculty, Sigmund Freud University Vienna, Austria; KLITM: Karl Landsteiner Institute for Traditional Medicine and Medical Anthropology, Vienna, Austria.
- WissHom: Scientific Society for Homeopathy, Koethen, Germany.
In fact, there are 12 authors reporting about 13 patients! But that might be trivial – so, let’s look at the paper itself. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to hospitalized patients with confirmed symptomatic SARS-CoV-2 infection.
Thirteen patients with COVID-19 were admitted. The mean age was 73.4 ± 15.0 (SD) years. The treating homeopathic doctor was instructed by the hospital on March 27, 2020, to adjunctively treat all inpatient COVID-19 patients homeopathically. The high potency homeopathic medicinal products were administered orally. Five globules were administered sublingually where they dissolved, three times a day. In ventilated patients in the ICU, medication was administered as a sip from a water beaker or 1 ml three times a day using a syringe. All ventilated patients exhibited dry cough resulting in respiratory failure. They were given Influenzinum, as were the patients at the general inpatient ward.
Twelve patients (92.3%) were speedily discharged without relevant sequelae after 14.4 ± 8.9 days. A single patient admitted in an advanced stage of septic disease died in the hospital. A time-dependent improvement of relevant clinical symptoms was observed in the 12 surviving patients. Six (46.2%) were critically ill and treated in the intensive care unit (ICU). The mean stay at the ICU of the 5 surviving patients was 18.8 ± 6.8 days. In six patients (46.2%) gastrointestinal disorders accompanied COVID-19.
The authors conclude that adjunctive homeopathic treatment may be helpful to treat patients with confirmed COVID-19 even in high-risk patients especially since there is no conventional treatment of COVID-19 available at present.
In the discussion section of the paper, the authors state this: “Given the extreme variability of pathology and clinical manifestations, a single universal preventive homeopathic medicinal product does not seem feasible. Yet homeopathy may have a relevant role to play precisely because of the number and diversity of its homeopathic medicinal products which can be matched with the diversity of the presentations. Patients with mild forms of disease can use homeopathic medicinal products at home using our simple algorithm. As this Case series suggests, adjunctive homeopathic treatment can play a valuable role in more serious presentations. For future pandemics, homeopathy agencies should be prepared by establishing rapid-response teams and efficacious lines of communication.”
There is nothing in this paper that would lead me to conclude that the homeopathic remedies had a positive effect on the natural history of the disease. All this article actually does do is this: it provides a near-perfect insight into the delusional megalomania of some homeopaths. These people are even more dangerous than I had feared.
The aim of this “multicenter cross-sectional study” was to analyze a cohort of breast (BC) and gynecological cancers (GC) patients regarding their interest in, perception of, and demand for integrative therapeutic health approaches.
The BC and GC patients were surveyed at their first integrative clinic visit using validated standardized questionnaires. Treatment goals and potential differences between the two groups were evaluated.
A total of 340 patients (272 BC, 68 GC) participated in the study. The overall interest in IM was 95.3% and correlated with older age, recent chemotherapy, and higher education. A total of 89.4% were using integrative methods at the time of enrolment, primarily exercise therapy (57.5%), and vitamin supplementation (51.4%). The major short-term goal of the BC patients was a side-effects reduction of conventional therapy (70.4%); the major long-term goal was the delay of a potential tumor progression (69.3%). In the GC group, major short-term and long-term goals were slowing tumor progression (73.1% and 79.1%) and prolonging survival (70.1% and 80.6%). GC patients were significantly more impaired by the side-effects of conventional treatment than BC patients [pain (p = 0.006), obstipation (< 0.005)].
The authors concluded that these data demonstrate a high overall interest in and use of IM in BC and GC patients. This supports the need for specialized IM counseling and the implementation of integrative treatments into conventional oncological treatment regimes in both patient groups. Primary tumor site, cancer diagnosis, treatment phase, and side effects had a relevant impact on the demand for IM in our study population.
This paper is, in my mind, an excellent example of pseudo-research:
- The ‘study’ turns out to be little more than a survey.
- The sample is small and not representative; therefore the findings cannot be generalized and are meaningless.
- The patients surveyed are those who decided to attend clinics of integrative medicine.
- These patients had used alternative therapies before and are evidently in favor of alternative medicine.
- The most frequently used alternative therapies (exercise, vitamins, trace elements, massage, lymph drainage) are arguably conventional treatments in Germany where the survey was conducted.
I have repeatedly commented on the plethora of useless surveys in so-called alternative medicine (SCAM). But this one might beat them all in its uselessness. The fact that close to 100% of patients attending clinics of integrative medicine are interested in SCAM and use some form of SCAM says it all, I think.
