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. 2012 Oct 17;2012(10):CD003584. doi: 10.1002/14651858.CD003584.pub2

Hoharitanon 2005.

Methods This was a RCT.
Participants There were 140 participants in the initial sample.
The total evaluable sample was 133 participants, who were not distributed equally between groups (group 1 = 18 participants; group 2 = 61 participants; group 3 = 54 participants).
Exclusion criteria of the trial
  • No topical therapy antifungal therapy within 30 days of the study

  • No systemic antifungal therapy within 2 months of the study

  • Chronic diseases, e.g. congestive heart failure

  • Gastric and liver disorders

  • Immunosuppression

  • Women of childbearing age

  • Pregnant and lactating women

  • Participants with known hypersensitivity to itraconazole or taking drugs with known interactions

Interventions
  • Group 1: itraconazole (Sporal) 200 mg twice daily for 1 week

  • Group 2: itraconazole (Itracon) 200 mg twice daily for 1 week

  • Group 3: itraconazole (Itra) 200 mg twice daily for 1 week

Outcomes Primary outcomes of the trial
  1. Cure, demonstrated by negative results on microscopy and culture


Secondary outcomes of the trial
  1. Reduction in clinical signs and symptoms

  2. Adverse Events

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Comment: The method of randomisation was not reported. Uneven groups were generated.
Allocation concealment (selection bias) Low risk Quote: "Twenty‐eight capsules of each were put into a non‐transparent enclosed sachet by randomised method." 
Comment: Each trial arm had the same number of tablets in concealed opaque sachets. Although the report did not state that these sachets were sequentially numbered, we have taken the view that allocation concealment was achieved.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "...double blind."
Comment: All participants received the same tablet regimen and number of tablets. Whilst it was not specifically stated if the participants were blinded, it was felt they were likely to be unaware of which study group they had been allocated; therefore, we judged this domain to be at low risk. 
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Comment: There was no report regarding where the tablets were accessed from/their distribution/how instructions were given.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: It was not clear from the report whether the outcome assessor was blinded; therefore, we judged this to be at unclear risk.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "The study initially included 140 participants, 133 of them completed all the phases of they study and met all the criteria." 
Comment: The authors did not specifically describe why 7 participants were not included in analysis. The attrition rate was 5%.
Selective reporting (reporting bias) Low risk Comment: The study protocol was not available. However, the outcomes stated in the methods of the report were all described in the results and discussion.
Other bias Low risk Comment: This appeared to be free from other potential sources of bias.