clinical trial
This systematic review aimed to assess the impact of Tai Chi on individuals with essential hypertension and to compare the effects of Tai Chi with other therapies. The researchers conducted a systematic literature search of the Medline, Scholar, Elsevier, Wiley Online Library, Chinese Academic Journal (CNKI) and Wanfang databases from January 2003 to August 2023. Using the methods of the Cochrane Collaboration Handbook, a meta-analysis was conducted to assess the collective impact of Tai Chi exercise in controlling hypertension. The primary outcomes measured included blood pressure and nitric oxide levels.
A total of 32 RCTs were included. The participants consisted of adults with an average age of 57.1 years who had hypertension (mean ± standard deviation systolic blood pressure at 148.2 ± 12.1 mmHg and diastolic blood pressure at 89.2 ± 8.3 mmHg). Individuals who practiced Tai Chi experienced reductions in systolic blood pressure of 10.6 mmHg, diastolic blood pressure of 4.7 mmHg and an increase in nitric oxide levels.
The authors concluded that Tai Chi can be a viable lifestyle intervention for managing hypertension. Greater promotion of Tai Chi by medical professionals could extend these benefits to a larger patient population.
Tai Chi allegedly incorporates principles rooted in the Yin and Yang theory, Chinese medicine meridians and breathing techniques, and creates a unique form of exercise characterized by its inward focus, continuous flow, the balance of strength and gentleness, and alternation between fast and slow movements. What sets Tai Chi apart from other forms of excercise is the requirement for mindful guidance during practice. This aspect may, according to the authors, be the reason why Tai Chi also outperforms general aerobic exercise in managing hypertension.
I can well imagine that any form of relaxation reduces blood pressure. What I find hard to believe is that Tai Chi is better than any other relaxing SCAMs. The 32 RCTs included in this new review fail to impress me because they are all from China, and – as we have often mentioned before – studies from China are to be taken with a pinch of salt.
Yet, the subject is important enough, in my view, to merit a few rigorous trials conducted by independent researchers. Until such data are available, I think, I prefer to rely on our own systematic review which conculded that the evidence for tai chi in reducing blood pressure … is limited. Whether tai chi has benefits over exercise is still unclear. The number of trials and the total sample size are too small to draw any firm conclusions.
So-called alternative medicine (SCAM) interventions are growing in popularity and are even advocated as treatments for long COVID symptoms. However, comprehensive analysis of current evidence in this setting is still lacking. This study aims to review existing published studies on the use of SCAM interventions for patients experiencing long COVID through a systematic review of randomized controlled trials (RCTs).
A comprehensive electronic literature search was performed in multiple databases and clinical trial registries from September 2019 to January 2023. RCTs evaluating efficacy and safety of SCAM for long COVID were included. Methodological quality of each included trial
was appraised with the Cochrane ‘risk of bias’ tool. A qualitative analysis was conducted due to heterogeneity of included studies.
A total of 14 RCTs with 1195 participants were included in this review. Study findings demonstrated that SCAM interventions could benefit patients with long COVID, especially those suffering from
- neuropsychiatric disorders,
- olfactory dysfunction,
- cognitive impairment,
- fatigue,
- breathlessness,
- mild-to-moderate lung fibrosis.
The main interventions reported were:
- self-administered transcutaneous auricular vagus nerve stimulation,
- neuro-meditation,
- dietary supplements,
- olfactory training,
- aromatherapy,
- inspiratory muscle training,
- concurrent training,
- online breathing programs,
- online well-being programs.
The authors concluded that SCAM interventions may be effective, safe, and acceptable to patients with symptoms of long COVID. However, the findings from this systematic review should be interpreted with caution due to various methodological limitations. More rigorous trials focused on CAM for long COVID are warranted in the future.
Such wishy-washy conclusions seem to be popular in the fantasy land of SCAM. Yet, they are, in my view, most ojectionable because:
- they tell us nothing of value;
- that something “MAY BE EFFECTIVE” has been known before and cannot be the result of but is the reason for a systematic review;
- a review of 14 RCTs of almost as many interventions cannot possibly tell us anything about the SAFETY of these treatments;
- it also does not provide evidence of effectiveness and merely indicates a lack of independent replications;
- if the abstract mentions an assessment of the study rigor, one expects that it also informs us about this important aspect.
