Search

Resumen Objetivo Elaborar recomendaciones para la prevencion de infeccion en pacientes adultos con enfermedades reumaticas autoinmunes sistemicas (ERAS). Metodos Un panel de expertos, seleccionados con base en su curriculum y experiencia, identifico preguntas clinicas de investigacion relevantes para el objetivo del documento. Se realizaron revisiones sistematicas de la evidencia, que se graduo de acuerdo con los criterios del Scottish Intercollegiate Guidelines Network. Tras ello, se formularon las recomendaciones. Resultados Se seleccionaron cinco preguntas, referentes a la prevencion de infeccion por Pneumocystis jirovecii con trimetoprim-sulfametoxazol, medidas profilacticas contra el virus de la hepatitis B, vacunacion contra el virus del papiloma humano, vacunacion contra el Streptococcus pneumoniae y vacunacion contra el virus de la gripe. Se formularon un total de 18 recomendaciones, estructuradas por pregunta, con base en la evidencia encontrada para las diferentes ERAS y/o consenso de expertos. Conclusiones Existe suficiente evidencia sobre la seguridad y eficacia de las vacunaciones y otras medidas profilacticas frente a los microrganismos revisados en este documento como para ser recomendadas especificamente en pacientes con ERAS.

The incidence of Pneumocystis jirovecii pneumonia (PJP) has increased over recent years in patients with systemic autoimmune rheumatic diseases (SARD). PJP prognosis is poor in those receiving immunosuppressive therapy and glucocorticoids in particular. Despite the effectiveness of cotrimoxazole against PJP, the risk of adverse effects remains significant, and no consensus has emerged regarding the need for PJP prophylaxis in SARD patients undergoing immunosuppressor therapies.Objective: To evaluate the efficacy and safety of cotrimoxazole prophylaxis against PJP in SARD adult patients receiving immunosuppressive therapies. Methods: We performed a systematic review, consulting MEDLINE, EMBASE, and Cochrane Library databases up to April 2020. Outcomes covered prevention of PJP, other infections, morbidity, mortality, and safety. The information obtained was summarized with a narrative review and results were tabulated. Of the 318 identified references, 8 were included. Two were randomized controlled trials and six observational studies. The quality of studies was moderate or low. Despite disparities in the cotrimoxazole prophylaxis regimens described, results were consistent in terms of efficacy, particularly with glucocorticoid doses > 20 mg/day. However, cotrimoxazole 400 mg/80 mg/day, prescribed three times/ week, or 200 mg/40 mg/day or in dose escalation, exhibited similar positive performances. Conversely, cotrimoxazole 400 mg/80 mg/day showed higher incidences of withdrawals and adverse effects. Cotrimoxazole prophylaxis against PJP exhibited efficacy in SARD, mainly in patients taking glucocorticoids ≥ 20 mg/day. All cotrimoxazole regimens exposed seemed equally efficacious, although, higher quality trials are needed. Adverse effects were observed 2 months after initiation, particularly with the 400 mg/80 mg/day regimen. Conversely, escalation dosing or 200 mg/40 mg/day regimens appeared better tolerated.

Resumen Objetivo La dificultad para el diagnostico y la variedad de manifestaciones clinicas que pueden determinar la eleccion del tratamiento del sindrome antifosfolipido (SAF) primario ha impulsado a la Sociedad Espanola de Reumatologia (SER) en la elaboracion de recomendaciones basadas en la mejor evidencia posible. Estas recomendaciones pueden servir de referencia para reumatologos y otros profesionales implicados en el manejo de pacientes con SAF. Metodos Se creo un panel formado por 4 reumatologos, una ginecologa y una hematologa, expertos en SAF, previamente seleccionados mediante una convocatoria abierta o por meritos profesionales. Las fases del trabajo fueron: identificacion de las areas claves para la elaboracion del documento, analisis y sintesis de la evidencia cientifica (utilizando los niveles de evidencia de SIGN, Scottish Intercollegiate Guidelines Network) y formulacion de recomendaciones a partir de esta evidencia y de tecnicas de «evaluacion formal» o «juicio razonado». Resultados Se han elaborado 46 recomendaciones que abordan 5 areas principales: diagnostico y evaluacion, medidas de tromboprofilaxis primaria, tratamiento del SAF o tromboprofilaxis secundaria, tratamiento del sindrome antifosfolipido obstetrico y situaciones especiales. Esta incluido tambien el papel de los nuevos anticoagulantes orales, el problema de las recurrencias o los principales factores de riesgo identificados en estos individuos. En este documento se reflejan las ultimas 25, referidas a las areas de: SAF obstetrico y situaciones especiales. El documento contiene una tabla de recomendaciones y algoritmos de tratamiento. Conclusiones Se presentan las recomendaciones de la SER sobre SAF. Este documento corresponde a la parte 2.a relacionada con el SAF obstetrico y las situaciones especiales. Estas recomendaciones se consideran herramientas en la toma de decisiones para los clinicos, teniendo en consideracion tanto la decision del medico experto en SAF como la opinion compartida con el paciente. Se ha elaborado tambien una parte I que aborda aspectos relacionados con el diagnostico, evaluacion y tratamiento.

Objective The difficulty in diagnosis and the spectrum of clinical manifestations that can determine the choice of treatment for primary antiphospholipid syndrome (APS) has fostered the development of recommendations by the Spanish Society of Rheumatology (SER), based on the best possible evidence. These recommendations can serve as a reference for rheumatologists and other specialists involved in the management of APS. Methods A panel of four rheumatologists, a gynaecologist and a haematologist with expertise in APS was created, previously selected by the SER through an open call or based on professional merits. The stages of the work were: identification of the key areas for drafting the document, analysis and synthesis of the scientific evidence (using the Scottish Intercollegiate Guidelines Network [SIGN] levels of evidence) and formulation of recommendations based on this evidence and formal assessment or reasoned judgement techniques (consensus techniques). Results 46 recommendations were drawn up, addressing five main areas: diagnosis and evaluation, measurement of primary thromboprophylaxis, treatment for APS or secondary thromboprophylaxis, treatment for obstetric APS and special situations. These recommendations also include the role of novel oral anticoagulants, the problem of recurrences or the key risk factors identified in these subjects. This document reflects the first 21, referring to the areas of: diagnosis, evaluation and treatment of primary APS. The document provides a table of recommendations and treatment algorithms. Conclusions An update of the SER recommendations on APS is presented. This document corresponds to part I, related to diagnosis, evaluation and treatment. These recommendations are considered tools for decision-making for clinicians, taking into consideration both the decision of the physician experienced in APS and the patient. A part II has also been prepared, which addresses aspects related to obstetric SAF and special situations.

