Osteopathic visceral manipulation (VM) is a bizarre so-called alternative medicine (SCAM) that has been featured on this blog with some regularity, e.g.:
- Osteopathic visceral manipulation: a new study fails to convince anyone
- Visceral manipulation…you couldn’t make it up
- Intravaginal manipulations by (German) osteopaths: a new low point for clinical research into alternative medicine?
- Visceral osteopathy is implausible and does not work … SO, LET’S FORGET ABOUT IT ONCE AND FOR ALL
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).
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.
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.
I was alerted to the following short article from ‘The Blackpool Gazette‘:
Criminals have been using the brand name Pfizer to sell fake homeopathic vaccines to residents, according to police. The white tablets are sold under the pretence that they are an alternative to traditional vaccines, but actually contain no active ingredient. Analysis conducted by Lancashire Police revealed the tablets were nothing more than sugar pills. “Please note Pfizer do not produce any tablets as a cure or prophylactic for COVID-19,” a spokesman for the force added.
Homeopathy is a “treatment” based on the use of highly diluted substances, which practitioners claim can help the body heal itself, according to the NHS. A 2010 House of Commons Science and Technology Committee report on homeopathy said that homeopathic remedies perform no better than placebos. In 2017, NHS England said it would no longer fund homeopathy on the NHS as the lack of any evidence for its effectiveness did not justify the cost. This was backed by a High Court judgement in 2018.
I think there might be a slight misunderstanding here. The homeopathic remedy might not be fake, as it was produced according to the concepts of homeopathy. It is homeopathy itself that is fake. To me, it looks as though we are dealing with the German product I mentioned a while ago. Let me remind you:
Many people believe that homeopathy is essentially plant-based – but they are mistaken! Homeopathic remedies can be made from anything: Berlin wall, X-ray, pus, excrement, dental plaque, mobile phone rays, poisons … anything you can possibly think of. So, why not from vaccines?
This is exactly what a pharmacist specialized in homeopathy thought.
It has been reported that the ‘Schloss-Apotheke’ in Koblenz, Germany offered for sale a homeopathic remedy made from the Pfizer vaccine. This has since prompted not only the Chamber of Pharmacists but also the Paul Ehrlich Institute and Pfizer to issue statements. On Friday (30/4/2021) morning, the pharmacy had advertised homeopathic remedies based on the Pfizer/Biontech vaccine. The Westphalia-Lippe Chamber of Pharmacists then issued an explicit warning against it. “We are stunned by this,” said a spokesman. The offer has since disappeared from the pharmacy’s website.
On Friday afternoon, the manufacturer of the original vaccine also intervened. The Paul Ehrlich Institute released a statement making it clear that a vaccine is only safe “if it is administered in accordance with the marketing authorization.”
The Schloss-Apotheke had advertised the product in question with the following words:
“We have Pfizer/BioNTech Covid-19-Vaccine in potentized form up to D30 as globules or dilution (for discharge) in stock.”
The chamber of pharmacists countered with a warming under the heading “Facts instead of Fake News” on Facebook and Instagram:
“Whatever they might contain: These remedies are no effective protection against Covid-19.”
Pharmacy manager, Annette Eichele, of the Schloss-Apotheke claimed she had not sold homeopathic Corona vaccines and stressed that effective vaccines of this kind do not exist. According to Eichele, only an additional “mini drop” of the original Biontech vaccine had been used and “highly potentized” and prepared homeopathically. According to Eichele, Corona vaccinations that had already been administered were thus to have a “better and more correct effect with this supplementary product, possibly without causing side effects … but this is not scientifically proven”. The homeopathic product had been produced only on customer request and had been sold less than a dozen times in the past weeks. Ten grams of the remedy were sold for about 15 Euros. On Twitter, Eichele stated: „Wir haben nichts Böses getan, wir wollten nur Menschen helfen!“ (We have done nothing evil, we only wanted to help people). I am reminded yet again of Bert Brecht who observed:
“The opposite of good is not evil but good intentions”.
If I am right, the remedy is not truly fake but a genuine product of a fake concept, namely homeopathy. In that case, the term ‘criminal’ might need to be applied to homeopathy itself – an interesting thought!
