Fibromyalgia and menopause: an open study on postmenopausal hormone therapy.

BACKGROUND: Fibromyalgia women (FM) seems to get worse at menopause suggesting some influence of estrogens on its pathophysiology. We aimed to study the influence of postmenopausal hormone therapy (HT) in FM, the relationship with sleep and FM impact. METHODS: We analyzed prospectively 69 menopausal women, divided in two groups, FM group (FMG; N.=32) and comparison group (CG; N.=28) submitted to HT for twelve weeks (1.2 mg/g transdermal estradiol, 100 mg micronized natural progesterone oral/daily). Data on Utian Quality of Life Questionnaire (UQOL) and Pittsburgh Sleep Quality Index (PSQI) were obtained in both groups, at entrance and twelve weeks after HT. FM patients also completed the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) and fibromyalgia severity (FS). RESULTS: FM patients improved significantly the FIQ-R (P=0.0001, median FIQ-R score 30% lower), mainly the severity of FM, assessed by FS (P<0.0001). Both groups had improved quality of life and sleep (UQOL: P=0.0001; P=0.001, PSQI: P<0.0001; P=0.007, respectively). Differences between first and second PSQI were greater for CG than for FMG (P=0.008). CONCLUSIONS: HT improving sleep and quality of life in both groups; it was a significant clinical improvement seen by FIQ and FS in FM patients. These changes characterize improvement of functional status and symptoms severity.

Incidence and risk factors for moderate/severe COVID-19 in rheumatic diseases patients on hydroxychloroquine: a 24-week prospective cohort.

OBJECTIVES: To evaluate the incidence of COVID-19 and its main outcomes in rheumatic disease (RD) patients on hydroxychloroquine (HCQ) compared to household cohabitants (HC). METHODS: This is a 24-week nationwide prospective multi-centre cohort with a control group without RD and not using HCQ. All participants were monitored through scheduled phone interviews performed by health professionals. Details regarding COVID-19 symptoms, and epidemiological, clinical, and demographic data were recorded on a specific web-based platform. COVID-19 was defined according to the Brazilian Ministry of Health criteria and classified as mild, moderate or severe. RESULTS: A total of 9,585 participants, 5,164 (53.9%) RD patients on HCQ and 4,421 (46.1%) HC were enrolled from March 29th, 2020 to September 30th, 2020, according to the eligibility criteria. COVID-19 confirmed cases were higher in RD patients than in cohabitants [728 (14.1%) vs. 427 (9.7%), p<0.001] in a 24-week follow-up. However, there was no significant difference regarding outcomes related to moderate/ severe COVID-19 (7.1% and 7.3%, respectively, p=0.896). After multiple adjustments, risk factors associated with hospitalisation were age over 65 (HR=4.5; 95%CI 1.35-15.04, p=0.014) and cardiopathy (HR=2.57; 95%CI 1.12-5.91, p=0.026). The final survival analysis demonstrated the probability of dying in 180 days after a COVID-19 diagnosis was significantly higher in patients over 65 years (HR=20.8; 95%CI 4.5-96.1) and with 2 or more comorbidities (HR=10.8; 95%CI 1.1-107.9 and HR=24.8; 95%CI 2.5-249.3, p=0.006, respectively). CONCLUSIONS: Although RD patients have had a higher COVID-19 incidence than individuals from the same epidemiological background, the COVID-19 severity was related to traditional risk factors, particularly multiple comorbidities and age, and not to underlying RD and HCQ.

High levels of immunosuppression are related to unfavourable outcomes in hospitalised patients with rheumatic diseases and COVID-19: first results of ReumaCoV Brasil registry.

