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Complementary and Alternative Medicine for Urological Symptoms(CAMUS) (CAMUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00603304
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : October 12, 2012
Last Update Posted : October 12, 2012
Sponsor:
Collaborators:
Office of Dietary Supplements (ODS)
National Center for Complementary and Integrative Health (NCCIH)
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, 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
Enrollment 369

Recruitment Details 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  
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description 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. Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Period Title: Overall Study
Started 183 186
Completed 151 155
Not Completed 32 31
Reason Not Completed
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
Arm/Group Title Saw Palmetto Placebo Total
Hide Arm/Group Description 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. Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 183 186 369
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 186 participants 369 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
123
  67.2%
125
  67.2%
248
  67.2%
>=65 years
60
  32.8%
61
  32.8%
121
  32.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 183 participants 186 participants 369 participants
61.25  (8.72) 60.70  (8.08) 60.86  (8.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 186 participants 369 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
183
 100.0%
186
 100.0%
369
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 183 participants 186 participants 369 participants
United States 167 169 336
Canada 16 17 33
1.Primary Outcome
Title Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.20
(-3.04 to -0.36)
-2.99
(-3.81 to -2.17)
2.Secondary Outcome
Title Participants Global Assessments of Improvement and Satisfaction at End of Study.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
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)
3.Secondary Outcome
Title Benign Prostate Hyperplasia (BPH) Impact Index Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.81
(-1.16 to -0.46)
-1.23
(-1.60 to -0.87)
4.Secondary Outcome
Title International Prostate Symptom Score Quality of Life (IPSS QOL) Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.34
(-0.52 to -0.16)
-0.49
(-0.67 to -0.31)
5.Secondary Outcome
Title American Urological Association(AUA) Nocturia Item
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.36
(-0.72 to 0)
-0.15
(-0.44 to 0.13)
6.Secondary Outcome
Title Peak Uroflow
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: mL/sec
-0.18
(-1.07 to .70)
-0.79
(-1.58 to 0)
7.Secondary Outcome
Title Post-void Residual
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population was determined by the number of participants that were randomized and included in the modified intention to treat analyses.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: mL
4.78
(-30.00 to 52)
1.17
(-33.00 to 34)
8.Secondary Outcome
Title Prostate Specific Antigen (PSA) Level
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
0.32
(-0.08 to 0.73)
-0.19
(-0.53 to 0.14)
9.Secondary Outcome
Title International Index of Erectile Function (IIEF)Scale Score.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.52
(-1.63 to 0.59)
-1.06
(-2.11 to -0.02)
10.Secondary Outcome
Title Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.38
(-1.04 to 0.28)
-0.09
(-0.63 to 0.45)
11.Secondary Outcome
Title International Continence Society Male Incontinence Symptom (ICSmale IS) Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.48
(-0.80 to -0.16)
-0.84
(-1.17 to -0.51)
12.Secondary Outcome
Title Jenkins Sleep Scale Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.80
(-1.34 to -0.27)
-1.63
(-2.25 to -1.01)
13.Secondary Outcome
Title NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0
(-0.08 to 0)
0
(-1.00 to 0)
14.Secondary Outcome
Title NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.35
(-0.67 to -0.03)
-0.86
(-1.22 to -0.49)
15.Secondary Outcome
Title NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description:
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.
Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
Overall Number of Participants Analyzed 176 181
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.85
(-1.16 to -0.53)
-1.08
(-1.39 to -0.77)
Time Frame Collected over 72 weeks
Adverse Event Reporting Description The number of participants at risk was determined by the number of participants that were randomized and included in the modified intention to treat analyses.
