SAW PALMETTO FOR BENIGN PROSTATIC HYPERPLASIA eak urinary flow rate over time in the ty dikelihood-ratio chi-square rest.0.87 with 2de 14 grees of freedom;P=0.65). Examination of the 13 12- sF-36,1n creat did .The pre subgroup analyses also sho ed no b enefit for e were to the baseline AUASI score (P=0.32),P tate size Screening Randomi-Mo 3 Mo6 Mo9 Mo 1 for UAS 1106101o prostate size(P=0.63),or PSA level (P= 0871 A total of 26 serious adverse even occurred Change in Peak Urinary Flow Rates in- in 17 participant during the s udy:8 in men as Values at screening represent prerandomization screening values rse event did not differ 6 able3.Serious Adverse Events. tween the two groups (P=0.31 by Fisher's exact Ihere wer nt in the ups (0.51 vs.0.4 P=0.7 by Student's ttest) Events Cardiovascular event 2 The adequacy of blinding was assessed by ask Bladder cance ing participants whether they believed they were al ing saw palmetto or placeb At 1 per om eebonmpaiewih6peentofmeminthe Mela placebo group (P=0.38). Prostate cance Shortness of breat DISCUSSION 0 Total In this year-long randomized trial,we found that Patients with≥1 event 6 1 saw palmetto was not superior to placebo for im proving rinary symptoms and ecuve mea were narrow,excluding clinically important ef that a clinically meaningful change in symptoms of b enign prostatic rplasia requires a enc -0.9339 101)is in the (includi ENGLJ MED 354:6 WWW.NEJM.ORG FEBRUARY 9.2006 563 Downloaded from r se only.N other use mhoupemison saw palmetto for benign prostatic hyperplasia n engl j med 354;6 www.nejm.org february 9, 2006 563 peak urinary flow rate over time in the two groups (likelihood-ratio chi-square test, 0.87 with 2 de￾grees of freedom; P = 0.65). Examination of the secondary outcome mea￾sures also revealed no significant difference be￾tween treatment groups (Table 2). Changes in prostate size, residual volume after voiding, the BPH Impact Index, the overall quality of life as measured by the SF-36, and serum PSA, creati￾nine, and testosterone levels did not differ sig￾nificantly between the two groups. The preplanned subgroup analyses also showed no benefit for any of the subgroups: for the AUASI outcome, there were no significant differences in response between the groups when stratified according to the baseline AUASI score (P = 0.32), prostate size (P = 0.23), or PSA level (P = 0.86). Similarly, for the peak urinary flow rate, there were no inter￾actions with the baseline AUASI score (P = 0.13), prostate size (P = 0.63), or PSA level (P = 0.87). A total of 26 serious adverse events occurred in 17 participants during the study: 8 in men as￾signed to saw palmetto and 18 in men assigned to placebo (Table 3). The risk of at least one seri￾ous adverse event did not differ significantly be￾tween the two groups (P = 0.31 by Fisher’s exact test). There were also no significant differences in the mean number of nonserious adverse events per participant in the saw palmetto and placebo groups (0.51 vs. 0.47, P = 0.72 by Student’s t-test) (Table 4) or in the change in laboratory values, including testosterone, PSA, and creatinine levels (Table 2). The adequacy of blinding was assessed by ask￾ing participants whether they believed they were taking saw palmetto or placebo capsules. At 12 months, 40 percent of men in the saw palmetto group believed they were taking the herbal ex￾tract, as compared with 46 percent of men in the placebo group (P = 0.38). Discussion In this year-long randomized trial, we found that saw palmetto was not superior to placebo for im￾proving urinary symptoms and objective mea￾sures of benign prostatic hyperplasia. The confi￾dence intervals around the finding of no effect were narrow, excluding clinically important ef￾fects. For example, the 95 percent confidence in￾terval for the difference in the change in the AUASI score between groups (−0.93 to 1.01) is consistent with only a 1-point improvement in the AUASI score. Previous research has suggested that a clinically meaningful change in symptoms of benign prostatic hyperplasia requires a change in the AUASI score of at least 3 points.26 Also, all symptomatic measures (including the AUASI and 14 Peak Urinary Flow Rate (ml/min) 9 10 11 12 13 0 Screening Randomi￾zation Mo 3 Mo 9 Mo 12 No. Analyzed Saw palmetto Placebo 101 105 100 103 101 102 Mo 6 101 106 106 107 112 113 Saw palmetto Placebo Figure 3. Mean (±SE) Change in Peak Urinary Flow Rates in the Saw Pal￾metto and Placebo Groups. Values at screening represent prerandomization screening values. Table 3. Serious Adverse Events. Variable Saw Palmetto (N = 112) Placebo (N = 113) number Events Cardiovascular event 2 7 Elective orthopedic surgery 3 3 Gastrointestinal bleeding 2 1 Bladder cancer 0 1 Colon cancer 0 1 Elective hernia repair 0 1 Hematoma 0 1 Melanoma 1 0 Prostate cancer 0 1 Shortness of breath 0 1 Rhabdomyolysis 0 1 Total 8 18 Patients with ≥1 event 6 11 The New England Journal of Medicine Downloaded from nejm.org on October 18, 2011. For personal use only. No other uses without permission. Copyright © 2006 Massachusetts Medical Society. All rights reserved