Why do people waste their time on such pseudo-research?
The best answer to this question is that it can be used for promotion. I found the paper by reading what seems to be a press release entitled: “Eine Studie bestätigt Patientenwunsch nach naturheilkundlicher Unterstützung”. This translates into “a study confirms the wish of patients for naturopathic support”. Needless to explain that the survey did not even remotely show this to be true.
What will they think of next?
I suggest a survey run in a BC clinic which amazingly discovers that nearly 100% of all patients are female.
A new study evaluated the effects of yoga and eurythmy therapy compared to conventional physiotherapy exercises in patients with chronic low back pain.
In this three-armed, multicentre, randomized trial, patients with chronic low back pain were treated for 8 weeks in group sessions (75 minutes once per week). They received either:
- Yoga exercises
- Eurythmy
- Physiotherapy
The primary outcome was patients’ physical disability (measured by RMDQ) from baseline to week 8. Secondary outcome variables were pain intensity and pain-related bothersomeness (VAS), health-related quality of life (SF-12), and life satisfaction (BMLSS). Outcomes were assessed at baseline, after the intervention at 8 weeks, and at a 16-week follow-up. Data of 274 participants were used for statistical analyses.
The results showed no significant differences between the three groups for the primary and secondary outcomes. In all groups, RMDQ decreased comparably at 8 weeks but did not reach clinical meaningfulness. Pain intensity and pain-related bothersomeness decreased, while the quality of life increased in all 3 groups. In explorative general linear models for the SF-12’s mental health component, participants in the eurythmy arm benefitted significantly more compared to physiotherapy and yoga. Furthermore, within-group analyses showed improvements of SF-12 mental score for yoga and eurythmy therapy only. All interventions were safe.
Everyone knows what physiotherapy or yoga is, I suppose. But what is eurythmy?
It is an exercise therapy that is part of anthroposophic medicine. It consists of a set of specific movements that were developed by Rudolf Steiner (1861–1925), the inventor of anthroposophic medicine, in conjunction with Marie von Sievers (1867-1948), his second wife.
Steiner stated in 1923 that eurythmy has grown out of the soil of the Anthroposophical Movement, and the history of its origin makes it almost appear to be a gift of the forces of destiny. Steiner also wrote that it is the task of the Anthroposophical Movement to reveal to our present age that spiritual impulse that is suited to it. He claimed that, within the Anthroposophical Movement, there is a firm conviction that a spiritual impulse of this kind must enter once more into human evolution. And this spiritual impulse must perforce, among its other means of expression, embody itself in a new form of art. It will increasingly be realized that this particular form of art has been given to the world in Eurythmy.
Consumers learning eurythmy are taught exercises that allegedly integrate cognitive, emotional, and volitional elements. Eurythmy exercises are based on speech and direct the patient’s attention to their own perceived intentionality. Proponents of Eurythmy believe that, through this treatment, a connection between internal and external activity can be experienced. They also make many diffuse health claims for this therapy ranging from stress management to pain control.
There is hardly any reliable evidence for eurythmy, and therefore the present study is exceptional and noteworthy. One review concluded that “eurythmy seems to be a beneficial add-on in a therapeutic context that can improve the health conditions of affected persons. More methodologically sound studies are needed to substantiate this positive impression.” This positive conclusion is, however, of doubtful validity. The authors of the review are from an anthroposophical university in Germany. They included studies in their review that were methodologically too weak to allow any conclusions.
So, does the new study provide the reliable evidence that was so far missing? I am afraid not!
The study compared three different exercise therapies. Its results imply that all three were roughly equal. Yet, we cannot tell whether they were equally effective or equally ineffective. The trial was essentially an equivalence study, and I suspect that much larger sample sizes would have been required in order to identify any true differences if they at all exist. Lastly, the study (like the above-mentioned review) was conducted by proponents of anthroposophical medicine affiliated with institutions of anthroposophical medicine. I fear that more independent research would be needed to convince me of the value of eurythmy.
Neuropathic pain is difficult to treat. Luckily, we have acupuncture! Acupuncturists leave us in no doubt that their needles are the solution. But are they correct or perhaps victims of wishful thinking?
This review was aimed at determining the proportion of patients with neuropathic pain who achieve a clinically meaningful improvement in their pain with the use of different pharmacologic and nonpharmacologic treatments.
