A Study to Evaluate the Efficacy of Individualized Homoeopathic Medicines in Treatment of Piles in the Light of Hahnemannian Concept: A Double-blind, Randomized, Placebo-Controlled Clinical Trial

Hemorrhoids or piles is the condition where veins of anorectum junction become congested, dilated and elongated, i.e., tortuous. About 3.3 million people of United States are suffering from the fourth leading gastrointestinal disease, i.e., piles, but only 4% seeks medical help. Clinical feature includes fresh bleeding, usually painless until complicated with other disease, history of constipation, due to hanging of overlying mucosa with varicose veins there is partial prolapsed of the rectum. A recent paper reported hemorrhoids as one of the most frequently encountered clinical conditions in a homeopathic hospital surgery and medicine outpatient in West Bengal, India and is treated with a considerable success rate of 60.3 to 82.3%. Treatment options mainly depend on the type and severity of hemorrhoids, patient’s preference, and the expertise of physicians. The current therapies can be grouped into 3 types. Increased fiber intake, medical therapies, and lifestyle changes are included in the conservative treatment for non-thrombosed hemorrhoids. Homeopathy ranks the most popular among the traditional, complementary, or alternative medicines. Thus piles were identified as one of the promising and priority research areas by this systematic documentation research. However, till date, clinical trials in this field have remained seriously compromised. In this double-blind, randomized, placebo controlled trial at State National Homoeopathic Medical College and Hospital, 140 patients suffering from piles will be randomized to either treatment (verum; n=70) or placebo (control; n=70) was aimed to investigate  whether there are any differences in outcomes between these two groups over 3 months of intervention. Anorectal symptom severity and Quality of Life Questionnaire (ARSSQoL), European Quality of Life (EQ-5D-5L), Modified Naranjo Criteria, and Patient Response Assessment Tool after Homoeopathic Treatment (PRATHoT) scores were used as the primary and secondary outcome measures respectively. Out of the 140 randomized, 122 were protocol-compliant. Intention-to-treat sample (n = 140) was analyzed. The level of significance was set at P less than 0.05 two-tailed. Statistically significant between-group differences were elicited in the ARSSQoL total (P < 0.001) and EQ-5D-5L VAS (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. Thus, IHMs demonstrated superior results over placebo in the short-term treatment of hemorrhoids of grades I-III. The findings need to be substantiated by further phase 3 trials.