Updated Edition!
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 literature of homeopathy is littered with papers that are weirdly hilarious. A recent example of this genre is an article by Indian authors published in the ‘INTERNATIONAL JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE’ entitled Homeopathy in chronic disease management: a critical review of the evidence. Here is its abstract:
Homeopathy remains one of the most widely practiced complementary and alternative medicine (CAM) modalities worldwide, particularly among individuals with chronic non-communicable diseases (NCDs) who seek safe, holistic, and personalized therapeutic options. Despite its global popularity, controversy continues regarding its mechanisms of action and clinical effectiveness. This review critically evaluates the current evidence on the role of homeopathy in chronic disease management. A comprehensive review of randomized controlled trials (RCTs), systematic reviews, and meta-analyses published between 2000 and 2025 was conducted. Studies were included if they examined homeopathic interventions in chronic conditions such as asthma, arthritis, type 2 diabetes mellitus, depression, chronic pain, and fibromyalgia. Data were synthesized thematically to assess efficacy, mechanistic plausibility, methodological quality, and safety outcomes. Mechanistic hypotheses suggest that hormesis, nanoparticle-mediated signaling, immune modulation, and neuropsychological or psychosocial mechanisms may contribute to the therapeutic effects of homeopathy. Meta-analytic evidence demonstrates modest but statistically significant improvements in subjective measures such as pain, fatigue, and quality of life across several chronic diseases, with standardized mean differences ranging from 0.18 to 0.25. However, objective clinical outcomes, including spirometry and HbA1c, rarely show consistent benefit. Methodological challenges, including small sample sizes, heterogeneous interventions, limited follow-up durations, and a high risk of bias, continue to constrain the reliability of existing findings. Importantly, homeopathy exhibits a favorable safety profile, with no serious adverse events reported across chronic disease studies. Current evidence indicates that homeopathy may provide modest adjunctive benefits for symptom relief and improved patient satisfaction among individuals with chronic illnesses, although its specific therapeutic mechanisms remain uncertain. Integration of homeopathy into evidence-based, patient-centered chronic disease management frameworks may enhance holistic care. Future research should emphasize large-scale, multicenter randomized trials with standardized outcome measures and mechanistic endpoints to better define clinical relevance and biological plausibility.
The lead author of this paper earns his living in the Department of Materia Medica, NatoreHomeo Medical College, Natore, Bangladesh. Thus, we might be surprised by the critical tone of this paper. However, having a closer look at it, we soon find that, under a thin veneer of critical assessment, the paper is a prime attempt of white-washing the established evidence. Let me explain; the authors claim that:
- “Mechanistic hypotheses suggest that hormesis, nanoparticle-mediated signaling, immune modulation, and neuropsychological or psychosocial mechanisms may contribute to the therapeutic effects of homeopathy.” Do the authors really suggest that all of these vague theories are true? Why not decide which one constitutes the actual mode of action? Why not tell the truth and state clearly that none of them are remotely plausible, none would explain how homeopathy works, and none is accepted by anyone outside the cult of homeopathy?
- ” Meta-analytic evidence demonstrates modest but statistically significant improvements in subjective measures such as pain, fatigue, and quality of life across several chronic diseases, with standardized mean differences ranging from 0.18 to 0.25. ” Do the authors not see that the meta-analyses demonstrating such outcomes are invariably done by overtly biased homeopath? Do they really not know that independent scientists are unable to confirm such findings?
- “Homeopathy exhibits a favorable safety profile…” Are the authors not aware that using homeopathy (or any other ineffective therapy) to treat serious conditions at best prolongs the suffering of patients and at worst hastens their death?
- “Homeopathy may provide modest adjunctive benefits for symptom relief…” Do the authors know that this statement is firstly untrue and secondly contradicts Hahnemann’s teaching (he called doctors who employed homeopathy as an add-on therapy “traitors” and insisted that homeopathy was not a symptomatic treatment but a causal cure of disease)?
Understanding that this is what homeopaths call a ‘CRITICAL’ review might be helpful: it explains, I think, why they they feel that true critical assessments are nothing but brutal and cynical destructions of their beautiful fantasies.
