clinical trial
It does not happen every day that the prestigeous German FRANKFURTER ALLGEMEINE ZEITUNG publishes an in-depth analysis of TCM (Traditional Chinese Medicine) and even discusses several of the themes that we, here on this blog, have often debated. Allow me, therefore, to translate a few passages from the recent FAZ article entitled “Der Fluch der alten Dinge” (The Curse of Old Things):
… TCM has countless followers in many countries. ‘TCM is a wonderful medicine that thinks ‘holistically’, that sees not just one organ but the whole person and that offers very good treatment options,’ says Dominik Irnich. He heads the German Medical Association for Acupuncture. Although there is not evidence for all indications, TCM is ‘a scientifically based option for a number of diseases, the effects of which have been proven many times over’…
Meanwhile, Beijing wants to utilise the positive image of TCM to present itself in a good light and promote exports. The current five-year plan also provides for the creation of around 20 TCM positions for epidemic prevention and control. Critics, on the other hand, see patients at risk due to insufficiently tested therapies – and medicine as a whole: many studies are hardly valid and distort the state of science…
The top leadership of the Chinese Communist Party is using the ‘old things’ to increase its global influence and utilise TCM not only in its own country, but also as an export hit. The global TCM market is estimated to be worth many billions of euros annually, but there are no reliable figures – not least because it often includes illegally traded products such as rhino horn or donkey skin, which has led to mass killings.
Officially, Beijing prosecutes illegal trade and promotes science-based medicine, but the interests are intertwined. Even under Mao, traditional methods were used in China as a favourable alternative to imported medicines, and Beijing is currently increasingly allowing them to be reimbursed. At the same time, China’s leadership is trying to anchor TCM products in healthcare worldwide, for example as part of a ‘health Silk Road’ in Africa. During the Covid-19 pandemic, the state not only used TCM products en masse in its own country, Chinese foreign representatives also distributed them to Chinese people in Europe. This included a product based on gypsum, apricot kernels and plant parts called Lianhua Qingwen. According to a report published by the consulate in Düsseldorf, this was distributed even though the sale of medicines outside of pharmacies is generally punishable by law.
Beijing has also been successful at the level of the World Health Organisation (WHO), which promotes traditional medicine from China. ‘This was part of the interests and election programme of former Chinese Director-General Margaret Chan,’ says WHO consultant Ilona Kickbusch. The WHO drew up standards for acupuncture training, including knowledge of the ‘function and interactive relationship of qi, blood, essence and fluid’, as the document states.
In 2019, the WHO member states decided to add a chapter on ‘traditional medicine’ to the standard classification of diseases. Doctors can now code alleged patterns of ‘qi stagnation’ or yang deficiency of the liver. The umbrella organisation of European science academies EASAC criticised this as a ‘significant problem’: doctors and patients could be misled and pressure could be exerted on healthcare providers to reimburse unscientific approaches. Nature magazine found: ‘The WHO’s association with drugs that have not been properly tested and could even be harmful is unacceptable for the organisation that has the greatest responsibility and power to protect human health.’ …
In general, the study situation on therapies that are categorised as TCM is extremely confusing. The evidence is ‘terrible’, says the physician Edzard Ernst, who has analysed such procedures. ‘There are thousands of studies – that’s part of the problem.’ Many studies come from China, but it is known that a large proportion are invalid or falsified. It is almost impossible to report critically on TCM there: according to media reports, a doctor was imprisoned for three months in 2018 after criticising a TCM remedy. In 2020, Beijing even considered banning criticism of TCM, but refrained from doing so after an outcry.
According to Ernst, the quality of even some of the meta-analyses from the respected Cochrane Collaboration is ‘hair-raising’ due to the inclusion of unreliable studies, and according to some Chinese researchers, acupuncture works for everything. Prof. Unschuld said at an event a year ago that he was asked in China not to address critical issues.
‘In a country without the open and free critical culture that is common in democratic countries, the control mechanisms are missing,’ says Jutta Hübner, Professor of Integrative Oncology at Jena University Hospital. The inclusion of Chinese studies, which almost never report negative results, can create a much too positive image of TCM at a formally very high level of scientific evidence, without the results being reliable…
Instead of allowing the research to be carried out by proponents, it would be desirable ‘if the universities in particular remembered that they have the duty to be critical,’ says physician Edzard Ernst. However, some university clinics prefer to advertise TCM methods in order to attract patients and money.
