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. 2020 Feb 28;2020(2):CD001168. doi: 10.1002/14651858.CD001168.pub3

Arunkumar 2015.

Methods Study design: RCT
Conducted in India
Number of centres: 1
Recruitment period: unspecified
Funding source: nil
Participants Inclusion criteria: people with symptomatic OLP (pain or burning sensation, or both) who were agreeing for the biopsy and were ready to apply the medication supplied
Exclusion criteria: people with a history of malignancy, immunocompromised diseases, current systemic or generalised infections, pregnancy or breastfeeding, received topical or systemic immunosuppressants, retinoids or any other systemic therapies known to cause or suspected to have an effect on OLP within the last 4 weeks and allergic to the drugs supplied
Group A: randomised 15; analysed 15
Group B: randomised 15; analysed 15
Interventions Group A: triamcinolone acetonide 0.1% oral paste 4 times daily for 2 months
Group B: pimecrolimus 1% oral paste 4 times daily for 2 months
Outcomes Pain (VAS), clinical score (Thongprasom), presence of erythematous areas
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: insufficient information to permit judgement.
Allocation concealment (selection bias) Unclear risk Comment: insufficient information to permit judgement.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: insufficient information to permit judgement.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: insufficient information to permit judgement.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no missing data. All randomised participants included in analysis.
Selective reporting (reporting bias) Low risk Planned outcomes reported.
Other bias Low risk No other sources of bias identified.