causation
The objective of this study was to evaluate the effect of acupuncture on cognitive task performance in college students.
Sixty students aged 18-25 years were randomly allocated into acupuncture group (AG) (n=30) and control group (CG) (n=30). The AG underwent 20 min of acupuncture/day, while the CG underwent their normal routine for 10 days. Assessments were performed before and after the intervention.
Between-group analysis showed a significant increase in AG’s six-letter cancellation test (SLCT) score compared with CG. Within-group analysis showed a significant increase in the scores of all tests (i.e. SLCT, forward and backward Digit span test [DST]) in AG, while a significant increase in backward DST was observed in CG.
The authors concluded that acupuncture has a beneficial effect on improving the cognitive function of college students.
I am unable to access the full paper [it is behind a paywall]. Thus, I am unable to assess the study in further detail. As I am skeptical about the validity of the effect, I can only assume that it is due to the expectation of the volunteers receiving acupuncture. There was not even an attempt to control for placebo effects!
The over-stated conclusion made me wonder what else the 1st author has published. It turns out he has three more Medline-listed papers to his name all of which are about so-called alternative medicine (SCAM).
The 1st one is an RCT similar to the one above, i.e. without an attempt to control for placebo effects. Its conclusion is equally over-stated: Acupuncture could be considered as an effective treatment modality for the management of primary dysmenorrhea.
The other two papers refer to one case report each. Despite the fact that case reports (as any researcher must know) do not lend themselves to conclusions about the effectiveness of the treatments employed, the authors’ conclusions seem to again over-state the case:
- This suggests that integrative Naturopathy and Yoga therapies could be considered as an adjuvant to conventional medicine in rheumatoid arthritis associated with type-2 diabetes and essential hypertension.
- Though the results are encouraging, further studies are required with larger sample size and advanced inflammatory markers.
What does that tell us?
I don’t know about you, but I would not rely on acupuncture to improve my mental performance.
Bioenergy (or energy healing) therapies are among the popular alternative treatment options for many diseases, including cancer. Many studies deal with the advantages and disadvantages of bioenergy therapies as an addition to established treatments such as chemotherapy, surgery, and radiation in the treatment of cancer. However, a systematic overview of this evidence is thus far lacking. For this reason, German authors reviewed and critically examined the evidence to determine what benefits the treatments have for patients.
In June 2022, a systematic search was conducted searching five electronic databases (Embase, Cochrane, PsychInfo, CINAHL and Medline) to find studies concerning the use, effectiveness, and potential harm of bioenergy therapies including the following modalities:
- Reiki,
- Therapeutic Touch,
- Healing Touch,
- Polarity Therapy.
From all 2477 search results, 21 publications with a total of 1375 patients were included in this systematic review. The patients treated with bioenergy therapies were mainly diagnosed with breast cancer. The main outcomes measured were:
- anxiety,
- depression,
- mood,
- fatigue,
- quality of life (QoL),
- comfort,
- well-being,
- neurotoxicity,
- pain,
- nausea.
The studies were predominantly of moderate quality and, for the most part, found no effect. In terms of QoL, pain, and nausea, there were some positive short-term effects of the interventions, but no long-term differences were detectable. The risk of side effects from bioenergy therapies appears to be relatively small.
The authors concluded that considering the methodical limitations of the included studies, studies with high study quality could not find any difference between bioenergy therapies and active (placebo, massage, RRT, yoga, meditation, relaxation training, companionship, friendly visit) and passive control groups (usual care, resting, education). Only studies with a low study quality were able to show significant effects.
Energy healing is as popular as it is implausible. What these ‘healers’ call ‘energy’ is not how it is defined in physics. It is an undefined, imagined entity that exists only in the imagination of its proponents. So why should it have an effect on cancer or any other condition?
My team conducted 2 RCT of energy healing (pain and warts); both failed to show positive effects. And here is what I stated in my recent book about energy healing for any ailment:
Energy healing is an umbrella term for a range of paranormal healing practices. Their common denominator is the belief in a mystical ‘energy’ that can be used for therapeutic purposes.
