Observational prospective study
Cephalalgia, Journal of Hellenic Headache Association
Volume 13, Number 3, July-September 2006
by S.Kivellos , J.Papatriantafyllou , K.Papilas , G.Vithoulkas , K.Karagerorgiou
BACKGROUND AND AIMS. Homeopathy trials of migraine prevention have yielded inconclusive results, partly due to different practice among various schools. We performed an observational prospective study of classical homeopathy in patients attending the Cephalalgia Clinic.
METHODS. Forty-two consecutive patients who attended the clinic while one of the authors was available were assigned to receive homeopathic treatment, according to the principles recommended by the I.A.C.H. and G.Vithoulkas. Additional evaluation by a neurologist was performed at baseline, 6 and 12 months. Primary and secondary measures of migraine severity and impact on quality of life were recorded and analyzed.
RESULTS. Thirty-six patients opted only for homeopathic treatment until the completion of the study, aged (mean±SD) 34±12 years, with a baseline HIT-6 score of 65±4. Significant improvement was recorded at 6 months (HIT-6 48±8, P<0.0009 vs baseline, Wilcoxon signed ranks test), which was further established at 12 months (HIT-6 41.2±7, P<0.0009 vs 6-months).
Eighteen patients had been previously administered TCAs or antiepileptics for sufficient time without remarkable improvement. A difference in HIT-6 score between those ‘resistant’ to previous therapy and ‘new’ patients was found at six months (51.5±7 vs 44.5±7, respectively, P<0.01, Mann-Whitney test), but not at baseline (66±3.8 vs 64±4, respectively) or after 12 months (41.6±8 vs 40.6±5.3, respectively).
Migraine severity (VAS) decreaed by 72% and frequency by 81 % at 12 months (P<0.0001 for both comparisons vs baseline). Mood was consistently higher at 12 months (Verbal Analogue Scale, P<0.001). Observed potential adverse effects on all 42 patients were an initial ‘aggravation’ of migraine symptoms in 69%, recurrence of past medical diseases (e.g. infections, eczema) in 33%, temporary emotional instability in 59% of the patients.
CONCLUSION. These results compare favorably with other modalities of migraine treatment. Therefore, homeopathy, as applied in this context, warrants further research with appropriately designed RCTs.