placebo
The aim of this study was to determine the effectiveness of spinal manipulation and clinician-supported biopsychosocial self-management vs medical care for adults with increased risk of chronic disabling LBP.
This 2 × 2 factorial randomized clinical trial enrolled participants in 3 research clinics at the Universities of Minnesota and Pittsburgh from November 2018 to May 2023; final follow-up was in June 2024. Adults with acute or subacute LBP at moderate to high risk of chronicity based on the STarT Back tool were randomized to 1 of 4 groups, with interventions lasting up to 8 weeks. Statistical analysis was conducted from November 2024 to June 2025.
These interventions were:
- Spinal manipulation therapy (n = 201),
- supported self-management (n = 305),
- combined supported self-management with spinal manipulation (n = 193),
- guideline-based medical care (n = 301).
Physical therapists and chiropractors provided spinal manipulation and supported self-management.
The 2 primary outcomes averaged over a follow-up of 1 year were monthly low back disability (Roland-Morris Disability Questionnaire) and weekly pain intensity (numerical rating scale). Secondary analysis examined the proportion of participants achieving a 50% or higher reduction in the primary outcome measures.
Among the 1000 participants randomized (mean [SD] age, 47 [16] years; 58% female), 93% completed the trial. The omnibus test for differences across the 4 treatment groups was statistically significant for disability (P = .001; supported self-management, 4.7; spinal manipulation, 5.5; combined supported self-management with spinal manipulation, 4.8; medical care, 5.9) but not pain intensity (P = .16; supported self-management, 2.8; spinal manipulation, 3.0; combined supported self-management with spinal manipulation, 2.8; medical care, 3.0). Averaged over 12 months, LBP disability was significantly lower compared with medical care for supported self-management (mean difference, −1.2 [95% CI, −1.9 to −0.5]) and supported self-management with spinal manipulation (mean difference, −1.1 [95% CI, −1.9 to −0.3]) but not spinal manipulation alone (mean difference, −0.4 [95% CI, −1.2 to 0.4]). Group differences in pain intensity were not statistically significant; point estimates ranged from −0.2 to 0. Both supported self-management groups had higher proportions of patients achieving a 50% or greater reduction in disability (supported self-management, 67%; spinal manipulation, 54%; combined supported self-management with spinal manipulation, 65%; medical care, 54%).
The authors concluded that for patients with acute or subacute LBP at increased risk of chronic disabling LBP, clinician-supported biopsychosocial self-management showed statistically significant but small reductions in disability, but not pain, vs medical care over 1-year follow-up, and spinal manipulation alone showed no significant difference for either outcome.
These findings are very bad news for chiropractors (the profession that uses spinal manipulations more than any other): spinal manipulation does not generate effects that are in the least convincing. This is particularly remarkable, since the study was not blinded. It means that, even the undoubtedly powerful placebo effect associated with spinal manipulation did not render the outcome more favourable.
I said it many times, and I will say it again: For LBP, many therapies generate similarly marginally positive effects but no treatment is truly convincing. In this situation, we should choose one that is at least inexpensive and free of severe adverse effects. And that evidently cannot be spinal manipulation!
The Center for Inquiry (CFI) is raising alarms about new federal legislation that would make it easier for homeopathy groups to market and sell their products. Opposing homeopathy is at the core of CFI’s mission, given that it is dangerous pseudoscience and misleads American patients and consumers to the tune of millions of dollars every year.
HR 7050 was introduced in the U.S. House of Representatives on January 14, 2026, by Rep. Pete Sessions (R-TX), co-sponsored by Reps. Jonathan Jackson (D-IL) and Mike Kennedy (R-UT). The bill seeks to ensure “continued consumer access” to homeopathic products by amending the existing Food, Drug, and Cosmetic Act (FDCA).
Any member of Congress who seeks to protect consumers from medical fraud should be fighting to remove homeopathic products from the marketplace, not ensure “access” to them. Homeopathy is grounded in pseudoscience from the late 1700s that claims the more dilute a medicine, the more potent it is. That is a demonstrably false claim. Homeopathic products typically contain no active ingredients that constitute medicine. They are no better than a placebo as a medical intervention.
