The safety and tolerability of ispaghula husk, which can now be used as an
adjunct to diet for the treatment of mild-to-moderate hypercholesterolaemia
, was assessed in 93 healthy subjects over a 52-week period. The study look
ed at the nutritional, biochemical, and haematological effects of ispaghula
. Over the study period there were small but statistically significant chan
ges in some measurements of minerals and vitamin levels, and in some haemat
ological and biochemical parameters. However, none of these were of clinica
l significance, with the possible exception of changes in vitamin B-12 leve
ls. A daily dose of 10.5 g ispaghula was well tolerated and the majority of
adverse events recorded were minor, of short duration and either unrelated
or possibly related to the study treatment. The results suggest that ispag
hula husk can be used with confidence for the long-term treatment of mild-t
o-moderate hypercholesterolaemia.