clinical trial
This systematic review and meta-analysis was aimed at analyzing the effectiveness of craniosacral therapy in improving pain and disability among patients with headache disorders.
PubMed, Physiotherapy Evidence Database, Scopus, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases were searched in March 2023. Two independent reviewers searched the databases and extracted data from randomized clinical trials comparing craniosacral therapy with control or sham interventions. The same reviewers assessed the methodological quality and the risk of bias using the PEDro scale and the Cochrane Collaboration tool, respectively. Grading of recommendations, assessment, development, and evaluations was used to rate the certainty of the evidence. Meta-analyses were conducted using random effects models using RevMan 5.4 software.
The searches retrieved 735 papers, and 4 studies were finally included. The craniosacral therapy provided statistically significant but clinically unimportant change on pain intensity (Mean difference = –1.10; 95% CI: –1.85, –0.35; I2: 44%), and no change on disability or headache effect (Standardized Mean Difference = –0.34; 95% CI –0.70, 0.01; I2: 26%). The certainty of the evidence was downgraded to very low.
The authors concluded that very low certainty of evidence suggests that craniosacral therapy produces clinically unimportant effects on pain intensity, whereas no significant effects were observed in disability or headache effect.
I find it strange that researchers seem so frequently unable to formulate their conclusions clearly. Is it political correctness? Or are they somehow favorably inclined (i.e. biased) towards the treatment that they pretend to critically evaluate?
Let’s look at the facts related to this review:
- Craniosacral therapy (CST) is utterly implausible.
- Only 4 RCTs were found.
- They were of poor quality.
- They were published mostly by people who want to promote CST.
- Therefore the overall statistically significant effect is most likely a false-positive result.
- This means that the conclusion should be much more straight forward.
I suggest something along the following lines:
A critical evaluation of the existing RCTs failed to find convincing evidence that CST is an effective treatment for headache disorders.
Exercise is often cited as a major factor contributing to improved cognitive functioning. As a result, the relationship between exercise and cognition has received much attention in scholarly literature. Systematic reviews and meta-analyses present varying and sometimes conflicting results about the extent to which exercise can influence cognition. The aim of this umbrella review was to summarize the effects of physical exercise on cognitive functions (global cognition, executive function, memory, attention, or processing speed) in healthy adults ≥ 55 years of age.
This review of systematic reviews with meta-analyses invested the effect of exercise on cognition. Databases (CINAHL, Cochrane Library, MEDLINE, PsycInfo, Scopus, and Web of Science) were searched from inception until June 2023 for reviews of randomized or non-randomised controlled trials. Full-text articles meeting the inclusion criteria were reviewed and methodological quality assessed. Overlap within included reviews was assessed using the corrected covered area method (CCA). A random effects model was used to calculate overall pooled effect size with sub-analyses for specific cognitive domains, exercise type and timing of exercise.
A total of 20 met the inclusion criteria. They were based on 332 original primary studies. Overall quality of the reviews was considered moderate with most meeting 8 or more of the 16 AMSTAR 2 categories. Overall pooled effects indicated that exercise in general has a small positive effect on cognition (d = 0.22; SE = 0.04; p < 0.01). Mind–body exercise had the greatest effect with a pooled effect size of (d = 0.48; SE = 0.06; p < 0.001). Exercise had a moderate positive effect on global cognition (d = 0.43; SE = 0,11; p < 0,001) and a small positive effect on executive function, memory, attention, and processing speed. Chronic exercise was more effective than acute exercise. Variation across studies due to heterogeneity was considered very high.
The authors concluded that mind–body exercise has moderate positive effects on the cognitive function of people aged 55 or older. To promote healthy aging, mind–body exercise should be used over a prolonged period to complement other types of exercise. Results of this review should be used to inform the development of guidelines to promote healthy aging.
It seems to me that the umbrella review hides the crucial fact that many of the primary studies had major flaws, e.g. in terms of:
- lack of randomisation,
- lack of blinding.
Eleven studies investigated the effects of aerobic exercise on cognition. Only three studies investigated the effects of mind body exercise on cognition, two analysed the effects of resistance exercise, and five investigated the effects of mixed exercise interventions. I am therefore mystified how the authors managed to arrive at such a hyped conclusion in favour of the effectiveness of mind body exercises. Even an optimistic interpretation of the data would allow merely a weak indication that a positive effect might exist. To state that mind body exercises should be promoted for ‘healthy aging’ borders on the irresponsible, in my view. Surely even the most naive researcher must see that, for such a far-reaching recommendation, we would need much more solid evidence.
