Policosanol is ineffective in the treatment of hypercholesterolemia: a randomized controlled trial.

Randomized controlled trial in ambulatory adults with mild hypercholesterolemia in the Charlotte, North Carolina area. The active policosanol arm had 19 completers; participants were middle-aged on average, mostly White, and included both men and women.

Adults received sugar cane-derived policosanol capsules orally at 20 mg/day, given as two 10 mg capsules daily for 8 weeks. The trial compared policosanol with placebo.

Policosanol was ineffective for lipid lowering in this 8-week trial. In the policosanol arm, LDL cholesterol changed from 4.02 to 3.73 mmol/L, with a percent change of -7.7 (-10.7 to -3.2), but there was no meaningful advantage over placebo for LDL cholesterol or other lipid parameters. Total cholesterol, HDL cholesterol, triacylglycerols, and CRP were also not improved versus placebo. The supplement was well tolerated, and no adverse events occurred.

The active intervention arm was small, with only 19 completers, which limits power to detect modest effects. The intervention period was short at 8 weeks, and the population was limited to adults with mild hypercholesterolemia from a single U.S. metropolitan area, reducing generalizability. Baseline use of concomitant medications and the brief follow-up also limit interpretation of longer-term lipid effects.