Background: Lowering cholesterol levels by natural dietary modification is an attractive first-line option for the treatment of mild-to-moderate hypercholesterolaemia. However, results have been less than impressive. The addition of soluble fibre - for example, psyllium or oat bran - to a modified diet has produced better results. In this study, the cholesterol-level-lowering effect of ispaghula husk and dietary advice was compared with placebo and dietary advice in treating patients with mild-to-moderate hypercholesterolaemia.
Methods: The double-blind, placebo-controlled, randomized comparison was conducted in 42 general practices and three hospital centres in the UK. There was an initial 8-week diet-only period and then a 1 2-week treatment period. Ispaghula treatment (7.0 or 10.5 g/day) was continued for a further 12 weeks for some patients. A total of 340 patients, aged 18 to 65, with mild-to-moderate hypercholesterolaemia [low-density lipoprotein (LDL) cholesterol levels of 4.1 mmol/l or more] entered the 12-week treatment phase. Levels of LDL cholesterol, total cholesterol, high-density lipoprotein cholesterol, triglycerides and apolipoproteins A1 and B were determined.
Results: LDL cholesterol and total cholesterol levels fell during the diet-only period. In members of the intention-to-treat population after the 8-week diet period, LDL cholesterol levels had fallen by 0.42 mmol/l (8.7%) for the 7.0 g ispaghula/day group after 12 weeks of treatment, whereas LDL cholesterol levels had fallen by 0.48 mmol/l (9.7%) for the 10.5 g ispaghula/day group. Ispaghula at both doses produced significantly greater reductions in LDL cholesterol levels than did placebo (7.0 g/day versus placebo, P=0.009; 10.5 g/day versus placebo, P<0.001). Ispaghula and modification of diet together reduced LDL cholesterol levels by 10.6-13.2% and total cholesterol levels by 7.7-8.9% during the 6-month period.
Conclusions: Ispaghula husk as an adjunct to diet is effective and well tolerated in the management of appropriate patients with mild-to-moderate primary hypercholesterolaemia.