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

clinical trial

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This paper examined the state of homeopathic clinical research by critically assessing the overall quality of peer-reviewed, recently published, English-language, homeopathic clinical research in terms of internal, external, and model validity using standard and homeopathic-specific instruments. Further, an international panel of nine experts in research methods and homeopathy to identifed gaps in homeopathic research and prioritize areas for future study.
The team reviewed 99 clinical research studies targeting a wide range of populations and conditions. Studies were conducted in Western and Asian countries, with the largest number (30 percent) conducted in India. Of the 99 studies reviewed,
  • 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.

The expert panel’s opinion was mixed on whether the homeopathic research literature was missing important populations and/or conditions, and they suggested a variety of priority areas. Panelists also expressed a variety of opinions about the types of homeopathy that should be prioritized for future study but also noted that since homeopathic practice differs by country, each country may have different priorities.
Panelists agreed with the findings of the literature review that the research literature was at least somewhat deficient in all three types of validity. Although the assessment of validity was [by necessity] based only on what was reported, it suggests the need for both better reporting and higher quality research. They recommended the use of reporting guidelines to improve all types of validity, the identification of exemplar studies to help guide researchers to improve internal validity, and, given the limitations of the instruments available to measure external and model validity, that these instruments be validated and configured to provide summary scores.
Finally, substantial discussion addressed the need to bring more research expertise into homeopathic studies. This could be done both by better training homeopathic researchers and by collaborating with experienced conventional medicine research groups.
The authors concluded that the state of homeopathic research could be substantially improved in terms of internal, external, and model validity. Strict adherence to reporting guidelines, with attention to quality criteria during study design, would likely result in most of the needed improvement. However, there is also a need for the homeopathic community to decide where to focus future research in terms of conditions, populations, and types of homeopathy studied. These focus areas could take many forms and should align with the community’s research goals.
One of the fascinating aspects here is that the panel was not asked to deliberate whether – in view of homeopathy’s implausibility and the largely negative clinical evidence – further reseach into the subject is meaningful or desirable.
But by now you probably ask yourself: who are the members of the expert panel? Here they are:
  1. Iris Bell, M.D., Ph.D., University of Arizona College of Medicine (Retired) and Sonoran University of Health Sciences;
  2. Dan Cherkin, Ph.D., Osher Center for Integrative Health, Department of Family Medicine, University of Washington;
  3. Roger Chou, M.D., Department of Medical Informatics & Clinical Epidemiology and Department of Medicine, Oregon Health & Science University;
  4. Katharina Gaertner, MBBS, Research Faculty of Health, University Witten/Herdecke;
  5. Klaus Linde, M.D., Ph.D., Scientific Coordinator, Technische Universität München, Institute of General Practice and Health Services Research;
  6. Alexander Tournier, Ph.D., Homeopathy Research Institute and Institute of Complementary and Integrative Medicine, University of Bern;
  7. 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;
  8. 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.

Dry needling (DN) is a treatment used by various healthcare practitioners, including physical therapists, physicians, and chiropractors. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. DN is mainly used to treat myofascial trigger points, but it is also used to target connective tissue, neural ailments, and muscular ailments. There is conflicting evidence regarding the effectiveness of DN for any condition.

Orofacial pain (OFP) typically has a musculoskeletal, dental, neural, or sinogenic origin. Our systematic review was aimed at evaluating the evidence base for the effectiveness of DN for OFP.

We searched Medline, Cochrane Central, and Web of Science (from their respective inceptions to February 2024) for RCTs evaluating the effectiveness of DN in patients with OFP. Studies with patients suffering from cervicogenic or tension type headaches as well as observational studies were excluded. Primary outcomes were pain intensity and severity; secondary outcomes were disability, quality of life, and adverse effects (AEs). The review adhered to the methods described by in the Cochrane Handbook.

Twenty-four RCTs with a total of 1,318 patients suffering from OFP could be included. Most had an unclear or high risk of bias, and the quality of the evidence ranged from very low to low for all comparisons and outcomes. A meta-analysis suggested that, compared with usual care alone, DN + usual care had no effect on pain intensity (visual analogue scale) (standardized mean difference = −1.89, 95% confidence intervals −5.81 to 2.02, very low certainty evidence) at follow-ups of up to 6 weeks. Only 6 RCTs (25%) mentioned AEs, and none of them reported that AEs had occurred. The remaining 18 (75%) studies failed to report AEs.

