Effectiveness of a Multicomponent Treatment based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioural Therapy, and Mindfulness in Patients with Fibromyalgia (FIBROWALK study) : A Randomized Controlled Trial

Methods. A randomised controlled trial (RCT) was carried out to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioural therapy and mindfulness, in addition to treatment as usual (TAU), compared to TAU only in patients with fibromyalgia (FM). The multicomponent treatment (2h weekly sessions) was delivered in groups of 20 participants. TAU was mainly based on pharmacotherapy. We collected data on functional impairment (the Revised Fibromyalgia Impact Questionnaire [FIQR], as primary outcome), pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, at 12 weeks and, for the multicomponent group only, at 6 and 9 months. An intention to treat approach was used to analyse between-group differences. We also analysed baseline differences between responders (> 20% FIQR reduction) and non-responders and computed the number needed to treat (NNT). Results. A total of 272 patients with FM were randomly assigned to either the multicomponent treatment (n = 135) or TAU (n = 137). Significant between-group differences (p .80) were found for functional impairment, pain, kinesiophobia, and physical function, whilst differences with a moderate size effect (Cohen's d > 0.50 and < 0.80) were found for fatigue, anxiety, and depressive symptoms. Non-responders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI 1.7 - 2.3). Conclusions. Our results indicate that, when compared to TAU, the multicomponent treatment was effective for improving FM-related symptoms. Nevertheless, we must temper our findings in light of some methodological limitations in the study design. Impact statement. This is the first RCT showing positive effects on a wide range of clinical outcomes of a multicomponent treatment that integrates pain neuroscience education for patients with fibromyalgia. This work reports promising results and it might be the first step towards a paradigm shift in the management of fibromyalgia

Effectiveness of two video-based multicomponent treatments for fibromyalgia : The added value of cognitive restructuring and mindfulness in a three-arm randomised controlled trial

Acord transformatiu CRUE-CSICUTP en procés de revisióBackground/objectives: The aim of this study was to examine the effectiveness of two video-based multicomponent programs (FIBROWALK) and the Multicomponent Physiotherapy Program (MPP) for patients with fibromyalgia (FM) compared to treatment-as-usual (TAU) only. We posit that FIBROWALK, due to inclusion of specific psychological ingredients (cognitive restructuring and mindfulness), can produce additional clinical benefits when compared to TAU or MPP alone. Methods: A total of 330 patients with FM were recruited and randomly allocated (1:1:1) to TAU only, TAU + FIBROWALK, or TAU + MPP. FIBROWALK and MPP consisted of weekly videos on pain neuroscience education, therapeutic exercise and self-management patient education, but only the FIBROWALK intervention provided cognitive restructuring and mindfulness. Both programs were structurally equivalent. Between-group differences in functional impairment, pain, kinesiophobia, anxious-depressive symptoms and physical functioning were evaluated at post-treatment following Intention-To-Treat and complete-case approaches. Results: Compared to TAU only, individuals in the FIBROWALK arm showed larger improvements in all clinical outcomes; similarly, participants in the MPP program also showed greater improvements in functional impairment, perceived pain, kinesiophobia, depressive symptoms compared to TAU only. The FIBROWALK intervention showed superior effects in improving pain, anxiety and depressive symptoms and physical functioning compared to MPP. Conclusions: This RCT supports the short-term effectiveness of the video-based multicomponent programs FIBROWALK and MPP for FM and provides evidence that cognitive-behavioural and mindfulness-based techniques can be clinically useful in the context of physiotherapeutic multicomponent treatment programs. Trial registration number: NCT04571528

Proof of concept of a treatment for fibromyalgia based on physical activity, psychological support, and exposure to nature (NAT-FM)

Aim: To provide a preliminary assessment of the efficacy of the NAT-FM protocol as a complimentary treatment in patients with fibromyalgia (FM). Methods: A trial was conducted, with two arms: TAU (n = 6) and TAU+NAT-FM (n = 6). Results: There was a reduction in physical limitations and anxious/depressive symptoms and an improvement in positive affect in the intervention group. Also, this group showed a decrease in pain, catastrophizing, negative affect, and positively refocusing, and an increase in positive affect. Intrasession assessments showed an increase in positive affect, self-efficacy, and energy, along with a decrease in stress. Intersession assessments revealed an increase in pain, valence, and dominance. Conclusion: The results suggest the appropriateness of the NAT-FM protocol

