Effect of Xiangbin Prescription in Gastrointestinal Function After Gynecological Abdominal Surgery: a Randomized Controlled Trial

Abstract Background: Recovery of gastrointestinal function after gynecological abdominal surgery is a major clinical problem. An effective intervention to promote the rapid recovery of gastrointestinal function postoperatively is lacking. This randomized trial investigated whether Xiangbin prescription (XBP) was feasible in terms of efficacy and safety on gastrointestinal function recovery in patients after gynecological abdominal surgery. Methods: A randomized controlled study was conducted, in which 190 patients with gynecological abdominal surgery who met the inclusion and exclusion criteria were enrolled. They were assigned randomly to XBP group, chewing gum group or blank control group, and respectively received the following treatments: took the XBP twice a day, chewed a piece of gum for about 15 minutes each 4 hours, or received conventional western basic treatment, starting on postoperative day 1 until defecation. Three groups were compared in terms of primary outcomes including the time of the first defecation and the time of the first flatus and secondary outcomes including the level of Ghrelin (GHRL) and the incidence of postoperative complications. Meanwhile, the safety of this trial was evaluated. Results: There was no statistical difference in baseline characteristics among the three groups. For the time of the first flatus, XBP group (22.33 ± 6.68 h) showed less time compared with the chewing gum group (23.06 ± 7.37 h), while it was shorter than that in the blank control group (25.86 ± 7.93 h) with significant difference (P < 0.05). As for the time of the first defecation, XBP group (38.65 ± 12.96 h) showed shorter time significantly compared with both the chewing gum group (47.29 ± 14.50 h) and the blank control group (54.01 ± 20.32 h) (P < 0.05). For the postoperative GHRL levels, XBP group was higher than that in the chewing gum group with no significant difference and had more significant improvement of the GHRL levels at postoperative day 3 compared with the blank control group (P < 0.05). For postoperative complications, XBP group had lower incidence than the other two groups but with no significant difference. For safety evaluations, no serious adverse events occurred in the three groups. Conclusions: XBP could promote the recovery of gastrointestinal function after gynecological abdominal surgery and it is overall safe. Trial registration: This trial was retrospectively registered by Chinese Clinical Trial Registry with the identifier number, ChiCTR1900026327, at September 30, 2019. http://www.chictr.org.cn/.