1.
Green tea polyphenols and Tai Chi for bone health: designing a placebo-controlled randomized trial.
Shen, CL, Chyu, MC, Yeh, JK, Felton, CK, Xu, KT, Pence, BC, Wang, JS
BMC musculoskeletal disorders. 2009;:110
Abstract
BACKGROUND Osteoporosis is a major health problem in postmenopausal women. Evidence suggests the importance of oxidative stress in bone metabolism and bone loss. Tea consumption may be beneficial to osteoporosis due to its antioxidant capability. However, lack of objective data characterizing tea consumption has hindered the precise evaluation of the association between tea ingestion and bone mineral density in previous questionnaire-based epidemiological studies. On the other hand, although published studies suggest that Tai Chi (TC) exercise can benefit bone health and may reduce oxidative stress, all studies were conducted using a relatively healthy older population, instead of a high-risk one such as osteopenic postmenopausal women. Therefore, this study was designed to test an intervention including green tea polyphenol (GTP) and TC exercise for feasibility, and to quantitatively assess their individual and interactive effects on postmenopausal women with osteopenia. METHODS/DESIGN One hundred and forty postmenopausal women with osteopenia (defined as bone mineral density T-score at the spine and/or hip between 1 to 2.5 SD below the reference database) were randomly assigned to 4 treatment arms: (1) placebo group receiving 500 mg medicinal starch daily, (2) GTP group receiving 500 mg of GTP per day, (3) placebo+TC group receiving both placebo treatment and TC training (60-minute group exercise, 3 times per week), and (4) GTP+TC group receiving both GTP and TC training for 24 weeks. The outcome measures were bone formation biomarker (serum bone alkaline phosphatase), bone resorption biomarker (serum tartrate resistant acid phosphatase), and oxidative DNA damage biomarker (urinary 8-hydroxy-2'-deoxyguanosine). All outcome measures were determined at baseline, 4, 12, and 24 weeks. Urinary and serum GTP concentrations were also determined at baseline, 4, 12, and 24 weeks for bioavailability. Liver function was monitored monthly for safety. A model of repeated measurements with random effect error terms was applied. Traditional procedures such as ANCOVA, chi-squared analysis, and regression were used for comparisons. DISCUSSION We present the rationale, design, and methodology of a placebo-controlled randomized trial to investigate a new complementary and alternative medicine strategy featuring a dietary supplement and a mind-body exercise for alleviating bone loss in osteopenic postmenopausal women.
2.
[Recruitment strategies for a randomized clinical study].
Chiechi, LM, Lobascio, A, Grillo, A, Valerio, T, Pompea Schiavelli, M
Minerva ginecologica. 2000;(1-2):1-4
Abstract
BACKGROUND To value the level of acceptance of the Memphis Study, (a random clinical study suggested verifying the efficacy of a diet enriched with phytoestrogens to prevent menopausal problems), and underlining the reasons which induce the acceptance or refusal of the study. STUDY DESIGN Prospective study. METHODS Meeting groups have been held with 82 women needing Day Hospital treatment for Menopause at III Department of Obstetrics and Gynecology of the University of Bari. The features of women and the reasons that induce these++ acceptance or refusal of the study were valued by an anonymous questionnaire with a precoded reply. RESULTS 92.9% of the women accepted participation in the study. The main reasons for acceptance were: 1) believing that the study was drawn up for women; 2) it was done by expert physicians; 3) it was not done for financial gain. The random standard was the main reason for refusal. CONCLUSIONS With this method we had a very high acceptance, talking over the goals and problems that study aimed to address and to resolve. The chance offered to judge the reliability and competence of physicians is important.
3.
A design for testing interventions to improve adherence within a hypertension clinical trial.
Johnson, BF, Hamilton, G, Fink, J, Lucey, G, Bennet, N, Lew, R
Controlled clinical trials. 2000;(1):62-72
Abstract
The Potassium Adherence Clinical Trial (PACT) incorporates one randomized clinical trial within another. A randomized trial of interventions to increase adherence to medication is nested within a second randomized clinical trial testing hypotensive effect of supplemental oral potassium. The trial aims principally to compare the effects of three intervention strategies: two sessions of individual patient counseling, two telephone contacts, or standard care. The trial aims secondarily to evaluate the effect of 60 mEq supplemental oral potassium daily on sitting systolic and diastolic blood pressure in hypertensive patients on established drug therapy. Therefore, it organizes the patients given potassium into three study groups for adherence interventions, and the patients assigned to placebo into a further three. We evaluate adherence primarily by means of the Medication Event Monitoring System (MEMS), an electronic system that records the date and time that the container of study medication is opened. Additional measurements, such as assessments of change in levels of urinary potassium, pill counts, appointment records, self-reporting by patients, and estimates by physician of adherence, are used and correlated with MEMS data. At a single center, the trial enrolled 107 participants between the ages of 26 and 80. This paper describes the background to this trial within a trial, details its design, documents the baseline characteristics of participants enrolled, and describes issues experienced during implementation of the trial.