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OBJECTIVE: To provide a summary of the noteworthy medical articles published in 2023 that are relevant to family physicians. SELECTING THE EVIDENCE: Articles were chosen and ranked by the PEER (Patients, Experience, Evidence, Research) team, a group of primary care health professionals focused on evidence-based medicine. The selection process involved routine surveillance of tables of contents in high-impact medical journals and continuous monitoring of EvidenceAlerts. Articles were prioritized based on their direct applicability to and potential to influence primary care practice. MAIN MESSAGE: Selected articles addressed various clinical areas of primary care. The topics included a comparison of a treat-to-target approach versus a high-intensity statins prescription for lipid management; semaglutide and its impact on cardiovascular outcomes; respiratory syncytial virus vaccine for older adults; chlorthalidone versus hydrochlorothiazide in preventing cardiovascular events; amitriptyline for irritable bowel syndrome; the role of opioids in acute back pain; safety of oral penicillin challenges in patients allergic to penicillin; spironolactone for facial acne; strategies to reverse frailty in older adults; and identifying the provider of chronic disease management. Two "up and coming" medications are also mentioned: retatrutide for weight loss and fezolinetant for vasomotor symptoms of menopause. CONCLUSION: Research published in 2023 yielded several high-quality articles with topics relevant to primary care, including cardiovascular care, irritable bowel syndrome, care of the elderly, and acne management.
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Acné Vulgar , Síndrome del Colon Irritable , Femenino , Humanos , Anciano , Analgésicos Opioides , Atención Primaria de Salud , PenicilinasRESUMEN
OBJECTIVE: To determine the proportions of patients who receive care from family physicians, specialists, and nurse practitioners for the management of common chronic medical conditions. DESIGN: Population-based retrospective cohort study. SETTING: Province of Alberta. PARTICIPANTS: Adults aged 19 years or older who were registered for provincial health services and each had 2 or more interactions with the same provider between January 1, 2013, and December 31, 2017, for any of 7 specified chronic medical conditions: hypertension, diabetes, chronic obstructive pulmonary disease (COPD), asthma, heart failure, ischemic heart disease, and chronic kidney disease. MAIN OUTCOME MEASURES: Numbers of patients being managed for these conditions and which provider types were involved in their care. RESULTS: Albertans receiving care for the chronic medical conditions being studied (n=970,783) had a mean (SD) age of 56.8 (16.3) years and 49.1% were female. Family physicians were the sole providers of care for 85.7% of patients with a diagnosis of hypertension, 70.9% with diabetes, 59.8% with COPD, and 65.5% with asthma. Specialists were sole providers of care for 49.1% of patients with ischemic heart disease, 42.2% with chronic kidney disease, and 35.6% with heart failure. Nurse practitioners were involved in the care of less than 1% of patients with these conditions. CONCLUSION: Family physicians were involved in the care of most patients with any of 7 chronic medical conditions included in this study and were the sole providers of care for the majority of patients with hypertension, diabetes, COPD, and asthma. Guideline working group representation and the setting of clinical trials should reflect this reality.
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Asma , Insuficiencia Cardíaca , Hipertensión , Isquemia Miocárdica , Enfermedad Pulmonar Obstructiva Crónica , Insuficiencia Renal Crónica , Adulto , Humanos , Femenino , Masculino , Alberta/epidemiología , Estudios Retrospectivos , Enfermedad Crónica , Insuficiencia Renal Crónica/epidemiología , Insuficiencia Renal Crónica/terapia , Asma/epidemiología , Asma/terapia , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapia , Hipertensión/epidemiología , Hipertensión/terapia , Manejo de la EnfermedadRESUMEN
OBJECTIVE: To determine the extent of chronic obstructive pulmonary disease (COPD) hospitalization in easily identifiable high-risk subgroups within a typical primary care practice. DESIGN: Prospective cohort analysis of administrative claims data. SETTING: British Columbia. PARTICIPANTS: British Columbia residents who were 50 years or older on December 31, 2014, and received a physician diagnosis of COPD between 1996 and 2014. MAIN OUTCOME MEASURES: Rate of acute exacerbation of COPD (AECOPD) or pneumonia hospitalization in 2015, broken down by risk identifiers including previous AECOPD admission, 2 or more community respirologist consultations, nursing home residence, or none of these. RESULTS: Of the 242,509 identified COPD patients (12.9% of British Columbia residents ≥50 years), 2.8% were hospitalized for AECOPD in 2015 (0.038 AECOPD hospitalizations per patient-year). The 12.0% with prior AECOPD hospitalization accounted for 57.7% of new AECOPD hospitalizations (0.183 hospitalizations per patient-year); the 7.7% with respirologist involvement accounted for 20.4% (0.102 hospitalizations per patient-year); and the 2.2% in nursing homes accounted for 3.6% (0.061 hospitalizations per patient-year). Those with any of the 3 risk identifiers accounted for only 1.5% more COPD hospitalizations (59.2%) than those with prior AECOPD hospitalization, suggesting prior AECOPD hospitalization is the most important indication of risk. A typical primary care practice held a median of 23 (interquartile range=4 to 65) COPD patients, of whom roughly 20 (86.4%) had none of these risk identifiers. This low-risk majority had only 0.018 AECOPD hospitalizations per patient-year. CONCLUSION: Most AECOPD hospitalizations occur in patients with previous such admissions. When time and resources are limited, COPD initiatives targeting primary care practices should focus more on the 2 to 3 patients with prior AECOPD hospitalization or more symptomatic disease, and less on the low-risk majority.
