Summary of findings 3. Bexarotene + PUVA compared to PUVA alone for mycosis fungoides.
| Bexarotene + PUVA compared to PUVA alone for mycosis fungoides | ||||||
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Patient or population: people with mycosis fungoides
Setting: tertiary care setting
Intervention: Bexarotene + PUVA
Comparison: PUVA alone Number of trials included: 1 (Whittaker 2012) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with PUVA alone | Risk with Bexarotene + PUVA | |||||
| Improvement of quality of life | ‐ | ‐ | ‐ | ‐ | ‐ | Not measured |
| Common adverse effects ‐ Photosensitivity (Time point of measurement: up to 16 weeks) | Zero events in with PUVA alone, so unable to calculate absolute effects. | RR 2.68 (0.11 to 64.04) | 87 (1 RCT) | ⊕⊕⊝⊝ Low a | ‐ | |
| Complete response (Time point of measurement: up to 16 weeks) | Study population | RR 1.41 (0.71 to 2.80) | 93 (1 RCT) | ⊕⊕⊝⊝ Low a | ‐ | |
| 222 per 1000 | 313 per 1000 (158 to 622) | |||||
| Objective response rate (Time point of measurement: up to 16 weeks) | Study population | RR 0.94 (0.61 to 1.44) | 93 (1 RCT) | ⊕⊕⊝⊝ Low a | ‐ | |
| 489 per 1000 | 460 per 1000 (298 to 704) | |||||
| *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; RR: Risk ratio | ||||||
| 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. | ||||||
a Downgraded by two levels to low‐certainty evidence. One level because of low internal validity (risk of bias ‐ high risk of performance bias) and one level because of low sample size (imprecision)