Effectiveness of a Multicomponent treatment for fibromyalgia based on Pain neuroscience education, Exercise therapy, Psychological support, and Nature exposure (NAT-FM): A Pragmatic randomized controlled trial

A recent study (FIBROWALK) has supported the effectiveness of a multicomponent treatment based on pain neuroscience education (PNE), exercise therapy (TE), cognitive behavioral therapy (CBT), and mindfulness in patients with fibromyalgia. The aim of the present RCT was: (a) to analyze the effectiveness of a 12-week multicomponent treatment (nature activity therapy for fibromyalgia, NAT-FM) based on the same therapeutic components described above plus nature exposure to maximize improvements in functional impairment (primary outcome), as well as pain, fatigue, anxiety-depression, physical functioning, positive and negative a ect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables) compared with treatment as usual (TAU); (b) to preliminarily assess the e ects of the nature-based activities included (yoga, Nordic walking, nature photography, and Shinrin Yoku); and (c) to examine whether the positive effects of TAU + NAT-FM on primary and secondary outcomes at post-treatment were mediated through baseline to six-week changes in process variables. A total of 169 FM patients were randomized into two study arms: TAU + NAT-FM vs. TAU alone. Data were collected at baseline, at six-week of treatment, at post-treatment, and throughout treatment by ecological momentary assessment (EMA). Using an intention to treat (ITT) approach, linear mixed-e ects models and mediational models through path analyses were computed. Overall, TAU + NAT-FM was significantly more e ective than TAU at posttreatment for the primary and secondary outcomes evaluated, as well as for the process variables. Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal. The number needed to treat (NNT) was 3 (95%CI = 1.6-3.2). The nature activities yielded an improvement in affective valence, arousal, dominance, fatigue, pain, stress, and self-effcacy. Kinesiophobia and perceived competence were the mediators that could explain a significant part of the improvements obtained with TAU + NAT-FM treatment. TAU + NAT-FM is an e ective co-adjuvant multicomponent treatment for improving FM-related symptoms

Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM) : Study Protocol of a Randomized Controlled Trial

The study protocol of a prospective and randomized controlled trial for the assessment of the efficacy of nature activity therapy for people with Fibromyalgia (NAT-FM) is described. The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation. A total of 160 patients with fibromyalgia will be divided into two arms: treatment-as-usual (TAU) and NAT-FM+TAU. Pre, during, post, +6, and +9 months assessments will be carried out, as well as an ecological momentary assessment (EMA) of intrasession and intersessions. Results will be subjected to a mixed group (NAT-FM+TAU vs. TAU) × phase (pre, post, +6 months, +9 months) general linear model. EMA intrasession measurements will be subjected to a 2 (pre vs. post) × 5 (type of activity) mixed-effects ANOVA. EMA between-session measurements obtained from both arms of the study will be analysed on both a time-domain and frequency-domain basis. Effect sizes and number needed to treat (NNT) will be computed. A mediation/moderation analysis will be conducted

Long-term etanercept survival in patients with psoriatic arthritis: a multicenter retrospective analysis in daily clinical practice in Spain

Although several randomized clinical trials and observational studies have evaluated the effectiveness, safety and drug survival of etanercept (ETN) in the treatment of psoriatic arthritis (PsA), long-term data regarding these aspects are currently scarce. For this reason, we sought to investigate the long-term survival and safety of ETN in PsA patients in 4 tertiary care Spanish hospitals over a 13-year observation period (from 2004 to 2017). The records of 85 PsA patients were reviewed. ETN showed an excellent survival profile, with rates of treatment discontinuation at 1, 3, 5 and 10 years of 15, 37, 46 and 59%, respectively. In our cohort, a trend toward longer drug survival in patients with shorter disease duration and those who were treated with ETN as their first biologic agent was observed. On the other hand, combination therapy with conventional disease-modifying antirheumatic drugs did not provide greater improvement on the long-term drug survival. Only 12% of the patients reported adverse events (AEs) during therapy, being most of them of mild to moderate intensity, and in only 7% AEs led to drug discontinuation. To the best of our knowledge, the present study shows the largest follow-up period of ETN-treated population analyzed in a real-life setting, and these results demonstrate the positive safety profile and long-term effectiveness of this biologic agent in the management of PsA patients

