What is the safety and efficacy of beta-sitosterol for Benign Prostatic Hyperplasia (BPH)?

From the Guidelines

Beta-sitosterol is considered safe and moderately effective for treating benign prostatic hyperplasia (BPH) symptoms, with a recommended dosage of 60-130 mg daily, divided into 2-3 doses with meals, as supported by various studies 1.

Key Points to Consider

• The efficacy of beta-sitosterol in treating BPH symptoms is well-documented, with improvements in urinary symptoms, increased urinary flow rate, and reduced nocturia 1.
• Beta-sitosterol works by inhibiting 5-alpha-reductase and through anti-inflammatory effects on prostate tissue, making it a viable option for men with mild BPH symptoms or those seeking to avoid pharmaceutical side effects 1.
• Patients should inform their healthcare providers about the use of beta-sitosterol, especially if taking medications that affect cholesterol levels, as it may enhance their effects 1.
• While beta-sitosterol is not as potent as prescription options like alpha-blockers or 5-alpha-reductase inhibitors, it offers a reasonable natural alternative for men with mild BPH symptoms 1.

Clinical Considerations

• The management of BPH symptoms should be individualized, taking into account the severity of symptoms, patient preferences, and potential risks and benefits of treatment options 1.
• Watchful waiting is a viable option for patients with mild symptoms or moderate to severe symptoms that are not bothersome, as the risks of medical therapy may outweigh the benefits of symptom improvement in this group of men 1.
• Patients with bothersome moderate to severe symptoms should be discussed with the patient using the Simplified Outcomes Tables, and treatment options should be defined in table 1.1, including watchful waiting, medical, minimally invasive, or surgical therapies 1.

From the Research

Safety and Efficacy of Beta-Sitosterol for BPH

• Beta-sitosterol has been shown to improve urinary symptom scores and flow measures in men with benign prostatic hyperplasia (BPH) 2, 3, 4.
• The weighted mean difference (WMD) for the International Prostate Symptom Score (IPSS) was -4.9 IPSS points (95%CI = -6.3 to -3.5, n = 2 studies) 2, 4.
• The WMD for peak urine flow was 3.91 ml/sec (95%CI = 0.91 to 6.90, n = 4 studies) and the WMD for residual volume was -28.62 ml (95%CI = -41.42 to -15.83, n = 4 studies) 2, 4.
• Beta-sitosterol did not reduce prostate size 2, 4.
• The long-term effectiveness, safety, and ability to prevent BPH complications are not known 2, 3, 4.
• Withdrawal rates for men assigned to beta-sitosterol and placebo were 7.8% and 8.0%, respectively, which was not significant 2, 4.

Comparison with Other Treatments

• 5-alpha reductase inhibitors (5-ARIs) are a mainstay of BPH management and have been demonstrated to decrease prostate volume, improve LUTS and urinary flow rates, and reduce the risk of AUR and BPH-related surgery 5.
• Combination therapy with 5-ARIs and alpha-blockers may be beneficial for some patients with BPH 6.
• Beta-sitosterol has been compared to placebo and other BPH medications, but its effectiveness compared to 5-ARIs and alpha-blockers is not well established 2, 4.

Long-Term Effects

• One study found that the beneficial effects of beta-sitosterol treatment were maintained for 18 months 3.
• However, further clinical trials are needed to confirm these results and establish the long-term safety and effectiveness of beta-sitosterol for BPH 3.