I strongly suspect that a proper review of the primary studies of mind body exercise with a critical evaluation of the quality of the primary studies would lead to dramatically different conclusion.
It has been reported that two London councils have written to parents to warn that children who are not vaccinated against measles may need to self-isolate for 21 days if a classmate is infected with the disease. It comes after modelling by the UK Health Security Agency (UKHSA) warned that up to 160,000 cases could occur in the capital alone as a result of low vaccination rates. Just three-quarters of London children have received the two required doses of the MMR jab, which protects against measles. This is 10 per cent lower than the national average.
Barnet Council wrote to parents on July 20 warning that any unvaccinated child identified as a close contact of a measles case could be asked to self-isolate for up to 21 days. “Measles is of serious concern in London due to low childhood vaccination rates. Currently we are seeing an increase in measles cases circulating in neighbouring London boroughs, so now is a good time to check that your child’s MMR vaccination – which not only protects your child against measles but also mumps and rubella – is up to date,” the letter reads. “Children who are vaccinated do not need to be excluded from school or childcare,” the letter added.
Neighbouring Haringey Council also warned that children without both MMR doses may be asked to quarantine for 21 days. Just over two-thirds (67.9 per cent) of children in the area had received both doses by the age of five. The councils stated that they had sent the letters based on guidance by the UKHSA, but the agency said that headteachers should consider “excluding” unvaccinated pupils who become infected with measles rather than instructing them to self-isolate.
Data published by the UKHSA showed that 128 cases of measles were recorded between January 1 and June 30 this year, compared to 54 cases in the whole of 2022. Two-thirds of the cases were detected in London. The agency have said that there is a high risk of cases linked to overseas travel leading to outbreaks in specific population groups such as young people and under-vaccinated communities.
Dr Vanessa Saliba, a consultant epidemiologist at UKHSA, said: “When there are measles cases or outbreaks in nurseries or schools, the UKHSA health protection team will assess the situation, together with the school and other local partners, and provide advice for staff and pupils. “Those who are not up to date with their MMR vaccinations will be asked to catch up urgently to help stop the outbreak and minimise disruption in schools.”
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Measles is a significant concern with approximately 10 million people infected annually causing over 100,000 deaths worldwide. In the US before use of the measles vaccine, there were estimated to be 3 to 4 million people infected with measles annually, causing 400 to 500 deaths. Complications of measles include otitis media, diarrhea, pneumonia, and acute encephalitis. Measles is a leading cause of blindness in the developing world, especially in those who are vitamin A deficient. Malnourished children with measles are also at higher risk of developing noma (or cancrum oris), a rapidly progressive gangrenous infection of the mouth and face. Most deaths due to measles are caused by pneumonia, diarrhea, or neurological complications in young children, severely malnourished or immunocompromised individuals, and pregnant women. A rare sequela of measles is subacute sclerosing panencephalitis.
Back in 2003, we investigated what advice UK homeopaths, chiropractors and general practitioners give on measles, mumps and rubella vaccination programme (MMR) vaccination via the Internet. Online referral directories listing e-mail addresses of UK homeopaths, chiropractors and general practitioners and private websites were visited. All addresses thus located received a letter of a (fictitious) patient asking for advice about the MMR vaccination. After sending a follow-up letter explaining the nature and aim of this project and offering the option of withdrawal, 26% of all respondents withdrew their answers. Homeopaths yielded a final response rate (53%, n = 77) compared to chiropractors (32%, n = 16). GPs unanimously refused to give advice over the Internet. No homeopath and only one chiropractor advised in favour of the MMR vaccination. Two homeopaths and three chiropractors indirectly advised in favour of MMR. More chiropractors than homeopaths displayed a positive attitude towards the MMR vaccination. We concluded that some complementary and alternative medicine providers have a negative attitude towards immunisation and means of changing this should be considered.
The problem is by no means confined to the UK. German researchers, for instance, showed that belief in homeopathy and other parental attitudes indicating lack of knowledge about the importance of vaccinations significantly influenced an early immunisation. Moreover, being a German homeopath has been independently associated with lower own vaccination behavior. Data from France paint a similar picture.