- slightly improved BPH symptoms measured with the International Prostate Symptom Score (IPSS) at follow-ups of up to 12 months (standardized mean difference [SMD] -2.06, 95% confidence intervals [CI] [-3.22, -0.91] very low certainty evidence, 6 studies),
- reduced prostate specific antigen (PSA) levels (mean difference [MD] -0.37 ng/ml, 95% CI [-0.50, -0.23] low certainty evidence, 4 studies)
- had little effect on quality of life (SMD -0.59, 95% CI [-1.57, 0.38] very low certainty evidence, 2 studies).
The main reasons for downgrading the evidence were study limitations (studies judged to be at an unclear or high risk of bias), inconsistency (considerable heterogeneity), and imprecision (small effect sizes and wide confidence intervals around effect estimates). All six studies reported no adverse-effects.
- positive but not truly honest about the limitations of the evidence (we see this regularly on my blog);
- or they are sufficiently critical and thus arrive, like our above paper, at unequivocal (and sadly not very helpul) conclusions.
As this is so, we see very few SRs that conclude “there is sound evidence to show that SCAM xy is effective (or ineffective)”. Yet, such verdicts would be what consumers need.
The cause of the first scenario (false-positive conclusion) is that reviewers are biased and want to demonstrate that SCAM works. Such authors behave unethically, in my view, because they mislead the public and might cause untold harm. The cause of the second scenario (unequivocal conclusion) is the poor quality of the primary studies. This phenomenon too is mostly due to over-enthusiastic researchers who want to prove their SCAM instead of testing it. Conducting a clinical trial is far from easy or cheap. It is beyond me, why so many SCAM trialists do not try their best to do it well!
If you think of it, the most likely reason is that they are not really interested in finding the truth but mainly want to promote their agenda. If you don’t believe me, have a look at my ALTERNATIVE MEDICINE HALL OF FAME and the amazing men and women in it.
It is time, I think, that SCAM researcher learn the most basic principle of their profession: science is not a game where you set out to confirm what you believe. Science works by
- formulating a hypothesis,
- doing your very best to prove your hypothesis wrong,
- only if it cannot be proven wrong, assuming that it probably is correct.
To put it bluntly: investigators who use science to prove their point are not scientists but pseudo-scientists, and sadly SCAM has more than its fair share of such charlatans (drunken men using a lamp-post for support rather than enlightenment!). To put it even more bluntly: to prevent serious harm – because that sort of thing does a lot of real harm! – researchers who repeatedly show themselves to be incapable of doing unbiased science (again, see my ALTERNATIVE MEDICINE HALL OF FAME), should be banned from doing research.
According to the authors of a recent paper, “the placebo response in clinical trials has four components: regression to the mean (RTM), measurement artefacts, natural tendency (NT) of the disease, and the genuine placebo effect”. The objective of their analysis was to determine what contributes to the size of the placebo effect in clinical drug trials by meta-regressions of randomized placebo-controlled clinical trials.
The authors identified 5 diseases where data on the rates of NT were available to search for a sample of n=150 (5×30) RCTs. They extracted various study descriptors and performed meta-regressions to predict improvement in treatment and placebo groups. The investigators sampled 30 trials each from the following diagnoses:
- osteoarthritis of the knee,
- irritable bowel syndrome,
- depression,
- sleep disorders,
- migraine,
and extracted relevant information. They estimated the effects due to RTM and NT and analyzed the improvement in the placebo and treatment groups by fitting two regression models. Both models were highly significant, explaining 72% of the variance. Improvement in the placebo group can be significantly predicted by improvement in the treatment group (beta= .84), whether a study was analyzed according to intention to treat (beta= -.10) or was a multicenter study (beta= .12). Improvement in the treatment group can be explained by the improvement in the placebo group (beta= .83), whether a study was a multi-center trial (beta = -.16), and by RTM (beta= -.18). The treatment effect is smaller in sleep studies (beta= -.17).
The authors concluded that the high correlation of r= .73 between placebo improvement and treatment improvement rates is genuine and not explainable by study or disease characteristics. We conclude from our data that the placebo-effect is the major driver of treatment effects in clinical trials that alone explains 69% of the variance. This leaves only limited space for effects due to pharmacological substances. Context effects are more important than pharmacological ones in the conditions studied by us.
