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.
Homeopathic remedies are highly diluted formulations without proven clinical benefits, traditionally believed not to cause adverse events. Nonetheless, published literature reveals severe local and non–liver-related systemic side effects. Here is the first series on homeopathy-related severe drug-induced liver injury (DILI) from a single center.
A retrospective review of records from January 2019 to February 2022 identified 9 patients with liver injury attributed to homeopathic formulations. Competing causes were comprehensively excluded. Chemical analysis was performed on retrieved formulations using triple quadrupole gas chromatography-mass spectrometry and inductively coupled plasma atomic emission spectroscopy.
Males predominated with a median age of 54 years. The most typical clinical presentation was acute hepatitis, followed by acute or chronic liver failure. All patients developed jaundice, and ascites were notable in one-third of the patients. Five patients had underlying chronic liver disease. COVID-19 prevention was the most common indication for homeopathic use. Probable DILI was seen in 77.8%, and hepatocellular injury predominated (66.7%). Four (44.4%) patients died (3 with chronic liver disease) at a median follow-up of 194 days. Liver histopathology showed necrosis, portal and lobular neutrophilic inflammation, and eosinophilic infiltration with cholestasis. A total of 29 remedies were consumed between 9 patients, and 15 formulations were analyzed. Toxicology revealed industrial solvents, corticosteroids, antibiotics, sedatives, synthetic opioids, heavy metals, and toxic phyto-compounds, even in ‘supposed’ ultra-dilute formulations.
The authors concluded that homeopathic remedies potentially result in severe liver injury, leading to death in those with underlying liver disease. The use of mother tinctures, insufficient dilution, poor manufacturing practices, adulteration and contamination, and the presence of direct hepatotoxic herbals were the reasons for toxicity. Physicians, the public, and patients must realize that Homeopathic drugs are not ‘gentle placebos.’
The authors also cite our own work on this subject:
A detailed systematic review of homeopathic remedies-induced adverse events from published case reports and case series by Posadzski and colleagues showed that severe side effects, some leading to fatality, are possible with classic and unspecified homeopathic formulations. The total number of patients included was 1159, of which 1142 suffered adverse events directly related to homeopathy. The direct adverse events had acute pancreatitis, severe allergic reactions, arsenical keratosis, bullous pemphigoid, neurocognitive disorders, sudden cardiac arrest and coma, severe dyselectrolytemia, interstitial nephritis, kidney injury, thallium poisoning, syncopal attacks, and focal neurological deficits as well as movement disorders. Fatal events involved advanced renal failure requiring dialysis, toxic polyneuropathy, and quadriparesis. The duration of adverse events ranged from a few hours to 7 months, and 4 patients died. The authors state that in most cases, the mechanism of action for side effects of homeopathy involved allergic reactions or the presence of toxic substances—the use of strong mother tinctures, drug contaminants, adulterants, or poor manufacturing (incorrect dilutions).
When we published our paper back in 2012, it led to a seies of angry responses from defenders of homeopathy who claimed that one cannot ‘have the cake and eat it’; either homeopathic remedies are placebos and thus harmless, or they have effects and thus also side-effects, they claimed. As the new publication by Indian researchers yet again shows, they were mistaken. In fact, homeopathy is dangerous in more than one way:
- the homeopathic remedies can do harm if not diluted or wrongly manufactured;
- the homeopaths can do harm through their often wrong advice in health matters;
- homeopathy erodes rational thinking (as, for instance, the resopnses to our 2012 paper demonstrated).
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?
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.
This systematic review with meta-analysis of randomized clinical trials (RCTs) estimated the benefits and harms of cervical spinal manipulative therapy (SMT) for treating neck pain. The authors searched the MEDLINE, Cochrane CENTRAL, EMBASE, CINAHL, PEDro, Chiropractic Literature Index bibliographic databases, and grey literature sources, up to June 6, 2022.
RCTs evaluating SMT compared to guideline-recommended and non-recommended interventions, sham SMT, and no intervention for adults with neck pain were eligible. Pre-specified outcomes included pain, range of motion, disability, health-related quality of life.
