Table 3 Summary of findings and quality of evidence assessment for the efficacy and safety of rectal NSAIDs versus no treatment in prevention of post-ERCP pancreatitis according to GRADE framework.
Main outcomes | Summary of findings | Quality of evidence assessment (GRADE) | ||||||
|---|---|---|---|---|---|---|---|---|
No. of patients (trials) | Effect size* (95% CI) | Study limitation§ | Inconsistency† | Indirectness | Imprecision‡ | Quality | Importance | |
Post-ERCP pancreatitis | ||||||||
Any | 6458 (16) | 0.55 (0.42–0.71) | None | None | None | None | High | Critical |
Mild | 6208 (14) | 0.59 (0.48–0.73) | None | None | None | None | High | Critical |
Moderate to severe | 5955 (13) | 0.51 (0.35–0.75) | None | None | None | None | High | Critical |
Amylase concentrations | ||||||||
2 h post-ERCP | 1126 (5) | −77.85 (−104.61–51.09) | None | None | None | None | High | Important |
24 h post-ERCP | 420 (3) | −285.02 (−440.22–129.83) | None | −1** | None | −1¶ | Low | Important |
Hyperamylasemia | 1759 (6) | 0.59 (0.36–0.96) | None | −1** | None | None | Moderate | Important |
Pain | 204 (2) | 0.31 (0.15–0.61) | None | None | None | −1¶ | Moderate | Important |
Adverse events | ||||||||
Bleeding | 4424 (15) | 1.03 (0.58–1.85) | None | None | None | None | High | Critical |
Perforation | 4424 (15) | 3.27 (0.34–31.12) | None | None | None | None | High | Critical |
Cholangitis | 4424 (15) | 0.74 (0.21–2.59) | None | None | None | None | High | Critical |
ARF | 4424 (15) | 0.21 (0.01–4.32) | None | None | None | None | High | Critical |
Anal itching | 4424 (15) | 1.02 (0.15–7.10) | None | None | None | None | High | Critical |
Death | 4424 (15) | 0.44 (0.14–1.42) | None | None | None | None | High | Critical |
Total | 4424 (15) | 0.82 (0.51–1.31) | None | None | None | None | High | Critical |
