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
Received 30 June 2017
Accepted for publication 15 December 2017
Published 16 March 2018 Volume 2018:12 Pages 375—397
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Johnny Chen
Harald J Hamre,1 Van N Pham,2 Christian Kern,3 Rolf Rau,4 Jörn Klasen,3 Ute Schendel,5 Lars Gerlach,6 Attyla Drabik,2 Ludger Simon6,†
1Institute for Applied Epistemology and Medical Methodology at the Witten/Herdecke University, Freiburg, Germany; 2Institute of Statistics in Medicine, Universitätsklinikum Düsseldorf, Düsseldorf, Germany; 3Department of Integrative Medicine, Asklepios Westklinikum, Hamburg, Germany; 4Department of Rheumatology, Evangelisches Fachkrankenhaus Ratingen, Ratingen, Germany; 5Department of Rheumatology, m&i-Fachklinik Bad Pyrmont, Bad Pyrmont, Germany; 6Department of Internal Medicine and Gastroenterology, Filderklinik, Filderstadt, Germany
†Dr Ludger Simon passed away on June 10, 2016
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, respectively. During follow-up, both groups not only had marked reduction of RA symptoms and C-reactive protein, but also some radiological disease progression. Also, 6.2% of A-patients needed DMARDs. Apart from adverse drug reactions (50.4% and 69.7% of A- and C-patients, respectively, p=0.0020), none of the primary outcomes showed any significant between-group difference.
Conclusion: Study results suggest that for most patients preferring anthroposophic treatment, satisfactory results can be achieved without use of DMARDs and with less use of corticosteroids and NSAIDs than in conventional care.
Limitation: Because of the non-randomized study design, with A-patients choosing anthroposophic treatment, one cannot infer how this treatment would have worked for C-patients.
Keywords: clinical trial, Phase IV, disease-modifying antirheumatic drugs, integrative medicine, patient preference, rheumatoid arthritis
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