Auriculotherapy Treatment in Fibromyalgia: A Randomized Trial

Background and Objective: A multidimensional approach is recommended for fibromyalgia (FM). Objective was to assess the efficacy of auriculotherapy, a complementary therapy based on normalizing body dysfunction by treating points on the external ear, in the quality of life of patients with FM. Design: Randomized placebo-controlled clinical trial. Setting: University hospital, France. Patients: 95 female patients presenting with FM. Intervention and Methods: Patients received treatment three times at 1-month intervals: auriculotherapy true treatment (AT group, n = 32), needle sham treatment (NST group, n = 32), and vaccaria seeds sham treatment (VSST group, n = 31). Evaluation was performed after the third treatment and 3 months later. Main Outcome Measure: Fibromyalgia Impact Questionnaire (FIQ) at early posttreatment evaluation (after the third treatment). Results: FIQ improved in all groups at early posttreatment evaluation whether this variable is expressed as a percentage change (56.0% in AT group, 55.2% in NST group, 76.0% in VSST group; p = 0.245) or as an absolute value or as variation from inclusion ( p = 0.910). At this time, secondary outcomes were similar between the three groups except for the Patients’ Global Impression of Change, which was different between the three groups ( p = 0.026). Patients reported a better impression of change in the AT group than in the VSST group ( p = 0.022). One serious adverse event occurred in the AT group. Conclusions: Mixed results lead us to propose qualitative studies in addition to quantitative studies to assess the effectiveness of a specific auriculotherapy treatment. Registration: This trial was registered on ClinicalTrials.gov; NCT02764788, (May 6, 2016).