Restless Legs Syndrome Duration Research Articles

The prevalence and clinical characteristics of restless legs syndrome in patients with iron deficiency anemia in Korea.

While the prevalence and clinical characteristics of restless legs syndrome (RLS) are known to vary according to ethnicity, a detailed evaluation of this condition among patients with iron deficiency anemia (IDA) has not yet been reported in an Asian population. We investigated the prevalence and clinical characteristics of RLS in patients with IDA in Korea compared with age- and sex-matched patients diagnosed with idiopathic RLS. This prospective single-center study was performed at a regional university hospital. Consecutive patients with IDA were enrolled over a 4-year period. Clinical interviews and laboratory tests were conducted at the first visit. RLS diagnosis was confirmed through face-to-face interviews. We randomly selected patients with idiopathic RLS without comorbid medical disorders from our sleep center dataset as control patients. The clinical characteristics of both groups were compared. We enrolled 124 patients with IDA. Fifty (40.3%) patients were diagnosed with RLS, with 82% exhibiting severe to very severe symptoms. Patients with IDA and RLS were older and reported more sleep deterioration than patients with IDA without RLS. Patients with IDA and RLS also had a more depressed mood and higher periodic limb movement index scores than patients with idiopathic RLS. The prevalence of RLS among patients with IDA in Korea was high, with the majority having severe to very severe symptoms. Patients with IDA and RLS had poorer sleep quality and more emotional problems than patients with IDA without RLS. Therefore, patients with IDA should be screened for RLS to prevent adverse effects on the quality of sleep and life.

0798 “Uncovering My Feet Alleviates My Restless Legs”: Impact of Different Activities and Conditions on Restless Legs Symptoms

Abstract Introduction The restless legs syndrome (RLS) is a resting wake state disorder with inactivity/decreased movement as an aggravating factor and activity/increased movement as an alleviating factor. Other activities and conditions may impact RLS symptoms but have not been systematically studied. Methods Fifty-six patients with primary severe RLS (age: 64.1±11.3; 66% women) responded about the effect of 20 activities/conditions on their RLS symptoms. Responses were assigned a numerical value: Aggravation (-1), No effect/Don’t know (0), Alleviation (+1), with calculating a mean effect score for each activity/condition and using a sign test to determine if that score was significantly above or below zero (no effect). Responses were further analyzed based on age, age at RLS onset, duration of RLS, RLS severity, gender, Familial/Non-familial RLS, and Painful/Non-Painful RLS. Association of continuous variables and categorical variables with each activity/condition was examined using Spearman correlation test and Fisher exact test, respectively. Bonferroni p threshold was set at p=0.00036. Results Activities/conditions with significant (p<0.0001) positive mean effect scores were: Feet uncovering (0.70); Leg massaging (0.63); Cold showers (0.54); and Manual activities (0.46). Activities with significant negative mean effect scores were: Vehicle passenger (-0.80); Show attendance (-0.70); Bedsheets weight on legs (-0.57); Watching TV (-0.54); High ambient temperature (-0.45); During meals (-0.39) (all p<0.0001); and Bedsheets rubbing on legs (-0.34; p=0.0002). Activities/conditions with no significant (all p>0.00036) mean effect scores were: Driving (0.00); Gambling (0.02); Professional activities (0.13); Hot showers (0.13); Using computer (0.14); Low ambient temperature (0.21); Sexual activities (0.27); Mental activities (0.29); and Sports activities (0.34). There was no significant association between each activity/condition and age, age at RLS onset, duration of RLS, RLS severity, gender, Familial/Non-familial RLS, or Painful/Non-Painful RLS. Conclusion There is a wide range of impact of different activities/conditions on RLS symptoms. These could be further considered in the non-pharmacological treatment or prevention of RLS symptoms. Support This study was not funded.

Correlates of Nonanemic Iron Deficiency in Restless Legs Syndrome.

