Guidelines for Clinical Research on Acupuncture
(1995; 68 pages)
Table of Contents
View the documentForeword
Open this folder and view contents1. Introduction
Open this folder and view contents2. Glossary
Open this folder and view contents3. Goals and objectives of the guidelines
Open this folder and view contents4. General considerations
Close this folder5. Research methodology
View the documentLiterature review
View the documentTerminology and technology
View the documentInvestigators
View the documentClinical research design and rational use of acupuncture
View the documentRandomized controlled clinical trial design
View the documentProtocol development
View the documentResearch knowledge
View the documentCase report forms
View the documentData management
View the documentEthics review board
View the documentStatistical analysis
View the documentMonitoring of studies
View the documentReporting
View the documentImplementation
View the documentConclusions
View the document6. Using the guidelines
Open this folder and view contentsAnnexes
View the documentBibliography
View the documentSelected WHO publications of related interest
View the documentBack cover


The various research methodologies outlined in these guidelines can all contribute some information in the context of research conducted for any purpose. Of all the research methodologies outlined, the randomized controlled (clinical) trials (RCTs) are considered to be the most sophisticated and in many ways have become the “gold standard” for clinical trials in modem clinical research.

There are, however, significant limitations to this approach of RCTs. First, they are often costly, cumbersome, and only incremental answers can be obtained. This is a major drawback in the context of evaluation of whole medical systems such as herbal medicine or acupuncture.

In addition, the RCTs, by definition, eliminate the possible influence of a patient’s preference and patient/therapist interaction on the outcome of the treatment. These limitations may be at least partially compensated by carefully designed retrospective and prospective outcome research as described under “Acupuncture epidemiology”. Properly planned prospective research is usually superior to retrospective research.

Thus, in the context of acupuncture research, an RCT could be indicated where the purpose of a study is to help improve acupuncture practice, for example, to determine which point combinations are most suited to treat a given condition.

In contrast, acupuncture epidemiology (outcome research) would be indicated where the purpose of research is to evaluate the preventive value of acupuncture or guide patients’ choice and health policy.

Finally, while clinical audit and single case studies (n of 1 trial) have a number of inherent limitations, they would be ideal to spur interest in acupuncture research among all researchers and practitioners. Such interest could result in valuable preliminary information generated by an increased positive and critical attitude to ancient traditional statements.

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