A total of 28 RCTs could be included. There was very low to low certainty evidence that SMT was more effective than recommended interventions for improving pain at short-term (standardized mean difference [SMD] 0.66; confidence interval [CI] 0.35 to 0.97) and long-term (SMD 0.73; CI 0.31 to 1.16), and for reducing disability at short-term (SMD 0.95; CI 0.48 to 1.42) and long-term (SMD 0.65; CI 0.23 to 1.06). Only transient side effects were found (e.g., muscle soreness).
The authors concluded that there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain.
Harms cannot be adequately investigated on the basis of RCT data. Firstly, because much larger sample sizes would be required for this purpose. Secondly, RCTs of spinal manipulation very often omit reporting adverse effects (as discussed repeatedly on this bolg). If we extend our searches beyond RCTs, we find many cases of serious harm caused by neck manipulations (also as discussed repeatedly on this bolg). Therefore, the conclusion of this review should be corrected:
Low certainty evidence exists supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain. The evidence of harm is, however, substantial. It follows that the risk/benefit ratio is not positive. Cervical SMT should therefore be discouraged.
MEDLINE (Pubmed), PEDro, SCOPUS, Cochrane Library and Web of Science databases were searched from inception to February 2022. PICO search strategy was used to identify randomized clinical trials applying visceral techniques in patients with LBP. Eligible studies and data extraction were conducted independently by two reviewers. Quality of the studies was assessed with the Physiotherapy Evidence Database scale, and the risk of bias with Cochrane Collaboration tool. Meta-analyses were conducted using random effects models according to heterogeneity assessed with I2 coefficient. Data on outcomes of interest were extracted by a researcher using RevMan 5.4 software.
Five studies were included in the systematic review involving 268 patients with LBP. The methodological quality of the included ranged from high to low and the risk of bias was high. Visceral osteopathy techniques have shown no improvements in pain intensity (Standardized mean difference (SMD) = -0.53; 95% CI; -1.09, 0.03; I2: 78%), disability (SMD = -0.08; 95% CI; -0.44, 0.27; I2: 0%) and physical function (SMD = -0.26; 95% CI; -0.62, 0.10; I2: 0%) in patients with LBP.
The authors concluded that this systematic review and meta-analysis showed a lack of high-quality studies showing the effectiveness of visceral osteopathy in pain, disability, and physical function in patients with LBP.
Visceral osteopathy (or visceral manipulation) is an expansion of the general principles of osteopathy and involves the manual manipulation by a therapist of internal organs, blood vessels and nerves (the viscera) from outside the body.
Visceral osteopathy was developed by Jean-Piere Barral, a registered Osteopath and Physical Therapist who serves as Director (and faculty) of the Department of Osteopathic Manipulation in Paris, France. 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. 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. Visceral osteopathy comprises of several different manual techniques firstly for diagnosing a health problem and secondly for treating it.
Several studies have assessed the diagnostic reliability of the techniques involved. The totality of this evidence fails to show that they are sufficiently reliable to be od practical use. Other studies have tested whether the therapeutic techniques used in visceral osteopathy are effective in curing disease or alleviating symptoms. The totality of this evidence fails to show that visceral osteopathy works for any condition.
The treatment itself seems to be safe, yet the risks of visceral osteopathy are nevertheless considerable: if a patient suffers from symptoms related to her inner organs, the therapist is likely to misdiagnose them and subsequently mistreat them. If the symptoms are due to a serious disease, this would amount to medical neglect and could, in extreme cases, cost the patient’s life.
My bottom line: if you see visceral osteopathy being employed anywhere, turn araound and seek proper healthcare whatever your illness might be.
 Guillaud A, Darbois N, Monvoisin R, Pinsault N (2018) Reliability of diagnosis and clinical efficacy of visceral osteopathy: a systematic review. BMC Complement Altern Med 18:65
We discussed the 2015 Australian NHMRC report on homeopathy many times before, e.g.:
- Homeopathy: the 2015 NHMRC report and its criticism re-analysed
- HOMEOPATHY: the NHMRC report revisited
- Ombudsman investigates ‘flawed’ homeopathic study
- The final verdict on homeopathy: it’s a placebo
In a nutshell, the report was an hugely influential analysis of the effectiveness of homeopathy which came to squarely negative conclusions. Thus it was celebrated as a thorough and conclusive piece evidence demonstrating the madness of homeopathy. Unsurprisingly, homeopaths did not like it at all and produced various criticisms claiming that it was neither thorough nor conclusive.
