Sage Journals: Discover world-class research

Abstract

As interest in complementary and alternative therapies grows, nurses can expect to be asked for advice regarding their use, but there are few clinical studies on which nurses can base their responses. Conducting research with complementary therapies is therefore important for nursing, but there are some pitfalls in doing research with these products, particularly if one is using standard clinical-trials methods. In this article, the authors outline some of those pitfalls based on their experience conducting a clinical trial to examine the effects of elk velvet antler on symptoms of rheumatoid arthritis. They discuss design issues related to justification, method, and ethics and explore some important regulatory issues of which nurses should be aware. Some recommendations are presented to help nurses engaging in such research to avoid problems that could interfere with the smooth conduct of their studies.

Keywords

complementary therapy clinical trial nursing research

Get full access to this article

View all access options for this article.

References

Allen, M. N. , Oberle. K. , Grace, M. , & Russell, A. (2002). Elk velvet antler in rheumatoid arthritis: Phase II Trial. Biological Research in Nursing, 3, 111-118.

National Center for Complementary and Alternative Medicine . (2002). Get the facts: What is complementary and alternative medicine (CAM)? Retrieved August 15, 2004, from the National Center for Complementary and Alternative Medicine Web site: http://nccam.nih.gov/health/whatiscam/

National Council on Ethics in Human Research . (1997). Canadian therapeutic products directorate guidelines. Retrieved August 15, 2004, from the NCEHR Web site: http://www.ncehrcnerh.org/engish/gcp/

National Institutes of Health . (2004). Guidelines for the conduct of research involving human subjects at the National Institutes of Health. Retrieved August 15, 2004, from the NIH Regulations and Ethical Guidelines Web site: http://www.nihtraining.com/ohsrsite/guidelines/graybook.htm

Tri-Council . (1998). Tri-Council policy statement: Ethical conduct for research involving humans. Retrieved August 15, 2004, from the Interagency Panel on Research Ethics Web site: http://www.pre.ethcis.gc.ca/english/policystatemnt/policystatement.cfm

U.S. Food and Drug Administration . (2004). Good clinical practice in FDA regulated clinical trials. Retrieved August 15, 2004, from the FDA Web site: http://www.fda.gov/oc/gcp/default.htm

Clinical Trials With Complementary Therapies

Abstract

Keywords

Get full access to this article

References