Walach (senior author of the paper) offers the following explanation for the findings:
“The design of a clinical study, with blinding and randomisation, fulfils the formal criteria necessary to establish a generalised entanglement correlation [6-8]. This would mean: part of the therapeutic effect of a pharmacological substance is also found in the control group; but only because an entanglement correlation was generated by the blinding and randomisation. To put it another way: it is not really possible to draw any conclusions about the true effects of verum interventions based on such studies. Rather, one would have to use very different study types and extract the effect by combining the different data, as we once proposed. If one were to take these effects really seriously, the methodological canon would crumble quite quickly. But they are also the reason why, in interventions where the specific effects may be very small, it is not possible to separate ‘real’ from ‘fake’ effects by means of blinded, placebo-controlled studies.”
I might suggest an alternative explanation:
SLOPPY SCIENCE.
Let me explain:
- The authors lumped together trials of various drugs as though they are a homogeneous entity in terms of effectiveness beyond placebo (which, of course, they are not).
- The placebo response is the measured improvement of a patient in a clinical trial after receiving a sham treatment. Yet, the authors claim “the placebo response in clinical trials has four components: regression to the mean (RTM), measurement artefacts, natural tendency (NT) of the disease, and the genuine placebo effect”. This is nonsense, and I even fear that the authors know it.
- The paper’s ‘highlight’ claims that contextual factors like expectations and doctor-patient interactions drive healing. Yet, these phenomena are seperate from the placebo-effect and were not the subject of this investigation.
- Correlation is not causation.
I am surprised that the Journal of Clinical Epidemiology published this rubbish!
We often encounter multiple systematic reviews on (almost) the same topic. This provides us with interesting comparisons and is, I think an opportunity to learn. Here is an example: two reviews of auricular acupuncture for post/peri-operative pain.
- A recent review from the Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, People’s Republic of China; Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, People’s Republic of China; Department of Integrated Chinese and Western Medicine, Sichuan Cancer Hospital, Chengdu, People’s Republic of China
Purpose: We conducted a more comprehensive systematic review and meta-analysis to evaluate the effectiveness of auricular acupuncture (AA) in perioperative pain management.
Methods: Randomized controlled trials (RCTs) findings were retrieved from the Embase, Cochrane Central Register of Controlled Trials, PubMed, Web of Science, Chinese Biomedical Literature Database, Wanfang, VIP, and China National Knowledge Infrastructure databases from their inception to March 2024 using the search terms “pain”, “auriculotherapy”, and “randomized controlled trial”. The experimental group was treated with AA alone or in combination with analgesic drugs, whereas the control group was treated with sham auricular acupuncture, placebo, conventional treatment, or no treatment. The primary outcome was the perioperative pain score. The secondary outcomes were analgesic requirements, anxiety score, and adverse events (AEs). RevMan version 5.4 was used for data analysis.
Results: The analysis included a total of 21 RCTs with 1527 participants. AA was superior to the control group for reducing pain intensity (mean difference [MD]= −0.44; 95% confidence interval [CI]: −0.72 to −0.17) and analgesic requirement (standardized mean difference [SMD]= −0.88, 95% CI: −1.29 to −0.46). Perioperative anxiety improvement did not differ significantly between the AA and control groups (MD= −5.45, 95% CI: −32.99 to 22.09). Subgroup analysis showed that AA exerted a significant analgesic effect as a preoperative intervention and in orthopedic surgery. The results of the sensitivity analysis demonstrated the stability of the results of the meta-analysis. AA-related AEs were mainly nausea, vomiting, and drowsiness. None of the patients in the experimental group dropped out of the trial due to AA-related AEs.
Conclusion: Current evidence suggests that AA may be a promising treatment option for improving perioperative pain with few AEs. However, owing to the low quality of the current evidence, large-sample, high-quality RCTs are needed to prove this conclusion.
- A not so recent review from the Department of Anaesthesiology and Intensive Care Medicine, University of Greifswald, Germany and the Department of Complementary Medicine, Exeter, UK.
The number of publications on the peri-operative use of auricular acupuncture has rapidly increased within the last decade. The aim was to evaluate clinical evidence on the efficacy of auricular acupuncture for postoperative pain control. Electronic databases: Medline, MedPilot, DARE, Clinical Resource, Scopus and Biological Abstracts were searched from their inception to September 2007. All randomised clinical trials on the treatment of postoperative pain with auricular acupuncture were considered and their quality was evaluated using the Jadad scale. Pain intensity and analgesic requirements were defined as the primary outcome measures. Of 23 articles, nine fulfilled the inclusion criteria. Meta-analytic approach was not possible because of the heterogeneity of the primary studies. In eight of the trials, auricular acupuncture was superior to control conditions. Seven randomised clinical trials scored three or more points on the Jadad scale but none of them reached the maximum of 5 points. The evidence that auricular acupuncture reduces postoperative pain is promising but not compelling.
