The NEW ENGLAND JOURNAL Of MEDICINE in however,no significant difference between groups in the mean change in AUASI scores over time (differen in mean ch ange.0.0 5 per shows that the fitted curves for the sw palmetto and placebo groups nearly coincide,indicating 2 Similarly.there was no significant difference Mo3 Mo5 Mo9 between groups in the change in the peak uri- nary flow rate du ng the one-year he pee 5 -0.25 1.10)in the saw palmetto group and by-0.01m per minute (95 percent confidence interval,-0.68 in the placebo group (me Values at screer prerandom alues.The ful val.-0.52 to 138).Figure 3 shows that the fitted curves for the saw palmetto and placebo groups nearly coincide,indicating similar changes in the Table 2.Changes in Primary and Secondary Outcome Measures. Measure 幽 meon仕S目change Primary outcomes AUASI scoret -0.68±0.35 0.72±035 0.041-0.93to1011 Peak urinary flow rate(ml/sec) 0.4240.34 -0.01±0.34 043(-0.52to1.38) Secondary outcomes Prostate volume (ml) 3.76=0.98 4.98±096 -1221-3.90to1.47刀 Prostate transitional-zone volume (ml) 32641.03 2.01±1.01 125（-1.57to4.07 Residual volume after voiding (ml) 14.10:724 18.62±7.14 -451-24.44to15.42） BPH Impact Index scoret -0.33±013 -0.09±0.13 -024(-0.60to0.13) SF-36 scoref Mental subscale -0.72±077 0.47±0.71 -1.18(-3.16to0.79 Physical subscale 0.10±0.6 0.51±0.66 0.61（-1.24to2.45) Sexual function (O'Leary scale) -0.06±010 0.07±0.10 -013（-0.40to0.14) Laboratory values Creatinine(mg/dl 0.002±0.0 -0.004±0.01 0.006（-0.02to0.03 Testosterone (ng/dl =16,82±874 -1.42±864 -15.40(-39.49to8.69 PSA (ng/dl) -0.005±0.07 0.15±0.07 -0.16（-0.36to0.04) SE.Toconver values to micromoles per iter,multiply by4.Cldenotes confidence interval. 35 ct li 0(no s ms)to 13(s to 1 res on the O L ating better functio 562 N ENGLJ MED 354:6 WWW.NEJM.ORG FEBRUARY 9.2006 Downloaded from neim.The new england journal o f medicine 562 n engl j med 354;6 www.nejm.org february 9, 2006 0.72 in the placebo group (95 percent confidence interval, −1.40 to −0.04) (Table 2). There was, however, no significant difference between groups in the mean change in AUASI scores over time (difference in mean change, 0.04 point; 95 per￾cent confidence interval, −0.93 to 1.01). Figure 2 shows that the fitted curves for the saw palmetto and placebo groups nearly coincide, indicating similar changes in AUASI scores over time in the two groups (likelihood-ratio chi-square test, 0.62 with 2 degrees of freedom; P = 0.73). Similarly, there was no significant difference between groups in the change in the peak uri￾nary flow rate during the one-year study period. The peak urinary flow rate changed by 0.42 ml per minute (95 percent confidence interval, −0.25 to 1.10) in the saw palmetto group and by −0.01 ml per minute (95 percent confidence interval, −0.68 to 0.66) in the placebo group (mean difference, 0.43 ml per minute; 95 percent confidence inter￾val, −0.52 to 1.38). Figure 3 shows that the fitted curves for the saw palmetto and placebo groups nearly coincide, indicating similar changes in the 18 AUASI Score 16 17 15 14 12 13 0 Screening Randomi￾zation Mo 3 Mo 9 Mo 12 No. Analyzed Saw palmetto Placebo 107 109 108 109 108 112 Mo 6 108 111 112 113 112 113 Saw palmetto Placebo Figure 2. Mean (±SE) Change in American Urological Association Symptom Index (AUASI) Scores in the Saw Palmetto and Placebo Groups. Values at screening represent prerandomization screening values. The full range of the scale is from 0 to 35, with higher numbers indicating more severe symptoms. Table 2. Changes in Primary and Secondary Outcome Measures.* Measure Saw Palmetto (N = 112) Placebo (N = 113) Difference between Groups (95% CI) mean (±SE) change Primary outcomes AUASI score† −0.68±0.35 −0.72±0.35 0.04 (−0.93 to 1.01) Peak urinary flow rate (ml/sec) 0.42±0.34 −0.01±0.34 0.43 (−0.52 to 1.38) Secondary outcomes Prostate volume (ml) 3.76±0.98 4.98±0.96 −1.22 (−3.90 to 1.47) Prostate transitional-zone volume (ml) 3.26±1.03 2.01±1.01 1.25 (−1.57 to 4.07) Residual volume after voiding (ml) 14.10±7.24 18.62±7.14 −4.51 (−24.44 to 15.42) BPH Impact Index score‡ −0.33±0.13 −0.09±0.13 −0.24 (−0.60 to 0.13) SF-36 score§ Mental subscale −0.72±0.72 0.47±0.71 −1.18 (−3.16 to 0.79) Physical subscale 0.10±0.67 −0.51±0.66 0.61 (−1.24 to 2.45) Sexual function (O’Leary scale)¶ −0.06±0.10 0.07±0.10 −0.13 (−0.40 to 0.14) Laboratory values Creatinine (mg/dl) 0.002±0.01 −0.004±0.01 0.006 (−0.02 to 0.03) Testosterone (ng/dl) −16.82±8.74 −1.42±8.64 −15.40 (−39.49 to 8.69) PSA (ng/dl) −0.005±0.07 0.15±0.07 −0.16 (−0.36 to 0.04) * Plus–minus values are means ±SE. To convert creatinine values to micromoles per liter, multiply by 88.4. CI denotes confidence interval, and PSA prostate-specific antigen. † Scores on the AUASI can range from 0 (no symptoms) to 35 (severe symptoms). ‡ Scores on the BPH Impact Index can range from 0 (no symptoms) to 13 (severe symptoms). § Scores on the SF-36 can range from 0 to 100; higher scores indicate a better quality of life. ¶ Overall scores on the O’Leary Scale of Sexual Function can range from 0 to 4, with higher scores indicating better function. 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