The Conners Continuous Performance Test CPT3 ™ : Is it a reliable marker to predict neurocognitive dysfunction in Myalgic encephalomyelitis/chronic fatigue syndrome?

The main objective is to delimit the cognitive dysfunction associated with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in adult patients by applying the Continuous Performance Test (CPT3 ™). Additionally, provide empirical evidence on the usefulness of this computerized neuropsychological test to assess ME/CFS. The final sample (n = 225; 158 Patients/67 Healthy controls) were recruited in a Central Sensitization Syndromes (CSS) specialized unit in a tertiary hospital. All participants were administered this neuropsychological test. There were significant differences between ME/CFS and healthy controls in all the main measures of CPT3 ™. Mainly, patients had a worse indicator of inattentiveness, sustained attention, vigilance, impulsivity, slow reaction time, and more atypical T-scores, which is associated with a likelihood of having a disorder characterized by attention deficits, such as Attention Deficit Hyperactivity Disorder (ADHD). In addition, relevant correlations were obtained between the CPT3 ™ variables in the patient's group. The most discriminative indicators of ME/CFS patients were Variability and Hit Reaction Time, both measures of response speed. The CPT3 ™ is a helpful tool to discriminate neurocognitive impairments from attention and response speed in ME/CFS patients, and it could be used as a marker of ME/CFS severity for diagnosing or monitoring this disease

Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia : Study protocol of a randomized, controlled trial (On&Out study)

Introduction: The On&Out study is aimed at assessing the effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative effectiveness nor their long-term effects. For the first time, this study will also evaluate the cost-utility (6-month time-horizon) and the effects on immune-inflammatory biomarkers and Brain-Derived Neurotrophic Factor (BDNF) levels of both interventions. The objectives of this 6-month, randomized, controlled trial (RCT) are 1) to examine the effectiveness and cost-utility of adding FIBRO-On or FIBRO-Out to Treatment-As-Usual (TAU) for individuals with fibromyalgia (FM); 2) to identify pre-post differences in blood biomarker levels in the three study arms and 3) to analyze the role of process variables as mediators of 6-month follow-up clinical outcomes. Methods and analysis: Participants will be 225 individuals with FM recruited at Vall d'Hebron University Hospital (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs. TAU + FIBRO-On vs. TAU + FIBRO-Out. A comprehensive assessment to collect functional impairment, pain, fatigue, depressive and anxiety symptoms, perceived stress, central sensitization, physical function, sleep quality, perceived cognitive dysfunction, kinesiophobia, pain catastrophizing, psychological inflexibility in pain and pain knowledge will be conducted pre-intervention, at 6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immune-inflammatory biomarkers [i.e., IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C-reactive protein (hs-CRP)] and Brain-Derived Neurotrophic Factor will be evaluated in 40 participants in each treatment arm (total n = 120) at pre- and post-treatment. Quality of life and direct and indirect costs will be evaluated at baseline and at 6-month follow-up. Linear mixed-effects regression models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed. Ethics and dissemination: This study has been approved by the Ethics Committee of the Vall d'Hebron Institute of Research. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities. Trial registration number NCT05377567 ()

Sustained low disease activity measured by ASDAS slow radiographic spinal progression in axial spondyloarthritis patients treated with TNF-inhibitors: data from REGISPONSERBIO

