Multi-centric clinical study of the effect of intervention time on efficacy of gastroparesis external application prescription treatment of gastrointestinal tumor postsurgical gastroparesis

Abstract

Objective: This intervention has been shown to be clinically efficacious and safe. The aim of this study was to determine the effect of different intervention times on the efficacy of gastroparesis external application prescription versus placebo for the treatment of gastrointestinal tumor postoperative, postsurgical gastroparesis. Methods: A multicenter, randomized, double-blind, placebo controlled phase III clinical trial was designed to demonstrate superiority and conducted at four grade 3A hospitals in Beijing. Patients diagnosed with gastrointestinal tumor postsurgical gastroparesis and local cold syndrome in the abdomen were enrolled and received conventional treatment (nutritional support, gastrointestinal decompression, and prokinetic medication). Treatment and control groups respectively received gastroparesis external application prescription or placebo acupoint application over a treatment course of 14 days or until the primary efficacy endpoint (clinical efficiency) was achieved. Results: A total of 120 patients were enrolled in the treatment and control groups (n = 60 per group), and 15 patients dropped out of the study because of skin allergies (n = 7) or poor efficacy (n = 8). The efficacy among patients in Class B of Group A(treatment group) was marginally better than that of Group B (control group) (64.28% vs. 55.56%) although the difference between the two groups was not significant. However, the efficacy among patients in Class C of Group A was significantly better than that of Group B (79.49% vs. 43.33%). For Group A, the time for patients in the three classes to achieve the efficacy endpoint increased significantly with disease progression (3.00, 6.78, and 8.29 days for Class A, B, and C, respectively). Conclusions: Gastroparesis external application prescription can effectively treat gastrointestinal tumor postsurgical gastroparesis and may be more efficacious in progressive disease compared placebo. Patients with gastrointestinal tumor postsurgical gastroparesis should therefore undergo intervention at an earlier stage.

Keywords

• Postsurgical gastroparesis
• Traditional Chinese medicine
• Acupoint application
• Intervention time