Some homeopaths, of course, claim that ‘homeopathic vaccinations’ are effective and preferable. My advice is: DON’T BELIEVE THESE CHARLATANS! A recent study demonstrated that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.
This randomised, double blind controlled trial compared the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
The interventions were:
- curcumin alone (C),
- omeprazole alone (O),
- curcumin plus omeprazole (C+O).
Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Main outcome measure was unctional dyspepsia symptoms on days 28 and 56, assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
A total of 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
The authors concluded that curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
This study, which was funded by the Thai Traditional and Alternative Medicine Fund, has been picked up by the press and is being lauded as a solid proof of efficacy. Its authors too are not half proud of their splendid trial:
This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia. PPIs, widely used and approved for over-the-counter use, were compared with curcumin, a popular herbal remedy. The study design, including double blind randomisation, minimised biases. Participants met strict criteria, underwent endoscopy and were tested for H pylori infection. Furthermore, we implemented measures to minimise biases by ensuring that the individuals administering the drugs, participants receiving the drugs and individuals conducting the assessment remained blinded to the type of medications administered to the participants. The trial was carried out in hospitals, and certified individuals used standardised questionnaires for assessments. Statistical methods were appropriate and followed accepted principles.
Two follow-up appointments were scheduled, and blood tests showed no abnormal symptoms or liver function abnormalities. However, participants with high body mass index indicated a trend towards liver function impairment in the curcumin group, suggesting the need for larger studies. Some participants did not provide follow-up information, which is a study weakness. However, the number of participants who provided this information was sufficient for statistical analysis and the majority of the participants attended the follow-up visit. Therefore, it can be deduced from the results that even if the number of participants followed after drug administration increased, the study findings would not be significantly different. Another limitation of this study was the absence of long term follow-up data for all patients after treatment. This is a question that will require further investigation.
The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects. The study was unbiased, partially funded by government organisations and the first well designed trial comparing curcumin with PPI for functional dyspepsia, with confirmation through endoscopy and ruling out H pylori infection. Limitations of this study included the small number of patients who were lost to follow-up and the lack of long term follow-up data.
However, I am far less impressed.
Why?
Curcumin is bright yellow and has a very distinct taste/smell. Even though curumin was given in capsules, patients can easily tell what they are taking. I therefore doubt that they were adequately blinded. In fact, the authors seem to agree when they state the following:
We observed that despite improvements in pain and non-pain scores, there was no significant improvement in the SODA satisfaction scores in the O and C+O groups (table 3). A possible explanation for this observation could be related to the taste and/or smell of curcumin, which might have caused reduced pleasantness for the participants while ingesting it. This potential discomfort could offset the improvements in pain and non-pain symptoms, leading to the non-significant change in satisfaction score. Further studies may be needed to explore this hypothesis as well as to improve the palatability of curcumin.
Sadly, the success of blinding (which under such circumstances should always be tested) was not reported and probably not even quantified. If many patients were de-blinded, it seems inevitable that their expectation influenced the results. In other words, the much-lauded effect of curcumin might just be due to placebo and curcumin might be entirely useless. Or, to put it bluntly, the trial was not nearly as good as many made it out to be.
PS
Sad to see that the reviewers of a reputable journal failed to pick up on this significant flaw.
The objectives of this randomized double-blind placebo-controlled clinical trial were to determine if there:
- (a) is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD;
- (b) are any specific effects the homeopathic consultation alone in the treatment of ADHD;
- (c) are any specific effects of homeopathic medicines in the treatment of ADHD.
Children aged 6–16 years diagnosed with ADHD were randomized to one of three arms:
- Arm 1 (Remedy and Consultation);
- Arm 2 (Placebo and Consultation);
- Arm 3 (Usual Care).
The primary outcome measure was the change of the Conner 3 Global Index-Parent T-score (CGI-P T score) between baseline and 28 weeks.
The results showed an improvement in ADHD symptoms as measured by the CGI-P T score in the two groups (Arms 1 and 2) that received consultations with a homeopathic practitioner when compared with the usual care control group (Arm 3). Parents of the children in the study who received homeopathic consultations (Arms 1 and 2) also reported greater coping efficacy compared with those receiving usual care (Arm 3). There was no difference in adverse events among the three study arms.
