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.

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dc.contributor.authorHamre, Harald J
dc.contributor.authorPham, Van N
dc.contributor.authorKern, Christian
dc.contributor.authorRau, Rolf
dc.contributor.authorKlasen, Jörn
dc.contributor.authorSchendel, Ute
dc.contributor.authorGerlach, Lars
dc.contributor.authorDrabik, Attyla
dc.contributor.authorSimon, Ludger
dc.date.accessioned2025-02-05T18:42:38Z
dc.date.available2025-02-05T18:42:38Z
dc.date.issued2018
dc.description.abstractWhile 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. 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. The groups were similar in most baseline characteristics, while A-patients had longer disease duration (mean 15.1 vs 10.8 months, <0.0001), slightly more bone destruction, and a much higher proportion of women (94.6% vs 69.7%, <0.0001). In months 0-12, corticosteroids were used by 45.7% and 81.6% (<0.0001) and NSAIDs by 52.8% and 68.5% (=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, =0.0020), none of the primary outcomes showed any significant between-group difference. 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. 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.
dc.identifier.citationHamre, H. J., Pham, V. N., Kern, C., Rau, R., Klasen, J., Schendel, U., Gerlach, L., Drabik, A., & Simon, L. (2018). 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. Patient Preference and Adherence, 12, 375–397. https://doi.org/10.2147/PPA.S145221
dc.identifier.doihttps://doi.org/10.2147/ppa.s145221
dc.identifier.issn1177-889X
dc.identifier.orcidhttps://orcid.org/0000-0003-1098-1079
dc.identifier.other29588576
dc.identifier.urihttps://hdl.handle.net/20.500.14430/756
dc.language.isoen
dc.subjectPhase IV
dc.subjectclinical trial
dc.subjectdisease-modifying antirheumatic drugs
dc.subjectintegrative medicine
dc.subjectpatient preference
dc.subjectrheumatoid arthritis
dc.titleA 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.
dc.typejournal article
dspace.entity.typePublication
oaire.citation.titlePatient Preference and Adherence
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