Effectiveness of individualized homeopathic treatment in perennial allergic rhinitis (PAR)

Abstract

Homeopathic therapy was formulated in 1796 by German physician Samuel Hahnemann aiming at stimulating the vital reaction of the organism against its own disturbs. The scientific rationality of homeopathy presents four main suppositions: principle of therapeutic similarity, experimentation of medicinal substances on healthy individuals, potentized medicines and individualized medicines. Shortly, homeopathy prescribes to sick individuals remedies that have caused similar symptoms in healthy individuals in infinitesimal doses (in order to avoid the initial aggravation of symptoms) by taking into account the varied individual traits of patients (mental, general and local symptoms) in the choice of the most suited remedy (individualized medicine). By using a global approach to semiology aimed at discovering the totality of symptoms and signs characteristic for a particular pair patient-disease, homeopathic physicians make some medicinal hypotheses among the thousands of tested substances which must be prescribed one by one gradually with periodical re-evaluations until the desired healing reaction is achieved (middle-to-long-term treatment). These particularities of the homeopathic model require specific attention when designing scientific research protocols as they differ significantly from the standards employed by clinical epidemiology. To begin with, a relative long period of time is needed in randomized controlled double-blind trials (RCTs) in order to find the suitable individualized remedies, which are the cornerstone for awakening a global homeostatic reaction and to alter the natural course of chronic diseases, which is the ideal aim of homeopathic cure. This doctoral thesis proposes a model for clinical trials complying with the standards of both conventional and homeopathic medicine. Taking into account the high rated of drop-outs in long-term RCTs in both cases, which makes traditional quantitative evaluation impossible, a "mixed" RCT was designed, including an initial closed phase (randomized, controlled, double-blind: Phase 1) lasting 6 months and a later open phase (Phase 2) lasting 12-36 months using exclusively homeopathic treatment, with quantitative and qualitative analyses all along the study (while taking into account the possible systematic error in this kind of clinical trial). This design, besides allowing the analysis of non specific data in homeopathic treatment (placebo effect, patient-doctor relationship, etc.) favors the restriction of placebo to 6 months, complying thus with ethical regulations for clinical research. Patients were assessed by a physician accredited in allergy and immunology nominated by the Department of Allergy and Clinical Immunology of FMUSP hospital, who had no direct association with this study and employed the Department's standard "Allergic Rhinitis Form", a score composed of the specific signs and symptoms of allergic rhinitis and the main outcome of treatments.