| Methods |
Study design: Randomised, double‐blind, placebo controlled, parallel trial.
Method of randomisation: Randomisation table.
Concealment of allocation: Distribution by randomisation table undertaken by manufacturer of strictly identical treatment packs. Code broken at end of trial.
Exclusions post randomisation: None.
Losses to follow up: None. |
| Participants |
Country: France.
Setting: Specialist outpatient clinic, 2 autumn and winter seasons.
No.: 31/31 primary RP.
Age: Mean 39.3 years (range 22 to 67 years).
Sex: Females 28; males 3.
Other: 27% smokers. Concomitant disease: 2 diabetes, 2 arterial disease.
Inclusion criteria: Severe idiopathic RP, at least 1 attack related to cold exposure per day within the past 2 years, according to clinical examination, blood tests and bilateral nailfold capillaroscopy.
Exclusion criteria: Unilateral RP secondary to thoracic outlet or locoregional pathologic disturbances. Bilateral cases secondary to collagen disease or scleroderma. Patients treated with a vasoactive or platelet aggregant drug less than 2 weeks prior to trial, pregnant or breast‐feeding women. |
| Interventions |
Treatment: Buflomedil 300 mg twice daily.
Control: Placebo identical.
Duration: 6 months. |
| Outcomes |
1. Mean number of attacks per day.
2. Severity of attacks (4 point score: 0: none, 1: slight, 2: moderate, 3: severe).
3. Adverse events.
4. Efficacy confirmed by capillaroscopic criteria. |
| Notes |
No power calculation; Jadad score = 5.
Support: Not stated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