____________________________
Before you now claim that the second review, with me as senior author, is bound to be far too critical, let me tell you that its two other authors were not from my team and are known proponents of acupuncture.
Some notable differences between the two reviews include the following:
- Our review was published in 2008, while the Chinses review is brand-new and dates from 2025.
- The Chinese team searched several Chinese data-banks, while we only searched Western ones.
- Our review included 9 RCTs, while the new review included 21 RCTs.
- Nine studies in the Chinese review were from China, whereas only 1 study in our review originated from China.
- The authors of the Chinese review stated that large-sample, high-quality RCTs are needed to prove their conclusion, while we thought that further rigorous research and independent replications, which effectively exclude bias, seem warranted.
So, what can we learn from comparing these papers?
- Obviously, as time goes by, more studies get published.
- In the case of acupuncture, most recent studies originate from China. As we have often discussed, Chinese acupuncture trials almost invariably report (false) positive results. It follows that, in future, we will see more and more (false) positive reviews of acupuncture (and other TCM topics). At present, I see no rational way of dealing with this problem (other than not at all considering papers from Chinese authors).
- It is often easy to find indications of bias in the way authors formulate their conclusions. Impartial researchers advocate to PROVE their assumptions, while scientists want to test them in the most rigorous way possible.
The most interesting finding from this comparison is, in my view, that our 2008 conclusion would also be well-suited for the 2025 review – I would argue even better than the odd conclusions from the original authors. What the evidence suggested in 2008 is very much the same evidence as 17 years later:
The evidence that auricular acupuncture reduces peri-operative pain is promising but not compelling.
And what does this fact – that the evidence does not clearly move in a positive direction – imply? I think, it suggests that the treatment in question is hardly worth taking seriously. In other words even my re-drafted conclusion above needs to change:
The evidence that auricular acupuncture reduces peri-operative pain is not compelling!
A standardized, synergistic combination of Punica granatum fruit rind and Theobroma cacao seed extracts (Pomegranate-cocoa extract LN18178) has been reported to increase serum testosterone levels in young and aging males.
This randomized, double-blind, placebo-controlled study assessed the efficacy of LN18178 on the sexual function of aging male volunteers (age: 40-70 years; serum total testosterone: ≥ 300 ng/dL). The subjects with mild to moderate erectile dysfunction [5-item version of the International Index of Erectile Function (IIEF-5) scores 17-25] and low sexual desire (score < 3 on items 11 and 12 of IIEF) participated in this investigation. 120 men were randomly allocated into either the LN18178 or placebo group; they took either a 400 mg of LN18178 or a matched placebo capsule daily with breakfast for 84 days.
Post-trial, the LN18178-supplemented participants reported significant (P < 0.05) improvements in total and domain scores of the Derogatis Interview for Sexual Functioning-Self Reporting Male (DISF-SR-M) questionnaire, as well as substantial improvements in IIEF-5 (International Index of Erectile Function-5) and erection hardness scores (EHS). Comparative analysis also revealed significant improvements in the multi-dimensional fatigue inventory (MFI) and general health survey (GHS) scores. LN18178 supplementation substantially (P < 0.05) increased the six-minute walk distance and hand-grip strength compared to placebo. The participants’ hemato-biochemical parameters, urinalysis, and vitals were within the normal range.
The authors concluded that LN18178 enhances sexual function, libido and improves psychological well-being, as well as neuromotor function and general well-being in aging males. LN18178 supplementation is safe and well tolerated by the participants.
This reads as though we have here a herbal Viagra!
Yet, I don’t quite buy it.
The more I studied the paper, the stronger became the whiff of ‘too good to be true’. My suspicion was not reduced when I found a similar study of the same herbal mixture concluding: LN18178 supplementation reduced AMS scores and improved sexual performance. Also, LN18178 groups exhibited superior muscular strength and reduction in perceived stress. Next I came across another trial; it concluded that LN18178 is a safe and tolerable herbal blend; it increases testosterone level and increases muscle strength and MUAC in young, healthy males.
