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Homeopathic Treatment of Mild Traumatic Brain Injury: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Chapman, Edward H. MD, DHt; Weintraub, Richard J. MD; Milburn, Michael A. PhD; Pirozzi, Therese O'Neil ScD, CCC/SP; Woo, Elaine MD

Journal of Head Trauma Rehabilitation: December 1999 - Volume 14 - Issue 6 - p 521–542
Focus on Clinical Research and Practice, Part 2

Background: Mild traumatic brain injury (MTBI) affects 750,000 persons in the United States annually. Five to fifteen percent have persistent dysfunction and disability. No effective, standard pharmacological treatment exists specifically for this problem. We designed a pilot research project to study the clinical effectiveness of homeopathic medicine in the treatment of persistent MTBI.

Method: A randomized, double-blind, placebo-controlled trial of 60 patients, with a four-month follow-up (N = 50), was conducted at Spaulding Rehabilitation Hospital (SRH). Patients with persistent MTBI (mean 2.93 years since injury, SD 3.1) were randomly assigned to receive a homeopathic medicine or placebo. The primary outcome measure was the subject-rated SRH-MBTI Functional Assessment, composed of three subtests: a Difficulty with Situations Scale (DSS), a Symptom Rating Scale (SRS), and a Participation in Daily Activities Scale (PDAS). The SRH Cognitive-Linguistic Test Battery was used as the secondary measure.

Results: Analysis of covariance demonstrated that the homeopathic treatment was the only significant or near-significant predictor of improvement on DSS subtests (P = .009; 95% CI − .895 to − .15), SRS (P = .058; 95% CI − .548 to .01) and the Ten Most Common Symptoms of MTBI (P = .027; 95% CI −.766 to −.048). These results indicate a significant improvement from the homeopathic treatment versus the control and translate into clinically significant outcomes.

Conclusions: This study suggests that homeopathy may have a role in treating persistent MTBI. Our findings require large-scale, independent replication.

Clinical Instructor, Harvard University School of Medicine (Chapman)

Assistant Clinical Professor of Psychiatry, Tufts University School of Medicine (Weintraub)

Professor, Department of Psychology, University of Massachusetts, Boston, Massachusetts (Milburn)

Assistant Professor, Department of Speech-Language, Pathology and Audiology, Northeastern University, Boston, Massachusetts (Pirozzi)

Instructor in Medicine, Harvard University School of Medicine, Boston, Massachusetts (Woo)

We are indebted to the National Institutes of Health, Office of Alternative Medicine, for its support and funding; to the staff of the Spaulding Rehabilitation Hospital for its openness in pursuing research in a therapy that is controversial; to Diane Gilbert, CRA, Rosemarie Lee, RNC, Ellen Bassuk, MD, Carol Faulkner, BA, and Patricia Casimira, BA, for their invaluable assistance; to Laboratoires Boiron for providing the medicines used in this trial; to the Boiron Research Foundation for supplemental funding; and to the men and women who volunteered themselves as subjects in this project, hoping to help find a therapy for the injury that has so profoundly affected their lives.

Address correspondence to Edward H. Chapman, MD, 91 Cornell St, Newton, MA 02462-1320.

© 1999 Lippincott Williams & Wilkins, Inc.