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Wissenschaft - Klinische Studien | |||||
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Renee Milligan, Hannah V. Bradford, Michaela Donohue, Georgetown University Medical Center, Washington, D.C. The group of Italian researchers, led by Cardini, published results of their largest study of breech version by acumoxa (BVA) in the 1998 issue of JAMA (280:1580-1584) dedicated to complementary and alternative medicine research. In this large randomized controlled study of 60 subjects and their prior uncontrolled study, Cardini's group showed over 75% success using BVA. Several research groups in China and one in Japan have been exploring the use of BVA and have all produced similar results. The Georgetown Study was designed to obtain preliminary data on safety and efficacy of BVA as well as to support development of a large scale randomized trial, to replicate and expand the Cardini investigation. In this study, ten women were recruited, 4 multiparous and 6 primiparous. Six women were in the 37th week of pregnancy, four in the 38th week. Subjects ranged in age from 22 to 40. A licensed acupuncturist administered three consecutive daily treatments, each lasting 20 minutes. Treatments were provided in the clinic proximal to the high tech labor and delivery suite at a tertiary care urban teaching hospital. The protocol was carefully controlled with standard technique to ensure subject safety. The intervention consisted of bilateral stimulation of the zhiyin point by pole moxibustion held above the skin. Parameters measured before and after each treatment included blood pressure, pulse, non-stress tests (NSTs) and abdominal assessment of fetal presentation. External fetal monitoring (EFM) was performed continuously throughout the treatment. Sonograms were performed prior to the first and after the last treatments. Eight women completed the protocol. One woman withdrew after two treatments due to illness and the second subject became concerned that she was undergoing an excessive number of sonograms. This woman completed only one treatment but, on her own, continued the moxa at home. None of the fetuses verted during or after moxibustion treatment. External cephalic version (ECV) was attempted in all eight women and was successful in four; of these, three women delivered vaginally and one underwent Cesarean section secondary to fetal distress. Three of the four remaining women underwent Cesarean sections; one delivered vaginally. All post-treatment NSTs were reactive. EFM produced no evidence of distress during the procedure. There were no significant changes in blood pressure or pulse in subjects. The study does suggest that acumoxa treatment is safe for women and fetuses but does not support the efficacy of moxa for breech version. The fact that no versions occurred is remarkable given that spontaneous correction of breech presentation between 37 weeks and delivery has been reported as high as 28%. Although both studies used the same technique and point, several differences are notable. In the Cardini study, treatment was administered in the 33rd week of gestation, for 30 minutes once or twice daily, and for one or two weeks. Additionally, treatment was administered at home, by a support person, and without EFM. Possible explanations for the marked failure of moxibustion in our trial include: moxibustion may be more successful earlier in pregnancy; longer duration of treatment may be necessary; location of treatment (home, hospital) and external monitoring may impact results. Getting research started: The Institutional Review Board hurdle William L Prensky, Graduate Program in Acupuncture and Oriental Medicine, Mercy College, Dobbs Ferry, NY; Division of Acupuncture, Sound Shore Medical Center of Westchester, New Rochelle, NY For the past 4 years the Graduate Program in Acupuncture and Oriental Medicine at Mercy College and Sound Shore Medical Center of Westchester have been engaged in a collaborative effort to bring education and research in Acupuncture and Oriental Medicine into mainstream hospital training. The Mercy College program is a formal, nationally standardized educational program in AOM, housed in a regionally accredited comprehensive graduate institution. Sound Shore Medical Center is an accredited teaching hospital. All students in the Mercy College program spend their clinical years in residence at Sound Shore Medical Center and all complete original clinical research projects as their theses. Negotiating the complexities of two interlocking Institutional Review Boards, neither of which was familiar with Acupuncture and Oriental Medicine research and the specific issues and techniques involved, has been one of the significant labors of the past four years. As each institution has become more comfortable with Acupuncture and the problems that Acupuncture research pose, the nature of the projects and the availability of collaborative efforts with other Departments of the hospital setting have expanded. Understanding the communication between Acupuncture as a discipline and the needs of Institutional Review Boards in both medical centers and in conventional academic institutions has generated a new language and a new appreciation of specific protocols for research in this field. In addition, the need to look at short-term projects for student research has led to the development of a set of research guidelines that can be useful to both the Acupuncture educational institution and to the conventional research setting. Deepening the appreciation within this emerging profession for the issues surrounding research and its place in the education of professionals has resulted in a new approach to education of the professional in Acupuncture. As students are required to take their thesis projects from early conceptualization to final performance, a model for developing clinical-practice-based research emerges.
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