OBJECTIVE: The objective of this study was to determine the efficacy of Go-rei-San (GRS), a Kampo medicine, in the treatment of postoperative nausea, vomiting, or both nausea and vomiting (PONV). DESIGN: The study was a randomized, controlled, single-blind study of two groups of adult female patients who were scheduled to undergo benign gynecological laparoscopic surgery under general anesthesia. Patients in each group possessed an American Society of Anesthesiologists physical status of 1 (normal, healthy patient) to 2 (patient with a mild systemic disease). Patients were randomly assigned to the GRS group or the no-intervention group. INTERVENTION: Patients in the GRS group were given 7.5 g of GRS orally the day before surgery. OUTCOME MEASURES: The primary outcome measure was the severity of nausea at 0-3 h and 0-24 h after tracheal extubation. The secondary outcome measures were the incidence of vomiting at 0-3 h and 0-24 h and the frequency of vomiting at 0-24 h. The severity of nausea was measured by the patient, who used an 11-point verbal scale to indicate her strongest nausea. RESULTS: Of the 100 female patients selected for the study, 99 completed the trial, and no adverse events occurred. The severity of nausea, frequency of vomiting, and incidence of vomiting were significantly lower in the GRS group than in the no-intervention group. CONCLUSIONS: This study suggests that GRS may be effective for the reduction of PONV.
RCT Entities:
OBJECTIVE: The objective of this study was to determine the efficacy of Go-rei-San (GRS), a Kampo medicine, in the treatment of postoperative nausea, vomiting, or both nausea and vomiting (PONV). DESIGN: The study was a randomized, controlled, single-blind study of two groups of adult female patients who were scheduled to undergo benign gynecological laparoscopic surgery under general anesthesia. Patients in each group possessed an American Society of Anesthesiologists physical status of 1 (normal, healthy patient) to 2 (patient with a mild systemic disease). Patients were randomly assigned to the GRS group or the no-intervention group. INTERVENTION: Patients in the GRS group were given 7.5 g of GRS orally the day before surgery. OUTCOME MEASURES: The primary outcome measure was the severity of nausea at 0-3 h and 0-24 h after tracheal extubation. The secondary outcome measures were the incidence of vomiting at 0-3 h and 0-24 h and the frequency of vomiting at 0-24 h. The severity of nausea was measured by the patient, who used an 11-point verbal scale to indicate her strongest nausea. RESULTS: Of the 100 female patients selected for the study, 99 completed the trial, and no adverse events occurred. The severity of nausea, frequency of vomiting, and incidence of vomiting were significantly lower in the GRS group than in the no-intervention group. CONCLUSIONS: This study suggests that GRS may be effective for the reduction of PONV.