study design
Shiatsu is a Japanese form of so-called alternative medicine (SCAM) derived from Traditional Chinese Medicine using deep pressure on the paths of the postulated acupuncture meridians. Clinical observations on this topic are said to be encouraging, especially for the treatment of sleep and conduct disorders, but there is a lack of empirical data.
The objective of this study was to examine the possible therapeutic effects of shiatsu in a clinical population of children treated in child and adolescent psychiatry. It was designed as a qualitative descriptive and non-interventional study, conducted on children treated in day-care hospital units and outpatient clinical settings. Shiatsu was administered, at least during 3 sessions, to children with an autism spectrum disorder or other disorders according to ICD-11 criteria (such as conduct disorders with impulsivity or attention deficit).
The evaluation was performed by two independent researchers (a child psychiatrist and a psychologist who were not the caregivers) based on direct observation of children during the shiatsu sessions, combined with semi-structured non-inductive interviews with their parents, and data collected from focus groups conducted with the children’s caregivers. A phenomenological interpretive analysis (IPA) approach with Nvivo coding software was used to analyze the data.
Based on semi-structured interviews with 13 parents cross-referenced with data from 2 focus groups and direct observations of 7 children during 2 full shiatsu sessions for each observation, the results show that shiatsu has positive effects on
- internal tension (a relief effect, notably on aggressive behaviors directed against others or self),
- sleep (including improvement of sleep quality),
- social interaction,
- attention,
- verbalization of affects and traumatic memories of early childhood,
- perception of bodily limits.
As these children had several other treatments as well, it cannot be proved that the positive effects observed in this study are related specifically to shiatsu practice. Shiatsu may participate and facilitate the effects of other treatments. It is noteworthy that most of the children came willingly to the shiatsu sessions, ask their parents to repeat the shiatsu sessions at home, and indicate to the practitioner, from one session to the next, their elective body points where they wish to receive the application of shiatsu.
The authors concluded that the findings suggest therapeutic benefits of shiatsu, especially on externalize violence with a relief of aggressive behavior directed against others or self (knowing, moreover, that internal tension, sleep disorders and non-verbalization of affects or traumatic memories, all improved by shiatsu, are also all risk factors for externalize violence). These results highlight, therefore, the need to develop a daily practice of shiatsu in child and adolescent psychiatry. Further research is required to clarify the effects of shiatsu and ascertain better its underlying mechanisms based on this exploratory pilot study.
I do appreciate that, with a treatment that has not been submitted to many controlled clinical trials, researchers feel that they have to start from scratch, e.g. simple observations. However, they also must realize that their observations do not lend themselves to firm conclusions about the effects of the treatment. In the present case, the researchers do seem to be aware of this caveat but nevertheless make statements that go way beyond of what is warranted:
- the results show that shiatsu has positive effects on …
- Shiatsu may participate and facilitate the effects of other treatments
- the findings suggest therapeutic benefits of shiatsu, especially on externalize violence
- These results highlight, therefore, the need to develop a daily practice of shiatsu in child and adolescent psychiatry
I fear that these statements are not merely exaggerated but suspect they are also untrue. Testing them in properly controlled clinical trials would show whether my suspicion is correct. Meanwhile, I would like to remind
- researchers,
- reviewers,
- and journal editors
of their duty to be truthful and not mislead the public.
This study aimed to evaluate the number of craniosacral therapy sessions that can be helpful to obtain a resolution of the symptoms of infantile colic and to observe if there are any differences in the evolution obtained by the groups that received a different number of Craniosacral Therapy sessions at 24 days of treatment, compared with the control group which did not received any treatment.
Fifty-eight infants with colic were randomized into two groups:
- 29 babies in the control group received no treatment;
- babies in the experimental group received 1-3 sessions of craniosacral therapy (CST) until symptoms were resolved.
Evaluations were performed until day 24 of the study. Crying hours served as the primary outcome measure. The secondary outcome measures were the hours of sleep and the severity, measured by an Infantile Colic Severity Questionnaire (ICSQ).
Statistically significant differences were observed in favor of the experimental group compared to the control group on day 24 in all outcome measures:
- crying hours (mean difference = 2.94, at 95 %CI = 2.30-3.58; p < 0.001);
- hours of sleep (mean difference = 2.80; at 95 %CI = – 3.85 to – 1.73; p < 0.001);
- colic severity (mean difference = 17.24; at 95 %CI = 14.42-20.05; p < 0.001).
Also, the differences between the groups ≤ 2 CST sessions (n = 19), 3 CST sessions (n = 10), and control (n = 25) were statistically significant on day 24 of the treatment for crying, sleep and colic severity outcomes (p < 0.001).
The authors concluded that babies with infantile colic may obtain a complete resolution of symptoms on day 24 by receiving 2 or 3 CST sessions compared to the control group, which did not receive any treatment.