The authors concluded that, in this study, homeopathic consultations provided over 8 months with the use of homeopathic remedy was associated with a decrease in ADHD symptoms in children aging 6–16 years when compared with usual treatment alone. Children treated with homeopathic consultations and placebo experienced a similar decrease in ADHD symptoms; however, this finding did not reach statistical significance when correcting for multiple comparisons. Homeopathic remedies in and of themselves were not associated with any change in ADHD symptoms.
In the discussion section, the authors make their findings a little clearer: “The findings are generally consistent with a recent meta-analysis that concluded that (i)ndividualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD. Similar to the meta-analysis, the authors found individualized homeopathy (consultation plus remedy) resulted in improvement in ADHD symptoms. However, the data suggest that this effect is not due to the remedy component of the intervention.”
The authors do not cite the (to the best of my knowledge) only study that had a very similar aim, namely differentiating between the effects of the homeopathic remedy and the homeopathic consultation. It was conducted by the late George Lweith who certainly was not against homeopathy. The conclusions of this trial were as follows: Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable rheumatoid arthritis.
Both trials confirm what rational thinkers have been saying for many years: the effects that many people experience after homeopathic therapy are not due to the homeopathic remedy but to the usually long and empathetic therapeutic encounter, the placebo effect, and other non-specific effects. To put it bluntly homeopathy is a kind of amateur psychotherapy.
Before someone now claims that this means homeopathy is fine, let me tell you this: no, it is not fine! If someone needs psychotherapy, he/she should see not an amateur but a professional, i.e. a psychologist who is properly trained in what she can and cannot do.
This study aimed to evaluate whether individualized homeopathic medicines have a greater adjunctive effect than adjunctive placebos in the treatment of moderate and severe cases of coronavirus disease 2019 (COVID-19). It was designed as a randomized, single-blind, placebo-controlled trial set in the clinical context of standard care. Patients admitted in a tertiary care hospital, suffering from moderate or severe COVID-19 and above 18 years of age were included. In total, 150 patients were randomly divided into two groups to receive either:
- individualized homeopathic medicines
- or placebos.
Both options were administered in addition to the standard treatment of COVID-19.
The primary outcome was time taken to achieve RT-PCR-confirmed virus clearance for COVID-19. Secondary outcomes were changes in the Clinical Ordinal Outcomes Scale (COOS) of the World Health Organization, the patient-reported MYMOP2 scale, and several biochemical parameters. Parametric data were analyzed using unpaired t-test. Non-parametric data were analyzed using the Wilcoxon signed rank test. Categorical data were analyzed using Chi-square test.
In total, 72 participants of the add-on homeopathy (AoH) group showed conversion of RT-PCR status to negative, in an average time of 7.53 ± 4.76 days (mean ± SD), as compared with 11.65 ± 9.54 days in the add-on placebo (AoP) group (p = 0.001). The mean COOS score decreased from 4.26 ± 0.44 to 3.64 ± 1.50 and from 4.3 ± 0.46 to 4.07 ± 1.8 in the AoH and AoP groups respectively (p = 0.130). The mortality rate for the AoH group was 9.7% compared with 17.3% in the AoP group. The MYMOP2 scores between the two groups differed significantly (p = 0.001), in favor of AoH. Inter-group differences in the pre- and post- mean values of C-reactive protein, fibrinogen, total leukocyte count, platelet count and alkaline phosphatase were each found to be statistically significant (p <0.05), favoring AoH; six other biochemical parameters showed no statistically significant differences.
The authors concluded that the study suggests homeopathy may be an effective adjunct to standard care for treating moderate and severe COVID-19 patients. More rigorous, including double-blinded, studies should be performed to confirm or refute these initial findings.
I do agree with the authors that more rigorous studies are needed before we can accept these findings. As it stands, this study seems to have multiple flaws:
- I fail to understand why they did not design their trial as a double-blind study. The reason given by the authors makes little sense to me.
- I also have my doubts that the study was even single-blind. If I understand it correctly, the placebo group was did not benefit from the detailed homeopathic history taking that is necessary to find the optimal homeopathic remedy. If that is so, unblinding of patients is inevitable.
- The authors themselves point out that the relevance of many outcome measures is questionable
Generally speaking, I find the results suspicious, implausible, and frankly too good to be true. I might also point out that the authors’ afilitation do not inspire much trust in their objectivity:
- 1Central Council for Research in Homoeopathy, New Delhi, India.
