Evaluation of efficacy and safety of diphenoxylate hydrochloride and atropine sulphate in patient with acute radiation or chemotherapy induced diarrhea

Background: Chemoradiotherapy (CRT)-induced diarrhea poses significant challenges for cancer patients, impacting both quality of life and treatment efficacy. Current management strategies often involve symptomatic relief with medications such as lomotil and loperamide, but limited data exist on the efficacy of lomotil for management of CRT-induced diarrhea. This study aimed to evaluate the efficacy and safety of lomotil in managing acute CRT-induced diarrhea. Methods: A cross-sectional observational trial was conducted at 25 Indian healthcare centers having medical records of adult patients with cancer who had received lomotil for the treatment of CRT-induced diarrhea. Adult patients (aged ?18 years) with confirmed diagnosis of cancer, who were experiencing CRT-induced diarrhea of grade II or grade III severity were included in this study. Demographic information and treatment history were collected. Moreover, data related to stool frequency, stool consistency, abdominal cramp, and occurrence of blood or mucus were collected at baseline, day 1, day 2, day 3, 2nd week, 3rd week, and 4th week. Results: A total of 177 patients were included in this study. Of these 30.51% underwent radiotherapy, while 26.55% received both chemotherapy and radiotherapy in combination. Post-lomotil treatment, diarrhea incidence declined significantly by week 4 [pre-treatment to week 4: 3.58 to 0.42; P<0.001]. The presence of blood or mucus decreased significantly from baseline to week 4 (0.25 to 0.05; p<0.01). The overall global assessment for improvement showed that a majority of the patients (80.79%) experienced improvement. Conclusions: Lomotil demonstrated efficacy in reducing CRT-induced diarrhea incidence and symptoms, with minimal adverse effects.