Table 5.
GRADE assessment of the quality of the evidence and the strength of the recommendations.
| Certainty assessment | No. of patients | Effect | Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | [Intervention] | [Comparison] | Relative (95% CI) | Absolute (95% CI) | ||
| VAS | ||||||||||||
| 13 | Randomised trials | Not serious | Not serious | Seriousa | Not serious | Publication bias strongly suspected dose response gradientb | 905 | 943 | – | SMD 0.47 lower (0.74 lower to 0.19 lower) |
⊕⊕⊕◯ moderate | Critical |
| % No/mild pain | ||||||||||||
| 6 | Non-randomised studies | Not serious | Seriousc | Seriousa | Not serious | Publication bias strongly suspectedb | 144/481 (29.9%) | 172/543 (31.7%) | OR 0.71 (0.32 to 1.59) |
69 fewer per 1000 (from 188 fewer to 108 more) |
⊕◯◯◯ very low | CriticaL |
| Days with no/mild pain | ||||||||||||
| 2 | Non-randomised studies | Not serious | Not serious | Seriousa | Not serious | None | 229 | 237 | – | MD 9 higher (8.93 higher to 9.07 higher) |
⊕◯◯◯ very low | Critical |
| n opioid conumption | ||||||||||||
| 3 | Non-randomised studies | Not serious | Not serious | Seriousa | Not serious | Strong association dose response gradient | 71/218 (32.6%) | 125/225 (55.6%) | OR 0.50 (0.33 to 0.76) |
171 fewer per 1000 (from 264 fewer to 68 fewer) |
⊕⊕⊕◯ moderate | Critical |
| Change SF-12/SF-36/EQ-5D | ||||||||||||
| 9 | Non-randomised studies | Not serious | Not serious | Seriousa | Not serious | Publication bias strongly suspected strong association dose response gradientb | 548 | 471 | – | SMD 0.39 higher (0.11 higher to 0.68 higher) | ⊕⊕◯◯ low | Critical |
| Any | ||||||||||||
| 7 | Randomised trials | Not serious | Seriousc | Seriousa | Not serious | Publication bias strongly suspectedb | 265/445 (59.6%) | 289/499 (57.9%) | OR 1.15 (0.67 to 1.97) | 34 more per 1,000 (from 99 fewer to 151 more) |
⊕◯◯◯ very low | Important |
CI, confidence interval; MD, mean difference; OR, odds ratio; SMD, standardised mean difference.
Different etiologies, doses, study design and follow-up times.
Publication bias assessed by visual inspection of funnel plots.
The results showed a wide variability.