Pregnancy Complications, Infectious , Sexually Transmitted Diseases , Syphilis, Congenital , Syphilis , Female , Humans , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/epidemiology , Syphilis/diagnosis , Syphilis/epidemiology , Syphilis, Congenital/diagnosis , Syphilis, Congenital/prevention & control
PURPOSE: This randomized double-blind, double-dummy, 2-treatment, 2-period crossover study aimed to compare the efficacy and tolerability of polyethylene glycol (PEG) and sennosides in ambulatory cancer patients with opioid-induced constipation. METHODS: Outpatients ≥ 18 years old with cancer, at risk of or already experiencing opioid-induced constipation, were randomly assigned to begin a standard bowel protocol of escalating doses of sennosides or PEG, plus a dummy preparation. After 3 weeks, the patients switched to the alternate active product and dummy preparation. Constipation was assessed using the revised Victoria Bowel Performance Scale (rBPS) at the end of each of the 2 consecutive 21-day study periods for the number of days with a satisfactory bowel movement, the time in days to goal rBPS (G), and the treatment preference of each patient. RESULTS: Seventy patients were recruited, with 42 completing their first treatment period and 28 completing both treatment periods. For the typical patient, the expected number of days with a satisfactory bowel movement per days of treatment was found to be 1.21 times higher on PEG than on sennosides in a particular period (95% credible interval 0.96 to 1.55). Patients taking PEG were 1.47 times more likely to reach a rBPS of G before patients taking sennosides in the first period (95% confidence interval 0.74 to 2.94). There was no evidence of a difference in patient preference between laxatives. CONCLUSION: Our study found weak evidence that PEG is superior to sennosides with respect to overall effectiveness in cancer patients with opioid-induced constipation.
Neoplasms/drug therapy , Opioid-Induced Constipation/drug therapy , Polyethylene Glycols/therapeutic use , Sennosides/therapeutic use , Adult , Aged , Aged, 80 and over , Analgesics, Opioid/adverse effects , Cancer Pain/drug therapy , Cross-Over Studies , Defecation/drug effects , Double-Blind Method , Female , Humans , Laxatives/therapeutic use , Male , Middle Aged , Patient Preference , Treatment Outcome , Young Adult