The cardiothoracic surgeon and famous US woo merchant, Dr. Mehmet Oz, is probably known to most readers. I have previously mentioned him several times, for instance, here and here. His institution, Columbia University in New York City, has had many (I’d say too many) years of patience with his relentless promotion of outright and often dangerous quackery. Now it has been reported that the university has finally cut ties with Dr. Oz:
“It took Columbia far too long to remove Oz from its otherwise distinguished medical faculty,” Henry Miller, MD, of the Pacific Research Institute in California, told MedPage Today via email. Miller stressed that “the ‘Oz controversy’ was never about free speech. It was about an unethical grifter whose claims and pronouncements were not supported by science and were injurious to consumers — in the interest of financial benefit to Oz himself. That constitutes professional misconduct.”
The university’s Irving Medical Center quietly ended its relationship with Oz at the end of April, according to The Daily Beast. He had been removed from several pages of the medical center’s website in mid-January. In 2018, Oz’s title had been changed to professor emeritus and special lecturer, according to reports. A spokesperson for Columbia University confirmed the 2018 change in an email to MedPage Today.
In 2015, Miller and colleagues sent a letter to Lee Goldman, MD, MPH, dean of the Faculties of Health Sciences and Medicine at the university, calling for Oz’s expulsion. Oz had “repeatedly shown disdain for science and for evidence-based medicine” and “manifested an egregious lack of integrity by promoting quack treatments and cures in the interest of personal financial gain,” according to Miller’s group…
In 2014, Oz was called to testify before the Senate Subcommittee on Consumer Protection, Product Safety, and Insurance during a hearing on false advertising in the diet and weight-loss industry. Senators grilled Oz regarding statements he made on “The Dr. Oz Show” that promoted green coffee bean extract as a “miracle pill” for weight loss.
But long before that hearing, tensions had built between Oz and the medical community because of his penchant for spouting dubious medical claims on his TV show and in the media. For example, in a 2011 segment, ABC News‘ chief health and medical editor Richard Besser, MD, called out a purported “study” of arsenic in apple juice that Oz conducted for an episode of his show.
Besser charged that Oz’s science was shoddy because he reported total arsenic rather than the breakdown between organic and inorganic arsenic — only the latter of which is known to be toxic. Even the FDA sent the show a letter before the segment aired saying it would be “irresponsible and misleading” to report the results.
Oz again broke with medical science during the pandemic when he touted hydroxychloroquine as a cure for COVID-19, even as evidence mounted that it had no effect on disease course.
Oz is currently running for a U.S. Senate seat in Pennsylvania as a Republican candidate. Former President Trump endorsed Oz, touting Oz’s medical and academic credentials in a statement, according to NPR: “He even said that I was in extraordinary health, which made me like him even more (although he also said I should lose a couple of pounds!).”
I have to admit that I find these reports somewhat puzzling. Don’t get me wrong: it’s not that I don’t think Oz deserves to be dismissed. In fact, he had already richly deserved it many years ago. What I find, however, odd is that giving someone the title ’emeritus professor’ can hardly be called ‘cutting ties’ with him. In some ways, it is even the opposite (I should know because I currently have this status).
When I looked up Oz, Columbia listed him as:
Oz, Mehmet C. (MD)
Special Lecturer in the Department of Surgery
Phone: 212.305.4434 · Fax: 212.342.3520
Location: MHB, Rm. 435-62
Similarly, the website of the Irving Medical Center is full of entries about Oz. Confusion is therefore more than justified, I think.
What is needed, I feel, is a clear statement from Columbia University about its relationship with Dr. Oz. Are they still proud of his considerable fame/notoriety, or did they in fact have the integrity to cut ties with one of the most self-aggrandizing woo merchants of all times?
Harad Matthes, the boss of the anthroposophical Krankenhaus Havelhoehe and professor for Integrative and Anthroposophical Medicine at the Charite in Berlin, has featured on my blog before (see here and here). Now he is making headlines again.
‘Die Zeit‘ reported that Matthes went on German TV to claim that the rate of severe adverse effects of COVID-19 vaccinations is about 40 times higher than the official figures indicate. In the MDR broadcast ‘Umschau’ Matthes said that his unpublished data show a rate of 0,8% of severe adverse effects. In an interview, he later confirmed this notion. Yet, the official figures in Germany indicate that the rate is 0,02%.
How can this be?
