Partial or complete relief may result from movement such as walking, stretching, or bending of the legs. Such relief is temporary, however, and symptoms return when movement ceases. Severe restless legs syndrome, however, is a chronic progressive disorder that may require long-term treatment. Prevalence estimates for RLS range from 3 to 10 percent, 3 and are higher for women and older people. RLS is believed to be idiopathic or primary RLS, or secondary to other conditions such as iron deficiency, end-stage renal disease and pregnancy 6,7.
Secondary RLS often starts later in life, is associated with more rapid progression than idiopathic RLS, and is often resolved when the underlying condition is treated. RLS has a wide spectrum of disease severity. However, severe RLS can have a crippling impact on quality of life. It can prevent participation in occupational or social activities, and reduce function and emotional well-being. RLS-induced sleep disruption may lead to poor daytime functioning, anxiety, and depression.
Indeed, sleep deprivation and daytime fatigue are the most common reasons RLS patients seek treatment. Treatments for RLS include nonpharmacological and pharmacological options Table 1. Pharmacological treatment is generally reserved for patients with severe RLS. Except for the limitations on pharmacological therapy imposed by pregnancy, 14 and the use of iron replacement for those with iron deficiency, treatment options are unlikely to vary for primary and secondary forms of RLS.
Clinical experience suggests that RLS associated with pregnancy is resolved postpartum in most of the patients; 16 however, there have been no evaluations of therapy in this population and very little is known about women with pregnancy-induced RLS whose symptoms persist even after delivery.
Sedation; pruritus; constipation; nausea or vomiting; dry mouth; dependence; exacerbation of sleep apnea. Several developed scales are used to assess RLS severity, impact, and specific health outcomes. Table 2. MCIDs have not been defined for these scales. We will systematically review the literature to assess the benefits and harms of treatment, especially long-term outcomes.
We will evaluate methods used to define RLS, assess its severity, and measure treatment benefits and harms. Further, we will identify gaps in the available evidence and develop a future research agenda.
RLS treatment choices vary by patient age and by the severity and impact of the disease. For patients suffering from severe RLS, the critical issue is how to identify the treatment options with the greatest long-term benefits and the least harms. Treating children and older adults with RLS presents specific challenges. We do not know the impact of long-term use of these drugs in children. We developed the key questions after a topic refinement process that included a preliminary review of the literature and consultation with a key informant panel of RLS experts and stakeholders.
Additionally, the panel emphasized the need to examine treatment durability and sustainability, because patients using RLS medications long-term often report the need to switch treatments as benefits diminish or cease over time. Based on key informant input, we made the following changes. We also sought input from a technical panel of experts TEP convened to provide methodological and content expertise to the review. In response to public comments and input from the TEP, we revised the key questions, adding iron status to the list of patient characteristics that may affect outcomes.
The TEP endorsed restricting study scope to individuals diagnosed with RLS and excluding studies on periodic limb movement disorder or other sleep-related conditions. The TEP also helped us prioritize outcomes on the basis of their relevance to improvements in patient function and quality of life. We expanded the list of nonpharmacological treatments to include counter pulsation devices and compression stockings.
What is the effect of patient characteristics age, gender, race, comorbidities, disease severity, etiology, iron status, pregnancy, end-stage renal disease on the benefits and harms of treatments for RLS?
For each of the outcomes, we will analyze total scale scores from validated scales noted above. For each scale, we will try to determine, the minimum change in score that translates to clinically meaningful improvement. Below we describe the general criteria used to identify eligible randomized controlled trials RCTs and observational studies. We will use evidence from observational studies to assess long-term harms of treatment; of particular interest are long-term, open label trials and followup studies.
Rationale: Our review of the literature and discussions with the technical expert panel indicate that studies relevant to this review, including clinical trials from countries in Europe are published in English language. Therefore, restricting studies to those published in English would not affect the findings of the review.
We will adapt this search strategy to conform to the syntax requirements of individual bibliographic databases. We will also evaluate the bibliographies of included primary studies and any identified systematic or nonsystematic reviews.
We will search the grey literature sources such as ClinicalTrials. Disagreements will be resolved by discussion or, when needed, by consultation with a third reviewer. Articles meeting eligibility criteria will be included for data abstraction. After the draft report is submitted, we will follow the same procedure to update the literature search covering the interval since completion of the original search.
Data from individual studies will be abstracted directly into evidence tables by one reviewer and validated by a second reviewer. Disagreements will be resolved between the two reviewers by discussion or, when needed, by consultation with a third reviewer. Blinding is a key component of assessing overall quality because assessment of treatment effectiveness is based primarily on patient reported outcomes and treatments are associated with a high placebo rate.
