Long-term efficacy of spa therapy in patients with rheumatoid arthritis
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Our previous crossover randomized trial suggested that spa therapy added to usual pharmacotherapy provides benefits that lasted 6 months over pharmacotherapy alone in rheumatoid arthritis patients. We now extend, and report the long-term results of that study. In the crossover trial, patients were randomized to spa therapy first group or control first group (first assignment, period 1, 6 months); after this period and washout phase (9 months), they crossed over to the other arm (second assignment, period 2, 6 months). In this long-term study, we now analyze the 15-month results of the first assignment, and 12-month results of the second assignment in the opposite side with a 6-month extension of the follow-up period. The clinical outcome measures were pain, patient and physician global assessment, Health Assessment Questionnaire, and Disease Activity Score-28. The 15-month results of first assignment revealed no statistically significant differences between the groups in any of the efficacy outcomes (p > 0.05 for all). The 12-month results for the second assignment after crossover revealed a statistically significant decrease between the groups regarding the patient global assessment scores (p = 0.016), physician global assessment scores (p = 0.003) and swollen joints counts (p = 0.030); however, no statistically significant difference was found between the groups in any of the other efficacy outcomes (p > 0.05 for all). The short- and medium-term beneficial effects of the 2-week spa therapy added to the usual pharmacotherapy observed through the initial 6-month evaluation period may be maintained mildly to moderately to the 12-month mark in rheumatoid arthritis patients receiving conventional disease-modifying antirheumatic drugs. Further studies with a larger sample size are needed for the confirmation of the study results.
KeywordsSpa therapy Balneotherapy Salt water Rheumatoid arthritis
The authors thank Özge Papakçı Aydın, medical illustrator, for her technical assistance in preparation of Figs. 1 and 2. The authors also thank Kadriye Gümüş, medical writer, for English editing, and proofreading of the manuscript.
Conception or design of the study: MK, MZK; data collection: MK, MZK; data analysis and interpretation: MK, SK, MZK; drafting the article: MK, SK, MZK; critical revision of the article: MK, SK, MZK; final approval of the version of the article to be published: MK, SK, MZK.
Compliance with ethical standards
Conflict of interest
The authors declare no conflicts of interest.
The study was not registered in a clinical trials registry.
The formal ethics approval was not required because this work was a non-interventional extension study of the previous interventional study, and its data were obtained without any additional therapy and it was carried out without interference in standard usual care. However, it was conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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