Objective: Iron deficiency anemia (IDA) is a well-known cause of secondary restless legs syndrome (RLS). Iron deficiency without anemia (IDNA) is insidious, and its association with RLS is less evaluated. We investigate prevalence and features of IDNA in a consecutive cohort of patients with RLS.Methods: We included sequential primary RLS patients and RLS patients with IDA. We also recruited age- and gender-matched healthy controls. RLS mimics and other comorbidities were carefully excluded.Results: One-hundred and ninety-six RLS patients without anemia, 26 RLS patients with IDA, and 63 controls were included. 42.3% of RLS patients without anemia had iron deficiency. Women were much more susceptible for IDNA with a relative risk of 5.51 (p < 0.0001). Women with IDNA and RLS had younger age both at interview and at RLS onset compared to women with RLS without iron deficiency (NID) (P < 0.01). IDNA RLS patients showed a tendency to higher risk of severe/very severe tiredness or sleepiness during the day as compared to NID RLS patients. Furthermore, IDNA RLS patients had longer duration of RLS (P < 0.01 in men, P < 0.05 in women) and younger age at onset (only in men, P < 0.05) compared to IDA RLS patients.Conclusion: IDNA is frequent in RLS and iron deficiency may be severe despite a normal hemoglobin level. Women are at much higher risk for IDNA, and IDNA in women presents some specific clinical features. Features of IDNA RLS are different from IDA RLS. Regular screening of peripheral iron parameters even in patients with normal blood counts is recommended for timely optimal management.

Restless legs syndrome and cardiovascular diseases: A case-control study.

ObjectiveThe association between restless legs syndrome (RLS), cardiovascular diseases (CVD) and hypertension is inconsistent. This case-control study examined i) the association between primary RLS, CVD and hypertension by taking into account many potential confounders and ii) the influence of RLS duration, severity and treatment, sleep and depressive symptoms on CVD and hypertension in primary RLS.MethodsA standardized questionnaire to assess the RLS phenotype, history of CVD and hypertension, sleep and depressive symptoms, drug intake and demographic/clinical features was sent to the France-Ekbom Patients Association members. A CVD event was defined as a self-reported history of coronary heart disease, heart failure, arrhythmia or stroke. Hypertension was also self-assessed. Current treatment for hypertension and arrhythmia also defined underlying hypertension and arrhythmia. Controls without RLS and without consanguinity were chosen by the patients.Results487 patients with primary RLS (median age 71 years; 67.4% women) and 354 controls (68 years, 47.7% women) were included. Most of the patients (91.7%) were treated for RLS, especially with dopaminergic agonists. The median age of RLS onset was 45 years. CVD and hypertension were associated with RLS in unadjusted association, but not after adjustment for age, sex and body mass index. Patients with RLS and with CVD and/or hypertension were significantly older, with hypercholesterolemia, sleep apnea and older age at RLS and at daily RLS onset compared with patients without CVD and/or hypertension. No significant difference was found for other RLS features, ferritin levels, daytime sleepiness, insomnia and depressive symptoms.ConclusionDespite some limitations in the design of this study, we found that most of the treated patients for primary RLS had no association with CVD and hypertension after controlling for key potential confounders. Comorbid CVD or hypertension was associated with cardiovascular risk factors, but not with RLS features except for older age at onset.

Incident Cardiovascular Events and Death in Individuals With Restless Legs Syndrome or Periodic Limb Movements in Sleep: A Systematic Review.

