Auriculotherapy treatment in fibromyalgia: A randomized trial

Introduction: A multidimensional approach is recommended for fibromyalgia (FM). Auriculotherapy, a complementary therapy based on normalizing body dysfunction by treating points on the external ear, has never been studied in FM.

Objective: To assess the efficacy of auriculotherapy in the quality of life of FM patients.

Design: Randomized placebo-controlled clinical trial.

Setting/Location: Tertiary care university hospital, Suresnes, France.

Subjects: Female patients, 18 to 80-years-old, presenting with FM.

Interventions: Participants were randomized to one of three arms: TT group (auriculotherapy true treatment), NST group (needle sham treatment), and VSST group (vaccaria seeds sham treatment). They received their treatment three times at one-month intervals.

Outcome Measures: Primary outcome was the Fibromyalgia Impact Questionnaire (FIQ). Secondary outcomes included pain scores, pain medications, sleep quality, fatigue, anxiety, depression, cognition, physical functional capacity, and global impression of change. All these outcomes measured at early and at late post-treatment evaluations were compared to the preinclusion evaluation.

Results: The percentage of patients having an improvement of FIQ were similar between groups (p=0.245); comparison between TT and VSST group patients was also not statistically significant (p=0.232). FIQ was also similar in the three groups at early post-treatment evaluation considered as absolute values or as variation from inclusion (p=0.910). All secondary outcomes were similar between groups but patients in the TT group presented less pain at the day of visit compared to patients in the VSST group (p=0.018) and global impression of change was statistically different between groups (p=0.029). Comparison between TT and VSST group patients was also different (p=0.012). One serious adverse event occurred in the TT group.

Conclusions: Mixed results lead us to propose qualitative studies in addition to quantitative studies to assess the effectiveness of a specific auriculotherapy treatment.

Methods
Randomized, controlled single-center trial was performed in a tertiary care university hospital, in accordance with the Declaration of Helsinki . Ethical approval for this study was provided by the Ethical Committee of CPP Ile de France VIII (n° 151288, December 17, 2015). The study was published on the Clinical.trials.gov website (May 6, 2016, NCT02764788) The process of Auriculotherapy was conducted according to STRICTA guidelines {MacPherson, 2010 #10907}. 

Three arms: TT group (auriculotherapy true treatment), NST group (needles sham treatment), and VSST group (vaccaria seeds sham treatment). Patients received their treatment three times at one-month intervals. 

Data were collected at five times: at inclusion; after each of the three treatments; early after the third treatment session with a maximal delay of two weeks (main outcome); three months after the end of the treatment. Patients completed a questionnaire with the help of an investigator if necessary.

The main objective of this preliminary study was to evaluate the efficacy of auriculotherapy on the quality of life of patients presenting with FM. The primary outcome was defined as the percentage of patients who have an improvement of FIQ at early post-treatment evaluation, compared to the preinclusion evaluation.  

Secondary objectives were the evaluation of the efficacy of auriculotherapy on pain scores, pain medications, sleep quality, fatigue, anxiety, depression, cognition, physical functional capacity, and global impression of change at early and distant post-treatment evaluations and the measure of the FIQ at distant post-treatment evaluation.