An exploration with proposed solutions of the problems and issues in conducting clinical research in acupuncture.
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.