OBJECTIVES: To evaluate risk factors associated with unfavourable outcomes: emergency care, hospitalisation, admission to intensive care unit (ICU), mechanical ventilation and death in patients with immune-mediated rheumatic disease (IMRD) and COVID-19. METHODS: Analysis of the first 8 weeks of observational multicentre prospective cohort study (ReumaCoV Brasil register). Patients with IMRD and COVID-19 according to the Ministry of Health criteria were classified as eligible for the study. RESULTS: 334 participants were enrolled, a majority of them women, with a median age of 45 years; systemic lupus erythematosus (32.9%) was the most frequent IMRD. Emergency care was required in 160 patients, 33.0% were hospitalised, 15.0% were admitted to the ICU and 10.5% underwent mechanical ventilation; 28 patients (8.4%) died. In the multivariate adjustment model for emergency care, diabetes (prevalence ratio, PR 1.38; 95% CI 1.11 to 1.73; p=0.004), kidney disease (PR 1.36; 95% CI 1.05 to 1.77; p=0.020), oral glucocorticoids (GC) (PR 1.49; 95% CI 1.21 to 1.85; p<0.001) and pulse therapy with methylprednisolone (PR 1.38; 95% CI 1.14 to 1.67; p=0.001) remained significant; for hospitalisation, age >50 years (PR 1.89; 95% CI 1.26 to 2.85; p=0.002), no use of tumour necrosis factor inhibitor (TNFi) (PR 2.51;95% CI 1.16 to 5.45; p=0.004) and methylprednisolone pulse therapy (PR 2.50; 95% CI 1.59 to 3.92; p<0.001); for ICU admission, oral GC (PR 2.24; 95% CI 1.36 to 3.71; p<0.001) and pulse therapy with methylprednisolone (PR 1.65; 95% CI 1.00 to 2.68; p<0.043); the two variables associated with death were pulse therapy with methylprednisolone or cyclophosphamide (PR 2.86; 95% CI 1.59 to 5.14; p<0.018). CONCLUSIONS: Age >50 years and immunosuppression with GC and cyclophosphamide were associated with unfavourable outcomes of COVID-19. Treatment with TNFi may have been protective, perhaps leading to the COVID-19 inflammatory process.

AAPT Diagnostic Criteria for Fibromyalgia.

Fibromyalgia (FM) is a common chronic pain disorder that presents diagnostic challenges for clinicians. Several classification, diagnostic and screening criteria have been developed over the years, but there continues to be a need to develop criteria that reflect the current understanding of FM and are practical for use by clinicians and researchers. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks (ACTTION) public-private partnership with the U.S. Food and Drug Administration (FDA) and the American Pain Society (APS) initiated the ACTTION-APS Pain Taxonomy (AAPT) to develop a diagnostic system that would be clinically useful and consistent across chronic pain disorders. The AAPT established an international FM working group consisting of clinicians and researchers with expertise in FM to generate core diagnostic criteria for FM and apply the multidimensional diagnostic framework adopted by AAPT to FM. The process for developing the AAPT criteria and dimensions included literature reviews and synthesis, consensus discussions, and analyses of data from large population-based studies conducted in the United Kingdom. The FM working group established a revised diagnosis of FM and identified risk factors, course, prognosis, and pathophysiology of FM. Future studies will assess the criteria for feasibility, reliability, and validity. Revisions of the dimensions will also be required as research advances our understanding of FM. PERSPECTIVE: The ACTTION-APS FM taxonomy provides an evidence-based diagnostic system for FM. The taxonomy includes diagnostic criteria, common features, comorbidities, consequences, and putative mechanisms. This approach might improve the recognition of FM in clinical practice.

New guidelines for the diagnosis of fibromyalgia.

OBJECTIVE: To establish guidelines based on scientific evidence for the diagnosis of fibromyalgia. MATERIAL AND METHODS: Evidence collection was performed based on 9 questions regarding the diagnosis of fibromyalgia, structured using the Patient, Intervention or Indicator, Comparison and Outcome (P.I.C.O.), with searches in the main, primary databases of scientific information. After defining the potential studies to support the recommendations, they were graded according to evidence and degree of recommendation.