Once we do come around looking at the methodological quality of the primary studies we realize that it is mostly miserable. This means that the conclusions of the review are not just irritating but plainly misleading. Responsible researchers should have concluded along the following lines:
The quantity and the quality of the evidence are both low. Therefore, the effectiveness and safety of SCAM interventions for long COVID remains unproven.
PS
This project was financially supported by The HEAD Foundation, Singapore and in part by the grant from the NIH R61 AT01218.
Shame on the authors, journal editors, peer-reviewers, and funders of this dangerous nonsense!
Since 1997, several meta-analyses (MAs) of placebo-controlled randomised efficacy trials of homoeopathy for any indication (PRETHAIs) have been published with different methods, results and conclusions. To date, a formal assessment of these MAs has not been performed. The main objective of this systematic review of MAs of PRETHAIs was to evaluate the efficacy of homoeopathic treatment.
The inclusion criteria were as follows: MAs of PRETHAIs in humans; all ages, countries, settings, publication languages; and MAs published from 1 Jan. 1990 to 30 Apr. 2023. The exclusion criteria were as follows: systematic reviews without MAs; MAs restricted to age or gender groups, specific indications, or specific homoeopathic treatments; and MAs that did not assess efficacy. We searched 8 electronic databases up to 14 Dec. 2020, with an update search in 6 databases up to 30 April 2023.
The primary outcome was the effect estimate for all included trials in each MA and after restricting the sample to trials with high methodological quality, according to predefined criteria. The risk of bias for each MA was assessed by the ROBIS (Risk Of Bias In Systematic reviews) tool. The quality of evidence was assessed by the GRADE framework. Statistical analyses were performed to determine the proportion of MAs showing a significant positive effect of homoeopathy vs. no significant difference.
Six MAs were included, covering individualised homoeopathy (I-HOM, n = 2), nonindividualised homoeopathy (NI-HOM, n = 1) and all homoeopathy types (ALL-HOM = I-HOM + NI-HOM, n = 3). The MAs comprised between 16 and 110 trials, and the included trials were published from 1943–2014. The median trial sample size ranged from 45 to 97 patients. The risk of bias (low/unclear/high) was rated as low for three MAs and high for three MAs.
Effect estimates for all trials in each MA showed a significant positive effect of homoeopathy compared to placebo (5 of 5 MAs, no data in 1 MA). Sensitivity analyses with sample restriction to high-quality trials were available from 4 MAs; the effect remained significant in 3 of the MAs (2 MAs assessed ALL-HOM, 1 MA assessed I-HOM) and was no longer significant in 1 MA (which assessed NI-HOM).
The authors concluded that the quality of evidence for positive effects of homoeopathy beyond placebo (high/moderate/low/very low) was high for I-HOM and moderate for ALL-HOM and NI-HOM. There was no support for the alternative hypothesis of no outcome difference between homoeopathy and placebo. The available MAs of PRETHAIs reveal significant positive effects of homoeopathy beyond placebo. This is in accordance with laboratory experiments showing partially replicable effects of homoeopathically potentised preparations in physico-chemical, in vitro, plant-based and animal-based test systems.
Reading this SR, I got the impression that it was designed to generate a positive result. The 6 included MAs are marginally positive (mainly due to publication bias and other artefacts) and thus very well known to fans of homeopathy. The authors of this paper must therefore have expected that combining them in a review would generate an overall positive finding.
The first question I asked myself while studying this paper was: who would want to do an SR of MAs (a most peculiar exercise); why not at least an SR of SRs which is already an unusual project but would make at least some sense. (An SR is a review that includes all studies that match a set of pre-definied criteria. A MA is a special form of SR where statistical pooling was possible.) The answer is, I fear, simple: this would not have generated a positive result: here are now dozens of SRs of homeopathy and most are not positive (as discussed regularly on this blog)
The authors themselves provide no real justification for their bizarre approach. All they tell us about it is this:
One approach is to focus on a specifc indication (e.g., depression [4], acute respiratory tract infections in children [5]) while often including open-label trials and observational studies. In this approach, data synthesis is grouped by design, thus yielding information about homoeopathy in patient care. Te opposite approach is to include all indications while restricting study designs to placebo-controlled trials and aggregating results in an MAs, thus yielding information about the specifc efects of homoeopathy beyond those of placebo. A major reason for using this approach has been the claim that ‘homoeopathy violates natural laws and thus any efect must be a placebo efect’ [6].