Background To evaluate the influence of the disease activity on radiographic progression in axial spondyloarthritis (axSpA) patients treated with TNF inhibitors (TNFi). Methods The study included 101 axSpA patients from the Spanish Register of Biological Therapy in Spondyloarthritides (REGISPONSERBIO), which had clinical data and radiographic assessment available. Patients were classified into 2 groups based on the duration of TNFi treatment at baseline: (i) long-term treatment (>= 4 years) and (ii) no long-term treatment (= 2 mSASSS units. At inclusion, approximately half of the patients (45.5%) were receiving long-term treatment with TNFi (>= 4 years). In this group of subjects, a significant difference in averaged Ankylosing Spondylitis disease Activity Score (ASDAS) across follow-up was found between progressors and non-progressors (2.33 vs 1.76, p=0.027, respectively). In patients not under long-term TNFi treatment (54.5%) though, no significant ASDAS differences were observed between progressors and non-progressors until the third year of follow-up. Furthermore, no significant differences were found in progression status, when disease activity was measured by Bath Ankylosing spondylitis Disease Activity Index (BASDAI) and C reactive protein (CRP). Conclusions Patients on long-term TNFi treatment with a mean sustained low disease activity measures by ASDAS presented lower radiographic progression than those with active disease

Prevalencia de la sensibilidad al gluten no celíaca y valoración de la respuesta a una dieta sin gluten en una cohorte de pacientes con fibromialgia