Randomized controlled trials were included that reported a responder analysis of adults with neuropathic pain-specifically diabetic neuropathy, postherpetic neuralgia, or trigeminal neuralgia-treated with any of the following 8 treatments: exercise, acupuncture, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), topical rubefacients, opioids, anticonvulsant medications, and topical lidocaine.
A total of 67 randomized controlled trials were included. There was moderate certainty of evidence that anticonvulsant medications (risk ratio of 1.54; 95% CI 1.45 to 1.63; number needed to treat [NNT] of 7) and SNRIs (risk ratio of 1.45; 95% CI 1.33 to 1.59; NNT = 7) might provide a clinically meaningful benefit to patients with neuropathic pain. There was low certainty of evidence for a clinically meaningful benefit for rubefacients (ie, capsaicin; NNT = 7) and opioids (NNT = 8), and very low certainty of evidence for TCAs. Very low-quality evidence demonstrated that acupuncture was ineffective. All drug classes, except TCAs, had a greater likelihood of deriving a clinically meaningful benefit than having withdrawals due to adverse events (number needed to harm between 12 and 15). No trials met the inclusion criteria for exercise or lidocaine, nor were any trials identified for trigeminal neuralgia.
The authors concluded that there is moderate certainty of evidence that anticonvulsant medications and SNRIs provide a clinically meaningful reduction in pain in those with neuropathic pain, with lower certainty of evidence for rubefacients and opioids, and very low certainty of evidence for TCAs. Owing to low-quality evidence for many interventions, future high-quality trials that report responder analyses will be important to strengthen understanding of the relative benefits and harms of treatments in patients with neuropathic pain.
This review was published in a respected mainstream journal and conducted by a multidisciplinary team with the following titles and affiliations:
- Associate Professor in the College of Pharmacy at the University of Manitoba in Winnipeg.
- Pharmacist in Edmonton, Alta, and Clinical Evidence Expert for the College of Family Physicians of Canada.
- Family physician and Assistant Professor at the University of Alberta.
- Family physician and Associate Professor in the Department of Family Medicine at the University of Alberta.
- Pharmacist, Clinical Evidence Expert Lead for the College of Family Physicians of Canada, and Associate Clinical Professor in the Department of Family Medicine at the University of Alberta.
- Pharmacist in Edmonton and Clinical Evidence Expert for the College of Family Physicians of Canada.
- Pharmacist and Clinical Evidence Expert at the College of Family Physicians of Canada.
- Family physician, Director of Programs and Practice Support at the College of Family Physicians of Canada, and Adjunct Professor in the Department of Family Medicine at the University of Alberta.
- Professor in the Faculty of Pharmaceutical Sciences at the University of British Columbia in Vancouver.
- Pharmacist at the CIUSSS du Nord-de-l’lle-de-Montréal and Clinical Associate Professor in the Faculty of Pharmacy at the University of Montreal in Quebec.
- Care of the elderly physician and Assistant Professor in the Department of Family Medicine at the University of Alberta.
- Family physician and Professor in the Department of Family Medicine at the University of Alberta.
- Assistant Professor in the Department of Family Medicine at Queen’s University in Kingston, Ont.
- Research assistant at the University of Alberta.
- Medical student at the University of Alberta.
- Nurse in Edmonton and Clinical Evidence Expert for the College of Family Physicians of Canada.
As far as I can see, the review is of sound methodology, it minimizes bias, and its conclusions are therefore trustworthy. They suggest that acupuncture is not effective for neuropathic pain.
But how can this be? Do the authors not know about all the positive evidence on acupuncture? A quick search found positive recent reviews of acupuncture for all of the three indications in question:
- Diabetic neuropathy: Acupuncture alone and vitamin B combined with acupuncture are more effective in treating DPN compared to vitamin B.
- Herpes zoster: Acupuncture may be effective for patients with HZ.
- Trigeminal neuralgia: Acupuncture appears more effective than pharmacotherapy or surgery.
How can we explain this obvious contradiction?
Which result should we trust?
Do we believe pro-acupuncture researchers who published their papers in pro-acupuncture journals, or do we believe the findings of researchers who could not care less whether their work proves or disproves the effectiveness of acupuncture?
I think that these papers offer an exemplary opportunity for us to study how powerful the biases of researchers can be. They also remind us that, in the realm of so-called alternative medicine (SCAM), we should always be very cautious and not accept every conclusion that has been published in supposedly peer-reviewed medical journals.
Mind-body interventions (MBIs) are one of the top ten so-called alternative medicine (SCAM) approaches utilized in pediatrics, but there is limited knowledge on associated adverse events (AE). The objective of this review was to systematically review AEs reported in association with MBIs in children.
