Lubiprostone in the treatment of chronic idiopathic constipation: an update on health-related quality of life and patient-reported outcomes

Figures & data

Table 1 Summary of evidence from RCT for SBM, disease-specific QOL, global QOL, GI symptoms (discomfort and bloating), and common adverse events

Reference study	Study design	Number (n)	Study duration	Dosage/day	SBM within 24 and/or 48 hours	SBM/week	Disease- specific QOL	Global QOL	Abdominal discomfort severity score (0–4)	Bloating severity score (0–4)	Common adverse events
Johanson and Ueno, 2007^Citation14	DB-RCT, parallel group, placebo controlled	129	3 weeks	24 μg 48 μg 72 μg placebo	Higher 44.8% 59.4% 63.6% 27.3% P=0.008	Higher Week 1 (P=0.006) Week 2 (P=0.014) Week 3 (P=0.046)	N/A	N/A	No significant difference	1.4 (72 μg) vs 1.9 (placebo) (P=0.006)	Nausea (n=33) Diarrhea (n=10)
Johanson et al, 2008^Citation15	Multicenter, DB- RCT, parallel group, placebo controlled	242	4 weeks	48 μg	Higher 56.7% vs 36.9% P=0.0024	(5.59–6.02) vs (3.5–3.7) P<0.002	N/A	N/A	1.23 vs 1.52 P<0.045	1.49 vs 1.75 P<0.031	Nausea (n=38) Headache (n=14)
Barish et al, 2010^Citation13	Multicenter, Phase 3, DB-RCT, parallel group, placebo controlled	237	4 weeks	48 μg	Higher 61.3% vs 31.4% P<0.001	Mean SBM/week 5.89 vs 3.99 P<0.001	N/A	N/A	No significant difference	1.71 vs 1.44 P=0.03 (only significant for week 1)	Nausea (n=25) Abdominal pain (n=8) Flatulence (n=7)
Fukudo et al, 2011^Citation17	Multicenter, Phase 2, DB-RCT, parallel group, placebo controlled	170	2 weeks	Placebo 16 μg 32 μg 48 μg	Higher 57.1% 73.2% 74.4.% 97.7% (P<0.0001 at 48 hours only)	Higher 1.5 2.3 3.5 6.8 (CIC only P<0.0001)	No significant difference	No significant difference	N/A	N/A	Diarrhea (n=12) Nausea (n=10)
Fukudo et al, 2015^Citation16 Study 1 and 2	Multicenter Phase 3, DB-RCT, parallel group, placebo controlled 48-week observational	124	4 weeks	48 μg 24 μg	Higher 58.1% vs 30.6% P<0.04	Higher 3.7 vs 1.3 P<0.01 (at the end of week 1)	Improved P<0.0001	Improved in some domains onlya	N/A	N/A	Diarrhea (n=9) Nausea (n=9)

Note:

a Domains included bodily pain, physical function, general health, role emotional, and vitality (at 24 weeks only).

Abbreviations: DB-RCT, double-blind randomized controlled trial; GI, gastrointestinal; N/A, not applicable; SBM, spontaneous bowel movements QOL, quality of life.

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