Methods | RCT of body parts (face halves) | |
Participants | Dx: homosexual men with advanced AIDS having facial SD; physician diagnosis implied within context | |
Interventions | Intervention: lithium succinate 8% ointment applied to one-half of the face twice daily for 8 weeks (n = 12) Control: ointment base applied similarly to the opposite half of the face (n = 12) |
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Outcomes | Erythema and scaling clearance rates. We used the following MD and P values from the paired t-test to calculate the MD (100-mm VAS score) and the SE to be put into RevMan using the general inverse variance method.
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Notes | Study was conducted in the UK; COI: grant received from Scotia Pharmaceuticals; side effect was reported for a single participant | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Baseline comparable? | Low risk | Each participant was his own control |
Patient blinded? | Low risk | Use of identical containers |
Provider blinded? | Low risk | Use of identical containers |
Outcome assessor blinded? | Low risk | Use of identical containers |
Co-interventions avoided? | High risk | "... and remained on all other medication which included azidothymidine (AZT) for seven patients" |
Compliance acceptable? | Unclear risk | Not reported |
Drop-out acceptable? | Low risk | "During the first week of treatment one patient died of an opportunistic infection and two others dropped out ... Ten patients were thus available for assessment" |
Selective outcome reporting acceptable? | Low risk | All outcomes were reported |
ITT? | Unclear risk | "The scores for each assessment were expressed as a percentage of baseline and the mean differences between the percentage changes for active and placebo treatment were assessed ..." |