Saw Palmetto, Even at High Dose, Does Not Improve Lower Urinary Symptoms in Men with BPH

DynaMed Weekly Update - Volume 6, Issue 39

Lower urinary tract symptoms are common in men with benign prostatic hypertrophy (BPH) and are frequently treated with natural plant extracts. Saw palmetto, at a dose of 320 mg/day, has been a popular choice though data supporting its efficacy has been inconsistent (Cochrane Database Syst Rev 2009 Apr 15;(2):CD001423). A new randomized trial has now evaluated saw palmetto at 3 times the standard dose in 369 men with BPH and lower urinary tract symptoms and has found no evidence for any benefits from the extract (level 1 [likely reliable] evidence).

Men ? 45 years old with peak urinary flow rate ? 4 mL/second were randomized to oral saw palmetto vs. placebo for 72 weeks. The saw palmetto dose started at 320 mg/day, increasing to 640 mg/day at 24 weeks, and to 960 mg/day at 48 weeks. All participants had a score of 8-24 on the American Urological Association Symptom Index (AUASI), which measures frequency of urinary symptoms on a scale from 0 to 35. A reduction of 3 points on the AUASI was considered clinically important.

At 72 weeks, there were no significant differences between groups in nocturia, patient global assessments, indices of sexual function, continence, sleep quality, or prostatitis symptoms. The mean reduction in AUASI score was 2.2 points for saw palmetto vs. 2.99 points for placebo (not significant). AUASI scores fell by at least 3 points in 42.6% vs. 44.2% (not significant). Additionally, there were no significant differences in change in peak flow rate or postvoid residual (JAMA 2011 Sep 28;306(12):1344).

For more information, see the Benign prostatic hypertrophy (BPH) topic in DynaMed.


Cytisine for 25 Days May Increase Smoking Cessation Rates at 12 Months

Cytisine is a nicotine partial agonist that has been available for smoking cessation in Eastern Europe for several decades (as Tabex), but has not been approved in Western countries. Derived from an extract of golden rain acacia seeds, it may have potential as a low-cost treatment for smoking cessation. A recent randomized trial in Poland evaluated cytisine (1.5 mg oral tablets) in 740 adults who smoked ? 10 cigarettes/day and were willing to attempt to stop smoking permanently. Patients were randomized to cytisine vs. placebo for 25 days. The dose was 6 tablets for the first 3 days, followed by 5 tablets/day on days 4-12, 4 tablets/day on days 13-16, 3 tablets/day on days 17-20, and finally 2 tablets/day on days 21-25. All patients received minimal counseling during 4 clinical visits and 3 telephone calls over 12 months.

Follow-up at 12 months after the end of treatment included 73% of the randomized patients. The sustained abstinence rate was 8.4% for cytisine vs. 2.4% for placebo (p = 0.001, NNT 17) (level 2 [mid-level] evidence). The cytisine group also had higher 7-day point prevalence for abstinence (13.2% vs. 7.3%, p = 0.01, NNT 17). Gastrointestinal adverse events (most commonly upper abdominal pain and nausea) were significantly increased for cytisine (13.8% vs. 8.1%, p < 0.05, NNH 17). Cytisine is currently available in Russia and Poland (at the equivalent of $6 to $15 per course) (N Engl J Med 2011 Sep 29;365(13):1193).

For more information, see the Tobacco use disorder topic in DynaMed.