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Hospitalización , Enfermedad Pulmonar Obstructiva Crónica , Humanos , Estudios Prospectivos , Colombia Británica/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/terapia , Atención Primaria de SaludRESUMEN
OBJECTIVE: To summarize 10 high-quality medical articles published in 2022 that are relevant to primary care physicians. SELECTING THE EVIDENCE: Routine surveillance of tables of contents in relevant medical journals and EvidenceAlerts was conducted by the PEER (Patients, Experience, Evidence, Research) team, a group of primary care health care professionals with an interest in evidence-based medicine. Articles were selected and ranked based on relevance to practice. MAIN MESSAGE: Published articles from 2022 most likely to influence primary care practice examined the following subjects: reducing dietary sodium for heart failure; timing of blood pressure medications to reduce cardiovascular outcomes; adding as-needed corticosteroids to rescue puffers for asthma exacerbations; influenza vaccination after myocardial infarction; comparing various medications for diabetes management; tirzepatide for weight loss; low FODMAP diet for irritable bowel syndrome; prune juice for constipation; impact of regular acetaminophen use on patients with hypertension; and time required to care for patients in primary care. Two "honourable mention" studies are also summarized. CONCLUSION: Research published in 2022 yielded several high-quality articles on various conditions relevant to primary care, including hypertension, heart failure, asthma, and diabetes.
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Asma , Diabetes Mellitus , Insuficiencia Cardíaca , Hipertensión , Humanos , Hipertensión/tratamiento farmacológico , Atención Primaria de SaludRESUMEN
OBJECTIVE: To assess the benefits and harms of lipid-lowering therapies used to prevent or manage cardiovascular disease including bile acid sequestrants (BAS), ezetimibe, fibrates, niacin, omega-3 supplements, proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, and statins. DATA SOURCES: MEDLINE, the Cochrane Database of Systematic Reviews, and a grey literature search. STUDY SELECTION: Systematic reviews of randomized controlled trials published between January 2017 and March 2022 looking at statins, ezetimibe, PCSK9 inhibitors, fibrates, BAS, niacin, and omega-3 supplements for preventing cardiovascular outcomes were selected. Outcomes of interest included major adverse cardiovascular events (MACE), cardiovascular mortality, all-cause mortality, and adverse events. SYNTHESIS: A total of 76 systematic reviews were included. Four randomized controlled trials were also included for BAS because no efficacy systematic review was identified. Statins significantly reduced MACE (6 systematic reviews; median risk ratio [RR]=0.74; interquartile range [IQR]=0.71 to 0.76), cardiovascular mortality (7 systematic reviews; median RR=0.85, IQR=0.83 to 0.86), and all-cause mortality (8 systematic reviews; median RR=0.91, IQR=0.88 to 0.92). Major adverse cardiovascular events were also significantly reduced by ezetimibe (3 systematic reviews; median RR=0.93, IQR=0.93 to 0.94), PCSK9 inhibitors (14 systematic reviews; median RR=0.84, IQR=0.83 to 0.87), and fibrates (2 systematic reviews; mean RR=0.86), but these interventions had no effect on cardiovascular or all-cause mortality. Fibrates had no effect on any cardiovascular outcomes when added to a statin. Omega-3 combination supplements had no effect on MACE or all-cause mortality but significantly reduced cardiovascular mortality (5 systematic reviews; median RR=0.93, IQR=0.93 to 0.94). Eicosapentaenoic acid ethyl ester alone significantly reduced MACE (1 systematic review, RR=0.78) and cardiovascular mortality (2 systematic reviews; RRs of 0.82 and 0.82). In primary cardiovascular prevention, only statins showed consistent benefits on MACE (6 systematic reviews; median RR=0.75, IQR=0.73 to 0.78), cardiovascularall-cause mortality (7 systematic reviews, median RR=0.83, IQR=0.81 to 0.90), and all-cause mortality (8 systematic reviews; median RR=0.91, IQR=0.87 to 0.91). CONCLUSION: Statins have the most consistent evidence for the prevention of cardiovascular complications with a relative risk reduction of about 25% for MACE and 10% to 15% for mortality. The addition of ezetimibe, a PCSK9 inhibitor, or eicosapentaenoic acid ethyl ester to a statin provides additional MACE risk reduction but has no effect on all-cause mortality.