 
Arm/Group Title Saw Palmetto Placebo
Hide Arm/Group Description One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks. One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
All-Cause Mortality
Saw Palmetto Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Saw Palmetto Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/176 (10.23%)      17/181 (9.39%)    
Cardiac disorders     
Episode of atrial fibrillation *  0/176 (0.00%)  0 1/181 (0.55%)  1
Hospitalized for chest pain due to coronary artery disease, underwent revascularization *  1/176 (0.57%)  1 0/181 (0.00%)  0
Inferior wall myocardial infarction *  1/176 (0.57%)  1 0/181 (0.00%)  0
Gastrointestinal disorders     
Lower gastointestinal diverticular bleeding *  0/176 (0.00%)  0 1/181 (0.55%)  1
Small bowel obstruction requiring laparoscopy lysis of adhesions *  0/176 (0.00%)  0 1/181 (0.55%)  1
Upper gastrointestinal bleeding requiring transfusion *  0/176 (0.00%)  0 1/181 (0.55%)  1
General disorders     
Hospitalized for chest pain *  0/176 (0.00%)  0 1/181 (0.55%)  1
Hospitalized for chest pain that proved noncardiac after the study *  0/176 (0.00%)  0 1/181 (0.55%)  1
Infections and infestations     
Hospitalized for cellulitis of the elbow, required intravenous antibiotics *  0/176 (0.00%)  0 1/181 (0.55%)  1
Hospitalized for diverticulitis *  1/176 (0.57%)  1 0/181 (0.00%)  0
Hospitalized for pneumonia *  1/176 (0.57%)  1 0/181 (0.00%)  0
Sepsis secondary to a pelvic fracture *  1/176 (0.57%)  1 0/181 (0.00%)  0
Severe Gastroenteritis *  1/176 (0.57%)  1 0/181 (0.00%)  0
Injury, poisoning and procedural complications     
Automobile accident with multiple injuries *  1/176 (0.57%)  1 0/181 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Hospitalized for knee pain secondary to torn vastus lateralis muscle *  0/176 (0.00%)  0 1/181 (0.55%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Cancer *  1/176 (0.57%)  1 0/181 (0.00%)  0
Hospitalized for radioactive iodine treatment for thyroid cancer *  1/176 (0.57%)  1 0/181 (0.00%)  0
Mestatic recurrent follicular thyroid carcinoma *  1/176 (0.57%)  1 0/181 (0.00%)  0
Pancreatic Cancer *  1/176 (0.57%)  1 0/181 (0.00%)  0
Nervous system disorders     
Cerebellar stroke *  1/176 (0.57%)  1 0/181 (0.00%)  0
Syncope with transient high grade atrioventricular block *  1/176 (0.57%)  1 0/181 (0.00%)  0
Renal and urinary disorders     
Gross hematuria *  1/176 (0.57%)  1 0/181 (0.00%)  0
Hospitalized for hypotension due to pneumonia and chronic kidney disease *  1/176 (0.57%)  1 0/181 (0.00%)  0
Reproductive system and breast disorders     
Bacterial epididymitis requiring intravenous antibiotics *  0/176 (0.00%)  0 1/181 (0.55%)  1
Surgical and medical procedures     
Appendectomy for appendicitis *  0/176 (0.00%)  0 1/181 (0.55%)  1
Appendectomy for ruptured appendix *  0/176 (0.00%)  0 1/181 (0.55%)  1
Back surgery for a lumbar spinal connective tissue cyst *  0/176 (0.00%)  0 1/181 (0.55%)  1
Colon resection for a polyp *  0/176 (0.00%)  0 1/181 (0.55%)  1
Elective knee replacement *  1/176 (0.57%)  1 0/181 (0.00%)  0
Elective knee replacement *  0/176 (0.00%)  0 1/181 (0.55%)  1
