Thesis--PlanB (M.S.)--University of Wisconsin--Stout, 2002. / Includes bibliographical references.

Many controlled clinical trials of acupuncture have been conducted since the mid 1970s, however, there is almost universal agreement that the quality of these trials has been poor. Previous reviews have exposed many problems in the quality of the clinical trials. While some recent trials have addressed these concerns, these improved methodologies have still not addressed other key problems. This study systematically exposes other problems in published clinical trials of acupuncture, proposes solutions to those problems, and then tests the solutions in a controlled clinical trial of acupuncture for neck pain. Key among the new problems that are exposed are problems with adequacy of knowledge about the nature and practice of acupuncture, consequent problems with the adequacy of the tested acupuncture treatments, problems with the appropriateness of the control needling procedures when so-called "sham" acupuncture is used, and problems with the generalizability of results from these studies. Proposals for improving the ability to control for the non-specific effects of treatment are also developed. Chapters one through three document the nature of the field and problems in common representations about the field, discussing previous studies and their reviews, developing new criteria for conducting clinical trials of acupuncture by documenting problems not systematically described before. Chapter four discusses the importance of assessing the reliability of diagnosis, and presents the design and results of preliminary studies investigating this. Chapter five presents strategies for addressing each methodological criteria developed in Chapters two and three. Chapter six presents the design of a controlled trial of acupuncture for neck pain. Chapter seven presents analysis and results of that trial. Chapter eight discusses those results in light of the goals of the overall study and details plans for improving the methodology for future trials. The trial found results suggesting a treatment effect that appears not to be attributable to non-specific effects alone, and succesfully piloted the methodology developed for clinical trials of acupuncture. This methodology with modifications could be useful for future trials. This study was funded by an intramural grant from the Research Committee of the Department of Anesthesia, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Supplies for the study were donated by the Seirin Needle Company, Tokyo, Japan.

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