Antipsychotic Drug

Antipsychotic medications are widely used to treat schizophrenia but may cause constipation, which can lead to abdominal discomfort, reduced quality of life, and poor treatment adherence. Xingqi Daozhi Decoction is a traditional Chinese medicine formula used to relieve constipation associated with qi stagnation. This study aims to evaluate the effectiveness and safety of Xingqi Daozhi Decoction for antipsychotic-induced constipation with a qi stagnation pattern. This is a single-center, randomized, double-blind, placebo-controlled exploratory study. A total of 46 participants with schizophrenia who developed constipation after taking antipsychotic medications will be enrolled. Participants will be randomly assigned to receive either Xingqi Daozhi Decoction granules or matching placebo granules twice daily for 8 weeks. Neither the participants nor the treating clinicians and outcome assessors will know the treatment assignment during the study. Participants will be evaluated regularly during treatment. The study will assess changes in bowel movements, constipation symptoms, constipation-related quality of life, and treatment safety. Participants will also undergo routine clinical and laboratory safety assessments, and adverse events will be recorded throughout the study. The primary outcome focuses on the proportion of participants who achieve an improvement in complete spontaneous bowel movements during treatment.

Functional dyspepsia (FD) is a common gastrointestinal disease, which is associated with decreased life quality and increased medical cost. Antipsychotic drugs were demonstrated to be effective in relieving symptoms in FD patients, especially for patients with refractory FD. However, the use of those drugs was associated with obvious adverse events. Cognitive behavioral therapy (CBT) has extensive applications and exhibited potential treatment effects in clinical practices, especially for treating anxiety, depression, pain or stress disorders. Several previous RCT studies have confirmed the effects of psychological intervention on improving dyspepsia in FD patients. Our hypothesis was that 8-week smartphone-based CBT would be non-inferior to conventional pharmacotherapy in reducing FD-related symptoms in patients with refactory FD.