BACKGROUNDRheumatoid arthritis (RA) is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not shown conclusive positive results. Acupuncture is regarded as a reflex therapy that has effects on the human autonomic nervous system. By establishing a traditional Chinese medicine (TCM) diagnosis first, the practitioner is able to choose acupoints according to the state of each individual patient.

METHODS/DESIGNWe are interested if acupuncture, using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun theory, can be effective in relieving pain, improving hand function and increasing health-related quality of life in RA.The authors intend to harmonize TCM diagnosis according to clinical and genetic profiles. Patients with the TCM diagnosis of a so-called Turning Point syndrome will be followed up in a randomized, prospective, double-blind, placebo-controlled, multicenter and three-armed parallel-group study with a standardized treatment in order to optimize potential therapeutic effects of acupuncture on pain, strength and muscle function of patients with RA as well as the influence on inflammation and quality of life.

DISCUSSIONThe findings of this study will provide important clinical information about the feasibility and efficacy of acupuncture treatment for RA patients. In addition, it will explore the feasibility of further acupuncture research.

TRIAL REGISTRATION NUMBERClinicalTrials.gov Identifier NCT02553005.

Acupuncture Therapy ; Arthritis, Rheumatoid ; psychology ; therapy ; Clinical Protocols ; Double-Blind Method ; Hand ; physiopathology ; Humans ; Medicine, Chinese Traditional ; Pilot Projects ; Quality of Life

OBJECTIVE: To identify and synthesize the most recent available evidence of effectiveness of acupuncture on pain, physical function and health-related quality of life (HRQoL) in patients with rheumatoid arthritis (RA). METHODS: A comprehensive search of 12 Western and Chinese databases was undertaken from their inception up to end of 2016. Randomized controlled trials (RCTs), concerning patients with RA treated with needle acupuncture, written in English, Portuguese, German or Chinese were included. Primary outcomes included pain, physical function and HRQoL. Secondary outcomes included morning stiffness, functional impairment, number of tender and swollen joints and serum concentrations of inflamatory markers. Methodological quality was assessed by three independent reviewers using the standardized critical appraisal instrument from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument. RESULTS: Twenty-two studies met the inclusion criteria. Of those, 9 studies were excluded after assessment of their methodological quality. The remaining 13 original RCTs included 974 patients. Ten of these studies published in China, showed favorable statistical significant effects of acupuncture in relieving symptoms of RA compared with controls. CONCLUSIONS Evidence suggests that acupuncture interventions may have a positive effect in pain relief, physical function and HRQoL in RA patients. However, due to the heterogeneity and methodologic limitations of the studies included in this systematic review, evidence is not strong enough to produce a best practice guideline.