IntroductionMusculoskeletal pain is a common affection due to ageing, sedentarism and injuries. The objective of this trial is to prove efficacy of a natural topical composition containing Arnica montana, Hypericum perforatum, Calendula officinalis, Melaleuca sp. and menthol in pain management in adults with acute or chronic pain.MethodsThis randomized, double-blinded and placebo-controlled trial included 200 patients with musculoskeletal pain, 100 in the intervention group receiving the topical formula and 100 in the placebo group, receiving a similar formula without active ingredients. The products were applied topically twice daily for 14 days in affected areas. Immediate pain alleviation and stiffness perception were monitored for two hours at days 0, 7 at 14. Pain reduction and recovery perception upon sustained application were assessed after 7 and 14 days.ResultsIntervention immediately reduced pain and stiffness at rest and in motion 30 minutes after application and kept being superior to placebo in all short-term timepoints (p < 0.05). Immediate pain reduction was maintained even at late stages of recovery. A two-week sustained intervention resulted in significant pain reduction and improvement in recovery perception. Even if both groups reached statistical significance with respect to baseline due to spontaneous lesion recovery, a significantly improved recovery was reported in the intervention group with respect to placebo.ConclusionsIntervention was found to reduce pain and stiffness upon minutes of its application and to improve pain and mobility over the 14 days of treatment, showing benefits both for immediate alleviation and for longer term recovery.Level of EvidenceTherapeutic Level I

Background. Breech presentation at the time of delivery is 3.8–4%. Fetuses that maintain a noncephalic presentation beyond 32 weeks will have a lower probability of spontaneous version before labor. Given the increasing interest in exploring the use of complementary medicine during pregnancy and childbirth, the moxibustion technique, a type of traditional Chinese medicine, could be another option to try turning a breech baby into a cephalic presentation. Objectives. To review the evidence from systematic reviews (SR) on the efficacy and safety of acupuncture and moxibustion in pregnant women with noncephalic presentation. Main Results. Our SR synthesizes the results from five clinical trials on pregnant women with a singleton noncephalic presentation. There is evidence that moxibustion reduces the number of noncephalic presentations at the time of birth compared with no treatment. The adverse effects that acupuncture and moxibustion can cause seem to be irrelevant. Most SRs agree that there are no adverse effects directly related to acupuncture and moxibustion. Conclusions. Even though the results obtained are positive and the five reviews conclude that moxibustion reduces the number of noncephalic presentations at birth (alone or combined with postural techniques or acupuncture), there is considerable heterogeneity between them. Better methodologically designed studies are required in the future to reaffirm this conclusion.

Resumen Las enfermedades reumaticas de afectacion axial que cursan con dolor cervical y lumbar son muy prevalentes y conllevan un importante consumo de recursos sanitarios. La acupuntura es un procedimiento medico avalado por la Organizacion Mundial de la Salud con un amplio abanico de indicaciones. Nuestro objetivo fue revisar la evidencia sobre la eficacia de la acupuntura en estas enfermedades. Se realizo busqueda sistematica: MEDLINE, CENTRAL y EMBASE (mayo de 2017): 535 citas, incluimos 4 revisiones globales (45 revisiones sistematicas) y 3 revisiones sistematicas (70 ensayos clinicos). La acupuntura mejora el dolor cervical y la funcionalidad de forma inmediata y a corto plazo. Tambien es eficaz en lumbalgia aguda y cronica como primera linea terapeutica, comparada con placebo, y como coadyuvante de otros tratamientos convencionales. Es una intervencion segura. Los resultados no son concluyentes en radiculopatias (cervicales y lumbares), estenosis canal lumbar y espondilitis anquilosante. Faltan estudios bien disenados con evaluacion a medio y largo plazo.

Background Almeria is a region in southeast Spain with optimal sunlight levels, along with low pluvial and pollution rates. If exposure to sunlight is sufficient to maintain adequate levels of vitamin D (25OHD), this population should display high serum levels. Objectives To describe 25OHD serum status in women from Almeria and evaluate the impact of long sunlight exposure along the seasons on 25OHD. Methods Cross-sectional study, performed in women consecutively recruited from an outpatient rheumatology clinic. Serum levels of 25OHD were assessed in all patients and evaluated according to age ( 60 yrs), season, and presence or absence of menopause. Clinical and laboratory variables that could affect status of vitamin D were also considered. Results The sample included 319 Caucasian female patients. Mean 25OHD were 30.2 ng/ml with 195 (61.1%) exhibiting 25OHD inadequate serum levels. Season had a significant effect on 25OHD levels, with autumn being the season in which 25OHD serum levels remained well above 30 ng/ml in all age bands, and winter the season with more levels of insufficiency. Menopause did not modify 25OH serum levels. Women whose age was below 48 and over 60 had inadequate levels of 25OHD during summer. Conclusions Optimal levels of sunlight could not overcome the problem of inadequate 25OHD serum levels, particularly in elderly and young female population. Vitamin D supplementation may be recommended predominantly in winter and summer in this population.