Since 1997, at least six MAs of placebo-controlled homoeopathy trials for any condition have been published [6–11]. These MAs have difered in their methods for trial inclusion, data synthesis and assessment of risk of bias; furthermore, their results and conclusions have been inconsistent. During this period, there have been substantial advancements in methodology and quality standards for MAs and other SRs [12–15], including SRs of SRs (also called overviews or umbrella reviews) [16–18]. To our knowledge, a formal SR of MAs of randomised placebo-controlled homoeopathy trials for any condition has not been performed. Herein, we report such an SR.
What the authors actually did is this: they knew of the 6 MA; they also knew that they arrived at cautiously positive conclusions; finally they also were aware of the fact that, obviously, the 6 MA included more or less almost the same primary studies. So, by pooling the MAs, they generated a positive result which was no longer marginally positive but strongly. Anyone looking through this strategy (which in effect multiplies the results of many primary studies by factor 6) must realize that this methods creates a false-positive impression.
My suspicion that this paper is a deliberate attempt at misleading us about the ‘efficacy’ (actually it should be effectiveness) is strengthened by further facts:
- One of the two MAs by Mathie et al excluded primary studies that reported positive findings (i.e. mine and the one by Walach et al)
- Funding: Open Access funding enabled and organized by Projekt DEAL. Funding specifcally for this SR was provided by Christophorus-Stiftung (No. 393 CST), Stiftung Marion Meyenburg (Date 24.09.2020), Dr. Hauschka Stiftung (Date 16.11.2020) and Gesellschaft für Pluralität im Gesundheitswesen (Dates 11.06.2021, 22.06.2021). General funding for IFAEMM was provided by the Software-AG Stiftung (SE-P 13544). The funders had no infuence on the writing of the protocol or on the planning, conduct and publication of this SR.
- Competing interests: In the past 3 years, HJH has received research grants from two manufacturers of anthroposophic medicinal products (Wala Heilmittel GmbH, Bad Boll/ Eckwälden, Germany; Weleda AG, Arlesheim Switzerland). Anthroposophic medicine is not based on the homoeopathic simile principle or on drug provings, but some anthroposophic medicinal products are potentized. The two manufacturers had no involvement with the present SR. Anthroposophic medicinal products were not part of the intervention in any of the trials evaluated in the MAs of this SR (Suppl. Table 15). DSR has received a development grant from Heel GmbH (manufacturer of homoeopathic products) for online training in case report writing. AG, KvA and HK declare that they have no competing interests.
- Author details: 1) Institute for Applied Epistemology and Medical Methodology at Witten/ Herdecke University (IFAEMM), Freiburg, Germany. 2) Faculty of Health, Department of Medicine, Chair of Medical Theory, Integrative and Anthroposophic Medicine, Witten/Herdecke University, Witten, Germany. 3) Maryland University of Integrative Health (MUIH), Laurel, MD, USA. 4) Homeopathic Pharmacopoeia Convention of the United States (HPCUS), Southeastern, PA, USA.
Personally, I do not find it surprising that these authors bend over backwards to publish something positive about homeopathy (such things happen in homeopathy all the time). However, I do find it astonishing that an allegedly decent journal passes such pseudoscience for publication as though it is serious science.
This study evaluated the effect of ear acupressure (auriculotherapy) on the weight-gaining pattern of overweight women during pregnancy. It was a single-blinded randomized clinical trial conducted between January and September 2022 and took place in health centers of Qom University of Medical Sciences in Iran.
One-hundred thirty overweight pregnant women were selected by a purposeful sampling method and then divided into two groups by block randomization method. In the intervention group, two seeds were placed in the left ear on the metabolism and stomach points, while two seeds were placed in the right ear on the mouth and appetite points. Participants in the intervention group were instructed to press the seeds six times a day, 20 minutes before a meal for five weeks. For the placebo group, the Vaccaria seedless label was placed at the same points as the intervention group.
A digital scale with an accuracy of 0.1 kg was used to weigh the pregnant women during each visit. Descriptive statistics, independent T-test, chi-square, and repeated measure ANOVA (analysis of variance) test were used to check the research objectives.