It has been reported that, under the ardent anti-vax Health Secretary Robert F. Kennedy Jr., the Centers for Disease Control and Prevention has named Lousiana Surgeon General Ralph Abraham as its new principal deputy director. His track record speaks fro itself: Under Abraham’s leadership, the Louisiana health department waited months to inform residents about a deadly whooping cough (pertussis) outbreak. Earlier this year, Abraham told a Louisiana news outlet that he doesn’t recommend COVID-19 vaccines because, as he put it: “I prefer natural immunity.” In February, Abraham ordered the health department to stop promoting mass vaccinations, including flu shots, and barred staff from running seasonal vaccine campaigns. Abraham also is a big fan of using the anti-malarial drug hydroxychloroquine and the de-worming drug ivermectin to treat COVID-19, despite studies finding both ineffective against the viral infection. In 2021, Abraham was the seventh-highest prescriber of ivermectin out of 12,000 practicing physicians in his state. This fits with his record of troubling prescriptions. In 2013, he was one of the top opioid prescribers.
Furthermore, Abraham believes the Affordable Care Act should be repealed and opposes the expansion of Medicaid. On the topic of COVID-19, Abraham has said that masking, lockdowns and vaccination requirements “were practically ineffective.” He said that the adverse effects of COVID vaccines were “suppressed”, that “we don’t know” whether recipients of COVID vaccines can safely donate blood, and suggested that COVID vaccines may be linked to miscarriages. Abraham issued a directive in February 2025 instructing Louisiana state workers to end long-standing mass vaccination clinics and stop promoting seasonal vaccines.
Of course, Abraham’s views are well-aligned with Kennedy’s. Abraham has even spoken out against adding fluoride to water, like the health secretary. Kennedy is diligently working to reshape the CDC to fit his anti-vaccine views, conspiracy theories, and unproven ideas. This was made very clear recently, when Kennedy directed the CDC to rewrite one of its webpages to falsely link vaccines to autism.
As soon as the appointment had been announced, experts started protesting against it. “Dr. Abraham is unqualified,” said Thomas Farley, who served as health commissioner in both New York City and Philadelphia. Dr. Nirav Shah, an epidemiologist who served on the CDC under the Biden administration, criticized the appointment on X. “Dr. Abraham has been on the wrong side of several important public health issues over the past decade,” Shah wrote. “His track record, which includes undermining confidence in vaccines and minimizing the risk of outbreaks, disqualifies him from steering an agency charged with protecting all Americans.”
Spinal epidural hematoma is a rare but potentially devastating condition that can result in permanent neurologic deficits if not diagnosed promptly. This case report presents a 48-year-old female patient with a medical history of systemic lupus erythematosus, renal transplantation, and hypertension who developed spinal epidural hematoma (SEH) after chiropractic manipulation, leading to acute quadriplegia. She came to the emergency department with progressively worsening midline back pain that had started 2 days earlier. The patient reported undergoing chiropractic manipulation at a private clinic for neck pain, after which she developed back pain that gradually worsened. The cause of the patients problems turned out to be a spinal epidural hematoma.
The objective of this report is to highlight the potential for spinal epidural hematoma development in patients with comorbidities or underlying risk factors, such as systemic autoimmune disease, hypertension, or organ transplantation, after chiropractic manipulation and to emphasize the importance of early recognition to prevent serious neurologic sequelae.
The authors concluded that SEH is a rare but serious condition that must be considered as a potential complication of chiropractic manipulation, particularly in patients with comorbidities that increase bleeding risk.
Such cases are rare, we hope (as there is no monitoring, we cannot be sure), but not unheard of. Similar cases have been described before, e.g.:
Spinal epidural hematoma (SEH) occurring after chiropractic spinal manipulation therapy (CSMT) is a rare clinical phenomenon. Our case is unique because the patient had an undiagnosed cervical spinal arteriovenous malformation (AVM) discovered on pathological analysis of the evacuated hematoma. Although the spinal manipulation likely contributed to the rupture of the AVM, there was no radiographic evidence of the use of excessive force, which was seen in another reported case. As such, patients with a known AVM who have not undergone surgical intervention should be cautioned against symptomatic treatment with CSMT, even if performed properly. Regardless of etiology, SEH is a surgical emergency and its favorable neurological recovery correlates inversely with time to surgical evacuation.
