Effects of pre-defined Homoeopathic medicines to mitigate adverse dermatological effects of radiotherapy and vomiting of chemotherapy in breast carcinoma: A randomised, double-blind, placebo-controlled, pilot trial in the context of usual care

• Main Authors: Purnima Shukla, Chaturbhuja Nayak, Mirza Qaiser Baig, Purak Misra
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2020-01-01
• Series: Indian Journal of Research in Homoeopathy
• Subjects: breast carcinoma; chemotherapy; homoeopathy; radiotherapy; randomised controlled trial; skin
• Online Access: http://www.ijrh.org/article.asp?issn=0974-7168;year=2020;volume=14;issue=3;spage=189;epage=199;aulast=Shukla

Background: Radiotherapy and chemotherapy are used in breast cancer, but they cause an array of adverse effects including dermatological changes and vomiting. Objective: The objective of the study was to examine whether Usual Care (UC) plus pre-defined homoeopathic remedies can produce different effect beyond UC plus placebo in dermatological adverse effects of radiotherapy and vomiting of chemotherapy in breast carcinoma. Methods: In this double-blind, randomised, placebo-controlled, parallel-arm trial, 88 females suffering from dermatological adverse effects due to radiotherapy (n = 41) or vomiting due to chemotherapy (n = 47) were randomised to receive either UC + Homoeopathy (verum; n = 44) or UC + Placebo (control; n = 44). The outcome measures were the number of responders showing any reduction of grades of Acute Radiation Morbidity Scoring Criteria (ARMSC) of the Radiation Therapy Oncology Group and Common Toxicity Criteria (CTC) for vomiting, measured at baseline and after 7 and 14 days. Relative Risk (RR) with 95% Confidence Intervals (CIs) was assessed; Chi-square tests were run to report P values. Results: A protocol-compliant sample (n = 80; 8 dropped out, verum: 4, control: 4) was analysed. The number of responders as per the ARMSC score after 7 days (11/18 vs. 1/19, RR = 3.3, 95% CI = 1.7–6.3, P = 0.001) and 14 days (16/18 vs. 1/19, RR = 9.4, 95% CI = 2.5–35.2, P < 0.001) was statistically significant, favouring verum over control. Similar results were obtained according to the CTC scoring after 7 days (15/22 vs. 2/21, RR = 3.3, 95% CI = 1.7–6.3, P < 0.001) and 14 days (21/22 vs. 4/21, RR = 15.1, 95% CI = 2.2–102.4, P < 0.001). Conclusion: Pre-identified homoeopathic medicines appeared superior to placebo, warranting further evaluation.