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. 2016 May 26;2016(5):CD007628. doi: 10.1002/14651858.CD007628.pub4

Kim 2009.

Methods This was a randomised, placebo‐controlled trial
Setting
Department of Dermatology, College of Medicine, Korea University, Seoul, Korea
Date of study
Unspecified (24‐week duration)
Participants 40 men and women (28 men, 12 women)
Mean age = 43.1 years
Inclusion criteria
  • Ability to understand the purpose and design of the study and ability to give informed consent.

  • Korean male or female patients who have been diagnosed with androgenic alopecia (AGA) for longer than 3 months.


Exclusion criteria
  • Receiving therapy for other disease (not clear if it only applies to systemic therapy or if it includes topical treatment as well).

  • Pregnant or lactating female.

  • Known allergic reaction to ginseng.

  • Participated in another trial within 3 months prior to being considered for this study.

  • Inability to understand purpose and methodology of the study.

  • Illiteracy.

  • Received other treatment for alopecia within 2 weeks prior to randomisation.

  • Clinical judgment that enrolment may not be appropriate.


Randomised
40 men and women were randomised (ginseng group = 20, placebo group = 20)
Withdrawals/losses to follow‐up
8/40 (20%) withdrawals/losses to follow‐up, 3/20 (15%) in ginseng group and 5/20 (25%) in placebo group, reasons unreported
Baseline data of the females 
 7 had Ludwig Grade I female pattern alopecia, and 5 had Grade II. None had Grade III
Interventions Intervention
  • Korean red ginseng powder capsule 1000 mg 3 times a day for 24 weeks.


Comparator
  • Placebo 3 times a day for 24 weeks.

Outcomes Assessments (3): at baseline, 12 weeks, and 24 weeks
Outcomes of the trial (as reported)
  • Hair density measured by Folliscope.¹

  • Hair thickness measured by Folliscope.¹

  • Patient‐reported outcome for a) size of vertex bald spot, b) hair loss on the vertex, c) receding temporal hairline, d) hair shedding, e) hair quality and f) overall satisfaction.¹

  • Physician's assessment of improvement or worsening of alopecia, based on photographs of the study participants and graded on a 7‐point scale.¹


¹Denotes outcomes prespecified for this review
Funding source The Korean Ginseng Corporation funded the study and provided the medications used in the intervention group
Declaration of interest None declared
Notes The trial did not stratify data by gender. We sent e‐mails were sent to the PI, but received no reply. See Table 8
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (page 223): "randomly".
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.
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 of the risk of bias.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote (page 223): "double‐blind trial."
Comment: the report did not provide sufficient detail about the measures used to blind study participants and personnel from knowledge of which intervention a participant received, to permit a clear judgement.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote (page 758): "double‐blind trial."
Comment: there was uncertainty regarding the effectiveness of blinding of outcomes assessors (participants, healthcare providers) during the study. There was insufficient information to permit a clear judgement.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 8/40 (20%) withdrawals/losses to follow‐up, 3/20 (15%) in ginseng group and 5/20 (25%) in placebo group (unbalanced), but the reasons were unreported.
Comment: we judged this as at a high risk of bias.
Selective reporting (reporting bias) Low risk The protocol for the study was unavailable, but the prespecified outcomes and those mentioned in the methods section appeared to have been reported.
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.