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Anticolesterolemiantes , Enfermedades Cardiovasculares , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Niacina , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Proproteína Convertasa 9 , Enfermedades Cardiovasculares/prevención & control , Inhibidores de PCSK9 , Revisiones Sistemáticas como Asunto , Ezetimiba/uso terapéutico , Lípidos , Ácidos Fíbricos , Atención Primaria de Salud , Anticolesterolemiantes/efectos adversosRESUMEN
OBJECTIVE: To update the 2015 clinical practice guideline and provide a simplified approach to lipid management in the prevention of cardiovascular disease (CVD) for primary care. METHODS: Following the Institute of Medicine's Clinical Practice Guidelines We Can Trust, a multidisciplinary, pan-Canadian guideline panel was formed. This panel was represented by primary care providers, free from conflicts of interest with industry, and included the patient perspective. A separate scientific evidence team performed evidence reviews on statins, ezetimibe, proprotein convertase subtilisin-kexin type 9 inhibitors, fibrates, bile acid sequestrants, niacin, and omega-3 supplements (docosahexaenoic acid with eicosapentaenoic acid [EPA] or EPA ethyl ester alone [icosapent]), as well as on 11 supplemental questions. Recommendations were finalized by the guideline panel through use of the Grading of Recommendations Assessment, Development and Evaluation methodology. RECOMMENDATIONS: All recommendations are presented in a patient-centred manner designed with the needs of family physicians and other primary care providers in mind. Many recommendations are similar to those published in 2015. Statins remain first-line therapy for both primary and secondary CVD prevention, and the Mediterranean diet and physical activity are recommended to reduce cardiovascular risk (primary and secondary prevention). The guideline panel recommended against using lipoprotein a, apolipoprotein B, or coronary artery calcium levels when assessing cardiovascular risk, and recommended against targeting specific lipid levels. The team also reviewed new evidence pertaining to omega-3 fatty acids (including EPA ethyl ester [icosapent]) and proprotein convertase subtilisin-kexin type 9 inhibitors, and outlined when to engage in informed shared decision making with patients on interventions to lower cardiovascular risk. CONCLUSION: These updated evidence-based guidelines provide a simplified approach to lipid management for the prevention and management of CVD. These guidelines were created by and for primary health care professionals and their patients.
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Anticolesterolemiantes , Enfermedades Cardiovasculares , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Humanos , Enfermedades Cardiovasculares/prevención & control , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Anticolesterolemiantes/uso terapéutico , Ácido Eicosapentaenoico , Canadá , Proproteína Convertasas , Atención Primaria de Salud , Subtilisinas , Ésteres , Prevención PrimariaRESUMEN
OBJECTIVE: To summarize 10 high-quality studies or guidelines from 2021 that have strong relevance to physicians in comprehensive family practice. SELECTING THE EVIDENCE: Routine literature surveillance of abstracts in high-impact journals and EvidenceAlerts was completed by the PEER (Patients, Experience, Evidence, Research) team, a group of health care professionals with a research interest in evidence-based medicine and primary care. Abstracts were screened, selected, and ranked by the PEER team. MAIN MESSAGE: The articles from 2021 that are most likely to impact primary care practice discuss the following topics: empagliflozin for heart failure with preserved ejection fraction; semaglutide for weight loss; stopping antidepressants in primary care; inhaled budesonide for COVID-19; acetylsalicylic acid for preeclampsia prevention; quarter-dose blood pressure medications for hypertension; aggressive blood pressure control for elderly patients; kangaroo care for low-birth-weight infants; footwear for knee osteoarthritis; and delayed antibiotics for pediatric respiratory infections. Two "honourable mention" studies are also briefly reviewed. CONCLUSION: Research from 2021 produced several high-quality studies in cardiovascular care but also addressed a variety of conditions relevant to primary care including weight loss, depression, and COVID-19.
