Abdominal pain, cramping or discomfort impairs quality of life in women: An internet-based observational pilot study focussing on impact of treatment.

Background Abdominal pain, cramping, and discomfort (APCD) are experienced by up to 30 % of adults in Europe. Objective To assess the impact of APCD on quality of life (QoL) and to investigate the effectiveness, tolerability, and impact on QoL of hyoscine butylbromide (HBB, Buscopan®) compared with STW 5 (Iberogast®) or analgesics in women with APCD. Methods An internet-based observational pilot study was conducted in Germany in women who had predominantly used HBB, STW 5, or analgesics (n = 240 per treatment) to treat APCD. This online survey included questions on QoL, effectiveness, and tolerability. Results A total of 720 completed questionnaires was evaluated. APCD had a major impact on QoL, with 96 % of women reporting that daily activities were disrupted at least sometimes, and 44 % at least often. Other aspects of QoL, such as quality of work, eating habits, and social activities, were also affected in most women. After taking their medication of choice, 91 % of women in the HBB group reported they could "very often" or "often" continue with their daily activities, compared with 84 % and 85 % in the STW 5 and analgesic groups, respectively (p < 0.05 for both comparisons). HBB was perceived to be the "best solution" to overcome APCD symptoms "very often" or "often" by more women (86 %) than STW 5 (75 %) and analgesics (74 %) (p < 0.05 for both comparisons). Conclusion Women with APCD have impaired QoL. All treatments were considered effective by the majority of participants. Compared with STW 5 or analgesics, HBB was reported to facilitate return to daily activities more frequently.

Btk inhibition treats TLR7/IFN driven murine lupus.

Bruton's tyrosine kinase (Btk) is expressed in a variety of immune cells and previous work has demonstrated that blocking Btk is a promising strategy for treating autoimmune diseases. Herein, we utilized a tool Btk inhibitor, M7583, to determine the therapeutic efficacy of Btk inhibition in two mouse lupus models driven by TLR7 activation and type I interferon. In BXSB-Yaa lupus mice, Btk inhibition reduced autoantibodies, nephritis, and mortality. In the pristane-induced DBA/1 lupus model, Btk inhibition suppressed arthritis, but autoantibodies and the IFN gene signature were not significantly affected; suggesting efficacy was mediated through inhibition of Fc receptors. In vitro studies using primary human macrophages revealed that Btk inhibition can block activation by immune complexes and TLR7 which contributes to tissue damage in SLE. Overall, our results provide translational insight into how Btk inhibition may provide benefit to a variety of SLE patients by affecting both BCR and FcR signaling.

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 > or =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.