To systematically review the current evidence examining restless legs syndrome (RLS) and periodic limb movements in sleep (PLMS) as prognostic factors for all-cause mortality and incident cardiovascular events (CVE) in longitudinal studies published in the adult population. All English language studies (from 1947 to 2016) found through Medline and Embase, as well as bibliographies of identified articles, were considered eligible. Quality was evaluated using published guidelines. Among 18 cohorts (reported in 13 manuscripts), 15 evaluated the association between RLS and incident CVE and/or all-cause mortality and 3 between PLMS and CVE and mortality. The follow-up periods ranged from 2 to 20 years. A significant relationship between RLS and CVE was reported in four cohorts with a greater risk suggested for severe RLS with longer duration and secondary forms of RLS. Although a significant association between RLS and all-cause mortality was reported in three cohorts, a meta-analysis we conducted of the four studies of highest quality found no association (pooled hazard ratio = 1.09, 95% confidence interval: 0.80-1.78). A positive association between PLMS and CVE and/or mortality was demonstrated in all included studies with a greater risk attributed to PLMS with arousals. The available evidence on RLS as a prognostic factor for incident CVE and all-cause mortality was limited and inconclusive; RLS duration, severity, and secondary manifestations may be important in understanding a possible relationship. Although very limited, the current evidence suggests that PLMS may be a prognostic factor for incident CVE and mortality.

Refining duration and frequency thresholds of restless legs syndrome diagnosis criteria.

This study assesses the prevalence of restless legs syndrome (RLS) using DSM-5 criteria and determines what is the most appropriate threshold for the frequency and duration of RLS symptoms. The Sleep-EVAL knowledge base system queried the interviewed subjects on life, sleeping habits, and health. Questions on sleep and mental and organic disorders (DSM-5, ICD-10) were also asked. A representative sample of 19,136 noninstitutionalized individuals older than 18 years living in the United States was interviewed through a cross-sectional telephone survey. The participation rate was 83.2%. The prevalence of the 4 leg symptoms describing RLS occurring at least 1 d/wk varied between 5.7% and 12.3%. When the frequency was set to at least 3 d/wk, the prevalence dropped and varied between 1.8% and 4.5% for the 4 leg symptoms. Higher frequency of leg symptoms was associated with greater distress and impairment with a marked increase at 3 d/wk. Symptoms were mostly chronic, lasting for more than 3 months in about 97% of the cases. The prevalence of RLS according to DSM-5 was 1.6% (95% confidence interval 1.4%-1.8%) when frequency was set at 3 d/wk. Stricter criteria for frequency of restless legs symptoms resulted in a reduction of prevalence of the disorder. The prevalence was further reduced when clinical impact was taken into consideration. In order to avoid inflation of case rates and to identify patients in whom treatment is truly warranted, using a more conservative threshold of 3 times or greater per week appears the most appropriate.

The Prevalence of Migraine in Restless Legs Syndrome

While previous studies have investigated the prevalence of restless legs syndrome (RLS) in patients with migraine, we aimed to explore the prevalence and characteristics of migraine in adult patients diagnosed with RLS. The association of primary headaches, especially of migraine, with RLS has recently attracted much attention. Migraine prevalence was reported to be higher in patients with RLS than in the general population, and the role of dopamine was strengthened. We evaluated 265 consecutive adult RLS patients (137 males and 128 females) followed up in a Sleep Disorders Unit and diagnosed according to criteria defined by the International Restless Legs Syndrome Study Group (IRLSSG). RLS characteristics, and the severity, were performed by using the IRLSSG severity scale. The diagnosis of headache subtypes was defined by the International Classification of Headache Disorders. Gender, age, age at RLS onset, duration of RLS, family history of RLS, family history of headache, presence of depression, any treatments given for RLS, and the change in headache following RLS treatment were questioned. The mean age of the study population was 50.4 ± 12.8 years, mean age at RLS onset was 41.6 ± 13.2 years, and mean disease duration was 8.40 ± 8.6 years. Of these, 163 patients had headache; 40 of them were diagnosed to have migraine-type headache (15.1%). The presence of migraine-type headache was 9.4% in males with RLS, and 21.1% in female RLS patients. In RLS patients with migraine, 67.5% were females, while 48.0% of RLS patients with other types of headache were females (P = .032), and only 41.2% of RLS patients without headache were females (P = .005). The severity of RLS was significantly higher in patients with migraine compared with those without headache (P < .001). The presence of depression, the family history of RLS, and headache were also higher in patients with migraine compared with RLS patients with other types of headache or those without headache. Thirty-six patients with headache reported partial or substantial benefit from RLS treatment. Our results did not suggest higher rates of migraine-type headache in RLS patients when compared with population-based prevalence studies from Turkey. Alternatively, the severity of RLS was significantly higher in patients with migraine. Although the increase in these scores does not constitute a relationship etiopathogenetic, it suggests a correlation between the type cross-model nociceptive systems. Moreover, the family history of RLS was higher in patients with migraine. The prevalence of migraine in patients with RLS, however, waits to be better demonstrated.