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COVID-19 , Hipertensión , Anciano , Niño , Humanos , Atención Primaria de Salud , Investigación , Pérdida de PesoRESUMEN
OBJECTIVE: To develop a clinical practice guideline to support the management of chronic pain, including low back, osteoarthritic, and neuropathic pain in primary care. METHODS: The guideline was developed with an emphasis on best available evidence and shared decision-making principles. Ten health professionals (4 generalist family physicians, 1 pain management-focused family physician, 1 anesthesiologist, 1 physical therapist, 1 pharmacist, 1 nurse practitioner, and 1 psychologist), a patient representative, and a nonvoting pharmacist and guideline methodologist comprised the Guideline Committee. Member selection was based on profession, practice setting, and lack of financial conflicts of interest. The guideline process was iterative in identification of key questions, evidence review, and development of guideline recommendations. Three systematic reviews, including a total of 285 randomized controlled trials, were completed. Randomized controlled trials were included only if they reported a responder analysis (eg, how many patients achieved a 30% or greater reduction in pain). The committee directed an Evidence Team (composed of evidence experts) to address an additional 11 complementary questions. Key recommendations were derived through committee consensus. The guideline and shared decision-making tools underwent extensive review by clinicians and patients before publication. RECOMMENDATIONS: Physical activity is recommended as the foundation for managing osteoarthritis and chronic low back pain; evidence of benefit is unclear for neuropathic pain. Cognitive-behavioural therapy or mindfulness-based stress reduction are also suggested as options for managing chronic pain. Treatments for which there is clear, unclear, or no benefit are outlined for each condition. Treatments for which harms likely outweigh benefits for all or most conditions studied include opioids and cannabinoids. CONCLUSION: This guideline for the management of chronic pain, including osteoarthritis, low back pain, and neuropathic pain, highlights best available evidence including both benefits and harms for a number of treatment interventions. A strong recommendation for exercise as the primary treatment for chronic osteoarthritic and low back pain is made based on demonstrated long-term evidence of benefit. This information is intended to assist with, not dictate, shared decision making with patients.
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Dolor Crónico , Dolor de la Región Lumbar , Neuralgia , Dolor Crónico/terapia , Guías como Asunto , Humanos , Dolor de la Región Lumbar/terapia , Neuralgia/terapia , Manejo del Dolor , Atención Primaria de SaludRESUMEN
OBJECTIVE: To summarize high-quality studies for 10 topics from 2020 that have strong relevance to primary care practice. SELECTING THE EVIDENCE: Study selection involved routine literature surveillance by a group of primary health care professionals. This included screening abstracts of high-impact journals and EvidenceAlerts, as well as searching the American College of Physicians Journal Club. MAIN MESSAGE: Topics of the 2020 articles most likely to affect primary care practice included whether antibiotic prophylaxis reduces maternal infections following operative vaginal birth; which second-line agent after metformin reduces cardiovascular outcomes for patients with diabetes; whether gabapentin is effective for alcohol use disorder; whether compression stockings prevent recurrent cellulitis; guideline recommendations for management of dyslipidemia to reduce cardiovascular risk; whether intermittent fasting is superior to consistent mealtimes for weight loss; whether vitamin C added to iron supplementation increases hemoglobin more than iron alone; whether antacid-lidocaine combinations are superior to antacid alone for epigastric pain; whether dapagliflozin improves renal and cardiovascular outcomes in chronic kidney disease; and whether empagliflozin improves cardiovascular outcomes in patients with heart failure. Five "runner-up" studies are also briefly reviewed. CONCLUSION: Research from 2020 produced several high-quality studies in diabetes and cardiovascular disease, but also included a variety of other conditions relevant to primary care such as vaginal operative births, alcohol use disorder, weight loss, and chronic leg edema.