There was a statistically significant difference between the auriculotherapy and placebo groups immediately after completing the study (1120.68 ± 425.83 vs. 2704.09 ± 344.96 (g); = 0.018), respectively. Also, there was a substantial difference in the weight gain of women two weeks (793.10 ± 278.38 vs. 1090.32 ± 330.31 (g); < 0.001) and four weeks after the intervention (729.31 ± 241.52 vs. 964.51 ± 348.35 (g); < 0.001) between the auriculotherapy and placebo groups.
The authors concluded that the results of the present study indicated the effectiveness of auriculotherapy in controlling the weight gain of overweight pregnant women. This treatment could be used as a safe method, with easy access, and low cost in low-risk pregnancies.
In order to understand these findings, it is worth reading the methods section of the paper. It explains what actually happened with the two groups:
After providing explanations to familiarize the participants with the working method and answering their questions, the participants were requested to be comfortable. The first author who has an auriculotherapy certificate did the intervention. The intervention began by disinfecting both ears with a 70% alcohol solution. After determining the location of metabolism and stomach points in the left ear and mouth and appetite points in the right ear related to weight and appetite control, the researcher placed the seeds on the desired points… The intervention lasted for a total of 5 weeks. The seeds were changed twice a week (once every three days) by the researcher. The participants in the intervention group were taught to press the seeds 6 times a day for one minute each time. The pressure method was to use moderate stimulation with continuous pressure. In the first session, the researcher fully taught the participants the amount of pressure and the duration of it in a practical way and asked them to do this once in her presence to ensure that it was correct. Participants were recommended to do this preferably 20 minutes before eating. The researcher reminded the participants in the intervention group of their daily interventions by phone or text message. Each night, they were asked to check if they had followed the instructions and completed the daily registration checklist. In each seed replacement session, which was performed every three days, the checklist of the previous session was viewed and checked, and a checklist was received every week at the same time as the participants were weighed. Subjects were also emphasized in case of any symptoms of allergies or infections and pain as soon as possible through the contact number provided to them to discuss the issue with the researcher to remove the seeds.
In the placebo group, instead of real seeds, a label without Vaccaria seed (waterproof fabric adhesive) was placed by the researcher at the desired points in both ears, and the participants did not receive training to compress the points. They also did not receive the list of daily pressing points. All follow-ups and replacement of labels were performed in the same way as the intervention group in the placebo group. Finally, all participants were requested to notify the researcher if any seeds or labels were removed for any reason. It should be noted that pregnant mothers were unaware of the nature of the group to which they belonged.
It seems clear, therefore, that the patients were NOT blinded and that the verum patients received different care and more attention/encouragement than the placebo group. This means firstly that the trial was NOT single-blind, as the authors claim. Secondly, it means that the outcomes were most likely NOT due to ear acupressure at all – they were caused by the non-specific effects of expectation, extra attention, etc. which, in turn, motivated the women to better control their weight. Consequently, the conclusions of this study should be re-phrased:
The results of the present study fail to indicate the effectiveness of auriculotherapy in controlling the weight gain of overweight pregnant women.
In addition, I feel that the researchers, supervisors, peer-reviewers, editors should all bow their heads in shame for trying to mislead us.
This systematic review and meta-analysis was aimed at analyzing the effectiveness of craniosacral therapy in improving pain and disability among patients with headache disorders.
PubMed, Physiotherapy Evidence Database, Scopus, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases were searched in March 2023. Two independent reviewers searched the databases and extracted data from randomized clinical trials comparing craniosacral therapy with control or sham interventions. The same reviewers assessed the methodological quality and the risk of bias using the PEDro scale and the Cochrane Collaboration tool, respectively. Grading of recommendations, assessment, development, and evaluations was used to rate the certainty of the evidence. Meta-analyses were conducted using random effects models using RevMan 5.4 software.
The searches retrieved 735 papers, and 4 studies were finally included. The craniosacral therapy provided statistically significant but clinically unimportant change on pain intensity (Mean difference = –1.10; 95% CI: –1.85, –0.35; I2: 44%), and no change on disability or headache effect (Standardized Mean Difference = –0.34; 95% CI –0.70, 0.01; I2: 26%). The certainty of the evidence was downgraded to very low.