Spinal epidural hematoma is a rare but potentially devastating complication of spinal manipulation therapy. This is a case report of a healthy pregnant female who presented to the emergency department with a cervical epidural hematoma resulting from chiropractic spinal manipulation therapy that responded to conservative treatment rather than the more common route of surgical management.
Objective: We report on the case of a patient with spinal epidural hematoma (SEH) after spinal manipulative therapy and review features of reported cases of a similar nature. Clinical features: The patient was undergoing Coumadin anticoagulant therapy for atrial fibrillation and presented to the chiropractor complaining of a stiff neck. After cervical manipulation, he developed paresthesia in both feet, progressing to motor deficits in all 4 extremities. He required a laminectomy and evacuation of a clot indenting the spinal cord. Results: Review of the literature revealed 7 reported cases of SEH after manipulation; 5 patients underwent cervical manipulation and 1 patient received Coumadin therapy. Conclusion: Practitioners of spinal manipulative therapy should be aware of SEH as a possible complication of manipulation in patients at risk and should exercise caution in the care of patients undergoing anticoagulant therapy.
Introduction: Spinal epidural hematoma is a rare complication after chiropractic manipulation. In the literature, only three cases have been reported, which all necessitated surgical treatment. Case report: A 27-year-old woman was treated with cervical chiropractic manipulation (C5/6) and facet joint infiltration. 10 minutes later the patient presented signs of intracranial pressure with nausea, vertigo, headache and vomiting. The magnetic resonance imaging of the spine demonstrated an epidural hematoma extending from the cervical to the sacral spine. As the patient had no sensible or motor deficits and recovered quickly, surgical treatment was not necessary. A few days later the patient had a complete persisting remission of symptoms. Conclusion: If neurological deficits occur after chiropractic manipulation, a spinal epidural hematoma should be considered to provide adequate therapy without delay. The current case report shows an unusual expansion of the hematoma which has not described so far after chiropractic manipulation. But, in contrast to the three cases reported before, a surgical intervention was not necessary.
Conclusion?
Well, I suppose you know mine: As chiropractic spinal manipulations are of uncertain (to put it mildly!) effectiveness, even rare but serious risks weigh heavily and make the risk/benefit balance tilt into the negative. In practical terms, this obviously means this: avoid chiros where you can!
It is a long time ago; I guess some 25 years. I had received an invitation by the German Green Party to give a lecture in Hannover on so-called alternative medicine (SCAM). As I wanted to re-visit Hannover (I had lived there for 2 happy years), I accepted. Little had I foreseen that the Greens were fans of homeopathy. Thus, they were irritated by me stating that homeopathy was far from evidence-based and could even quite dangerous under certain circumstances. Needless to say, that I never again received an invitation from the Greens!
Ever since, the German Greens have stuck to their conviction that homeopathy is the best thing since sliced bread. But, as I have stated countless times: the evidence will always prevail. No matter how strong the belief, in healthcare, science is stronger; it might take a long time, but the evidence will win the argument.
As it turns out, I was not far off! Here is the news that was recently reported in the ‘Bild Zeitung’ (my translation):
After years of wrangling, everything suddenly happened very quickly: at the Green Party conference in Hanover, delegates cleared up a highly controversial issue. In future, statutory health insurance funds will no longer pay for homeopathic treatments. A turning point for the environmental and eco-friendly party!
This was preceded by a brief, factual discussion late on Friday evening. Many Greens had previously been almost ashamed that the issue was even up for discussion – the debate had been so heated and the fronts so entrenched. In addition, the general consensus was that it was time to ‘look ahead’ – a renewed debate about globules, Bach flowers and mother tinctures seemed long outdated to many.
Now, Berlin pharmacist Cedrik Schamberger (Tempelhof-Schöneberg district association) has prevailed. “The solidarity community should not pay for therapies whose effectiveness beyond the placebo effect has not been scientifically proven,” stated the motion initiated by Schamberger. Furthermore, reimbursement by health insurance companies suggests that homeopathic remedies are effective; this “misleading of patients” must be stopped. Schamberger: “A policy based on superstition is neither fair nor sustainable.”