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Enfermedades Cardiovasculares , Diabetes Mellitus , Dislipidemias , Femenino , Humanos , Atención Primaria de Salud , VitaminasRESUMEN
OBJECTIVE: To determine the proportion of patients with neuropathic pain who achieve a clinically meaningful improvement in their pain with the use of different pharmacologic and nonpharmacologic treatments. DATA SOURCES: MEDLINE, EMBASE, the Cochrane Library, and a gray literature search. STUDY SELECTION: Randomized controlled trials that reported a responder analysis of adults with neuropathic pain-specifically diabetic neuropathy, postherpetic neuralgia, or trigeminal neuralgia-treated with any of the following 8 treatments: exercise, acupuncture, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), topical rubefacients, opioids, anticonvulsant medications, and topical lidocaine. SYNTHESIS: A total of 67 randomized controlled trials were included. There was moderate certainty of evidence that anticonvulsant medications (risk ratio of 1.54; 95% CI 1.45 to 1.63; number needed to treat [NNT] of 7) and SNRIs (risk ratio of 1.45; 95% CI 1.33 to 1.59; NNT = 7) might provide a clinically meaningful benefit to patients with neuropathic pain. There was low certainty of evidence for a clinically meaningful benefit for rubefacients (ie, capsaicin; NNT = 7) and opioids (NNT = 8), and very low certainty of evidence for TCAs. Very low-quality evidence demonstrated that acupuncture was ineffective. All drug classes, except TCAs, had a greater likelihood of deriving a clinically meaningful benefit than having withdrawals due to adverse events (number needed to harm between 12 and 15). No trials met the inclusion criteria for exercise or lidocaine, nor were any trials identified for trigeminal neuralgia. CONCLUSION: There is moderate certainty of evidence that anticonvulsant medications and SNRIs provide a clinically meaningful reduction in pain in those with neuropathic pain, with lower certainty of evidence for rubefacients and opioids, and very low certainty of evidence for TCAs. Owing to low-quality evidence for many interventions, future high-quality trials that report responder analyses will be important to strengthen understanding of the relative benefits and harms of treatments in patients with neuropathic pain.
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Dolor Crónico , Neuralgia Posherpética , Neuralgia , Adulto , Analgésicos , Dolor Crónico/tratamiento farmacológico , Humanos , Neuralgia/tratamiento farmacológico , Neuralgia Posherpética/tratamiento farmacológico , Atención Primaria de Salud , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVE: To refine the process for endorsement of guidelines and establish the expectations of the College of Family Physicians of Canada (CFPC) regarding the quality and relevance of clinical practice guidelines targeting family physicians and their patients. COMPOSITION OF THE COMMITTEE: Initially, a group of 6 CFPC staff and selected College members reviewed the previous process for endorsement with the aim of providing a new direction, if needed. The work was then assumed by the Guideline and Knowledge Translation Expert Working Group, a purposefully selected group of 9 family physicians from across Canada with expertise in research, evidence, guidelines, knowledge translation, and continuing professional development and education. METHODS: The initial task force reviewed the endorsement process and identified areas for improvement. A draft new process and core criteria for high-quality guidelines were developed. This was approved by the CFPC board. A Guideline and Knowledge Translation Expert Working Group was then formed to further refine the process and the criteria. Multiple resources were used to inform the criteria. The Guideline and Knowledge Translation Expert Working Group will manage the endorsement process of external submitted guidelines, as well as provide high-level guidance to the CFPC regarding in-house guidelines and continuing professional development content. REPORT: This article provides the expectations of the CFPC regarding clinical practice guidelines and describes in detail the process and criteria for endorsement. Key principles include family physician involvement and guideline funding unlikely to introduce bias, with most criteria falling under 4 themed areas: relation to family medicine, CFPC values, patient engagement and decision making, and scientific rigour. The Guideline and Knowledge Translation Expert Working Group will report to the CFPC board at least once a year. It is hoped that this fully transparent process and these criteria will help advance the quality and standards of clinical practice guideline production in Canada. CONCLUSION: A comprehensive but reasonable list has been provided that reflects the best standards and recommendations and is consistent with the CFPC's values while recognizing the landscape of guideline development for its national partners and colleagues. As with all processes, careful consideration and evaluation will be essential.
