Table 1.
Study | Total (N) | Length of study | Constipation type | Baseline stool frequency (SD) | Concomitant laxative use | Age mean (SD) years | Gender (% male) | Polyethylene glycol formulation and daily dose | Polyethylene glycol (N) | Comparator and daily dose | Comparator (N) |
---|---|---|---|---|---|---|---|---|---|---|---|
Andorsky RI 1990 [12] | 37 | 2 × 5 days | Chronic | 87.5 % ≤ 2 stools/week | Continued use of fibre and bulk-forming agents. Laxatives or enemas for treatment failure: P = 12.5 %, C = 18.8 % | P1: 62 | P1: 25 % | PEG3350 + E | High dose 16 | Placebo | 16 |
P2: 58 | P2: 19 % | High dose 16 oz | Low dose 16 | ||||||||
Low dose 8 oz | |||||||||||
Attar A 1999 [13] | 115 | 4 weeks | Chronic | Not specified | Suppositories, micro-enemas allowed. Any use: P = 16 %, C = 34 % | P: 55 (24) | P: 15 % | PEG3350 + E | 60 | Lactulose | 55 |
C: 55 (22) | C: 22 % | 13–39 g | 10–30 g | ||||||||
Awad RA 2010 [14] | 47 | 30 days | Irritable bowel syndrome (IBS-C) | P: 1.3 (0.6) | Not allowed. P: 1 use of glycerine suppository | P: 30.7 (8) | 12 % | PEG3350 | 23 | Placebo | 24 |
C: 1.5 (0.7) | C: 1 use of enema | C: 36.5 (10) | 10.35 g | ||||||||
Bouhnik Y 2004 [15] | 65 | 28 days | Chronic, idiopathic | 85 % < 3 stools/week | Suppositories, enemas allowed during washout, stopped 48 hours before baseline. 9 % of patients took concomitant treatment at study entry and all were stopped | 57 (18) | 14 % | PEG4000 10–30 g | 32 | Lactulose 10–30 g | 33 |
Chapman RW 2013 [16] | 139 | 28 days | Irritable bowel syndrome (IBS-C) | P: 1.28 (0.912) | Rescue medication bisacodyl if no bowel movement for 3 consecutive days. Mean No. weekly rescue doses: P = 0.30, C = 0.44 | 41.3 (14.8) | 17 % | PEG3350 + E | 68 | Placebo | 71 |
C: 1.37 (0.849) | 13.8–41.4 g | ||||||||||
Chaussade S 2003 [17] | 266 | 2 weeks | Chronic, idiopathic | P(H): 2.0 (0.9) | Rescue medication suppository if no bowel movement for 3 consecutive days. Stools post-suppository use were not included in study results | 52.2 (18.5) | 15 % | PEG3350 + E | High dose 69 | PEG4000 High dose 20 g | High dose 67 |
P(L): 2.2 (1.3) | High dose 11.8 g | Low dose 69 | Low dose 10 g | Low dose 65 | |||||||
Low dose 5.9 g | |||||||||||
C(H): 2.4 (1.7) | |||||||||||
C(L): 1.8 (1.0) | |||||||||||
Cinca R 2013 [18] | 240 | 2 weeks | Chronic | P: 0.7 (0.8) | Rescue medication ducosate micro-enema if no bowel movement for 3 consecutive days. Use of micro-enema: P = 0.8 %, C = 3.4 % | P: 40.0 (14.5) | 0 % | PEG335 0 + E | 120 | Prucalopride 1–2 mg (serotonin [5-HT4] agonist) | 116 |
C: 0.7 (0.8) | C: 40.5 (13.2) | 13.71–27.42 g | |||||||||
Cleveland MV 2001 [19] | 23 | 2 × 2 weeks | History of constipation | 2.6 (1.75) | Not allowed | 47.7 | 4 % | PEG3350 10.35 g | 23 | Placebo | 23 |
Corazziari E 1996 [20] | 55 | 4 weeks | Chronic | P: 2.2 (0.5) | Rescue medication, laxatives if no bowel movement for 5 consecutive days. Use of laxatives: P = 16 %, C = 48 % | 41.8 (14.8) | P: 32 % | PEG4000 + E 17.5 g | 25 | Placebo | 23 |
C: 1.9 (0.8) | C: 13 % | ||||||||||
Corazziari E 2000 [21] | 70 | 20 weeks | Chronic | P: 1.53 (1.35) | Rescue medication, laxatives if no bowel movement for 5 consecutive days. Use of laxatives was less frequent in PEG + E than placebo (P < 0.001) | 43 (15) | 17 % | PEG4000 + E 35 g | 33 | Placebo | 37 |
C: 1.29 (1.04) | |||||||||||
Di Palma JA 1999 [22] | AM: 50 LT 35 | 10 days | Reported constipation | Not specified | Not allowed | AM: 36.2 | AM: 6 % | PEG3350 | AM high dose: 50 | Placebo | AM: 50 |
LT: 75.7 | LT: 46 % | AM high dose: 34 g | AM low dose: 50 | LT: 17 | |||||||
AM low dose: 17 g | LT high dose: 17 | ||||||||||
LT high dose: 12 g | LT low dose: 17 | ||||||||||
LT low dose: 6 g | |||||||||||
Di Palma JA 2000 [23] | 151 | 14 days | History of constipation | Not specified | Not allowed | 45.2 | 13 % | PEG3350 17 g | 80 | Placebo | 71 |
Di Palma JA 2007A [24] | 100 | 4 Weeks | Secondary to medications | Not specified | Fibre or other laxatives not allowed | 58 | 26 % | PEG3350 17 g | 46 | Placebo | 46 |
Di Palma JA 2007B [25] | 304 | 6 months | Chronic | P: 86.5 % < 3 stools/week | Fibre not allowed. Rescue medication bisacodyl if no bowel movement for 4 consecutive days. Mean use of bisacodyl 5 mg: P = 2.8, C = 3.9 tablets/week | 53 | 15 % | PEG3350 17 g | 202 | Placebo | 100 |
C: 94.4 % < 3 stools/week | |||||||||||
Di Palma JA 2007C [26] | 237 | 28 days | Chronic | 100 % < 3 stools/week | Fibre not allowed. Rescue medication bisacodyl if no bowel movement for 4 consecutive days. Mean use of bisacodyl 5 mg: P = 1.4, C = 1.0 tablets/week | 46 | 10 % | PEG3350 17 g | 118 | Tegaserod 12 mg (serotonin [5-HT4] agonist) | 116 |
Freedman MD 1997 [27] | 57 | 3 × 2 weeks | Opioid-induced | Not specified | Additional milk of magnesia or bisacodyl allowed. No difference in use between PEG + E and lactulose | Range 18–50 | Not specified | PEG3350 + E 14 g | 57 | Placebo Lactulose 30 mL | Placebo 57 |
Lactulose 57 | |||||||||||
Klauser AG 1995 [28] | 8 | 2 × 6 weeks | Chronic | Median 3 | Sodium picosulfate was allowed except for the last week of each study period. Median drops per day: P = 0, C = 4 | 46 (4) | 0 % | PEG4000 60 g | 8 | Placebo | 8 |
Seinela L 2009 [29] | 65 | 4 weeks | Chronic functional | P: 9.3 | Continued use of Plantago ovata seeds was allowed. Rescue medication bisacodyl 10 mg suppository if no bowel movement for 3 consecutive days. Use of suppositories: PEG + E = 12.5 % | 86 | 34 % | PEG4000 + E 6–24 g | 32 | PEG4000 6–24 g | 30 |
C: 8.4 | |||||||||||
PEG = 3.3 % | |||||||||||
Wang H 2005 [30] | 126 | 2 weeks | Chronic functional | P: 1.18 (0.77) | Not allowed | P: 51. 2 (14.8) | 40 % | PEG3350 + E 27.6 g | 63 | Isphagula husk 7 g (bulk forming) | 63 |
C: 1.33 (0.68) | C: 50.0 (17.1) | ||||||||||
Zangaglia R 2007 [31] | 57 | 8 weeks | History of constipation amongst Parkinson’s Disease | P: 1.9 (0.56) | Rescue medication, rectal laxatives. Use of rectal laxatives: P = 4.3 % week 4 & 0 % week 8 | 71.0 (6.5) | 60 % | PEG4000 + E 7.3–21.9 g | 29 | Placebo | 28 |
C: 2.0 (0.6) | C = 9.5 % week 4 & 12.5 % week 8 |
P Polyethylene glycol group, C Comparator group, AM Ambulatory healthy outpatients, LT Long term, H High dose, L Low dose