| Methods |
Study design: double blind, randomised, placebo‐controlled trial.
Method of randomisation: not stated.
Concealment of allocation: not stated.
Exclusions post randomisation: none. Drop outs 22.
Losses to follow up: none.
Intention to treat: not evident from result and not stated |
| Participants |
Country: New Zealand.
Setting: hospital.
No: 68 randomised.
Age: 40 to 74 years.
Sex: male 64; female 4.
Inclusion criteria: PAD of aorta or lower limb vessels (new referrals or those with previous surgery).
Exclusions: DM and multiple drug therapy. |
| Interventions |
Treatment: betapyridyl carbinol up to 1.8 g plus advice (anti‐smoking, weight loss and exercise).
Control: identical placebo plus advice.
Duration: 2 yr. |
| Outcomes |
Mortality; walking distance; symptoms; side effects. |
| Notes |
Biochemical parameters measured pre, during, and at end of study. Active treatment associated with reduced tChol.
Two male patients developed liver toxicity while on Betapyridyl carbinol. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
