Clinical efficacy of prucalopride in the treatment of severe chronic constipation

Abstract

Objective To investigate the clinical efficacy of prucalopride in the treatment of severe chronic constipation. Methods The clinical data of 60 patients with severe chronic constipation [slow transit constipation (STC), functional defecation disorder (FDD) and constipation-predominant irritable bowel syndrome (IBS-C)] who were admitted to the Third Affiliated Hospital of Nanjing University of Chinese Medicine from February to August 2014 were prospectively analyzed. A prospective, clinical observational study was performed. Treatment plans included that patients withdrew the initial treatments of laxative and exema and took orally 2 mg prucalopride once daily for 2 weeks, and continued to be treated by oral prucalopride if frequency of the spontaneous complete bowel movement (SCBM) per week was satisfactory (or improvement of symptoms was more than 50%) till 4 weeks, and then were followed up after stopping prucalopride. If improvement of symptoms was less than 50% after 2-week treatment, other treatment plans were performed according to symptoms of patients from week 3 to week 6: (1)for patients with STC, prucalopride+ two chain bacillus subtilis probiotic capsules were administered orally if patients were satisfied with frequency of SCBM per week and without improvement of abdominal distension; prucalopride+ Chinese herb decoction were administered orally if patients had improvement of frequency of SCBM per week with abdominal distension or poor stool output; oral prucalopride+ acupuncture were administered if patients were unsatisfied with frequency of SCBM per week or less bowel movements and without improvement of abdominal distension or poor stool output. (2)For patients with FDD, oral prucalopride+ acupuncture+ biofeed-back therapy were administered. (3)For patients with IBS-C, prucalopride+ two chain bacillus subtilis probiotic capsules were administered orally if patients had abdominal distension; prucalopride Chinese herb decoction were administered orally if patients had improvement of frequency of SCBM per week and no improvement of abdominal distension or poor stool output. All patients used a diary for recording the frequency of SCBM per week, stool consistence, exertion in defecation and adverse reactions, which was submitted to doctors for inputting data at the return visit weekly. Results There was good overall medicine compliance in patients. Of 60 patients, 43 patients completed treatments (21 with STC, 11 with FDD and 11 with IBS-C). After 2-week treatment, there were 19 patients with satisfied therapeutic effects, 14 with improvement of constipation and 10 with poor therapeutic effects. After 4-week treatment, constipation in 17 patients was cured, constipation in 18 patients was improved, and constipation in 8 patients was not improved. Nineteen of 60 patients were complicated with adverse reactions within 1 week of the medication, including 6 patients dropping out of the trial due to medication withdrawal and others with improvement by symptomatic treatment or spontaneous remission. Conclusions Prucalopride is effective for the treatment of severe chronic constipation with a good toleration, and it can improve the overall satisfaction of patients combined with Chinese herb decoction and acupuncture. Key words: Severe chronic constipation; Prucalopride; Slow transit constipation; Functional defecation disorder; Constipation dominant irritable bowel syndrome