The bill would prohibit federal consumer protection agencies, such as the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), from ensuring that homeopathic products meet objective standards of safety and efficacy. Instead, it codifies the so-called standards in the Homeopathic Pharmacopoeia of the United States, effectively leaving it to the homeopathic industry to police itself. The Pharmacopoeia is shrouded in secrecy, and CFI has had to go to the length of suing the Department of Health and Human Services in an effort to access its contents.
Moreover, in 2016 the FTC expressly declared in a policy statement that homeopathic products can only be legally marketed if they communicate clearly to consumers that there is no scientific evidence the products work! It is this kind of consumer protection that the homeopathy industry hopes to defeat with this legislation.
Additionally, the bill exempts homeopathic drug products from doing the laboratory testing that would establish the potency of each active ingredient. Other drugs are held to these standards, but it’s clear that the homeopathic industry does not want it known that their ingredients have no discernible therapeutic value.
Finally, the bill directs the Secretary of Health and Human Services – currently Robert F. Kennedy, Jr. – to create a Homeopathic Drug Product Advisory Committee to advise the Secretary regarding the regulation of homeopathy. The majority of the committee’s ten members would be representatives from homeopathic manufacturers, from the Homeopathic Pharmacopoeia Convention, and from other groups with obvious ties to homeopathy (as well as one member who is a naturopathic doctor). Again, the theme is insider and deferential regulation.
HR 7050 is currently before the House Committee on Energy and Commerce. CFI’s Office of Public Policy will be aggressively lobbying against the bill. We urge every CFI supporter to contact their Representatives and Senators in Congress and to call on them to vote against HR 7050.
Many families explore so-called alternative medicine (SCAM) to manage autism spectrum disorder (ASD) and many SCAM practitioners claim to be able to treat ASD effectively. This review evaluated the efficacy and safety of SCAM therapies, including acupuncture, cupping, massage, dietary changes, herbal medicine, apitherapy, and Ayurveda medicine.
Systematic searches were carried out in PubMed, Scopus, and Web of Science to identify studies of SCAM interventions for ASD. The review adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, including various study types. Data extraction focused on design, population, intervention, outcomes, and bias risk.
The inclusion criteria were met by 45 studies, which encompassed six SCAM modalities. Acupuncture and massage consistently exhibited enhancements in sensory processing, communication, and social interaction levels. Dietary interventions, particularly probiotic supplementation and gluten-/casein-free regimens, had beneficial effects on behavioral and GI domains. While Ayurveda therapies such as Medhya Rasayanas (Bacopa monnieri), Swarnaprashana, and Panchakarma techniques improved cognition and reduced social deficits in small clinical series, herbal and apitherapy treatments primarily demonstrated neuroprotective and anti-inflammatory effects in preclinical studies. Control groups received no treatment, sham interventions, or standard care. The methodological limitations and heterogeneity of the study design limited the ability to draw definitive conclusions.
The authors conclused that the evidence indicates that SCAM approaches, including acupuncture, massage, and Ayurveda therapies, may be effective adjuncts in the management of ASD. The current body of research is constrained by the moderate-to-high risk of bias, variable protocols, and small sample sizes. Standardized, large-scale randomized trials are required to establish efficacy and safety. Clinicians should balance patient safety with innovation by adopting an integrative, evidence-informed approach.
This is almost complete nonsense:
- The authors claim to have followed the PRISMA guidelines. As one of the co-authors of these guidelines, I can affirm that this is untrue.
- The authors included 10 animal studies that provided mechanistic support for clinical findings, 18 RCTs, 12 pre-post controlled studies, and 5 case series or pilot studies comprised the designs. Several of these study types are unable to “evaluate the efficacy and safety of SCAM therapies” which is the stated aim of the review.
- Most of the included studies fail to control for placebo effects. Therefore, they cannot provide evidence regarding the “efficacy” of the treatments in question.
In view of these – and many other – flaws of the review, I fear that I might have to re-write the conclusions:
Many SCAMs have been studied as treatments for ASD. The results of these investigations fail to show that any of them is effective in alleviating the symptoms of ASD. Unless sound evidence emerges, SCAM cannot be recommended for ASD.