Objectives To develop recommendations for the prevention of infection in adult patients with systemic autoimmune rheumatic diseases (SARD). Methods Clinical research questions relevant to the objective of the document were identified by a panel of experts selected based on their experience in the field. Systematic reviews of the available evidence were conducted, and evidence was graded according to the Scottish Intercollegiate Guidelines Network criteria. Specific recommendations were made. Results Five questions were selected, referring to prevention of infection by Pneumocystis jirovecii with trimethoprim/sulfamethoxazole, primary and secondary prophylactic measures against hepatitis B virus, vaccination against human papillomavirus, vaccination against Streptococcus pneumoniae and vaccination against influenza virus, making a total of 18 recommendations, structured by question, based on the evidence found for the different SARD and/or expert consensus. Conclusions There is enough evidence on the safety and efficacy of vaccinations and other prophylactic measures against the microorganisms reviewed in this document to specifically recommend them for patients with SARD.

Supplemental Digital Content is available in the text, Background: Venous thromboembolism (VTE) is a serious, sometimes life-threatening complication that can occur following spine surgery. The incidence of VTE, and the optimal type and timing of thromboprophylaxis for this complication in elective spine surgery is a matter of debate. Objective: To perform a systematic review with the aim of clarifying the efficacy and adverse effects of mechanical and chemical prophylaxis for preventing thromboembolic complications in elective spine surgery for conditions other than trauma and malignant disease. Methods/design: A search strategy of related articles up to March 2018 was designed and executed in Medline and Embase. Patients: adolescents (>10 years) and adults undergoing elective surgery for spinal deformity or degenerative disease (from C1 to S1). Intervention: Perioperative mechanical and chemical thromboprophylaxis. Studies could be randomized controlled trials or observational studies that reported data on any relevant clinical outcomes. Results: In total, 2451 uniquecitations were identified and 35 studies were ultimately included in the systematic review. The overall mean incidence of complications was 3.7% for deep venous thrombosis, 0.0% for pulmonary embolism, and 3.7% for bleeding in chemoprophylaxis group; 2.9% for deep venous thrombosis, 0.4% for pulmonary embolism and 0.0% for bleeding in mechanoprophylaxis; and 0.7% for deep venous thrombosis, 0.1% for pulmonary embolism and 0.2% for bleeding in mixed prophylaxis group with no specific data on these rates for the type of patient and type and location of surgery. None of the articles retrieved provided information on the adolescent population. Discussion and Conclusions: The poor design and high variability among the studies regarding characteristics of study population, details of interventions, and definitions of outcomes, determines a low quality of the available evidence and limits the interpretation of the results. We were unable to identify a clear advantage of one type of thromboprophylaxis over the other, although there was an increased risk of bleeding with chemoprophylaxis, which could favor the use of mechanoprophylaxis in this scenario.

Resumen La evidencia cientifica determina la validez en todas las intervenciones de salud. Estudios anteriores han demostrado la existencia de evidencia cientifica favorable en acupuntura. Actualmente, por sesgo de opinion o por desinformacion, se intenta clasificar a la acupuntura como una seudociencia. Este estudio se justifica por la necesidad de actualizar y demostrar la evidencia cientifica en las indicaciones de la acupuntura medica en el abordaje de determinadas condiciones de salud. Se realiza una revision no sistematica de las publicaciones recientes que abarca mecanismos de accion, indicaciones medicas principales y guias de practica clinica. Se incluyen los estudios con mayor nivel de evidencia como revisiones sistematicas, metaanalisis, revision de revisiones y, en algunas condiciones, estudios controlados aleatorizados. Los resultados se disponen en tablas para facilitar el acceso a la evidencia cientifica publicada para condiciones especificas. Se concluye que la acupuntura es un procedimiento tecnico medico con un elevado nivel de evidencia cientifica y no se puede considerar una seudociencia.

Aims The purpose of this study was to assess the evidence for an appropriate dose-response of vitamin D supplementation in patients with obesity with inadequate vitamin D serum levels. Methods We performed a systematic review consulting Medline, Embase and Cochrane Library up to September 2020 to identify studies that included (1) adult obese individuals with vitamin D serum levels below 75 nmol/l, (2) receiving cholecalciferol or calcidiol therapy (3) vitamin D serum levels assessment. Results The electronic search identified 705 potentially eligible studies, 11 of which were included and analysed. The heterogeneity of the studies did not permit a meta-analysis. Five studies (45.5%) were of high quality. Oral daily cholecalciferol resulted the route of administration that prevailed in most studies. We found that a minimum dose of =>2000UI/day might be needed to normalize 25OHD serum levels. Conversely, oral calcidiol Conclusions Exposed evidence suggests that vitamin D requirements remain higher in patients with obesity compared to lean patients. In order to normalize 25OHD serum levels, patients taking cholecalciferol might need to triple the actual recommended vitamin D doses. In contrast, calcidiol doses are still to be clarified.

Purpose: To compare the healing and clinical outcomes of anterior cruciate ligament (ACL) reconstruction between patients with or without intraoperative administration of adipose-derived regenerative stem cells (ADRC). Methods: Between 2013 and 2014, the outcomes of 20 soccer players undergoing ACL reconstruction using bone–patellar tendon–bone autograft infiltrated with ADRC at the end of the procedure were compared to a historical, matched cohort of 19 soccer players undergoing the same procedure without ADRC. Outcomes were obtained at baseline, and 6 and 12 months postop for IKDC (International Knee Documentation Committee), Lysholm, and Lequesne, and at 2, 4, 6, and 12 months postop for VAS (visual analogue scale) for pain and graft maturation to evaluate the ligamentization process (magnetic resonance imaging (MRI)-based). Results: Both groups significantly improved the IKDC (p < 0.001 in both groups), Lysholm (p < 0.001 in both groups), Lequesne index (p < 0.001 in both groups), VAS for pain (p = 0.002 for the ADRC and p < 0.001 for the control group), and MRI scores (p < 0.001 in both groups) in the 12 months postop compared to baseline scores. However, there were no significant differences in the improvement of the outcomes between groups across time (p > 0.05). All patients returned to sports after surgery, but 8 (40%) patients in the ADRC and 13 (68.4%) patients in the control group had lower Tegner activity score at 12 months postop. Conclusions: Patients receiving ADRC at the time of ACL reconstruction significantly improved knee function and healing/maturation of the graft at 12 months. However, this improvement was not statistically significant compared to a control group undergoing ACL reconstruction alone., Journal of Orthopaedic Surgery, 27 (3)

