The goal of this clinical trial is to learn if fluoxetine works to treat refractory constipation . It will also learn about the safety of fluoxetine. The main questions it aims to answer are: Does fluoxetine increase the number of completely spontaneous bowel movements (CSBMs) per week? What medical problems do participants have when taking fluoxetine? Does fluoxetine improve psychological symptoms such as anxiety and depression in participants with refractory constipation? Researchers will compare fluoxetine to polyethylene glycol (PEG, a commonly used laxative) to see if fluoxetine works to treat refractory constipation. Participants will: Take fluoxetine (40 mg/day) or polyethylene glycol (once daily) for 6 months. Visit the clinic at baseline, and at 1 month, 3 months, and 6 months for checkups and tests. Record their bowel movements and any changes in symptoms, including anxiety, depression, and side effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
316
Patients in the fluoxetine group received oral fluoxetine starting at 40 mg/day for six months. Treatment was discontinued if serious adverse reactions developed or if no improvement was observed after dose escalation. Compliance and treatment progress were monitored via telephone follow-ups. For patients unable to have a bowel movement for three consecutive days or experiencing intolerable symptoms, polyethylene glycol (PEG, 10 g) was provided as rescue medication. Bowel movements within 24 hours of rescue medication use were excluded from the count of complete spontaneous bowel movements (CSBM).
The control group (PEG) used polyethylene glycol as a rescue medication under the same conditions, following similar monitoring and follow-up procedures.
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
Proportion of patients with a CSBM of 3 or more per week
The primary endpoint of this study is the proportion of patients achieving a weekly frequency of three or more complete spontaneous bowel movements (CSBMs) after six months of treatment. A CSBM is defined as a bowel movement that occurs without the use of rescue medication (e.g., polyethylene glycol) within the preceding 24 hours. This endpoint aims to evaluate the efficacy of fluoxetine in improving bowel function in patients with refractory constipation as compared to the control group.
Time frame: baseline, six months after treatment
Mean number of spontaneous bowel movements (SBMs) per week
Time frame: baseline, 1 month, 3 months, 6 months
Mean number of complete spontaneous bowel movements (CSBMs) per week
Time frame: baseline, 1 month, 3 months, 6 months
Stool consistency (Bristol Stool Form Scale, BSFS, scores of 3-5)
Time frame: baseline, 1 month, 3 months, 6 months
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