Elective plastic surgery *  1/176 (0.57%)  1 0/181 (0.00%)  0
Elective tonsillectomy and deviated nasal septum repair *  0/176 (0.00%)  0 1/181 (0.55%)  1
Hospitalized after pacemaker insertion *  0/176 (0.00%)  0 1/181 (0.55%)  1
Hospitalized for abdominal pain, underwent laparascopic cholecystectomy *  0/176 (0.00%)  0 1/181 (0.55%)  1
Vascular disorders     
Elective repair of abdominal aortic aneurysm *  1/176 (0.57%)  1 0/181 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Saw Palmetto Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   138/176 (78.41%)      139/181 (76.80%)    
Gastrointestinal disorders     
Diarrhea *  14/176 (7.95%)  14 8/181 (4.42%)  8
Constipation *  7/176 (3.98%)  7 7/181 (3.87%)  7
Hemorrhoids *  1/176 (0.57%)  1 1/181 (0.55%)  1
Hernia *  1/176 (0.57%)  1 3/181 (1.66%)  3
Reflux *  4/176 (2.27%)  4 5/181 (2.76%)  5
Abdominal Pains *  1/176 (0.57%)  1 2/181 (1.10%)  2
Rectal Bleed *  1/176 (0.57%)  1 2/181 (1.10%)  2
Gastroenteritis *  4/176 (2.27%)  4 1/181 (0.55%)  1
Barrett's Esophagus *  3/176 (1.70%)  3 0/181 (0.00%)  0
Flatulence *  2/176 (1.14%)  2 3/181 (1.66%)  3
Nausea *  4/176 (2.27%)  4 4/181 (2.21%)  4
Fatty Liver *  1/176 (0.57%)  1 0/181 (0.00%)  0
Diverticulitis *  3/176 (1.70%)  3 2/181 (1.10%)  2
Dysphagia *  1/176 (0.57%)  1 0/181 (0.00%)  0
Esophagitis *  2/176 (1.14%)  2 0/181 (0.00%)  0
Bloating *  1/176 (0.57%)  1 2/181 (1.10%)  2
White Stool *  1/176 (0.57%)  1 0/181 (0.00%)  0
Upset Stomach/Flu *  1/176 (0.57%)  1 9/181 (4.97%)  9
Appendicitis *  0/176 (0.00%)  0 2/181 (1.10%)  2
Black Stool *  0/176 (0.00%)  0 1/181 (0.55%)  1
Colon Polyp *  0/176 (0.00%)  0 2/181 (1.10%)  2
Emesis *  0/176 (0.00%)  0 1/181 (0.55%)  1
Irritable Bowel Syndrome *  0/176 (0.00%)  0 1/181 (0.55%)  1
Anal Itching *  0/176 (0.00%)  0 1/181 (0.55%)  1
Musculoskeletal and connective tissue disorders     
Back Pain *  11/176 (6.25%)  11 13/181 (7.18%)  13
Knee Pain *  11/176 (6.25%)  11 7/181 (3.87%)  7
Gout *  1/176 (0.57%)  1 5/181 (2.76%)  5
Foot Pain *  1/176 (0.57%)  1 8/181 (4.42%)  8
Tendonitis *  2/176 (1.14%)  2 0/181 (0.00%)  0
Muscle Spasms *  1/176 (0.57%)  1 0/181 (0.00%)  0
Hip Pain *  6/176 (3.41%)  6 2/181 (1.10%)  2
Shoulder Pain *  8/176 (4.55%)  8 10/181 (5.52%)  10
Elbow Pain *  4/176 (2.27%)  4 2/181 (1.10%)  2
Broken Tooth *  1/176 (0.57%)  1 0/181 (0.00%)  0
Chest Discomfort *  2/176 (1.14%)  2 1/181 (0.55%)  1
Bursitis *  1/176 (0.57%)  1 0/181 (0.00%)  0
Arthritis *  2/176 (1.14%)  2 1/181 (0.55%)  1
Cyst *  1/176 (0.57%)  1 0/181 (0.00%)  0
Osteoporosis *  1/176 (0.57%)  1 0/181 (0.00%)  0
Hernia *  2/176 (1.14%)  2 2/181 (1.10%)  2
Facial Edema *  1/176 (0.57%)  1 0/181 (0.00%)  0
C-Spine Degenerative Disease *  1/176 (0.57%)  1 0/181 (0.00%)  0
Bruised Ribs/Pain *  2/176 (1.14%)  2 0/181 (0.00%)  0
Flank Pain *  3/176 (1.70%)  3 0/181 (0.00%)  0
Joint Pain *  1/176 (0.57%)  1 0/181 (0.00%)  0
Fore Arm Pain *  2/176 (1.14%)  2 2/181 (1.10%)  2
Lump in Right Calf *  1/176 (0.57%)  1 0/181 (0.00%)  0
Neck Pain *  3/176 (1.70%)  3 3/181 (1.66%)  3
Spinal Stenosis *  2/176 (1.14%)  2 0/181 (0.00%)  0
Hand Pain *  3/176 (1.70%)  3 1/181 (0.55%)  1
