Individualized homeopathic treatment of anal fissure: a double-blind, randomized, placebo-controlled, clinical trial

Anal fissure is one of the most frequent and painful analdiseases. It is very painful, because it affects the multilayer squamousepithelium of the anoderm, which is richly innervated with pain fibers. Duringdefecation, the lesion is stretched with consequent painful symptomatology,which can persist for a certain amount of time and be accompanied by slightbleeding. The pain can be so intense as to induce thepatient to avoid defecation with consequent hardening of the faeces andexacerbation of the problem. It is associated with spasm of the internal analsphincter which may lead to reduction of blood flow and delayed healing. The pain characteristics of anal fissure isintense burning pain that appears immediately or later after evacuation of thebowels, of variable duration, described as passing a ‘‘razor blade’’ or‘‘broken glass’’. Anal fissures are not common in patients olderthan 65 years, and in this age group must be suspected to be associated withother pathologies. The lifetime incidence is calculated to be 11%. The diagnosis is based on the presence ofintense pain, with possible bleeding, during or after defecation. Digitalexploration should be avoided – spasm and pain can make diagnosis impossible. Improving diet and defecation habits is a goodlong-term strategy. Therefore, patients with primary chronic anal fissures areadvised to assume liquids and fibre supplements as well as bulk-formingemollient laxatives and to use warm sitz baths. Clinical management of anal fissure is stillcontroversial. Inefficacy of medical therapies in many cases and in order toavoid post-surgical complications, many a patients refer to CAM therapies. Homeopathy may have immense potential to offerin successful treatment of anal fissure, but has remained seriouslyunder-researched till date. We intend to uptake a prospective, double-blind, randomized, parallelarm, placebo-controlled, clinical trial testing efficacy of individualized homeopathic treatment of anal fissure. As per eligibility criteria, 150 patients will be enrolled in the trial from the outpatients or inpatients of MaheshBhattacharyya Homoeopathic Medical College & Hospital. Patients will be randomized to receive either individualized homeopathy medicines or indistinguishable placebo. All theparticipants will be encouraged to have sitz bath twice a day regularly,maintain local hygiene, correct constipation, consume adequate water, and correct unhealthy defecation habits. Outcome data, in terms of pain 0-10 numeric rating scale and patient-administered translated Bengali version of theGastrointestinal Quality of Life Index (GQLI) questionnaire will be obtained at baseline and after 3 months. Collected data will be analyzed statistically and will be published in scientific journals.