We concluded that DN cannot be considered as an effective treatment option for OFP. This is due to the uncertainties of the available evidence. We believe that larger, rigorous, and better reported trials with more homogeneous comparators might potentially reduce the current uncertainties. Such trials should strictly adhere to the classifications provided by the International Headache Society and published in the International Classification of Orofacial Pain. 

Yet again, I need to stress that the vast majority od RCTs failed to mention AEs. When will the last (pseudo-) researcher have learnt that the non-reporting of AEs is a violation of research ethics?

The Bavarian homeopathy study has been aborted!

As I posted in 2019, the Bavarian government has given the go-ahead to a major study of homeopathy.

The study was aimed at clarifying whether the use of homeopathic remedies can reduce the use of antibiotics in humans and animals. The vote was carried because of the CDU delegates being in favour. The debate of the project was, however, controversial. Critics stressed that, at best, the study is superfluous and pointed out that the project is negligent because it implies that homeopathics might be effective, whereas the evidence shows the opposite. A SPD delegate stated that he is ‘open moth’, homeopathy works because of the doctor-patient contact and not because of its remedies which are pure placebos. The project was tabled because some people had worried about antibiotic resistance and felt that homeopathy might be an answer. Some CSU delegates stated that in ENT medicine, there is evidence that homeopathics can reduce the use of antibiotics. Even in cases of severe sepsis, there was good evidence, they claimed.

The FRANKFURTER ALLGEMEINE just reported more details about this remarkable project and its failure to produce meaningful results:

The double-blind, placebo-controlled RCT carried out at the Technical University of Munich examined women with regular urinary tract infections – all were to be given antibiotics or ibuprofen if necessary. Around 120 of the women were to receive either placebo or individually selected globules as a preventative measure. Differences were to be measured by whether infections occurred less frequently in the globule group and whether antibiotics were necessary.

The results should have been available a long time ago. However, as the lead-investigator of the study, nephrologist Lutz Renders, has now revealed that the study has apparently come to nothing. ‘The study has cancelled recruitment because the required number of test subjects could not have been reached within a reasonable period of time,’ he explains. Only the women who have already been included will now be followed up until the beginning of 2025.

‘Of the 200 or so women who registered, around 40 were found to have urinary tract infections’, says Renders, ‘so that they could be included in the study. It is a pity that the actual aim of the study was not achieved, as it is possible that something could be learnt about urinary tract infections in general from the extensive examinations of the women. I don’t have much to do with homeopathy,’ says Renders.

Georg Schmidt, head of the ethics committee at the Technical University of Munich, says that the committee found it ‘extremely difficult’ to authorise the study at all. ‘We had a heated discussion along the lines that you can’t compare nothing with nothing. We all agreed that homeopathy is ineffective.’ The commission decided to ensure that the risk of a false-positive result is as low as possible – the statistics have been tightened up for this purpose’.

___________________________

The notion that a definitive test of homeopathy is needed seems to beset German govenments from time to time – the last such initiative occurred during the Third Reich. Perhaps, one day, even politicians will understand that, on the scientific level, the discussion about homeopathy is now well and truly over, and that no more money needs to be wasted on it?

 

This study evaluated the real-world impact of acupuncture on analgesics and healthcare resource utilization among breast cancer survivors.

The authors selected from a United States (US) commercial claims database (25% random sample of IQVIA PharMetrics® Plus for Academics) 18–63 years old malignant breast cancer survivors who were experiencing pain and were ≥ 1 year removed from cancer diagnosis. Using the difference-in-difference technique, annualized changes in analgesics [prevalence, rates of short-term (< 30-day supply) and long-term (≥ 30-day supply) prescription fills] and healthcare resource utilization (healthcare costs, hospitalizations, and emergency department visits) were compared between acupuncture-treated and non-treated patients.