Prevalence and associated features of restless legs syndrome in a population of Iranian women during pregnancy

ObjectiveTo investigate the prevalence of restless legs syndrome (RLS) during pregnancy and to evaluate factors associated with RLS in a population of Iranian pregnant women. MethodsIn the present cross-sectional study, 443 consecutive pregnant women admitted for delivery underwent an interview within 2days of parturition. The diagnosis of RLS was established by the 4 criteria of the International Restless Legs Syndrome Study Group (IRLSSG). The severity of RLS was assessed through the IRLSSG Rating Scale. ResultsSeventy-nine (17.8%) women met the RLS diagnostic criteria, with most (74.7%) having RLS of moderate severity. The mean RLS duration before delivery was 3.1±2.1months among 69 (87.3%) women; 10 (12.7%) had RLS onset before pregnancy. Sleep disturbances including insomnia and early awakening were significantly more common among women with RLS than among those without (P<0.001), and the frequency of cesarean delivery was also significantly higher (58.2% versus 44.5%, P=0.027; odds ratio 2.4). There were no significant differences between the 2 groups in terms of age, number of pregnancies, folate and iron supplementation, hemoglobin level, and neonatal anthropometric data. ConclusionRestless legs syndrome is common during pregnancy and is associated with poor sleep and an increased risk of cesarean delivery.

Augmentation in restless legs syndrome: poor response to sudden withdrawal of dopaminergic therapy

Augmentation in restless legs syndrome: poor response to sudden withdrawal of dopaminergic therapy Roger Kurlan, Marcie Rabin Atlantic Neuroscience Institute, Overlook Medical Center, Summit, NJ, USA Background: Augmentation is a common complication of long-term dopaminergic therapy for restless legs syndrome (RLS). Methods: We conducted a retrospective chart review of patients with RLS and augmentation to learn more about the condition, including response to therapy. Results: We identified 14 patients (nine women, five men; mean age 65.7 years; mean duration of RLS 23.6 years) with augmentation. Thirteen patients were taking a dopamine agonist and one was taking levodopa. Mean duration of dopaminergic therapy was 5.5 years. The dopaminergic drug was withdrawn at one time and replaced by gabapentin (n = 9), tramadol (n = 5), clonazepam (n = 4), propoxyphene (n = 2), or codeine (n = 1). Seven patients required more than one drug to control symptoms. The mean time until augmentation resolved was 12.5 (range 1&ndash;43) weeks, shortest when gabapentin was used first (2.6 weeks) and longer when clonazepam (14.9 weeks) or tramadol (22.3 weeks) was the initial replacement drug. Conclusion: Augmentation was the most common problem associated with referral of a patient with RLS to a movement disorders specialist, yet referring physicians did not appear to know how to treat it. Regaining satisfactory control of symptoms following sudden withdrawal of the offending dopaminergic drug was difficult, taking longer than 3 months on average. The optimum treatment of drug-induced augmentation is unclear and needs further investigation. Keywords: restless legs syndrome, dopamine agonists, levodopa, augmentation