These studies all had the same whiff about them; they were seemingly well-done but somehow they did not ring true.
Then I saw that all of these trials are sponsored:
The authors thank Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India, for providing the financial support to conduct the research.
And finally, I realized that the mixture is heavily markeded as an expensive dietary supplement!
Pehaps I am unduely suspicious but I do feel that caution is indicated.
So, before I recommend anyone to buy the supplement, I advise to wait until we have an independent replication.
This open-label, randomized, controlled trial was aimed to assess the effectiveness and safety of Vuong Hoat (VH) natural health supplement for reducing the negative impact of low back pain, improving the quality of life, and enhancing functional activities in patients with lumbar degenerative disc disease (LDD).
The study involved 60 patients suffering from low back pain caused by LDD. The participants were randomly assigned to:
- a study group (SG) comprising 30 subjects who received VH in conjunction with the same electro-acupuncture,
- a control group (CG) comprising 30 subjects who received treatment with electro-acupuncture.
These treatments lasted for 28 days.
The clinical progression and tolerability of both groups were compared based on seven objective measurements:
- visual analog scale index,
- Schober test,
- fingertip-to-floor distance,
- spinal flexion,
- spinal extension,
- spinal tilt,
- spinal rotation.
Already after 14 days of treatment, the SG showed a significant improvement in overall outcomes compared to the CG. Specifically, 43.3% of SG patients achieved very good results, 53.3% had good results, and 3.4% had moderate results, whereas corresponding figures for the CG were 6.7%, 76.7%, and 16.6%, respectively (P < .05).
After 28 days of treatment, both groups demonstrated a shift toward very good results, with the SG continuing to show better outcomes than the CG (P < .05). In the SG, the very good results increased to 76.7%, good results decreased to 20%, and moderate results were 3.3%. On the other hand, the CG had 46.7% very good results, 43.3% good results, and 10% moderate results. Notably, no side effects were reported from the VH treatments during the study.
The authors concluded that their findings of this study indicate that VH health supplement is a safe and effective approach for managing low back pain and limited spinal movement in patients with LDD.
I have several concerns and questions, some are trivial others are not:
- What does VH contain? I have no free access to the actual paper but even the abstract should mention this information.
- How do the investigators know that low back pain was caused by LDD? Lots of people have LDD without pain and vice versa.
- The A+B vs B design is known to produce false positive results due to its failure to control for placebo effects; why not use a placebo (which would have been very easy in this case)?
- Contrary to the authors statement, the outcome measures are NOT objective.
- It seems highly implausible that no side effects of VH occurred. Even placebos cause side-effects in ~6% of all cases.
- Conclusions about safety are NEVER warranted based on just 30 patients.
- Why does an allegedly respectable journal publish such rubbish?
Removing the chest tube in cardiac patients after surgery is one of the worst experiences of hospitalization in the intensive care units. Various pharmacological and non-pharmacological methods are available to control pain in these patients. This study aimed to investigate the combined effect of reflexology massage and respiratory relaxation on pain following chest tube removal in cardiac surgery patients of Shahid Beheshti Hospital in Shiraz, Iran, in 2023.
The study was a double-blind randomized clinical trial performed on 140 patients who underwent heart surgery and had a chest tube in Shiraz, Iran. The samples were randomly divided into four groups:
1- control group,
2- respiratory relaxation group,
3- foot reflex massage group,
4- a combination of respiratory relaxation and reflexology massage.
To collect data, two demographic questionnaires, and a visual analog scale were used.
The participants of the 4 groups were not meaningfully different in terms of age, BMI, duration of surgical operation, gender, job, education, place of residency, number of chest tubes, history of operation (P = 0.99, 0.31, 0.06, 0.81, 0.97, 0.96, 0.17, 0.10, 0.89 respectively).
The mean scores of pain intensity during chest tube removal, and 15 min after chest tube removal were not statistically different among the 4 groups. However, just after chest tube removal, the mean scores of pain intensity differed meaningfully among four groups (P = 0.008).
The authors concluded that the results showed that reflexology massage and respiratory relaxation both reduce pain immediately after chest tube removal in heart surgery patients. Also, the combination of these two techniques was more effective in reducing patients’ average pain.
Double blind?
Really?
How did they do that?
