Yoke 2006.
| Methods | Study design: RCT Conducted in Singapore, South Korea, India, Thailand Number of centres: 4: Singapore, Seoul (South Korea), Madras (India), Bangkok (Thailand) Recruitment period: 2000–2003 Funding source: National Medical Research Council, Ministry of Health, Singapore. Trident Pharm Pte Ltd (Singapore) assisted with the distribution of Kenalog to the overseas centres; Novartis Pte Ltd (Singapore) provided Sandimmun Neoral (ciclosporin) at cost for the trial and assisted in co‐ordinating the trial supplies at the overseas centres |
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| Participants | Inclusion criteria: histologically confirmed OLP and with both clinical signs and symptoms of OLP requiring treatment Exclusion criteria: treated previously by either of the trial medications and had worsened during that treatment or had uncontrolled or severe hypertension, serious active or recurrent infections, severe respiratory, renal, or heart disease, recent history of malignancy, insulin‐dependent diabetes, active peptic ulcer disease, active inflammatory gastrointestinal disease or pregnancy Group A: randomised 71; analysed 71 Group B: randomised 68; analysed 68 |
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| Interventions | Group A: ciclosporin solution 0.1%, 3 times daily for 8 weeks Group B: triamcinolone acetonide 0.1% in Orabase, 3 times daily for 8 weeks |
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| Outcomes | Pain (VAS), clinical score (Thongprasom) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "patients were randomly assigned to receive steroid or cyclosporin through central randomization office of the Clinical trials and Epidemiology Research Unit, Singapore." |
| Allocation concealment (selection bias) | Low risk | Quote: "Once eligibility had been confirmed […] patients were randomly assigned […] by telephone (Singapore and South Korea) or sealed envelope (India and Thailand)." |
| 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 | ITT analysis. 23/139 (16.5%) participants lost at follow‐up, balanced (13 and 10). |
| Selective reporting (reporting bias) | Low risk | Clinical improvement, pain and adverse effects reported. |
| Other bias | Low risk | No other sources of bias identified. |
EI: Efficacy Index; ITT: intention to treat; LED: light‐emitting diode; LP: lichen planus; OHIP: Oral Health Impact Profile; OHQoL: Oral Health related Quality of Life; OLP: oral lichen planus; RCT: randomised controlled trial; UVB: ultraviolet B; VAS: visual analogue scale; WHO: World Health Organization.