Kim 2013.
Methods | This was a randomised, double‐blind, sham device‐controlled trial Setting Multicentre (2), Korea Date of study Unspecified (24‐week duration) |
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Participants | 40 men and women (26 men, 14 women) Mean age (SD) = 43.9 years (12.2) in the low level light therapy group, 44.5 years (11.4) in the sham device group Inclusion criteria
Exclusion criteria
Randomised 40 participants were randomised (low level light therapy group = 20, sham group = 20) Withdrawals/losses to follow‐up There were 11/40 (27.5%) withdrawals/losses to follow‐up: 5/20 (25%) in the low‐level light therapy group, and 6/20 (30%) in the sham group
Baseline data Duration hair loss (SD): low level light therapy group = 114.3 months (86.2), sham group = 100.55 months (84.8)
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Interventions |
Intervention
Comparator
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Outcomes | Assessments (3): at baseline, week 12, and week 24 Primary outcomes (as reported)
Secondary outcomes (as reported)
¹Denotes outcomes prespecified for this review |
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Funding source | Quote (page 1177): "This study was supported by Won Technology, Daejeon, Republic of Korea." | |
Declaration of interest | Quote (page 1177): "The authors have indicated no significant interest with commercial supporters" | |
Notes | The trial did not stratify data by gender. We sent e‐mails to the PI, but received no reply. See Table 8 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote (page 1177): "randomized" and "We randomly assigned". Comment: the trial authors did not report the method used to generate the allocation sequence in sufficient detail to allow a clear assessment of whether it would produce comparable groups. After e‐mail communication: "coin throw method for the allocation" Comment: this was probably done. |
Allocation concealment (selection bias) | Unclear risk | The trial did not report the method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment. Comment: there was insufficient information to permit a clear judgement. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote (page 1177): "double‐blind" and "The sham device was identical in appearance and its regulator operated, although it emitted no light", and (page 1179) " they were totally blinded". Comment: we judged this as at an unclear risk of bias in view of the fact that the helmet did not emit light. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote (page 1177): "double‐blind", (page 1179 " the investigators in charge of efficacy assessment were totally blinded". Comment: both investigators and participants were outcome assessors. We judged this as at an unclear risk of bias as the helmet did not emit light and might have influenced the outcome assessment by the participants. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There were 11/40 (27.5%) withdrawals/losses to follow‐up: 5/20 in the low‐level light therapy group (25%), and 6/20 in the sham group (30%). The data analysis was per‐protocol. Comment: the large number of dropouts (26%), incomplete outcome data, and inappropriate analysis were potential sources of bias. |
Selective reporting (reporting bias) | Low risk | The protocol for the study was unavailable, but the trial appeared to report the prespecified outcomes and those mentioned in the methods section. Comment: we judged this as at a low risk of bias. |
Other bias | Low risk | Comment: the study appeared to be free of other forms of bias. |