DOI: 10.5061/dryad.r2280gbms
title: Auriculotherapy treatment in fibromyalgia: A randomized trial

description: 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.
description: 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.  
description: Two files are included: * INCLUSION: data describing patients at inclusion
 * MEASUREMENTS: data observed during treatment Note that "na"
 indicates "not available" ### INCLUSION * id_data: Patient
 number * Group: "TT group: auriculotheray true treatment: NST group:
 needle sham treatment: VSST group: vaccaria seeds sham treatment" *
 Age: "1: &lt;50 years: 2: 50 years and +" * Time since onset of
 symptoms: , years * Number of painful points: number * WPI: Widespread
 pain index ranging from 0 to 19 * SS: Symptom severity score * FIQ:
 Fibromyalgia impact questionnaire ranging from 0 to 100 * Pain during the
 visit: 11-point numerical pain scale from 0 to 10 (from 0, no pain, to 10,
 the worst pain imaginable) * Pain during last 24 hours: 11-point numerical
 pain scale from 0 to 10 (from 0, no pain, to 10, the worst pain
 imaginable) * Pain during last week: 11-point numerical pain scale from 0
 to 10 (from 0, no pain, to 10, the worst pain imaginable) * MOS: Medical
 outcomes study sleep scale ranging from 12 to 71 * Anxiety scale: 14 items
 rated from 0 to 3 * Depression scale: 14 items rated from 0 to 3 * Trail
 Maling Test A: Maximum score is 100 seconds * Trail Maling Test B: Maximum
 score B is 300 seconds * Six-minute walk test : Meters ### MEASUREMENTS *
 id_data: Patient number * Group: "TT group: auriculotheray true
 treatment: NST group: needle sham treatment: VSST group: vaccaria seeds
 sham treatment" * Visit number: "4: early post-treatment
 evaluation : 5: visit: late post-treatment evaluation" * FIQ:
 Fibromyalgia impact questionnaire ranging from 0 to 100 * Pain during the
 visit: 11-point numerical pain scale from 0 to 10 (from 0, no pain, to 10,
 the worst pain imaginable) * Pain during last 24 hours: 11-point numerical
 pain scale from 0 to 10 (from 0, no pain, to 10, the worst pain
 imaginable) * pain during last week: 11-point numerical pain scale from 0
 to 10 (from 0, no pain, to 10, the worst pain imaginable) * MOS: Medical
 outcomes study sleep scale ranging from 12 to 71 * MFI-20:
 Multidimensional fatigue inventory-20 scale (range 20-100) * Anxiety
 scale: 14 items rated from 0 to 3 * Depression scale: 14 items rated from
 0 to 3 * Trail Maling Test A: Maximum score is 100 seconds * Trail Maling
 Test B: Maximum score B is 300 seconds * PGIC score: Number between 1 to 7
 * Six-minute walk test : Meters