Die ZEIT ONLINE did some research and found that Matthes’ data are based on extremely shoddy science and mistakes. The Carite also distanced themselves from Matthes’ evaluation: “The investigation is an open survey and not really a scientific study. The data are not suitable for drawing definitive conclusions regarding incidence figures in the population that can be generalized” The problems with Matthes’ ‘study’ seem to be sevenfold:
- The data are not published and can thus not be scrutinized.
- Matthes’ definition of a severe adverse effect is not in keeping with the generally accepted definition.
- Matthes did not verify the adverse effects but relied on the information volunteered by people over the Internet.
- Matthes’ survey is based on an online questionnaire accessible to anyone. Thus it is wide open to selection bias.
- The sample size of the survey is around 10 000 which is far too small for generalizable conclusions.
- There is no control group which makes it impossible to differentiate a meaningful signal from mere background noise.
- The data contradict those from numerous other studies that were considerably more rigorous.
Despite these obvious flaws Matthes insisted in a conversation with ZEIT ONLINE that the German official incidence figures are incorrect. As Germany already has its fair share of anti-vaxxers, Matthes’ unfounded and irresponsible claims contribute significantly to the public sentiments against COVID vaccinations. They thus endangering public health.
In my view, such behavior amounts to serious professional misconduct. I, therefore, feel that his professional body, the Aerztekammer, should look into it and prevent further harm.
The Lancet is a top medical journal, no doubt. But even such journals can make mistakes, even big ones, as the Wakefield story illustrates. But sometimes, the mistakes are seemingly minor and so well hidden that the casual reader is unlikely to find them. Such mistakes can nevertheless be equally pernicious, as they might propagate untruths or misunderstandings that have far-reaching consequences.
A recent Lancet paper might be an example of this phenomenon. It is entitled “Management of common clinical problems experienced by survivors of cancer“, unquestionably an important subject. Its abstract reads as follows:
Improvements in early detection and treatment have led to a growing prevalence of survivors of cancer worldwide.
Models of care fail to address adequately the breadth of physical, psychosocial, and supportive care needs of those who survive cancer. In this Series paper, we summarise the evidence around the management of common clinical problems experienced by survivors of adult cancers and how to cover these issues in a consultation. Reviewing the patient’s history of cancer and treatments highlights potential long-term or late effects to consider, and recommended surveillance for recurrence. Physical consequences of specific treatments to identify include cardiac dysfunction, metabolic syndrome, lymphoedema, peripheral neuropathy, and osteoporosis. Immunotherapies can cause specific immune-related effects most commonly in the gastrointestinal tract, endocrine system, skin, and liver. Pain should be screened for and requires assessment of potential causes and non-pharmacological and pharmacological approaches to management. Common psychosocial issues, for which there are effective psychological therapies, include fear of recurrence, fatigue, altered sleep and cognition, and effects on sex and intimacy, finances, and employment. Review of lifestyle factors including smoking, obesity, and alcohol is necessary to reduce the risk of recurrence and second cancers. Exercise can improve quality of life and might improve cancer survival; it can also contribute to the management of fatigue, pain, metabolic syndrome, osteoporosis, and cognitive impairment. Using a supportive care screening tool, such as the Distress Thermometer, can identify specific areas of concern and help prioritise areas to cover in a consultation.
You can see nothing wrong? Me neither! We need to dig deeper into the paper to find what concerns me.
In the actual article, the authors state that “there is good evidence of benefit for … acupuncture …”; the same message was conveyed in one of the tables. In support of these categorical statements, the authors quote the current Cochrane review entitled “Acupuncture for cancer pain in adults”. Its abstract reads as follows:
Background: Forty per cent of individuals with early or intermediate stage cancer and 90% with advanced cancer have moderate to severe pain and up to 70% of patients with cancer pain do not receive adequate pain relief. It has been claimed that acupuncture has a role in management of cancer pain and guidelines exist for treatment of cancer pain with acupuncture. This is an updated version of a Cochrane Review published in Issue 1, 2011, on acupuncture for cancer pain in adults.
Objectives: To evaluate efficacy of acupuncture for relief of cancer-related pain in adults.
Search methods: For this update CENTRAL, MEDLINE, EMBASE, PsycINFO, AMED, and SPORTDiscus were searched up to July 2015 including non-English language papers.
Selection criteria: Randomised controlled trials (RCTs) that evaluated any type of invasive acupuncture for pain directly related to cancer in adults aged 18 years or over.
