Characteristics of randomised controlled trials of pharmacological therapies versus placebo in chronic idiopathic constipation
| Study | Country, and number of centres | Setting | Criteria used to define chronic idiopathic constipation | Criteria used to define response | Number of patients (% female) | Drug and dose used | Duration of therapy | Methodology |
| Miner 199932 | Not stated | Not stated | Modified Rome II criteria* | ≥3 CSBMs per week | 229 (not stated) | Prucalopride 0.5 mg, 1 mg, 2 mg, or 4 mg od | 4 weeks | Randomisation and concealment of allocation unclear, double-blind |
| Emmanuel 200233 | UK, 1 site | Tertiary care | ≤2 spontaneous bowel movements per week or straining on at least 25% of occasions, and negative investigations | Therapeutic effect rated as moderate or above by investigator | 77 (100) | Prucalopride 1 mg od | 4 weeks | Randomisation and concealment of allocation unclear, double-blind |
| Coremans 200334 | Belgium, 1 site | Tertiary care | Modified Rome II criteria and negative investigations | ≥3 stools per week, straining, hard stools, or tenesmus <25% of time | 53 (98.1) | Prucalopride 4 mg od | 4 weeks | Randomisation and concealment of allocation unclear, double-blind |
| Camilleri 200835 | USA, 38 sites | Secondary and tertiary care | Modified Rome II criteria | ≥3 CSBMs per week | 620 (87.9) | Prucalopride 2 mg or 4 mg od | 12 weeks | Randomisation and concealment of allocation stated, double-blind |
| Quigley 200936 | USA, 41 sites | Secondary and tertiary care | Modified Rome II criteria | ≥3 CSBMs per week | 641 (86.6) | Prucalopride 2 mg or 4 mg od | 12 weeks | Randomisation and concealment of allocation stated, double-blind |
| Tack 200937 | Multinational, number of sites not stated | Secondary and tertiary care | Modified Rome II criteria | ≥3 CSBMs per week | 716 (90.8) | Prucalopride 2 mg or 4 mg od | 12 weeks | Randomisation and concealment of allocation unclear, double-blind |
| Muller-Lissner 201038 | Multinational, 48 sites | Secondary and tertiary care | Modified Rome II criteria | ≥3 CSBMs per week | 303 (70.0) | Prucalopride 1 mg, 2 mg, or 4 mg od | 4 weeks | Randomisation and concealment of allocation stated, double-blind |
| Johanson 200740 | USA, 8 sites | Secondary and tertiary care | Modified Rome II criteria and negative investigations | Increase ≥3 SBMs per week relative to baseline | 129 (90.6) | Lubiprostone 24 μg od, bid, or tid | 3 weeks | Randomisation and concealment of allocation unclear, double-blind |
| Johanson 200841 | USA, 20 sites | Secondary and tertiary care | Modified Rome II criteria and negative investigations | ≥3 SBMS per week | 244 (89.7) | Lubiprostone 24 μg bid | 4 weeks | Randomisation and concealment of allocation stated, double-blind |
| Barish 201039 | Not stated, 20 sites | Secondary and tertiary care | Modified Rome II criteria and negative investigations | ≥4 SBMs per week | 237 (88.2) | Lubiprostone 24 μg bid | 4 weeks | Randomisation unclear, concealment of allocation stated, double-blind |
| Lembo 2010a42 | USA, 57 sites | Secondary and tertiary care | Modified Rome II criteria with negative colonoscopy within last 10 years | ≥3 CSBMs per week and an increase ≥1 relative to baseline for 75% of treatment weeks | 310 (92.0) | Linaclotide 75 μg, 150 μg, 300 μg, or 600 μg od | 4 weeks | Randomisation and concealment of allocation stated, double-blind |
| Lembo 2010b43 | USA and Canada, 108 sites | Secondary and tertiary care | Modified Rome II criteria | ≥3 CSBMs per week and an increase ≥1 relative to baseline for 75% of treatment weeks | 630 (89.0) | Linaclotide 133 μg or 266 μg od | 12 weeks | Randomisation and concealment of allocation stated, double-blind† |
| Lembo 2010c43 | USA, 105 sites | Secondary and tertiary care | Modified Rome II criteria | ≥3 CSBMs per week and an increase ≥1 relative to baseline for 75% of treatment weeks | 642 (89.0) | Linaclotide 133 μg or 266 μg od | 12 weeks | Randomisation and concealment of allocation stated, double-blind† |
↵* Modified Rome II criteria; ≤2 spontaneous bowel movements per week, with hard stools, sensation of incomplete evacuation, and straining on at least 25% of bowel movements.
↵† Full information not reported in published article, but obtained after correspondence with the authors.
bid, twice daily; CSBM, complete spontaneous bowel movement; od, once daily; SBM, spontaneous bowel movement; tid, thrice daily.