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.