Data collection and analysis: We planned to pool data to provide an overall measure of effect and to calculate the number needed to treat to benefit, but this was not possible due to heterogeneity. Two review authors (CP, OT) independently extracted data adding it to data extraction sheets. Data sheets were compared and discussed with a third review author (MJ) who acted as arbiter. Data analysis was conducted by CP, OT and MJ.
Main results: We included five RCTs (285 participants). Three studies were included in the original review and two more in the update. The authors of the included studies reported benefits of acupuncture in managing pancreatic cancer pain; no difference between real and sham electroacupuncture for pain associated with ovarian cancer; benefits of acupuncture over conventional medication for late stage unspecified cancer; benefits for auricular (ear) acupuncture over placebo for chronic neuropathic pain related to cancer; and no differences between conventional analgesia and acupuncture within the first 10 days of treatment for stomach carcinoma. All studies had a high risk of bias from inadequate sample size and a low risk of bias associated with random sequence generation. Only three studies had low risk of bias associated with incomplete outcome data, while two studies had low risk of bias associated with allocation concealment and one study had low risk of bias associated with inadequate blinding. The heterogeneity of methodologies, cancer populations and techniques used in the included studies precluded pooling of data and therefore meta-analysis was not carried out. A subgroup analysis on acupuncture for cancer-induced bone pain was not conducted because none of the studies made any reference to bone pain. Studies either reported that there were no adverse events as a result of treatment, or did not report adverse events at all.
Authors’ conclusions: There is insufficient evidence to judge whether acupuncture is effective in treating cancer pain in adults.
This conclusion is undoubtedly in stark contrast to the categorical statement of the Lancet authors: “there is good evidence of benefit for … acupuncture …“
What should be done to prevent people from getting misled in this way?
- The Lancet should correct the error. It might be tempting to do this by simply exchanging the term ‘good’ with ‘some’. However, this would still be misleading, as there is some evidence for almost any type of bogus therapy.
- Authors, reviewers, and editors should do their job properly and check the original sources of their quotes.
In case someone argued that the Cochrane review is just one of many, here is the conclusion of an overview of 15 systematic reviews on the subject: The … findings emphasized that acupuncture and related therapies alone did not have clinically significant effects at cancer-related pain reduction as compared with analgesic administration alone.
Yes, Today is ‘WORLD SLEEP DAY‘ and you are probably in bed hoping this post will put you back to sleep.
This study aimed to synthesise the best available evidence on the safety and efficacy of using moxibustion and/or acupuncture to manage cancer-related insomnia (CRI).
The PRISMA framework guided the review. Nine databases were searched from its inception to July 2020, published in English or Chinese. Randomised clinical trials (RCTs) of moxibustion and or acupuncture for the treatment of CRI were selected for inclusion. The methodological quality was assessed using the method suggested by the Cochrane collaboration. The Cochrane Review Manager was used to conduct a meta-analysis.
Fourteen RCTs met the eligibility criteria; 7 came from China. Twelve RCTs used the Pittsburgh Sleep Quality Index (PSQI) score as continuous data and a meta-analysis showed positive effects of moxibustion and or acupuncture (n = 997, mean difference (MD) = -1.84, 95% confidence interval (CI) = -2.75 to -0.94, p < 0.01). Five RCTs using continuous data and a meta-analysis in these studies also showed significant difference between two groups (n = 358, risk ratio (RR) = 0.45, 95% CI = 0.26-0.80, I 2 = 39%).
The authors concluded that the meta-analyses demonstrated that moxibustion and or acupuncture showed a positive effect in managing CRI. Such modalities could be considered an add-on option in the current CRI management regimen.
Even at the risk of endangering your sleep, I disagree with this conclusion. Here are some of my reasons:
- Chinese acupuncture trials invariably are positive which means they are as reliable as a 4£ note.
- Most trials were of poor methodological quality.
- Only one made an attempt to control for placebo effects.
- Many followed the A+B versus B design which invariably produces (false-) positive results.
- Only 4 out of 14 studies mentioned adverse events which means that 10 violated research ethics.
Sorry to have disturbed your sleep!
Bioresonance is an alternative therapeutic and diagnostic method employing a device developed in Germany by Scientology member Franz Morell in 1977. The bioresonance machine was further developed and marketed by Morell’s son-in-law Erich Rasche and is also known as ‘MORA’ therapy (MOrell + RAsche). Bioresonance is based on the notion that one can diagnose and treat illness with electromagnetic waves and that, via resonance, such waves can influence disease on a cellular level.