- 2Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India, New Delhi, India.
- 3Rejoice Health Foundation, New Delhi, India.
- 4Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital and National Cancer Institute, All India Institute of Medical Sciences, Ministry of Health and Family Welfare, New Delhi, India.
- 5Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, Ministry of Health and Family Welfare, New Delhi, India.
Neither do these statements:
Funding
The study was funded by the Central Council for Research in Homoeopathy, Ministry of AYUSH, Government of India. The funder approved the study through its review committees, delegated/recruited staff for conducting the study, and facilitated all collaborative procedures.
Conflict of Interest
None declared.
Lastly, I do wonder why the authors published their study in the 3rd class journal ‘Homeopathy’. Surely, such findings – if true – deserve to be published in a journal of a decent reputation!
This study aimed to compare the effects of cognitive functional therapy (CFT) and movement system impairment (MSI)-based treatment on pain intensity, disability, Kinesiophobia, and gait kinetics in patients with chronic non-specific low back pain (CNSLBP).
In a single-blind randomized clinical trial, the researchers randomly assigned 91 patients with CNSLBP into CFT (n = 45) and MSI-based treatment (n = 46) groups. An 8-week training intervention was given to both groups. The researchers measured the primary outcome, which was pain intensity (Numeric rating scale), and the secondary outcomes, including disability (Oswestry disability index), Kinesiophobia (Tampa Kinesiophobia Scale), and vertical ground reaction force (VGRF) parameters at self-selected and faster speed (Force distributor treadmill). They evaluated patients at baseline, at the end of the 8-week intervention (post-treatment), and six months after the first treatment. Mixed-model ANOVA was used to evaluate the effects of the interaction between time (baseline vs. post-treatment vs. six-month follow-up) and group (CFT vs. MSI-based treatment) on each measure.
CFT showed superiority over MSI-based treatment in reducing pain intensity (P < 0.001, Effect size (ES) = 2.41), ODI (P < 0.001, ES = 2.15), and Kinesiophobia (P < 0.001, ES = 2.47) at eight weeks. The CFT also produced greater improvement in VGRF parameters, at both self-selected (FPF[P < 0.001, ES = 3], SPF[P < 0.001, ES = 0.5], MSF[P < 0.001, ES = 0.67], WAR[P < 0.001, ES = 1.53], POR[P < 0.001, ES = 0.8]), and faster speed, FPF(P < 0.001, ES = 1.33, MSF(P < 0.001, ES = 0.57), WAR(P < 0.001, ES = 0.67), POR(P < 0.001, ES = 2.91)] than the MSI, except SPF(P < 0.001, ES = 0.0) at eight weeks.
The authors concluded that this study suggests that the CFT is associated with better results in clinical and cognitive characteristics than the MSI-based treatment for CNSLBP, and the researchers maintained the treatment effects at six-month follow-up. Also, This study achieved better improvements in gait kinetics in CFT. CTF seems to be an appropriate and applicable treatment in clinical setting.
To understand this study, we need to know what CFT and MSI exactly entailed. Here is the information that the authors provide:
Movement system impairment-based treatment
The movement system impairment-based treatment group received 11 sessions of MSI-based treatment over the 8 weeks for 60 min per session with a supervision of a native speaker experienced (above 5 years) physical therapist with the knowledge of MSI-based treatment. The researchers designed the MSI-based treatment uniquely for each patient based on the interview, clinical examination, and questionnaires, just like they did with the CFT intervention. First, they administered standardized tests to characterize changes in the patient’s low back pain symptoms, and then they modified the treatment to make it more specific based on the participant’s individual symptoms. Depending on the participant’s direction-specific low back pain classification, they performed the intervention following one of the five MSI subgroups namely [1] rotation, [2] extension, [3] flexion, [4] rotation with extension, and [5] rotation with flexion. Finally, Patients treated using the standardized MSI protocol as follows: [1] education regarding normal postures and movements such as sitting, walking, bending, standing, and lying down; [2] education regarding exercises to perform trunk movements as painlessly as possible; and [3] prescription of functional exercises to improve trunk movement [32].