- Forms of energy healing have existed in many ancient cultures. The ‘New Age’ movement has brought about a revival of these ideas, and today energy healing systems are amongst the most popular alternative therapies in the US as well as in many other countries. Popular forms of energy healing include those listed above. Each of these are discussed and referenced in separate chapters of this book.
- Energy healing relies on the esoteric belief in some form of ‘energy’ which is distinct from the concept of energy understood in physics and refers to some life force such as chi in Traditional Chinese Medicine, or prana in Ayurvedic medicine.
- Some proponents employ terminology from quantum physics and other ‘cutting-edge’ science to give their treatments a scientific flair which, upon closer scrutiny, turns out to be but a veneer of pseudo-science.
- The ‘energy’ that energy healers refer to is not measurable and lacks biological plausibility.
- Considering its implausibility, energy healing has attracted a surprisingly high level of research activity. Its findings are discussed in the respective chapters of each of the specific forms of energy healing.
- Generally speaking, the methodologically best trials of energy healing fail to demonstrate that it generates effects beyond placebo.
- Even though energy healing is per se harmless, it can do untold damage, not least because it significantly undermines rational thought in our societies.
As you can see, I do not entirely agree with my German friends on the issue of harm. I think energy healing is potentially dangerous and should be discouraged.
This randomized clinical trial (RCT) tested whether acupuncture is effective for the prevention of chronic tension-type headaches (CTTH). The researchers recruited 218 participants who were diagnosed with CTTH.
- The participants in the intervention group received 20 sessions of true acupuncture (TA group) over 8 weeks. The acupuncture treatments were standardized across participants, and each acupuncture site was needled to achieve deqi sensation. Each treatment session lasted 30 minutes.
- The participants in the control group received the same sessions and treatment frequency of superficial acupuncture (SA group)—defined as a type of sham control by avoiding deqi sensation at each acupuncture site.
The main outcome measure was the responder rate at 16 weeks after randomization. Followed-up was 32 weeks. A responder was defined as a participant who reported at least a 50% reduction in the monthly number of headache days (MHDs).
The responder rate was 68.2% in the TA group (n=110) versus 48.1% in the SA group (n=108) at week 16 (odds ratio, 2.65; 95%CI, 1.5 to 4.77; p<0.001); and 68.2% in the TA group versus 50% in the SA group at week 32 (odds ratio, 2.4; 95%CI, 1.36 to 4.3; p<0.001). The reduction in MHDs was 13.1±9.8 days in the TA group versus 8.8±9.6 days in the SA group at week 16 (mean difference, 4.3 days; 95%CI, 2.0 to 6.5; p<0.001), and the reduction was 14±10.5 days in the TA group versus 9.5±9.3 days in the SA group at week 32 (mean difference, 4.5 days; 95%CI, 2.1 to 6.8; p<0.001). Four mild adverse events were reported; three in the TA group versus one in the SA group.
The authors concluded that the 8-week TA treatment was effective for the prophylaxis of CTTH. Further studies might focus on the cost-effectiveness of the treatment.
“Our study showed that deqi sensation could enhance the effect of acupuncture in the treatment of chronic TTH, and the effect of acupuncture lasted at least 6 months when the treatment was stopped,” said co-investigator Ying Li, MD, PhD, The Third Hospital/Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Why am I not convinced?
Assuming that all the findings are correctly reported, the study does not at all show that the treatment was effective. It merely demonstrates that those patients who knew that were receiving TA told the researcher that they improved more than those who knew they has sham acupuncture. The difference in outcomes is not in the least surprising: patients’ knowledge of having had the verum leads to a placebo effect and to social desirability (patients giving the researchers positive responses simply because they were thankful for being looked after). Patients’ knowledge of having had the sham treatment leads to disappointment and thus worse outcomes.
But this is not the only reason why I am skeptical about this study. The authors claim they achieved deqi at every treatment. That is 20 treatments in 110 patients or 2 200 deqis! I think someone might be telling porkies here. Deqi cannot reliably be elicited on every single occasion. I, therefore, feel that perhaps the authors of this trial were a bit more than generous when writing up their study, and I am reminded of the recent report claiming that more than 80% of clinical trial data from China are fabricated.
