MD, PhD, MAE, FMedSci, FRCP, FRCPEd.

scientific misconduct

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Needle-based acupuncture is used in some detoxification settings. However, its efficacy for illicit drug use disorders remains uncertain because prior reviews often mixed comparator types, co-interventions, or non-needle modalities. This review aimed to evaluate needle-based acupuncture monotherapy using comparator-stratified meta-analysis.

The authors searched PubMed, Embase, Web of Science, Cochrane Library, CNKI, CBM/SinoMed, trial registries, and supplementary sources from inception to September 12, 2025. The quantitative synthesis was restricted to randomized trials of manual acupuncture, electroacupuncture, or needle-insertion auricular acupuncture delivered without concomitant pharmacotherapy or psychotherapy. Although the registered protocol allowed non-randomized comparative studies, none were pooled because of insufficient comparability and a higher risk of confounding. Sensitivity analyses excluded trials with moxibustion co-treatment.

Thirteen randomized trials (n = 1,027) were included in the meta-analysis. For the prespecified primary outcome of withdrawal severity at the end of treatment, acupuncture favored blank/no-acupuncture controls [g = −2.089, 95% confidence interval (CI): −2.869 to −1.309; τ² = 0.712; I² = 82.9%], but the prediction interval (PI) crossed the null (PI: −4.306 to 0.128). Against active non-acupuncture comparators, the pooled effect was imprecise (g = −1.70, 95% CI: −5.43 to 2.02; PI: −23.49 to 20.09). Against sham acupuncture, two comparisons yielded an imprecise estimate (g = −1.45, 95% CI −9.41 to 6.51), and no PI was estimated. Among secondary outcomes, anxiety favored acupuncture over blank/no-acupuncture controls (g = −1.537, 95% CI: −2.047 to −1.026; PI: −2.939 to −0.134), whereas evidence from sham-controlled studies was less certain (g = −0.998, 95% CI: −1.744 to −0.252; PI: −2.828 to 0.832). For depression outcomes, PIs crossed the null in both blank- and sham-controlled analyses. The certainty of the evidence was low to very low.

The authors concluded that acupuncture exhibited favorable average effects on withdrawal severity, but null-crossing PIs limited confidence in the reproducibility of these effects across different settings and treatment protocols. Anxiety was interpreted as a secondary finding. No serious acupuncture-related adverse events were explicitly reported, although surveillance was often passive or insufficiently described.

The review treats acupuncture as “effective” for illicit drug disorders by highlighting short-term improvements in craving or anxiety, while the outcomes that matter for addiction – abstinence, relapse, use frequency, and retention – show no reliable benefit.

This, I think, is a classic case of presenting a negative result as a positive finding!

The review explicitly found no consistent difference between acupuncture and comparators for substance use endpoints, and the apparent positive outcomes were limited by low-quality evidence and publication bias. By foregrounding surrogate outcomes and obscuring the lack of clinically decisive effects, the paper misleads readers into perceiving acupuncture as a viable monotherapy for drug use disorders. Yet the evidence does clearly not support that conclusion.

The Spanish Agency for Medicines and Medical Products (AEMPS) has just published a comprehensive technical report entitled “Homeopathy and Homeopathic Products: Evaluation of Evidence on Their Efficacy and Safety”, which categorically concludes that there is no scientific evidence supporting the efficacy of homeopathy as a therapeutic tool. After a systematic review of scientific literature and evaluations by state agencies internationally, the report states that the observed effects are comparable to placebo.

The report, which analyzed 64 systematic reviews published since 2009, highlights that most studies suggesting benefits from homeopathy have low methodological quality, often invalidated by small samples, short follow-up periods, or biases in randomization. Furthermore, it notes that as the quality and rigor of clinical trials increase, the supposed effect of homeopathy diminishes until it disappears entirely.

From a scientific standpoint, the principles of homeopathy clash with the laws of physics and current pharmacology. In typical dilutions like 12 CH—where one part of the original substance is mixed with 100 parts of solvent twelve times consecutively—it is mathematically impossible for a single molecule of the original ingredient to remain in the preparation, breaking any cause-and-effect relationship between the product and the therapeutic effect.