Why do SCAM researchers so often have no problem leaving the control group of patients in clinical trials without any treatment at all, while shying away from administering a placebo? Is it because they enjoy being the laughingstock of the science community? Probably not.
I suspect the reason might be that often they know that their treatments are placebos and that their trials would otherwise generate negative findings. Whatever the reasons, this new study demonstrates three things many of us already knew:
- Colic in babies always resolves on its own but can be helped by a placebo response (e.g. via the non-blinded parents), by holding the infant, and by paying attention to the child.
- Flawed trials lend themselves to drawing the wrong conclusions.
- Craniosacral therapy is not biologically plausible and most likely not effective beyond placebo.
Guest post by Norbert Aust and Viktor Weisshäupl
Readers of this blog may remember the recent study of Frass et al. about the adjunct homeopathic treatment of patients suffering from non-small cell lung cancer (here). It was published in 2020 by the ‘Oncologist’, a respectable journal, and came to stunning results about to the effectiveness of homeopathy.
In our analysis, however, we found strong indications for duplicity: important study parameters like exclusion criteria or observation time were modified post hoc, and data showed characteristics that occur when unwanted data sets get removed.
We, that is the German Informationsnetzwerk Homöopathie and the Austrian ‘Initiative für wissenschaftliche Medizin’, had informed the Medical University Vienna about our findings – and the research director then asked the Austrian Agency for Scientific Integrity (OeAWI) to review the paper. The analysis took some time and included not only the paper and publicly available information but also the original data. In the end, OeAWI corroborated our findings: The results are not based on sound research but on modified or falsified data.
Here is their conclusion in full:
The committee concludes that there are numerous breaches of scientific integrity in the Study, as reported in the Publication. Several of the results can only be explained by data manipulation or falsification. The Publication is not a fair representation of the Study. The committee cannot for all the findings attribute the wrongdoings and incorrect representation to a single individual. However following our experience it is highly unlikely that the principal investigator and lead author, but also the co-authors were unaware of the discrepancies between the protocols and the Publication, for which they bear responsibility. (original English wording)
Profil, the leading news magazine of Austria reported in its issue of October 24, 2022, pp 58-61 (in German). There the lead author, Prof. M. Frass, a member of Edzard’s alternative medicine hall of fame, was asked for his comments. Here is his concluding statement:
All the allegations are known to us and completely incomprehensible, we can refute all of them. Our work was performed observing all scientific standards. The allegation of breaching scientific integrity is completely unwarranted. To us, it is evident that not all documents were included in the analysis of our study. Therefore we requested insight into the records to learn about the basis for the final statement.
(Die Vorwürfe sind uns alle bekannt und absolut unverständlich, alle können wir entkräften. Unsere Arbeit wurde unter Einhaltung aller wissenschaftlichen Standards durchgeführt. Der Vorhalt von Verstößen gegen die wissenschaftliche Intergrität enbehrt jeder Grundlage. Für uns zeigt sich offenkundig, dass bei der Begutachtung unserer Studie nicht alle Unterlagen miteinbezogen wurden. Aus diesem Grunde haben wir um Akteneinsicht gebeten, um die Grundlagen für das Final Statment kennenzulernen.)
The OeAWI together with the Medical University Vienna asked the ‘Oncologist’ for a retraction of this paper – which has not occurred as yet.
Aging often contributes to a decrease in physical activity. As age advances, a decrease in muscle mass, muscle strength, and flexibility can impair physical function. One obvious way to prevent these developments might be regular physical exercise.
This open-label, randomized trial was intended to evaluate the effects of an integrated yoga module in improving the flexibility, muscle strength, and quality of life (QOL) of older adults. Participants were 96 older adults, aged 60-75 years (64.1 ± 3.95 years). The program was a three-month, yoga-based lifestyle intervention. The participants were randomly allocated to the intervention group (n = 48) or to a waitlisted control group (n = 48). The intervention group underwent three one-hour sessions of yoga weekly, with each session including loosening exercises, asanas, pranayama, and meditation spanning.
At baseline and post-intervention, the following assessments were made:
- spinal flexibility using a sit-and-reach test,
- back and leg strength using a back leg dynamometer,
- handgrip strength (HGS) and endurance (HGE) using a hand-grip dynamometer,
- Older People’s Quality of Life (OPQOL) questionnaire.
Analysis was performed employing Wilcoxon’s Sign Rank tests and Mann-Whitney Tests, using an intention-to-treat approach.
The results show that, compared to the control group, the intervention group experienced a significantly greater increase in spinal flexibility (P < .001), back leg strength (P < .001), HGE (P < .01), and QOL (P < .001) after three months of yoga.
The authors concluded that yoga can be used safely for older adults to improve flexibility, strength, and functional QOL. Larger randomized controlled trials with an active control intervention are warranted.