Among 495 (3%) acupuncture-treated patients (median age: 55 years, stage 4: 12%, average 2.5 years post cancer diagnosis), most had commercial health insurance (92%) and experiencing musculoskeletal pain (98%). Twenty-seven percent were receiving antidepressants and 3% completed ≥ 2 long-term prescription fills of opioids. Prevalence of opioid usage reduced from 29 to 19% (P < 0.001) and NSAID usage reduced from 21 to 14% (P = 0.001) post-acupuncture. The relative prevalence of opioid and NSAID use decreased by 20% (P < 0.05) and 19% (P = 0.07), respectively, in the acupuncture-treated group compared to non-treated patients (n = 16,129). However, the reductions were not statistically significant after adjustment for confounding. Patients receiving acupuncture for pain (n = 264, 53%) were found with a relative decrease by 47% and 49% (both P < 0.05) in short-term opioid and NSAID fills compared to those treated for other conditions. High-utilization patients (≥ 10 acupuncture sessions, n = 178, 36%) were observed with a significant reduction in total healthcare costs (P < 0.001) unlike low-utilization patients.

The authors concluded that, although adjusted results did not show that patients receiving acupuncture had better outcomes than non-treated patients, exploratory analyses revealed that patients treated specifically for pain used fewer analgesics and those with high acupuncture utilization incurred lower healthcare costs. Further studies are required to examine acupuncture effectiveness in real-world settings.

Oh, dear!

Which institutions support such nonsense?

  • School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 802 W Peltason Dr, Irvine, CA, 92697-4625, USA.
  • School of Pharmacy, Chapman University, RK 94-206, 9401 Jeronimo Road, Irvine, CA, 92618, USA.
  • College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
  • Integrative Medicine Program, Departments of Supportive Care Medicine and Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
  • School of Pharmacy, Chapman University, RK 94-206, 9401 Jeronimo Road, Irvine, CA, 92618, USA. [email protected].
  • School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 802 W Peltason Dr, Irvine, CA, 92697-4625, USA. [email protected].

And which journal is not ashamed to publish it?

It’s the BMC Med!

The conclusion is, of course, quite wrong.

Please let me try to formulate one that comes closer to what the study actually shows:

This study failed to show that a ‘real world impact’ of acupuncture exists. Since the authors were dissatisfied with a negative result, subsequent data dredging was undertaken until some findings emerged that were in line with their expectations. Sadly, no responsible scienctist will take this paper seriously.

Spanish colleagues and I just published an article entitled “Is Osteopathic Manipulative Treatment Clinically Superior to Sham or Placebo for Patients with Neck or Low-Back Pain? A Systematic Review with Meta-Analysis”. Here is its abstract:

The aim of this systematic review and meta-analysis was to compare whether osteopathic manipulative treatment (OMT) for somatic dysfunctions was more effective than sham or placebo interventions in improving pain intensity, disability, and quality of life for patients with neck pain (NP) or low-back pain (LBP). Methods: A systematic review and meta-analysis was carried out. Searches were conducted in PubMed, Physiotherapy Evidence Database, Cochrane Library, and Web of Science from inception to September 2024. Studies applying a pragmatic intervention based on the diagnosis of somatic dysfunctions in patients with NP or LBP were included. The methodological quality was assessed with the PEDro scale. The quantitative synthesis was performed using random-effect meta-analysis calculating the standardized mean difference (SMD) with RevMan 5.4. The certainty of evidence was evaluated using GRADEPro. Results: Nine studies were included in the qualitative synthesis, and most of them showed no superior effect of OMTs compared to sham or placebo in any clinical outcome. The quantitative synthesis reported no statistically significant differences for pain intensity (SMD = −0.15; −0.38, 0.08; seven studies; 1173 patients) or disability (SMD = −0.09; −0.25, 0.08; six studies; 1153 patients). The certainty of evidence was downgraded to moderate, low, or very low. Conclusions: The findings of this study reveal that OMT is not superior to sham or placebo for improving pain, disability, and quality of life in patients with NP or LBP.

As always, it seems important to stress that our review has several limitations. Firstly, the searches were conducted in the most relevant databases; however, some studies not indexed in these sources may have been missed. Secondly, the diverse NP and LBP diagnosis, as well as the lack of data reported by some studies, complicates the interpretation of the results and may weaken our conclusion. Thirdly, the primary studies pragmatically applied interventions based on diagnoses of various somatic dysfunctions, resulting in a high degree of heterogeneity among the treatments applied.

