Lack of Lasting Effectiveness of PEG 3350 Laxative Treatment of Constipation

Abstract

PEG 3350 (MiraLax, Braintree Laboratories Inc., Braintree, MA) 17 g daily has been shown to be safe and effective in a 14-day trial for constipation. This present investigation was designed to extend the treatment and safety experience with PEG 3350 and to evaluate any lasting effectiveness during a 30-day post-treatment observation period. Study subjects met Rome II criteria for constipation and reported <3 bowel movements a week. They were treated with PEG 3350 17 g daily for 14 days. Treatment efficacy was defined by resolution of constipation symptoms as determined by the Rome II and stool frequency definitions during the treatment period. Fifty healthy constipated subjects formed the study group. There were 42 females and 8 males. Mean age was 52 +/- 15.5 years (+/-SD). Symptom duration was 22.6 +/- 16.7 months (+/-SD). At baseline, all had <3 bowel movements a week and met Rome II criteria. Two were lost to follow-up. Two took enemas or laxatives and 2 discontinued active treatment because of "gas" and were considered treatment failures. At the end of 14 days, 40 of 48 (83.3%) had >3 stools in the last week and no longer met Rome criteria. Thirty-two of 45 (71.1%) reported satisfaction with the first bowel movement after initiating treatment. Thirty days after active treatment, 29 of 47 (61.7%) responded that they needed laxative treatment. PEG 3350 relieved constipation in most treated study subjects. During a 30-day post-treatment observation period, 29 of 47 (61.7%) had additional constipation treatment interventions.