Summary of findings 6. Oral immunosuppressants: oral cyclosporin versus topical betamethasone dipropionate.
| Oral cyclosporin compared to topical betamethasone for patient with hand eczema | ||||||
| Patient or population: people with hand eczema, continuously for 6 months, significant disability, inadequate response to conventional treatment, confirmation by histopathology Setting: secondary care setting at a single centre in Finland Intervention: oral cyclosporin 3 mg/kg/d and placebo cream for 6 weeks Comparison: topical betamethasone dipropionate 0.05% cream and placebo capsules for 6 weeks | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed riska | Corresponding risk | |||||
| Risk with topical betamethasone | Risk with oral cyclosporin | |||||
|
Primary: investigator‐ rated good/excellent control of symptomsb Follow‐up: 6 weeks |
Study population | RR 1.88 (0.88 to 3.99) | 34 (1 RCT) | ⊕⊕⊕⊝ Moderatec | ‐ | |
| 333 per 1000 | 627 per 1000 (293 to 1000) | |||||
|
Primary: participant‐rated good/excellent control of symptomsb Follow‐up: 6 weeks |
Study population | RR 1.25 (0.69 to 2.27) | 34 (1 RCT) | ⊕⊕⊕⊝ Moderatec | ‐ | |
| 500 per 1000 | 625 per 1000 (345 to 1000) | |||||
|
Primary: adverse events ‐ at least 1 adverse event Follow‐up: 36 weeks |
Study population | RR 1.22 (0.80 to 1.86) | 55d (1 RCT) | ⊕⊕⊕⊝ Moderatec | Because of partial cross‐over design, a different number of participants is given for this outcome | |
| 556 per 1000 | 678 per 1000 (444 to 1000) | |||||
|
Secondary: investigator‐rated reduction in severityb Follow‐up: 6 weeks |
Mean investigator‐rated reduction in severity in total disease activity score after 6 weeks of treatment was 5.7 | MD 0.30 higher (2.50 lower to 3.10 higher) | ‐ | 34 (1 RCT) | ⊕⊕⊕⊝ Moderatec | ‐ |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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. Granlund 1996 | ||||||
| GRADE Working Group grades of evidence. High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate. | ||||||
aThe assumed risk is the mean control group risk.
bObserver‐rated disease activity score: grading 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe) on erythema, scaling, infiltration, excoriation, crusting, and vesicles for both hands. A high score represents severe hand eczema.
cDowngraded by one level to moderate‐certainty evidence. Imprecision downgraded by one level: small sample size.
dThe number of participants varies between different outcomes because this is a cross‐over study, and adverse events were included from all different phases of the trial.