A clinical-controlled trial compared carom caraway (black cumin, Niggella sativa) and metoclopramide in functional dyspepsia

摘要

The treatment of patients with functional dyspepsia remains unsatisfactory. We assessed the efficacy of carom caraway (black cumin) in comparison with metoclopramide, in patients with functional dyspepsia. Outpatients who were considered functional dyspepsia (Rom II criteria) were eligible for the trial. Dyspeptic symptoms had to be present for at least 12 weeks within the preceding 12 months, without any identifiable structural disease and GERD on endoscopy. TheHelicobacter pylori infection had been ruled out by ELISA (Enzyme-linked immunosorbent assay) antibody and urea breath test (UBT). Patients were randomly separated into two groups with block design. The study medication was packaged identically. We used 10 grades visual analog scale to assess the severity of dyspeptic symptoms before and after a two-week treatment. We used SPSS 13 software for analyzing the data, estimated odds ratio and its 95% CI, the P value (0.05) were statistically estimated significant. 160 eligible patients were recruited, 80 in each group, 36 (45%) males in cumin and 33 (41.25%) males in metoclopramide group respectively. the mean age in the cumin group was 38.56 (SD=13.65) and in metoclopramide group, it was 36.41 (SD=12.15). The visual analog scale assessment of symptoms in pre and post treatment is shown in given. Dyspeptic symptoms in two groups after dichotomous variable changes were compared. We conclude that carom caraway has effects of similar magnitude on metoclopramide to control the symptoms of functional dyspepsia, and encourages safety profiles.