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. 2018 Nov 24;2018(11):CD009435. doi: 10.1002/14651858.CD009435.pub2

Wahab 2008.

Methods Parallel design, randomised controlled trial
Duration of the trial: from January, 2004 to May, 2007
Participants 60 participants from three medical centres in Dhaka, Bangladesh
Inclusion criteria: cases having moderate to severe acne as categorised by the Global Acne Grading Score, GAGS
Exclusion criteria: not provided
Age: for all participants, range from 15 to 30 years
Age: by group, mean ± standard deviation (years)
  • Group A (n = 30): 21.03 ± 4.21

  • Group B (n = 30): 21.50 ± 4. 16


Gender: male/female
  • Group A (n = 30): 17/13 (high risk of performance and detection bias, besides the absence of allocation concealment)

  • Group B (n = 30): 16/14


Duration of acne: mean ± standard deviation (months)
  • Group A (n = 30): 9.57 ± 5.52

  • Group B (n = 30): 12.93 ± 6.20


Acne severity: moderate/severe
  • Group A (n = 30): 20/10

  • Group B (n = 30): 25/5

Interventions
  • Group A (n = 30): oral isotretinoin, 0.5 to 1 mg/kg body weight according to severity of the disease, for 5 months

  • Group B (n = 30): azithromycin 500 mg three days a week for 3 months

Outcomes
  • Improvement on acne severity evaluated by physician assessment, on the basis of global acne grading score, as excellent: complete clearing of lesions; good: 75% clearing of lesions; good: 50 a 75% clearing of lesions; poor: < 50% clearing of lesions; and no response*

  • Relapse during the follow‐up period

  • Frequency of recorded side effects*


There were monthly assessments of the outcomes during the treatment phase
* Indicates outcomes which matched those prespecified for this review
Funding body None stated
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: The report did not provide any information about random sequence generation. However, after being contacted by email, an author said that they used drawing of lots
Allocation concealment (selection bias) High risk Comment: There was no statement regarding methods of allocation concealment in the study. However, after being contacted by email, an author said that no concealment method was used while allocating interventions
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: The study did not provide any information to permit judgement. However, after being contacted by email, an author said that no method was used to ensure blinding of participants and personnel
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: The study did not provide any information to permit judgement. However, after being contacted by email, an author said that no method was used to ensure blinding of outcome assessors
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: There was no statement regarding loss to follow‐up or exclusions in the report. However, after being contacted by email, an author said that there were no missing data
Selective reporting (reporting bias) Low risk Comment: No protocol available; however, there was an adequate report of outcomes listed in the methods section
Other bias Low risk Comment: There were no other apparent sources of bias