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Complementary and Alternative Medicine for Urological Symptoms(CAMUS)

This study has been completed.
Sponsor:
Collaborators:
Office of Dietary Supplements (ODS)
National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cornell University
New York University
Kaiser Permanente
Northwestern University
Queen's University
University of Colorado, Denver
University of Iowa
University of Maryland
University of Texas
Washington University School of Medicine
Yale University
Information provided by (Responsible Party):
Alan Cantor, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00603304
First received: December 20, 2007
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Urological
Interventions: Drug: Saw Palmetto - first 24 weeks
Drug: Placebo - first 24 weeks
Drug: Saw Palmetto - weeks 24 - 48
Drug: Placebo - weeks 24 - 48
Drug: Saw Palmetto - weeks 48 - 72
Drug: Placebo - weeks 48 - 72

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 1032 men were prescreened for Complementary and Alternative Medicine for Urological Symptoms (CAMUS), usually by telephone; interested and preliminary eligible men were scheduled for a first screening visit.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Participant Flow:   Overall Study
    Saw Palmetto     Placebo  
STARTED     183     186  
COMPLETED     151     155  
NOT COMPLETED     32     31  
Lost to Follow-up                 5                 7  
Withdrawal by Subject                 8                 5  
Protocol Violation                 1                 0  
Adverse Event                 4                 2  
Unacceptable Treatment Toxicity                 5                 8  
Crossed Over to Open Label Therapy                 3                 3  
Exclusionary Medication                 2                 3  
Non-Compliant                 0                 1  
Moved Away                 0                 2  
Not Specified                 2                 0  
Patient Decision                 2                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Saw Palmetto     Placebo     Total  
Number of Participants  
[units: participants]
 		  183     186     369  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     123     125     248  
>=65 years     60     61     121  
Age  
[units: years]
Mean ± Standard Deviation 		  61.25  ± 8.72     60.70  ± 8.08     60.86  ± 8.38  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     183     186     369  
Region of Enrollment  
[units: participants]
 		     
United States     167     169     336  
Canada     16     17     33  



  Outcome Measures
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1.  Primary:   Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.   [ Time Frame: Baseline to 72 weeks ]

Measure Type Primary
Measure Title Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.
Measure Description The primary outcome was the mean difference in the AUA Symptom Score between baseline and 72 weeks between the saw palmetto and placebo groups. The AUA Symptom Score index is a seven item questionnaire assessing the frequency of lower urinary tract symptoms (LUTS). The questions are scored on a scale of zero to five, with zero being never, one to four being one to four accordingly, and five equaling five or more times. A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
Placebo One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  -2.20  
  ( -3.04 to -0.36 )   		  -2.99  
  ( -3.81 to -2.17 )  

No statistical analysis provided for Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.



2.  Secondary:   Participants Global Assessments of Improvement and Satisfaction at End of Study.   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title Participants Global Assessments of Improvement and Satisfaction at End of Study.
Measure Description Participants' global assessments of improvement and satisfaction at the end of the study. Likert scales were transformed to a 0 - 100 scale. The lowest possible score is 0 and the highest possible score is 100, which would reflect better outcomes.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
Placebo One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
Participants Global Assessments of Improvement and Satisfaction at End of Study.  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		   
Global Assessment: Change from Baseline     49.9  
  ( 46.0 to 54.0 )   		  50.58  
  ( 46.0 to 55.0 )  
Global Assessment: Satisfaction with Symptoms     48.9  
  ( 44.9 to 52.9 )   		  50.6  
  ( 46.4 to 54.8 )  

No statistical analysis provided for Participants Global Assessments of Improvement and Satisfaction at End of Study.



3.  Secondary:   Benign Prostate Hyperplasia (BPH) Impact Index Score   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title Benign Prostate Hyperplasia (BPH) Impact Index Score
Measure Description The mean difference in the BPH Impact Index score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The BPH Index Score is a self administered 4 item index. Three questions are scored on a scale from 0 to 3, with zero being none, one being only a little, two being some, and three being a lot. One question is scored on a scale from 0 to 4, with zero being none of the time, one being a little of the time, two being some of the time, three being most of the time, and four being all of the time. The lowest possible score is 0 and the highest possible score is 13, which would represent the greatest dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
Benign Prostate Hyperplasia (BPH) Impact Index Score  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  -0.81  
  ( -1.16 to -0.46 )   		  -1.23  
  ( -1.60 to -0.87 )  