To illustrate this disproportion, the report points out that a dilution of just 6 CH (far less extreme than 12 CH) equates to dissolving a packet of sugar in the entire Mediterranean Sea. For this reason, the AEMPS classifies theories like “water memory”—the belief that the liquid retains the properties of a substance even without its molecules—as empirically baseless postulates that challenge scientific and rational thinking.

In compliance with European and national regulations, the AEMPS has completed a regularization process that has resulted in the market withdrawal of numerous products. As of the report’s publication date, no homeopathic product with authorized therapeutic indications exists in Spain. The 976 that remain registered did so via a simplified procedure, based on extreme dilutions ensuring the preparation’s innocuousness, which does not require proof of therapeutic effect and legally prohibits any therapeutic claims on labeling.

Spain aligns with a global trend of health institutions adopting critical stances:

  • United Kingdom: The Science and Technology Committee recommended halting public funding and requiring labeling warnings about lack of efficacy.
  • Australia: The National Health and Medical Research Council concluded that homeopathy should not be used for chronic or serious diseases.
  • France: The Haute Autorité de Santé eliminated public reimbursement for these products in 2021 due to lack of demonstrated efficacy.
  • Germany: Approval is expected in 2026 for the definitive removal of homeopathy coverage from statutory health insurance.
  • United States: The Food and Drug Administration (FDA) considers these products “unapproved new drugs,” and the Federal Trade Commission requires warnings that there is no scientific evidence of their functioning.

Although there is a popular belief that these preparations are innocuous because they are “natural,” serious adverse reactions have been reported, including poisonings from poor dosing and infant deaths linked to teething products in other countries.

However, the AEMPS warns that the main associated risk is the abandonment or delay of proven effective medical treatments. Citizens opting for homeopathy to treat serious or chronic conditions may endanger their health by replacing evidence-based therapies with products lacking such evidence.

The AEMPS report reaffirms the Ministry’s commitment to public health protection and evidence-based medicine. In line with other international agencies, it emphasizes the need for transparent information so citizens can make safe health decisions. The conclusion of the report is firm:

Given the lack of evidence of efficacy, homeopathy cannot be considered a valid therapeutic alternative, and its use must not lead to delaying or abandoning treatments proven to be effective.

The suppression of scientific data within US federal agencies represents a fundamental tension between independent public health expertise and political ideology. This conflict seems to have now reached a boiling point at the ‘Centers for Disease Control and Prevention’ (CDC), where the Trump administration’s political leadership has indefinitely delayed the publication of an important report demonstrating the continued benefits of the COVID-19 vaccine. This action marks a pivotal shift in how the US manages public health information, signalling an era where data is scrutinized not just for its accuracy, but for its alignment with a specific political narrative.

The controversy centres on a study conducted by career scientists within the CDC’s ‘National Center for Immunization and Respiratory Diseases’. It analyzed data from the winter of 2025 and showed that COVID-19 vaccinations reduced the risk of hospitalization by 55% and emergency room visits by 50% among healthy adults. These figures provide a compelling argument for the vaccine’s role in mitigating the burden on the US healthcare system. However, despite being scheduled for release in the agency’s Morbidity and Mortality Weekly Report (MMWR) in mid-March, the study remains unpublished.

The primary figure behind this delay is the Acting CDC Director, Dr. Jay Bhattacharya. Appointed by the Trump administration and a vocal advocate for the “Great Barrington Declaration,” Bhattacharya has challenged the report’s methodology, specifically the “test-negative design”. This is an observational study design often used to estimate vaccine effectiveness. It compares people who seek care and are test-positive for the target infection with similar people who seek care but are test-negative. The key idea is simple:

  • Recruit people with similar symptoms who come for testing.
  • Split them into cases, who test positive, and controls, who test negative.
  • Compare the odds of prior vaccination or another exposure between the two groups.

If vaccinated people are less common among the test-positive group than among the test-negative group, that suggests the vaccine is effective. This design is efficient because both cases and controls come from the same care-seeking population which reduces confounding. It is also practical during outbreaks, since cases and controls can be identified quickly from testing records.

While Bhattacharya frames his criticism as a commitment to rigorous quality control, the scientific community begs to differ and stress that the test-negative design has been the gold standard for assessing vaccine effectiveness for over twenty years. Indeed, a flu vaccine study using the exact same methodology was approved for publication by the same leadership just days prior, suggesting a double standard applied specifically to COVID-19 data.