I agree with the authors that this trial was too small and not properly controlled. I disagree that their study shows yoga to be effective or safe. In fact, the two sentences of the conclusion do not seem to fit together at all.
Is it surprising that doing yoga exercises is better than doing nothing at all?
No!
Is it relevant to demonstrate this fact in an RCT?
No!
If anyone wants to test the value of yoga exercises, they must compare them to conventional exercises. And why don’t they do this? Could it be because they know they would be unlikely to show that yoga is superior?
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.
The present study was conducted to evaluate the effect of date palm on the sexual function of infertile couples. It was designed as a double-blind, placebo-controlled clinical trial conducted on infertile women and their husbands who referred to infertility clinics in Iran in 2019.
The intervention group was given a palm date capsule and the control group was given a placebo. Data were collected through female sexual function index and International Index of Erectile Function.
The total score of sexual function of females in the intervention group increased significantly from 21.06 ± 2.58 to 27.31 ± 2.59 (P < 0.0001). Also, other areas of sexual function in females (arousal, orgasm, lubrication, pain during intercourse, satisfaction) in the intervention group showed a significant increase compared to females in the control group, which was statistically significant (P < 0.0001).
All areas of male sexual function (erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction) significantly increased in the intervention group compared to the control group (P < 0.0001).
The authors concluded that the present study revealed that 1-month consumption of date palm has a positive impact on the sexual function of infertile couples.
In an attempt to explain the rational for this study, the authors state that, since ancient times, date palm has been used in Greece, China and Egypt to treat infertility and increase sexual desire and fertility in females. Rasekh indicated that Palm Pollen is effective in sperm parameters of infertile men. Administering date palm to male rats and measuring the sexual parameters of rats showed an improvement in their sexual function. Studies on animals have shown its effect on the parameters of semen analysis in male animals and increasing hormones.
So, the trial was what might call a ‘long shot’, even a very long one. But that does not render its findings less interesting. If the results could be confirmed, they would certainly have considerable significance.
But can they be confirmed?
I have some doubts.
Two things are remarkable, in my view.
- The study only had subjective endpoints.
- There was as good as no placebo effect in the control group.
How can this be?
One explanation might be that the verum and the placebo capsules were easily identified by their taste of other features. This would then lead to many patients being ‘deblinded’; in other words, the patients on verum would have known and expected to experience an effect, while the patients on placebo would have also known and be disappointed thus not even experiencing a placebo response.
This might be an apt reminder for trialists to include a check of the success of blinding in their list of outcome measures.
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.
This study aimed to evaluate the efficacy of Persian barley water in controlling the clinical outcomes of hospitalized COVID-19 patients. It was designed as a single-blind, add-on therapy, randomized controlled clinical trial and conducted in Shiraz, Iran, from January to March 2021. One hundred hospitalized COVID-19 patients with moderate disease severity were randomly allocated to receive routine treatment (per local protocols) with or without 250 ml of Persian barley water (PBW) daily for two weeks. Clinical outcomes and blood tests were recorded before and after the study period. Multivariable modeling was applied using Stata software for data analysis.
The length of hospital stay (LHS) was 4.5 days shorter in the intervention group than the control group regardless of history of cigarette smoking (95% confidence interval: -7.22, -1.79 days). Also, body temperature, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and creatinine significantly dropped in the intervention group compared to the control group. No adverse events related to PBW occurred.
The authors from the Department of Traditional Medicine, Shiraz University of Medical Sciences, Shiraz, Iran, concluded that this clinical trial demonstrated the efficacy of PBW in minimizing the LHS, fever, and levels of ESR, CRP, and creatinine among hospitalized COVID-19 patients with moderate disease severity. More robust trials can help find safe and effective herbal formulations as treatments for COVID-19.
I must admit, I did not know about PBW. The authors explain that PBW is manufactured from Hordeum vulgare via a specific procedure. According to recent studies, barley is rich in constituents such as selenium, tocotrienols, phytic acid, catechin, lutein, vitamin E, and vitamin C; these compounds are responsible for their antioxidant and anti-inflammatory properties. Barley grains also have immune-stimulating effects, antioxidant properties, protective effects on the liver and digestive systems, anti-cancer effects, and act to reduce uric acid levels.
But even if these effects would constitute a plausible mechanism for explaining the observed effects (which I do not think they do), the study itself is more than flimsy.
I do not understand why researchers investigating an important issue do not make sure that their study is as rigorous as possible.
- Why not use an adequately large sample size?
- Why not employ a placebo?
- Why not double-blind?
- Why not report the most important outcome, i.e. mortality?
As it stands, nobody will take this study seriously. Perhaps this is a good thing – but perhaps PBW does have positive effects (I know it’s a long shot) and, in this case, a poor-quality study would only prevent an effective therapy come to light.