Serum levels of leptin and adiponectin and clinical parameters in women with fibromyalgia and overweight/obesity

ABSTRACT Objectives The objectives of this study were to evaluate the serum levels of adipokines in women with fibromyalgia with and without overweight/obesity, and to correlate the adipokines levels with clinical parameters associated with fibromyalgia and adipose tissue mass (body fat). Subjects and methods The study included 100 women divided into four groups: (a) fibromyalgia and overweight/obesity; (b) fibromyalgia and normal weight; (c) controls and overweight/obesity; and (d) controls and normal weight. Patients and controls were evaluated for clinical, anthropometric, and fibromyalgia-related parameters. Assessments included serum levels of leptin, adiponectin, monocyte chemoattractant protein-1 (MCP-1), and C-reactive protein (CRP). Levels of adipokines were further adjusted for fat mass. Results Fibromyalgia patients with overweight/obesity or normal weight had no differences in clinical parameters. Unadjusted leptin levels were lower in fibromyalgia patients than controls, a finding that was more remarkable in fibromyalgia patients with overweight/obesity. Leptin levels had no correlation with clinical parameters of fibromyalgia or inflammation markers (MCP-1 and CRP), and adiponectin levels showed no difference between groups. Conclusions No correlation was observed between adjusted leptin levels and clinical parameters of fibromyalgia. Patients with fibromyalgia and overweight/obesity presented lower levels of leptin than controls with overweight/obesity.

EpiFibro (Brazilian Fibromyalgia Registry): data on the ACR classification and diagnostic preliminary criteria fulfillment and the follow-up evaluation / EpiFibro (Registro Brasileiro de Fibromialgia): dados sobre a classificação do ACR e preenchimento dos critérios diagnósticos preliminares e avaliação de seguimento

Abstract Introduction: EpiFibro (Brazilian Epidemiological Study of Fibromyalgia) was created to study Fibromyalgia patients. Patients were included since 2011 according to the 1990 American College of Rheumatology Classification Criteria for Fibromyalgia (ACR1990). Objectives: To determine how many patients still fulfill the ACR1990 and the ACR2010 criteria in 2014; to determine the correlation between the impact of FM and to describe data on the follow-up evaluation. Methods: This is a cross sectional study in a multicenter cohort of patients. The data was collected between 2013 and 2015. Physician included patients that fulfilled the ACR1990 criteria on the date of entry. The follow-up data were considered only for patients with at least two evaluations. A minimally significant change was considered to be a 30% variation of parameters scores. Results: 810 patients’ data were analyzed. Patients presented a mean age of 51.8 ± 11.5 years old. There were 786 female. Most patients met both criteria. There was a greater fulfilling of the ACR2010. There was a moderate correlation between Polysymptomatic Distress Scale and Fibromyalgia Impact Questionnaire. Three hundred fourteen patients with more than one assessment were found, but 88 patients were excluded. Thus, 226 patients with one follow-up monitoring parameter were considered (Fibromyalgia Impact Questionnaire: 222; Polysymptomatic Distress Scale: 199; both: 195). The mean follow-up time was 9.1 ± 7.5 months (1–44). Most patients became stable. Conclusion: InEpiFibro, most patients fulfill simultaneously the ACR1990 and ACR2010. A larger number of patients fulfill the ACR2010 at the time of the evaluation. There was a moderate correlation between the Polysymptomatic Distress Scale and the Fibromyalgia Impact Questionnaire. Most patients remained stable over time.

