Efficacy and Safety of Fingerroot (Boesenbergia rotunda) Extract in Patients with Functional Dyspepsia: A Randomized, Placebo-Controlled Trial

Abstract

<b><i>Background:</i></b> Functional dyspepsia (FD) is a common upper gastrointestinal disorder, but the current treatments are still unsatisfactory. Fingerroot (<i>Boesenbergia rotunda</i> [L.] Mansf.; BR) is used as a traditional medicine for dyspepsia despite a lack of proven evidence. <b><i>Objective:</i></b> This study aimed to evaluate the efficacy and safety of BR extract in the treatment of patients with FD. <b><i>Methods:</i></b> In a randomized, double-blinded, placebo-controlled trial, 160 patients with FD based on Rome IV criteria were to be recruited and randomly assigned (1:1 ratio) to receive BR (350 mg extract powder) or placebo 3 times daily for 4 weeks. Primary end point was change in the summed total score of Short-Form Leeds Dyspepsia Questionnaire. Secondary end points were the rate of symptom relief, the reduction of blood inflammatory markers and the improvement in gastric histology according to the Updated Sydney System. <b><i>Results:</i></b> One hundred sixty patients (62 [38.8%] men, aged 56.9 ± 14.8 years) were randomized to the BR group (<i>n</i> = 80) and placebo group (<i>n</i> = 80), and 138 patients completed this study. Overall symptom improvement was significantly greater in the BR group than in the placebo group (−7.1 ± 2.0 vs. −3.7 ± 0.8, repeated measures ANOVA, <i>p</i> &#x3c; 0.05). Total symptom scores significantly improved with decrease in blood inflammatory markers in the BR group compared with the placebo group (<i>p</i> &#x3c; 0.05). Proportion of responders was higher in the BR group (58%) than in the placebo group (34.6%) according to the intention-to-treat analysis (<i>p</i> &#x3c; 0.05) with the number needed to treat calculated as 4.3. No difference in gastric histology was observed in both groups. BR extract was well tolerated with few adverse events. These effects were associated with acute phase reactants reduction. <b><i>Conclusions:</i></b> BR extract represents an effective and safe alternative to manage dyspepsia symptoms in FD patients.