Smoking, but not use of complementary and alternative medicine predicts residual functional disability in patients with inflammatory arthritis on biologic disease-modifying anti-rheumatic drugs: Results from the Singapore National Biologics Register.

AIMS: To describe inflammatory arthritis (IA) patients initiating biologic disease-modifying anti-rheumatic drugs (bDMARDs) who use complementary and alternative medicine (CAM), and determine the impact of CAM on predicting modified Health Assessment Questionnaire (mHAQ) at 6 months. METHODS: This was a prospective inception cohort study of patients ≥21 years old initiating a bDMARD for IA after July 2016. Data were obtained via questionnaires and abstraction from medical records. Baseline characteristics between ever-CAM and CAM non-users were compared. CAM as a predictor of mHAQ ≥1 at 6 months after bDMARD initiation was analyzed using multivariate logistic regression, adjusting for other baseline characteristics. RESULTS: We recruited 299 patients (36.2% male, mean age 49.0 years). There were 45.8% who had rheumatoid arthritis, 54.2% had a spondyloarthropathy, median disease duration of 1.1 years and median mHAQ of 0.4. Compared to CAM non-users, ever-CAM users had a lower mean body mass index, were less likely to speak English, and more likely to smoke and drink alcohol. There was no association of CAM use with high mHAQ and no interaction with smoking. Smoking (odds ratio [OR] 938.9; 95% CI 3.20-275 884.1), baseline mHAQ (OR 252.2; 95% CI 5.34-11 899.2) and Charlson's Comorbidity Index score ≥4 (OR 237.4; 95% CI 1.22-46 184.4) independently predicted high mHAQ at 6 months. CONCLUSIONS: CAM use was not associated with high mHAQ at 6 months. Smoking was an independent predictor of residual functional disability at 6 months, even after adjusting for age, comorbidity and baseline mHAQ. Greater emphasis on smoking cessation may improve long-term functional outcomes in IA patients on bDMARDs.

Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial.

BACKGROUND: Axial spondyloarthritis (AxSpA) is a chronic disease which results in fatigue, pain, and reduced quality of life (QoL). Traditional Chinese medicine (TCM), especially acupuncture, has shown promise in managing pain. Although a TCM collaborative model of care (TCMCMC) has been studied in cancer, there are no randomized controlled trials investigating TCM in AxSpA. Therefore, we will conduct a pragmatic trial to determine the clinical effectiveness, safety, and cost-effectiveness of TCMCMC for patients with AxSpA. We define TCMCMC as standard TCM history taking and physical examination, acupuncture, and TCM non-pharmacological advice and communications with rheumatologists in addition to usual rheumatologic care. The purpose of this paper is to describe the rationale for and methodology of this trial. METHODS/DESIGN: This pragmatic randomized controlled trial will recruit 160 patients who are diagnosed with AxSpA and have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). Simple randomization to usual rheumatologic care or the intervention (TCMCMC) with a 1:1 allocation ratio will be used. Ten 30-min acupuncture sessions will be provided to patients assigned to the TCMCMC arm. All participants will continue to receive usual rheumatologic care. The primary endpoint - spinal pain - will be evaluated at week 6. Secondary endpoints include clinical, quality of life, and economic outcome measures. Patients will be followed up for up to 52 weeks, and adverse events will be documented. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of a TCMCMC for patients with AxSpA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03420404 . Registered on 14 February 2018.