Dietary supplements are touted for cognitive protection, but supporting evidence is mixed. COSMOS-Mind tested whether daily administration of cocoa extract (containing 500 mg/day flavanols) versus placebo and a commercial multivitamin-mineral (MVM) versus placebo improved cognition in older women and men.
COSMOS-Mind, a large randomized two-by-two factorial 3-year trial, assessed cognition by telephone at baseline and annually. The primary outcome was a global cognition composite formed from mean standardized (z) scores (relative to baseline) from individual tests, including the Telephone Interview of Cognitive Status, Word List and Story Recall, Oral Trail-Making, Verbal Fluency, Number Span, and Digit Ordering. Using intention-to-treat, the primary endpoint was change in this composite with 3 years of cocoa extract use. The pre-specified secondary endpoint was change in the composite with 3 years of MVM supplementation. Treatment effects were also examined for executive function and memory composite scores, and in pre-specified subgroups at higher risk for cognitive decline.
A total of 2262 participants were enrolled (mean age = 73y; 60% women; 89% non-Hispanic White), and 92% completed the baseline and at least one annual assessment. Cocoa extract had no effect on global cognition (mean z-score = 0.03, 95% CI: -0.02 to 0.08; P = .28). Daily MVM supplementation, relative to placebo, resulted in a statistically significant benefit on global cognition (mean z = 0.07, 95% CI 0.02 to 0.12; P = .007), and this effect was most pronounced in participants with a history of cardiovascular disease (no history: 0.06, 95% CI 0.01 to 0.11; history: 0.14, 95% CI -0.02 to 0.31; interaction, nominal P = .01). Multivitamin-mineral benefits were also observed for memory and executive function. The cocoa extract by MVM group interaction was not significant for any of the cognitive composites.
The authors concluded that the Cocoa extract did not benefit cognition. However, COSMOS-Mind provides the first evidence from a large, long-term, pragmatic trial to support the potential efficacy of a MVM to improve cognition in older adults. Additional work is needed to confirm these findings in a more diverse cohort and to identify mechanisms to account for MVM effects.
This trial certainly has a few stunning features. For instance, its sample size was impressive and its follow-up period long. But it also has a few weak points. The study was conducted remotely via mail or telephone which means that compliance was impossible to control. Moreover, the outcome measures were subjective, and blinding was not checked. In addition, I fail to see a plausible mechanism of action. Most importantly, the generalizability of the results to the population at large seems questionable. It might make sense that older individuals many of whom might have low vitamin levels can profit from MVM. Whether this is also true for younger people who are well-nourished might be a different matter.
Even though most people do not think about it in this way, tea is a herbal remedy. We know that it is pleasant, but is it also effective?
This study explored the associations between tea drinking and the incident risk of type 2 diabetes mellitus(T2 DM). A dynamic prospective cohort study among a total of 27 841 diabetes-free permanent adult residents randomly selected from 2, 6, and 7 rural communities between 2006-2008, 2011-2012, and 2013-2014, respectively. Questionnaire survey, physical examination, and laboratory test were carried out among the participants. In 2018, the researchers conducted a follow-up through the electronic health records of residents. Cox regression models were applied to explore the association between tea drinking and the incident risk of T2 DM and estimate the hazard ratio(HR), and its 95%CI.
Among the 27 841 rural community residents in Deqing County, 10 726(39%) were tea drinkers, 8215 (77%) of which were green tea drinkers. A total of 883 new T2 DM incidents were identified until December 31, 2018, and the incidence density was 4.43 per 1000 person-years (PYs). The incidence density was 4.07/1000 PYs in those with tea drinking habits and 4.71/1000 PYs in those without tea drinking habits. The incidence density was 3.79/1000 PYs in those with green tea drinking habits. After controlling for sex, age, education, farming, smoking, alcohol consumption, dietary preference, body mass index, hypertension, impaired fasting glucose, and family history of diabetes, the risk of T2 DM among rural residents with tea drinking habits was 0.79 times higher than that among residents without tea drinking habits(HR=0.79, 95%CI 0.65-0.96), and the risk of T2 DM among residents with green tea drinking habits was 0.72 times higher than that among residents without tea drinking habits(HR=0.72, 95%CI 0.58-0.89). No significant associations were found between other kinds of tea and the risk of T2 DM, nor the amount of green tea-drinking.
