A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer.

BACKGROUND: Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. This study assesses biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome. METHODS: This randomized, multi-center, double-blind phase II, dose-exploring trial randomized men with a rising PSA and without metastases to receive 1 or 3 g of POMx, stratified by baseline PSADT and Gleason score. Patients (104) were enrolled and treated for up to 18 months. The intent-to-treat (ITT) population was 96% white, with median age 74.5 years and median Gleason score 7. This study was designed to detect a 6-month on-study increase in PSADT from baseline in each arm. RESULTS: Overall, median PSADT in the ITT population lengthened from 11.9 months at baseline to 18.5 months after treatment (P < 0.001). PSADT lengthened in the low-dose group from 11.9 to 18.8 months and 12.2 to 17.5 months in the high-dose group, with no significant difference between dose groups (P = 0.554). PSADT increases >100% of baseline were observed in 43% of patients. Declining PSA levels were observed in 13 patients (13%). In all, 42% of patients discontinued treatment before meeting the protocol-definition of PSA progression, or 18 months, primarily due to a rising PSA. No significant changes occurred in testosterone. Although no clinically significant toxicities were seen, diarrhea was seen in 1.9% and 13.5% of patients in the 1- and 3-g dose groups, respectively. CONCLUSIONS: POMx treatment was associated with ≥ 6 month increases in PSADT in both treatment arms without adverse effects. The significance of this on-study slowing of PSADT remains unclear, reinforcing the need for placebo-controlled studies in this patient population.

Relationship between symptoms, subjective well-being and medication use in gastro-oesophageal reflux disease.

AIM: To report data from a multinational survey investigating the relationship between gastro-oesophageal reflux disease (GERD) symptoms, treatment and subjective well-being. METHODS: Patients formally diagnosed with GERD (n=929) and undiagnosed subjects with symptoms suggestive of GERD (n=924) were included. RESULTS: Sixty per cent of diagnosed (mean age: 51.7 years) and 54% of undiagnosed (mean age: 44.3 years) participants were female. Over 50% of participants were overweight or obese. Most respondents consumed alcohol, and one-third were smokers. In total, 78% of diagnosed subjects were currently receiving medication prescribed by their doctor, and 65% were taking over-the-counter (OTC) treatments. The majority (97%) of undiagnosed subjects were taking OTC medication, the most common of which were antacids (78%). Despite medication, 58% of diagnosed and 73% of undiagnosed subjects still experienced GERD symptoms some of the time. Approximately one-third of subjects in each group reported that they ate less than usual, felt generally unwell, were tired/worn out or worried/fearful for the majority of the time because of their GERD symptoms, and around half reported decreased well-being, including reduced work or leisure time productivity. CONCLUSIONS: These findings attest to the severity and impact of GERD symptoms, highlighting the need to improve the management of GERD in routine practice. Many symptomatic and long-term sufferers, for example, may benefit from taking steps towards a healthier lifestyle (e.g. weight reduction) in addition to optimisation of acid-suppressive therapy.

Efficacy and safety of pomegranate juice on improvement of erectile dysfunction in male patients with mild to moderate erectile dysfunction: a randomized, placebo-controlled, double-blind, crossover study.

This randomized-controlled trial examined the efficacy of wonderful variety pomegranate juice versus placebo in improving erections in 53 completed subjects with mild to moderate erectile dysfunction. The crossover design consisted of two 4-week treatment periods separated by a 2-week washout. Efficacy was assessed using International Index of Erectile Function (IIEF) and Global Assessment Questionnaires (GAQ). Of the 42 subjects who demonstrated improvement in GAQ scores after beverage consumption, 25 reported improvement after drinking pomegranate juice. Further, 17 subjects showed preference of one beverage to the other. Subjects were more likely to have improved scores when pomegranate juice was consumed (P=0.058). Although overall statistical significance was not achieved, this pilot study suggests the possibility that larger cohorts and longer treatment periods may achieve statistical significance.

Blood pressure and body size in precocious puberty.

Blood pressure increases with age in normal children. This increase appears to be related to body size. To assess the role of body size as a determinant of blood pressure in precocious puberty, we compared the blood pressure of 81 children with precocious puberty with the blood pressure standards for normal children from the NHLBI Task Force on Blood Pressure Control in Children. Children with precocious puberty had significantly increased blood pressure for chronologic age (p less than 0.05) but generally appropriate blood pressure for height age or weight age. These data are consistent with the hypothesis that increased body size causes the increased blood pressure for chronologic age in children with precocious puberty. Physicians who evaluate such children should assess whether blood pressure is appropriate for height age rather than chronologic age.