Benefits
Urinary symptom scores and urinary flow in older men
A Cochrane review pooled 4 double-blind trials in 519 men with an enlarged prostate. Compared with placebo, beta-sitosterol improved the IPSS symptom score by about 4.9 points (2 trials) and peak urine flow by about 3.9 mL/s (4 trials). Prostate size did not shrink. The trials lasted only 4 to 26 weeks, and the one using a pure glucoside form showed no flow improvement.
Six-month trial: symptom scores and urine flow in 200 men
In a 6-month double-blind trial, 200 men with an enlarged prostate took 20 mg of beta-sitosterol three times daily or placebo. The main symptom score fell by 6.7 points versus 2.1 on placebo, and IPSS by 7.4 versus 2.1. Peak flow rose from 9.9 to 15.2 mL/s on beta-sitosterol and did not change on placebo. Prostate volume did not change in either group.
Results held at 18 months in men who kept taking it
In an open follow-up of the 6-month trial, 117 of the 200 men were re-examined at 18 months. The 38 who stayed on beta-sitosterol kept their gains, and 27 former placebo takers who switched to it improved to a similar degree. Men chose their own treatment, so this was not a blinded comparison, and the authors called for further trials.
LDL cholesterol lowering at gram doses (plant sterols as a group)
A meta-analysis of 124 studies found that plant sterols and stanols at 0.6 to 3.3 g a day lowered LDL cholesterol by about 6 to 12%, with the effect rising up to about 3 g. These studies tested plant sterol mixtures, not beta-sitosterol capsules at the 60 mg used in the urinary trials, which is far below these intakes.
Mechanism of action
Less cholesterol absorbed from the gut
At about 2 g a day, plant sterols and stanols partly block the absorption of cholesterol from the intestine, which lowers LDL cholesterol by roughly 8 to 10%, according to a European Atherosclerosis Society consensus review. This needs gram doses, far more than the amounts used in the prostate trials.
Urinary effects without prostate shrinkage
In the trials, urinary symptoms and flow improved while prostate size did not change, so any benefit does not come from shrinking the gland. The authors of the main trial noted that no precise mechanism of action has been described for plant-derived products like beta-sitosterol.
Proposed enzyme and anti-inflammatory effects (lab evidence)
Lab and animal studies have suggested that beta-sitosterol weakly inhibits 5-alpha-reductase, the enzyme that turns testosterone into DHT, and has anti-inflammatory activity. None of this was measured in the human trials, so these remain possible explanations rather than shown effects.
Clinical trials
Randomized, double-blind, placebo-controlled multicentre trial of 20 mg beta-sitosterol three times daily for 6 months; primary outcome modified Boyarsky score (Berges et al. 1995, Lancet)
200 men with symptomatic benign prostatic hyperplasia, recruited between April and October 1993.
The modified Boyarsky score fell by 6.7 points versus 2.1 on placebo (p<0.01). IPSS fell by 7.4 versus 2.1, peak flow rose from 9.9 to 15.2 mL/s and residual urine fell from 65.8 to 30.4 mL on beta-sitosterol, with no change on placebo. Prostate volume did not change meaningfully in either group.
Cochrane systematic review of randomized, placebo-controlled, double-blind trials lasting 4 to 26 weeks (Wilt et al. 2000, Cochrane Database Syst Rev)
519 men with benign prostatic hyperplasia in 4 trials.
Beta-sitosterols improved IPSS by 4.9 points (95% CI 3.5 to 6.3, 2 trials), peak urine flow by 3.91 mL/s (4 trials) and residual volume by 28.6 mL (4 trials) versus placebo. Prostate size did not shrink. Withdrawal rates were similar (7.8% vs 8.0%). The reviewers said long-term effectiveness and safety are not known.
Open extension of the 6-month double-blind trial, in which men chose their own further treatment (Berges et al. 2000, BJU Int)
117 of the original 200 men (59%) were re-evaluated at 18 months.
The 38 men who continued beta-sitosterol had stable scores and flow; the 41 who stopped had slightly worse symptom scores and residual urine. The 27 former placebo takers who started beta-sitosterol improved to a similar degree. The authors said further trials are needed before concluding it is effective.
Meta-analysis of randomized controlled studies grouped by dose (Ras et al. 2014, Br J Nutr)
124 studies (201 dose strata) of plant sterols, stanols or both; average intake 2.1 g/day.
Intakes of 0.6 to 3.3 g/day lowered LDL cholesterol by about 6 to 12%, with comparable dose responses for sterols and stanols and an average effect of about 12% near 3 g/day. Two of the three authors worked for Unilever.