Complementary and Alternative Medicine for Urological Symptoms(CAMUS)

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.

Timeline

Start

2008-02

Primary completion

2010-12

Completion

2010-12

Publications

• Background Lee J, Andriole G, Avins A, Crawford ED, Foster H, Kaplan S, Kreder K, Kusek J, McCullough A, McVary K, Meleth S, Naslund M, Nickel JC, Nyberg L, Roehrborn C, Dale Williams O, Barry M. Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials. 2009 Dec;6(6):628-36. doi: 10.1177/1740774509352199. Epub 2009 Dec 9.
• Background Lee JY, Foster HE Jr, McVary KT, Meleth S, Stavris K, Downey J, Kusek JW. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med. 2011 May;17(5):469-72. doi: 10.1089/acm.2010.0300. Epub 2011 May 9.
• Results Barry MJ, Avins AL, Meleth S; Complementary and Alternative Medicine for Urological Symptoms Study Group. Performance of the American Urological Association Symptom Index with and without an additional urge incontinence item. Urology. 2011 Sep;78(3):550-4. doi: 10.1016/j.urology.2011.04.017. Epub 2011 Jul 8.
• Results Helfand BT, McVary KT, Meleth S, Sharp V, Foster H, Naslund M, Williams OD; CAMUS Study Group. The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial. J Urol. 2011 Jun;185(6):2223-8. doi: 10.1016/j.juro.2011.02.012. Epub 2011 Apr 17.
• Results Barry MJ, Meleth S, Lee JY, Kreder KJ, Avins AL, Nickel JC, Roehrborn CG, Crawford ED, Foster HE Jr, Kaplan SA, McCullough A, Andriole GL, Naslund MJ, Williams OD, Kusek JW, Meyers CM, Betz JM, Cantor A, McVary KT; Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Study Group. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA. 2011 Sep 28;306(12):1344-51. doi: 10.1001/jama.2011.1364.
• Helfand BT, Lee JY, Sharp V, Foster H, Naslund M, Williams OD, McVary KT; CAMUS Study Group. Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial. J Urol. 2012 Dec;188(6):2288-93. doi: 10.1016/j.juro.2012.07.104. Epub 2012 Oct 22.

Drugs

Indications