Summary of findings 2. Extracorporeal photopheresis compared to PUVA for mycosis fungoides.
| Extracorporeal photopheresis compared to PUVA for mycosis fungoides | ||||||
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Patient or population: people with mycosis fungoides
Setting: tertiary care setting
Intervention: Extracorporeal photopheresis (ECP)
Comparison: PUVA Number of trials included: 1 (Child 2004) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with PUVA | Risk with Extracorporeal photopheresis | |||||
| Improvement of quality of life | ‐ | ‐ | ‐ | ‐ | ‐ | Not measured |
| Common adverse effects (Time point of measurement: three months of PUVA or six months of ECPc) |
Some participants reported mild nausea after PUVA. However, incidences and time points were not stated. One participant starting in the ECP group had hypotension leading to withdrawal from the study. | ‐ | 16 (1 RCT) b | ⊕⊝⊝⊝ Very low a | ‐ | |
| Complete response (Time point of measurement: three months of PUVA or six months of ECPc) |
Study population | RR 0.20 (0.01 to 3.61) | 16 (1 RCT) b | ⊕⊝⊝⊝ Very low a | ‐ | |
| 250 per 1000 | 50 per 1000 (3 to 903) | |||||
| Objective response rate (Time point of measurement: three months of PUVA or six months of ECPc) |
Study population | RR 0.08 (0.01 to 1.17) | 16 (1 RCT) b | ⊕⊝⊝⊝ Very low a | Additionally computed 95% CI by the use of the method described by Miettinen 1985 (adverse effects requiring discontinuation): 95% CI by Miettinen 0.00 to 0.40, Fisher test P = 0.002 | |
| 750 per 1000 | 53 per 1000 (0 to 750) | |||||
| *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 three levels to very low‐certainty evidence. One level because of low internal validity (risk of bias ‐ high risk of attrition bias) and two levels because of very low sample size (imprecision)
b Cross‐over design, no carry‐over effect suspected due to long washout phase of three months
c The PUVA‐first group was given PUVA twice a week for 3 months followed by ECP once monthly for 6 months (doses not reported). The ECP‐first group was given ECP once monthly for 6 months followed by PUVA twice a week for 3 months (doses not reported).