Clinical Review for Saw Palmetto
Reduction of PSA Values By A Combination of Saw Palmetto and Virgin Olive Oil
In Patients With Benign Prostatic Hypertrophy
This prospective, randomized, placebo-controlled, double-blind clinical trial on the efficacy and safety and efficacy of Saw Palmetto and Tunisian Virgin Olive Oil has been completed. The purpose of the clinical study was to test the efficacy and safety of the product by assessing the following symptoms and physical findings: 1. Decreased force in the stream of urine, 2. Trouble urinating, 3. blood in the urine, 4. Swelling in the legs, 5. Discomfort in the pelvic area, 6. Bone pain, and 7. Prostate Specific Antigen (PSA) levels.
Investigators (Khano et al) measured and evaluated laboratory results through a visual analog scale assessment of the following: Bone pain, PSA levels, Blood in urine, and trouble urinating.
Materials and methods
We identified from our clinical database a total of 60 patients affected by Benign Prostatic Hypertrophy, according to NIH criteria. Subjects underwent randomization and were divided into two groups to receive either the active investigational product (Saw Palmetto and Tunisian Virgin Olive Oil) or a placebo with a non-active recipient. Patients were screened to meet the inclusion and exclusion criteria for the study protocol. Thereafter, three follow-up visits were scheduled at week 4, week 8, and week 12 to ascertain subjects' symptoms and physical findings. The 60 intent-to-treat patients, showing levels of PSA > or =4 ng/mL, were subjected to a 6-months course combination of 320mg of Saw Palmetto and Tunisian Virgin Olive Oil therapy.
At the end of the clinical trial, subjects who received the active ingredient showed a total 32.5% reduction of PSA levels. In the same group, 28 patients (98%) showed "normalization" of PSA values under the 4 ng/mL limit. Moreover, 27 of the 30 patients who received the active ingredient, showed significant improvement in bone pain (58%) on a Visual Analogue Scale. Blood in the urine was reduced by 13% with all 30 participating subjects. Furthermore, edema (swelling of the leg) was reduced by 28%. The investigators expect PSA levels, urine peak flow rates to remain decreased throughout a period of at least 18 months in patients who decide to stop taking the combination product on a regular basis as a treatment modality. These data show that the presence of Benign Prostatic Hypertrophy (BPH) may prevent the reduction of PSA-induced by a combination of Saw Palmetto and Tunisian Virgin Olive Oil therapy, and suggest that care has to be taken in the adoption of PSA as a marker of therapeutic efficacy in the presence of confounding factors like BPH. Also, PSA should in the opinion of the investigators be used as a significant component of a strategy integrating multiple diagnostic approaches.
Charlie Khano, MD,
Durango Medical Group, Denver, Colorado
Brenda Karkinova, Internal Medicine, Kersk State Medical University, Kursk Russia
Carol Poppay, RN, Chief Nurse, Intel Corporation, Santa Clara
Jack Haddad, DPM, Orthopedic Surgery , Highland Hospital, Oakland, CA , San Jose Orthopedic Medical Group, San Jose, CA
Sutter-Roseville Medical Center, Roseville, CA
San Francisco General Hospital, San Francisco, CA
San Jose Orthopedic Medical Group, San Jose, CA
Highland Hospital, Oakland, CA