The authors concluded that drinking green tea may reduce the risk of T2 DM among adult population in rural China.
Epidemiological studies of this nature resemble big fishing expeditions that can bring up all sorts of rubbish and – if lucky – also some fish. The question thus is whether this study identified an interesting association or just some odd rubbish.
A quick look into Medline seems to suggest great caution. Here are the conclusions from a few further case-control studies:
- In Chinese adults, daily green tea consumption was associated with a lower risk of incident T2D and a lower risk of all-cause mortality in patients with diabetes, but the associations for other types of tea were less clear. In addition, daily tea consumption was associated with a lower risk of diabetic microvascular complications, but not macrovascular complications.
- Green tea drinking was associated with an increased risk of T2D in Chinese adults. The mechanisms underlying the association need to be elucidated.
- Tea consumers had reduced risks of all-cause mortality and partial cause-specific mortality, but not for the risk of death from cancer. On the contrary, daily tea drinkers with smoking habits and excessive alcohol drinking had an increased risk of death from cancer.
Thus the question of whether tea drinking might prevent diabetes remains open, in my view.
Yet, the paper might teach us two important lessons:
- Case-control studies must be taken with a pinch of salt.
- Correlation is not the same as causation.
As numerous of my posts have demonstrated, chiropractic manipulations can cause severe adverse effects, including deaths. Several hundred have been documented in the medical literature. When discussing this fact with chiropractors, we either see denial or we hear the argument that such events are but extreme rarities. To the latter, I usually respond that, in the absence of a monitoring system, nobody can tell how often serious adverse events happen. The resply often is this:
You are mistaken because the Royal College of Chiropractors’ UK-based Chiropractic Patient Incident Reporting and Learning System (CPiRLS) monitors such events adequately.
I have heard this so often that it is time, I feel, to have a look at CPiRLS. Here is what it says on the website:
CPiRLS is a secure website which allows chiropractors to view, submit and comment on patient safety incidents.
Access to CPiRLS
CPiRLS is currently open to all UK-based chiropractors, all ECU members and members of the Chiropractic and Osteopathic College of Australasia. To access the secure area of the CPiRLS website, please click the icon below and insert the relevant CPiRLS username and password when prompted.
In the UK, these can normally be found on your Royal College of Chiropractors’ membership card unless the details are changed mid-year. Alternatively, email [email protected] from your usual email address and we will forward the details.
Alternatively, in the UK and overseas, secure access details can be obtained from your professional association.
National associations and organisations wishing to use CPiRLS, or obtain trial access to the full site for evaluation purposes, should contact The Royal College of Chiropractors at [email protected]
Please click the icon below to visit the CPiRLS site.
Yes, you understood correctly. The public cannot access CPiRLS! When I click on the icon, I get this:
Welcome to CPiRLS
CPiRLS, The Chiropractic Patient Incident Reporting and Learning System – is an online reporting and learning forum that enables chiropractors to share and comment on patient safety incidents.
The essential details of submitted reports are published on this website for all chiropractors to view and add comments. A CPiRLS team identifies trends among submitted reports in order to provide feedback for the profession. Sharing information in this way helps to ensure the whole profession learns from the collective experience in the interests of patients.
All chiropractors are encouraged to adopt incident reporting as part of a blame-free culture of safety, and a routine risk management tool.
CPiRLS is secure and anonymous. There is no known way that anyone reporting can be identified, nor do those running the system seek to identify you. For this security to be effective, you require a password to participate.
Please note that reporting to CPiRLS is NOT a substitute for the reporting of patient safety incidents to your professional association and/or indemnity insurers.
So, how useful is CPiRLS?
Can we get any information from CPiRLS about the incidence of adverse effects?
No!
Do we know how many strokes or deaths have been reported?
No!
Can chiropractors get reliable information from CPiRLS about the incidence of adverse effects?
No, because reporting is not mandatory and the number of reports cannot relate to incidence.