No statistical analysis provided for Benign Prostate Hyperplasia (BPH) Impact Index Score



4.  Secondary:   International Prostate Symptom Score Quality of Life (IPSS QOL) Score   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title International Prostate Symptom Score Quality of Life (IPSS QOL) Score
Measure Description The mean difference in the IPSS Quality-of-Life Question from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IPSS Quality-of-Life Question is an additional question to the AUA Symptom Score. The self administered question is scored on a scale from 0 to 6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed-about equally satisfied and dissatisfied, four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 6, which would represent the greatest dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
International Prostate Symptom Score Quality of Life (IPSS QOL) Score  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  -0.34  
  ( -0.52 to -0.16 )   		  -0.49  
  ( -0.67 to -0.31 )  

No statistical analysis provided for International Prostate Symptom Score Quality of Life (IPSS QOL) Score



5.  Secondary:   American Urological Association(AUA) Nocturia Item   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title American Urological Association(AUA) Nocturia Item
Measure Description The mean difference in the nocturia item of the AUA Symptom Score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The nocturia item is a self administered question from the AUA Symptom Score Index that assesses the number of times a participant typically gets up to urinate from the time he goes to bed at night until the time he gets up in the morning. The question is scored on a scale of zero to five, with zero being none, one being one time, two being two times, three being three times, four being four times, and five being five or more times. The lowest possible score is 0 and the highest possible score is 5, which would represent the highest level dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
American Urological Association(AUA) Nocturia Item  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  -0.36  
  ( -0.72 to 0 )   		  -0.15  
  ( -0.44 to 0.13 )  

No statistical analysis provided for American Urological Association(AUA) Nocturia Item



6.  Secondary:   Peak Uroflow   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title Peak Uroflow
Measure Description The mean difference in the participants' peak uroflow from baseline to 72 weeks in the modified intention to treat analysis. The peak uroflow was measured in milliliters/seconds. The higher units indicated greater dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
Peak Uroflow  
[units: mL/sec]
Mean ( 95% Confidence Interval ) 		  -0.18  
  ( -1.07 to .70 )   		  -0.79  
  ( -1.58 to 0 )  

No statistical analysis provided for Peak Uroflow



7.  Secondary:   Post-void Residual   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title Post-void Residual
Measure Description The mean difference in the participants' post-void residual from baseline to 72 weeks in the modified intention to treat analysis. The post-void residual was measured in milliliters. The higher units indicated greater dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population was determined by the number of participants that were randomized and included in the modified intention to treat analyses.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
Post-void Residual  
[units: mL]
Mean ( 95% Confidence Interval ) 		  4.78  
  ( -30.00 to 52 )   		  1.17  
  ( -33.00 to 34 )  

No statistical analysis provided for Post-void Residual



8.  Secondary:   Prostate Specific Antigen (PSA) Level   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title Prostate Specific Antigen (PSA) Level
Measure Description The mean difference in the PSA level from baseline to 72 weeks in the modified intention to treat analysis. The PSA level was measured in nanograms/milliliters. The higher units indicated greater dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
Prostate Specific Antigen (PSA) Level  
[units: ng/mL]
Mean ( 95% Confidence Interval ) 		  0.32  
  ( -0.08 to 0.73 )   		  -0.19  
  ( -0.53 to 0.14 )  

No statistical analysis provided for Prostate Specific Antigen (PSA) Level



9.  Secondary:   International Index of Erectile Function (IIEF)Scale Score.   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title International Index of Erectile Function (IIEF)Scale Score.
Measure Description The mean difference in the IIEF score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IIEF is a multidimensional scale for assessment of erectile dysfunction. The six item self administered questionnaire is scored on a scale from 0 to 5, with zero being no sexual activity, one being never or almost never, two being a few times (much less than half the time), three being sometimes (much less than half the time), four being most times (much more than half the time), and five being always or almost always. The lowest possible score is 0 and the highest possible score is 30, which represents less dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
International Index of Erectile Function (IIEF)Scale Score.  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  -0.52  
  ( -1.63 to 0.59 )   		  -1.06  
  ( -2.11 to -0.02 )  

No statistical analysis provided for International Index of Erectile Function (IIEF)Scale Score.