Now the final evaluation of what has been going on was finally published (ISSUED BY THE COMMONWEALTH OMBUDSMAN, IAIN ANDERSON, ON 4 AUGUST 2023):
The Office of the Commonwealth Ombudsman (the Office) has finalised an investigation relating to the National Health and Medical Research Council’s (NHMRC) review of the evidence for the effectiveness of homeopathy, conducted between 2010 and 2015. We commenced this investigation in September 2017 in response to concerns raised with us about how the NHMRC review had proceeded.
The Office conducts its investigations in private, and the Ombudsman generally does not make a public statement in the absence of a formal report. In the circumstances of this matter, including that the then-Ombudsman released a public statement on 4 June 2021 which acknowledged the Office was investigating, we believe it is important to share publicly the information we can, now that the investigation is complete.
Our investigation was finalised in July 2023. We acknowledge the length of time the investigation has taken. This is in part due to the extensive efforts the Office made to source independent scientific expertise to advise us on some detailed and specific questions of scientific methodology that were raised with our Office, including some that were only brought to our attention as our investigation progressed. Despite our best efforts, it was not possible to engage an expert (or experts) to provide independent advice to our Office on this subject. In the absence of independent, expert scientific expertise we have not been able to conclusively determine those matters of scientific methodology. This did not prevent our Office from forming a view on other aspects of the matter.
Our investigation did not result in any adverse findings about the review or the NHMRC. When finalising investigations, we may offer comments and suggestions to an agency about areas for future improvement. In this instance, we offered comments and suggestions to the NHMRC about how it records and publicly explains decisions about its activities. The NHMRC also independently made several improvements to its processes during the course of our investigation.
In essence, this means that the conclusions of the report stand:
Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
Thus the matter is closed – that is closed for rational thinkers. For irrationalists, the matter will no doubt continue to be a stone of contention. No, homeopath will be able to accept these conclusions simply because a member of a cult ceases to be a cultist once he/she accepts the criticism agaist the cult.
As we have recently discussed diet and its effects on health, it seems reasonable to ask whether there is a diet that is demonstrably healthy. A recent investigation attempted to answer this question.
This study was aimed at developing a healthy diet score that is associated with health outcomes and is globally applicable. It used data from the Prospective Urban Rural Epidemiology (PURE) study and tried to replicate it in five independent studies on a total of 245 000 people from 80 countries.
A healthy diet score was developed on the basis of the data from 147 642 people from the general population, from 21 countries in the PURE study. The consistency of the associations of the score with events was examined in five large independent studies from 70 countries.
The healthy diet score was developed based on six foods each of which has been associated with a significantly lower risk of mortality [i.e. fruit, vegetables, nuts, legumes, fish, and dairy (mainly whole-fat); range of scores, 0–6]. The main outcome measures were all-cause mortality and major cardiovascular events [cardiovascular disease (CVD)].
During a median follow-up of 9.3 years in PURE, compared with a diet score of ≤1 point, a diet score of ≥5 points was associated with a lower risk of:
- mortality [hazard ratio (HR) 0.70; 95% confidence interval (CI) 0.63–0.77)],
- CVD (HR 0.82; 0.75–0.91),
- myocardial infarction (HR 0.86; 0.75–0.99),
- stroke (HR 0.81; 0.71–0.93).
In three independent studies with vascular patients, similar results were found, with a higher diet score being associated with lower mortality (HR 0.73; 0.66–0.81), CVD (HR 0.79; 0.72–0.87), myocardial infarction (HR 0.85; 0.71–0.99), and a non-statistically significant lower risk of stroke (HR 0.87; 0.73–1.03). Additionally, in two case-control studies, a higher diet score was associated with lower first myocardial infarction [odds ratio (OR) 0.72; 0.65–0.80] and stroke (OR 0.57; 0.50–0.65). A higher diet score was associated with a significantly lower risk of death or CVD in regions with lower than with higher gross national incomes (P for heterogeneity <0.0001). The PURE score showed slightly stronger associations with death or CVD than several other common diet scores (P < 0.001 for each comparison).
The authors concluded that consumption of a diet comprised of higher amounts of fruits, vegetables, nuts, legumes, and a moderate amount of fish and whole-fat dairy is associated with a lower risk of CVD and mortality in all world regions, but especially in countries with lower income where consumption of these natural foods is low. Similar associations were found with the inclusion of meat or whole grain consumption in the diet score (in the ranges common in the six studies that we included). Our findings indicate that the risks of deaths and vascular events in adults globally are higher with inadequate intake of protective foods.
