Complementary Herbal Approach to Rheumatoid Management Study (CHARMS)

From the Traditional Chinese Medicine (TCM) perspective, RA is part of the Bi Syndrome. Si Miao Xiao Bi Tang is one of the formulas listed in the guidelines for treatment of Damp-Heat syndrome. Till date, few studies have explored use of CHM, in particular Si Miao Xiao Bi Tang, in treating RA. According to past systematic reviews of radnomised controlled trials performed on Chinese herbs in RA patients, most studies were of low methodological quality and small numbers, resulting in lack of generalizability. Studies looking into cost effectiveness are also lacking. Proposed project is a randomised double-blind placebo-controlled trial to be conducted over a period of three years, anchored to the Consolidated Standards of Reporting Trials (CONSORT) guidelines and CONSORT extension for CHM. Eligible patients will be randomly allocated to receive CHM and methotrexate or methotrexate and placebo on a 1:1 basis via random permuted block randomization. Intervention group and control group patients receive methotrexate and CHM or methotrexate and placebo respectively for 12 weeks. They will attend rheumatologist reviews at weeks 0, 4, 8, and 12, including physical exams and disease monitoring. Safety is tracked through blood tests, and further tests are ordered as needed. TCM physicians participate by counselling and diagnosing TCM syndrome and monitoring for side effects during study visits at weeks 0, 4, 8 and 12. American College of Rheumatology 20% improvement criteria (ACR20) at week 8 is the primary outcome. To achieve an ACR20 response, a patient with RA must demonstrate a 20% improvement in both tender and swollen joint counts, and 20% improvement in at least three of the following five criteria: patient's assessment of disease activity, physician's assessment of treatment response, patient's ability to perform daily activities based on Health Assessment Questionnaire-Disability Index (HAQ-DI), pain level, and serum inflammation markers. Secondary outcomes include ACR20 response ACR50 response, ACR70 response, 28-joint disease activity score using ESR (DAS28-ESR), impact of RA on disability as measured using the Health Assessment Questionnaire Disability Index (HAQ-DI), severity of synovitis as determined using the EULAR-OMERACT ultrasound scoring system, quality of life as measured using the Medical Outcomes Study Short-Form (36-item) Health Survey (SF-36), fatigue level as measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale and safety of the trial. Exploratory outcome is improvement in ultrasound inflammation at week 8 as compared to baseline, based on EULAR-OMERACT ultrasound scoring system.