Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.

OBJECTIVES: This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). DESIGN: Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. SETTINGS: The study was conducted at 11 clinical centers in North America. PARTICIPANTS: Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). OUTCOME MEASURES: Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. RESULTS: For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. CONCLUSIONS: Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto.

Feasibility of an evidence-based weight loss intervention for a faith-based, rural, African American population.

BACKGROUND: African Americans and rural residents are disproportionately affected by obesity. Innovative approaches to address obesity that are sensitive to the issues of rural African Americans are needed. Faith-based and community-based participatory approaches show promise for engaging racial/ethnic minorities to change health outcomes, but few faith-based weight loss interventions have used a community-based participatory approach. COMMUNITY CONTEXT: A faith-based weight loss intervention in the Lower Mississippi Delta arose from a 5-year partnership between academic and community partners representing more than 30 churches and community organizations. METHODS: Community and academic partners translated the 16 core sessions of the Diabetes Prevention Program for rural, church-going African American adults. The feasibility of the lay health advisor-led delivery of the 16-week (January-May 2010), 16-session, adapted intervention was assessed in 26 participants from 3 churches by measuring recruitment, program retention, implementation ease, participant outcomes, and program satisfaction. OUTCOME: Twenty-two of 26 participants (85%) provided 16-week follow-up data. Lay health advisors reported that all program components were easy to implement except the self-monitoring component. Participants lost an average of 2.34 kg from baseline to 16-week follow-up, for a mean weight change of -2.7%. Participants reported enjoying the spiritual and group-based aspects of the program and having difficulties with keeping track of foods consumed. The intervention engaged community partners in research, strengthened community-academic partnerships, and built community capacity. INTERPRETATION: This study demonstrates the feasibility of delivering this adapted intervention by lay leaders through rural churches.

Effects of omega-3 fatty acid supplementation on vascular access thrombosis in polytetrafluorethylene grafts.

OBJECTIVE: The purpose of this study was to investigate the effects of orally administered over-the-counter omega-3 (n-3) fatty acid supplements on primary patency of polytetrafluoroethylene (PTFE) grafts. DESIGN: This study was conducted with a triple-blind, permuted-block, randomized, placebo-controlled experimental design. SETTING: Dialysis clinics with patients who, in accordance with physician diagnosis, needed a new PTFE graft. PATIENTS AND OTHER PARTICIPANTS: Patients on long-term hemodialysis with newly placed PTFE grafts who were unable to receive a native arteriovenous fistula. INTERVENTION: Patients were followed prospectively for 8 months after they had been placed into an n-3 fatty acid or control group and were monitored for primary patency. MAIN OUTCOME VARIABLE: Primary patency of the PTFE graft. RESULTS: The n-3 fatty acid group had a mean PTFE graft primary patency rate of 254.2 days (SEM = 51.8), and the control group had a mean PTFE graft primary patency rate of 254.1 days (SEM = 34.6), revealing no significant difference in survival time between groups. CONCLUSIONS: No significant differences in primary patency rates were noted in the experimental and control groups.