Are chiropractors likely to report adverse effects?
No, because they have no incentive and might even feel that it would give their profession a bad name.
Is CPiRLS transparent?
No!
Is CPiRLS akin to postmarketing surveillance as it exists in conventional medicine?
No!
How useful is CPiRLS?
I think I let my readers answer this question.
Earlier this year, I started the ‘WORST PAPER OF 2022 COMPETITION’. As a competition without a prize is no fun, I am offering the winner (that is the lead author of the winning paper) one of my books that best fits his/her subject. I am sure this will overjoy him or her.
And how do we identify the winner? I will continue blogging about nominated papers (I hope to identify about 10 in total), and towards the end of the year, I let my readers decide democratically.
In this spirit of democratic voting, let me suggest to you ENTRY No 8 (it is so impressive that I must show you the unadulterated abstract):
Introduction
Female sexual dysfunction (FSD) seriously affects the quality of life of women. However, most women do not have access to effective treatment.
Aim
This study aimed to determine the feasibility and effectiveness of the use of acupuncture in FSD treatment based on existing clear acupuncture protocol and experience-supported face-to-face therapy.
Methods
A retrospective analysis was performed on 24 patients with FSD who received acupuncture from October 2018 to February 2022. The Chinese version of the female sexual function index , subjective sensation, sexual desire, sexual arousal, vaginal lubrication, orgasm, sexual satisfaction, and dyspareunia scores were compared before and after the treatment in all 24 patients.
Main Outcome Measure
A specific female sexual function index questionnaire was used to assess changes in female sexual function before and after the acupuncture treatment.
Results
In this study, the overall treatment improvement rate of FSD was 100%. The Chinese version of the female sexual function index total score, sexual desire score, sexual arousal score, vaginal lubrication score, orgasm score, sexual satisfaction score, and dyspareunia score during intercourse were significantly different before and after the treatment (P < .05). Consequently, participants reported high levels of satisfaction with acupuncture. This study indicates that acupuncture could be a new and effective technique for treating FSD. The main advantages of this study are its design and efficacy in treating FSD. To the best of our knowledge, this is the first study to evaluate the efficacy of acupuncture in the treatment of FSD using the female sexual function index scale from 6 dimensions. The second advantage is that the method used (ie, the nonpharmacological method) is simple, readily available, highly safe with few side effects, and relatively inexpensive with high patient satisfaction. However, limitations include small sample size and lack of further detailed grouping, pre and post control study of patients, blank control group, and pre and post control study of sex hormones.
Conclusion
Acupuncture can effectively treat FSD from all dimensions with high safety, good satisfaction, and definite curative effect, and thus, it is worthy of promotion and application.
My conclusion is very different: acupuncture can effectively kill any ability for critical thinking.
I hardly need to list the flaws of this paper – they are all too obvious, e.g.:
- there is no control group; the results might therefore be due to a host of factors that are unrelated to acupuncture,
- the trial was too small to allow far-reaching conclusions,
- the study does not tell us anything about the safety of acupuncture.
The authors call their investigation a ‘pilot study’. Does that excuse the flimsiness of their effort? No! A pilot study cannot draw conclusions such as the above.
What’s the harm? you might ask; nobody will ever read such rubbish and nobody will have the bizarre idea to use acupuncture for treating FSD. I’m afraid you would be wrong to argue in this way. The paper already got picked up by THE DAILY MAIL in an article entitled “Flailing libido? Acupuncture could help boost sex drive, scientists say” which was as devoid of critical thinking as the original study. Thus we can expect that hundreds of desperate women are already getting needled and ripped off as we speak. And in any case, offensively poor science is always harmful; it undermines public trust in research (and it renders acupuncture research the laughing stock of serious scientists).
England’s record goalscorer Ellen White has revealed she suffered a punctured lung while receiving acupuncture treatment. The injury accelerated her decision to retire. White, 33, said she was still coming to terms with the “traumatic” injury.
