Center Research
UIC / NIH CENTER FOR BOTANICAL DIETARY SUPPLEMENTS RESEARCH
Prior to being studied in a clinical trial, botanicals must undergo intense scientific scrutiny using basic science methodology before being tested in humans. Center scientists employ scientific testing procedures using sophisticated techniques and costly machinery. This process may take several months to complete. First botanicals must undergo botanical verification, then they are evaluated chemically for the identification of specific compounds (Project 1) which are further evaluated to determine their biological activity (Project 2). When botanicals can be characterized both chemically and biologically, then their metabolic pathways are further investigated (Project 3 and Core B). All of this is done in advance of testing in humans to assure that botanicals being tested are verified, standardized, show desired activity and have undergone preliminary toxicity studies.
Since its inception, the UIC Botanical Center has focused on botanicals that are used for women's health and has conducted in-depth research on eight plants initially selected based on the scientific and ethnobotanical literature: Cimicifuga racemosa (black cohosh), Trifolium pratense (red clover), Vitex agnus-castus (chaste berry), Humulus lupulus (hops), Vaccinium macrocarpon (cranberry), Viburnum prunifolium (black haw), Angelica sinensis (dong quai), and Valeriana officinalis (valerian). New plant targets have been identified and work is underway on Cimicifuga americana , Cimicifuga rubifolia, Pueraria mirifica , and Cornus officinalis among others.
Although women have experimented with herbal remedies for gynecological complaints for centuries, only a few limited systematic investigations of botanicals have been carried out in the United States . As the daily intake of botanical dietary supplements among Americans has increased over the years, a new focus on conducting systematic research culminating in clinical trials has developed in the scientific community. Supported by the NIH's Office of Dietary Supplements and The National Center for Complementary and Alternative Medicine, the UIC Botanical Center conducted a Phase I clinical trial of Cimicifuga racemosa and Trifolium pratense , two species that are reported to alleviate the symptoms of menopause. A Phase II trial of the safety and efficacy of these plants is in progress. More details below.
The UIC Botanical Center 's Clinical Evaluation Group (Project 4) is conducting a “ Phase II, randomized, double-blinded, placebo-controlled study to determine the efficacy of black cohosh, red clover, and Prempro® in the management of menopausal symptoms.” This study follows women for one year, examining both efficacy for relief of vasomotor symptoms and long term safety. The study has an active control arm – hormone therapy – and consists of a diverse patient population, with 55% of the randomized women representing underserved minorities (50% African American). Study recruitment opened in May 2003 at University of Illinois at Chicago and a second site at Northwestern Memorial Hospital , Chicago began recruitment in March 2004.
A total of 1450 women have been screened, resulting in 89 randomized participants. Randomization has been completed and the desired sample size of 89 women has been achieved. Enrollees in the Phase II trial represent the diversity of the Chicago-area population with participants from the African-American, Hispanic and Caucasian communities However, despite very strong interest in participating in the study approximately 94 percent of the screened subjects have been ineligible due to stringent exclusion criteria resulting in a 6% randomization rate based on the number of women screened. Of the 89 women that have been randomized, 64 women had completed the study by the end of June, 2007. The study has maintained an extremely low drop-out rate of 1%.
The biostatistics team has supported the randomization process and data collection activities of the Phase II trial as well as assisted in the design and analysis of several basic research experiments. The biostatistics team conducts theoretical research on optimal crossover designs with particular emphasis on their applicability to CAM research.
The final data collection is expected to be completed by the end of January 2008. The final data analysis for the primary paper will be conducted in January-February 2008 and the manuscript for the primary paper should be completed by March-April 2008.
We anticipate that the trial results will be extremely reliable not just because of the active control arm, but as a one-year trial, any placebo effect should be minimal. Additionally, our safety data includes routine liver function tests, as well as ongoing screening of the breast and endometrium. UIC researchers are looking forward to the successful conclusion of this important trial.