HYPOTHESIS: To determine the effect of receiving the visual feedback of the sphygmomanometer on lumbopelvic motor control (LPMC) tests in professional swimmers. METHOD: 31 professional swimmers to participate in the study. The outcome was maximum absolute mmHg variation in the pressure biofeedback unit's manometer with and without visual feedback on four LPMC tests. RESULTS: Test scores were significantly affected by visual feedback F = 10.07, p = 0.002, η(2)(p) = 0.117 and the type of test F = 32.53, p

Background Sarcopenia is the loss of skeletal muscle mass, strength and function that occurs as a consequence of aging. This condition result in physical disability, which limits the capacity to walk, increases the risk of falls and osteoporotic fractures. Several studies suggested an inverse relation between 25OHD serum levels, muscular strength and physical performance in the eldest. Objectives To evaluate if vitamin D supplementation in patients > 50 years improves muscle mass, strength and performance in older patients. Methods We performed a systematic review through Medline, Cochrane Library, and EMBASE. Inclusion criteria: 1) patients > 50 years old, 2) receiving treatment with vitamin D 3) muscle mass and muscle strength measurements 4) systematic reviews (SR) 5) randomized clinical trials (RCT) 6) Papers written in English or Spanish. Results Five studies were included (4 SR and 1 RCT), n patients ranged from 121 to 5615. Patients mean age oscillated between 58-88 years, receiving variable vitamin D dose. Follow-up period fluctuated from 6 to 12 months. Conclusion · Vitamin D supplementation in patients > 65 years with inadequate 25OHD serum levels, improve muscular strength. · There were no benefits in muscle mass or muscular performance. References [1] Beaudart C, Dawson A, Shaw S C, Harvey N H, Kanjis J A, Binkley N, et al. Nutrition and Physical activity in the prevention and treatment of sarcopenia.: systematic review. Osteopor Int2017; 28: 1817-1833. [2] Cangussu LM, Nahas-Neto J, Orsatti CL, Bueloni-Dias FN, Nahas EAP. Effect of Vitamin D supplementation alone on muscle function in postmenopausal women: a randomized double-blind, placebo-controlled clinical trial. Osteopor Int 2015; 26:2413-2421. Disclosure of Interests None declared

Rheumatic diseases involving the spine, mainly cervical and lumbar spine, are highly prevalent, and consume considerable health resources. Acupuncture is a medical procedure endorsed by the WHO, with a wide spectrum of medical applications. The aim of this study was to review the evidence on acupuncture efficacy in these diseases. A literature search was performed in MEDLINE, CENTRAL and EMBASE (May 2017): 535 citations. We included four global reviews(45 systematic reviews) and three Systematic Reviews(70 clinical trials). Acupuncture improved cervical pain and functionality both immediately and in the short term. It also proved effective in the treatment of acute and chronic low back pain as the first therapeutic line, compared with placebo, and as an adjunct to other conventional treatments. Acupuncture is a safe intervention. However, acupuncture efficacy in radiculopathies (cervical, lumbar), lumbar spinal stenosis and ankylosing spondylitis is still inconclusive. Well-designed studies with medium and long-term evaluation are required.

Resumen Introduccion El dolor musculoesqueletico (DME) asociado a estatinas es el efecto adverso mas frecuente y responsable de su abandono. Diversos trabajos sugieren que el deficit de vitamina D incrementa el riesgo de padecer dolor asociado a estatinas. Objetivos Evaluar una posible asociacion entre el nivel de vitamina D y la presencia de DME en pacientes en tratamiento con estatinas. Metodos Se realizo una busqueda bibliografica en Medline, Cochrane Central y EMBASE para identificar estudios que: 1) incluyeran pacientes tratados con estatinas; 2) en los que valoraran niveles sericos de vitamina D, 3) en relacion con DME. Resultados Se identificaron 127 estudios de los que se incluyeron y analizaron finalmente 3. La heterogeneidad de los estudios no permitio realizar metaanalisis. Una revision sistematica y 2 estudios de cohorte no incluidos en la revision previa mostraron una asociacion significativa entre el deficit de vitamina D y el DME. Conclusiones La evidencia sugiere una asociacion significativa entre niveles sericos de 25OHD

Introduction Musculoskeletal pain associated to statin use, is the most common adverse event, leading to cessation of treatment. Several studies proposed Vitamin D deficiency to increase the risk of pain associated to statin intake. Objectives To evaluate whether vitamin D status is linked to musculoskeletal pain associated to statin use. Methods We performed a systematic review based on electronic searches through MEDLINE, Cochrane Central and EMBASE to identify studies that (1) included patients on statin therapy, (2) with vitamin D serum levels assessment, (3) in relation to musculoskeletal pain. Results The electronic search identified 127 potentially eligible studies, of which three were included and analyzed in the present study. The heterogeneity of studies did not allow metaanalysis. A systematic review and two cohort studies not included in the previous systematic review, revealed a statistically significant association of vitamin D deficit in patients with musculoskeletal pain on statin therapy. Conclusion The displayed evidence suggests a significant association between 25OHD serum levels