Resumo Introdução: O EpiFibro (Estudo Epidemiológico Brasileiro de Fibromialgia) foi criado para estudar pacientes com fibromialgia. Foram incluídos pacientes desde 2011 de acordo com os critérios de classificação para a fibromialgia do American College of Rheumatology de 1990 (ACR1990). Objetivos: Determinar quantos pacientes ainda atendem aos critérios ACR1990 e ACR2010 em 2014; determinar a correlação entre o impacto da FM medido pelo Questionário de Impacto da Fibromialgia (FIQ) e pela Polysymptomatic Distress Scale (PDS) e descrever dados sobre a avaliação de seguimento. Métodos: Estudo transversal em uma coorte multicêntrica de pacientes. Os dados foram coletados entre 2013 e 2015. O médico incluiu pacientes que atenderam aos critérios ACR1990 no momento da entrada. Consideraram-se os dados de seguimento apenas dos pacientes com pelo menos duas avaliações. Uma variação de 30% nos escores dos parâmetros foi considerada uma alteração minimamente significativa. Resultados: Analisaram-se os dados de 810 pacientes. Os pacientes apresentaram média de 51,8 ± 11,5 anos. Havia 786 mulheres. A maior parte dos pacientes atendeu a ambos os critérios. Houve um maior atendimento aos critérios ACR2010. Houve uma correlação moderada entre a PDS e o FIQ. Encontraram-se 314 pacientes com mais de uma avaliação, mas 88 pacientes foram excluídos. Assim, foram considerados 226 pacientes com um parâmetro de monitoramento no seguimento. (FIQ: 222; PDS: 199; ambos: 195). O tempo médio de seguimento foi de 9,1 ± 7,5 meses (1 a 44). A maior parte dos pacientes tornou-se estável. Conclusão: No EpiFibro, a maior parte dos pacientes atendia simultaneamente ao ACR1990 e ao ACR2010. Uma maior quantidade de pacientes atendia ao ACR2010 no momento da avaliação. Houve uma correlação moderada. A maior parte dos pacientes manteve-se estável ao longo do tempo.

EpiFibro (Brazilian Fibromyalgia Registry): data on the ACR classification and diagnostic preliminary criteria fulfillment and the follow-up evaluation.

INTRODUCTION: EpiFibro (Brazilian Epidemiological Study of Fibromyalgia) was created to study Fibromyalgia patients. Patients were included since 2011 according to the 1990 American College of Rheumatology Classification Criteria for Fibromyalgia (ACR1990). OBJECTIVES: To determine how many patients still fulfill the ACR1990 and the ACR2010 criteria in 2014; to determine the correlation between the impact of FM and to describe data on the follow-up evaluation. METHODS: This is a cross sectional study in a multicenter cohort of patients. The data was collected between 2013 and 2015. Physician included patients that fulfilled the ACR1990 criteria on the date of entry. The follow-up data were considered only for patients with at least two evaluations. A minimally significant change was considered to be a 30% variation of parameters scores. RESULTS: 810 patients' data were analyzed. Patients presented a mean age of 51.8±11.5 years old. There were 786 female. Most patients met both criteria. There was a greater fulfilling of the ACR2010. There was a moderate correlation between Polysymptomatic Distress Scale and Fibromyalgia Impact Questionnaire. Three hundred fourteen patients with more than one assessment were found, but 88 patients were excluded. Thus, 226 patients with one follow-up monitoring parameter were considered (Fibromyalgia Impact Questionnaire: 222; Polysymptomatic Distress Scale: 199; both: 195). The mean follow-up time was 9.1±7.5 months (1-44). Most patients became stable. CONCLUSION: InEpiFibro, most patients fulfill simultaneously the ACR1990 and ACR2010. A larger number of patients fulfill the ACR2010 at the time of the evaluation. There was a moderate correlation between the Polysymptomatic Distress Scale and the Fibromyalgia Impact Questionnaire. Most patients remained stable over time.

Impact of Moving From a Widespread to Multisite Pain Definition on Other Fibromyalgia Symptoms.

