Summary of findings 8. Hyaluronic acid compared with neutral vehicle for leg ulcers.
| Hyaluronic acid compared with neutral vehicle for leg ulcers | ||||||
| Patient or population: people with leg ulcers Setting: patients' homes and care facilities; general centres Intervention: hyaluronic acid Comparison: neutral vehicle | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with neutral vehicle | Risk with hyaluronic acid | |||||
| Complete wound healing (60 days) | Study population | RR 2.11 (1.46 to 3.07) | 526 (4 RCTs) | ⊕⊕⊕⊝ Moderate 1 | Hyaluronic acid probably improves complete ulcer healing when compared with neutral vehicle. | |
| 130 per 1000 | 267 per 1000 (184 to 388) | |||||
| Time to complete wound healing |
Dereure 2012a, Mikosinski 2021a, and Mikosinski 2021b did not report this outcome. The authors of Humbert 2013 stated: "Other performance secondary endpoints (time to complete ulcer healing and global performance) were comparable between treatment groups, at any visit". However, no numbers were provided. |
‐ | 89 (1 RCT) | ⊕⊝⊝⊝ Very low 2 3 | It is uncertain if hyaluronic acid improves time to complete ulcer healing when compared with neutral vehicle. | |
| Adverse events ‐ incidence of infection | 122 per 1000 | 109 per 1000 (65 to 182) | RR 0.89 (0.53 to 1.49) | 425 (3 RCTs) | ⊕⊝⊝⊝ Very low 1 3 | It is uncertain if hyaluronic alters the incidence of infection when compared with neutral vehicle. |
| Health‐related quality of life ‐ not reported | No studies provided evidence for this outcome. | |||||
| Pain (VAS, mm), reduction from baseline | ‐ | MD 8.55 lower (14.77 lower to 2.34 lower) | ‐ | 337 (3 RCTs) | ⊕⊕⊝⊝ Low 1 4 | Hyaluronic acid may slightly increase reduction in pain from baseline when compared with neutral vehicle. |
| Change in ulcer size (45 days) | ‐ | MD 30.44 higher (15.57 higher to 45.31 higher) | ‐ | 190 (2 studies) | ⊕⊝⊝⊝ Low 1 4 | Hyaluronic acid may slightly increase change in ulcer size when compared with neutral vehicle. |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio; VAS: visual analogue scale | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
1Downgraded once for risk of bias due to unclear blinding of participants and personnel and high risk of attrition bias in one study. 2Downgraded twice for risk of bias. 3Downgraded twice for imprecision due to small sample size and wide or unknown confidence intervals. 4Downgraded once for imprecision due to small numbers of participants.