International Restless Legs Scale Scores Research Articles

Coexistence of periodic limb movements during sleep with restless legs syndrome and its association with hypertension in Japanese patients

BackgroundCaucasian patients with restless legs syndrome (RLS) frequently exhibit periodic limb movements during sleep (PLMS), which may increase the risk of hypertension. We evaluated the positivity rate of PLMS and factors associated with positivity in Japanese patients with RLS, and tested whether the complications of PLMS are associated with the presence of hypertension. MethodsWe retrospectively investigated polysomnographic data and the presence or absence of hypertension in patients with RLS. Patients with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg or those taking antihypertensive medication were categorized as the group with hypertension. ResultsAmong 468 patients, 200 (42.7%) had periodic limb movement index (PLMI) values ≥ 15/h and 108 (23.1%) met the criteria of positivity for hypertension. Multiple logistic regression analysis revealed that only higher age was significantly associated with PLMI values ≥ 15/h. Multiple linear regression analyses of factors associated with an increased PLMI also showed that increased PLMI was significantly correlated with higher age and male sex, but not with the international restless legs scale scores. Multiple logistic regression analysis also revealed that higher age and body mass index, not PLMI values ≥ 15/h, were significantly associated with the presence of hypertension. ConclusionThe PLMS-positivity rate may be lower in Japanese patients with RLS than in Caucasian patients, and it increases with age and male sex, but not with the severity of the disorder. Furthermore, PLMS complications were not associated with the risk of hypertension in Japanese patients with RLS.

SUBCLINICAL TARGET ORGAN DAMAGE IN PATIENTS WITH RESTLESS LEGS SYNDROME. A PRELIMINARY OBSERVATIONAL STUDY

Objective: Restless legs syndrome (RLLS) is a frequent and often underdiagnosed type of insomnia. Since other types of insomnia present a strict association with cardiovascular disease, our study aimed to evaluate the possible association of RLLS with some early markers of cardiovascular organ damage. Design and method: Patients with other types of insomnia and those with central nervous system diseases were excluded. Twenty-eight patients (mean age: 63,1±13,9 years; 28.6% males) participated in the study. Fourteen subjects with diagnosis of RLLS according to International diagnostic criteria (Allen RP et al. 2014 Sleep Medicine) (disease mean duration 9.6±9.2 years; International Restless Legs Scale score 22.9±5.2) were matched for sex, age and major cardiovascular risk factors with 14 controls. In both groups, peripheral Blood Pressure (pBP), central Blood Pressure (cBP) and Pulse Wave Velocity (PWV) were assessed by the SphygmoCorXCEL. Carotid Intima-Media Thickness (cIMT) and the carotid Distensibility Coefficient (cCD) were assessed by ultrasound connected with an image acquisition and analysis system (CardiovascularSuite). Results: We did not find any significant difference between the two groups in the indices of subclinical vascular damage. In the RLS group, blood pressure measurements significantly correlated with all the markers of subclinical vascular damage, particularly pSBP was associated with PWV (r = 0.53, p = 0.009), Pulse Pressure correlated with cIMT (r = 0.58, p = 0.01) and cDBP was inversely related to cDC (r = -0.53; p = 0.03). Conclusions: Our data did not show significant differences in markers of early vascular damage between patients with RLS and matched controls. As expected, the markers of vascular damage were associated with BP. The present is only a pilot study; further studies with a larger sample size are required to confirm our findings.

Iron for the treatment of restless legs syndrome.

Iron for the treatment of restless legs syndrome.

Rate of augmentation and risk factors with long-term follow-up in Japanese patients with restless legs syndrome.

Preventing augmentation is the critical clinical issue for RLS treatment. As for augmentation in Asian RLS patients, there have been only four studies and the follow-up durations of these studies were not long. We investigated Japanese RLS patients with longer duration of treatment in a clinical setting. This study is a retrospective assessment of 42 RLS patients with follow-up durations of longer than 18months (78.4 ± 29.2, range 19-139) at two urban sleep centers in Osaka, Japan from May 2004 to April 2014. The mean age of first visit was 63.5 ± 14.1years old and the estimated age of RLS onset was 47.9 ± 16.5years old. Twenty-eight out of 42 patients were female. At initial evaluation, the mean International Restless Legs Scale score (IRLS score) was 22.0 ± 5.9. Thirty-one of 42 had already visited other clinics before coming to our sleep centers, and the number of clinics visited was 1.3 ± 0.6. Augmentation developed in two patients (4.8%), and the dosage of dopamine equivalent in patients with and without augmentation was 12.5 and 18.8mg vs. 15.8 ± 17.7mg. In the two RLS patients with augmentation, ferritin was 113.1 and 114.1ng/mL, respectively, and the number of clinics before coming to our sleep centers was both three. The augmentation rate of Japanese RLS patients from our study is low compared with previous Western and Asian studies. It might be attributable to racial difference, lower dosage of dopaminergic treatment, and the level of ferritin.

A double-blind, randomized, controlled trial to compare the efficacy and tolerability of fixed doses of ropinirole, bupropion, and iron in treatment of restless legs syndrome (Willis-Ekbom disease).