The authors concluded that very low certainty of evidence suggests that craniosacral therapy produces clinically unimportant effects on pain intensity, whereas no significant effects were observed in disability or headache effect.
I find it strange that researchers seem so frequently unable to formulate their conclusions clearly. Is it political correctness? Or are they somehow favorably inclined (i.e. biased) towards the treatment that they pretend to critically evaluate?
Let’s look at the facts related to this review:
- Craniosacral therapy (CST) is utterly implausible.
- Only 4 RCTs were found.
- They were of poor quality.
- They were published mostly by people who want to promote CST.
- Therefore the overall statistically significant effect is most likely a false-positive result.
- This means that the conclusion should be much more straight forward.
I suggest something along the following lines:
A critical evaluation of the existing RCTs failed to find convincing evidence that CST is an effective treatment for headache disorders.
Exercise is often cited as a major factor contributing to improved cognitive functioning. As a result, the relationship between exercise and cognition has received much attention in scholarly literature. Systematic reviews and meta-analyses present varying and sometimes conflicting results about the extent to which exercise can influence cognition. The aim of this umbrella review was to summarize the effects of physical exercise on cognitive functions (global cognition, executive function, memory, attention, or processing speed) in healthy adults ≥ 55 years of age.
This review of systematic reviews with meta-analyses invested the effect of exercise on cognition. Databases (CINAHL, Cochrane Library, MEDLINE, PsycInfo, Scopus, and Web of Science) were searched from inception until June 2023 for reviews of randomized or non-randomised controlled trials. Full-text articles meeting the inclusion criteria were reviewed and methodological quality assessed. Overlap within included reviews was assessed using the corrected covered area method (CCA). A random effects model was used to calculate overall pooled effect size with sub-analyses for specific cognitive domains, exercise type and timing of exercise.
A total of 20 met the inclusion criteria. They were based on 332 original primary studies. Overall quality of the reviews was considered moderate with most meeting 8 or more of the 16 AMSTAR 2 categories. Overall pooled effects indicated that exercise in general has a small positive effect on cognition (d = 0.22; SE = 0.04; p < 0.01). Mind–body exercise had the greatest effect with a pooled effect size of (d = 0.48; SE = 0.06; p < 0.001). Exercise had a moderate positive effect on global cognition (d = 0.43; SE = 0,11; p < 0,001) and a small positive effect on executive function, memory, attention, and processing speed. Chronic exercise was more effective than acute exercise. Variation across studies due to heterogeneity was considered very high.
The authors concluded that mind–body exercise has moderate positive effects on the cognitive function of people aged 55 or older. To promote healthy aging, mind–body exercise should be used over a prolonged period to complement other types of exercise. Results of this review should be used to inform the development of guidelines to promote healthy aging.
It seems to me that the umbrella review hides the crucial fact that many of the primary studies had major flaws, e.g. in terms of:
- lack of randomisation,
- lack of blinding.
Eleven studies investigated the effects of aerobic exercise on cognition. Only three studies investigated the effects of mind body exercise on cognition, two analysed the effects of resistance exercise, and five investigated the effects of mixed exercise interventions. I am therefore mystified how the authors managed to arrive at such a hyped conclusion in favour of the effectiveness of mind body exercises. Even an optimistic interpretation of the data would allow merely a weak indication that a positive effect might exist. To state that mind body exercises should be promoted for ‘healthy aging’ borders on the irresponsible, in my view. Surely even the most naive researcher must see that, for such a far-reaching recommendation, we would need much more solid evidence.
I strongly suspect that a proper review of the primary studies of mind body exercise with a critical evaluation of the quality of the primary studies would lead to dramatically different conclusion.
It has been reported that two London councils have written to parents to warn that children who are not vaccinated against measles may need to self-isolate for 21 days if a classmate is infected with the disease. It comes after modelling by the UK Health Security Agency (UKHSA) warned that up to 160,000 cases could occur in the capital alone as a result of low vaccination rates. Just three-quarters of London children have received the two required doses of the MMR jab, which protects against measles. This is 10 per cent lower than the national average.