Manchester City had sourced a “specialist” – evidently not such an excellent acupuncturist because the complication is avoidable with proper knowledge of anatomy – outside the club to provide her with acupuncture to treat her back problem because of a high number of injuries in the squad at the time. “If you’d said to me two or three years ago that you’re going to retire, I would have said ‘absolutely not’, but I’ve got to a time in my career,” she said. “I had a challenging time last year – coming back from the Olympics, I basically punctured my lung, and it was a lot for me to have to go through and a big reason that accelerated my want to retire.”
The injury happened when she returned to her club with a back spasm last summer. “It punctured my lung which isn’t something that happens normally, obviously,” she said. “It was a really traumatic time for me and something that I’m still figuring out now, still working through. I had to wait for the lung to basically inflate again. I had a needle put into my chest to drag all the air out then hopefully the lung would inflate again – which it has. At the time, I think for me, I just got into a zone of: ‘I need to get back playing. We’ve got these games – I want to be back playing for my club; I want to be back playing for England. I went very tunnel vision,” she said. “It wasn’t until a good two or three months later, it just hit me like a train, what actually happened and how traumatic it was.”
Despite her quick return to goalscoring form, which included becoming the Lionesses record goalscorer in November, the striker says she is still affected by the injury and suffers “phantom pain” where it feels like it is happening again. “It’s important for me now to tell my story, and say it was a big factor in my year and leading up to the decision of wanting to retire. Obviously, there are other factors that come into that as well. I don’t want it to happen to anybody else again is my main thing. I don’t want to walk away from the sport having not told it and not say that I want things in place for it not to happen to anyone else.”
______________________________
Pneumothorax is by far the most common of all the serious, potentially fatal complications caused by acupuncture. In thin individuals, several acupuncture points over the upper thorax are just a few centimeters away from the lung. Therefore, it is easily possible to puncture a lung by inserting an acupuncture needle. This is from my 2010 review of the subject:
About 90 deaths after acupuncture have been anecdotally documented in the medical literature. Thus, acupuncture has been associated with more deaths than most other ‘alternative’ therapies except herbal medicine … The fatalities are usually due to an acupuncture needle penetrating a vital organ. This, in turn, can cause pneumothorax, cardiac tamponade, or major haemorrhage. Most instances of this nature are reported in the Asian literature which, for most of us, is not easily accessible.
A 2013 review of ours located 1104 cases that had been reported in the Korean literature alone. However, the truth of the matter is that nobody can be sure of the exact incidence figures. Why? Because there is no monitoring system that would reliably record such incidences.
I would argue that every single case of acupuncture-induced pneumothorax tells us that the acupuncturist was not adequately trained. With proper knowledge of anatomy, such complications should not happen. Therefore, such instances are a rude reminder that so-called alternative medicine (SCAM) is far too often in the hands of “specialists” who are a danger to the public.
According to the authors of this study, research is lacking regarding osteopathic approaches in treating polycystic ovary syndrome (PCOS), one of the prevailing endocrine abnormalities in reproductive-aged women. Limited movement of pelvic organs can result in functional and structural deficits, which can be resolved by applying visceral manipulation (VM). Already with these two introductory sentences, I have problems. But for the moment, we can leave this aside and have a look at their trial.
The study was aimed at analyzing the effect of VM on dysmenorrhea, irregular, delayed, and/or absent menses, and premenstrual symptoms in PCOS patients.
Thirty Egyptian women with PCOS, with menstruation-related complaints and free from systematic diseases and/or adrenal gland abnormalities, prospectively 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 received the same hypocaloric diet plus VM to the pelvic organs and their related structures, according to assessment findings, 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 of treatments.
A total of 30 patients were included, with baseline mean age, weight, BMI, and 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. 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.
VM involves the manual manipulation by a therapist of internal organs, blood vessels and nerves (the viscera) mostly from outside the body, but sometimes, the therapist also puts his/her fingers into the patient’s vagina. It was developed by the osteopath Jean-Piere Barral. He stated that through his clinical work with thousands of patients, he created this modality based on organ-specific fascial mobilization. And through work in a dissection lab, he was able to experiment with visceral manipulation techniques and see the internal effects of the manipulations. According to its proponents, visceral manipulation is based on the specific placement of soft manual forces looking to encourage the normal mobility, tone, and motion of the viscera and their connective tissues. The idea is that these gentle manipulations may potentially improve the functioning of individual organs, the systems the organs function within, and the structural integrity of the entire body.
