The frequency of LUTS in the study group was significantly increased compared with that in the control group (p<0.01); the mean AUASI score in the study group (6.61) was higher than that in the control group (2.56).
Furthermore, there was a positive correlation between AUASI measurements and HAD anxiety scores (anxiety was increased with increasing LUTS) (p<0.05) (Figure 1).
By using the same symptom scoring system (AUASI
) as many studies in the previous Cochrane reviews, Barry et al were able to compare their findings with those of other high-quality studies with similar methodologies and outcome measures.
The primary outcome was the change in AUASI score at 72 weeks.
Similarly, the proportion of men who achieved a minimal (3-point) decrease in AUASI score over time was 42.6% with saw palmetto and 44.2% with placebo, slightly favoring placebo.
The primary outcome measure was the change in AUASI
score at 72 weeks.
The researchers measured the differences between the AUASI score at the start of the trial and after 72 weeks of treatment.
Between baseline and 72 weeks, mean AUASI scores decreased from 14.4 to 12.2 points with saw palmetto extract and from 14.7 to 11.7 points with placebo.
Outcome Measures: The primary outcome measures were the changes in the scores on the AUASI and the maximal urinary flow rates.
Key Findings: Both groups had a small decrease in AUASI score during the 12-month study period--0.68 in the saw palmetto group (95% CI, -1.37 to 0.001) and 0.72 in the placebo group (95% CI, -1.40 to -0.04).
Results: The results of the trial suggested there were no significant differences between the saw palmetto and placebo groups in the change in AUASI
scores, maximum urinary flow rate, prostate size, residual volume after voiding, quality of life, or serum prostate-specific antigen (PSA) levels.
The patients in both groups had small, equivalent decreases in AUASI
scores during the study period (saw palmetto, 0.68; placebo, 0.72).