Topography of the sensations in primary restless legs syndrome

ObjectivesTo evaluate the topography of restless legs syndrome (RLS) sensations and to compare subgroups of patients based on RLS topography. MethodsForty-four treated patients with primary RLS were interviewed and reported the localization of RLS sensations on body diagrams. ResultsRLS sensations were felt deep inside the muscles of mainly the middle portions of the lower limbs in 86% of patients. Superposition of patients' drawings showed a predominant involvement of the upper calves (75%). RLS sensations were diffuse, affecting on average 21% of the body. They occurred bilaterally, but also unilaterally (41%). During symptomatic periods, 66% of the patients experienced sensations spreading, frequently from the legs to other limbs segments. Clinical features were similar in patients with sensations: superficial versus strictly deep; limited or not to the lower limbs; unilateral versus strictly bilateral; and spreading or not. The percentage of affected surface did not correlate with patient age, age at RLS onset, RLS duration and severity. The percentage of affected area in the lower limbs correlated with the one in the upper limbs (r=0.53; p=0.0003). ConclusionRLS sensations affect large body areas (predominantly the upper calves). Body diagrams could be used to explore the evolution of RLS topography and treatment effects.

Acupuncture for restless legs syndrome.

Restless legs syndrome (RLS) is a common movement disorder for which patients may seek treatment with acupuncture. However, the benefits of acupuncture in the treatment of RLS are unclear and have not been evaluated in a systematic review until now. To evaluate the efficacy and safety of acupuncture therapy in patients with RLS. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2007), MEDLINE (January 1950 to February 2007), EMBASE (January 1980 to 2007 Week 8), Chinese Biomedical Database (CBM) (1978 to February 2007), China National Knowledge Infrastructure (CNKI) (1979 to February 2007), VIP Database (1989 to February 2007), Japana Centra Revuo Medicina (1983 to 2007) and Korean Medical Database (1986 to 2007). Four Chinese journals, relevant academic conference proceedings and reference lists of articles were handsearched. Randomized controlled trials and quasi-randomized trials comparing acupuncture with no intervention, placebo acupuncture, sham acupuncture, pharmacological treatments, or other non-acupuncture interventions for primary RLS were included. Trials comparing acupuncture plus non-acupuncture treatment with the same non-acupuncture treatment were also included. Trials that only compared different forms of acupuncture or different acupoints were excluded. Two authors independently identified potential articles, assessed methodological quality and extracted data. Relative risk (RR) was used for binary outcomes and weighted mean difference for continuous variables. Results were combined only in the absence of clinical heterogeneity. Fourteen potentially relevant trials were identified initially, but twelve of them did not meet the selection criteria and were excluded. Only two trials with 170 patients met the inclusion criteria. No data could be combined due to clinical heterogeneity between trials. Both trials had methodological and/or reporting shortcomings. No significant difference was detected in remission of overall symptoms between acupuncture and medications in one trial (RR 0.97, 95% CI 0.76 to 1.24). Another trial found that dermal needle therapy used in combination with medications and massage was more effective than medications and massage alone, in terms of remission of unpleasant sensations in the legs (RR 1.36, 95% CI 1.06 to 1.75; WMD -0.61, 95% CI -0.96 to -0.26) and reduction of RLS frequency (WMD -3.44, 95% CI -5.15 to -1.73). However, there was no significant difference for the reduction in either the longest or the shortest duration of RLS (WMD -2.58, 95% CI -5.92 to 0.76; WMD -0.38, 95% CI -1.08 to 0.32). There is insufficient evidence to determine whether acupuncture is an efficacious and safe treatment for RLS. Further well-designed, large-scale clinical trials are needed.

Effectiveness and Tolerability of Istradefylline for the Treatment of Restless Legs Syndrome: An Exploratory Study in Five Female Patients