This scandalous incident does not exist in a vacuum; it is a manifestation of a broader overhaul of US public health spearheaded by Health Secretary Robert F. Kennedy Jr. Under this leadership, the administration has sought to deprioritize standard immunization schedules and has integrated vaccine skeptics into the Advisory Committee on Immunization Practices (ACIP). By suppressing data that proves vaccine efficacy, the administration creates a vacuum of information that can be filled by more skeptical, politically convenient narratives.

The consequences of all this are profound. When political appointees act as gatekeepers for scientific data, it erodes the public’s trust in the CDC as a neutral, evidence-based institution. High-profile resignations, such as that of Dr. Fiona Havers, suggest a demoralized workforce of career scientists who feel their objective research is being censored. Furthermore, by withholding data that quantifies the protection offered by vaccines, the government limits the ability of healthcare providers and citizens to make informed decisions about their own health risks.

In conclusion, the suppression of the 2026 CDC vaccine report is a watershed moment for scientific integrity in government. It illustrates the danger of a system where data is viewed through a lens of political utility rather than public safety. As the administration continues to reshape federal health policy, the ongoing struggle between career researchers and political leadership will likely define the future of public health transparency in the US. The losers, no doubt, will be the people – primarily in the US but likely also globally.

The Indian Ministry of Ayush was established in 2014 with a vision of reviving the profound knowledge of India’s ancient systems of medicine and ensuring the optimal development and propagation of the Ayush systems of healthcare. Earlier, the Department of Indian System of Medicine and Homoeopathy (ISM&H) formed in 1995, was responsible for the development of these systems. It was then renamed as the Department of Ayurveda, Yoga, and Naturopathy, Unani, Siddha and Homoeopathy (Ayush) in November 2003 with focused attention towards education and research in these therapies.

In the global landscape of public health, India’s Ministry of AYUSH stands as a profound anomaly. While most middle‑ and high‑income countries have converged around evidence‑based, scientifically grounded medicine, India has instead expanded this large, state‑run administrative apparatus where cultural nationalism and traditionalist narratives dominates over clinical efficacy and scientific rigor. The Ministry’s current trajectory reveals a troubling pattern: the systematic promotion of unproven therapies, flawed research, and notorious breaches of ethical principles, particularly with respect to the treatment of India’s most vulnerable populations.

The Homeopathy Anomaly

The most glaring anomaly must be the Ministry’s continued, high‑level support for homoeopathy. India is currently the only country in the world that maintains a dedicated national ministry and a statutory regulatory framework – via the National Commission for Homoeopathy – specifically to promote a system widely regarded as implausible, ineffective and harmful. Global assessments, including those by no less than 28 independent organisations worldwide, have concluded that there is no reliable evidence that homeopathic remedies work beyond placebo. Yet the AYUSH Ministry funds and publicizes a central research council (the Central Council for Research in Homoeopathy, CCRH) as well as a network of homoeopathic hospitals and teaching institutions, with annual budget allocations now exceeding ₹4,400 crore (roughly 470–480 million US dollars at current exchange rates). By directing substantial taxpayer funds to homoeopathic research and infrastructure, the state effectively endorses a “placebo‑as‑medicine” model, elevating it to the status of a national health strategy. This is not merely an academic dispute; it is a policy outlier that places India’s healthcare posture at odds with well‑established chemical and physical principles, as well as with the recommendations of leading international scientific bodies.

The Facade of Rigor

The Ministry tends to defend its approach by claiming a pivot toward “evidence‑based” or “scientific” AYUSH medicine, but an examination of its research output suggests a facade of rigor rather than its substance. Much of the work produced by bodies such as the Central Council for Research in Ayurveda (CCRA) and their counterparts in Unani and Siddha consists of investigations that are methodologically weak and wide open to bias. Key methodological flaws recur:

  • Small sample sizes: Many trials involve fewer than 50–100 participants, rendering them statistically underpowered.​
  • Lack of blinding: A large proportion of studies is open‑label, where both clinicians and patients know the assigned intervention, amplifying placebo effects and observational bias.
  • Selective reporting and publication bias: Negative findings – where AYUSH interventions fail to demonstrate benefit – are rarely published.​

By branding such useless studies as “scientific proof,” the Ministry engages in a form of “science‑washing.” This practice misleads the public, uncritical clinicians, and policymakers into believing that AYUSH therapies have undergone the same rigorous, independent scrutiny as conventional therapies.