10.  Secondary:   Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.   [ Time Frame: Baseline to 72 weeks. ]

Measure Type Secondary
Measure Title Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.
Measure Description The mean difference in the MSHQ-EjD from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The MSHQ-EjD scale is used for the assessment ejaculatory dysfunction (EjD). The MSHQ-EjD consists of four self administered questions. Three of the items are scored on a scale from 0 to 5, with zero being all the time, one being most of the time, two being some of the time, three being a little of the time, four being none of the time, and five being no sexual activity. The fourth item is scored on a scale of 1 – 5, with one being not at all bothered, two being a little bit bothered, three being moderately bothered, four being very bothered, and five being extremely bothered. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.
Time Frame Baseline to 72 weeks.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  -0.38  
  ( -1.04 to 0.28 )   		  -0.09  
  ( -0.63 to 0.45 )  

No statistical analysis provided for Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.



11.  Secondary:   International Continence Society Male Incontinence Symptom (ICSmale IS) Score   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title International Continence Society Male Incontinence Symptom (ICSmale IS) Score
Measure Description The mean difference in the ICSmaleIS score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The six item self administered questionnaire is scored on a scale from 0 to 4, with zero being never, one being occasionally, two being sometimes, three being most of the time, and four being all of the time. The lowest possible is 0 and the highest possible score is 24, which represents the the highest level of dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
International Continence Society Male Incontinence Symptom (ICSmale IS) Score  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  -0.48  
  ( -0.80 to -0.16 )   		  -0.84  
  ( -1.17 to -0.51 )  

No statistical analysis provided for International Continence Society Male Incontinence Symptom (ICSmale IS) Score



12.  Secondary:   Jenkins Sleep Scale Score   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title Jenkins Sleep Scale Score
Measure Description The mean difference in the Jenkins Sleep Dysfunction score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. Jenkins Sleep Dysfunction score is used to assess sleep dysfunction. The four item self administered questionnaire is scored on a scale from 0 to 5, with zero being not at all, one being 1 -3 days, two being 4 – 7 days, three being 8 – 14 days, four being 15 – 21 days, and five being 22 – 31 days. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
Jenkins Sleep Scale Score  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  -0.80  
  ( -1.34 to -0.27 )   		  -1.63  
  ( -2.25 to -1.01 )  

No statistical analysis provided for Jenkins Sleep Scale Score



13.  Secondary:   NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale
Measure Description The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale is a four item self administered questionnaire. Three of the four items are scored on a scale from 0 – 1, with zero being no and one being yes. The fourth item is scored on a scale from 0 – 10, with zero being no pain and ten being pain as bad as you can imagine. The lowest possible score is 0 and the highest possible score is 21, which represents the highest level of pain.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  0  
  ( -0.08 to 0 )   		  0  
  ( -1.00 to 0 )  

No statistical analysis provided for NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale



14.  Secondary:   NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale
Measure Description The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale consists of two self administered questions. The questions are scored on a scale from 0 – 5, with zero being not at all, one being less than 1 time in 5, two being less than half the time, three being about half the time, four being more than half the time, and five being almost always. The lowest possible score is 0 and the highest possible score is 10, which represents the highest level of dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  -0.35  
  ( -0.67 to -0.03 )   		  -0.86  
  ( -1.22 to -0.49 )  

No statistical analysis provided for NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale



15.  Secondary:   NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale   [ Time Frame: Baseline to 72 weeks ]

Measure Type Secondary
Measure Title NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale
Measure Description The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale consists of three self administered questions. Two of the questions are scored on a scale of 0 – 3, with zero being none, one being only a little, two being some, and three being a lot. The third question is scored on a scale of 0 -6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed (equally satisfied and dissatisfied), four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 12, which represents the highest level of dysfunction.
Time Frame Baseline to 72 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.

Reporting Groups
  Description
Saw Palmetto Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.

Measured Values
    Saw Palmetto     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  176     181  
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale  
[units: units on a scale]
Mean ( 95% Confidence Interval ) 		  -0.85  
  ( -1.16 to -0.53 )   		  -1.08  
  ( -1.39 to -0.77 )  

No statistical analysis provided for NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale




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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Alan Cantor
Organization: University of Alabama at Birmingham
phone: (205) 934-6887
e-mail: acantor@uab.edu


Publications of Results:

Other Publications:

Publications automatically indexed to this study:


Responsible Party: Alan Cantor, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00603304     History of Changes
Obsolete Identifiers: NCT00097136
Other Study ID Numbers: X021004002, U01DK063788, Tracking # (UAB) 000175609
Study First Received: December 20, 2007
Results First Received: April 26, 2012
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration