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Table 4 Safety and tolerability of polyethylene glycols from the individual studies

From: Comparison of the effectiveness of polyethylene glycol with and without electrolytes in constipation: a systematic review and network meta-analysis

Study Type of polyethylene glycol Comparator Safety signals (Laboratory data, vital signs) Tolerability (Adverse events)
Andorsky RI 1990 [12] PEG3350 + E Placebo NA Adverse events with PEG + E were infrequent and generally tolerable and included; cramping, gas, nausea, loose stools, and unpleasant taste.
Attar A 1999 [13] PEG3350 + E Lactulose No significant changes in laboratory measurements; except for 1 case of mild hypokalaemia with concurrent diuretics. In the 2 month open label extension study, lower mean serum folate levels, but all values were within the normal range. No differences in tolerability between the two groups, but flatus was less frequently reported with PEG + E. 2 adverse events leading to PEG + E withdrawal; acute diarrhoea with vomiting and fever; and abdominal pain. Additional 4 adverse events leading to drug withdrawal in the extension study; acute diarrhoea with fever (1), abdominal pain (2); vomiting (1).
Awad RA 2010 [14] PEG3350 Placebo NA No difference in tolerability of PEG vs placebo. 1 case of abdominal pain with PEG.
Bouhnik Y 2004 [15] PEG4000 Lactulose NA No serious adverse events were reported. 3 PEG patients discontinued therapy due to adverse events; abdominal pain or abdominal distension.
Chapman RW 2013 [16] PEG3350 + E Placebo NA More patients taking PEG 3350 + E experienced adverse events compared to placebo (38.8 % vs 32.9 %). No serious adverse events. The most common drug-related adverse events (>3 %); abdominal pain (4.5 %), diarrhoea (4.5 %). 2 patients discontinued PEG + E due to adverse events; abdominal rigidity (1), flatulence and abdominal pain (1).
Chaussade S 2003 [17] PEG3350 + E and PEG4000 PEG4000 No clinical issues reported. No differences in tolerability. Common GI adverse events; dose-related diarrhoea, distention, flatulence, abdominal pain.
Cinca R 2013 [18] PEG3350 + E Prucalopride No clinically significant differences in laboratory measurements, vital signs or ECG. 68.3 % of patients taking PEG + E experienced a treatment-emergent adverse event, mostly mild-moderate intensity. 5.3 % of the events were possibly or probably related to PEG + E. Events included; headache (36.7 %), nausea (5.8 %), vomiting (2.5 %) and abdominal pain (2.5 %), UTI (3.3 %). Adverse event were generally more common with prucalopride.
Cleveland MV 2001 [19] PEG3350 Placebo No clinically significant differences in blood chemistry, CBC, or urinalysis. No serious adverse events. Three cases of loose stools or mild diarrhoea with PEG.
Corazziari E 1996 [20] PEG4000 + E Placebo NA No difference in tolerability of PEG + E vs placebo.
Corazziari E 2000 [21] PEG4000 + E Placebo No significant changes in heart frequency, blood pressure, blood count or laboratory measurements. No difference in tolerability of PEG + E vs placebo. 2 discontinuations due to adverse events; abdominal bloating and fissura in the anus. Most common adverse events were nausea and epigastric pain/discomfort.
Di Palma JA 1999 [22] PEG3350 Placebo No clinically significant changes in laboratory measurements. Ambulatory care patients: dose-related diarrhoea or loose stools. Long-term care patients: 5 serious adverse events, but all were due to pre-existing conditions and not PEG use.
Di Palma JA 2000 [23] PEG3350 Placebo No statistically or clinically significant differences in laboratory measurements. No difference in tolerability of PEG vs placebo.
Di Palma JA 2007A [24] PEG3350 Placebo No clinically significant changes in vital signs, physical examination, weight, or laboratory measurements. No statistical difference in tolerability of PEG vs placebo.
Di Palma JA 2007B [25] PEG3350 Placebo No clinically significant changes in laboratory measurements. No differences in adverse events between PEG and placebo except for gastrointestinal complaints (PEG 39.7 %, placebo 25 %, P = 0.015). GI events included abdominal distension, diarrhoea, loose stools, flatulence, and nausea. Most events were mild or moderate. No difference in tolerability of PEG + E vs placebo amongst elderly patients.
Di Palma JA 2007C [26] PEG3350 Tegaserod NA No serious adverse events. Adverse events (>3 %) with PEG were; GI (30.8 %), diarrhoea (20 %) and nausea (5.2 %).
Freedman MD 1997 [27] PEG3350 + E Placebo Lactulose NA No difference in frequency of gas or severe cramping with PEG + E vs control.
Klauser AG 1995 [28] PEG4000 Placebo NA NA
Seinela L 2009 [29] PEG4000 + E and PEG4000 PEG4000 Small, but not clinically relevant changes in plasma sodium level; PEG mean decrease from 138.8 to 137.7 mmol/L; PEG + E mean increase from 138.6 to 138.9 mmol/L (P = 0.012). No other significant differences between the groups in any of the other electrolyte or laboratory safety variables, or in heart rate, blood pressure or weight. Low incidence of mild to moderate adverse events in both groups. Four serious adverse events with PEG + E; 1 leading to discontinuation of PEG + E, but none with PEG.
Wang H 2005 [30] PEG3350 + E Isphagula husk No change in mean sodium, potassium or chloride ion levels. No differences in adverse events between PEG + E and isphagula husk. No serious events. Most common adverse event for PEG + E was dizziness (5 %).
Zangaglia R 2007 [31] PEG4000 + E Placebo No clinically significant changes in haematology, serum biochemistry, or urinalysis. A higher rate of withdrawals with PEG + E vs placebo (31 % vs. 18 %). 4 drug-related discontinuations were due to nausea, diarrhoea, poor treatment compliance due to the taste or volume of preparation.
  1. NA No applicable data reported, AM Ambulatory healthy outpatients, LT Long term