Despite these limitations, it is fair to say, I think, that OMT is not nearlly as solidly supported by reliable evidence as most osteopaths try to make us believe. In essence, this means that, if you suffer from NP or LBP, you best concult a proper doctor or physiotherapist.

The ‘WORLD JOURNAL OF PHARMACEUTICAL RESEARCH‘ just published a paper entitled RESEARCH TRIAL TO EVALUATE THE EFFICACY OF HOMEOPATHIC MEDICINES IN ACUTE PHARYNGITIS- AN OBSERVATIONAL STUDY. It is remarkable, in my view; please let me show you its abstract:

This observational study aims to evaluate the efficacy of homeopathic medicines in the management of acute pharyngitis. Acute pharyngitis, commonly caused by viral or bacterial infections, presents with symptoms such as sore throat, fever, and difficulty swallowing, significantly affecting patient quality of life. Despite the widespread use of conventional treatments, there is a growing interest in homeopathic remedies as a potential alternative. This trial involved a cohort of patients diagnosed with acute pharyngitis who received individualized homeopathic treatments based on their specific symptoms and constitutional type. Clinical outcomes were assessed using standardized symptom severity scales at baseline and follow-up visits. Data analysis focused on symptom resolution, patient-reported outcomes, and overall satisfaction with treatment. Preliminary results indicate a significant reduction in symptom severity and improvement in quality of life among participants receiving homeopathic interventions compared to standard care. These findings suggest that homeopathic medicines may offer a viable complementary approach to the management of acute pharyngitis, warranting further research to establish definitive therapeutic protocols and validate these observations.

Yes, you are right:

  1. This study cannot possibly assess the ‘efficacy of homeopathic medicines’. Its design does simply not allow this.
  2. The results are to be expected due to the natural history of the condition and say nothing about the ‘efficacy’ of the interventions.

Despite these obvious caveats, the authors reinforce their wrong message many times in the article; here are a few further quotes:

  • According to the study, there was significant improvement in 61.67% of cases.
  • Overall, our study emphasizes Homoeopathy as an effective treatment for acute pharyngitis and suggests its wider consideration in clinical practice.
  • Homoeopathy provides a holistic, individualized, and safe approach to treating acute pharyngitis, with benefits such as minimal side effects, long-term health improvements, and enhanced patient empowerment, establishing it as a valuable therapeutic option for managing this common condition.

Who publishes such nonsense?

Surely not professionals with a higher degree!

Wrong! In fact, the authors are three professors:

  • M.D. (Hom.), Phd, Assistant Professor- Department of Community Medicine State
    Government Homoeopathic Medical College, Aligarh, Uttar Pradesh.
  • MD (Hom.), PhD, Associate Professor- Department of Pathology, G.C. Homoeopathic
    Medical College, Lucknow, Uttar Pradesh.
  • M.D. (Hom.), PhD, Professor- PG Department of Homoeopathic Pharmacy S.S. Agrawal
    Homoeopathic Medical College, Navsari, Gujarat.

And what does the ‘WORLD JOURNAL OF PHARMACEUTICAL RESEARCH‘ think they are doing when publishing such scientific misconduct? They think they serve Science & Mankind at the highest levels of Professional Ethical Conduct.

No, I am not kidding; here is a quote from their website:

“The Journal particularly aims to foster the dissemination of scientific information by publishing manuscripts related to current Pharmaceutical Drug Delivery and related fields. We started with a Mission to encourage contribution to Research in Sciences & Technology for achieving better future lives for all. We serve Science & Mankind at the highest levels of Professional Ethical Conduct.”

 This study seeked to examine and compare the respective impacts of warm foot baths and foot reflexology on depression in patients undergoing radiotherapy.

A randomized clinical trial was conducted at Mashhad University of Medical Sciences in Iran in 2019, following CONSORT guidelines. Participants included non-metastatic cancer patients aged 18-60 undergoing a 28-day radiotherapy course. Patients were randomly assigned to receive either warm footbaths or foot reflexology as interventions, performed daily for 20 min over 21 days. The data were analyzed using appropriate statistical tests.