Not everyone was willing to accept this. Homeopathic services would cost health insurance companies “only” 22 million euros per year (as of 2021), argued former Bundestag member and current federal treasurer Manuela Rottmann (53). She called for a discussion of the “real” problems instead.
The majority of party conference participants saw things differently. The fact that homeopathy is paid for, but contraceptives are not, is a “real” problem, another delegate called out in the hall.
The current decision could only backfire on one person: Cem Özdemir (59), who wants to become Minister President of Baden-Württemberg. The state is home to several large companies that specialize in homeopathy. However, the Swabian has so far done well to distance himself from his party’s course (combustion engines out, migration policy) – so he would just have to continue as before.
No, I do not think that it was my lecture of ~25 years ago that did the trick. As already mentioned, I am convinced that, in healthcare, evidence will prevail.
BETTER LATE THAN NEVER!
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.
Low back pain (LBP) is a significant public health issue due to its high prevalence and associated disability burden. Clinical practice guidelines recommend non-pharmacological/non-surgical interventions for managing pain and function in people with LBP. This overview of Cochrane review is aimed ato providing accessible, high-quality evidence on the effects of non-pharmacological and non-surgical interventions for people with LBP and to highlight areas of remaining uncertainty and gaps in the evidence regarding the effects of these interventions for people with LBP.
the team searched the Cochrane Database of Systematic Reviews from inception to 15 April 2023, to identify Cochrane reviews of randomised controlled trials testing the effect of non-pharmacological/non-surgical interventions, unrestricted by language. Major outcomes were pain intensity, function and safety. Two authors independently assessed eligibility, extracted data and assessed the quality of the reviews using AMSTAR 2 (A MeaSurement Tool to Assess Systematic Reviews) and the certainty of the evidence using GRADE. The primary comparison was placebo/sham.
A total of 31 Cochrane reviews were included of 644 trials that randomised 97,183 adults with LBP. The team had high confidence in the findings of 19 reviews, moderate confidence in the findings of two reviews, and low confidence in the findings of 10 reviews. They present results for non-pharmacological/non-surgical interventions compared to placebo/sham or no treatment/usual care at short-term (≤ three months) follow-up. Placebo/sham comparisons Acute/subacute LBP Compared to placebo, there is probably no difference in function (at one-week follow-up) for spinal manipulation (standardised mean difference (SMD) -0.08, 95% confidence interval (CI) -0.37 to 0.21; 2 trials, 205 participants; moderate-certainty evidence). Data for safety were reported only for heated back wrap. Compared to placebo, heated back wrap may result in skin pinkness (6/128 participants versus 1/130; 2 trials; low-certainty evidence). Chronic LBP Compared to sham acupuncture, acupuncture probably provides a small improvement in function (SMD -0.38, 95% CI -0.69 to -0.07; 3 trials, 957 participants; moderate-certainty evidence). Compared to sham traction, there is probably no difference in pain intensity for traction (0 to 100 scale, mean difference (MD) -4, 95% CI -17.7 to 9.7; 1 trial, 60 participants; moderate-certainty evidence). Data for safety were reported only for acupuncture. There may be no difference between acupuncture and sham acupuncture for safety outcomes (risk ratio (RR) 0.68, 95% CI 0.42 to 1.10; I2 = 0%; 4 trials, 465 participants; low-certainty evidence). No treatment/usual care comparisons Acute/subacute LBP Compared to advice to rest, advice to stay active probably provides a small reduction in pain intensity (SMD -0.22, 95% CI -0.02 to -0.41; 2 trials, 401 participants; moderate-certainty evidence). Compared to advice to rest, advice to stay active probably provides a small improvement in function (SMD -0.29, 95% CI -0.09 to -0.49; 2 trials, 400 participants; moderate-certainty evidence). Data for safety were reported only for massage. There may be no difference between massage and usual care for safety (risk difference 0, 95% CI -0.07 to 0.07; 1 trial, 51 participants; low-certainty evidence). Chronic LBP Compared to no treatment, acupuncture probably provides a medium reduction in pain intensity (0 to 100 scale, mean difference (MD) -10.1, 95% CI -16.8 to -3.4; 3 trials, 144 