Evidence of safety—pooled relative risk (RR*) and 95% confidence interval (CI)
| Intervention† | Adverse events | RR (95% CI) | Category of evidence |
|---|---|---|---|
| *RR, relative risk between treatment group and control group; RR = 1, no different from the control population; RR>1, more risky than the control population; RR<1, less risky than the control population. Pooled RR was estimated for more than one study; †compared with placebo/non-exposure unless otherwise stated. | |||
| H2 Blockers, histamine type 2 receptor antagonists; PPIs, proton pump inhibitors; GI, gastrointestinal; CV, cardiovascular; CNS, central nervous system. | |||
| Paracetamol | GI discomfort | 0.80 (0.27 to 2.37) | RCTs |
| GI perforation/bleed | 3.60 (2.60 to 5.10) | Case-control study | |
| GI bleeding | 1.2 (0.8 to 1.7) | Case-control studies | |
| Renal failure | 0.83 (0.50 to 1.39) | Cohort study | |
| Renal failure | 2.5 (1.7 to 3.6) | Case-control study | |
| NSAIDs | GI perforation/ulcer/bleed | 5.36 (1.79 to 16.10) | RCTs |
| GI perforation/ulcer/bleed | 2.70 (2.10 to 3.50) | Cohort studies | |
| GI perforation/ulcer/bleed | 3.00 (2.70 to 3.70) | Case-control studies | |
| Coxibs v NSAIDs | Endoscopic GI ulcer | 0.18 (0.14 to 0.23) | RCTs |
| CV events | 0.79 (0.40 to 1.55) | RCTs | |
| Coxibs v naproxen | CV events | 1.69 (1.07 to 2.69) | RCTs |
| Misoprostol | Endoscopic GI ulcer | 0.26 (0.17 to 0.39) | RCTs |
| Diarrhoea | 1.81 (1.52 to 2.16) | RCTs | |
| H2 Blockers (double doses) | Endoscopic GI ulcer | 0.44 (0.03 to 0.74) | RCTs |
| PPIs | Endoscopic GI ulcer | 0.40 (0.32 to 0.51) | RCTs |
| Opioids+paracetamol v paracetamol | GI upset/constipation | 14.00 (1.86 to 105.16) | RCT |
| Diacerhein | Diarrhoea | 3.73 (2.61 to 5.32) | RCT |
| Skin rash/pruritus | 2.40 (1.01 to 5.69) | RCT | |