Background: Studies of istradefylline (KW6002), an adenosine A 2A-receptor antagonist, have provided evidence of its efficacy as a nondopaminergic antiparkinsonian drug. Antiparkinsonian drugs have also had efficacy in treating restless legs syndrome (RLS). Objectives: The aims of this study were to assess the effectiveness and tolerability of istradefylline in the treatment of RLS. Methods: This was a single-center, multiparametric, prospective trial of istradefylline as a treatment for moderate to severe idiopathic RLS. It was conducted at the Shands/Jacksonville Sleep Disorders Center, University of Florida, Jacksonville, Florida, from March 2003 to October 2003. Patients received a single PO 80-mg dose QD of istradefylline in the late afternoon or early evening for 6 weeks. Appropriate tolerability evaluations (ie, vital assessments, physical examination, clinical laboratory tests, and electrocardiogram) were performed at screening, while on study drug, and after withdrawal of study drug. Results: Fifteen participants (mean [SD] age, 61 [7.1] years; range, 50-69 years) were screened for enrollment. The mean duration of RLS was 18 years. Of the 15 potential patients, 6 did not meet entry criteria, 2 withdrew consent, 1 had not completed baseline procedures at the time of study suspension, and 1 was excluded for administrative reasons. Therefore, a total of 5 patients received the study drug. Of these, 3 (60%) patients responded favorably to istradefylline treatment. Improvement in the periodic limb movement index was observed in 3 patients compared with baseline (patients 2, 4, and 5 [index score: 6, 4, 9 vs 50, 35, 18, respectively]). Improvement in the International RLS Rating Scale scores was observed in 3 patients compared with baseline (patients 2, 4, and 5 [index score: 7, 23, 9 vs 35, 25, 20, respectively]). There was a return to baseline severity in 2 of the 3 patients after withdrawal of study drug. Improvement in RLS symptoms was observed in 3 patients treated with istradefylline for 6 weeks. A clinical worsening of baseline insomnia was observed in 2 patients. Conclusions: Although we could not definitively conclude a beneficial effect based on this small exploratory trial, we found the data to be encouraging. The study drug was well tolerated. Further study of this compound in the treatment of RLS is justified.

Auditory Startle Reaction is disinhibited in idiopathic Restless Legs Syndrome

Because the auditory startle reaction is abnormal in disorders with substantia nigra pathology, we hypothesized that auditory startle responses (ASRs) might also be altered in restless legs syndrome (RLS). Neurophysiologic study of the auditory startle reaction. Neurology departments of a university hospital and an affiliated local hospital. Fifteen patients with idiopathic RLS (6 de novo, 9 untreated after a 7-day wash-out period of levodopa, mean duration of RLS [corrected] symptoms 21.2 +/- 17.9 years, mean IRLS [corrected] severity score 23.5 +/- 6.7) and 15 sex- and age-matched healthy controls were investigated. Not applicable. ASRs were elicited by 8 high-intensity auditory stimuli differing randomly in tonal frequency and intensity. Reflex electromyographic activity was simultaneously recorded with surface electrodes from 8 facial, neck, arm, and leg muscles. In RLS patients, ASRs were significantly more frequent (541 of 960 possible responses; controls, 430 of 960), and ASR area under the curve was significantly larger (3812 +/- 450 microVms; controls, 1756 +/- 226 microVms). Analysis per body region revealed that ASRs were significantly more frequent in RLS patients than in controls in leg muscles (138/360 vs 55/360); ASR latencies to leg muscles were significantly shorter in RLS patients (129 +/- 6 ms vs 160 +/- 11 ms); ASR area under the curve was significantly larger in RLS patients in facial (7547 +/- 1326 mmicroVms vs 2982 +/- 448 microVms) and leg muscles (1373 +/- 308 microVms vs 541 +/- 193 microVms). Our data demonstrate disinhibition of reticulospinal pathways in RLS patients as compared to normal controls, likely originating from dysfunction rostral to the lower brainstem.

Nature and variants of idiopathic restless legs syndrome: observations from 152 patients referred to secondary care in the UK

Heterogeneity in clinical presentation and daytime somnolence in restless legs syndrome (RLS) have been poorly explored in the UK. Analysis of database of 152 cases of primary RLS compiled from clinical consultation using a structured questionnaire administration and clinical examination, spanning six years of referral. Standard evaluations included use of the Epworth Sleepiness Scale (ESS). Secondary RLS was excluded and polysomnography performed in some when clinically indicated. The mean duration of RLS before appropriate treatment initiation was 12.7 years (age range of patients 26-90 years). 79% of patients had insomnia while 30% had excessive daytime sleepiness (EDS). Severe pain, restless arms and paroxysmal RLS causing lifestyle alterations also occurred. This study suggests that there is considerable delay before appropriate therapy in RLS. A large number have EDS and insomnia among others, is the commonest presenting feature. Phenotypic heterogeneity may cause diagnostic difficulty.

