The Oregon College of Oriental Medicine has been awarded a $250,000 grant by the National Center for Complementary and Alternative Medicine (NCCAM). The grant, the first of its kind awarded to a school of Oriental medicine, will be used to fund a two-year research project comparing the effectiveness of Chinese medicine versus hormone therapy for endometriosis, a painful condition that affects approximately five million women in the United States.
"This is the first major grant the National Center for Complementary and Alternative Medicine at NIH has awarded to an acupuncture and Oriental medicine college," proclaimed the school's president, Dr. Liza Goldblatt. "We are very pleased to be selected for this important research project, especially as it expands our research program with other health care institutions."
In the study, 66 women with laparoscopy-diagnosed endometriosis will be randomly assigned to one of two groups. The first group will receive conventional hormone therapy; the other group will receive traditional Chinese medicine in the form of acupuncture and an herbal formula, with the treatments for each group lasting 12 weeks.
Researchers will use two standardized evaluation forms - one completed by the patient, the other by the examining practitioner - to rate the severity of pelvic pain. Evaluations will be taken at five intervals (baseline; six weeks into the course of treatment; 12 weeks into the course of treatment; and 12 and 24 weeks post-treatment) to determine the short-and long-term effectiveness of each therapy. Data gathered from both groups will then be analyzed and used to design a large-scale research trial.
Richard Hammerschlag, PhD, OCOM's director of research, will be the principal investigator on the project. In an interview with Acupuncture Today, Hammerschlag related some of the factors behind the creation of the study, as well as some of the project's goals.
"This (endometriosis) is a significant public health issue that affects 10-15% of women of childbearing age, many of whom suffer persistent pelvic pain and infertility," he explained. He added that while biomedical treatment options such as surgery and hormone therapy are often "temporarily effective," they also bring about a variety of unwanted side-effects, including menopausal-like conditions such as hot flashes and night sweats. "Our hypothesis is that TCM will be at least as effective as hormone therapy but with fewer side effects," he said.
"With the limited federal funds that have recently become available for research into CAM, I think it's important not to put the major focus as NIH usually does on placebo-controlled trials, but in this case, to compare traditional Chinese medicine to what people normally use in biomedicine," Hammerschlag continued. "It's also important for clinical research to study Chinese medicine as it is practiced, as a system of medicine. We are especially pleased to have been funded for a trial that combines acupuncture and herbs."
Another key aspect of the trial is that women assigned to the TCM group will not all receive a single standardized treatment. Instead, they will be divided into four sub-groups on the basis of their TCM diagnostic category of endometriosis. A pre-established acupuncture protocol and herbal formula specific for each sub-group will be followed.
Co-investigators on the project include Kenneth A. Burry, MD, Vice Chair of Obstetrics and Gynecology at Oregon Health & Science University and Hong Jin, LAc, MD (China), dean of faculty at OCOM. Registered nurses Barbara Krauss and Christine Toomey will serve as clinical trial coordinators, while Dr. Mikel Aiken of the Kaiser Permanente Center for Health Research will serve as a biostatistical consultant.