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. 2016 Jul 13;2016(7):CD011272. doi: 10.1002/14651858.CD011272.pub2

Summary of findings 2. Summary of findings for topical administration.

Topical rapamycin compared with placebo for people with TSC
Patient or population: people with TSC
Settings: outpatient
Intervention: topical rapamycin
Comparison: placebo
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of Participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
Placebo Topical Rapamycin
Response to skin lesions ‐ rapamycin
(6 months)
38% of participants1 73% of participants1 RR: 1.81 (0.80 ‐ 4.06) 28 (1) ⊕⊕
 low2 P = 0.15
*The basis for the assumed risk is provided in footnotes. The corresponding risk (and its 95% CI) 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 quality: further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: 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 quality: we are very uncertain about the estimate.

1. The study reported only the percentages. The absolute numbers of responder in each treatment arm were inferred from the percentages. While there are 5 dropouts, no reports on which treatment arm they came from. ITT principle is in effect for the analysis, assuming all participants completed the protocol.

2. We judged the quality of evidence as low due to incomplete outcome data reported from the study (Koenig 2012) and we needed to infer the results from percentages. The evidence is downgraded twice for this reason.