participants; moderate-certainty evidence), and a small improvement in function (SMD -0.39, 95% CI -0.72 to -0.06; 3 trials, 144 participants; moderate-certainty evidence). Compared to usual care, acupuncture probably provides a small improvement in function (MD 9.4, 95% CI 6.15 to 12.65; 1 trial, 734 participants; moderate-certainty evidence). Compared to no treatment/usual care, exercise therapies probably provide a small to medium reduction in pain intensity (0 to 100 scale, MD -15.2, 95% CI -18.3 to -12.2; 35 trials, 2746 participants; moderate-certainty evidence), and probably provide a small improvement in function (0 to 100 scale, MD -6.8, 95% CI -8.3 to -5.3; 38 trials, 2942 participants; moderate-certainty evidence). Compared to usual care, multidisciplinary therapies probably provide a medium reduction in pain intensity (SMD -0.55, 95% CI -0.83 to -0.28; 9 trials, 879 participants; moderate-certainty evidence), and probably provide a small improvement in function (SMD -0.41, 95% CI -0.62 to -0.19; 9 trials, 939 participants; moderate-certainty evidence). Compared to no treatment, psychological therapies using operant approaches probably provide a small reduction in pain intensity (SMD -0.43, 95% CI -0.75 to -0.11; 3 trials, 153 participants; moderate-certainty evidence). Compared to usual care, psychological therapies (including progressive muscle relaxation and behavioural approaches) probably provide a small reduction in pain intensity (0 to 100 scale, MD -5.18, 95% CI -9.79 to -0.57; 2 trials, 330 participants; moderate-certainty evidence), but there is probably no difference in function (SMD -0.2, 95% CI -0.41 to 0.02; 2 trials, 330 participants; moderate-certainty evidence). It is uncertain whether there is a difference between non-pharmacological/non-surgical interventions and no treatment/usual care for safety (very low-certainty evidence).
The authors concluded that spinal manipulation probably makes no difference to function compared to placebo for people with acute/subacute LBP. Acupuncture probably improves function slightly for people with chronic LBP, compared to sham acupuncture. There is probably no difference between traction and sham traction for pain intensity in people with chronic LBP. Compared to advice to rest, advice to stay active probably reduces pain intensity slightly and improves function slightly for people with acute LBP. Acupuncture probably reduces pain intensity, and improves function slightly for people with chronic LBP, compared to no treatment. Acupuncture probably improves function slightly for people with chronic LBP, compared to usual care. Exercise therapies probably reduce pain intensity, and improve function slightly for people with chronic LBP, compared to no treatment/usual care. Multidisciplinary therapies probably reduce pain intensity, and improve function slightly for people with chronic LBP, compared to usual care. Compared to usual care, psychological therapies probably reduce pain intensity slightly, but probably make no difference to function for people with chronic LBP.
The findings of this overview might surprise some chiropractors, however, it did not surprise me at all*. I have stated more often than I care to remember that, for LBP, we currently have no approach that is truly convincing. One form of so-called alternative medicine (SCAM) seems to be roughly as effective (or ineffective) as the next. Where they might differ is safety and cost. On both of these measures chiropractic spinal manipulation is less convincing than some of the other options available, as we have discussed ad nauseam on this blog.
So, in a nutshell, the message to LBP patients can be put simply: stay away from chiros, keep active and, if you insist, use whatever other form of SCAM that you fancy, that is safe and inexpensive.
PS
*I was, however, surprised that the authors had low confidence in the findings of 10 of the 31 reviews. Cochrane reviews should be the most reliable evidence available to date!!!
Taekwondo (TKD) and Tai Chi (TC) are promoted for enhancing the health of older people, yet few studies have compared their effects across multiple domains. This study aimed to compare the effects of TKD versus TC on health status in independent older women.
A randomized controlled trial was conducted with two parallel groups: TKD (n = 11) and TC (n = 10). Both groups trained three times per week for 8 weeks. Pre- and post-intervention assessments included anthropometry, submaximal CPX, 2-min step test, Timed Up-and-Go (TUG), isometric mid-thigh pull (IMTP), maximal isometric handgrip strength (MIHS), 30 s chair stand, 30 s arm curl, sit-and-reach, and back scratch.