Gender differences in the presentation of subjects with restless legs syndrome

Background and purpose To better understand the origin of the disproportionate number of women in previous treatment studies of patients with restless legs syndrome (RLS). Patients and methods We conducted a survey in a self-selected group of patients who responded to print and radio recruiting advertisements regarding a clinical trial for RLS. Subjects completed a questionnaire which solicited information on presenting features of RLS, sleep-related symptoms, co-morbidities and family history. Results A total of 158 (63% female) subjects with a mean age of 49 (±16) years fulfilled the criteria for putative diagnosis of RLS and participated in the study. There was no gender bias as far as duration of RLS, incidence of family history, number of affected days per week, or severity of daytime sleepiness was concerned. There was a subtle gender bias in sleep-related symptoms (involuntary movements when awake, sleep onset difficulties and frequent wakings at night) where a disproportionately high number of women subjects presented with all three symptoms. For any one symptom, or any pair of symptoms, there were no gender differences. Women also were more likely to present with co-existent hypothyroidism. Both male and female subjects were more likely to recall female relatives affected with RLS. Conclusions Gender differences associated with symptom load, co-morbidities of RLS and possible patterns of inheritance may contribute to increased numbers of women presenting for treatment of RLS.

Restless legs syndrome: clinical experience with long-term treatment

Background and purpose There are limited data on long-term treatment efficacy, and almost none on predictors of treatment response in patients with restless legs syndrome (RLS). To assess: (1) long-term efficacy of RLS treatment in a clinical setting, (2) predictors of a good treatment response, and (3) the value of the RLS-severity score according to the criteria of the International Restless Legs Syndrome Study Group (IRLSSG). Patients and methods Over three years 70 patients (36 men, 34 women; mean age: 59 years; range: 29–79) with RLS were prospectively assessed. Diagnosis of RLS was made according to international criteria Severity of RLS symptoms was were assessed at the outset by the IRLSSG rating scale. Treatment was chosen individually according to clinical judgement. After a mean follow-up time of 16 months (range: 1–106 months) evolution of symptoms was assessed by both overall clinical impression and IRLSSG rating scale. Clinical characteristics and treatment effect were compared between patients never treated for RLS before this study (‘naïve’=N-pts) and those with previous treatment (‘treated’=T-pts). Predictors of treatment response were sought for comparing patients with good treatment response (good, better or much better on follow-up) and those with bad (B-pts) treatment response. Results There were 40 N-pts and 30 T-pts. The mean IRLSSG score (hereinafter, IRLSSG) at baseline was 26 (range 12–38). No significant differences were found between N-and T-pts in age, gender, etiology and duration of RLS, positive family history, presenting sleep complaint, IRLSSG, or percentage of patients with periodic limb movements in sleep (PLMS) on polysomnography (PSG). At final follow-up 30 (76%) of 40 N-pts and 23 (77%) of 30 T-pts had a good (G-pts) treatment response. The mean IRLSSG at follow-up was 19 (range:1–36). There was a significant correlation between improvement of overall clinical impression (better or much better on final follow-up) and reduction of IRLSSG ( P<0.0001). PLMS were more common in B- than G-pts (100 vs 58% of patients, P=0.02). In all other variables considered the two groups were similar. Conclusion (1) A good long-term treatment response can be obtained and maintained in a clinical setting in about 80% of RLS patients. (2) Patients with RLS and without PLMS may have a better long-term treatment response, and (3) the IRLSSG is a useful tool for assessment of evolution of RLS symptoms over time in individual patients.