Cognitive functional therapy
Cognitive functional therapy was prescribed for each patient in CFT group based the CFT protocol conducted by O’Sullivan et al. (2015). Patients received supervised 12 sessions of training over the 8-week period with 60 min per session provided with another physical therapist who had been trained in CFT treatment. In this protocol, a physical therapist with more than 5 years of experience conducted an interview and physical examination of the patients to determine their own unique training programs, considering modifiable cognitive, biopsychosocial, functional, and lifestyle behavior factors. The intervention consists of the following 3 main stages: [1] making sense of pain that is completely reflective, where physical therapist could use the context of the patient’s own story to provide a new understanding of their condition and question their old beliefs [2] exposure with control which is designed to normalize maladaptive or provocative movement and posture related to activities of daily living that is integrated into each patient’s functional impairments, including teaching how to relax trunk muscles, how to have normal body posture while sitting, lying, bending, lifting, moving, and standing, and how to avoid pain behaviors, which aims to break poor postural habits; and [3] lifestyle change which is investigating the influence of unhealthy lifestyles in the patient’s pain context. Assessing the individual’s body mass, nutrition, quality of sleep, levels of physical activity or sedentary lifestyle, smoking, and other factors via video calls. Identifying such lifestyle factors helped us to individually advise and design exercise programs, rebuild self-confidence and self-efficacy, promote changes in lifestyle, and design coping strategies.
I must admit that I am not fully convinced.
Firstly, the study was not large and we need – as the authors state – more evidence. Secondly, I am not sure that the results show CFT to be more effective that MSI. They might merely indicate 1) that the bulk of the improvement is due to non-specific effects (e.g. reression towards the mean, natural history of the condition, placebo) and 2) that CFT is less harmful than MSI.
My conclusion:
we need not just more but better evidence.
This study aimed to compare the effectiveness of three distinct interventions – Yoga, Naturopathy, and Conventional medical management – in alleviating pain, reducing disability, enhancing spinal mobility, and improving the quality of life in individuals with low back pain. Ninety participants were recruited and randomly divided into three groups.
- The first group (group 1) received Yoga,
- the second group (group 2) received Naturopathy treatments,
- the third group served as the control and received conventional medications.
Visual Analogue Scale (VAS) scores, Oswestry Disability Index (ODI), Flexion Test-Finger to Floor Test (FTFT) results, and Quality of Life (QOL) were assessed at baseline and after a 10-day intervention period for all groups.
Overall comparisons between the groups, utilizing ANOVA, revealed marked differences in pain severity, disability index, daily functional capacity, and Quality of Life (QoL) improvements following respective interventions. Substantial improvements were also noted within the yoga and naturopathic medicine groups across multiple variables.
The authors concluded that the results of this comparative analysis emphasize the effectiveness of Yoga, Naturopathy, and Conventional Medical Treatment in managing low back pain. All three interventions demonstrated significant improvements in pain intensity, disability, spinal mobility, and quality of life. This study contributes valuable insights into the diverse therapeutic approaches for low back pain management, highlighting the potential of holistic and alternative treatments to enhance patients’ well-being.
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This is a remarkably poor study. Its flaws are too numerous to account for them all here. Let me focus on just a three that stand out.
- All we learn about the 3 treatment regimen is this (and it clearly not enough to do an independent replication of this trial):
Yoga Group:
Participants in the Yoga Group underwent a specifically designed integrated approach of Yoga therapy (IAYT) for back pain, incorporating relaxation techniques, spinal movements, breathing exercises, pranayama, and deep relaxation techniques. The intervention was conducted by qualified yoga instructors at SDM College of Naturopathy and Yogic Sciences.
Naturopathy Group:
Participants in the Naturopathy Group received neutral spinal baths and partial massages. The spinal bath was administered at Government Yoga & Nature Cure Out Patient Center, Puttur, and massages were performed by trained naturopathy therapists.
Conventional Medicine Group:
Participants in the Conventional Medicine Group received standard medical treatments for low back pain as recommended by orthopedic physicians from S.D.M Medical College, Dharward
- As an equivalence trial, the sample size of this study is far too small. This means that its findings are most likely caused by coincidence and not by the interventions applied.
- There was no attempt of blinding the patients. Therefore, the results – if they were otherwise trustworthy – would be dominated by expectations and not by the effects of the treatments.
Altogether, this study is, I think, a good example for the fact that
poor research often is worse than no research at all.
