MD, PhD, MAE, FMedSci, FRCP, FRCPEd.
This three-month, double-blind, randomized (1:1), placebo-controlled trial evaluated whether individualized homeopathic medicinal products (IHMPs) are superior to placebo in reducing anorectal symptom severity and improving quality of life over 3 months in adults with hemorrhoids, and to assess their safety and tolerability.
A total of 134 adults with grade I–III hemorrhoids received either:
  • IHMPs (verum; n = 67),
  • or identical-looking placebos (control; n = 67)

Both treatments were administered alongside standard concomitant care including sitz baths, pelvic floor exercises, and dietary advice.

The primary outcome was the change in the Anorectal Symptom Severity and Quality-of-Life (ARSSQoL) total score over 3 months. Secondary outcomes included ARSSQoL subscales, numeric rating scales (NRSs), and EQ-5D-5L questionnaire and visual analog scale. Outcomes were assessed monthly for up to 3 months. The primary analysis compared model-based estimates of change over time between groups using repeated measures analysis of variance; the secondary analyses comprised multivariate linear mixed models, Bayesian hierarchical modeling, and sensitivity analyses under intention-to-treat and per-protocol frameworks.
After 3 months, IHMPs demonstrated significantly greater improvement than placebo in ARSSQoL total (mean group difference −6.5, 95% confidence interval −8.7, −4.2; p < 0.001), with large effect sizes. Most ARSSQoL subscales, NRSs, and EQ-5D-5L scores favored IHMPs. Multivariate and Bayesian analyses confirmed consistent intervention-by-time effects, with a high probability of directional superiority for IHMPs in symptom reduction and self-rated health, while sensitivity analyses showed the findings to be robust to protocol deviations. Kent’s repertory was the most frequently used in remedy selection. Nitricum acidum emerged as the most effective remedy. No treatment-related serious adverse events were observed.
The authors concluded that, in this randomized, double-blind trial, IHMPs were associated with greater reductions in the ARSSQoL improvements in quality of life compared with placebo over 3 months. Although the magnitude and consistency of effects across multiple analytic approaches suggest potential clinical relevance, the absence of a validated minimal clinically important difference for the ARSSQoL warrants cautious interpretation. Further independent replications and methodological refinement of outcome thresholds are needed.
I must admit that I am puzzled. Homeopathic treatment of hemorhoids would normally require giving a remedy that, in a healthy person, causes the symptoms of this condition. This, however, is not the case for any of the administered remedies. Homeopaths might counter that a form of homeopathy was used called ‘clinical homeopathy’ where one prescribes remedies according to the condition, Arnica for cuts and bruises, for instance. But this is not ‘individualised homeopathy’ which the authors claimed to have used and where the remedies are prescribed not according to the disease but according to the individual’s symptoms and type.
So, what is going on here?
In my search for an answer, I looked at the authors affiliations:
  • Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Government of West Bengal, Kolkata, India.
  • East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, under Department of Health & Family Welfare, Government of West Bengal, Parganas, India.
  • Department of Pathology & Microbiology, D. N. De Homoeopathic Medical College and Hospital, Government of West Bengal, Kolkata, India.
  • Department of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Government of West Bengal, Kolkata, India.
  • Department of Materia Medica, D. N. De Homoeopathic Medical College and Hospital, Government of West Bengal, Kolkata, India.
  • Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Government of India, Salt Lake, Kolkata, India.
  • Department of Community Medicine, D. N. De Homoeopathic Medical College and Hospital, Government of West Bengal, Tangra, India.

This list does not inspire me with confidence that this study is reliable.

Next I looked around for further trials of homeopathy for hemorrhoids – and I found another study by the same authors published 2 years earlier in the same dodgy journal:

Objectives: To investigate the efficacy and safety of individualized homeopathic medicines (IHMs) in treating hemorrhoids compared with placebo. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The trial was conducted at the surgery outpatient department of the State National Homoeopathic Medical College and Hospital, Lucknow, Uttar Pradesh, India. Subjects: Patients were 140 women and men, aged between 18 and 65 years, with a diagnosis of primary hemorrhoids grades I-III for at least 3 months. Excluded were the patients with grade IV hemorrhoids, anal fissure, and fistula, hypertrophic anal papillae, inflammatory bowel disease, coagulation disorders, rectal malignancies, obstructed portal circulation, patients requiring immediate surgical intervention, and vulnerable samples. Interventions: Patients were randomized to Group 1 (n = 70; IHMs plus concomitant care; verum) and Group 2 (n = 70; placebos plus concomitant care; control). Outcome measures: Primary-the anorectal symptom severity and quality-of-life (ARSSQoL) questionnaire, and secondary-the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire and EQ visual analogue scale (VAS); all of them were measured at baseline, and every month, up to 3 months. Results: Out of the 140 randomized patients, 122 were protocol compliant. Intention-to-treat sample (n = 140) was analyzed. The level of significance was set at p < 0.05 two tailed. Statistically significant between-group differences were elicited in the ARSSQoL total (Mann-Whitney U [MWU]: 1227.0, p < 0.001) and EQ-5D-5L VAS (MWU: 1228.0, p = 0.001) favoring homeopathy against placebos. Sulfur was the most frequently prescribed medicine. No harm or serious adverse events were reported from either of the groups. Conclusions: IHMs demonstrated superior results over placebo in the short-term treatment of hemorrhoids of grades I-III. The findings are promising, but need to be substantiated by further phase 3 trials.

Are we to believe that the authors were able to pull off 2 large almost identical studies within just 2 years?

Pull the other one!

5 Responses to Treatment of Hemorrhoids with Individualized Homeopathy

  • I have an experince regarding this case. I know – just an anecdotical story, but one that gives you a case where friend of your forum can add a real world example to this study.

    I was suffering from hemorrhids for many years. I was treated with rubber band ligature for years. I stopped that therapy after a medical expert told me that it was no good idea to get regularily wonds that leave scars in the gut. I had no therapy anymore and problems came back.

    I found a noodge from hemorrhids and I took a few globule only once – and problems vanished and never came back. I can’t tell you right now what potentation it was, but the bottel should still be in my house and I could look for it.

    There are a few kinds of homeopatic remedies where I made so many good experience, that I would say: they work. However there are also remedies that never worked for me, even though tested multiple times.

    Best regards,
    Holger

  • You wrote:
    Anecdotal “evidence” is meaningless! (Especially in the case of “hemorrhids)!

    Each report about a successful healing is useful.
    The aim is not the prove – this was successfully done by the study!
    However, if there are reported cases where thw result of the study could be verified, is just another strenthening. It is helpful even though not giving scientific prove. It is after and above that

    • “Each report about a successful healing is useful.
      The aim is not the prove – this was successfully done by the study!”

      Nicht wahr! Das ist falsch.

      The aim is exactly about the proof. Reports of successful healings remain anecdotal and, as such, are useless.

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