Here is their description:
“For the blinding purpose of the study, a nurse who worked at the ICU had to record the pain intensity and the data, so the possible researcher bias did not impact the results. Also, the patients knew the concept of the study but did not know that there were whether in single relaxation groups or mixed methods groups and did not know that other patients had different methods used for them. Also, the pain intensity data for the control group was routinely checked by the nurses, and along with the fact that they had no information that some of the patients were in the intervention groups and received complementary and alternative therapies, therefore, their data were also considered blinded. Therefore, the study could have their initial aim to use the double-blinded design.”
Double blind usually means that the therapist and the patient were masked as to the group alloca. Blinding the nurse is fine, but the therapists were not blind and could therefore have influenced the patients via verbal and non-verbal communications.
According to the authors, patients did not know whether they were “in single relaxation groups or mixed methods groups”. I think that cannot be true. Even if it were, what about the control group? Surely every patient knows whether or not he/she receives a reflexology massage!
It follows, I think, that the study was NOT double-blind, not even single-blind!
Does that matter?
Yes!
Firstly, I don’t want to be misled in this way.
Secondly, as blinding did not happern, the findings can be explaind by the effects of patient expectation and might therefore NOT be the result of the therapies. In other words, the conclusions drawn by the authors are not warranted.
Probiotics are live microorganisms promoted claimed to provide health benefits when consumed, generally by improving or restoring the gut microbiota. Prebiotics are compounds in food that foster growth or activity of beneficial microorganisms such as bacteria and fungi. Both are sold as dietary supplements, and there is hardly a human disease or symptom for which these supplements are not said to be effective.
One such claim is that the ingestion of prebiotics during pregnancy and lactation has immunomodulatory benefits for the developing fetal and infant immune system and provide a potential dietary strategy to reduce the risk of allergic diseases.
This study sought to determine whether maternal supplementation with dietary prebiotics reduces the risk of allergic outcomes in infants with hereditary risk.
A double-blind randomized controlled trial was conducted in which pregnant women were allocated to consume prebiotics (14.2 g daily of galacto-oligosaccharides and fructo-oligosaccharides in the ratio 9:1) or placebo (8.7 g daily of maltodextrin) powder. The treatment lasted from less than 21 weeks’ gestation until 6 months postnatal during lactation. All eligible women had infants with a first-degree relative with a history of medically diagnosed allergic disease. The primary outcome was medically diagnosed infant eczema by age 1 year, and secondary outcomes included allergen sensitization, food allergy, and recurrent wheeze by age 1 year.
A total of 652 women were randomized between June 2016 and November 2021 (329 in the prebiotics group and 323 in the placebo group). There was no significant difference between groups in the percentage of infants with medically diagnosed eczema by age 1 year (prebiotics 31.5% [103 of 327 infants] vs placebo 32.6% [105 of 322 infants]; adjusted relative risk, 0.98; 95% CI, 0.77-1.23; P = .84). Secondary outcomes and safety measures also did not significantly differ between groups.
The authors concluded that they found little evidence that maternal prebiotics supplementation during pregnancy and lactation reduces the risk of medically diagnosed infant eczema by age 1 year in infants who are at hereditary risk of allergic disease.
It is rare that we come across a well-planned, well-conducted and well-reported study of pro/prebiotics. When we do, it often casts doubts on the numerous claims made for these products.
Here we have such a study.
I congratulate the Australian authors for conducting it.
- 85 were controlled trials;
- 79 of these were randomized.
There were many areas where the quality of the studies could be improved. About two-thirds of the 85 controlled trials had either high (42 percent) or unclear (24 percent) risk of bias according to internationally recognized standards for internal validity.
Of the 14 observational (cohort) studies, over one-third did not control for important confounders in the outcome analyses. Regarding external validity, adherence was reported in less than a third of studies (n=31). Forty percent of studies (79% of observational studies) did not report on safety. Regarding model validity, fewer than two-thirds of the studies were consistent with homeopathic principles.
- Iris Bell, M.D., Ph.D., University of Arizona College of Medicine (Retired) and Sonoran University of Health Sciences;
- Dan Cherkin, Ph.D., Osher Center for Integrative Health, Department of Family Medicine, University of Washington;
- Roger Chou, M.D., Department of Medical Informatics & Clinical Epidemiology and Department of Medicine, Oregon Health & Science University;
- Katharina Gaertner, MBBS, Research Faculty of Health, University Witten/Herdecke;
- Klaus Linde, M.D., Ph.D., Scientific Coordinator, Technische Universität München, Institute of General Practice and Health Services Research;
- Alexander Tournier, Ph.D., Homeopathy Research Institute and Institute of Complementary and Integrative Medicine, University of Bern;
- Esther van der Werf, M.Sc., Ph.D., Clinical Research Lead, Homeopathy Research Institute, and Honorary Senior Lecturer, Primary Care Infection, Bristol Medical School, University of Bristol;
- Harald Walach, Ph.D., CHSInstitute.