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Medicina Familiar y Comunitaria , Médicos de Familia , Canadá , HumanosRESUMEN
OBJECTIVE: To determine the proportion of chronic low back pain patients who achieve a clinically meaningful response from different pharmacologic and nonpharmacologic treatments. DATA SOURCES: MEDLINE, EMBASE, Cochrane Library, and gray literature search. STUDY SELECTION: Published randomized controlled trials (RCTs) that reported a responder analysis of adults with chronic low back pain treated with any of the following 15 interventions: oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs), exercise, acupuncture, spinal manipulation therapy, corticosteroid injections, acetaminophen, oral opioids, anticonvulsants, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors, cannabinoids, oral muscle relaxants, or topical rubefacients. SYNTHESIS: A total of 63 RCTs were included. There was moderate certainty that exercise (risk ratio [RR] of 1.71; 95% CI 1.37 to 2.15; number needed to treat [NNT] of 7), oral NSAIDs (RR = 1.44; 95% CI 1.17 to 1.78; NNT = 6), and SNRIs (duloxetine; RR = 1.25; 95% CI 1.13 to 1.38; NNT = 10) provide clinically meaningful benefits to patients with chronic low back pain. Exercise was the only intervention with sustained benefit (up to 48 weeks). There was low certainty that spinal manipulation therapy and topical rubefacients benefit patients. The benefit of acupuncture disappeared in higher-quality, longer (> 4 weeks) trials. Very low-quality evidence demonstrated that corticosteroid injections are ineffective. Patients treated with opioids had a greater likelihood of discontinuing treatment owing to an adverse event (number needed to harm of 5) than continuing treatment to derive any clinically meaningful benefit (NNT = 16), while those treated with SNRIs (duloxetine) had a similar likelihood of continuing treatment to attain benefit (NNT = 10) as those discontinuing the medication owing to an adverse event (number need to harm of 11). One trial each of anticonvulsants and topical NSAIDs found similar benefit to that of placebo. No RCTs of acetaminophen, cannabinoids, muscle relaxants, selective serotonin reuptake inhibitors, or tricyclic antidepressants met the inclusion criteria. CONCLUSION: Exercise, oral NSAIDs, and SNRIs (duloxetine) provide a clinically meaningful reduction in pain, with exercise being the only intervention that demonstrated sustained benefit after the intervention ended. Future high-quality trials that report responder analyses are required to provide a better understanding of the benefits and harms of interventions for patients with chronic low back pain.
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Dolor de la Región Lumbar , Adulto , Antiinflamatorios no Esteroideos , Humanos , Dolor de la Región Lumbar/tratamiento farmacológico , Atención Primaria de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéuticoRESUMEN
PURPOSE: Without supporting evidence, clinicians commonly recommend that warfarin be taken in the evening. We conducted a randomized controlled trial to evaluate the effect of administration time (morning vs evening) on the stability of warfarin's anticoagulant effect. METHODS: A total of 236 primary care physicians serving 54 western Canadian communities mailed letters of invitation to all their warfarin-using patients. Eligible patients were community-dwelling warfarin users (any indication) with at least 3 months of evening warfarin use and no plans for discontinuation. Participants were randomized (by web-based allocation) to morning vs continued evening warfarin ingestion. We used the Rosendaal method to determine the proportion of time within therapeutic range (TTR) of the international normalized ratio (INR) blood test month 2 to 7 postrandomization vs the 6 months prerandomization. The primary outcome was the percent change in proportion of time outside target INR range (with an a priori minimum clinically important difference of ±20%). All analyses were intention to treat. RESULTS: Between March 8, 2015 and September 30, 2016, we randomized 109 participants to morning and 108 to evening warfarin use. TTR rose from 71.8% to 74.7% in the morning group, and from 72.6% to 75.6% in the evening group, for a change in TTR of 2.9% in the former vs 3.0% in the latter (difference, -0.1%; P = .97; 95% CI for the difference, -6.1% to 5.9%). The difference in percent change in proportion of time outside the therapeutic INR range (obtained via Hodges-Lehmann estimation of the difference in medians) was 4.4% (P = .62; 95% CI for the difference, -17.6% to 27.3%). CONCLUSIONS: Administration time has no statistically significant nor clinically important impact on the stability of warfarin's anticoagulant effect. Patients should take warfarin whenever regular compliance would be easiest.