Compared with TC, the TKD group showed significantly greater improvements in several cardiorespiratory outcomes, including VO2 at VT1 and VT2, power output, VO2/HR, OUES, and VE/VCO2 slope (p < 0.05 to p < 0.001; d = 0.69–1.29). TKD participants also exhibited superior gains in maximal and relative IMTP, MIHS, relative MIHS, 30 s arm curl repetitions, and TUG performance (p < 0.05 to p < 0.001; d = 0.61–1.26). Both groups improved similarly in the 30 s chair stand test (p < 0.05). Flexibility outcomes diverged, with TKD improving sit-and-reach and TC showing greater gains in the back scratch test (p < 0.05).
The authors concluded that TKD was more effective than TC in improving cardiorespiratory fitness, muscle strength, and balance in older women and may represent a valuable health-oriented training strategy for this population.
On the one hand, it is to be applauded that studies compare different forms of physical/mental exercise in order to find out which is more effective. On the other hand, this trial was worngly designed and therefore cannot provide a useful answer to the question.
- As an equivalence study, its sample size was at least one dimention too small.
- It employed to treatments with largely unproven efficacy, which is never a good idea for equivalence studies.
- If you want to determine the ‘health status’ of older women, you need more and different outcome measures.
- Eight weeks is too short a follow-up time for determining a relevant effect.
My conclusion is therefore (yet again):
If you design a nonsense study, you are bound to get a nonsense result.
Clinical trials of so-called alternative medicine (SCAM) – and of course other treatments as well – are often poorly designed. If you don’t believe me, read some of my pervious posts; I have written about this more regularly than about any other subject. Such trials are not a mere nuisance but they violate fundamental ethical principles and can can lead to significant harm. Here is a brief summary of the damage they can cause.
- Waste of participants’ good will: If a study design is scientifically flawed, it is sure to produce an uninterpretable or irrelevant result. This means that the subjects have endured the burdens of participating (e.g. time, pain, inconvenience) unnecessarily. Strictly speaking, this is unethical.
- Waste of money: If a study is poorly designed and thus unable to produce a meaningful result, the often considerable amounts of money that have gone into the trial are wasted. Strictly speaking, this is unethical.
- Waste of effort: If a study does not contribute meaningfully to advancing our knowledge, the time spent by researchers to conduct it is wasted and should have been spent more wisely. Strictly speaking, this is unethical.
- Misleading conclusions: Flawed trial methodologies (e.g., selection bias, inappropriate endpoints, incorrect statistical analysis) lead to inaccurate, misleading or wrong results that send us all up the garden path. This can cause considerable harm to patients. Strictly speaking, this is not only unethical but also very dangerous.
- Erosion of Public Trust: Trials that are useless destroy public trust in science and medical research, making future, ethical studies more difficult to conduct. Strictly speaking, this is dangerous.
- Unwarranted credibility: Poorly designed trials of an implausible SCAM transfer unwarranted credibility to that form of treatment. Consequently consumers might believe it to be evidence-based and use it. Strictly speaking, this can harm their health and is therefore dangerous.
The lesson for SCAM researchers is simple: design your studies well. Unfortunately translating this lesson into action is not simple.
Many of you will remember the multiple posts on this blog about this study and about the fact that Frass himself has stated that his dubious ‘homeopathy for cancer study’ will be retracted. At the time, our resident defender of the indefensible (pseudonym ‘sandbox’) commented (as almost aways incorrectly) as follows:
1. Ernst attempted to retract a high-quality article using falsehoods.
2. Ernst accused the principal investigator of fraud without evidence.
3. Ernst sent a letter to the editor that was not published.
4. The verdict allowed the clinical trial to continue through a corrigendum.
5. Ernst felt desperate and, with his group of friends, pressed to try again to retract the article.
6. Ernst realises that, apparently (from a vague statement by Frass), the trial is going to be retracted.
7. Ernst congratulates himself because he has managed to retract the article, but admits that, not for his reasons, he has no confirmation (yet) from The Oncologist.
