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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 World+J+Gastrointest+Pharmacol+Ther
2016 ; 7
(2
): 274-82
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Polyethylene glycol 3350 in occasional constipation: A one-week, randomized,
placebo-controlled, double-blind trial
#MMPMID27158544
McGraw T
World J Gastrointest Pharmacol Ther
2016[May]; 7
(2
): 274-82
PMID27158544
show ga
AIM: To evaluate the efficacy and safety of polyethylene glycol (PEG) 3350 in
subjects with self-reported occasional constipation. METHODS: Eligible subjects ?
17 years of age were randomized to receive either placebo or PEG 3350 17 g once
daily in this multicenter, double-blind trial. Evaluations were conducted before
(baseline) and after a 7-d treatment period. The primary efficacy variable was
the proportion of subjects reporting complete resolution of straining and hard or
lumpy stools. Secondary efficacy variables assessed the severity of the subjects'
daily bowel movement (BM) symptoms, and preference of laxatives based on diary
entries, visual analog scale scores, and questionnaires. RESULTS: Of the 203
subjects enrolled in the study, 11 had major protocol violations. Complete
resolution was noted by 36/98 (36.7%) subjects in the PEG 3350 group and 23/94
(24.5%) in the placebo group (P = 0.0595). The number of complete BMs without
straining or lumpy stools was similar between both groups. Subjects receiving PEG
3350 experienced significant relief in straining and reduction in hardness of
stools over a 7-d period (P < 0.0001). Subjects reported that PEG 3350 had a
better effect on their daily lives, provided better control over a BM, better
relief from constipation, cramping, and bloating, and was their preferred
laxative. Adverse events (AEs) were balanced between the PEG 3350 and the placebo
groups. No deaths, serious AEs, or discontinuations due to AEs were reported.
This trial is registered at clinicaltrials.gov as NCT00770432. CONCLUSION: Oral
administration of 17 g PEG 3350 once daily for a week is effective, safe, and
well tolerated in subjects with occasional constipation.