Background:The incidence of Pneumocistis jirovencii pneumonia (PCP) has increased substantially during the past years in patients with systemic autoimmune diseases (SAD). Mortality associated to PCP was reported to be up to 20 to 58%, particularly in those receiving immunosuppressive therapy, such as tumoral necrosis antagonist factors or glucocorticoid therapy. Though, there is clear evidence of the effectiveness of Cotrimoxazole against PCP, the risk of adverse effects is important, increasing morbidity and mortality. Up to date, there is no consensus about the need of PCP prophylaxis in SAD patients with immunosuppressed therapies.Objectives:To analyse the efficacy and safety of Cotrimoxazole prophylaxis against PCP in SAD adult patients receiving immunosuppressive therapies.Methods:We performed a comprehensive literature search, screening different databases, MEDLINE, EMBASE and Cochrane Library up to April 2019. Outcomes covered prevention of PCP or other infections, morbidity, mortality and safety. All categories of studies were included. Two reviewers selected and extracted data from studies. The information obtained was summarized through a narrative review and results tabulated.Results:From the initial 340 identified references, 12 were finally included. Two were randomized controlled trials, six observational studies, and four case reports. The quality in the majority of studies resulted moderate or low, with limited level of evidence. Besides, all Cotrimoxazole prophylaxis regimens described in each study were distinct. Results were consistent to exhibit the efficacy of Cotrimoxazole prophylaxis, compared to non-prophylaxis in the prevention of PCP in patients receiving immunosupresor therapy, particularly, those taking high glucocorticoid dose above 20mg/day. In terms of efficacy, Cotrimoxazole 400mg/80mg/day, given three times per week, or 200mg/40mg/day or in dose escale exhibited a similar performance. In contrast, Cotrimoxazole 400mg/80mg/day displayed a higher incidence of adverse effects.Conclusion:Cotrimoxazole prophylaxis against PCP exhibited efficacy compared to non-prophylaxis, mainly in patients treated with high dose of glucocorticoids (≥20mg/day), causing a significant reduction in mortality. Positive efficacy results did not differ despite the diverse Cotrimoxazol regimens exposed. However, Cotrimoxazole adverse effects were observed after two months from initiation; particularly with daily dose of 400mg/80mg. In contrast, escalate dose or 200mg/40mg/day dose regimens appeared better tolerated.**This review is part of the Spanish Rheumatology Society –SER- recommendations on Systemic Autoimmune Diseases.References:[1] Utsunomiya, M., et al. (2017). “Optimal regimens of sulfamethoxazole-trimethoprim for chemoprophylaxis of Pneumocystis pneumonia in patients with systemic rheumatic diseases: results from a non-blinded, randomized controlled trial.” Arthritis Res Ther 19(1): 7.[2] Yamamoto, T., et al. (2014). “A feasibility study assessing tolerability of daily versus twice weekly trimethoprim-sulfamethoxazole regimen for prophylaxis against pneumocystis pneumonia in patients with systemic autoimmune diseases on glucocorticoid therapy.” Japanese Journal of Clinical Pharmacology and Therapeutics 45(3): 89-92.Disclosure of Interests:None declared

The difficulty in diagnosis and the spectrum of clinical manifestations that can determine the choice of treatment for primary antiphospholipid syndrome (APS) has fostered the development of recommendations by the Spanish Society of Rheumatology (SER), based on the best possible evidence. These recommendations can serve as a reference for rheumatologists and other specialists involved in the management of APS.A panel of four rheumatologists, a gynaecologist and a haematologist with expertise in APS was created, previously selected by the SER through an open call or based on professional merits. The stages of the work were: identification of the key areas for drafting the document, analysis and synthesis of the scientific evidence (using the Scottish Intercollegiate Guidelines Network [SIGN] levels of evidence) and formulation of recommendations based on this evidence and formal assessment or reasoned judgement techniques (consensus techniques).46 recommendations were drawn up, addressing five main areas: diagnosis and evaluation, measurement of primary thromboprophylaxis, treatment for APS or secondary thromboprophylaxis, treatment for obstetric APS and special situations. These recommendations also include the role of novel oral anticoagulants, the problem of recurrences or the key risk factors identified in these subjects. This document reflects the first 21, referring to the areas of: diagnosis, evaluation and treatment of primary APS. The document provides a table of recommendations and treatment algorithms.An update of the SER recommendations on APS is presented. This document corresponds to partI, related to diagnosis, evaluation and treatment. These recommendations are considered tools for decision-making for clinicians, taking into consideration both the decision of the physician experienced in APS and the patient. A partII has also been prepared, which addresses aspects related to obstetric SAF and special situations.

To identify risk and predictors of lymphoma or lymphoproliferative disease in patients with primary Sjögren syndrome. Articles were identified through a comprehensive search strategy in Medline, Embase and Cochrane CENTRAL. Studies had to investigate primary Sjögren syndrome patients, 18 years of age or older, with the goal of examining potential clinical, immunological and hematological risk factors for lymphoma or lymphoproliferative disease. The quality of the studies was graded using the Oxford Levels of Evidence Scale. Whenever possible, the authors created evidence tables and performed meta-analysis. Of 900 studies identified, 18 were selected for inclusion. These studies provided data from over 15,000 patients (90 % female) for analysis. Lymphadenopathy, parotid enlargement, palpable purpura, low C4 serum levels and cryoglobulins were the most consistent non-Hodgkin´s lymphoma/lymphoproliferative disease predictors. Additionally, some of the studies identified splenomegaly, low C3 serum levels, lymphopenia and neutropenia as significant prognostic factors. The detection of germinal center-like lesions in primary Sjögren Syndrome diagnostic salivary biopsies was also proposed as highly predictive of non-Hodgkin´s lymphoma. In contrast, anemia, anti-Ro, anti-La, antinuclear antibodies, rheumatoid factor, male gender and hypergammaglobulinemia were not associated with lymphoma or lymphoproliferative disease. Patients with primary Sjögren syndrome have an increased risk of lymphoma or lymphoproliferative disease compared to the general population. Ascertaining relevant and reliable predictors in this patient population would greatly facilitate the identification of patients at elevated risk for closer monitoring in the context of limited resources.

The aim of the present study was to evaluate the efficacy and safety of non-supervised home-based exercise versus individualized and supervised programs delivered in clinic-based settings for the functional recovery immediately after discharge from a primary TKA. Medline, Embase, Cochrane, and PEDro databases were screened, from inception to April 2015, in search for randomized clinical trials (RCT) of home-based exercise interventions versus individualized and supervised outpatient physical therapy after primary TKA. Target outcomes were: knee range of motion (ROM), patient-reported pain and function, functional performance, and safety. Risk of bias was assessed with the PEDro scale. After assessing homogeneity, data were combined using random effects meta-analysis and reported as standardized mean differences or mean differences. We set a non-inferiority margin of four points in mean differences. The search and selection process identified 11 RCT of moderate quality and small sample sizes. ROM active extension data suitable for meta-analysis was available from seven studies with 707 patients, and ROM active flexion from nine studies with 983 patients. Most studies showed no difference between groups. Pooled differences were within the non-inferiority margin. Most meta-analyses showed significant statistical heterogeneity. Short-term improvements in physical function and knee ROM do not clearly differ between outpatient physiotherapy and home-based exercise regimes in patients after primary TKA; however, this conclusion is based on a meta-analysis with high heterogeneity. I.