Barnet Council wrote to parents on July 20 warning that any unvaccinated child identified as a close contact of a measles case could be asked to self-isolate for up to 21 days. “Measles is of serious concern in London due to low childhood vaccination rates. Currently we are seeing an increase in measles cases circulating in neighbouring London boroughs, so now is a good time to check that your child’s MMR vaccination – which not only protects your child against measles but also mumps and rubella – is up to date,” the letter reads. “Children who are vaccinated do not need to be excluded from school or childcare,” the letter added.
Neighbouring Haringey Council also warned that children without both MMR doses may be asked to quarantine for 21 days. Just over two-thirds (67.9 per cent) of children in the area had received both doses by the age of five. The councils stated that they had sent the letters based on guidance by the UKHSA, but the agency said that headteachers should consider “excluding” unvaccinated pupils who become infected with measles rather than instructing them to self-isolate.
Data published by the UKHSA showed that 128 cases of measles were recorded between January 1 and June 30 this year, compared to 54 cases in the whole of 2022. Two-thirds of the cases were detected in London. The agency have said that there is a high risk of cases linked to overseas travel leading to outbreaks in specific population groups such as young people and under-vaccinated communities.
Dr Vanessa Saliba, a consultant epidemiologist at UKHSA, said: “When there are measles cases or outbreaks in nurseries or schools, the UKHSA health protection team will assess the situation, together with the school and other local partners, and provide advice for staff and pupils. “Those who are not up to date with their MMR vaccinations will be asked to catch up urgently to help stop the outbreak and minimise disruption in schools.”
____________________________
Measles is a significant concern with approximately 10 million people infected annually causing over 100,000 deaths worldwide. In the US before use of the measles vaccine, there were estimated to be 3 to 4 million people infected with measles annually, causing 400 to 500 deaths. Complications of measles include otitis media, diarrhea, pneumonia, and acute encephalitis. Measles is a leading cause of blindness in the developing world, especially in those who are vitamin A deficient. Malnourished children with measles are also at higher risk of developing noma (or cancrum oris), a rapidly progressive gangrenous infection of the mouth and face. Most deaths due to measles are caused by pneumonia, diarrhea, or neurological complications in young children, severely malnourished or immunocompromised individuals, and pregnant women. A rare sequela of measles is subacute sclerosing panencephalitis.
Back in 2003, we investigated what advice UK homeopaths, chiropractors and general practitioners give on measles, mumps and rubella vaccination programme (MMR) vaccination via the Internet. Online referral directories listing e-mail addresses of UK homeopaths, chiropractors and general practitioners and private websites were visited. All addresses thus located received a letter of a (fictitious) patient asking for advice about the MMR vaccination. After sending a follow-up letter explaining the nature and aim of this project and offering the option of withdrawal, 26% of all respondents withdrew their answers. Homeopaths yielded a final response rate (53%, n = 77) compared to chiropractors (32%, n = 16). GPs unanimously refused to give advice over the Internet. No homeopath and only one chiropractor advised in favour of the MMR vaccination. Two homeopaths and three chiropractors indirectly advised in favour of MMR. More chiropractors than homeopaths displayed a positive attitude towards the MMR vaccination. We concluded that some complementary and alternative medicine providers have a negative attitude towards immunisation and means of changing this should be considered.
The problem is by no means confined to the UK. German researchers, for instance, showed that belief in homeopathy and other parental attitudes indicating lack of knowledge about the importance of vaccinations significantly influenced an early immunisation. Moreover, being a German homeopath has been independently associated with lower own vaccination behavior. Data from France paint a similar picture.
Some homeopaths, of course, claim that ‘homeopathic vaccinations’ are effective and preferable. My advice is: DON’T BELIEVE THESE CHARLATANS! A recent study demonstrated that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.
This randomised, double blind controlled trial compared the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
The interventions were:
- curcumin alone (C),
- omeprazole alone (O),
- curcumin plus omeprazole (C+O).
Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Main outcome measure was unctional dyspepsia symptoms on days 28 and 56, assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
A total of 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
The authors concluded that curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
This study, which was funded by the Thai Traditional and Alternative Medicine Fund, has been picked up by the press and is being lauded as a solid proof of efficacy. Its authors too are not half proud of their splendid trial:
This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia. PPIs, widely used and approved for over-the-counter use, were compared with curcumin, a popular herbal remedy. The study design, including double blind randomisation, minimised biases. Participants met strict criteria, underwent endoscopy and were tested for H pylori infection. Furthermore, we implemented measures to minimise biases by ensuring that the individuals administering the drugs, participants receiving the drugs and individuals conducting the assessment remained blinded to the type of medications administered to the participants. The trial was carried out in hospitals, and certified individuals used standardised questionnaires for assessments. Statistical methods were appropriate and followed accepted principles.
