Prevention of Functional Dyspepsia with Carica Papaya Extract

Abstract

Functional dyspepsia (FD) is a set of relapsing or chronic dyspeptic symptoms in the absence of structural organic lesions. Approximately 15-20% of the general population in many developed countries suffers from dyspeptic symptoms at any time in a year, whereas in Pakistan, 14-22 % of general population suffers from FD. Objective: This study was designed to evaluate the effectiveness of carica papaya extract (CP) in preventing functional dyspepsia in human volunteers.Methodology: A community based, placebo-controlled, double -blind, multi-centered, and randomized clinical trial through systematic random sampling was conducted in Lahore urban community. After initial diagnostic investigations in 200 patients diagnosed as cases of FD fulfilling Rome III criteria were recruitedafter taking written consent and randomly assigned to one of 2 treatment groups (CP extract group or placebo) in equal number. A 7 days medication free period was observed before the start of trial. Each patient received the treatment for 6 weeks. The primary outcome variable was the improvement in gastrointestinalsymptom score (GIS) consisting of evaluation of 10 dyspeptic symptoms rated on Likert scale. Dyspeptic symptoms were assessed at the start of trial then after 2, 4 and 6 weeks. Results: In this trial, 200 patients fully participated in this study (age 36.31±9.711 years, range 18-55, 60% female). Compared with placebo, Carica papaya extract (CP group) showed a clinically significant improvement. The GIS significantly decreased in CP group during the first 2 weeks, compared to the placebo (p < 0.05). During the second and third 2-week period, symptoms further improved in CP group (p < 0.05). After 6 weeks, 95.7% on CP treatment and 3.1% on placebo were completely relieved of FD symptoms (p < 0.001). Conclusions: CP extract was significantly effective gastro-protective as compared with placebo.