Comparison of efficacy and safety of two doses of two different polyethylene glycol-based laxatives in the treatment of constipation.
OBJECTIVE
To compare standard and maximum daily doses of polyethylene glycol 3350 plus electrolytes (Transipeg) and polyethylene glycol 4000 (Forlax) in a multicentre, double-blind, randomized, parallel-group study.


METHODS
Ambulatory patients with idiopathic chronic constipation were randomized to receive Forlax (10 or 20 g) or Transipeg (5.9 or 11.8 g) for 1 month. The primary efficacy end-point was stool frequency. Secondary efficacy parameters included stool consistency, date of occurrence of first motion, straining on defecation, rectal evacuation, abdominal pain and distension. Adverse events were recorded.


RESULTS
Stool frequency was significantly increased compared with baseline in all treatment groups (P = 0.0001). Most patients (> or = 67.3%) had their first stool within 1 day of starting treatment. Stool consistency significantly improved compared with baseline in all treatment groups (P = 0.0001). The percentage of patients with normal stool consistency was significantly higher for standard-dose Transipeg vs. both maximum-dose treatments (P < 0.01). Other secondary parameters were also significantly improved compared with baseline in all treatment groups (P = 0.0001). All medications were well tolerated.


CONCLUSIONS
Standard-dose Transipeg (5.9 g) normalized stool consistency with less semi-liquid or liquid stools than maximum-dose Transipeg and Forlax, with a non-significant trend towards less semi-liquid or liquid stools than standard-dose Forlax.
Chaussade
S
S
Department for Hepatogastroenterology, Hôpital Cochin, Pavillon Achard, 27 rue du faubourg Saint Jacques, 75679 Paris cedex 14, France. chaussade.s@wanadoo.fr
Minić
M
M
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D002400:Cathartics / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; D003248:Constipation / Q000188:drug therapy*; D004311:Double-Blind Method; D004573:Electrolytes / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome
D002400:Cathartics; D004573:Electrolytes; D011092:Polyethylene Glycols