Women experience more problems in their sexual functioning after childbirth. Due to the high prevalence of sexual problems during the lactation period, the World Health Organization suggests that measures are needed to improve women’s sexual functioning during breastfeeding. This study investigated the effect of auricular acupressure on sexual functioning among lactating women.
A randomized, sham-controlled trial was conducted between October 2019 to March 2020 in urban comprehensive health centers of Qazvin, Iran. Seventy-six women who had been lactating between six months and one year postpartum were randomly assigned to auricular acupressure group (n=38) or sham control group (n=38) using a balanced block randomization method. The intervention group received ear acupressure in 10 sessions (at four-day intervals) and control group received the sham intervention at the same intervals. Sexual functioning was the primary outcome of the study (assessed using the Female Sexual Function Index) before and at three time points post-intervention (immediately after, one month after, and two months after). The secondary outcome was sexual quality of life assessed using Sexual Quality of Life-Female Version.
Auricular acupressure had a large effect on female sexual functioning at all three post-intervention time points:
- immediately after the intervention (adjusted mean difference [95% CI]: 8.37 [6.27; 10.46] with Cohen’s d [95% CI]: 1.81[1.28; 2.34]),
- one month after the intervention (adjusted mean difference [95% CI]: 8.44 [6.41; 10.48] with Cohen’s d [95% CI]: 2.01 [1.46; 2.56]),
- two months after the intervention (adjusted mean difference [95% CI]: 7.43 [5.12; 9.71] with Cohen’s d [95% CI]: 1.57 [1.06; 2.08]).
Acupressure significantly increased participants’ sexual quality of life on the Sexual Quality of Life-Female scale by 13.73 points in the intervention group compared to the control group (p<0.001). The effect size of intervention for female sexual quality was large (adjusted Cohen’s d [95% CI]: 1.09 [0.58; 1.59]). Weekly frequency of sexual intercourse in the intervention group significantly increased compared to sham control group (p<0.001). These changes were clinically significant for sexual functioning and sexual quality of life.
The authors concluded that auricular acupressure was effective in increasing quality of sexual life and sexual functioning among lactating women. Although further research is needed to confirm the efficacy of auricular acupressure, based on the present study’s findings, the use of auricular acupressure by women’s healthcare providers after childbirth is recommended.
One possible explanation for this result is that the study was de-blinded; the sham treatment might not have been distinguished from the verum, or the verbal and/or non-verbal communications between the therapist and the patients contributed to a de-blinding effect. As the sucess of blinding was not reported and probably not even tested, we cannot know. The authors explain that auricular acupressure might improve both endocrine function (increased sex hormones including androgens and estrogens) and its physiological consequences (e.g., vaginal dryness, and vaginal epithelial atrophy), as well as reducing fatigue and insomnia problems (which might increase sexual desire).
Personally, I find this VERY hard to believe. Auricular acupressure or auriculotherapy, as it is also called, was invented by Paul Nogier in the 1950s. Its assumptions are not in line with our knowledge of anatomy and physiology. The different maps used by proponents of auriculotherapy show embarrassing disagreements. The therapy is being promoted as a treatment for many conditions. However, the clinical evidence that it might be effective is weak, not least because many of the clinical trials are of low quality and thus unreliable. One of the first rigorous tests of auriculotherapy was published in 1984 by one of the most prominent researchers of pain, R. Melzack. Here is the abstract[2]:
Enthusiastic reports of the effectiveness of electrical stimulation of the outer ear for the relief of pain (“auriculotherapy”) have led to increasing use of the procedure. In the present study, auriculotherapy was evaluated in 36 patients suffering from chronic pain, using a controlled crossover design. The first experiment compared the effects of stimulation of designated auriculotherapy points, and of control points unrelated to the painful area. A second experiment compared stimulation of designated points with a no-stimulation placebo control. Pain-relief scores obtained with the McGill Pain Questionnaire failed to show any differences in either experiment. It is concluded that auriculotherapy is not an effective therapeutic procedure for chronic pain.
