Ulrika Hinkel

A multinational survey of prevalence and patterns of laxative use among adults with self‐defined constipation

Background  While numerous studies report prevalence of constipation, use of laxatives is poorly understood.

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.

M1217 Diet and Physical Activity in Constipation Revisited - Too Little or Too Much?

capture important symptom change. To address this, we developed a daily diary version of the GCSI. The aim of this study was to compare the responses of this daily GCSI diary to the GCSI using the conventional 2 week recall period. Methods: 12 patients with confirmed delayed gastric emptying were recruited from one clinical center; 5 were diabetic, 75% women, 100% Caucasian with average age of 43.9 (SD=10.6) years (range 25 to 62 years). Patients recorded their symptoms using the daily GCSI diary over a 2 week period, and then filled the conventional GCSI using a 2 week recall period. The daily GCSI scores were compared with the 2-week recall GCSI scores. Variability over the 2 weeks was calculated as the standard deviation of the daily scores for each patient. Results: Daily variability was present in the individual symptoms, the subscores, and the daily GCSI scores. For the 12 patients, the average of the daily GCSI scores (1.4±0.9 [SD]) compared well to the 2 week recall GCSI (1.6±1.0; p>0.10). The daily variation over 2 weeks is indicated by the 0.9 SD of the individual diary patient scores. Interestingly, the 2 week recall GCSI correlated extremely well with the average daily GCSI scores over 2 weeks (r=0.931; p<0.001) and was better than the correlation of the 2 week recall GCSI with the daily diary GCSI score for the last day (r=0.785; p=0.002) when the 2 week recall GCSI was assessed. In comparing the 2 week recall versus the daily diary for the GCSI subscores, there was excellent correlation in the postprandial/early satiety subscore (r=0.956) and bloating subscore (0.945). The N/ V subscore had good correlation (r=0.890) with high correlation coefficients for the symptoms of nausea (r=0.961) and retching (r=0.961), but a lower coefficient for vomiting (r=0.633). Conclusions: The GCSI daily diary captures daily variability of gastroparetic symptoms. Even so, the conventional GCSI using a 2 week recall is well correlated with the average of the GCSI daily diary over 2 weeks. Thus, the conventional 2 week diary captures patients overall experience with their symptoms, but the daily diary can capture more rapidly occurring changes in symptoms. TheGCSI has the characteristics to be a good patient reported outcome for evaluating the effectiveness of treatments in clinical trials for gastroparesis.