Background: Estimating a realistic effect size is an important issue in the planning of clinical studies of complementary and alternative medicine therapies. When a minimally important difference is not available, researchers may estimate effect size using the published literature. This evidence-based effect size estimation may be used to produce a range of empirically-informed effect size and consequent sample size estimates. We provide an illustration of deriving plausible effect size ranges for a study of acupuncture in the relief of post-chemotherapy fatigue in breast cancer patients.

Objective Explore patterns in patients’ disclosures of supplement use and identify provider and patient characteristics associated with disclosures. Methods Cross-sectional study of 61 outpatient primary care, integrative medicine, and complementary medicine providers, and 603 of their patients. Primary outcomes were supplement disclosures (based on audio recorded office visits, post-visit patient surveys and medical record abstractions for the day of the visits). Results Seventy-nine percent of 603 patients reported on a post-visit survey that they took a total of 2107 dietary supplements. Of those taking supplements, 232 patients (48.6%) discussed at least one supplement with their provider on the day of their office visit. However patients disclosed only 714 (33.9%) of the 2107 supplements they were taking. Patients more frequently disclosed supplement use when they saw providers who attributed greater importance to asking about supplements. Patient characteristics, such as patient activation, number of medical conditions, and use of prescription medications were not associated with disclosure of supplement use. Conclusions Provider rating of the importance of asking about supplements is a major factor prompting patients’ disclosures of supplement use. Practice Implications Provider-targeted interventions to encourage provider awareness about potential supplement-drug interactions are needed to increase disclosures about dietary supplement use.

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Single-dose kinetics of fosinopril, a new phosphorus-containing angiotensin-converting enzyme inhibitor and its active diacid, fosinoprilat, were investigated in patients with mild, moderate, or severe renal impairment and in those with normal renal function. After an intravenous dose of 14C-fosinoprilat (7.5 mg), total body clearance of fosinoprilat was significantly greater (p less than 0.05) in patients with normal renal function than in renally impaired patients but was not related to the degree of renal impairment in patients with creatinine clearance values of 11 to 72 ml/min/1.73 m2. Decreases in renal clearance were compensated for by increases in hepatic clearance, so that total clearance was maintained. After oral 14C-fosinopril (10 mg), plasma kinetics and bioavailability of fosinoprilat were similar for the three groups of renally impaired patients. The dual elimination of fosinoprilat by the liver and the kidney distinguishes fosinopril from other angiotensin-converting enzyme inhibitors.

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