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 ofDamp‐Heat syndrome. Till date, few studies have explored use of CHM, in particular SiMiao Xiao Bi Tang, in treating RA. According to past systematic reviews of radnomisedcontrolled trials performed on Chinese herbs in RA patients, most studies were of lowmethodological quality and small numbers, resulting in lack of generalizability. Studieslooking into cost effectiveness are also lacking.Proposed project is a randomised double‐blind placebo‐controlled trial to be conductedover a period of three years, anchored to the Consolidated Standards of Reporting Trials(CONSORT) guidelines and CONSORT extension for CHM. Eligible patients will be randomlyallocated to receive CHM and methotrexate or methotrexate and placebo on a 1:1 basis viarandom permuted block randomization.Intervention group and control group patients receive methotrexate and CHM ormethotrexate and placebo respectively for 12 weeks. They will attend rheumatologistreviews at weeks 0, 4, 8, and 12, including physical exams and disease monitoring. Safetyis tracked through blood tests, and further tests are ordered as needed. TCM physiciansparticipate by counselling and diagnosing TCM syndrome and monitoring for side effectsduring study visits at weeks 0, 4, 8 and 12.American College of Rheumatology 20% improvement criteria (ACR20) at week 8 is theprimary 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 leastthree of the following five criteria: patient's assessment of disease activity,physician's assessment of treatment response, patient's ability to perform dailyactivities based on Health Assessment Questionnaire‐Disability Index (HAQ‐DI), painlevel, and serum inflammation markers.Secondary outcomes include ACR20 response ACR50 response, ACR70 response, 28‐jointdisease activity score using ESR (DAS28‐ESR), impact of RA on disability as measuredusing the Health Assessment Questionnaire Disability Index (HAQ‐DI), severity ofsynovitis as determined using the EULAR‐OMERACT ultrasound scoring system, quality oflife 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 IllnessTherapy‐Fatigue (FACIT‐F) scale and safety of the trial.Exploratory outcome is improvement in ultrasound inflammation at week 8 as compared tobaseline, based on EULAR‐OMERACT ultrasound scoring system.