I don’t see any reason to believe the concepts of VM are plausible. Thus I find the hypothesis of this trial extremely far-fetched. The results are equally unconvincing. As we have often discussed, the ‘A+B vs B’ design cannot prove a causal relationship between the intervention and the outcome.
The most likely explanation for the findings is that the patients receiving VM experienced or merely reported improvements because the extra attention of mildly invasive treatments produced a powerful placebo effect. To put it bluntly: this is a poor, arguably unethical study where over-enthusiastic researchers reach a conclusion that is not supported by the data.
Despite considerable doubts about its effectiveness, osteopathic manipulative treatment (OMT) continues to be used for a range of pediatric conditions. Here is just one example of many osteopaths advertising their services:
I qualified as an Osteopath in 2009 after 4 years of intensive training from the British College of Osteopathic medicine, where I received a distinction for my efforts. After having two children I decided to do a 2-year Postgraduate training in Pediatric Osteopathy from the Osteopathic Centre for Children in London. Whilst at the centre I was lucky enough to meet a wide variety of children from premature babies in a Neonate Hospital ward to children with developmental issues and disabilities, children on the Autistic spectrum, to kids doing exams or experiencing high levels of stress. We also saw lots of children with normal coughs, colds, lumps and bumps.
And the ‘Institute of Osteopathy states this:
Parents visit osteopaths for a range of reasons to support their child’s health. Children, like adults, can be affected by general joint and muscle issues, which is one of the reasons people visit an osteopath. Parents will also take their children to visit an osteopath for a variety of other health reasons that may benefit from osteopathic care.
As osteopathic care is based on the individual needs of the patient, it will vary depending on your child’s age and the diagnosis. Osteopaths generally use a wide range of gentle hands-on techniques that focus on releasing tension, improving mobility and optimising function. This is often used together with exercise and helpful advice. Some osteopaths have been trained in very gentle techniques which are particularly suitable to assess and treat very young children, including new-borns. You do not need to consult your GP before you visit an osteopath, although you may wish to do so.
So, how good or bad is osteopathy for kids? Our systematic review wanted to find out. Specifically, the aim of this paper is to update our previous systematic review (SR) initially published in 2013 by critically evaluating the evidence for or against this treatment.
Eleven databases were searched (January 2012 to November 2021). Only randomized clinical trials (RCTs) of OMT in pediatric patients compared with any type of controls were considered. The Cochrane risk-of-bias tool was used. In addition, the quality of the evidence was rated using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria, as recommended by the Cochrane Collaboration.
Thirteen trials met the eligibility criteria, of which four could be subjected to a meta-analysis. The findings show that, in preterm infants, OMT has little or no effect on reducing the length of hospital stay (standardized mean difference (SMD) -0.03; 95% confidence interval (CI) -0.44 to 0.39; very low certainty of the evidence) when compared with usual care alone. Only one study (8.3%) was judged to have a low risk of bias and showed no effects of OMT on improving exclusive breastfeeding at one month. The methodological quality of RCTs published since 2013 has improved. However, adverse effects remain poorly reported.
We concluded that the quality of the primary trials of OMT has improved during recent years. However, the quality of the totality of the evidence remains low or very low. Therefore, the effectiveness of OMT for selected pediatric populations remains unproven.
These days, it is not often that I am the co-author of a systematic review. So, allow me to discuss one of my own papers for a change by making a few very brief points:
- Considering how many osteopaths treat children, the fact that only 13 trials exist is shameful. To me, it suggests that the osteopathic profession has little interest in research.
- The finding that adverse effects are poorly reported is even more shameful, in my view. It suggests that the few osteopaths who do some research don’t mind violating research ethics.
- The fact that overall our review fails to yield good evidence that osteopathy is effective for any pediatric condition is the most shameful finding of them all. It means that osteopaths are either not informed about the evidence for their own approach, or that they are informed but don’t give a hoot and treat kids regardless. In both cases, they behave unethically.