Plantar Fascitis *  1/176 (0.57%)  1 1/181 (0.55%)  1
Toe Surgery *  1/176 (0.57%)  1 1/181 (0.55%)  1
Leg Pain *  1/176 (0.57%)  1 0/181 (0.00%)  0
Knee Replacement *  0/176 (0.00%)  0 1/181 (0.55%)  1
Groin Pain *  0/176 (0.00%)  0 4/181 (2.21%)  4
Osteopenia *  0/176 (0.00%)  0 1/181 (0.55%)  1
Jaw Pain *  0/176 (0.00%)  0 1/181 (0.55%)  1
Sciatic Nerve Pain *  0/176 (0.00%)  0 3/181 (1.66%)  3
Sore Coccyx *  0/176 (0.00%)  0 1/181 (0.55%)  1
Wrist Surgery *  0/176 (0.00%)  0 1/181 (0.55%)  1
Renal and urinary disorders     
Hematuria *  2/176 (1.14%)  2 1/181 (0.55%)  1
Nocturia *  10/176 (5.68%)  10 7/181 (3.87%)  7
Decreased Libido *  3/176 (1.70%)  3 3/181 (1.66%)  3
Kidney Stones *  1/176 (0.57%)  1 4/181 (2.21%)  4
Elevated PSA *  1/176 (0.57%)  1 0/181 (0.00%)  0
Testicular Pain *  2/176 (1.14%)  2 2/181 (1.10%)  2
Tip of Penis Swollen *  2/176 (1.14%)  2 0/181 (0.00%)  0
BPH Symptoms *  27/176 (15.34%)  27 33/181 (18.23%)  33
Pain in Groin *  1/176 (0.57%)  1 0/181 (0.00%)  0
Incontinence *  3/176 (1.70%)  3 2/181 (1.10%)  2
Prostatitis *  2/176 (1.14%)  2 2/181 (1.10%)  2
Small Spermatocele found in physical exam *  1/176 (0.57%)  1 0/181 (0.00%)  0
Prostate nodule left lobe *  1/176 (0.57%)  1 0/181 (0.00%)  0
Peyronies Disease *  1/176 (0.57%)  1 0/181 (0.00%)  0
Urinary Tract Infection *  1/176 (0.57%)  1 1/181 (0.55%)  1
Increase Firmness Erection *  1/176 (0.57%)  1 0/181 (0.00%)  0
Anal Itching *  0/176 (0.00%)  0 1/181 (0.55%)  1
Epididymitis *  0/176 (0.00%)  0 1/181 (0.55%)  1
Increased PVR *  0/176 (0.00%)  0 1/181 (0.55%)  1
Trace WBC in Urine *  0/176 (0.00%)  0 1/181 (0.55%)  1
Urological Disorder - Bloating *  0/176 (0.00%)  0 1/181 (0.55%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchitis *  4/176 (2.27%)  4 3/181 (1.66%)  3
Cold *  23/176 (13.07%)  23 19/181 (10.50%)  19
Frost bite to bronchial tubes *  1/176 (0.57%)  1 0/181 (0.00%)  0
Increase mucus *  1/176 (0.57%)  1 0/181 (0.00%)  0
Strep Throat *  1/176 (0.57%)  1 1/181 (0.55%)  1
Pharyngitis *  1/176 (0.57%)  1 2/181 (1.10%)  2
Congestion *  3/176 (1.70%)  3 1/181 (0.55%)  1
Sinus Infection *  9/176 (5.11%)  9 12/181 (6.63%)  12
Sneezing *  9/176 (5.11%)  9 0/181 (0.00%)  0
Sore Throat *  2/176 (1.14%)  2 2/181 (1.10%)  2
Respiratory Infection *  2/176 (1.14%)  2 10/181 (5.52%)  10
Rhinitis *  0/176 (0.00%)  0 2/181 (1.10%)  2
Rhinorrhea *  0/176 (0.00%)  0 1/181 (0.55%)  1
Post Nasal Drip *  0/176 (0.00%)  0 1/181 (0.55%)  1
Pre-Existing Lower Back Pain *  0/176 (0.00%)  0 1/181 (0.55%)  1
Tonsilectomy and Deviated Septum Repair *  0/176 (0.00%)  0 1/181 (0.55%)  1
Cough *  5/176 (2.84%)  5 5/181 (2.76%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Alan Cantor
Organization: University of Alabama at Birmingham
Phone: (205) 934-6887
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 ( U.S. NIH Grant/Contract )
Tracking # (UAB) 000175609 ( Other Identifier: Institutional Tracking number for OGCA )
First Submitted: December 20, 2007
First Posted: January 29, 2008
Results First Submitted: April 26, 2012
Results First Posted: October 12, 2012
Last Update Posted: October 12, 2012