Highton 2011.
Methods | This was a within‐patient RCT in which 1 side of an anatomical site was treated, and the other received no treatment There was a 4‐week treatment period followed by a 12‐month observation phase |
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Participants | The trial randomised 18 participants with a clinical diagnosis of HS with moderate to severe disease, defined as Hurley stage II or III Participants were required to have bilateral disease in an affected region, and overall, there was no significant difference in disease severity at the control and intervention sites at baseline (P value = 0.31, paired t test). However, information was not provided regarding whether disease severity was comparable on both sides of an affected region for individual participants Disease locations were axillary (12 participants), groin (4 participants), and inframammary (2 participants). 1 participant with inframammary disease dropped out after a single treatment |
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Interventions | Left and right sides of a single anatomical location were randomised in a 1:1 ratio:
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Outcomes |
Primary outcome
Secondary outcome
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Notes | The publication gave only pooled results for all anatomical locations, but following correspondence, the authors provided a breakdown based on the site of involvement. The trial authors declared no financial conflicts of interest | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The paper provided no details ‐ "patients were randomised" |
Allocation concealment (selection bias) | Unclear risk | The paper provided no details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were unblinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Detection bias was low risk for the Sartorius score – the outcome assessor was not the treating clinician and was blinded to treatment allocation. Scoring was repeated from photographs by 2 additional blinded assessors. The trial was high risk for participant satisfaction; participants were unblinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 participant dropped out of the study, due to treatment‐related pain |
Selective reporting (reporting bias) | Unclear risk | The study was not registered prospectively |
Other bias | Low risk | We found no other significant bias |