We searched systematically for randomized controlled trials, comparing moxibustion with a nonmoxibustion control group or other methods such as external cephalic version, postural methods, and acupuncture in databases, both Western and Chinese, up to June 2007. Six studies, with 1087 subjects and a high degree of heterogeneity, compared moxibustion vs observation or postural methods and reported a rate of cephalic version among the moxibustion group of 72.5% vs 53.2% in the control group (relative risk, 1.36; 95% confidence interval, 1.17-1.58); the number needed to treat was 5 (95% confidence interval, 4-7). In terms of safety, no significant differences were found in the comparison of moxibustion with other techniques. Moxibustion at acupuncture point BL67 has been shown to produce a positive effect, whether used alone or in combination with acupuncture or postural measures, in comparison with observation or postural methods alone, for the correction of nonvertex presentation, although these results should be viewed with caution, given the considerable heterogeneity found among studies.

BACKGROUND: Fibromyalgia is a clinically well-defined chronic condition with a biopsychosocial aetiology. Fibromyalgia is characterized by chronic widespread musculoskeletal pain, sleep problems, cognitive dysfunction, and fatigue. Patients often report high disability levels and poor quality of life. Since there is no specific treatment that alters the pathogenesis of fibromyalgia, drug therapy focuses on pain reduction and improvement of other aversive symptoms. OBJECTIVES: To assess the benefits and harms of selective serotonin reuptake inhibitors (SSRIs) in the treatment of fibromyalgia. METHODS: Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 5), MEDLINE (1966 to June 2014), EMBASE (1946 to June 2014), and the reference lists of reviewed articles. Selection criteria: We selected all randomized, double-blind trials of SSRIs used for the treatment of fibromyalgia symptoms in adult participants. We considered the following SSRIs in this review: citalopram, fluoxetine, escitalopram, fluvoxamine, paroxetine, and sertraline. Data collection and analysis: Three authors extracted the data of all included studies and assessed the risks of bias of the studies. We resolved discrepancies by discussion. MAIN RESULTS: The quality of evidence was very low for each outcome. We downgraded the quality of evidence to very low due to concerns about risk of bias and studies with few participants. We included seven placebo-controlled studies, two with citalopram, three with fluoxetine and two with paroxetine, with a median study duration of eight weeks (4 to 16 weeks) and 383 participants, who were pooled together. All studies had one or more sources of potential major bias. There was a small (10%) difference in patients who reported a 30% pain reduction between SSRIs (56/172 (32.6%)) and placebo (39/171 (22.8%)) risk difference (RD) 0.10, 95% confidence interval (CI) 0.01 to 0.20; number needed to treat for an additional beneficial outcome (NNTB) 10, 95% CI 5 to 100; and in global improvement (proportion of patients who reported to be much or very much improved: 50/168 (29.8%) of patients with SSRIs and 26/162 (16.0%) of patients with placebo) RD 0.14, 95% CI 0.06 to 0.23; NNTB 7, 95% CI 4 to 17. SSRIs did not statistically, or clinically, significantly reduce fatigue: standard mean difference (SMD) -0.26, 95% CI -0.55 to 0.03; 7.0% absolute improvement on a 0 to 10 scale, 95% CI 14.6% relative improvement to 0.8% relative deterioration; nor sleep problems: SMD 0.03, 95 % CI -0.26 to 0.31; 0.8 % absolute deterioration on a 0 to 100 scale, 95% CI 8.3% relative deterioration to 6.9% relative improvement. SSRIs were superior to placebo in the reduction of depression: SMD -0.39, 95% CI -0.65 to -0.14; 7.6% absolute improvement on a 0 to 10 scale, 95% CI 2.7% to 13.8% relative improvement; NNTB 13, 95% CI 7 to 37. The dropout rate due to adverse events was not higher with SSRI use than with placebo use (23/146 (15.8%) of patients with SSRIs and 14/138 (10.1%) of patients with placebo) RD 0.04, 95% CI -0.06 to 0.14. There was no statistically or clinically significant difference in serious adverse events with SSRI use and placebo use (3/84 (3.6%) in patients with SSRIs and 4/84 (4.8%) and patients with placebo) RD -0.01, 95% CI -0.07 to 0.05. AUTHORS' CONCLUSIONS: There is no unbiased evidence that SSRIs are superior to placebo in treating the key symptoms of fibromyalgia, namely pain, fatigue and sleep problems. SSRIs might be considered for treating depression in people with fibromyalgia. The black box warning for increased suicidal tendency in young adults aged 18 to 24, with major depressive disorder, who have taken SSRIs, should be considered when appropriate.

La fibromialgia (FM) es un sindrome multisintomatico, de etiologia desconocida, cuyos mecanismos fisiopatologicos no se conocen por completo. A esta dificultad en su conocimiento se anade que no hay ningun dato objetivo que permita hacer un diagnostico de certeza, por lo que resulta dificil valorar y medir la magnitud del problema en cada paciente. Ante esta situacion, no es dificil adivinar que los tratamientos aplicados en la FM sean de lo mas diverso y, en algunos casos, la valoracion en cuanto a su eficacia, muy dificil. La FM esta englobada en los sindromes «medicamente inexplicables» referidos por Charcot en el siglo XIX, frente a los que progresivamente hemos cambiado nuestra actitud, desde la creencia de que eran alteraciones puramente psicologicas hasta el enfoque actual, en el que se piensa que hay alteraciones funcionales que, en un futuro, podremos observar y medir. Recientes trabajos sobre neuroimagen 1 y neuromoduladores espinales 2

