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A 4-year non-randomized comparative phase-IV study of early rheumatoid arthritis: integrative anthroposophic medicine for patients with preference against DMARDs versus conventional therapy including DMARDs for patients without preference

作者:Harald J. Hamre, Van N. Pham, Christian Kern, Rolf Rau, Jörn Klasen, Ute Schendel, Lars Ole Gerlach, Attyla Drabik, Ludger Simon · 发表于:Patient Preference and Adherence · 年份:2018 · DOI:10.2147/ppa.s145221 · 被引用次数:11 · 研究领域:Complementary and Alternative Medicine Studies、Pain Management and Placebo Effect、Therapeutic Uses of Natural Elements

Background: While disease-modifying antirheumatic drugs (DMARDs) are a mainstay of therapy for rheumatoid arthritis (RA), some patients with early RA refuse DMARDs. In anthroposophic medicine (AM), a treatment strategy for early RA without DMARDs has been developed. Preliminary data suggest that RA symptoms and inflammatory markers can be reduced under AM, without DMARDs. Patients and methods: Two hundred and fifty-one self-selected patients aged 16–70 years, starting treatment for RA of <3 years duration, without prior DMARD therapy, participated in a prospective, non-randomized, comparative Phase IV study. C-patients were treated in clinics offering conventional therapy including DMARDs, while A-patients had chosen treatment in anthroposophic clinics, without DMARDs. Both groups received corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs). Primary outcomes were intensity of RA symptoms measured by self-rating on visual analog scales, C-reactive protein, radiological progression, study withdrawals, serious adverse events (SAE), and adverse drug reactions in months 0–48. Results: The groups were similar in most baseline characteristics, while A-patients had longer disease duration (mean 15.1 vs 10.8 months, p <0.0001), slightly more bone destruction, and a much higher proportion of women (94.6% vs 69.7%, p <0.0001). In months 0–12, corticosteroids were used by 45.7% and 81.6% ( p <0.0001) and NSAIDs by 52.8% and 68.5% ( p =0.0191) of A- and C-patients, respectiv...