Urological
Conditions
Keywords
Serenoa repens, Urological symptoms, hyperplasia, BPH
Brief summary
The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills. This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study, men will not know which of the two treatments they are assigned to. They will be followed very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial will be studied over 72 weeks. Tests and all medications needed as part of the study will be provided at no charge to the participant. Participants will be responsible for all other costs not associated with the study tests and medications. All information on study participants will be held in the strictest confidence and no one would have access to patient information other than the required authorized health care and research personnel.
Detailed description
The CAMUS trial is studying the outcomes using herbal therapy for benign prostatic hyperplasia (BPH). BPH is a common problem for older men. With BPH, the prostate grows larger. Over time, this growth can cause bothersome urinary symptoms. These symptoms can include frequent and/or urgent urination during the day or at night. Men with BPH can also have a weak urine stream, a stream that stops and starts, a feeling of not emptying the bladder all the way, and/or a need to strain to get urination started. BPH is NOT the same as prostate cancer. A number of natural products (extracts of different plants) seem to be able to reduce the bothersome symptoms of BPH with very few side effects over a few months. One of the plant extracts comes from the dwarf palm tree (Saw palmetto). The investigators do not know whether these plant extracts will reduce the symptoms of BPH over a longer period of treatment.
Interventions
DRUGSaw Palmetto - first 24 weeks
Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
DRUGPlacebo - first 24 weeks
Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
DRUGSaw Palmetto - weeks 24 - 48
Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
DRUGPlacebo - weeks 24 - 48
Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks.
DRUGSaw Palmetto - weeks 48 - 72
Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
DRUGPlacebo - weeks 48 - 72
Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
Sponsors
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
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be eligible for the study, potential participants must meet all of the following eligibility criteria: 1. Male at least 45 years of age. 2. Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml. 3. AUA symptom score ≥ 8 and ≤ 24 at both screening visits. 4. Voluntarily signed informed consent agreement prior to the performance of any study procedures.
Exclusion criteria
Potential participants that meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants. | Baseline to 72 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Benign Prostate Hyperplasia (BPH) Impact Index Score | Baseline to 72 weeks | 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. |
| International Prostate Symptom Score Quality of Life (IPSS QOL) Score | Baseline to 72 weeks | 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. |
| American Urological Association(AUA) Nocturia Item | Baseline to 72 weeks | 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. |
| Peak Uroflow | Baseline to 72 weeks | 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. |
| Post-void Residual | Baseline to 72 weeks | 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. |
| Prostate Specific Antigen (PSA) Level | Baseline to 72 weeks | 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. |
| Participants Global Assessments of Improvement and Satisfaction at End of Study. | Baseline to 72 weeks | 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. |
| Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score. | Baseline to 72 weeks. | 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. |
| International Continence Society Male Incontinence Symptom (ICSmale IS) Score | Baseline to 72 weeks | 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. |
| Jenkins Sleep Scale Score | Baseline to 72 weeks | 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. |
| NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale | Baseline to 72 weeks | 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. |
| NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale | Baseline to 72 weeks | 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. |
| NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale | Baseline to 72 weeks | 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. |
| International Index of Erectile Function (IIEF)Scale Score. | Baseline to 72 weeks | 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. |
Countries
Canada, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 183 |
| Placebo Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks. | 186 |
| Total | 369 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Crossed Over to Open Label Therapy | 3 | 3 |
| Overall Study | Exclusionary Medication | 2 | 3 |
| Overall Study | Lost to Follow-up | 5 | 7 |
| Overall Study | Moved Away | 0 | 2 |
| Overall Study | Non-Compliant | 0 | 1 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Patient Decision | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Unacceptable Treatment Toxicity | 5 | 8 |
| Overall Study | Withdrawal by Subject | 8 | 5 |
Baseline characteristics
| Characteristic | Saw Palmetto | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 60 Participants | 61 Participants | 121 Participants |
| Age, Categorical Between 18 and 65 years | 123 Participants | 125 Participants | 248 Participants |
| Age Continuous | 61.25 years STANDARD_DEVIATION 8.72 | 60.70 years STANDARD_DEVIATION 8.08 | 60.86 years STANDARD_DEVIATION 8.38 |
| Region of Enrollment Canada | 16 participants | 17 participants | 33 participants |
| Region of Enrollment United States | 167 participants | 169 participants | 336 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 183 Participants | 186 Participants | 369 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 138 / 176 | 139 / 181 |
| serious Total, serious adverse events | 18 / 176 | 17 / 181 |
Outcome results
Primary
Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants. | -2.20 units on a scale | 95% Confidence Interval 5.83 |
| Placebo | Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants. | -2.99 units on a scale | 95% Confidence Interval 5.65 |
Secondary
American Urological Association(AUA) Nocturia Item
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | American Urological Association(AUA) Nocturia Item | -0.36 units on a scale | 95% Confidence Interval 1.22 |
| Placebo | American Urological Association(AUA) Nocturia Item | -0.15 units on a scale | 95% Confidence Interval 1.22 |
Secondary
Benign Prostate Hyperplasia (BPH) Impact Index Score
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | Benign Prostate Hyperplasia (BPH) Impact Index Score | -0.81 units on a scale | 95% Confidence Interval 2.38 |
| Placebo | Benign Prostate Hyperplasia (BPH) Impact Index Score | -1.23 units on a scale | 95% Confidence Interval 2.57 |
Secondary
International Continence Society Male Incontinence Symptom (ICSmale IS) Score
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | International Continence Society Male Incontinence Symptom (ICSmale IS) Score | -0.48 units on a scale | 95% Confidence Interval 2.22 |
| Placebo | International Continence Society Male Incontinence Symptom (ICSmale IS) Score | -0.84 units on a scale | 95% Confidence Interval 2.46 |
Secondary
International Index of Erectile Function (IIEF)Scale Score.