For each RCT, we will assess risk of bias using the Cochrane risk of bias tool. We will evaluate random allocation of the subjects to the treatment groups; adequacy of allocation concealment and randomization; masking of the treatment status; intention-to-treat principles; and selective outcome reporting. We will assume a low risk of bias when RCTs meet all the quality criteria; a moderate risk of bias if at least one of the quality criteria was not met; and a high risk of bias if two or more quality criteria were not met.
We will conclude there is an unknown risk of bias for the studies with poorly reported quality criteria. For observational studies, we will evaluate strategies used to reduce selection bias; adjustments made for confounding; validity of outcome measures; and length and completeness of follow-up.
Accessed Nov. Ondo WG. Clinical features and diagnosis of restless legs syndrome and periodic limb movement disorder in adults. Silber MH. Treatment of restless legs syndrome and periodic limb movement disorder in adults.
Garcia-Borreguero D, et al. Sleep Medicine. Winkelman JW, et al. Practice guideline summary: Treatment of restless legs syndrome in adults — Report of the guideline development, dissemination and implementation subcommittee of the American Academy of Neurology. Silber MH, et al. The appropriate use of opioids in the treatment of refractory restless legs syndrome. Mayo Clinic Proceedings. Trenkwalder, et al. Comorbidities, treatment and pathophysiology in restless legs syndrome.
The Lancet Neurology. Restless legs syndrome. Genetics Home Reference. Riggin EA. All rights reserved. Always consult your doctor about your medical conditions. Use of the site is conditional upon your acceptance of our terms of use. By Editorial Team August 26, Share to Facebook Share to Twitter email print page Bookmark for later comment 0 Reactions 0 reactions. You cannot sleep nor get comfortable. It is hell. Sign up for emails from RestlessLegsSyndrome. Reactions 0 reactions.
Comments 5 comments. Sleep deprivation and other sleep conditions like sleep apnea also may aggravate or trigger symptoms in some people. Reducing or completely eliminating these factors may relieve symptoms.
The five basic criteria for clinically diagnosing the disorder are:. Individuals may be asked about frequency, duration, and intensity of symptoms; if movement helps to relieve symptoms; how much time it takes to fall asleep; any pain related to symptoms; and any tendency toward daytime sleep patterns and sleepiness, disturbance of sleep, or daytime function.
Laboratory tests may rule out other conditions such as kidney failure, iron deficiency anemia which is a separate condition related to iron deficiency , or pregnancy that may be causing symptoms of RLS. Blood tests can identify iron deficiencies as well as other medical disorders associated with RLS. Periodic limb movement of sleep during a sleep study can support the diagnosis of RLS but, again, is not exclusively seen in individuals with RLS. Diagnosing RLS in children may be especially difficult, since it may be hard for children to describe what they are experiencing, when and how often the symptoms occur, and how long symptoms last.
Pediatric RLS can sometimes be misdiagnosed as "growing pains" or attention deficit disorder. RLS can be treated, with care directed toward relieving symptoms. Moving the affected limb s may provide temporary relief. Sometimes RLS symptoms can be controlled by finding and treating an associated medical condition, such as peripheral neuropathy, diabetes, or iron deficiency anemia. Iron supplementation or medications are usually helpful but no single medication effectively manages RLS for all individuals.
Trials of different drugs may be necessary. In addition, medications taken regularly may lose their effect over time or even make the condition worse, making it necessary to change medications. Lifestyle changes. Certain lifestyle changes and activities may provide some relief in persons with mild to moderate symptoms of RLS. These steps include avoiding or decreasing the use of alcohol and tobacco, changing or maintaining a regular sleep pattern, a program of moderate exercise, and massaging the legs, taking a warm bath, or using a heating pad or ice pack.
There are new medical devices that have been cleared by the U. Aerobic and leg-stretching exercises of moderate intensity also may provide some relief from mild symptoms. For individuals with low or low-normal blood tests called ferritin and transferrin saturation, a trial of iron supplements is recommended as the first treatment.
Iron supplements are available over-the-counter. A common side effect is upset stomach, which may improve with use of a different type of iron supplement.
Because iron is not well-absorbed into the body by the gut, it may cause constipation that can be treated with a stool softeners such as polyethylene glycol. Others may require iron given through an IV line in order to boost the iron levels and relieve symptoms. Anti-seizure drugs.
Anti-seizure drugs are becoming the first-line prescription drugs for those with RLS. The FDA has approved gabapentin enacarbil for the treatment of moderate to severe RLS, This drug appears to be as effective as dopaminergic treatment discussed below and, at least to date, there have been no reports of problems with a progressive worsening of symptoms due to medication called augmentation.
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