Non-specific low back pain is a common condition with substantial socioeconomic implications. Pulsed electromagnetic field (PEMF) therapy is said to generate benefits in pain reduction and improvement of physical function in patients with pain-associated disorders like osteoarthritis. However, studies had heterogeneous settings. The aim of this systematic review was to assess the effects of PEMF on pain and function on patients with non-specific low back pain.
A systematic literature search of randomized controlled trials in PubMed, MEDLINE, EMBASE, Cochrane Library, and PEDro was performed (from inception until 15/5/2023). Outcome measures assessed pain and function.
Nine randomized controlled trials with 420 participants (n = 420) were included. The studies compared PEMF vs. placebo-PEMF, PEMF and conventional physical therapy vs. conventional physical therapy alone, PEMF and conventional physical therapy vs. placebo-PEMF and conventional physical therapy, PEMF vs. high-intensity laser therapy (HILT) vs. conventional physical therapy, and osteopathic manipulative treatment (OMT) and PEMF vs. PEMF alone vs. placebo-PEMF vs. OMT alone. Five of the nine included studies showed statistically significant pain reduction and improvement in physical function in comparison to their control groups (p < 0.05). There was substantial heterogeneity among the groups of the study, with a wide range of duration (10-30 min), treatments per week (2-7/week), applied frequencies (3-50 Hz), and intensities (2mT-150mT). No serious adverse event had been reported in any study. The included studies showed solid methodological quality, with an overall score of 7.2 points according to the PEDro scale.
The authors concluded that the results of the present systematic review suggest that the use of PEMF for patients with non-specific low back pain is beneficial in terms of pain reduction and enhancement of physical function, particularly if used as an addition to conventional physical therapy modalities. It has also been shown that PEMF is a safe therapy for the treatment of non-specific low back pain. Further high-quality studies with larger sample sizes and standardized protocols are necessary. The studies should also focus on determining the optimal parameters of frequency and intensity to advance PEMF application for all pain disorders.
PEMF therapy is a non-invasive treatment widely used by physiotherapist and some practitioners of so-called alternative medicine (SCAM). It applies low-frequency electromagnetic waves to the body. PEMF therapy acts like a wireless charger for your body, sending pulses of energy that penetrate deep into your tissues to jumpstart cellular recovery. Because your body contains conductive fluids (like blood) and charged ions (like calcium and potassium), the PEMF device is said to induce very small electrical currents within your tissues. In turn, the induced current is claimed to stimulate the mitochondria. This, according to proponents, boosts the production of ATP. The pulses are also said to influence the movement of ions across cell membranes, particularly calcium which triggers a cascade of beneficial biochemical reactions, such as the release of nitric oxide, which dilates blood vessels to improve circulation. Lastly, PEMF are claimed to help “calm” the chemical signals that cause chronic inflammation, switching the cellular environment from a state of stress to a state of healing.
While these assumptions look like wild extrapolations, the more crucial question is whether PEMF is clinically effective. The present review seems to tell us that it works for back pain. Yet, I am not convinced.
Most of the RCTs are not of good quality. Many did not blind patients or therapists. Only 2 made a direct comparison against a placebo, and those did not blind patients or check the success of blinding them. As the authors noted, there is plenty of heterogeneity in the included RCTs. All this adds up to a high level of uncertainty about the effectiveness of PEMF.
In summary, I fear that the authors of this review are too optimistic and lack critical thinking in evaluating the existing evidence. My conclusion therefore differs from theirs:
Many RCTs suggest that PEMF is effective for non-specific low back pain. Yet, due to serious limitations of the primary studies, no firm conclusion can be drawn.
Opioid withdrawal involves sympathetic hyperactivity and reduced parasympathetic tone, which standard pharmacological treatments may not adequately address, contributing to relapse vulnerability. This study evaluated yoga as adjuvant therapy to accelerate opioid withdrawal recovery and assess its impact on heart rate variability, anxiety, sleep, and pain.
