Reduction of PSA Values Using a Combination of Saw Palmetto and Virgin Olive Oil in Patients with Benign Prostatic Hypertrophy
Abstract: 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 and reviewed by several non-conventional peer-review journals.
Objective: To assess the effects of Saw Palmetto combined with Virgin Olive oil on PSA levels, urination issues, and bone pain.on men with benign prostatic hypertrophy.
Materials & 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 the subjects’ symptoms and physical findings. The 60 intent-to-treat patients, showing levels of PSA > or =4 ng/mL, were subjected to a 6-month course combination of 320mg of Saw Palmetto and Tunisian Virgin Olive Oil therapy.
Conclusions: At the end of the clinical trial, subjects who received the Saw Palmetto oil/Virgin olive oil combination 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 Saw Palmetto oil/Virgin olive oil combination 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, the peak low urine rates to remain decreased throughout a period of at least 18 months in patients who decide to stop taking the combination product regularly 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.
Study Investigators
Charlie Khano, MD, Internal Medicine, 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, MD, MBA, Portfolio Manager, MD Capital Management, UCSF Medical Center
Affiliated Hospitals
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