Introducció. Resulta d'especial interès estudiar la relació existent entre la Fibromiàlgia i la Sensibilitat al Gluten No Celíaca (SGNC) per la prevalença d'ambdues malalties, pels símptomes extra intestinals semblants i per la resposta a una Dieta Sense Gluten (DSG) objectivada en alguns pacients amb Fibromiàlgia. Hipòtesi. La prevalença de la SGNC seria més gran en pacients amb Fibromiàlgia que l'estimada a la població general, un percentatge de pacients amb Fibromiàlgia superior al 25% respondria a una DSG de sis setmanes de durada, un percentatge de pacients responedors a la DSG superior al 50 % no compliria els criteris diagnòstics per a SGNC i les característiques basals dels pacients s'associarien tant a la resposta a la DSG com al compliment dels criteris diagnòstics de SGNC. Objectius. L'objectiu principal va ser establir la prevalença de la SGNC segons els criteris dels experts de Salerno en una cohort de pacients adults amb Fibromiàlgia d'una unitat hospitalària especialitzada. Els objectius secundaris van ser avaluar la resposta clínica a la DSG de sis setmanes de durada, l'evolució de la simptomatologia intestinal i extra intestinal, el percentatge de pacients responedors a la DSG que no van complir els criteris diagnòstics i les característiques basals que es van associar tant a la resposta a la DSG com al compliment dels criteris diagnòstics de SGNC. Mètodes. Estudi experimental no controlat dut a terme en una cohort de pacients amb Fibromiàlgia d'una Unitat Hospitalària entre Juny de 2018 i Desembre de 2019. Dels candidats a participar a l'estudi, pacients adults que complien criteris de classificació i de diagnòstic per a Fibromiàlgia, es van excloure aquells amb diagnòstics previs d'Al·lèrgia al Blat (AB), Malaltia Celíaca (MC) i aquells que estaven realitzant una DSG. Posteriorment, se'ls va fer una analítica i una fibrogastroscòpia i es van descartar aquells pacients que complien criteris d'AB o MC. Tots els pacients seleccionats van seguir els dos passos dels criteris de Salerno: avaluació de la resposta a la DSG i provocació amb gluten controlada amb placebo a simple cec als responedors a la dieta. Es va analitzar el percentatge de pacients que complien els criteris diagnòstics de Salerno, que responien a la DSG, que milloraven més del 30% i del 50% en determinades variables clíniques després de la dieta, el canvi mitjà en aquestes variables, les diferències en les característiques basals entre pacients responedors i no responedors a la dieta i entre complidors i no complidors dels criteris i els factors predictors de resposta i de compliment dels criteris mitjançant els tests estadístics corresponents. Resultats. 142 pacients amb Fibromiàlgia van ser seleccionats per participar a l'estudi. Es va objectivar una prevalença de la SGNC del 5,6%, similar a l'estimada a la població general. Només un 21,8% dels pacients va respondre a la DSG, preferentment a expenses de millora en la simptomatologia intestinal. No es va observar una millora significativa de la simptomatologia extra intestinal. Un 74,2% dels pacients que van respondre a la DSG no van complir els criteris diagnòstics de SGNC. Els factors predictors de la resposta a la DSG van ser la presència de diarrea i de limfòcitosi intraepitelial i un menor grau d'ansietat. No es van trobar característiques basals associades al compliment dels criteris de SGNC en responedors a causa del baix nombre de pacients que van discriminar entre gluten i placebo. Conclusió. Segons els resultats obtinguts en aquest estudi, no es pot recomanar una DSG de forma sistemàtica a tots els pacients amb Fibromiàlgia, encara que es podria valorar en aquells amb presència de diarrea i/o de limfocitosi intraepitelial per avaluar si es produeixen millores en la seva simptomatologia intestinal.Introducción. Resulta de especial interés estudiar la relación existente entre la Fibromialgia y la Sensibilidad al Gluten No Celíaca (SGNC) por la prevalencia de ambas enfermedades, por sus síntomas extra intestinales parecidos y por la respuesta a una Dieta Sin Gluten (DSG) objetivada en algunos pacientes con Fibromialgia. Hipótesis. La prevalencia de la SGNC sería mayor en pacientes con Fibromialgia que la estimada en la población general, un porcentaje de pacientes con Fibromialgia superior al 25% respondería a una DSG de seis semanas de duración, un porcentaje de pacientes respondedores a la DSG superior al 50% no cumpliría los criterios diagnósticos para SGNC y características basales de los pacientes se asociarían tanto a la respuesta a la DSG como al cumplimiento de los criterios diagnósticos de SGNC. Objetivos. El objetivo principal fue establecer la prevalencia de la SGNC según los criterios de los expertos de Salerno en una cohorte de pacientes adultos con Fibromialgia de una unidad hospitalaria especializada. Los objetivos secundarios fueron evaluar la respuesta clínica a la DSG de seis semanas de duración, la evolución de la sintomatología intestinal y extra intestinal, el porcentaje de pacientes respondedores a la DSG que no cumplieron los criterios diagnósticos y las características basales que se asociaron tanto a la respuesta a la DSG como al cumplimiento de los criterios diagnósticos de SGNC. Métodos. Estudio experimental no controlado llevado a cabo en una cohorte de pacientes con Fibromialgia de una Unidad Hospitalaria entre Junio de 2018 y Diciembre de 2019. De los candidatos a participar en el estudio, pacientes mayores de edad que cumplían criterios de clasificación y de diagnóstico para Fibromialgia, se excluyeron aquellos con diagnósticos previos de Alergia al Trigo (AT), Enfermedad Cedlíaca (EC) y aquellos que estaban realizando una DSG. Posteriormente, se les realizó una analítica y una fibrogastroscopia y se descartaron aquellos pacientes que cumplían criterios de AT o EC. Todos los pacientes seleccionados siguieron los dos pasos de los criterios de Salerno: evaluación de la respuesta a la DSG y provocación con gluten controlada con placebo a simple ciego en los respondedores a la dieta. Se analizó el porcentaje de pacientes que cumplían los criterios diagnósticos de Salerno, que respondían a la DSG, que mejoraban más del 30% y del 50% en determinadas variables clínicas tras la dieta, el cambio medio en estas variables, las diferencias en las características basales entre pacientes respondedores y no respondedores a la dieta y entre cumplidores y no cumplidores de los criterios y los factores predictores de respuesta y de cumplimiento de los criterios mediante los test estadísticos correspondientes. Resultados. 