This 2-arm, early-stage randomized clinical trial was conducted at an addiction medicine inpatient ward in India from April 30, 2023 to March 31, 2024. The outcome assessors and data analyst were blinded to group allocation. Participants included adults aged 18 to 50 years with opioid use disorder experiencing mild to moderate withdrawal symptoms (Clinical Opiate Withdrawal Scale [COWS] scores 4-24). Exclusion criteria included severe withdrawal, neurological conditions affecting autonomic function, severe psychiatric conditions, and recent yoga training. Of 68 individuals screened, 59 were randomized (30 yoga and 29 control participants).
Participants in the yoga group received (A) 10 supervised 45-minute sessions during 14 days alongside (B) standard buprenorphine treatment, including relaxation practices, postures, breathing techniques, and guided relaxation. Participants in the control group received (B) standard buprenorphine treatment only. Co-primary outcomes included time to withdrawal stabilization (COWS score <4) and heart rate variability parameters. Secondary outcomes included anxiety (Hamilton Anxiety Rating Scale), sleep latency, and pain scores. Assessments were conducted at baseline (day 1) and day 15.
Fifty-nine participants (59 male [100%]; mean [SD] age, 25.6 [3.9] years) completed intent-to-treat analysis. Participants in the yoga group recovered faster than those in the control group (hazard ratio [HR], 4.40; 95% CI, 2.40-8.07; P < .001), with a median stabilization time of 5 days (95% CI, 4-6 days) for those in the yoga group vs 9 days (95% CI, 7-13 days) for the control group. Participants in the yoga group showed superior heart rate variability improvements with large effects on low frequency (LF) power (ω2 = 0.16), high frequency (HF) power (ω2 = 0.14), and LF/HF ratio (ω2 = 0.12); all effects were statistically significant (P < .001). Mediation analysis showed that increases in parasympathetic activity accounted for 23% of the treatment effect (indirect HR, 1.38; 95% CI, 1.10-2.03). Anxiety reduction was significantly greater among those in the yoga group (ω2 = 0.28; P < .001), with moderate improvements in sleep latency (a 61-minute reduction; P = .008) and pain (P = .004).
The authors concluded that in this randomized clinical trial, yoga significantly accelerated opioid withdrawal recovery and improved autonomic regulation, anxiety, sleep, and pain. These findings support integrating yoga into withdrawal protocols as a neurobiologically informed intervention addressing core regulatory processes beyond symptom management.
This conclusion is demonstrably wrong, and I am dismayed that a reputable journal published it.
The study followed the infamous ‘A+B versus B’ design. It is infamous because it is seemingly rigorous (“A RANDOMIZED CLINICAL TRIAL”!!!), while invariably generating a positive result for the tested intervention – even if it happens to be nothing more than a placebo tretment. And because of this, it is, in my view, unethical to use it for concluding about the specific effects of the tested intervention. I have explained this so often that I hesitate to do it again:
- Imagine the treatments as two amounts of money.
- Amount (treatmet) A equals £1.
- Amount (treatment) B equals £2.
- If one (the verum) group gets A+B, it will have £3.
- If the other (control) group gets just £2, it will have £2.
- A+B is always more that B.
- If A is a placebo, the A+B > B still applies, due to the existance of placebo effects
- QED!
The crux is obviously that the A+B vs B design only appears to be rigorous but, in fact, does NOT control for placebo effects. Since placebo effects exist, the A+B vs B design must produce a positive result, even if the verum is ineffective and merely generates a placebo response.
As the type of yoga employed in this study is bound to generate a sizable placebo effect, it would easily be enought to cause the observed outcomes. Let me put it even more bluntly: this study design is unable to tell us whether the yoga therapy or a placebo response was responsible for the observed result*.
In view of this, I will re-formuate the first sentence of the conclusion as follows:
In this randomized clinical trial, a placebo effect accelerated opioid withdrawal recovery and improved autonomic regulation, anxiety, sleep, and pain.
But what about the 2nd sentence of the conclusion?
Arguably, it is even worse!
To claim that the findings of one single study sufiice for calling for the integration of the tested treatment into routine healthcare ignores the need for independent replications and is therefore dangerous nonsense.
