Efficacy of Raynaud's phenomenon and digital ulcer pharmacological treatment in systemic sclerosis patients: a systematic literature review.

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.

Efficacy and safety of DMARDs in psoriatic arthritis: a systematic review.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Recommendations for prevention of infection in systemic autoimmune rheumatic diseases.

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.

Recommendations for prevention of infection in systemic autoimmune rheumatic diseases. / Recomendaciones SER sobre prevención de infección en enfermedades reumáticas autoinmunes sistémicas.

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.

Efficacy of acupuncture in rheumatic diseases with spine involvement: Systematic review. / Eficacia de la acupuntura en las enfermedades reumáticas que afectan el raquis: revisión sistemática.

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.

25-Hydroxyvitamin D serum levels in rheumatic female patients in southeast Spain: The paradigm of daily optimal sunshine levels and inadequate vitamin D status.

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 (<48 yrs, 48-53 yrs, 54-60 yrs and >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 30.2ng/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 30ng/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.

Is there really a relationship between serum vitamin D (25OHD) levels and the musculoskeletal pain associated with statin intake? A systematic review. / ¿Existe relación entre los niveles séricos de vitamina D (25OHD) y el dolor musculoesquelético relacionado con la ingesta de estatinas? Revisión sistemática.

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 analysed in the present study. The heterogeneity of studies did not allow metanalysis. 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<30ng/ml and the presence of musculoskeletal pain in patients on statin therapy.

¿Existe relación entre los niveles séricos de vitamina D (25OHD) y el dolor musculoesquelético relacionado con la ingesta de estatinas? Revisión sistemática / Is there really a relationship between serum vitamin D (25OHD) levels and the musculoskeletal pain associated with statin intake? A systematic review

Introducción. El dolor musculoesquelético (DME) asociado a estatinas es el efecto adverso más frecuente y responsable de su abandono. Diversos trabajos sugieren que el déficit de vitamina D incrementa el riesgo de padecer dolor asociado a estatinas. Objetivos. Evaluar una posible asociación entre el nivel de vitamina D y la presencia de DME en pacientes en tratamiento con estatinas. Métodos. Se realizó una búsqueda bibliográfica en Medline, Cochrane Central y EMBASE para identificar estudios que: 1) incluyeran pacientes tratados con estatinas; 2) en los que valoraran niveles séricos de vitamina D, 3) en relación con DME. Resultados. Se identificaron 127 estudios de los que se incluyeron y analizaron finalmente 3. La heterogeneidad de los estudios no permitió realizar metaanálisis. Una revisión sistemática y 2 estudios de cohorte no incluidos en la revisión previa mostraron una asociación significativa entre el déficit de vitamina D y el DME. Conclusiones. La evidencia sugiere una asociación significativa entre niveles séricos de 25OHD<30ng/ml y la presencia de DME (AU)

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 analysed in the present study. The heterogeneity of studies did not allow metanalysis. 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<30ng/ml and the presence of musculoskeletal pain in patients on statin therapy (AU)

Eficacia de la acupuntura en las enfermedades reumáticas que afectan el raquis: revisión sistemática / Efficacy of acupuncture in rheumatic diseases with spine involvement: Systematic review

Las enfermedades reumáticas de afectación axial que cursan con dolor cervical y lumbar son muy prevalentes y conllevan un importante consumo de recursos sanitarios. La acupuntura es un procedimiento médico avalado por la Organización 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 realizó búsqueda sistemática: MEDLINE, CENTRAL y EMBASE (mayo de 2017): 535 citas, incluimos 4 revisiones globales (45 revisiones sistemáticas) y 3 revisiones sistemáticas (70 ensayos clínicos).La acupuntura mejora el dolor cervical y la funcionalidad de forma inmediata y a corto plazo. También es eficaz en lumbalgia aguda y crónica como primera línea terapéutica, comparada con placebo, y como coadyuvante de otros tratamientos convencionales. Es una intervención segura. Los resultados no son concluyentes en radiculopatías (cervicales y lumbares), estenosis canal lumbar y espondilitis anquilosante. Faltan estudios bien diseñados con evaluación a medio y largo plazo

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

25-Hydroxyvitamin D serum levels in rheumatic female patients in southeast Spain: The paradigm of daily optimal sunshine levels and inadequate vitamin D status / Concentraciones séricas de 25-hidroxivitamina D en mujeres reumáticas del sureste de España: el paradigma de los niveles diarios óptimos de luz solar y la insuficiencia de vitamina D

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 (<48 yrs, 48-53 yrs, 54-60 yrs and >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 30.2ng/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 30ng/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