On this blog, we have discussed the idiocy bioresonance several times (for instance, here and here). My favorite study of bioresonance is the one where German investigators showed that the device cannot even differentiate between living and non-living materials. Despite the lack of plausibility and proof of efficacy, research into bioresonance continues.
The aim of this study was to evaluate if bioresonance therapy can offer quantifiable results in patients with recurrent major depressive disorder and with mild, moderate, or severe depressive episodes.
The study included 140 patients suffering from depression, divided into three groups.
- The first group (40 patients) received solely bioresonance therapy.
- The second group (40 patients) received pharmacological treatment with antidepressants combined with bioresonance therapy.
- The third group (60 patients) received solely pharmacological treatment with antidepressants.
The assessment of depression was made using the Hamilton Depression Rating Scale, with 17 items, at the beginning of the bioresonance treatment and the end of the five weeks of treatment.
The results showed a statistically significant difference for the treatment methods applied to the analyzed groups (p=0.0001). The authors also found that the therapy accelerates the healing process in patients with depressive disorders. Improvement was observed for the analyzed groups, with a decrease of the mean values between the initial and final phase of the level of depression, of delta for Hamilton score of 3.1, 3.8 and 2.3, respectively.
The authors concluded that the bioresonance therapy could be useful in the treatment of recurrent major depressive disorder with moderate depressive episodes independently or as a complementary therapy to antidepressants.
One could almost think that this is a reasonably sound study. But why did it generate such a surprising result?
When reading the full paper, the first thing one notices is that it is poorly presented and badly written. Thus there is much confusion and little clarity. The questions keep coming until one comes across this unexpected remark: the study was a retrospective study…
This explains some of the confusion and it certainly explains the surprising results. It remains unclear how the patients were selected/recruited but it is obvious that the groups were not comparable in several ways. It also becomes very clear that with the methodology used, one can make any nonsense look effective.
In the end, I am left with the impression that mutton is being presented as lamb, even worse: I think someone here is misleading us by trying to convince us that an utterly bogus therapy is effective. In my view, this study is as clear an example of scientific misconduct as I have seen for a long time.
The purpose of this recent investigation was to evaluate the association between chiropractic utilization and use of prescription opioids among older adults with spinal pain … at least this is what the abstract says. The actual paper tells us something a little different: The objective of this investigation was to evaluate the impact of chiropractic utilization upon the use of prescription opioids among Medicare beneficiaries aged 65 plus. That sounds to me much more like trying to find a CAUSAL relationship than an association.
Anyway, the authors conducted a retrospective observational study in which they examined a nationally representative multi-year sample of Medicare claims data, 2012–2016. The study sample included 55,949 Medicare beneficiaries diagnosed with spinal pain, of whom 9,356 were recipients of chiropractic care and 46,593 were non-recipients. They measured the adjusted risk of filling a prescription for an opioid analgesic for up to 365 days following the diagnosis of spinal pain. Using Cox proportional hazards modeling and inverse weighted propensity scoring to account for selection bias, they compared recipients of both primary care and chiropractic to recipients of primary care alone regarding the risk of filling a prescription.
The adjusted risk of filling an opioid prescription within 365 days of initial visit was 56% lower among recipients of chiropractic care as compared to non-recipients (hazard ratio 0.44; 95% confidence interval 0.40–0.49).
The authors concluded that, among older Medicare beneficiaries with spinal pain, use of chiropractic care is associated with significantly lower risk of filling an opioid prescription.
The way this conclusion is formulated is well in accordance with the data. However, throughout the paper, the authors imply that chiropractic care is the cause of fewer opioid prescriptions. For instance: The observed advantage of early chiropractic care mirrors the results of a prior study on a population of adults aged 18–84. The suggestion is that chiropractic saves patients from taking opioids.
It does not need a lot of fantasy to guess why some people might want to create this impression. I am sure that chiropractors would be delighted if the US public felt that their manipulations were the solution to the opioid crisis. For many months, they have been trying hard enough to pretend this is true. Yet, I know of no convincing data to demonstrate it.
The new investigation thus turns out to be a lamentable piece of pseudo research. Retrospective case-control studies can obviously not establish cause and effect, particularly if they do not even account for the severity of the symptoms or the outcomes of the treatment.