8. Ernst calls The Oncologist incompetent for publishing an editorial in which they only ask to test each of the drugs used in the trial.
That was around a month ago. Now, finally, an official retraction notice has appeared:
This is a retraction of: Michael Frass, Peter Lechleitner, Christa Gründling, Claudia Pirker, Erwin Grasmuk‐Siegl, Julian Domayer, Maximilian Hochmair, Katharina Gaertner, Cornelia Duscheck, Ilse Muchitsch, Christine Marosi, Michael Schumacher, Sabine Zöchbauer‐Müller, Raj K. Manchanda, Andrea Schrott, Otto Burghuber, Homeopathic Treatment as an Add‐On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non‐Small Cell Lung Cancer: A Prospective, Randomized, Placebo‐Controlled, Double‐Blind, Three‐Arm, Multicenter Study, The Oncologist, Volume 25, Issue 12, December 2020, Pages e1930–e1955, https://doi.org/10.1002/onco.13548.
The journal published the article in November 20201 and a correction in March 2021.2 In August 2022, the journal received a request from the Commission for Research Integrity of the Austrian Agency for Research Integrity (OeAWI) to retract the article following an investigation they conducted at the request of the Vice Rector of the Medical University of Vienna. The journal published an Expression of Concern in October 2022,3 followed by a second correction4 and accompanying Editorial in September 2024.5
Subsequent to the two corrections, concerns have continued to be raised about the study. In light of this continued uncertainty and the issues previously covered in the corrections, the journal no longer has confidence in the results and conclusions reported in the article and has decided to retract.
Many co-authors disagree with the journal’s decision to retract6, while one agrees7 and others have not commented either way.
REFERENCES
1 Michael Frass, Peter Lechleitner, Christa Gründling, Claudia Pirker, Erwin Grasmuk‐Siegl, Julian Domayer, Maximilian Hochmair, Katharina Gaertner, Cornelia Duscheck, Ilse Muchitsch, Christine Marosi, Michael Schumacher, Sabine Zöchbauer‐Müller, Raj K. Manchanda, Andrea Schrott, Otto Burghuber, Homeopathic Treatment as an Add‐On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non‐Small Cell Lung Cancer: A Prospective, Randomized, Placebo‐Controlled, Double‐Blind, Three‐Arm, Multicenter Study, The Oncologist, Volume 25, Issue 12, December 2020, Pages e1930–e1955, https://doi.org/10.1002/onco.13548
2 Michael Frass, Peter Lechleitner, Christa Gründling, Claudia Pirker, Erwin Grasmuk-Siegl, Julian Domayer, Maximilian Hochmair, Katharina Gaertner, Cornelia Duscheck, Ilse Muchitsch, Christine Marosi, Michael Schumacher, Sabine Zöchbauer-Müller, Raj K. Manchanda, Andrea Schrott, Otto Burghuber, Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study, The Oncologist, Volume 26, Issue 3, March 2021, Page e523, https://doi.org/10.1002/onco.13693
3 Expression of Concern: Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study, The Oncologist, Volume 27, Issue 12, December 2022, Page e985, https://doi.org/10.1093/oncolo/oyac221
5 Correction to: Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study, The Oncologist, Volume 29, Issue 11, November 2024, Pages e1631–e1632, https://doi.org/10.1093/oncolo/oyae253
4 William D Figg, Susan E Bates, Clinical trial results: each patient’s participation should count, The Oncologist, Volume 30, Issue 7, July 2025, oyae252, https://doi.org/10.1093/oncolo/oyae252
6 Michael Frass, Peter Lechleitner, Christa Gründling, Katharina Gaertner, Cornelia Duscheck, Ilse Muchitsch, Christine Marosi, Raj K. Manchanda, and Otto Burghuber disagree with the journal’s decision to retract.
7 Sabine Zöchbauer-Müller agrees with the journal’s decision to retract.
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I am of course pleased that this is finally done, but believe that the wholly incompetent Editorial (ref 4 above) needs retracting as well. Finally, I feel that an appology from the editor(s) (for their endless delay tactics, their refusal to understand the issues at hand, for not answering multiple emails, etc., etc.) might be in order.