OBJECTIVE: To investigate whether associations between pain and the additional symptoms associated with fibromyalgia are different in persons with chronic widespread pain (CWP) compared to multisite pain (MSP), with or without joint areas. METHODS: Six studies were used: 1958 British birth cohort, Epidemiology of Functional Disorders, Kid Low Back Pain, Managing Unexplained Symptoms (Chronic Widespread Pain) in Primary Care: Involving Traditional and Accessible New Approaches, Study of Health and its Management, and Women's Health Study (WHEST; females). MSP was defined as the presence of pain in ≥8 body sites in adults (≥10 sites in children) indicated on 4-view body manikins, conducted first to include joints (positive joints) and second without (negative joints). The relationship between pain and fatigue, sleep disturbance, somatic symptoms, and mood impairment was assessed using logistic regression. Results are presented as odds ratios (ORs) with 95% confidence intervals (95% CIs). RESULTS: There were 34,818 participants across the study populations (adults age range 42-56 years, male 43-51% [excluding WHEST], and CWP prevalence 12-17%). Among those reporting MSP, the proportion reporting CWP ranged between 62% and 76%. Among those reporting the symptoms associated with fibromyalgia, there was an increased likelihood of reporting pain, the magnitude of which was similar regardless of the definition used. For example, within WHEST, reporting moderate/severe fatigue (Chalder fatigue scale 4-11) was associated with a >5-fold increase in likelihood of reporting pain (CWP OR 5.2 [95% CI 3.9-6.9], MSP-positive joints OR 6.5 [95% CI 5.0-8.6], and MSP-negative joints OR 6.5 [95% CI 4.7-9.0]). CONCLUSION: This large-scale study demonstrates that regardless of the pain definition used, the magnitude of association between pain and other associated symptoms of fibromyalgia is similar. This finding supports the continued collection of both when classifying fibromyalgia, but highlights the fact that pain may not require to follow the definition outlined within the 1990 American College of Rheumatology criteria.

Serum levels of leptin and adiponectin and clinical parameters in women with fibromyalgia and overweight/obesity.

OBJECTIVES: The objectives of this study were to evaluate the serum levels of adipokines in women with fibromyalgia with and without overweight/obesity, and to correlate the adipokines levels with clinical parameters associated with fibromyalgia and adipose tissue mass (body fat). SUBJECTS AND METHODS: The study included 100 women divided into four groups: (a) fibromyalgia and overweight/obesity; (b) fibromyalgia and normal weight; (c) controls and overweight/obesity; and (d) controls and normal weight. Patients and controls were evaluated for clinical, anthropometric, and fibromyalgia-related parameters. Assessments included serum levels of leptin, adiponectin, monocyte chemoattractant protein-1 (MCP-1), and C-reactive protein (CRP). Levels of adipokines were further adjusted for fat mass. RESULTS: Fibromyalgia patients with overweight/obesity or normal weight had no differences in clinical parameters. Unadjusted leptin levels were lower in fibromyalgia patients than controls, a finding that was more remarkable in fibromyalgia patients with overweight/obesity. Leptin levels had no correlation with clinical parameters of fibromyalgia or inflammation markers (MCP-1 and CRP), and adiponectin levels showed no difference between groups. CONCLUSIONS: No correlation was observed between adjusted leptin levels and clinical parameters of fibromyalgia. Patients with fibromyalgia and overweight/obesity presented lower levels of leptin than controls with overweight/obesity.

Polyphenol-Rich Foods Alleviate Pain and Ameliorate Quality of Life in Fibromyalgic Women.

Objectives: The present study aimed to describe the antioxidant dietary intake of patients with fibromyalgia and explore the association of the results with glutathione status, pain, quality of life, and socioeconomic status. METHODS: 38 fibromyalgic female patients and 35 female controls (mean age = 48.6 ± 8.1 and 47.6 ± 10.0 years, respectively) were evaluated. The number of tender points, pain threshold, quality of life, physical activity, socioeconomic status, nutritional status, intake of antioxidant micronutrients and foods with high total antioxidant capacity, and total salivary glutathione were evaluated. RESULTS: The number of tender points, pain threshold, and quality of life were worse in the fibromyalgia group. The consumption of vegetable juices was more common among women with fibromyalgia and consumption of red wine and beer were more common among healthy women. The adjusted mean intakes of antioxidant vitamins as well as selenium were higher for the control group (p ≤ 0.01). There was no difference for salivary levels of glutathione between the groups and no correlation for intake of antioxidant micronutrients and pain or quality of life among fibromyalgic women. However, intake of foods rich in polyphenols was associated with lower numbers of tender points (coffee, r = - 0.346; pear, r = - 0.331) and better quality of life (red fruits, r = - 0.342; dark chocolate, r = - 0.404) in the fibromyalgic group. In these women, associations between glutathione levels and food intake, pain or quality of life were not found. CONCLUSION: This study indicated that antioxidant protection from bioactive compounds present in fruit and vegetables could have an adjuvant role in fibromyalgia treatment.