*(Btw: this is also the reason why it is so popular with pseudoscientists trying to show that their pet therapy works.]
The WHO says it is sifting the wheat from the chaff in order to save lives – but critics fear it is pandering to India and China; this TELEGRAPH article is worth reading in full; here I will merely quote a few passages from it.
Mongolian shamans beat wicker drums to summon ancestral spirits. A Peruvian man in a headdress unleashes a piercing ululation. And a man from Kentucky tells me the body can rid itself of cancer if you eat the right shrubs. It is a line-up one might expect at the healing field at Glastonbury but this is a conference centre in New Delhi and the event has been organised by the World Health Organization; the WHO Global Summit on Traditional Medicine. It’s the second gathering of its kind, following an inaugural meeting in Gujarat in 2023, and the three-day event has drawn hundreds of delegates from around the world. Alongside yoga instructors, aromatherapists, Chinese herbal practitioners and a small army of homeopaths, sit senior WHO officials, leading scientists and health ministers from across Africa, Asia and Latin America. Only Gwyneth Paltrow and her wellness website Goop is missing. They are here to “harness the potential” of traditional medicine, a catch-all term for practices that pre-date, and sit outside, modern evidence-based healthcare; therapies that for the most part have long been dismissed as quackery by mainstream science. What counts as “traditional medicine” ranges from drinking herbal teas to Indian Ayurveda, a holistic “wellness system” combining oils, herbs, homeopathy, yoga and meditation to “balance” and “heal” the body. To critics – and there are many – the scene is absurd.
So why is the WHO – a global authority on evidence-based health – giving a platform to this stuff? Has it fallen victim to the seductive power of TikTok-based wellness like so many of the west’s middle classes? Or has it – as some critics allege – been bought off by the traditional medicine super powers of India and China? …
The WHO says its Summit on Traditional Medicine is essentially about repeating this sifting process for traditional remedies used in other parts of the world. It aims to apply rigorous scientific analysis to all them in order to properly assess their claimed benefits and potential harms. By 2034, it says, it will publish a definitive list of which traditional treatments work – and which don’t. “Working on traditional medicine doesn’t mean we will use shortcuts or endorse things that are unproven,” Dr Sylvie Briand, the WHO’s Chief Scientist, told The Telegraph at the conference in New Delhi. The aim was first to document what traditional treatments existed around the world “and then see what could be more useful to address the disease of this century”.
One idea is that some traditional practices like yoga and meditation, while perhaps not offering direct curative benefits, could play an important role in preventative medicine. After all, so-called non-communicable diseases, often caused by lifestyle factors such as poor diet, chronic stress and a lack of exercise are now by far the biggest killers across the globe. “Many traditional systems of medicine take a holistic view and focus on strengthening the person as a whole, not just treating isolated symptoms,” Dr Sung Chol Kim, Unit Head for Traditional, Complementary and Integrative Medicine at the WHO told The Telegraph in Delhi. But others are sceptical. They fear the WHO, which is struggling for funding in the wake of the US leaving the organisation and widespread aid cuts, is simply pandering to India and China where traditional medicine is big business. Even if well intentioned, they worry that the discovery process the WHO has set in motion will end up promoting and legitimising quackery. “I think highly of the WHO. However, by giving a platform to traditional medicine practitioners who promote treatments that are unproven – or even disproven – such as homeopathy, the organisation risks legitimising quackery. That, in my view, is both unethical and irresponsible,” said Dr Edzard Ernst, a British-German academic who specialises in the study of complementary and alternative medicine…
Even within the WHO, there is tension over what is being platformed at the summit. One senior official, speaking on condition of anonymity, described homeopathy … as “complete nonsense”. “There is not one shred of evidence anywhere, absolutely anywhere, that suggests it works,” the official said, while acknowledging pressure to engage rather than alienate powerful member states. Dr Ernst, the British-German academic, said: “Many experts are puzzled by this attitude. The most likely explanation is that the WHO is bowing to political will instead of science.” ….
