OBJECTIVE -To investigate the presence of restless legs syndrome (RLS) and the quality of sleep in a population of type 2 diabetic patients.RESEARCH DESIGN AND METHODS -The study population was composed of 100 consecutive patients regularly attending a diabetes clinic at the University Hospital of the Federal University of Ceará. The subjects' quality of sleep was assessed by the Pittsburgh Sleep Quality Index, and excessive daytime sleepiness (EDS) was measured by the Epworth Sleepiness Scale. The RLS was diagnosed using the four minimum criteria defined by the International Restless Legs Syndrome Study Group. Other relevant clinical and laboratory parameters were obtained by interview and chart review.RESULTS -RLS was found in 27% of patients. Poor sleep quality was present in 45% of cases and was associated with age (P ϭ 0.04), peripheral neuropathy (P ϭ 0.001), and RLS (P ϭ 0.000). EDS was found in 26% of patients. Logistic regression analysis revealed an association between RLS and peripheral neuropathy (odds ratio 12.85 [95% CI 2.83-58.40], P ϭ 0.001).CONCLUSIONS -RLS is common in type 2 diabetic patients and can be a major cause of sleep disruption in these patients. Diabetes Care 28:2633-2636, 2005 Diabetes is a lifelong disease of increasing incidence in the Western world and is frequently comorbid with other disorders such as retinopathy, peripheral neuropathy, and nephropathy (1,2). Most patients develop diabetes after age 40 years, and, although much progress has been made in therapy, the majority of diabetic patients continue to die from macrovascular complications (i.e., cardiovascular disease) (3).Recently it has become clear that sleep disturbances (e.g., chronic insomnia, sleep apnea) have a major impact on health and quality of life; this adverse impact can usually be reversed by adequate diagnosis and treatment (4). Neuropathy may also contribute to the significant reduction in quality of life for patients (5).These problems are frequently overlooked on routine medical interviews; furthermore, in some cases, short-term disturbances of sleep may evolve into chronic conditions (6). The indiscriminate use of sleeping pills may further disrupt the sleep-wake cycle and contribute to stress in patients with sleep disorders (7). In type 2 diabetes, sleep disturbances are believed to be common (8) and have been attributed to impaired glucose metabolism and general physical distress (9).Restless legs syndrome (RLS) is a common neurological condition characterized by unpleasant sensations deep inside the legs that occur at rest, especially at bedtime (10,11). The paresthesias are accompanied by an irresistible urge to move the limbs, with movement temporarily relieving the symptoms (12,13). RLS patients experience discomfort and complain of disturbances in initiating and maintaining sleep, sleepiness, and lessrefreshing sleep (14). The intensity of sensory and motor symptoms can vary throughout a patient's lifetime but generally tends to increase with advancing age. RLS has been reported in association ...

Avaliação da segurança clínica de um fi toterápico contendo Mikania glomerata, Grindelia robusta, Copaifera offi cinalis, Myroxylon toluifera, Nasturtium offi cinale, própolis e mel em voluntários saudáveis ABSTRACT: "Clinical safety evaluation of a phytomedicine containing Mikania glomerata, Grindelia robusta, Copaifera offi cinalis, Myroxylon toluifera, Nasturtium offi cinale, honey and propolis in healthy volunteers". Calmatoss® is a phytomedicine used in several respiratory tract pathologies treatment composed of seven medicinal plants such as Mikania glomerata, Grindelia robusta, Copaifera offi cinalis, Myroxylon toluifera, Nasturtium offi cinale, as well as honey and propolis. The present study investigated the chronic administration of 15 mL Calmatoss® syroup four times a day during 21 days for any toxic effect on healthy volunteers. The clinical trial consisted of an open study with 24 volunteers included in the study only when considered healthy after clinical evaluation, physical examination and laboratory tests, which preceded the study. The laboratory tests included: heamatologic, biochemical and sorologic analysis. This evaluation was repeated after the fi rst, second and third week of treatment and at post-study seven days after the last administration. Calmatoss® was well tolerated by the volunteers. Variations in the laboratory were observed and all of these laboratory changes returned to normal levels during or after the study. Cañigueral; Vila, 1998, Mills;Bone, 2000). De acordo com Alonso (1998) o Bálsamo de Tolú, Myroxylon toluifera ou Toluifera balsamum é originário da América do Sul (Venezuela, Colômbia e Peru). A oleoresina extraída do tronco mediante cortes em "V" é rica em substâncias com propriedades antisépticas expectorantes (Boyd, 1954, Melo;Melo 2005), espasmolíticas, cicatrizantes e antiparasitárias (Alonso, 1998). É empregado topicamente no tratamento de sarnas, feridas e úlceras dérmicas (Cañigueral;Vila, 1998) Albumina (g/dL) 4,09 ± 0,2 4,09 ± 0,2 4,3 ± 0,2 4,3 ± 0,2 ALT (U/L) 22,4 ± 13,5 18,5 ± 10,7 20,9 ± 11,4 18,6 ± 13,2 AST (U/L) 23,67 ± 8,63 20,8 ± 5,4 22,3 ± 6,5 17,4 ± 4,5 Bilirrubina (mg/dL) 0 15,6 ± 20,7 Glicemia (mg/dL) 82,9 ± 8,5 82,3 ± 10,8 84,9 ± 6,2 87,3 ± 8,1 Hematócrito (%) 40,61 ± 3,1 40,22 ± 2,9 42,83 ± 2,9 42,6 ± 3,9 Hemoglobina (g/dL)13,8 ± 1,3 13,4 ± 1,2 14,7 ± 1,0 14,3 ± 1,1 Leucócitos (cels/mm 3 ) 7,1 ± 1,3 7,2 ± 0,8 6,5 ± 1,5 6,2 ± 1,4 Plaquetas (cels/mm 3 ) 272,3 ± 6,0 299,6 ± 55,5 242,7 ± 28,7 237,4 ± 32,6 Potássio (Mmol/L) 4,1 ± 0,3 4,2 ± 0,2 4,3 ± 0,4 4,2 ± 0,2 Proteína total 7,4 ± 0,4 7,3 ± 0,3 7,4 ± 0,3 7,2 ± 0,3 Sódio (Mmol/L) 138,8 ± 2,6 138,8 ± 1,0 140,4 ± 1,9 138,8 ± 3,2 TP 1,1 ± 0,1 1,2 ± 0,1 1,2 ± 0,1 1,1 ± 0,1 TPTA (%) 1,0 ± 0,1 1,0 ± 0,1 1,0 ± 0,1 1,0

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