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Anticoagulantes/administración & dosificación , Coagulación Sanguínea/efectos de los fármacos , Relación Normalizada Internacional , Warfarina/administración & dosificación , Anciano , Anciano de 80 o más Años , Esquema de Medicación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención Primaria de Salud , Estudios Prospectivos , Método Simple CiegoRESUMEN
BACKGROUND: Skeletal muscle cramps are common and often occur in association with pregnancy, advanced age, exercise or motor neuron disorders (such as amyotrophic lateral sclerosis). Typically, such cramps have no obvious underlying pathology, and so are termed idiopathic. Magnesium supplements are marketed for the prophylaxis of cramps but the efficacy of magnesium for this purpose remains unclear. This is an update of a Cochrane Review first published in 2012, and performed to identify and incorporate more recent studies. OBJECTIVES: To assess the effects of magnesium supplementation compared to no treatment, placebo control or other cramp therapies in people with skeletal muscle cramps. SEARCH METHODS: On 9 September 2019, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, CINAHL Plus, AMED, and SPORTDiscus. We also searched WHO-ICTRP and ClinicalTrials.gov for registered trials that might be ongoing or unpublished, and ISI Web of Science for studies citing the studies included in this review. SELECTION CRITERIA: Randomized controlled trials (RCTs) of magnesium supplementation (in any form) to prevent skeletal muscle cramps in any patient group (i.e. all clinical presentations of cramp). We considered comparisons of magnesium with no treatment, placebo control, or other therapy. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion and extracted data. Two review authors assessed risk of bias. We attempted to contact all study authors when questions arose and obtained participant-level data for four of the included trials, one of which was unpublished. We collected all data on adverse effects from the included RCTs. MAIN RESULTS: We identified 11 trials (nine parallel-group, two cross-over) enrolling a total of 735 individuals, amongst whom 118 cross-over participants additionally served as their own controls. Five trials enrolled women with pregnancy-associated leg cramps (408 participants) and five trials enrolled people with idiopathic cramps (271 participants, with 118 additionally crossed over to control). Another study enrolled 29 people with liver cirrhosis, only some of whom suffered muscle cramps. All trials provided magnesium as an oral supplement, except for one trial which provided magnesium as a series of slow intravenous infusions. Nine trials compared magnesium to placebo, one trial compared magnesium to no treatment, calcium carbonate or vitamin B, and another trial compared magnesium to vitamin E or calcium. We judged the single trial in people with liver cirrhosis and all five trials in participants with pregnancy-associated leg cramps to be at high risk of bias. In contrast, we rated the risk of bias high in only one of five trials in participants with idiopathic rest cramps. For idiopathic cramps, largely in older adults (mean age 61.6 to 69.3 years) presumed to have nocturnal leg cramps (the commonest presentation), differences in measures of cramp frequency when comparing magnesium to placebo were small, not statistically significant, and showed minimal heterogeneity (I² = 0% to 12%). This includes the primary endpoint, percentage change from baseline in the number of cramps per week at four weeks (mean difference (MD) -9.59%, 95% confidence interval (CI) -23.14% to 3.97%; 3 studies, 177 participants; moderate-certainty evidence); and the difference in the number of cramps per week at four weeks (MD -0.18 cramps/week, 95% CI -0.84 to 0.49; 5 studies, 307 participants; moderate-certainty evidence). The percentage of individuals experiencing a 25% or better reduction in cramp rate from baseline was also no different (RR 1.04, 95% CI 0.84 to 1.29; 3 studies, 177 participants; high-certainty evidence). Similarly, no statistically significant difference was found at four weeks in measures of cramp intensity or cramp duration. This includes the number of participants rating their cramps as moderate or severe at four weeks (RR 1.33, 95% CI 0.81 to 2.21; 2 studies, 91 participants; moderate-certainty evidence); and the percentage of participants with the majority of cramp durations of one minute or more at four weeks (RR 1.83, 95% CI 0.74 to 4.53, 1 study, 46 participants; low-certainty evidence). We were unable to perform meta-analysis for trials of pregnancy-associated leg cramps. The single study comparing magnesium to no treatment failed to find statistically significant benefit on a three-point ordinal scale of overall treatment efficacy. Of the three trials comparing magnesium to placebo, one found no benefit on frequency or intensity measures, another found benefit for both, and a third reported inconsistent results for frequency that could not be reconciled. The single study in people with liver cirrhosis was small and had limited reporting of cramps, but found no difference in terms of cramp frequency or cramp intensity. Our analysis of adverse events pooled all studies, regardless of the setting in which cramps occurred. Major adverse events (occurring in 2 out of 72 magnesium recipients and 3 out of 68 placebo recipients), and withdrawals due to adverse events, were not significantly different from placebo. However, in the four studies for which it could be determined, more participants experienced minor adverse events in the magnesium group than in the placebo group (RR 1.51, 95% CI 0.98 to 2.33; 4 studies, 254 participants; low-certainty evidence). Overall, oral magnesium was associated with mostly gastrointestinal adverse events (e.g. diarrhoea), experienced by 11% (10% in control) to 37% (14% in control) of participants. AUTHORS' CONCLUSIONS: It is unlikely that magnesium supplementation provides clinically meaningful cramp prophylaxis to older adults experiencing skeletal muscle cramps. In contrast, for those experiencing pregnancy-associated rest cramps the literature is conflicting and further research in this population is needed. We found no RCTs evaluating magnesium for exercise-associated muscle cramps or disease-state-associated muscle cramps (for example amyotrophic lateral sclerosis/motor neuron disease) other than a single small (inconclusive) study in people with liver cirrhosis, only some of whom suffered cramps.
