Comparison of Effectiveness, Tolerability, and Compliance of Pharmacotherapies in Patients with Functional Constipation: A Real-World Evidence Study

Background: duphalac® bulk, a combination of bulking agents and an osmotic laxative might prove beneficial in the management of functional constipation (FC) as compared to the existing therapies. Objective: To evaluate and compare the effectiveness, safety, and compliance of duphalac® bulk with other available therapeutic options for the management of constipation. Methods: In this retrospective study, electronic medical records (EMRs) of adult patients suffering from FC who were prescribed various dietary fibers or their combinations between May 2021 to September 2021 and visiting healthcare setups/clinics were reviewed. The patients were divided into four groups (2:1:1:1): Group I-duphalac® bulk; Group II-isabgol alone; Group III-lactitol and isabgol combination; and Group IV-Polyethylene glycol (PEG) and isabgol combination. Effectiveness was determined using the constipation scoring system (CSS). Adverse events and compliance were assessed. Additionally, lipid and glycemic parameters were analyzed. Results: Out of 110 patients screened, 96 met the inclusion criteria and participated in the study. Majority of the patients (42.7%) received duphalac® bulk, followed by lactitol and isabgol combination (19.7%), PEG and isabgol combination (18.7%), and isabgol (18.7%). A significant reduction in overall mean CSS was observed among all the groups; however, the maximum decrease (3.49, p<0.001) was found in Group I as compared to Groups II (3.28, p<0.001), III (2.58, p=0.001), and IV (2.50, p=0.002). All treatments were well tolerated. Improvements in glycemic and lipid parameters were observed in all groups. Conclusion: duphalac® bulk was well tolerated with significant symptomatic improvement in patients suffering from FC. Keywords: Constipation scoring system, Duphalac® bulk, Functional constipation, Glycemic control, Lipid profile