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New Research Shows Promise in Using Traditional Research Methods to Assess Efficacy of Complementary Therapies

Friday, November 13, 2009 General News J E 4
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MINNEAPOLIS New research findings presented today at the Society for Integrative Oncology's (SIO) Sixth International Conference in New York show promise in assessing the efficacy and safety of complementary and alternative medicine (CAM) using traditional research methods. Susan Sencer, MD, Medical Director, Hematology/Oncology at Children's Hospitals and Clinics of Minnesota (Children's), presented findings on the use of the homeopathic agent Traumeel SŪ in children with mucositis undergoing stem cell transplantation (SCT). Investigated by the Children's Oncology Group, the multi-center randomized placebo controlled trial is the first large-scale pediatric oncology trial of a CAM treatment.

Mucositis is a painful side effect of many cancer treatment regimens. Mucositis can cause intense pain, infection and the inability to eat, drink or swallow, and there are few known treatments for the condition. A small pilot study of the homeopathic agent Traumeel SŪ had previously shown promise in treating and preventing this serious complication of cancer therapy. Results of the current larger study did not confirm the earlier study, but showed the potential for CAM therapies to be evaluated using the same methodology as other medical treatments. Mainstream medicine relies upon conventional, validated research methods such as the randomized, blinded controlled trial to help guide clinical practice; CAM methods have not always been easily evaluated with these techniques, contributing to CAM's lack of acceptance by many physicians.

"We know complementary treatments can be very helpful for pediatric patients, but there is limited research to support our clinical observations," said Dr. Sencer. "While we found this treatment to be ineffective for mucositis, I'm excited about the potential this trial has for the future of complementary and alternative medicine research."

The 190 eligible patients in the trial received either Traumeel SŪ or a placebo five times daily as a swish and swallow rinse for the treatment. Results showed Traumeel SŪ to be ineffective at preventing and treating mucositis in SCT patients. No adverse events were found to be related to use of the study drug.

At Children's, CAM is often used in pediatric oncology patients to reduce pain, discomfort and other side-effects associated with treating cancer. The Hematology/Oncology Program at Children's is the largest in the upper Midwest with treatment outcomes that consistently rank Children's as one of the top ten programs in the U.S. The Integrative Medicine Program at Children's, which combines the best of complementary and conventional medical therapies, is the largest, longest-running pediatric, clinical integrative medicine program in North America.

About Children's Hospitals and Clinics of Minnesota

Serving as Minnesota's children's hospital since 1924, Children's Hospitals and Clinics of Minnesota is the seventh-largest pediatric health care organization in the United States, with 332 staffed beds at its two hospitals in St. Paul and Minneapolis. An independent, not-for-profit health care system, Children's of Minnesota provides care through more than 14,000 inpatient visits and more than 200,000 emergency room and other outpatient visits every year. Children's is the only Minnesota hospital system to provide comprehensive care exclusively to children. For more information, visit www.childrensmn.org.

SOURCE Children's Hospitals and Clinics of Minnesota
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