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British Homeopathic Journal (2000) 89, Suppl 1, S60 2000 Macmillan Publishers Ltd All rights reserved 00070785/00

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Homeopathic treatment of patients with persistent mild traumatic brain injury


EH Chapman1*
1

91 Cornell Street, Newton, MA 02162-1320, USA

Objectives
We conducted a pilot, randomized placebo-controlled clinical trial of 61 patients with persistent mild traumatic brain injury (MTBI) treated between 1994 96 at Spaulding Rehabilitation Hospital (SRH), Boston, MA, USA. MTBI is a devastating functional disturbance, which persists beyond six months after head injury in 5 15% of patients, resulting in considerable social and economic disruption. Spontaneous recovery after six months is rare. There is no single conventional pharmacological therapy that addresses the scope of the impairment or stimulates recovery. Although results of the pilot study were statistically signicant, the interpretation of the outcomes of the pilot study was limited by the small sample size, short duration of treatment, the number of remedies (18) and potencies (200C) used, and questions about the validity and reliability of the primary outcome measurement, the SRH Speech and Language MTBI (SRH-SL-MTBI) Survey, a 1 5 Likert scale measuring symptom intensity and difculty functioning. Our goals are to design and implement a large-scale denitive trial to conrm the observed efcacy of the homeopathic treatment of MTBI, and then develop practical methods to incorporate homeopathy into standard medical practice.

will be used to design algorithms to facilitate homeopathy's use by conventional providers.

Result
There were 11 dropouts; data from the 50 subjects and completing the pilot protocol demonstrated statistically signicant reductions in patients' symptom intensity (P 0.01) and difculty functioning (P 0.0008). The relative frequencies of positive response from verum prescription conrmed that remedies historically prescribed for head injury were helpful: Opium (4a7), Nux vomica (3a4), Natrum muriaticum (2a2), Natrum sulphuricum (1a5), Arnica montana (1a1). Helleborus niger (1a2). Calcarea carbonica (1a4), Cicuta virosa (1a1), Sulphur (1a3), Nux moschata (1a1) and Lachesis mutans (1a1). A number of cases did not t the picture of any of the 18 pilot homeopathic medicines. We performed several analyses with relevance to homeopathic treatment of MTBI. An analysis of the interaction between time-since injury (range 6 month 17 y) and the onset of homeopathic treatment suggested that the relative benet of homeopathic treatment appeared to increase with duration since injury, a hopeful nding for a condition previously considered untreatable. Previous use of conventional medicines, though correlated with a higher level of initial symptoms and difculty functioning, had no effect on the response to homeopathic treatment. Concurrent use of allopathic medication with homeopathic medicines was effective and safe, but appeared to have a dampening effect, though not statistically signicant. These nding will contribute to improving prescribing strategies.

Methods
We will rst rene and validate the SRH-SL-MTBI Survey. Using this scale along with the SF-12 Health Survey, and a panel of neuro-psychological studies and measures, we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial, enrolling 80 subjects at each of three oparticipating rehabilitation hospitals. The modied protocol will increase the treatment duration to one year and remove restriction on the homeopathic medicines and potencies used. We will generate a comprehensive database of the symptoms, prescribing indications and posologies for remedies used for the treatment of MTBI. This data
*Correspondence: EH Chapman, 91 Cornell Street, Newton, MA 02162-1320, USA.

Conclusion
Homeopathy may have a role in the therapy for persistent MTBI. The pilot study generated preliminary information important to homeopathic prescribing which will be supplemented by data generated by the proposed randomised controlled trial.

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