Antecedentes: Almería es una región del sureste de España con un grado óptimo de luz solar, junto con bajas tasas de contaminación y lluvia. Si la exposición a la luz solar es suficiente para mantener niveles adecuados de vitamina D (25OHD), esta población debería presentar concentraciones séricas altas. Objetivos: Describir los valores séricos de 25OHD en mujeres de Almería y evaluar el efecto de la exposición prolongada a la luz solar sobre la 25OHD a lo largo de las distintas estaciones. Métodos: Estudio transversal en mujeres reclutadas consecutivamente en una consulta externa de reumatología. Se determinaron las concentraciones séricas de 25OHD en todas las pacientes y se valoraron en función de la edad (< 48 años, 48-53 años, 54-60 años y > 60 años), la estación y la presencia o ausencia de menopausia. También se tuvieron en cuenta las variables clínicas y analíticas que pudieran afectar al estado de la vitamina D. Resultados: La muestra incluyó 319 mujeres de raza blanca. El valor medio de 25OHD fue de 30,2 ng/ml, y 195 (61,1%) mostraron concentraciones séricas inadecuadas de 25OHD. La estación tenía un efecto importante en las concentraciones de 25OHD, y el otoño era la estación en la que los valores séricos de 25OHD se mantenían bastante por encima de 30 ng/ml en todas las franjas de edad, y el invierno la estación con más grado de insuficiencia. La menopausia no modificaba las concentraciones séricas de 25OH. Las mujeres menores de 48 años y mayores de 60 años tenían niveles insuficientes de 25OHD durante el verano. Conclusión: La luz solar óptima no podía superar el problema de la insuficiencia de las concentraciones séricas de 25OHD, sobre todo en las poblaciones de mujeres mayores y jóvenes. Pueden recomendarse suplementos de vitamina D predominantemente en invierno y en verano en esta población

Revisión sistemática: ¿es recomendable el empleo de toxina botulínica como tratamiento del dolor en el síndrome miofascial? / Systematic review: can botulinum toxin be recommended as treatment for pain in myofascial syndrome?

El dolor miofascial tiene un posible componente de contractura muscular. Objetivos: Dado que la toxina botulínica ha resultado beneficiosa en enfermedades asociadas a hipertonía, se quiso evaluar la eficacia de la toxina botulínica en la reducción del dolor en el síndrome miofascial (SM). Métodos: Se realizó una revisión sistemática con búsqueda en Medline, EMBASE y Cochrane Library Plus de todos los ensayos clínicos de toxina botulínica en dolor regional. Además, se efectuó una búsqueda manual entre los resúmenes de los congresos del ACR y EULAR de los últimos 3 años. Los estudios seleccionados fueron revisados y analizados de forma independiente por 2 revisoras. Resultados: Ocho estudios cumplían los criterios de inclusión, y la calidad metodológica general fue baja. Toxina botulínica se comparó frente a solución salina fisiológica en 6 estudios, frente a esteroides en 2 y frente a lidocaína y aguja seca en 1 (brazo de 1 estudio). La población estudiada incluía cervicalgia (n = 3), lumbalgia (n = 2), síndrome piriforme (n = 2), puntos gatillo varios (n = 1) y voluntarios sanos a los que se provocaba dolor (n = 1). Toxina botulínica mostró una cierta ventaja sobre placebo y corticoides. Un metaanálisis de los 3 estudios con medidas de eficacia agrupables dio como resultado una diferencia media ponderada en una escala visual analógica de dolor de 0- 10 de –2,72 (intervalo de confianza del 95%, –3,86 a –1,58). Sin embargo, toxina botulínica no mostró superioridad frente a lidocaína (p > 0,016). Conclusiones: La evidencia en esta revisión no permite confirmar la efectividad de toxina botulínica A o B en el tratamiento del SM. Son necesarios estudios rigurosos, de mayor calidad y a largo plazo dado el alto coste de la toxina botulínica(AU)

Myofascial pain syndrome (MPS) may have an intrinsic muscle spasm component. Aim: Since botulinum toxin has been successfully used to reduce hypertonicity in several neurological disorders, we analyzed the efficacy of botulinum toxin A or B in reducing pain in MPS. Methods: We performed a systematic review through an electronic search in MEDLINE, EMBASE, and Cochrane Library Plus. All clinical trials of botulinum toxin and regional pain were selected. In addition, the abstracts of the ACR and EULAR meetings in the previous 3 years were searched manually. The studies identified were reviewed and analyzed by 2 independent reviewers. Results: Eight studies met the inclusion criteria. The methodological quality was generally low. Botulinum toxin was compared to saline solution (6 studies), to steroids (2 studies), and to lidocaine and dry needle (1 study arm). The population studied included persons with neck pain (n = 3), low back pain (n = 2), piriformis syndrome (n = 2), several trigger points (n = 1), and healthy volunteers in whom pain was provoked (n = 1). Botulinum toxin showed a certain advantage over saline solution and steroids in pain control. A meta-analysis of the 3 studies with efficacy measures that could be combined showed a weighted mean difference in pain on a 0-10 visual analogue scale of -2.72 (95% CI: –3.86; –1.58). However, botulinum toxin showed no advantage over lidocaine (p > 0.016). Conclusions: Currently, there is insufficient evidence to confirm the real efficacy of botulinum toxin A and B in the treatment of MPS. Given the high cost of botulinum toxin, long-term high quality studies are required(AU)

Intervenciones no farmacológicas y tratamientos alternativos en la fibromialgia / Non pharmacologic and alternative treatments in fibromyalgia

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