To evaluate the efficacy of current treatments for the Raynaud phenomenon (RP) in patients with systemic sclerosis (SSc), a systematic literature search was performed using Medline, EMBASE, and Cochrane Central Register of Controlled Trials (from 1961 to October 2011). We included meta-analyses, systematic reviews, clinical trials, and high-quality cohort studies published in English or Spanish. Patient populations had to include adults diagnosed with limited cutaneous or diffuse SSc who had associated RP and/or digital ulcers under pharmacological treatment. Efficacy of treatments was evaluated based on: number of RP episodes, RP severity, episode-free time, ulcer improvement/healing, and appearance of new ulcers. We used the Jadad scale of methodological quality to evaluate the quality of randomized clinical trials, and the 2009 Oxford Centre for Evidence-Based Medicine classification for other studies. Of a total of 1617 studies identified, only 27 fulfilled inclusion criteria. Drugs received the following grade recommendations: Grade A for nifedipine, nicardipine, quinapril, IV iloprost, bosentan, tadalafil, and MQx-503; Grade B for beraprost, cicaprost, DMSO, cyclofenil, and atorvastatin; and Grade C for misoprostol, prazosin, OPC-2826, enalapril, sildenafil, antioxidant, and stanazolol. Calcium channel blockers, prostanoids, tadalafil, and bosentan received the highest recommendation level for their effectiveness. However, most systematic reviews reviewed just a handful of studies with small sample sizes and short follow-ups. Our review shows that the existing evidence on the efficacy of RP treatment in SSc patients is inconclusive which calls for further research, especially in the form of prospective studies of high quality with long-term follow-ups.

Background Low back pain is a large and frequent disorder, with a lifetime prevalence that ranges from 60 to 80%. It is also the main cause of work absence and permanent disability. Exercise therapies appear to be an effective treatment to reduce pain and improve axial performance in patients with chronic low back pain. Yet, abdominal CORE exercises have been incorporated for several years in different rehabilitation programmes. Core muscles, can be divided into two groups: 1- deep muscles or stabilizing muscles (connected to lumbar vertebral segment) and 2- shallow muscles, (not connected to lumbar spine (LS)) but enables additional spinal control. Physical activity focused on these groups of muscles could contribute to pain alleviation and spinal functional improvement. Objectives To perform a global review (overview) of systematic reviews (SR) to evaluate the beneficial effect of abdominal core stabilization exercises on: 1- pain, 2- LS performance, 3-evaluate adverse effects. Methods We conducted a global review of systematic reviews (SR), based on 3 online databases: CENTRAL, MEDLINE/Pubmed y PEDro, in English and Spanish. Critical appraisal of included studies was performed by 3 authors independently. AMSTAR system was used to rate the quality of SR. Results From 17 potential studies found, 9 were included and analysed. Quality of SR was good (AMSTAR 6–11). Metanalysis was performed in 55, 5% of references, Quality of references included in SR were rated on different scales: PeDro (3), Cochrane collaboration (5) and Jadad (1). Globally there were 59 articles included but two were not RCT. Interventions and comparisons assessed were deeply heterogeneous. In addition the study population was small. In general, pain and LS function experimented improvement with CORE stabilization exercises in the short and medium term follow-up, but not in the long term. The types of exercises performed on CORE muscles were drastically heterogeneous. The five papers were metanalysis was performed, showed a significant improvement of pain and LS function with Motor Control exercises (MCE) when compared to general exercises or minimal interventions or control. This was observed in the short and medium term, but not in the long term. No studies mentioned adverse effects. Conclusions 1. The reviews analysed showed methodological limitations 2. CORE stabilization exercises improve pain and LS function in the short and medium term, but not in the long term. 3. MCE appear to be better than general exercises, minimal interventions or control for pain and LS function. 4. There is no information about adverse effects. 5. Due to the different exercises programmes performed on CORE muscles, and different comparisons evaluated, the clinical efficacy remain uncertain. References Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG.Cochrane Database Syst Rev. 2016 Jan 7;1:CD012004 Chang WD, Lin HY, Lai PT. Core strength training for patients with chronic low back pain. J Phys Ther Sci. 2015;27(3):619–22. Disclosure of Interest None declared

Background Fibromyalgia (FM) syndrome is a chronic condition of unknown aetiology characterised by musculoskeletal pain that often co-exists with sleep disturbance, cognitive dysfunction and fatigue. Patients often report high disability levels and poor quality of life. Since there is no specific treatment that alters the pathogenesis of FM, drug therapy focuses on pain reduction and improvement of other bothersome symptoms. Objectives The objective of this review was to assess the effectiveness and safety of monoamine oxidase inhibitors (MAOIs) in the treatment of FM syndrome. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 10), MEDLINE (1966 to November 2010), EMBASE (1980 to November 2010) and the reference lists of reviewed articles. Selection criteria We selected all randomised, double-blind trials of MAOIs used for the treatment of FM pain in adult participants. Data collection and analysis Two authors assessed risk of bias and extracted data independently onto a specially designed pro forma and a third review author cross-checked them. Main results We included two studies of inconsistent risk of bias with a total of 230 patients diagnosed with FM. We evaluated two MAOIs: pirlindole and moclobemide. Pirlindole showed statistically significant results compared with placebo for several outcomes (pain, tender points and overall assessment by the patient and the physician), whereas moclobemide did not show statistically significant differences between groups. Pooled results of the two studies displayed a modest effect size in pain (mean difference (MD) -1.45 (121 patients; 95% confidence interval (CI) -2.71 to -0.20; number needed to treat (NNT) 2 (95% CI 1 to 12); I2 = 59%)), implying a minimal clinically important difference (MCID) and a small effect on tender points (standardised mean difference (SMD) -0.36 (121 patients; 95% CI -0.72 to -0.00; I2 = 31%)). No effect was seen on global assessment by patient. Physical function and sleep disturbance were not measured. The most frequent adverse events were nausea and vomiting, with statistically significant differences between groups (risk ratio (RR) 7.82 (89 patients; 95% CI 1.02 to 59.97; NNT 7 (95% CI 4 to 33)). Authors' conclusions Data suggest that the effectiveness of MAOIs for the treatment of FM symptoms is limited. Although we observed a moderate effect size on pain and a small one on tender points, these results should be taken with caution as they are only based on two studies with a small number of patients and inconsistent risk of bias among them.