Electronic databases MEDLINE, Embase, CINAHL, CDSR, and CCRCT were searched from inception to August 2018. The authors included primary studies on participants ≤ 21 years of age that used an MBI. Experimental studies were assessed for whether AEs were reported on or not, and all other study designs were included only if they reported an AE.
A total of 441 were included as primary pediatric MBI studies. Of these, 377 (85.5%) did not explicitly report the presence/absence of AEs or a safety assessment. In total, there were 64 included studies: 43 experimental studies reported that no AE occurred, and 21 studies reported AEs. A total of 37 AEs were found, of which the most serious were grade 3. Most of the studies reporting AEs did not report on severity (81.0%) or duration of AEs (52.4%).
The authors concluded that MBIs are popularly used in children; however associated harms are often not reported and lack important information for meaningful assessment.
SCAM is far too often considered to be risk-free. This phenomenon is particularly stark if the SCAM in question does not involve physical or pharmacological treatments. Thus MBIs are seen and often waved through as especially safe. Consequently, many researchers do not even bother to monitor AEs in their clinical trials. This might be understandable, but it is nevertheless a violation of research ethics.
This new review is important in that it highlights these issues. It is high time that we stop giving researchers in SCAM the benefit of the doubt. They may or may not make honest mistakes when not reporting AEs. In any case, it is clear that they are not properly trained and supervised. All too often, we still see clinical trials run by amateurs who have little idea of methodology and even less of ethics. The harm this phenomenon does is difficult to quantify, but I fear it is huge.
Qigong is a branch of Traditional Chinese Medicine using meditation, exercise, deep breathing, and other techniques with a view of strengthening the assumed life force ‘qi’ and thus improving health and prolong life. There are several distinct forms of qigong which can be categorized into two main groups, internal qigong, and external qigong. Internal qigong refers to a physical and mental training method for the cultivation of oneself to achieve optimal health in both mind and body. Internal qigong is not dissimilar to tai chi but it also employs the coordination of different breathing patterns and meditation. External qigong refers to a treatment where qigong practitioners direct their qi-energy to the patient with the intention to clear qi-blockages or balance the flow of qi within that patient. According to Taoist and Buddhist beliefs, qigong allows access to higher realms of awareness. The assumptions of qigong are not scientifically plausible and its clinical effectiveness remains unproven.
The aim of this study was to investigate the effects of internal Qigong for the management of a symptom cluster comprising fatigue, dyspnea, and anxiety in patients with lung cancer.
A total of 156 lung cancer patients participated in this trial, and they were randomized to a Qigong group (6 weeks of intervention) or a waitlist control group receiving usual care. A professional coach with 12 years of experience in teaching Qigong was employed to guide the participants’ training. The training protocol was developed according to the “Qigong Standard” enacted by the Chulalongkorn University, Thailand. The training involved a series of simple, repeated practices including body posture/movement, breathing practice, and meditation performed in synchrony. It mainly consisted of gentle movements designed to bring about a deep state of relaxation and included 7 postures. The symptom cluster was assessed at baseline, at the end of treatment (primary outcome), and at 12 weeks, alongside measures of cough and quality of life (QOL).
The results showed no significant interaction effect between group and time for the symptom cluster, the primary outcome measure of this study, overall and for fatigue and anxiety. However, a significant trend towards improvement was observed on fatigue (P = .004), dyspnea (P = .002), and anxiety (P = .049) in the Qigong group from baseline assessment to the end of intervention at the 6th week (within-group changes). Improvements in dyspnea and in the secondary outcomes of cough, global health status, functional well-being and QOL symptom scales were statistically significant between the 2 groups (P = .001, .014, .021, .001, and .002, respectively).
The authors concluded that Qigong did not alleviate the symptom cluster experience. Nevertheless, this intervention was effective in reducing dyspnea and cough, and improving QOL. More than 6 weeks were needed, however, for detecting the effect of Qigong on improving dyspnea. Furthermore, men benefited more than women. It may not be beneficial to use Qigong to manage the symptom cluster consisting of fatigue, dyspnea, and anxiety, but it may be effective in managing respiratory symptoms (secondary outcomes needing further verification in future research). Future studies targeting symptom clusters should ensure the appropriateness of the combination of symptoms.
I am getting very tired of negative trials getting published as (almost) positive ones. The primary outcome measure of this study did not yield a positive result. The fact that some other endpoints suggested a positive might provide an impetus for further study but does not demonstrate Qigong to be effective. I know the first author of this study is a fan of so-called alternative medicine (SCAM), but this should not stop him from doing proper science.