Two very obvious things should be noted about this panel:
- There are not 9 but only 8 members.
- Almost all are individuals who are pro-homeopathy, and no informed critic of homeopathy was invited.
The latter fact seems important. Anyone who has worked with panels knowns that one can pre-determine the outcome of the deliberations by the choice of the members.
The panel essentially concluded that homeopathic research could be substantially improved. Considering its highly biased composition, this is remarkable. It means that, in fact,
HOMEOPATHIC RESEARCH IS DISMAL.
Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental condition affecting children
and adults, characterized by symptoms of inattention, hyperactivity, and impulsivity. Despite the effectiveness of conventional treatments, such as stimulants, side effects drive interest in alternative therapies like homeopathy. This systematic review was aimed at determining the effectiveness of homeopathy as a treatment for ADHD.
A comprehensive search of PubMed, SCOPUS, and Google Scholar was conducted to identify clinical studies evaluating homeopathic treatments for ADHD. After applying selection criteria, eight studies were reviewed, consisting of randomized controlled trials, comparative studies, randomized open-label Pilot study, and clinical trials, were included in the final review.
The results suggest that some homeopathic treatments showed potential in reducing ADHD symptoms, particularly inattention and hyperactivity.
The authors concluded that homeopathy, particularly individualized treatment, shows promise as an adjunct or alternative treatment for ADHD, especially for those children whose caregivers seek alternatives to stimulant medications. Studies report that homeopathic treatment can significantly improve ADHD symptoms in some children, particularly when the correct remedy is identified. However, the evidence is mixed, with several studies showing improvements that may be attributable to the consultation process rather than the remedy itself. Given the increasing interest in Complementary and Alternative Medicine (CAM) among parents of children with ADHD, homeopathy may provide a valuable therapeutic option. Nevertheless, larger, more rigorous trials are required to confirm these findings and establish clear guidelines for its use in clinical practice. The potential for homeopathy to serve as an adjunct to conventional treatments, especially for younger patients or those intolerant to stimulants, remains an area worthy of further exploration.
What journal publishes such misleading drivel? It’s the African Journal of biomedical Research. No, I also had never heard of it! And who are the authors of this paper, their titles and affiliations? Here they are:
- Professor & HOD, Department of Anatomy, Dr. D.Y. Patil Homoeopathic Medical College & Research Centre, Dr. D.Y. Patil Vidyapeeth (Deemed to be University), Pimpri, Pune, Maharashtra, India,
- Professor & HOD, Department of Homoeopathic Pharmacy, Dr. D.Y. Patil Homoeopathic Medical College &
Research Centre, Dr. D.Y. Patil Vidyapeeth (Deemed to be University), Pimpri, Pune, Maharashtra, India, - Department of Homoeopathic Pharmacy, Dr. D.Y. Patil Homoeopathic Medical College & Research Centre, Dr. D.Y. Patil Vidyapeeth (Deemed to be University), Pimpri, Pune, Maharashtra, India,
- Department of Homoeopathic Pharmacy, Dr. D.Y. Patil Homoeopathic Medical College & Research Centre, Dr. D.Y. Patil Vidyapeeth (Deemed to be University), Pimpri, Pune, Maharashtra, India,
- Principal, Professor & HOD, Department of Forensic Medicine and Toxicology, Dr. D.Y. Patil Homoeopathic
Medical College & Research Centre, Dr. D.Y. Patil Vidyapeeth (Deemed to be University), Pimpri, Pune,
Maharashtra, India.
Five guys with the same name?
No, one chap with 5 rather pomopous titles!
And what is wrong with this ‘systematic review’?
Everything!
It has almost none of the qualities that render a paper a systematic review. Foremost, it does not account for the quality of the primary studies – the most reliable show no effect!
Therefore, I’d like to re-phrase and shorten the conclusions as follows:
There is no reliable evidence to shoe that homeopathy is effective for ADHD.