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Magnesio/uso terapéutico , Calambre Muscular/tratamiento farmacológico , Músculo Esquelético , Complicaciones del Embarazo/tratamiento farmacológico , Adulto , Factores de Edad , Anciano , Estudios Cruzados , Femenino , Humanos , Magnesio/efectos adversos , Masculino , Persona de Mediana Edad , Calambre Muscular/etiología , Placebos/uso terapéutico , Embarazo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVE: To determine the effect of mask use on viral respiratory infection risk. DATA SOURCES: MEDLINE and the Cochrane Library. STUDY SELECTION: Randomized controlled trials (RCTs) included in at least 1 published systematic review comparing the use of masks with a control group, either in community or health care settings, on the risk of viral respiratory infections. SYNTHESIS: In total, 11 systematic reviews were included and 18 RCTs of 26 444 participants were found, 12 in the community and 6 in health care workers. Included studies had limitations and were deemed at high risk of bias. Overall, the use of masks in the community did not reduce the risk of influenza, confirmed viral respiratory infection, influenzalike illness, or any clinical respiratory infection. However, in the 2 trials that most closely aligned with mask use in real-life community settings, there was a significant risk reduction in influenzalike illness (risk ratio [RR] = 0.83; 95% CI 0.69 to 0.99). The use of masks in households with a sick contact was not associated with a significant infection risk reduction in any analysis, no matter if masks were used by the sick individual, the healthy family members, or both. In health care workers, surgical masks were superior to cloth masks for preventing influenzalike illness (RR = 0.12; 95% CI 0.02 to 0.98), and N95 masks were likely superior to surgical masks for preventing influenzalike illness (RR = 0.78; 95% CI 0.61 to 1.00) and any clinical respiratory infections (RR = 0.95; 95% CI 0.90 to 1.00). CONCLUSION: This systematic review found limited evidence that the use of masks might reduce the risk of viral respiratory infections. In the community setting, a possible reduced risk of influenzalike illness was found among mask users. In health care workers, the results show no difference between N95 masks and surgical masks on the risk of confirmed influenza or other confirmed viral respiratory infections, although possible benefits from N95 masks were found for preventing influenzalike illness or other clinical respiratory infections. Surgical masks might be superior to cloth masks but data are limited to 1 trial.
Asunto(s)
Gripe Humana/prevención & control , Dispositivos de Protección Respiratoria , Infecciones del Sistema Respiratorio/prevención & control , Personal de Salud , Humanos , Control de Infecciones , Equipo de Protección PersonalRESUMEN
OBJECTIVE: To determine how many patients with chronic osteoarthritis pain respond to various non-surgical treatments. DATA SOURCES: PubMed and the Cochrane Library. STUDY SELECTION: Published systematic reviews of randomized controlled trials (RCTs) that included meta-analysis of responder outcomes for at least 1 of the following interventions were included: acetaminophen, oral nonsteroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, cannabinoids, counseling, exercise, platelet-rich plasma, viscosupplementation, glucosamine, chondroitin, intra-articular corticosteroids, rubefacients, or opioids. SYNTHESIS: In total, 235 systematic reviews were included. Owing to limited reporting of responder meta-analyses, a post hoc decision was made to evaluate individual RCTs with responder analysis within the included systematic reviews. New meta-analyses were performed where possible. A total of 155 RCTs were included. Interventions that led to more patients attaining meaningful pain relief compared with control included exercise (risk ratio [RR] of 2.36; 95% CI 1.79 to 3.12), intra-articular corticosteroids (RR = 1.74; 95% CI 1.15 to 2.62), SNRIs (RR = 1.53; 95% CI 1.25 to 1.87), oral NSAIDs (RR = 1.44; 95% CI 1.36 to 1.52), glucosamine (RR = 1.33; 95% CI 1.02 to 1.74), topical NSAIDs (RR = 1.27; 95% CI 1.16 to 1.38), chondroitin (RR = 1.26; 95% CI 1.13 to 1.41), viscosupplementation (RR = 1.22; 95% CI 1.12 to 1.33), and opioids (RR = 1.16; 95% CI 1.02 to 1.32). Preplanned subgroup analysis demonstrated no effect with glucosamine, chondroitin, or viscosupplementation in studies that were only publicly funded. When trials longer than 4 weeks were analyzed, the benefits of opioids were not statistically significant. CONCLUSION: Interventions that provide meaningful relief for chronic osteoarthritis pain might include exercise, intra-articular corticosteroids, SNRIs, oral and topical NSAIDs, glucosamine, chondroitin, viscosupplementation, and opioids. However, funding of studies and length of treatment are important considerations in interpreting these data.