Jean-Michel Vix

Efficacy and safety of bisacodyl in the acute treatment of constipation: a double‐blind, randomized, placebo‐controlled study

Although laxatives are a first‐line treatment for constipation, there are few randomized placebo‐controlled trials assessing their efficacy.

Comparison of bisacodyl and sodium picosulphate in the treatment of chronic constipation

ABSTRACT Background: Chronic constipation is a widespread condition. Although laxatives are generally accepted as being effective treatments, few studies have made formal comparisons of their efficacy and safety in chronic use. Objective: To compare the safety and efficacy of bisacodyl and sodium picosulphate in the treatment of chronic constipation over a 4-week period. Methods: Patients with chronic constipation (N = 144), recruited from out-patient clinics, were analysed for safety and efficacy in this open-label, randomised, parallel-group study. Patients were treated daily for 4 weeks (bisacodyl, 5–10 mg daily: 70 patients; sodium picosulphate, 5–10 mg daily: 74 patients). Primary efficacy criteria consisted of the number of bowel movements and stool consistency. Secondary efficacy criteria were straining at stool and physicians’ global efficacy assessment. Safety assessments included adverse event monitoring, tolerability and changes in laboratory parameters. Results: Both treatments were equally effective in treating chronic constipation, providing sustained improvement in symptoms. Compared to baseline, there were significant ( p < 0.001) improvements in stool frequency and consistency and in the occurrence of straining at 14 and 28 days for both treatment groups. Based on the physicians’ global assessment, a significant improvement was observed in 74.6% (bisacodyl) and 79.2% (sodium picosulphate) of patients. Neither treatment had significant effects on serum electrolytes. There was a trend for better tolerability in patients receiving bisacodyl treatment based on the number of drug-related adverse events (bisacodyl: 7; sodium picosulphate: 14, two patients withdrawn). Conclusions: Bisacodyl and sodium picosulphate are equally well tolerated and effective in the treatment of chronic constipation over a 4-week period.

Randomised, placebo-controlled, double-blind study to investigate the efficacy and safety of the acute use of sodium picosulphate in patients with chronic constipation.

There are few studies supporting the effective and safe use of laxatives for constipation. This study examined the short‐term efficacy and safety of sodium picosulphate in patients with chronic constipation. Patients with a history of chronic constipation for at least 3 months were randomised to receive 7 mg sodium picosulphate or placebo for three consecutive nights. Patients recorded stool frequency and consistency, straining, bloating, and pain at baseline and during treatment. Vital signs, haematocrit, serum creatinine and electrolytes were monitored. Primary end‐point for efficacy was the occurrence of a response to treatment, defined as improvement in stool frequency and occurrence of straining. All 57 randomised patients (sodium picosulphate n = 29, placebo n = 28; mean age 54.8 and 54.1 years) completed the study. Sodium picosulphate produced a treatment response (improved stool frequency and straining) in 82.8% compared with 50% in the placebo group (p = 0.010) and reduced bloating more often than placebo. There were no serious adverse events and one patient with diarrhoea and another with abdominal pain in each treatment group. There were no cardiovascular effects, changes in serum haematocrit, creatinine or electrolytes in either group. This study confirmed that sodium picosulphate is an effective, well‐tolerated and safe laxative in the acute treatment of constipation.