Arunkumar 2015.
Methods | Study design: RCT Conducted in India Number of centres: 1 Recruitment period: unspecified Funding source: nil |
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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 |
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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 |
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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. |