Statistical analysis indicated no significant differences in demographic attributes between the two groups. Both interventions led to a significant reduction in depression scores post-treatment compared to pre-treatment assessments. Foot reflexology showed a greater reduction in depression scores compared to footbaths with warm water.

The authors concluded that both warm footbaths and foot reflexology are effective in alleviating depression in patients undergoing radiotherapy, with foot reflexology showing a greater impact on improving depression levels. The study recommends foot reflexology as a preferred intervention for managing depression in these patients if conditions and facilities permit.

Proponents of reflexology suggest that manipulating specific points on the sole of the foot influences the physiological responses of corresponding organs. By exerting pressure on these reflex areas, numerous nerve endings in the soles are claimed to get activated, triggering the release of endorphins. This process helps block the transmission of pain signals, promotes comfort, reduces tension, and fosters a sense of tranquility. These assumptions fly in the face of science, of course. Yet, they impress many patients. By contrast, a footbath is just a footbath. Nobody makes any hocucpocus claimes about it.

What I am trying to explain is this: the placebo effect associated with a footbath is bound to be smaller than that of reflexology. And the minimal difference in outcomes (9.5 versus 8.9 on a scale ranging from 0 to 63) observed in this study are likely to be unrelated to reflexology itself – most probably, they are due to placebo responses.

So, what would you prefer, a footbath that is straight forwardly agreeable, or a treatment like reflexology that generates slightly better effects due to placebo and expectation but indoctrinates you with all sorts of pseudoscientific nonsense that undermines rational thinking about your health?

Some research have suggested that aromatherapy with lavender essential oil can be effective in reducing pain and anxiety in various medical settings. Yet, the efficacy of lavender aromatherapy in the postoperative setting after cesarean delivery is less well-studied. This study aimed to assess the effectiveness of lavender essential oil therapy in the management of pain and anxiety after cesarean delivery.

This was a monocentric randomized controlled double-blind trial conducted over a period of five months during 2023. A hundred women undergoing c-sections under spinal anesthesia were enrolled and randomly assigned; using block randomization of 4 items per block with allocation ratio 1:1, into two groups:

  1. The aromatherapy group received inhaled Lavender essential oil.
  2. The placebo group received distilled water instead.

The primary outcomes were pain (at rest and after mobilization) and anxiety levels and after the intervention.

A total of 100 women were included (50 women in each group aromatherapy and the placebo group). The two groups were comparable regarding baseline characteristics and pre-intervention parameters with no statistically significant difference. After the intervention, the pain at rest (38,76 ± 22,9 vs. 23,84 ± 18,01; p < 0.001), the pain after mobilization (60,28 ± 23,72 vs. 40,12 ± 22,18; p < 0.001), and degree of anxiety (46,76 ± 6,59 vs. 44,3 ± 5,17; p = 0.03) were all significantly lower in the aromatherapy group. No adverse effects were reported by participants in both groups.

The authors concluded that aromatherapy using Lavender essential oil is effective in reducing pain and anxiety after cesarean delivery without adverse effects.

I beg to differ!

The authors point out that, to address the potential for participants to differentiate between the lavender and the placebo based on olfactory cues, they were informed that they would receive a natural inhalation product; however, they were not informed that it was an essential oil or specifically lavender. This is a lame attemp to prevent patients from guessing in which group they were. I doubt that it was successful. As a minimum, the authors should have checked whether binding was achieved!

Yes, it is difficult to patient-blind such studies. But it is possible. For instance, the control arm might have received an arificial oil with a lavender scent which aromatherapists claim to be ineffective. Alternatively two different essential oils could have been tested – lavender against an oil that is not said to affect pain and anxiety. These options are fairly obvious and well-known to aromatherapists. Why then were they not incorporated? I suspect because the trialists suspect that this would not produce the desired result.

As it stands, the honest conclusion should be something like this: aromatherapy using Lavender essential oil might reduce pain and anxiety after cesarean delivery. Whether this is due to a specific effect of the oil or the non-specific effects of expectation needs to be seen.