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | International Index of Erectile Function (IIEF)Scale Score. | -0.52 units on a scale | 95% Confidence Interval 7.59 |
| Placebo | International Index of Erectile Function (IIEF)Scale Score. | -1.06 units on a scale | 95% Confidence Interval 7.39 |
Secondary
International Prostate Symptom Score Quality of Life (IPSS QOL) Score
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | International Prostate Symptom Score Quality of Life (IPSS QOL) Score | -0.34 units on a scale | 95% Confidence Interval 1.26 |
| Placebo | International Prostate Symptom Score Quality of Life (IPSS QOL) Score | -0.49 units on a scale | 95% Confidence Interval 1.27 |
Secondary
Jenkins Sleep Scale Score
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | Jenkins Sleep Scale Score | -0.80 units on a scale | 95% Confidence Interval 3.59 |
| Placebo | Jenkins Sleep Scale Score | -1.63 units on a scale | 95% Confidence Interval 4.38 |
Secondary
Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.
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.
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score. | -0.38 units on a scale | 95% Confidence Interval 4.51 |
| Placebo | Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score. | -0.09 units on a scale | 95% Confidence Interval 3.75 |
Secondary
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale | 0 units on a scale | 95% Confidence Interval 2.85 |
| Placebo | NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale | 0 units on a scale | 95% Confidence Interval 2.82 |
Secondary
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale | -0.85 units on a scale | 95% Confidence Interval 2.14 |
| Placebo | NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale | -1.08 units on a scale | 95% Confidence Interval 2.16 |
Secondary
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale | -0.35 units on a scale | 95% Confidence Interval 2.19 |
| Placebo | NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale | -0.86 units on a scale | 95% Confidence Interval 2.53 |
Secondary
Participants Global Assessments of Improvement and Satisfaction at End of Study.
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saw Palmetto | Participants Global Assessments of Improvement and Satisfaction at End of Study. | Global Assessment: Change from Baseline | 49.9 units on a scale | 95% Confidence Interval 26.9 |
| Saw Palmetto | Participants Global Assessments of Improvement and Satisfaction at End of Study. | Global Assessment: Satisfaction with Symptoms | 48.9 units on a scale | 95% Confidence Interval 26.9 |
| Placebo | Participants Global Assessments of Improvement and Satisfaction at End of Study. | Global Assessment: Change from Baseline | 50.58 units on a scale | 95% Confidence Interval 28.7 |
| Placebo | Participants Global Assessments of Improvement and Satisfaction at End of Study. | Global Assessment: Satisfaction with Symptoms | 50.6 units on a scale | 95% Confidence Interval 28.8 |
Secondary
Peak Uroflow
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | Peak Uroflow | -0.18 mL/sec | 95% Confidence Interval 6.03 |
| Placebo | Peak Uroflow | -0.79 mL/sec | 95% Confidence Interval 5.55 |
Secondary
Post-void Residual
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
Population: The analysis population was determined by the number of participants that were randomized and included in the modified intention to treat analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | Post-void Residual | 4.78 mL | 95% Confidence Interval 83.7 |
| Placebo | Post-void Residual | 1.17 mL | 95% Confidence Interval 76.12 |
Secondary
Prostate Specific Antigen (PSA) Level
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saw Palmetto | Prostate Specific Antigen (PSA) Level | 0.32 ng/mL | 95% Confidence Interval 0.82 |
| Placebo | Prostate Specific Antigen (PSA) Level | -0.19 ng/mL | 95% Confidence Interval 1.16 |