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

Hesen 2017.

Methods Study design: 3‐arm RCT
Conducted in Egypt
Number of centres: 2
Recruitment period: unclear
Funding source: unspecified
Participants Inclusion criteria: both sexes, aged 25–60 years, with clinically and histologically confirmed erosive/atrophic OLP and free from any systemic disease
Exclusion criteria: people with history of drug‐induced lichenoid lesions or potential treatment for OLP (for < 2 weeks by topical or 4 weeks by systemic therapy) before start of study; pregnant or breastfeeding women; smokers; known hypersensitivity or adverse effects to treatment drugs; losses of pliability or flexibility in tissues involved by oral lesions or histological signs of epithelial dysplasia or lichenoid lesions
Group A: randomised 10; analysed 10
Group B: randomised 10; analysed 10
Group C: randomised 10; analysed 10
Interventions Group A: topical triamcinolone acetonide 0.1% oral paste (GEO ORALOG; Geopharma, Cairo, Egypt) 4 times daily + glucosamine sulphate 500 mg capsules orally 3 times daily (glucosamine; GlaxoSmithKline, Cairo, Egypt) for 8 weeks
Group B: topical triamcinolone acetonide 0.1% oral paste twice daily + glucosamine sulphate 500 mg 3 times daily for 8 weeks
 Group C: topical triamcinolone acetonide 0.1% oral paste alone 4 times daily for 8 weeks
Outcomes Pain (VAS, resolution), clinical score (Thongprasom Classification score)
Measured at baseline, 1, 2, 4, 6, 8 and 12 weeks
Notes We compared the outcomes of Group A and Group C as the triamcinolone daily dose was the same (4 times daily).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomised into three groups (10 patients each) using computer‐generated randomisation assignment."
Allocation concealment (selection bias) Low risk Quote: "allocation concealment with sealed envelopes."
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 High risk Comment: participants (self‐assessed, pain was primary outcome) were not blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no missing data. All randomised participants included in result analysis.
Selective reporting (reporting bias) High risk Adverse effects, mentioned in the Methods were not reported in the Results.
Other bias Low risk No other sources of bias identified.