This pragmatic, randomised controlled trial was conducted between September 2018 and February 2021 and compared the difference between primary homoeopathic and conventional paediatric care in treating acute illnesses in children in their first 24 months of life. It was conducted at the Central Council for Research in Homoeopathy (CCRH) Collaborative Outpatient Department of the Jeeyar Integrated Medical Services (JIMS) Hospital in Telangana, India, a tertiary-care hospital that provides integrated patient-centric care, using homoeopathy and Ayurveda alongside conventional medicine.

One hundred eight Indian singleton newborns delivered at 37 to 42 weeks gestation were randomised at birth (1:1) to receive either homoeopathic or conventional primary care for any acute illness over the study period. In the homoeopathic group, conventional medical treatment was added when medically indicated. Clinicians and parents were unblinded.

The study’s primary outcome was a comparison of the number of sick days due to an acute illness experienced during the first 24 months of life by children receiving homoeopathic vs. conventional treatment. Sick days were defined as days with any acute illness (febrile or afebrile) reported by the parent and confirmed by the physician. Febrile illness was recorded when body temperature, measured via the ear canal, exceeded 37.5 °C.

The secondary outcomes compared were as follows:

  • The number of sickness episodes, defined as illness events (febrile or afebrile), reported by the parent and confirmed by the physician.
  • Number of respiratory illness episodes and days during the 24 months. Respiratory illnesses included infections in any part of the respiratory tract (nose, middle ear, pharynx, larynx, trachea, bronchi, bronchioles, and lungs) .
  • Number of diarrhoeal episodes and days during the 24 months. Diarrhoea was defined as three or more episodes of watery stool/day, with or without vomiting, with indications of dehydration, weight loss, or defective weight gain.
  • Anthropometric data included weight (measured by electronic scales to the nearest 5 g), height (measured in triplicate to the nearest 0.2 cm using a rigid-length board), head circumference (HC), and mid-upper arm circumference (MUAC) (measured with a standard measuring tape to the nearest 0.2 cm every 3 months until the 24th month).
  • Developmental status was evaluated according to the Developmental Assessment Scales for Indian Infants (DASII) every 6 months from the age of 6 to 24 months.
  • Direct cost of treatment for illnesses during the 24 months, including cost of medications, inpatient admissions, investigations, supplements, and treatment outside the hospital facility or study site (consultation and/or medicines).
  • Use of antibiotics during the 24 months, defined as the number of antibiotic episodes during the study.
  • Mortality: death due to any acute illness episode.

The results show that children in the homoeopathic group experienced significantly fewer sick days than those in the conventional group (RR: 0.37, 95% CI: 0.24-0.58; p < 0.001), with correspondingly fewer sickness episodes (RR: 0.53, 95% CI: 0.32-0.87; p = .013), as well as fewer respiratory illnesses over the 24-month period. They were taller (F (1, 97) = 8.92, p = .004, partial eta squared = 0.84) but not heavier than their conventionally treated counterparts. They required fewer antibiotics, and their treatment cost was lower.

The authors concluded that homoeopathy, using conventional medicine as a safety backdrop, was more effective than conventional treatment in preventing sick days, sickness episodes, and respiratory illnesses in the first 24 months of life. It necessitated fewer antibiotics and its overall cost was lower. This study supports homoeopathy, using conventional medicine as a safety backdrop, as a safe and cost-effective primary care modality during the first 2 years of life.

Here we have another study designed in such a way that a positive result was inevitable. Both groups of children received the necessary conventional care and treatment. The verum group received homeopathy in addition. There were no placebo controls and everyone knew which child belonged to which group. Thus the verum group benefitted from a poweful placebo effect, while the control group experience disappointment over not receiving the extra attention and medication. One might argue that newborn babies cannot experience a placebo response nor disappointment. Yet, one would be wrong and in need of reading up about placebo effects by proxy.

A+B is always more than B alone

To boldy entitle the paper ‘Homoeopathy vs. conventional primary care in children during the first 24 months of life’ and state that the trial aimed to “compared the difference between primary homoeopathic and conventional paediatric care in treating acute illnesses in children in their first 24 months of life”, is as close to scientific misconduct as one can get, in my view!

Yet again, I might ask: what do we call a study that is designed in such a way that a positive result was inevitable?

  • misleading?
  • waste of resources?
  • unethical?
  • fraud?

And again, I let you decide.

 

PS

I feel disappointed that a decent journal published this paper without even a critical comment!

 

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