The Ethical Violations

In my view, the most serious concern is ethical. Under the banner of “Self‑Reliant India” (Atmanirbhar Bharat), the Ministry has aggressively promoted AYUSH products, for instance, during the COVID‑19 pandemic. This push could be viewed as an exercise in cultural pride and national self‑reliance but, in fact, it carries serious risks.

Medical ethics rely on two core principles: informed consent and non‑maleficence. When a state body, backed by cabinet‑level authority, “flogs” unproven and potentially dangerous treatments to a largely rural population with limited health literacy, it undermines both. Many patients are not able to distinguish between an ancient tradition and a clinically validated drug, yet they may be led by government‑sponsored messaging to defer or abandon evidence‑based treatments.

This is particularly dangerous in chronic conditions such as diabetes mellitus and hypertension, where effective pharmacological control and regular monitoring are both available and potentially life‑saving. If patients substitute proven allopathic regimens with state‑endorsed AYUSH alternatives of uncertain efficacy, the consequences can be dire. They include uncontrolled blood glucose, stroke‑risk elevation, organ damage, and avoidable mortality. The Ministry’s conduct, in effect, offloads these risks onto the most vulnerable while shielding itself behind appeals to tradition and national identity.​

Conclusion

The Ministry of AYUSH has become the institutional vehicle for a “pluralistic” health model that, in practice, functions as a state‑funded rejection of the scientific method. This constitutes a regression in public‑health governance rather than a progressive pluralism. Until the Ministry subjects its therapies to the same scrutiny as any other medicine, and until it accepts transparent, independent evaluations without recourse to political or cultural vindication, it will remain less a health body and more a department of cultural preservation and doctrine.

I am sure that many of my readers have no idea what ‘Slinding Cupping Therapy’ is. It is a TCM therapy that, according to the authors of this paper, receives much appreciation for treating plaque psoriasis. This study was designed to test the hypothesis that sliding cupping therapy is non-inferior to narrowband ultraviolet B (NBUVB) therapy in improving disease severity in patients with plaque psoriasis.

This prospective trial recruited 60 patients with plaque psoriasis who were randomized to receive either sliding cupping intervention or NBUVB treatment. The cup was moved 30 times for each skin lesion until the target skin area turned purple. The initial dose (mJ/cm2) of ultraviolet radiation b (UVB) was determined based on sun-reactive skin types I through VI, which ranged from 300 mJ/cm2 to 800 mJ/cm2. Both treatments were performed 3 times per week for 8 weeks. The primary endpoint was the percentage reduction in Psoriasis Area and Severity Index (PASI) score at week 8, with secondary endpoints, including Physician’s Global Assessment (PGA), body surface area, visual analogue scale scores, and quality of life measures.

The total response rates were 69% (18/26) and 79% (19/24) for patients receiving sliding cupping intervention and those receiving NBUVB treatment, respectively, which showed no significant difference (P = .526). The PASI scores, body surface area, and PGA were reduced in patients with plaque psoriasis at W0, W4 and W8 after either sliding cupping intervention or NBUVB treatment (P <.001), and these reductions were not significantly different between the patients receiving sliding cupping intervention and those receiving NBUVB treatment at W0, W4, W8, and W12. At W8, the mean percentage reduction in PASI was 62.4% (95% CI, 54.9–69.8) in the sliding cupping group and 66.9% (95% CI, 59.6–74.2) in the NBUVB group, with no significant difference between groups. The total response rates were 69.23% (18/26) and 79.17% (19/24), respectively (P = .526). Patients receiving sliding cupping intervention and those receiving NBUVB treatment did not show statistically significant differences in these outcomes at W0, W4, W8, and W12 (P >.05).

The authors concluded that the overall results suggest that sliding cupping therapy exhibits statistically similar efficacy and safety profiles as NBUVB treatment, especially at 8 weeks after treatment.

Sliding cupping therapy is a form of cupping in which cups producing mild suction are placed on oiled skin and then moved along the body surface, generating a “reverse massage” that lifts rather than compresses the subcutaneous tissues. The negative pressure is thought to increase local blood flow and lymphatic drainage, reduce perceived muscle tension, and temporarily improve range of motion, though high‑quality clinical evidence for most claimed benefits remains limited.