Background:We aimed to compare the efficacy of fixed doses of bupropion and ropinirole and iron alone for the treatment of restless legs syndrome (RLS) and to look for the tolerability of these medications.Materials and Methods:Patients diagnosed with RLS were randomly divided into three groups with thirty patients in each group (Group A: Bupropion [300 mg/day], Group B: Ropinirole [0.25–0.5 mg/day], and Group C: Oral iron [150 mg elemental iron] along with folic acid [500 μg]). Each participant was then assessed for severity of RLS, as well as RLS-related quality at the baseline, and thereafter, every 14th day till 6 weeks based on the International Restless Legs Scale (IRLS) severity rating scale and Restless Legs Syndrome Quality of Life (RLSQoL) Questionnaire, respectively.Results:IRLS scores differed significantly from baseline visit to last (F = 4.85; P = 0.01). The interaction between the time x treatment group was significant (F = 10.37; P < 0.001) showing an improvement with the therapy in all the groups. Pair-wise comparison depicted that ropinirole group differed from other two groups in IRLS score (F = 7.06; P = 0.001), which were comparable to each other. Regarding quality of life of these cases, within each group scores differed among all the four visits (F = 5.12; P = 0.002). Unlike IRLS, there was no significant difference among the RLSQOL scores between groups at any point of time (F = 1.2; P = 0.28).Conclusion:RLS severity decreased across time in all three groups; however, the ropinirole treatment was better than the bupropion and iron-folate therapy. Moreover, RLS-related quality of life although improved among all groups, it was comparable among three groups.

Restless legs syndrome and post polio syndrome: a case-control study.

The aim was to investigate the prevalence of restless legs syndrome (RLS), fatigue and daytime sleepiness in a large cohort of patients affected by post polio syndrome (PPS) and their impact on patient health-related quality of life (HRQoL) compared with healthy subjects. PPS patients were evaluated by means of the Stanford Sleepiness Scale and the Fatigue Severity Scale (FSS). The Short Form Health Survey (SF-36) questionnaire was utilized to assess HRQoL in PPS. RLS was diagnosed when standard criteria were met. Age and sex matched healthy controls were recruited amongst spouses or friends of PPS subjects. A total of 66 PPS patients and 80 healthy controls were enrolled in the study. A significantly higher prevalence of RLS (P<0.0005; odds ratio 21.5; 95% confidence interval 8.17-57) was found in PPS patients (PPS/RLS+ 63.6%) than in healthy controls (7.5%). The FSS score was higher in PPS/RLS+ than in PPS/RLS- patients (P=0.03). A significant decrease of SF-36 scores, including the physical function (P=0.001), physical role (P=0.0001) and bodily pain (P=0.03) domains, was found in PPS/RLS+ versus PPS/RLS- patients. Finally, it was found that PPS/RLS+ showed a significant correlation between International Restless Legs Scale score and FSS (P<0.0001), as well as between International Restless Legs Scale score and most of the SF-36 items (physical role P=0.0018, general health P=0.0009, vitality P=0.0022, social functioning P=0.002, role emotional P=0.0019, and mental health P=0.0003). Our findings demonstrate a high prevalence of RLS in PPS, and that RLS occurrence may significantly influence the HRQoL and fatigue of PPS patients. A hypothetical link between neuroanatomical and inflammatory mechanisms in RLS and PPS is suggested.

Treatment of restless legs syndrome with pregabalin

To assess the therapeutic efficacy, required dose, and tolerability of pregabalin in patients with idiopathic restless legs syndrome (RLS). This was a double-blind, placebo-controlled trial with polysomnographic control, providing Class II evidence. Ninety-eight patients underwent a 2-week single-blind period with placebo; 58 were randomized to receive pregabalin or placebo for 12 weeks under a flexible-dose schedule. Endpoints were mean change from baseline in the International Restless Legs Scale (IRLS) total score, Clinical Global Impression (CGI), and RLS-6 scales, as well as changes in periodic limb movements (PLMs) and sleep architecture. Patients under treatment with pregabalin had a greater improvement in IRLS score than under placebo (63% vs 38.2%; p < 0.05). The mean effective dose of pregabalin at the end of treatment was 322.50 mg/day (+/-98.77), although therapeutic effects were already seen at a mean dose of 139 mg/day. Similarly, improvements were observed on the CGI, RLS-6 scale, and the Medical Outcomes Study sleep scale (all p < 0.01) when compared to placebo. Treatment with pregabalin also resulted in a reduction of the mean (+/-SD) PLM index (p < 0.001). Furthermore, there was a marked improvement in sleep architecture with an increase in slow wave sleep (p < 0.01), and decreases in wake after sleep onset and stages 1 and 2 (p < 0.05). Pregabalin was generally well-tolerated. Adverse events were mild but common, and included unsteadiness, daytime sleepiness, and headache. This study shows significant therapeutic effects of pregabalin on both sensorial and motor symptoms in restless legs syndrome. Treatment with pregabalin was associated with an improvement of sleep architecture and periodic limb movements. Adverse events included unsteadiness and sleepiness and should be screened carefully in the working population, particularly when pregabalin is administered in the afternoon. This study provides Class II evidence that pregabalin is effective for the treatment of restless legs syndrome and improves sleep architecture and periodic limb movements in placebo-unresponsive patients.