Globally, an estimated 4.6 billion people already use some form of traditional medicine. In sub-Saharan Africa, millions rely on traditional healers as their first – and sometimes only – point of care. Its use can delay access to appropriate treatment, and some practices have been linked to the spread of disease. This week, 41 people were reported to have died after undergoing rituals to initiate them into manhood in South Africa, a central part of which involves unsafe and brutal circumcisions. Another example, common in places like Uganda, Benin, and Burkina Faso, includes small skin incisions into which herbs are rubbed – sometimes referred to as “vaccinations” – increasing the risk of HIV transmission through the reuse of razors and knives. Efforts to regulate practitioners are underway, but progress remains slow. Malawi’s Minister for Health and Sanitation, Madalitso Baloyi, said her government wants clear guidance from the WHO. “As a Ministry, we want to ensure [traditional remedies] are tested and quality checked,” she told The Telegraph. She added that, at the moment, traditional medicine is being done “behind closed doors”, and that the WHO process would help bring it into the open where it can be better monitored.
Yet the WHO seems undeterred. “Some traditional remedies will probably be found to be really active and really useful. Others will just be a placebo – for example, you feel better when you drink tea,” said Dr Reeder. The WHO argues that investing in traditional medicine could also help tackle the leading killers of the 21st century: non-communicable diseases such as obesity, diabetes, cardiovascular disease and mental illness. Holistic approaches to wellness incorporating exercise, a more considered diet and stress reduction could complement conventional treatments, placing “an emphasis on prevention over cure,” said Dr Tedros…
Colic in infants causes excessive crying in an otherwise healthy and thriving baby. Colic is a common but poorly understood and often frustrating problem for caregivers. The objective of this trial was to study whether osteopathic treatments of infants with infantile colic / excessive crying (IC/EC) have an impact on the subjectively perceived psychological stress of caregivers compared to usual care.
The study was designed as a prospective, multicenter, randomized controlled trial. Infants aged 1 week to 3 months and who met Rome IV criteria for IC/EC were included. By means of external randomization, infants were allocated to an intervention group or a control group. Infants in the intervention group received three osteopathic treatments at intervals of one week. The treatments were custom-tailored and based on osteopathic principles. Controls received their osteopathic treatment after a 3 week untreated period. The primary outcome parameter was the assessment of parental psychological stress (three questions), measured using a numeric rating scale (NRS; 0-10). Furthermore, the average daily crying time (measured using the Likert scale), the crying intensity (measured using the NRS) and the parents’ self-confidence (measured using the Karitane Parenting Confidence Scale) were assessed.
A total of 103 infants (average age 39.4 ±19.2 days) were included, 52 in the intervention group and 51 in the control group. An inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome – parameter psychological stress – for all 3 questions (e.g., for question 2 respectively 3, NRS: between group difference of means 3.5; 95% CI: 2.6 to 4.4; p < 0.001). For the secondary outcome parameters of crying intensity and crying time/day, the changes were of similar magnitude.
The authors concluded that three osteopathic treatments given over a period of two weeks led to statistically significant and clinically relevant positive changes of parental psychological stress.
This is a cleverly designed study. I say ‘cleverly’ because the casual reader might not even notice that it compared osteopathic treatments with doing nothing. It is well-documented that just hadling babies with IC/EC has an effect on outcomes. Thus the positive effect may not have anything to do with osteopathy and be due simply to the extra attention given to the child. In other words, the positive result of the study was sure even before the 1st baby was entered into the trial.
I am impressed!
Perhaps this study should be in the textbook entitled:
HOW TO CHEAT WITH SEEMINGLY RIGOROUS CLINICAL TRIALS?
The aim of this randomized, triple-blind, placebo-controlled clinical trial was to analyze the effect of using Bach’s emergency compound, Five-Flower essence, on the stress level of mothers with premature newborns.