The authors rightly stress that their analyses have a number of limitations:
First, diet (as in most large epidemiologic studies) was self-reported and variations in reporting might lead to random errors that could dilute real associations between diet scores and clinical outcomes. Therefore, the beneficial effects of a healthier diet may be larger than estimated.
Second, the researchers did not examine the role of individual types of fruits and vegetables as components in the diet score, since the power to detect associations of the different types of fruits and vegetables vs. CVD or mortality is low (i.e. given that the number of events per type of fruit and vegetable was relatively low). Recent evidence suggests that bioactive compounds and, in particular, polyphenols which are found in certain fruit or vegetables (e.g. berries, spinach, and beans) may be especially protective against CVD.
Third, in observational studies, the possibility of residual confounding from unquantified or imprecise measurement of covariates cannot be ruled out—especially given that the differences in risk of clinical events are modest (∼10%–20% relative differences). Ideally, large randomized trials would be needed to clarify the clinical impact on events of a policy of proposing a dietary pattern in populations.
Fourth, the use of the median intake of each food component as a cut-off in the scoring scheme for each diet may not reflect the full range of consumption or provide a meaningful indicator of consumption associated with the disease. However, the use of quintiles instead of medians within each study or within each region yielded the same results indicating the robustness of our findings.
Fifth, the level of intake to meet the cut-off threshold for each food group in the diet score may differ between countries. However, in sensitivity analyses where region-specific median cut-offs were used to classify participants on each component of the diet score, the results were similar to using the overall cohort median of each food component. Further, with unprocessed red meat and whole grains included or excluded from the diet score in these sensitivity analyses, the results were again similar.
Sixth, misclassification of exposures cannot be ruled out as repeat measures of diet were not available in all studies. However, the ORIGIN study, in which repeat diet assessments at 2 years were conducted, showed similar results based on the first vs. second diet assessments. This indicates that misclassification of dietary intake during follow-up was not undermining the findings.
Seventh, one unique aspect of the study is the focus on only protective foods, i.e. a dietary pattern score that highlights what is missing from the food supply, especially in poorer world regions, but this does not negate the importance of limiting the consumption of harmful foods such as highly processed foods. While the PURE diet score had significantly stronger associations with events than other diet scores, the HRs were only slightly larger for PURE than for most other diet scores. However, the Planetary score was the least predictive of events. The analyses provide empirical evidence that all diet scores (other than the Planetary diet score) are of value to predicting death or CVD globally and in all regions of the world.
So, what should we, according to these findings, be looking for and how much of it should we consume? Here is the table that should answer these questions:
|Fruits and vegetables||4 to 5 servings daily||1 medium apple, banana, pear; 1 cup leafy vegs; 1/2 cup other vegs|
|Legumes||3 to 4 servings weekly||1/2 cup beans or lentils|
|Nuts||7 servings weekly||1 oz., tree nuts or peanuts|
|Fish||2 to 3 servings weekly||3 oz. cooked (pack of cards size)|
|Dairy||14 servings weekly||1 cup milk or yogurt; 1 ½ oz cheese|
|Whole grainsc||Moderate amounts (e.g. 1 serving daily) can be part of a healthy diet||1 slice (40 g) bread; ½ medium (40 g) flatbread; ½ cup (75–120 g) cooked rice, barley, buckwheat, semolina, polenta, bulgur, or quinoa|
|Unprocessed meatsc||Moderate amounts (e.g. 1 serving daily) can be part of a healthy diet||3 oz. cooked red meat or poultry|
Charles has a well-documented weakness for so-called alternative medicine (SCAM) – not just any SCAM but predominantly the type of SCAM that is both implausible and ineffective. Therefore, nobody can be all that surprised to read in THE TIMES that he has decided to use SCAM for helping women who have difficulties getting pregnant.
If one really wanted to employ SCAM for this aim one is spoilt for choice. In fact, there are only few SCAMs that don’t claim to be useful for this purpose.
A recent review, for instance, suggested that some supplements might be helpful. Other authors advocate SCAMs such as acupuncture, moxibustion, Chinese herbal medicine, psychological intervention, biosimilar electrical stimulation, homeopathy, or hyperbaric oxygen therapy.
