Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis: protocol for a multicentre, randomised, placebo-controlled study.

INTRODUCTION: Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity. METHODS AND ANALYSIS: A double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan. ETHICS AND DISSEMINATION: The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.

Shared care or nursing consultations as an alternative to rheumatologist follow-up for rheumatoid arthritis outpatients with low disease activity--patient outcomes from a 2-year, randomised controlled trial.

OBJECTIVES: To compare patient outcomes of three regimes of follow-up care for rheumatoid arthritis (RA) outpatients with low disease activity. METHODS: RA outpatients (n=287) with Disease Activity Score (DAS28-CRP)<3.2 and Health Assessment Questionnaire<2.5 from two Danish rheumatology clinics were randomised to 2-year follow-up by either: (1) planned rheumatologist consultations, (2) shared care without planned consultations or (3) planned nursing consultations. The primary outcome was change in disease activity. DAS28-CRP, Health Assessment Questionnaire, visual analogue scale (VAS)-pain, fatigue, global health, confidence and satisfaction, quality-of-life by the Short Form 12 and self-efficacy measured by the RA Self-Efficacy questionnaire and the Arthritis Self-Efficacy Scale, were recorded annually and safety measures were recorded. x-Rays of hands and feet were taken at baseline and at 2-year follow-up. Mixed effect models were used to explore differences between the three groups over time. RESULTS: At 2-year follow-up, the group allocated to nursing consultations had lower disease activity than the group that underwent rheumatologist consultations (DAS28-CRP -0.3, p=0.049). The nursing group increased their self-efficacy (Arthritis Self-Efficacy Scale 18.8, p=0.001), confidence (10.7, p=0.001) and satisfaction (10.8, p<0.001) compared with the rheumatologist group. The shared care group reported a transient lower satisfaction compared with the rheumatologist group after 1 year (-8.8, p=0.004). No statistically significant differences were seen in other outcome variables. CONCLUSIONS: It is safe to implement shared care and nursing consultations as alternatives to rheumatologist consultations for RA outpatients with low disease activity without deterioration in disease control. Nursing consultations can enhance patients' self-efficacy, confidence and satisfaction.

Fracture risks for women in long-term care: high prevalence of calcaneal osteoporosis and hypovitaminosis D.

STUDY OBJECTIVES: To determine the prevalence of osteoporosis as assessed by peripheral bone mineral density (BMD) in women living in a nursing home, to determine how many women with low BMD had received a diagnosis of osteoporosis, to assess the prevalence of vitamin D deficiency, and to seek reasons for vitamin D deficiency. DESIGN: Measurement of calcaneal BMD and serum 25-hydroxyvitamin D. SETTING: Skilled nursing facility. PATIENTS: Forty-nine women aged 68-100 years. MEASUREMENTS AND MAIN RESULTS: Bilateral calcaneal BMD was measured by dual-energy x-ray absorptiometry and serum 25-hydroxyvitamin D by radioimmunoassay. Medical records were reviewed to assess osteoporosis risk factors, previous documentation of osteoporosis or malabsorption, and supplemental vitamin D intake. Fifty-nine percent of the 39 women with calcaneal BMD measurements (95% confidence interval [CI] 44-74%) exhibited calcaneal osteoporosis (T score < -2.5). Sixty percent (95% CI 46-74%) had 25-hydroxyvitamin D levels of 20 ng/ml or less, which is associated with secondary hyperparathyroidism; only 4% of women had levels above 30 ng/ml, recently recommended as optimal. Vitamin D status was suboptimal even in most women taking multivitamins. Osteoporosis was documented in the records of 17% of 23 women with calcaneal osteoporosis. CONCLUSION: Osteoporosis was prevalent but poorly documented in women living in the nursing home. Peripheral BMD measurements have the potential to improve the recognition and management of osteoporosis in women in long-term care facilities. The high prevalence of vitamin D deficiency, even in those taking multivitamins, indicates that practical new approaches for vitamin D repletion in this population are urgently needed.