The treatment is used mainly by massage therapists, physiotherapists, and TCM practitioners in musculoskeletal and sports‑rehab settings, as well as in wellness and spa‑oriented clinics; it is commonly applied to the back, shoulders, neck, limbs, and along fascial lines or acupuncture meridians, often for pain, stiffness, “trigger‑point”‑type tension, and post‑exercise recovery. The popularity of this therapy is best characterised as a niche within broader cupping and fascial‑release practice rather than a mainstream standard treatment.

The new study is a text-book example of how to mislead people with seemingly reliable research. The fact that it was grossly under-powered – and not the effectiveness of the sliding cupping therapy – is obviously the cause of the lack of a difference between the effective therapy (NBUVB) and the sliding quackery.

Let me give you an example: say, we compare antibiotics (A) to homeopathy (H) as treatments for bacterial pneumonia. We treat 10 patientsin each group, and 8 of them recover in group A within a week, while in the H-group the amount is 6 (many patients recover even without an effective treatment). We run statistical tests which tell us that the difference is not significant. Thus we falsely conclude that homeopathy is as effective as antibiotics in the treatment of pneumonia. The 2 treatments were, in fact, not equal but the lack of power of the small study failed to detect the existing difference.

It seems rather obvious to me that a similar thing has happened with the above study. Its authors are to be congratulated for cheating so slyly that neither the editors nor the reviewers of the journal ‘Medicine’ managed to see through their simple litte trick.

During the 1st year of his second presidency, Trump and his administration changed US science beyond recognition. Officials started instantly firing thousands of researchers and other government employees and cut billions of dollars of US support for global-health programmes, including dismantling the US Agency for International Development (USAID). They also arrested some scholars from outside the United States as they stepped up efforts to restrict entry into the country and free speech. The US government then took steps to exert total control over universities by withholding tens of billions of dollars in research grants.

The objective of this systematic review was to investigate trustworthiness, i.e. the methodological rigor, transparency, good governance, research integrity, and absence of misconduct, of randomized clinical trials (RCTs) of osteopathic manual therapy.

The team searched MEDLINE, EMBASE, CINAHL, AMED, PEDro, ostmed.dr, and Chiroindex for RCTs evaluating osteopathic treatments (January 2021-June 2024). Risk of bias (RoB) was assessed using Cochrane tool 2, while trustworthiness was assessed with the Cochrane Pregnancy and Childbirth Screening Tool and the REAPPRAISED checklist. Journal trustworthiness, misleading representations in abstracts (“spin”), and results plausibility (via meta-analysis) were also assessed. Findings were synthesized descriptively.

Sixty-one RCTs were included (median sample size 45, interquartile range (IQR) 30-76), largely studying healthy volunteers (29%). The findings are sobering:

  • Most had high RoB (74%).
  • Only 7% acknowledged potential conflicts from authors’ professional ties.
  • Only 27% of contactable authors engaged with reviewers.
  • Only 7 abstracts (12%) were free of spin.
  • Methodological concerns included poor missing data handling (31%), selective analyses (38%), unacknowledged multiple testing (36%), and outcome switching (12%).
  • Meta-analysis found two outliers and 5 further with very large effects.
  • 19% of the studies provided inadequate data for pooling.
  • Limitations included incomplete reports and lack of validated trustworthiness assessment tools.

The authors concluded that adherence to best practices in osteopathic RCTs needs improvement to enhance evidence-based decision-making, reduce research waste, and enhance reproducibility. Further research should explore whether these findings apply to other small, under-resourced fields.

Considering that many of the authors are affiliated to osteopathic institutes, this is a remarkably critical review. Its results cannot surprise anyone who regularly studies the literature in this field. What is surprising, however, is the conclusion: ADHERENCE TO BEST PRACTICES NEEDS IMPROVEMENT. This is undoubtedly true, but it is not the most direct conclusion of what the data show. In my mind, it should be something more akin to this:

MOST OSTEOPATHIC RCTs ARE OF POOR QUALITY AND THEIR FINDINGS ARE THUS UNRELIABLE.

 

It has been reported that HHS Secretary Robert F. Kennedy Jr. took the top spot in this year’s Shkreli Awards from the Lown Institute. The annual awards call out greed and fraud in the healthcare industry. Lown Institute president Vikas Saini, MD, explained that the purpose of the awards is to call out “systemic problems” in which healthcare organizations and clinicians “chase money and greed to the point where they cut corners … with devastating results to patient care.”