Yes, I know! The evidence for these treatments is lousy, and I would never issue a recommendation based on such flimsy evidence.
Yet, the SCAM project at Dumfries House, the Scottish stately home Charles restored in 2007, offers acupuncture, reflexology, massage, yoga, and hypnotherapy for infertile women.
Reflexology, also called zone therapy, is a manual treatment where pressure is applied usually to the sole of the patient’s foot and sometimes also to other areas such as the hands or ears. According to its proponents, foot reflexology is more than a simple foot massage that makes no therapeutic claims beyond relaxation. It is based on the idea that the human body is divided into 10 zones each of which is represented on the sole of the foot. Reflexologists employ maps of the sole of the foot where the body’s organs are depicted. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs. While reflexology is mostly used as a therapy, some therapists also claim they can diagnose health problems through feeling tender or gritty areas on the sole of the foot which, they claim, correspond to specific organs.
Reflexology is not merely implausible as a treatment for infertility, it also boasts of some fairly rigorous trial evidence. A clinical trial (perhaps even the most rigorous of all the trials of SCAM for female fertility problems) testing whether foot reflexology might have a positive effect on the induction of ovulation stated that “the results suggest that any effect on ovulation would not be clinically relevant”.
So, as so often before in the realm of SCAM, Charles has demonstrated that his lack of critical thinking leads him to the least promising options.
Well done, Your Majesty!
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM) that can cause annoying symptoms. To address this condition, several treatment approaches have been proposed, including static magnetic field (SMF) therapy, which has shown promise in treating neurological conditions. Therefore, this study aimed to investigate the effects of SMF therapy on symptomatic DPN and the quality of life (QoL) in patients with type 2 diabetes.
A double-blind, randomized, placebo-controlled trial was conducted from April to October 2021. Sixty-four DPN patients (20 males, 44 females) were recruited for the study via invitation. The participants were divided into two groups: the magnet group, which used magnetic ankle bracelets (155 mT) for 12 weeks, and the sham group, which used non-magnetic ankle bracelets for the same duration. Neuropathy Symptom Score (NSS), Neuropathic Disability Score (NDS), and Visual Analogue Scale (VAS) were used to assess neuropathy symptoms and pain. In addition, the Neuropathy Specific Quality of Life Questionnaire (Neuro-QoL) tool was used to measure the patients’ quality of life.
Before treatment, there were no significant differences between the magnet and sham groups in terms of the NSS scores (P = 0.50), NDS scores (P = 0.74), VAS scores (P = 0.17), and Neuro-QoL scores (P = 0.82). However, after 12 weeks of treatment, the SMF exposure group showed a significant reduction in NSS scores (P < 0.001), NDS scores (P < 0.001), VAS scores (P < 0.001), and Neuro-QoL scores (P < 0.001) compared to the baseline. The changes in the sham group, on the other hand, were not significant.
The authors concluded that according to obtained data, SMF therapy is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL in diabetic type-2 patients.
Our own study and systematic review of the effects of magnetic bracelets and similar devices suggested that the effects of such treatments are due to placebo responses. Therefore, I find the findings of this new study most surprising. Not only that, to be honest, I also find them suspect. Apart from the fact that the treatment has no biological plausibility, I have three main reasons for my skepticism.
- The authors stated that there was no distinguishable difference between the sham and SMF devices in terms of their appearance, weight, or texture, which helped to ensure that the study was double-blinded. This is nonsense, I am afraid! The verum device is magnetic and the sham device is not. It is hardly conceivable that patients who handle such devices for any length of time do not discover this simple fact and thus de-blind themselves. In turn, this means that a placebo effect can easily explain the outcomes.
- Authors who feel that their tiny study of a highly implausible therapy lends itself to concluding that their therapy ‘is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL’ can, in my view, not be taken seriously.
- Something that always makes me suspicious of clinical trials is a lack of a placebo response where one would normally expect one. In this study, the control group exhibits hardly any placebo response. Wearing a strap around your ankle that allegedly emits therapeutic radiation would result in quite a strong placebo effect, according to our own findings.
So, forgive me if I do not trust this study any further than I can throw it! And pardon me if I still think that our previous conclusion is correct: The evidence does not support the use of static magnets for pain relief, and therefore magnets cannot be recommended as an effective treatment.