Disease-modifying antirheumatic drugs (DMARDs) are frequently prescribed as a first step therapy in active psoriatic arthritis (PsA). However, evidence is sparse and scattered. The objective of this study is to evaluate the efficacy and safety of DMARDs in PsA.We performed a systematic review based on electronic searches through Medline, Cochrane Central and Embase (from July 1980-2010) for randomised control trials (RCTs) in PsA. Outcome measures were those included in the core-set from Outcome Measures in Rheumatology Clinical Trials (OMERACT) and adverse effects.A preliminary search identified 3781 potentially relevant RCTs, while only 11 fulfilled inclusion criteria. Ten studies had a parallel design and, one was a cross-over trial. Quality reached a Jadad score over 3 in 6/11 (54.6%). We observed evidence of a moderate improvement of pain and reduction of ESR with DMARDs. The global risk of withdrawals due to adverse events was 2.41 [95% confidence interval (CI) 1.53, 3.82]. The risk of GI adverse effects (nausea, vomiting, abdominal pain, diarrhoea and/or oral ulcers) was 2.02 [95% CI 1.34, 3.03] and of headache was 2.34[95% CI 1.05, 5.19]. There were no significant differences in the rate of increase of flu-like symptoms, rash, or liver enzymes.The evidence of DMARD efficacy in PsA is certainly limited, basically due to the small number of studies, dissimilar outcomes being evaluated, high withdrawal rates, and absence of new published studies. With regard to adverse effects, only GI events and headaches were significant compared to placebo.

STUDY DESIGN Systematic review. OBJECTIVE To systematically review the evidence on the efficacy, effectiveness, and safety of percutaneous thermocoagulation intradiscal techniques for discogenic low back pain. SUMMARY OF BACKGROUND DATA The intervertebral disc is thought to be the source of pain in a relevant proportion of cases of low back pain (LBP). Two percutaneous thermocoagulation intradiscal techniques have been described to treat discogenic LBP: percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) and intradiscal electrothermal therapy (IDET). METHODS An electronic search was performed in MEDLINE, EMBASE, and the Cochrane Library databases up to 2005, to identify nonrandomized controlled trials and randomized controlled trials (RCTs) on those techniques. All relevant studies were methodologically assessed independently by 3 reviewers. RCTs were assessed following the criteria recommended by the Cochrane Back Review Group. A qualitative synthesis of results was performed. RESULTS Six studies were included with a total of 283 patients. Two open, nonrandomized trials (95 patients) showed positive results for IDET compared with rehabilitation and PIRFT. Results from 2 RCTs showed no differences between PIRFT and placebo, and between different PIRFT techniques. Two RCTs compared IDET with placebo. One suggested differences only in pain and in disability, while the best quality RCT showed no differences. CONCLUSIONS The available evidence does not support the efficacy or effectiveness of percutaneous thermocoagulation intradiscal techniques for the treatment of discogenic low back pain.

Background Raynaud Phenomenon (RP) is present in more than 90% of the patients with Systemic sclerosis (SSc) and it may progress to scars, ulcers, necrosis resulting in an incapacitating problem for many of them. Objectives To evaluate the efficacy of the most common drugs used in clinical practice in SSc patients with RP (SSc-RP). Methods A systematic literature search was performed in Medline, EMBASE and Cochrane Central Register of Controlled Trials (from the beginning to October 2011) and a manual search. We selected meta-analysis, systemic literature reviews, randomized clinical trials (RCT) and high quality cohorts studies (English, Spanish) which included SSc-RP (limited cutaneous and diffuse) patients, aged 18 years or above, with RP and/or digital ulcers on: calcium channel blockers, ACEI,ARB, endothelin receptor antagonist, phosphodiesterase inhibitors, prostanoids, antioxydants, NAC, SRA, cyclofenil, atorvastatin, stanazolol, hyperbaric oxygen, ulcers topical treatment, electrical neurostimulator, sympatectomy or nitroglycerine. Efficacy was evaluated as: number of RP episodes, RP severity, time without flares, ulcers improvement and healing, change of ulcers size, number of new ulcers, etc. Studies including patients with primary RF and basic science were excluded. Title and abstract selection and subsequent detailed review of selected articles were independently performed by two reviewers, BN and CP. Evidence tables were generated. The included studies quality was graded using the 2001 Oxford Levels of Evidence Scale, and results expressed as level of evidence (LE), recommendation grade (RG). Results A total of 1,541 studies were identified, of which 29 fulfilled inclusion criteria. Quality was good in 19/29 (65.5%) studies. We found a great variability in the outcomes evaluated in the included studies. The efficacy in terms of level of evidence and grade of recommendation in SSc-RP patients are as follows: alpha adrenergic blockers: prazosin (LE 1a, GR A), OPC-2826 (LE 1c, GR B); ACEI: quinapril (LE 1a, GR A), enalapril (LE 1c, GR B); prostanoids: Iloprost iv (LE 1a, GR A), beroprost (LE 1a, GR A), cisoprost (LE 1b, GR B), misoprostol (LE 1c, GR B); endothelin receptor antagonist: bosentan (LE 1a, GR A); phosphodiesterase inhibitors: tadalafil (LE 1a, GR A), sildenafil (LE 1c, GR B); topic treatments: MQQx-503 (LE 1a, GR A), DMSO (LE 1b, GR B); other drugs: cyclofenil (LE 1b, GR B), atorvastatin (LE 1b, GR B), antioxydants (LE 1c, GR B), stanozolol (LE 1c, GR B). Conclusions The evidence on the efficacy of the different pharmacological treatments for SSc-RP patients is heterogeneous. The best evidence regarding to the efficacy in SSc-RP patients was found in the following drugs: calcium channel blockers, ACEI, prostanoids, tadalafil and bosentan. There is a lack of high quality prospective studies. Disclosure of Interest None Declared