Two follow-up appointments were scheduled, and blood tests showed no abnormal symptoms or liver function abnormalities. However, participants with high body mass index indicated a trend towards liver function impairment in the curcumin group, suggesting the need for larger studies. Some participants did not provide follow-up information, which is a study weakness. However, the number of participants who provided this information was sufficient for statistical analysis and the majority of the participants attended the follow-up visit. Therefore, it can be deduced from the results that even if the number of participants followed after drug administration increased, the study findings would not be significantly different. Another limitation of this study was the absence of long term follow-up data for all patients after treatment. This is a question that will require further investigation.
The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects. The study was unbiased, partially funded by government organisations and the first well designed trial comparing curcumin with PPI for functional dyspepsia, with confirmation through endoscopy and ruling out H pylori infection. Limitations of this study included the small number of patients who were lost to follow-up and the lack of long term follow-up data.
However, I am far less impressed.
Why?
Curcumin is bright yellow and has a very distinct taste/smell. Even though curumin was given in capsules, patients can easily tell what they are taking. I therefore doubt that they were adequately blinded. In fact, the authors seem to agree when they state the following:
We observed that despite improvements in pain and non-pain scores, there was no significant improvement in the SODA satisfaction scores in the O and C+O groups (table 3). A possible explanation for this observation could be related to the taste and/or smell of curcumin, which might have caused reduced pleasantness for the participants while ingesting it. This potential discomfort could offset the improvements in pain and non-pain symptoms, leading to the non-significant change in satisfaction score. Further studies may be needed to explore this hypothesis as well as to improve the palatability of curcumin.
Sadly, the success of blinding (which under such circumstances should always be tested) was not reported and probably not even quantified. If many patients were de-blinded, it seems inevitable that their expectation influenced the results. In other words, the much-lauded effect of curcumin might just be due to placebo and curcumin might be entirely useless. Or, to put it bluntly, the trial was not nearly as good as many made it out to be.
PS
Sad to see that the reviewers of a reputable journal failed to pick up on this significant flaw.
The objectives of this randomized double-blind placebo-controlled clinical trial were to determine if there:
- (a) is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD;
- (b) are any specific effects the homeopathic consultation alone in the treatment of ADHD;
- (c) are any specific effects of homeopathic medicines in the treatment of ADHD.
Children aged 6–16 years diagnosed with ADHD were randomized to one of three arms:
- Arm 1 (Remedy and Consultation);
- Arm 2 (Placebo and Consultation);
- Arm 3 (Usual Care).
The primary outcome measure was the change of the Conner 3 Global Index-Parent T-score (CGI-P T score) between baseline and 28 weeks.
The results showed an improvement in ADHD symptoms as measured by the CGI-P T score in the two groups (Arms 1 and 2) that received consultations with a homeopathic practitioner when compared with the usual care control group (Arm 3). Parents of the children in the study who received homeopathic consultations (Arms 1 and 2) also reported greater coping efficacy compared with those receiving usual care (Arm 3). There was no difference in adverse events among the three study arms.
The authors concluded that, in this study, homeopathic consultations provided over 8 months with the use of homeopathic remedy was associated with a decrease in ADHD symptoms in children aging 6–16 years when compared with usual treatment alone. Children treated with homeopathic consultations and placebo experienced a similar decrease in ADHD symptoms; however, this finding did not reach statistical significance when correcting for multiple comparisons. Homeopathic remedies in and of themselves were not associated with any change in ADHD symptoms.
In the discussion section, the authors make their findings a little clearer: “The findings are generally consistent with a recent meta-analysis that concluded that (i)ndividualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD. Similar to the meta-analysis, the authors found individualized homeopathy (consultation plus remedy) resulted in improvement in ADHD symptoms. However, the data suggest that this effect is not due to the remedy component of the intervention.”