Today we have an abundance of clinical trials of this therapy. Their results are by no means uniform. It is therefore best not to rely on single studies but on systematic reviews that include the evidence from all reliable trials. Our review concluded that “because of the paucity and of the poor quality of the data, the evidence for the effectiveness of auricular therapy for the symptomatic treatment of insomnia is limited. Further, rigorously designed trials are warranted to confirm these results.”[3] Other, less rigorous reviews arrive at more positive conclusions; due to the often poor quality of the primary studies, they should, however, be interpreted with great caution.[4]
The most frequently reported adverse events of auriculotherapy include local skin irritation and discomfort, mild tenderness or pain, and dizziness. Most of these events were transient, mild, and tolerable, and no serious adverse events were identified.[5]
In view of all this, I think that we need much more and much better evidence for auricular acupressure to be recommended for ANY condition.
[1] Wirz-Ridolfi A. The History of Ear Acupuncture and Ear Cartography: Why Precise Mapping of Auricular Points Is Important. Med Acupunct. 2019 Jun 1;31(3):145-156. doi: 10.1089/acu.2019.1349.
[2] Melzack, R., & Katz, J. (1984). Auriculotherapy fails to relieve chronic pain. A controlled crossover study. JAMA, 251(8), 1041–1043.
[3] Lee MS, Shin BC, Suen LK, Park TY, Ernst E (2008) Auricular acupuncture for insomnia: a systematic review. Int J Clin Pract 62(11):1744–1752.
[4] Usichenko, T. I., Hua, K., Cummings, M., Nowak, A., Hahnenkamp, K., Brinkhaus, B., & Dietzel, J. (2022). Auricular stimulation for preoperative anxiety – A systematic review and meta-analysis of randomized controlled clinical trials. Journal of clinical anesthesia, 76, 110581.
[5] Tan JY, Molassiotis A, Wang T, Suen LK (2014) Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med 2014:506758
Manual therapy is considered a safe and less painful method and has been increasingly used to alleviate chronic neck pain. However, there is controversy about the effectiveness of manipulation therapy on chronic neck pain. Therefore, this systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to determine the effectiveness of manipulative therapy for chronic neck pain.
A search of the literature was conducted on seven databases (PubMed, Cochrane Center Register of Controlled Trials, Embase, Medline, CNKI, WanFang, and SinoMed) from the establishment of the databases to May 2022. The review included RCTs on chronic neck pain managed with manipulative therapy compared with sham, exercise, and other physical therapies. The retrieved records were independently reviewed by two researchers. Further, the methodological quality was evaluated using the PEDro scale. All statistical analyses were performed using RevMan V.5.3 software. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) assessment was used to evaluate the quality of the study results.
Seventeen RCTs, including 1190 participants, were included in this meta-analysis. Manipulative therapy showed better results regarding pain intensity and neck disability than the control group. Manipulative therapy was shown to relieve pain intensity (SMD = -0.83; 95% confidence interval [CI] = [-1.04 to -0.62]; p < 0.0001) and neck disability (MD = -3.65; 95% CI = [-5.67 to – 1.62]; p = 0.004). However, the studies had high heterogeneity, which could be explained by the type and control interventions. In addition, there were no significant differences in adverse events between the intervention and the control groups.
The authors concluded that manipulative therapy reduces the degree of chronic neck pain and neck disabilities.
Only a few days ago, we discussed another systematic review that drew quite a different conclusion: there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain.
How can this be?
Systematic reviews are supposed to generate reliable evidence!
How can we explain the contradiction?
There are several differences between the two papers:
- One was published in a SCAM journal and the other one in a mainstream medical journal.
- One was authored by Chinese researchers, the other one by an international team.
- One included 17, the other one 23 RCTs.
- One assessed ‘manual/manipulative therapies’, the other one spinal manipulation/mobilization.
The most profound difference is that the review by the Chinese authors is mostly on Chimese massage [tuina], while the other paper is on chiropractic or osteopathic spinal manipulation/mobilization. A look at the Chinese authors’ affiliation is revealing:
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China.
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].
What lesson can we learn from this confusion?
Perhaps that Tuina is effective for neck pain?
No!
What the abstract does not tell us is that the Tuina studies are of such poor quality that the conclusions drawn by the Chinese authors are not justified.
What we do learn – yet again – is that
- Chinese papers need to be taken with a large pintch of salt. In the present case, the searches underpinning the review and the evaluations of the included primary studies were clearly poorly conducted.
- Rubbish journals publish rubbish papers. How could the reviewers and the editors have missed the many flaws of this paper? The answer seems to be that they did not care. SCAM journals tend to publish any nonsense as long as the conclusion is positive.
