| Methods |
Randomised, parallel group trial
Randomisation by a computer random number table
Blinding not possible |
| Participants |
31 leprosy patients with nerve deficit < 6 months duration
Unit of randomisation: ulnar, median, common peroneal or posterior tibial nerve.
Unit of analysis: nerve
Nerves randomised: unclear
Nerves analysed: 93 (a: 47 , b: 46) |
| Interventions |
(a) Prednisone start at 40 mg/day for 15 days and thereafter gradually tapered with 5 mg/15 or 30 days until 6 months completed (total 3450 mg)
(b) Same intervention plus external nerve decompression and a simple, longitudinal epineurotomy |
| Outcomes |
Change in:
(1) Sensory score after 2 years
(2) Voluntary muscle testing (VMT) score after 2 years
(3) Nerve pain after 2 years |
| Notes |
Single centre
Conducted in Senegal |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation by a computer random number table |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Blinding of patients and clinicians not possible; blinding of outcome assessor not reported |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
2/31 (6%) of participants lost to follow‐up, but unclear how many nerves were involved; no intention‐to‐treat analysis was performed. |
| Selective reporting (reporting bias) |
Unclear risk |
The occurrence of adverse effects was not adequately reported |
| Other bias |
High risk |
No separate analysis was done using only one independent outcome from each patient |