The authors do not cite the (to the best of my knowledge) only study that had a very similar aim, namely differentiating between the effects of the homeopathic remedy and the homeopathic consultation. It was conducted by the late George Lweith who certainly was not against homeopathy. The conclusions of this trial were as follows: Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable rheumatoid arthritis.
Both trials confirm what rational thinkers have been saying for many years: the effects that many people experience after homeopathic therapy are not due to the homeopathic remedy but to the usually long and empathetic therapeutic encounter, the placebo effect, and other non-specific effects. To put it bluntly homeopathy is a kind of amateur psychotherapy.
Before someone now claims that this means homeopathy is fine, let me tell you this: no, it is not fine! If someone needs psychotherapy, he/she should see not an amateur but a professional, i.e. a psychologist who is properly trained in what she can and cannot do.
This study aimed to evaluate whether individualized homeopathic medicines have a greater adjunctive effect than adjunctive placebos in the treatment of moderate and severe cases of coronavirus disease 2019 (COVID-19). It was designed as a randomized, single-blind, placebo-controlled trial set in the clinical context of standard care. Patients admitted in a tertiary care hospital, suffering from moderate or severe COVID-19 and above 18 years of age were included. In total, 150 patients were randomly divided into two groups to receive either:
- individualized homeopathic medicines
- or placebos.
Both options were administered in addition to the standard treatment of COVID-19.
The primary outcome was time taken to achieve RT-PCR-confirmed virus clearance for COVID-19. Secondary outcomes were changes in the Clinical Ordinal Outcomes Scale (COOS) of the World Health Organization, the patient-reported MYMOP2 scale, and several biochemical parameters. Parametric data were analyzed using unpaired t-test. Non-parametric data were analyzed using the Wilcoxon signed rank test. Categorical data were analyzed using Chi-square test.
In total, 72 participants of the add-on homeopathy (AoH) group showed conversion of RT-PCR status to negative, in an average time of 7.53 ± 4.76 days (mean ± SD), as compared with 11.65 ± 9.54 days in the add-on placebo (AoP) group (p = 0.001). The mean COOS score decreased from 4.26 ± 0.44 to 3.64 ± 1.50 and from 4.3 ± 0.46 to 4.07 ± 1.8 in the AoH and AoP groups respectively (p = 0.130). The mortality rate for the AoH group was 9.7% compared with 17.3% in the AoP group. The MYMOP2 scores between the two groups differed significantly (p = 0.001), in favor of AoH. Inter-group differences in the pre- and post- mean values of C-reactive protein, fibrinogen, total leukocyte count, platelet count and alkaline phosphatase were each found to be statistically significant (p <0.05), favoring AoH; six other biochemical parameters showed no statistically significant differences.
The authors concluded that the study suggests homeopathy may be an effective adjunct to standard care for treating moderate and severe COVID-19 patients. More rigorous, including double-blinded, studies should be performed to confirm or refute these initial findings.
I do agree with the authors that more rigorous studies are needed before we can accept these findings. As it stands, this study seems to have multiple flaws:
- I fail to understand why they did not design their trial as a double-blind study. The reason given by the authors makes little sense to me.
- I also have my doubts that the study was even single-blind. If I understand it correctly, the placebo group was did not benefit from the detailed homeopathic history taking that is necessary to find the optimal homeopathic remedy. If that is so, unblinding of patients is inevitable.
- The authors themselves point out that the relevance of many outcome measures is questionable
Generally speaking, I find the results suspicious, implausible, and frankly too good to be true. I might also point out that the authors’ afilitation do not inspire much trust in their objectivity:
- 1Central Council for Research in Homoeopathy, New Delhi, India.
- 2Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India, New Delhi, India.
- 3Rejoice Health Foundation, New Delhi, India.
- 4Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital and National Cancer Institute, All India Institute of Medical Sciences, Ministry of Health and Family Welfare, New Delhi, India.
- 5Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, Ministry of Health and Family Welfare, New Delhi, India.
Neither do these statements:
Funding
The study was funded by the Central Council for Research in Homoeopathy, Ministry of AYUSH, Government of India. The funder approved the study through its review committees, delegated/recruited staff for conducting the study, and facilitated all collaborative procedures.
Conflict of Interest
None declared.
Lastly, I do wonder why the authors published their study in the 3rd class journal ‘Homeopathy’. Surely, such findings – if true – deserve to be published in a journal of a decent reputation!