The study was conducted with 117 postpartum women. They were divided into intervention (with five-flower) and control groups. Their children were admitted to a Maternity Hospital in São Paulo, Brazil, from June 2019 to May 2021. The use of the Five-Flower essence was proposed during hospitalization (4 drops every 15 min four times a day) and at home (16 drops a day at pre-determined times) in the ten days after the first intervention. The pre-and post-intervention parameters were evaluated using the Instrument Parental Stress Scale: Neonatal Intensive Care Unit and cortisol analysis. Student’s T, Mann-Whitney, Chi-square, Fisher’s exact tests, and Generalized Estimating Equation models were used to analyze the data. The 5 % significance level was considered in statistical tests.
The groups were homogeneous regarding sociodemographic, obstetric, and neonatal characteristics (p > 0.05). Mean stress scores were calculated for the control (3.75) and intervention (3.82) groups before intervention and a range was observed for the control (2.75-3.44) and intervention (2.55-3.54) groups after the intervention; the difference between groups was statistically significant (p < 0.05). Mean cortisol levels were calculated for the control (3.53) and intervention (3.45) groups before intervention and a range was observed for the control (3.38-2.75) and intervention (2.32-2.86) groups after intervention, showing distinct declines in the groups but without statistical difference (p > 0.05).
The authors concluded that the use of the Five-Flower essence as a non-pharmacological therapy is effective in reducing the stress and cortisol levels in mothers of premature newborns admitted to neonatal and semi-intensive care units.
This is odd!
The remedy does not contain relevant doese of pharmacologically active molecules (other than alcohol). This means that, in this study, the authors tested one placebo against another one. Why then is there a differnce in the outcome?
I read the paper carefully in an attempt to find out. Here is what might have happened (the article does not disclose all the relevant details, so I can only guess):
- The placebo which the authors fail to describe was a water solution or a solution that tasted different than the verum.
- The authors do, however, state this: “Regarding blinding, the manufacturer of the flower essences previously identified the bottles as A and B, one of which was the intervention and the other the placebo.”
- It is possible that the patients were de-blinded, meaning one or two knew how the Bach remedy should taste and communicated this to the several other patients.
- In this case, the expectation of patients affected the results accordingly. In other words, the results are due to a placebo effect.
In any case, the conclusion (even if the ‘Five-Flower essence’ did work exactly as described) is far too optimistic. Before anyone might accept the results, we need an INDEPENDENT replication of this dubious study.
- Reiki,
- sham Reiki (i.e., Feiki),
- mindfulness meditation,
- waitlist control.
Treatments were delivered in four weekly 30-minute sessions.
- Reiki was superior to doing nothing (waiting list) which can be expected due to a placebo effect.
- Mindfulness was superior to doing nothing (waiting list) which can be expected not least due to a placebo effect.
- Mindfulness was superior to Feiki which can be expected as mindfulness might work.
- Reiki demonstrated effects comparable to mindfulness which is due to an inadequate sample size; for comparing two allegedly effective treatments, one would need a proper equivalence study with much larger sample sizes.
- The above argument also applies to the fact that “reductions in symptoms (>30 %) were reported by 55 % of participants in the Reiki and mindfulness groups, compared to 20 % in the Feiki group”.
The most interesting result is not mentioned in the abstract: there was no difference between Reiki and Feiki interventions. Thus, if this trial shows anything meaningful at all, it must be this:
THE CLINICAL EFFECTS OF REIKI RELY ON PLACEBO.
Or to put it differently:
REIKI HAS NO SPECIFIC EFFECTS.
Or to put it bluntly:
REIKI IS BOGUS!
- Why use adolescents when wanting to improve cognitive function? This parameter is impaired mostly in the eldely!
- If the study had generated a positive finding, would it have been attributed to shiatsu or to aromatherapy. Well-planned trials are designed to answer specific questions.
- A controlled clinical trial is for comparing outcomes between groups. For looking within group changes, we do not need a control group. Analysing within group changes in a controlled trial is irrelevant nonsense. Thus these findings should be discarded.
- What did this controlled trial control for? It certainly did not control for placebo effects!
- Why use “rest in sitting position for 10 minutes” as the control intervention? This is not remotely similar to the verum! A possible control treatment might have been to use shiatsu massage on non-acupuncture points with a nice smelling fragrance that is not an aromatherapy oil.
So, here is my conclusion of this study:
If you design a lousy trial, you get a lousy result.
