Allocation and treatment
Consenting eligible patients were randomly allocated to one of three garlic
groups (g1, g2 and g4) or placebo using a computer-generated random
number table provided by an independent consulting statistician. Patients
were assigned either one, two or four capsules daily of Kyolic aged garlic
extract (High Potency Everyday Formula 112; Wakunaga/Wagner, Sydney,
Australia)20 containing either 240/480/960mg of aged garlic extract and
0.6/1.2/2.4mg S-allylcysteine or placebo capsules for 12 weeks. Placebo
capsules were matched in number, shape, size, colour and odour to the
active capsules and were packaged in identical opaque containers by
independent staff not involved in the trial. Sachets with a drop of liquid
Kyolic were added to the containers for garlic odour. Patients, investigators
and the research nurse were blinded to treatment allocation. Blinding
success of patients was assessed at the end of the trial by questionnaire.
Patients were instructed to take all trial capsules with the evening meal.
Patients were reminded to take their usual prescription medication as
instructed by their doctor. Compliance was assessed by daily entries in
provided calendars.