Kennedy garnered the lion’s share of judges’ votes for his baseless claims about causes of autism that have baffled the public and angered medical experts. “Citing studies that showed correlation but no causal evidence, and despite clinicians, toxicologists, and major medical organizations having looked at the research and rejected the claim, he asserted a link between acetaminophen use during pregnancy and autism,” the Lown judges said.

Kennedy then suggested infants undergoing circumcision have higher rates of autism because they likely received acetaminophen for pain, yet his evidence was an unreviewed and unpublished preprint, judges said. “While this spectacle of erratic scientific leadership around autism is supposedly tied to Making America Healthy Again, many are now asking not what Kennedy can do for his country, but how his country can undo what he has already done,” the judges wrote.

Saini stated that Kennedy may be asking reasonable questions, like what is causing autism. The problem is that he then “makes brash announcements … and trumpets them like the Second Coming, saying, ‘We’re going to just fix all this,’ which is playing fast and loose with the facts, and really undermines confidence in decision making and leadership.”

_________________________

Needless to say that I agree with this award. On this blog, I have repeatedly commented on Kennedy’s irrational and dangerous views, actions and initiatives. In my view, he does not belong into any position of responsibility, particularly in the area of healthcare. In a nutshell, he uses science like a drunken man uses a lamppost – not for illumination, but for support.

Acupuncture is considered an effective complementary therapy for major depressive disorder (MDD), yet current findings remain inconsistent, and its overall quality is uncertain. Therefore, this systematic review summarizes the existing evidence on acupuncture for MDD, providing an overview of the current research, identifying gaps and limitations in the literature, and offering guidance for future research.

A Chinese team of researchers systematically searched eight electronic databases (PubMed, EMBASE, CDSR, CENTRAL, CNKI, Wanfang, VIP, and SinoMed) and seven guideline repositories (Trip, AHRQ, NICE, NZGG, GIN, CMACPG, and NHMRC) from inception to November 15, 2024, for RCTs, systematic reviews, and clinical practice guidelines on acupuncture for major depressive disorder. Eligibility criteria were defined according to the PICOS framework. Two reviewers independently screened studies, extracted data, and assessed quality using the Cochrane Risk of Bias tool for randomized controlled trials (RCTs) and AMSTAR-2 for systematic reviews (SRs). Key evidence and recommendations were synthesized and presented in tables and figures.

A total of 374 studies were identified, including 330 RCTs, 35 SRs, and 9 clinical guidelines. Among these studies, 307 (93.03%) were published in Chinese and 23 (6.97%) in English. The RCTs generally involved small sample sizes (50 to 100 participants). The primary intervention was acupuncture combined with antidepressant medication (50%), while 79.39% of studies used antidepressants as the main control. Nearly all studies (97.88%) used changes in depression severity as the primary outcome, although the risk of bias was unclear in 80.3% of cases.

Of the SRs, 97.14% reported positive findings favoring acupuncture’s potential benefits, but 74.29% were rated as very low in methodological quality, lacking thorough bias assessments. Among the two acupuncture-specific guidelines and seven broader guidelines, recommendations for acupuncture in managing MDD varied considerably.

The authors concluded that the evidence from RCTs, SRs, and clinical guidelines suggests that acupuncture may reduce depressive symptom severity and provide additional benefits for patients with comorbid anxiety, sleep disturbances, or somatic symptoms, particularly when used as an adjunctive therapy. However, these findings are mainly based on small-scale trials with methodological limitations, and most guidelines recommend acupuncture only as a third-line complementary option. Further large, high-quality RCTs are needed to strengthen the evidence base and inform future guideline development.

For the following reasons, the conclusions are, in my opinion, wrong:

  • Almost all RCTs came from China (we have discussed the untrustworthiness of these trials many times previously, e.g. here or here).
  • Almost all studies were methodologically flawed.

Therefore, I suggest a more accurate conclusion based on the available data:

The evidence from RCTs, SRs, and clinical guidelines is unreliable due to the poor quality of the available data. Until reliable evidence is available, acupuncture is not a recommendable therapy for MDD, a life-threatening condition.

 

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).

Fig. 2

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.

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