New guidelines for the diagnosis of fibromyalgia / Novas diretrizes para o diagnóstico da fibromialgia

Abstract Objective To establish guidelines based on scientific evidence for the diagnosis of fibromyalgia. Material and methods Evidence collection was performed based on 9 questions regarding the diagnosis of fibromyalgia, structured using the Patient, Intervention or Indicator, Comparison and Outcome (P.I.C.O.), with searches in the main, primary databases of scientific information. After defining the potential studies to support the recommendations, they were graded according to evidence and degree of recommendation.

Resumo Objetivo Estabelecer diretrizes baseadas em evidências científicas para o diagnóstico da fibromialgia. Material e métodos A coleta de evidências foi elaborada a partir de nove questões sobre diagnóstico da fibromialgia, estruturadas por meio do PICO (Paciente, Intervenção ou Indicador, Comparação e Outcome), com busca nas principais bases primárias de informação científica. Após definir os estudos potenciais para sustentação das recomendações, esses foram graduados pela força da evidência e grau de recomendação. Resultados e conclusões As questões resultaram em nove recomendações para o diagnóstico da fibromialgia com base nas evidências de literatura e na opinião dos experts que participaram do trabalho.

Injecction of trigger points in the temporal muscles of patients with miofascial syndrome.

OBJECTIVE: The aim was to examine the effect of blocking trigger points in the temporal muscles of patients with masticatory myofascial pain syndrome, fibromyalgia and headache. METHOD: Seventy patients with one trigger point were randomly divided into 3 groups: injection with saline or anesthetic and non-injected (control). RESULTS: Pain was reduced in 87.71% patients injected with saline and 100% injected with anesthetic. Similar results were obtained for headache frequency. With regard to headache intensity, the injection groups differed from the control group, but not between themselves. CONCLUSION: Treatment with injection at trigger points decreased facial pain and frequency and intensity of headache. Considering the injected substance there was no difference.

Injecction of trigger points in the temporal muscles of patients with miofascial syndrome / Infiltrações de pontos-gatilho na musculatura temporal em pacientes com fibromialgia e cefaleia

Objective : The aim was to examine the effect of blocking trigger points in the temporal muscles of patients with masticatory myofascial pain syndrome, fibromyalgia and headache.Method : Seventy patients with one trigger point were randomly divided into 3 groups: injection with saline or anesthetic and non-injected (control).Results : Pain was reduced in 87.71% patients injected with saline and 100% injected with anesthetic. Similar results were obtained for headache frequency. With regard to headache intensity, the injection groups differed from the control group, but not between themselves.Conclusion : Treatment with injection at trigger points decreased facial pain and frequency and intensity of headache. Considering the injected substance there was no difference.

Objetivo : Comparar o efeito terapêutico do bloqueio de pontos-gatilho na musculatura temporal com soro fisiológico e anestésico em pacientes com síndrome da dor miofascial mastigatória, fibromialgia e cefaleia, entre sí e com controles não-infiltrados.Método : Setenta pacientes que apresentaram pelo menos um ponto-gatilho na musculatura temporal foram aleatoriamente divididas em 3 grupos: infiltração com soro fisiológico, infiltração com anestésico e controle (não-infiltradas).Resultados : Houve redução na intensidade de dor na face em 87,71% dos pacientes infiltrados com soro fisiológico e em 100% dos pacientes infiltrados com anestésico, mas não no grupo controle. Houve similaridade dos resultados considerando a frequência da cefaléia. Quanto à intensidade da cefaléia, tanto a infiltração com soro fisiológico, quanto com anestésico foram efetivos e sem diferença significativa entre sí, ao contrário do grupo controle.Conclusões : O tratamento com infiltração diminui a dor na face, bem com a frequência e a intensidade da cefaléia. Quando considerado a substância infiltrada não há diferenças no tratamento.