Xu 2002.
Methods | Study design: RCT Conducted in China Number of centres: 1 Recruitment period: unclear Funding source: unspecified |
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Participants | Inclusion criteria: clinical and histopathological diagnosis of OLP Exclusion criteria: systemic diseases, other oral mucosa diseases or advanced periodontal diseases; any immunomodulating drug in last 3 months Group A: randomised 20; analysed 20 Group B: randomised 19; analysed 19 |
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Interventions | Group A: 3‐step treatment by traditional and Western medicine combined (herbal topical and decoction + prednisone 5–10 mg 3 times daily chlorphenamine 4 mg 3 times daily, vitamin C 0.1 g 3 times daily). Herbal treatment applied topically, followed by herbal decoction + decreasing doses of Western medicine, followed by herbal decoction only. Treatment duration 6 weeks Group B: Western medicine (prednisone 5–10 mg 3 times daily, chlorphenamine 4 mg 3 times daily, vitamin C 0.1g 3 times daily), dosage gradually decreased over 4‐week period |
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Outcomes | Clinical score (4‐grade score), relapse rate | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomised trial." Method of sequence generation not available. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not feasible. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data. All randomised participants included in result analysis. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement. |
Other bias | Low risk | No other sources of bias identified. |