O0050 Restless legs syndrome patients: International Restless Legs Scale scores, serum ferritin levels and Suggested Immobilization Test results

O0050 Restless legs syndrome patients: International Restless Legs Scale scores, serum ferritin levels and Suggested Immobilization Test results

Ropinirole in the Treatment of Patients With Restless Legs Syndrome: A US-Based Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Restless legs syndrome (RLS), a condition found in 5% to 10% of adults, consists of an urge to move the legs usually accompanied by uncomfortable sensations that tend to occur at times of rest or inactivity, especially at night. Movement relieves the symptoms, at least in part. The timing of symptoms and periodic leg movements (PLMs) make it difficult to fall and remain asleep, and affected patients experience a lowered quality of life. Because dopaminergic dysfunction appears to have a central role in RLS, dopamine agonists are the preferred treatment in most patients having symptoms on a daily basis. This study compared the dopamine agonist ropinirole with placebo in a 12-week double-blind, randomized, flexible-dose trial that enrolled patients who had moderate to severe primary RLS based on International Restless Legs Scale (IRLS) scores. The trial was completed by 164 patients randomized to receive ropinirole and 167 given placebo. Daily doses of 0.25 to 4 mg were given as needed and as tolerated 1 to 3 hours before bedtime. After 12 weeks, patients taking ropinirole had a significantly greater reduction in IRLS scores than did placebo recipients. The mean daily dose of ropinirole at this time was 2.1 mg. Significantly more of the actively treated patients exhibited a response on the Clinical Global Impression-I scale, and PLM scores also favored ropinirole. Treated patients improved in all domains of the Medical Outcomes Study sleep scale, and they had a substantially greater change from baseline in an RLS Quality of Life questionnaire than did placebo patients. Anxiety scores decreased with ropinirole treatment, whereas depression scores declined in both groups. A majority of patients in both groups reported adverse effects, but most of these were mild or moderate. Only one patient—in the placebo group—had a serious adverse effect consisting of chest pain. These findings support those from previous international studies of ropinirole as a treatment for RLS. The drug consistently lessens symptoms of RLS, reduces anxiety, improves sleep and the overall self-rated quality of life, and is generally well tolerated.

Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: A 12‐week, double‐blind, randomized, parallel‐group, placebo‐controlled study

Restless legs syndrome (RLS) is a neurological condition with significant impact on sleep and quality of life (QoL). This double-blind, randomized, 12-week, multinational study compared the efficacy and safety of ropinirole and placebo in RLS. In total, 267 outpatients with moderate-to-severe RLS were randomly assigned to ropinirole (0.25-4.0 mg/day) or placebo, 1 to 3 hours before bedtime. The primary endpoint was the change in International Restless Legs Scale (IRLS) score at week 12. Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression-Improvement (CGI-I) scale at week 12 and changes in IRLS and CGI-I scale scores at week 1. Other measures included the Medical Outcomes Study sleep scale and Restless Legs Syndrome Quality of Life questionnaire. Improvements were significantly greater for ropinirole than placebo for change in IRLS score at week 12 (-11.2 [SE 0.76] vs. -8.7 [0.75], respectively; adjusted treatment difference -2.5 [95% confidence interval [CI], -4.6, -0.4], P = 0.0197); all key secondary endpoints; sleep and QoL parameters. Adverse events were typical for dopamine agonists; disease augmentation, although not directly assessed, was not reported during treatment. Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well tolerated.

Correlation between rating scales and sleep laboratory measurements in restless legs syndrome

Objectives The aim of this study was to test the external validity of the International Restless Legs Scale (IRLS) by assessment of the correlation between IRLS scores and objective measures of severity such as polysomnography (PSG) and Suggested Immobilization Test (SIT). Designs Correlation analysis between rating scales for RLS (IRLS and Johns Hopkins RLS Scale –JHRLSS‐) and sleep laboratory measurements in untreated RLS patients. Methods The study included 30 untreated patients diagnosed with RLS according to the criteria of the International RLS Study Group. Diagnostic procedures included physical exam, laboratory analysis, PSG and a nocturnal SIT. Statistical analysis was performed by means of Spearman's correlations and Kruskal-Wallis test. Results IRLS correlated significantly with Periodic Leg Movement of Sleep-index (PLMS), and PLMS‐arousal index during PSG as well as with Periodic Leg Movement of Wakefulness (PLMW) during SIT (SIT-PLMW) (all r=0.4; p<0.01). There was no correlation between IRLS and the number of PLMW in PSG (PSG‐PLMW) or any other sleep variable during PSG. Nor was any correlation found between IRLS scores and ferritin, age, duration of illness or any other clinical variables. Conclusions This study represents the first demonstration of a correlation between IRLS and objective parameters of motor dysfunction such as PLMS-index or SIT. This finding is particularly relevant for the design of future clinical trials. Furthermore, the association between PLMS and SIT‐PLMW supports the view that both PLMS and PLMW might share a common mechanism.