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| |  Oral Sodium Picosulphate Alleviates Chronic, Functional Constipation: Presented at GASTRO 2009 (UEGW/WCOG) By Sara Freeman LONDON -- December 2, 2009 -- Sodium picosulphate (SPS) increased the number of complete spontaneous bowel movements (CSBMs) per week in patients with functional constipation to a greater extent than placebo, the results of a randomised, double-blind, multicentre study show. The results of the 4-week trial reported here on November 25 at GASTRO 2009 also show that the oral laxative is well tolerated in the treatment of chronic constipation. “This study proved the efficacy and safety of sodium picosulphate,” said study author Ulrika Hinkel, RPh, Boehringer Ingelheim GmbH, Ingelheim, Germany. She noted that although laxatives are commonly recommended as a first-line treatment for constipation, there are few studies to support their safety and efficacy. Dr. Hinkel reported the results of the 367-patient trial, stating that the primary aim was to look at the efficacy of the SPS, which was assessed as the number of CSBMs recorded by patients in a daily electronic diary. For inclusion, patients had to have chronic constipation, defined in accordance with the ROME III criteria. Following recruitment from primary care practices, eligible patients were randomised to receive treatment with SPS, given as oral drops at a dose of 10 mg/day (n = 233) or placebo (n = 134). After 4 weeks’ treatment, a significantly higher number of CSBMs were reported in the actively treated patients, increasing from 0.9 to 3.4 per week in the SPS and from 1.1 to 1.7 in the placebo group. Dr. Hinkel noted that the adjusted mean difference between the 2 treatment arms was 1.8 (P < .0001). “SPS significantly and substantially increased complete spontaneous bowel movements and overall bowel frequency in patients with chronic constipation compared to placebo,” Dr. Hinkel said. In addition, “SPS improved quality of life assessed by the PACQOL [Patient Assessment of Constipation Quality of Life Questionnaire] instrument.” Indeed, using the PACQOL, patients treated with SPS showed significantly greater improvements overall and in the following domains: Worries and concerns; Physical discomfort; Psychosocial discomfort; and Satisfaction. Adverse events reported were those already known to occur with the drug, including abdominal discomfort, abdominal pain, abdominal cramps, and diarrhoea. Dr. Hinkel observed that only 1 serious advent occurred and that was in the placebo group. She concluded that not only was the SPS “benefit maintained over the 4-week study period,” but also “treatment with SPS was well tolerated.” The study was funded by Boehringer Ingelheim. GASTRO 2009 is jointly organised by the United European Gastroenterology Federation (UEGF), the World Gastroenterology Organisation (WGO), the World Organisation of Digestive Endoscopy (OMED), and the British Society of Gastroenterology (BSG). [Presentation title: Multicenter, 4-Week, Double-Blind, Randomized, Placebo-Controlled Trial of Sodium Picosulfate in Patients With Chronic Constipation. Abstract OP455]
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