The main rapid cell proliferation inhibitors of ReaLife+TM stem from its acetogenic composition. Studied extensively1 annonaceous acetogenins are natural substances isolated from plant extracts and found to be toxic to rapidly proliferating cells. Mechanistically, acetogenins were found to inhibit the formation of ATP, the molecule that provides energy to rapidly proliferating cells. By depriving them of their energy source, these cells lose vitality and eventually perish. Supported by clinical studies2, ReaLife+TM has shown positive results.
The study was a phase-2 self-controlled clinical trial with a single arm. Sixty patients that were independently diagnosed by clinicians with prostate cancer were recruited into the study. The primary objective of the study was to evaluate the effect of administering ReaLife+TM on prostate cancer by following the patients’ Gleason and PSA scores and to assess any treatment-benefits. The secondary objective was to report any side effects based on self-report questionnaires.
Patients that were biopsy-confirmed for prostate cancer by independent clinicians were assigned to the study. Any patient that had any type of treatment before this study was excluded. All patients were referred by a physician. Gleason scores were assigned based on a trans-rectal needle biopsy of the prostate. All sixty patients took ReaLife+TM twice a day and were monitored for one year. The Gleason score was reported as the primary outcome, measured 6 months after beginning the regime and at 12 months when the study was completed.
As a secondary outcome, blood Prostate-Specific Antigen (PSA) concentration was measured on a bi-monthly basis and was reported as a total PSA in nanograms per ml. The measurements were done by independent laboratories using standard methods.
The patients also filled out a questionnaire to screen for commonly reported side effects and marked them as “severe”, “moderate”, “mild ”. or “none”.
The data were analyzed with standard statistical tools (the software used, e.g. Graphpad). Any differences in the mean Gleason score or PSA score was set as significant if the p value < 0.05 in a Student t-test. Effect size measures were calculated using Cohen’s d values. A d-value>0.45 was considered high.
- The Gleason Grading system is used to help evaluate the prognosis of men with prostate cancer.
- It is incorporated with other parameters into a strategy of prostate cancer staging which predicts prognosis and helps guide therapy.
- A Gleason grade is given to prostate cancer based upon its microscopic appearance. Cancers with a higher Gleason grade are more aggressive and have a worse prognosis.
- A urologist or radiologist will remove a biopsy of prostate tissue for diagnosis by a pathologist. A pathologist examines the biopsy specimen and attempts to give a score to the two patterns.
-First called the primary grade, represents the majority of tumor (has to be greater than 50% of the total pattern seen).
-Second - a secondary grade - relates to the minority of the tumor (has to be less than 50%, but at least 5%, of the pattern of the total cancer observed).
-These grades are then added to obtain the final Gleason score.