Stefan A. Mueller-Lissner

Multicenter, 4-Week, Double-Blind, Randomized, Placebo-Controlled Trial of Sodium Picosulfate in Patients With Chronic Constipation

OBJECTIVES:Although it has been used as a laxative for many years, high-quality trials assessing the efficacy of the laxative sodium picosulfate (SPS) are lacking. The purpose of this study was to assess the efficacy and safety of 4-week treatment with SPS in patients with functional constipation as defined by the Rome III diagnostic criteria.METHODS:This study was a randomized, double-blind, placebo-controlled, parallel-group study in 45 general practices in Germany. A total of 468 patients with chronic constipation presenting to their general practitioner and fulfilling the Rome III diagnostic criteria were screened. After a 2-week baseline period, 367 patients were randomized to either SPS drops or matching placebo in a 2:1 ratio for 4 weeks. Dose titration was permitted throughout treatment. Patients without a bowel movement for more than 72 h were allowed to use a “rescue” bisacodyl suppository. The primary end point was the mean number of complete spontaneous bowel movements (CSBMs) per week. A spontaneous bowel movement (SBM) was defined as a stool not induced by rescue medication, whereas a CSBM was defined as an SBM associated with a sensation of complete evacuation.RESULTS:The mean number (±s.e.) of CSBMs per week increased from 0.9±0.1 to 3.4±0.2 in the SPS group and from 1.1±0.1 to 1.7±0.1 in the placebo group (P<0.0001). The percentage of patients reaching an increase of ≥1 in the mean number of CSBMs per week compared to baseline was 65.5% vs. 32.3%, respectively (P<0.0001). The percentage of patients reaching a mean number of at least three CSBMs per week was 51.1% in the SPS group and 18.0% in the placebo group (P<0.0001). After 24 h, approximately 69% of patients in the SPS group and 53% in the placebo group had their first SBM. The SPS dose was titrated down during the study by nearly 50% of patients. Assessment of quality of life (QoL) by the constipation-related Patient Assessment of Constipation (PAC)-QoL questionnaire showed significant improvement in SPS-treated patients compared to the placebo group.CONCLUSIONS:Treatment of chronic constipation with SPS improves bowel function, symptoms, and QoL and is well tolerated. The dose can be adjusted individually while maintaining benefit.

Survey of laxative use by adults with self-defined constipation in South America and Asia: a comparison of six countries

Background  In contrast to the US and Europe, prevalence and laxative use for self‐defined constipation among adults was previously reported to be unassociated with age among adults in South Korea and Brazil.

Characteristics of Acute Pain Attacks in Patients With Irritable Bowel Syndrome Meeting Rome III Criteria

OBJECTIVES:An international multicenter, prospective, non-interventional, 2-month study characterized acute pain attacks in patients with irritable bowel syndrome (IBS).METHODS:Adult patients meeting the Rome III IBS diagnostic criteria with a history of ≥3 pain attacks per month participated in a survey that captured daily and episodic information regarding IBS symptoms and pain attacks for 2 months. Acute pain attacks were defined as a sudden onset or increase in the intensity of IBS abdominal pain with a minimum intensity of 4 (0–10 scale).RESULTS:The majority (84%) of the 158 patients taking the survey were women with a mean age of 41 years and time since IBS diagnosis of 5 years. The median pain attack frequency was 5.4 attacks per month and was significantly higher in the IBS with diarrhea (IBS-D, 6.4 per month) group vs. the IBS with constipation (4.4 per month) and the IBS with mixed pattern (5.5 per month) groups (P=0.019). The median pain attack duration was 2.8 h and the median intensity score was 7. The majority of pain attacks resulted in defecation (78%), and occurred more often in IBS-D patients than in other subgroups. The majority of pain attacks (63%) interfered with work and/or daily activities. Medication to manage pain attacks was used by 44% of patients during 29% of attacks. Although used by less than half of all patients, medication helped 66% of attacks treated.CONCLUSIONS:The frequency of severe pain attacks was 1.4 per week and the majority affected daily activities. However, most of the pain attacks were untreated in IBS patients. Pain attack management is an unmet need of IBS treatment.