142 pacientes con Fibromialgia fueron seleccionados para participar en el estudio. Se objetivó una prevalencia de la SGNC del 5,6%, similar a la estimada en la población general. Sólo un 21,8% de los pacientes respondió a la DSG, preferentemente a expensas de mejoría en la sintomatología intestinal. No se observó mejoría significativa de la sintomatología extra intestinal. Un 74,2% de los pacientes que respondieron a la DSG no cumplieron los criterios diagnósticos de SGNC. Los factores predictores de la respuesta a la DSG fueron la presencia de diarrea y de linfocitosis intraepitelial y un menor grado de ansiedad. No se hallaron características basales asociadas al cumplimiento de los criterios de SGNC en respondedores debido al bajo número de pacientes que discriminaron entre gluten y placebo. Conclusión. Según los resultados obtenidos en este estudio, no puede recomendarse una DSG de forma sistemática a todos los pacientes con Fibromialgia, aunque podría valorarse en aquellos con presencia de diarrea y/o de linfocitosis intraepitelial para evaluar si se producen mejorías en su sintomatología intestinal.Introduction. It is of special interest to study the relationship between Fibromyalgia and Non-Celiac Gluten Sensitivity (NCGS), for its prevalence, for its similar extra intestinal symptoms and for the response to a Gluten Free Diet (FGD) objectified in some patients with Fibromyalgia. Hypothesis. The prevalence of NCGS would be higher in patients with Fibromyalgia than the estimated in the general population, a percentage of Fibromyalgia patients greater than 25% would respond to a six-week GFD, a percentage of responders to a GFD greater than 50% would not fulfill the NCGS diagnostic criteria and there would be baseline characteristics of the patients that would be associated with the response to a GFD and the fulfillment of the NCGS diagnostic criteria. Objectives. The main objective of the study was to establish the prevalence of NCGS according to the Salerno experts' criteria in a cohort of Fibromyalgia patients from a Specialized Hospital Unit. The secondary objectives were to evaluate the clinical response to the six-week GFD, the evolution of intestinal and extra intestinal symptoms, the percentage of responders to the GFD who did not fulfill the NCGS diagnostic criteria and the baseline characteristics that were associated with the response to the GFD and the fulfillment of the NCGS diagnostic criteria. Methods. Uncontrolled experimental study in a cohort of patients with Fibromyalgia from a Hospital Unit between June 2018 and December 2019. Of the candidates for the participation in the study, consecutive patients who fulfilled the classification and the diagnostic criteria for Fibromyalgia at least 18 years old, those with previous diagnoses of Wheat Allergy (WA) or Celiac Disease (CD) and those who were already following a GFD were excluded. Subsequently, a blood test and a fibro gastroscopy were performed and those patients who fulfilled criteria for WA or CD were excluded. All the selected patients followed the two steps of the Salerno Experts' criteria: evaluation of the response to the six-week GFD and placebo-controlled gluten challenge in responders performed by a single blinded procedure. The percentage of patients that fulfilled the Salerno Experts' Criteria for NCGS, that responded to a six-week GFD, that achieved greater than 30% and 50% improvements in clinical outcomes, the mean changes in these outcomes from baseline, the differences in baseline characteristics between responders and non-responders to the GFD and between criteria fulfillers and criteria non-fulfillers and baseline characteristics associated with the response to the GFD and the fulfillment of the NCGS diagnostic criteria were analyzed using appropriate statistical test. Results. 142 patients with Fibromyalgia in whom CD and WA had been excluded were selected for participating in the study. A prevalence of NCGS of 5.6%, similar to that estimated in the general population (0.6-6%), was observed. Only 21.8% of the patients responded to the GFD, preferably at the expense of improvement in intestinal symptoms. No significant improvement in extra intestinal symptoms was observed. 74.2% of the patients who responded to the GFD did not fulfill the Salerno Experts' Criteria for NCG. Predictive factors of the response to the GFD were the presence of diarrhea and intraepithelial lymphocytosis and lower levels of anxiety. No baseline characteristics were found associated with the fulfillment of the NCGS criteria in responders to the GFS due to the low number of patients who discriminated between gluten and placebo in placebo-controlled gluten challenge. Conclusion. According to the results obtained in this study, a FGD cannot be systematically recommended to all patients with Fibromyalgia, although it could be evaluated in those with diarrhea or intraepithelial lymphocytosis to evaluate if there are improvements in their intestinal symptoms