The Consensus on restless legs syndrome is an effort of neurologists from several Brazilian states, which tirelessly reviewed the literature of recent years in search of evidence, both in regard to diagnosis and treatment, according to the Oxford Centre for Evidence-based Medicine.
restless leg; diagnostic criteria; treatment
| ( 1 ) The need or urge to move the legs, usually accompanied by discomfort or annoyance |
| ( 2 ) Symptoms are worse or exclusively present at rest or inactivity: sitting or lying |
| ( 3 ) Relieving symptoms totally or partially with the movement |
| ( 4 ) The perceived symptoms during rest and inactivity worsen or occur exclusively at night |
| ( 5 ) The above symptoms are not better explained by other diseases or conditions |
| Support Criteria for the Diagnosis of Restless Legs Syndrome |
| Positive family history |
| Clinical course |
| Positive response to dopaminergic agonist |
| High PLM index on PSG |
| Remarks |
| Eventually the need and/or urge to move the legs may be present without the associated symptoms. Involvement of other areas of the body like the upper limbs . |
| For children , the description of these symptoms should be taken by their own words. |
| When symptoms are very pronounced, relief for the activity can not be perceived , but was previously present. |
| When symptoms are very intense , worse at night can not be observed but should be previously present. |
| Conditions that mimic RLS often have been confused with this syndrome, particularly in epidemiological surveys and RLS can also be present with them. |
| The criterion of clinical symptoms does not apply to pediatric cases and even some cases of RLS in pregnancy as those caused or induced by drugs, in which the frequency can be high but limited to the duration of the predisposing condition. |
| Inquietação, incômodo | Queimação, calor |
| Irritação | Choque |
| Fisgada, picada | Estrangulamento, contração |
| Dormência | Dor, dor no osso, dor “no fundo” |
| Cansaço | Angústia, ansiedade, desespero, aflição, tensão |
| Coceira, comichão | Sensação de pernas nervosas |
| Formigamento, “formigação” | “Ruindade” |
| Sensação de peso | “Cãibras” |
| Repuxamento | Pinicar, “pinicamento” |
| Vontade de não ficar quieto | Friagem nos ossos |
| Cócega | Regionalmente |
| Vontade de espichar | “Farnizim” |
| “Um bicho dentro da perna” | “Gastura” |
| Restlessness, nuisance |
| Irritation |
| Sting |
| Numbness |
| Tiredness |
| Itching |
| Tingling |
| Heaviness |
| Desire to move |
| Tickle |
| Willingness to broach |
| A critter inside leg |
| Burning, heat |
| Shock |
| Strangulation, contraction |
| Pain, bone pain, pain “in the background” |
| Distress, anxiety, despair, grief, tension |
| Feeling nervous legs |
| Badness |
| Cramps |
| Chill in the bones |
| “Farnizim” |
| “Gastura” |
| Insomnia | Vascular insifficiency |
| Renal failure | Iron deficiency anemia |
| Hepatic failure | Use of alcohol |
| COPD | Use of caffeine |
| Fibromyalgia | Medicines |
| Multiple Sclerosis | Metoclopramide |
| Parkinson’s disease | Antihistamines |
| Charcot-Marie type II | Lithium carbonate |
| Gastrectomy or bariatric surgery | Neuroleptic dopamine antagonists |
| Gestation | Antidepressants (except bupropion) |
| Rheumatoid arthritis | Levothyroxine |
| Agent | Study | N | Duration | Dose* (mg) | Parameter# |
|---|---|---|---|---|---|
| Pramipexole | Ferini-Strambi et al., 200818 | 357 | 12 weeks | 0.75 | IRLS, QoL, MOS |
| Inoue et al., 201019 | 41 | 6 weeks | 0.75 | IRLS, MPM, PGI, CGI, PSQI | |
| Montagna et al., 201120 | 402 | 12 weeks | 0.75 | IRLS | |
| Montplaisir et al., 199921 | 10 | 4 weeks | 1.5 | MPM, AS | |
| Oertel et al., 200722 | 338 | 6 weeks | 0.75 | IRLS, CGI, PGI | |
| Partinen et al., 200623 | 86 | 3 weeks | 0.75 | IRLS, CGI | |
| Winkelman et al., 200624 | 339 | 12 weeks | 0.75 | IRLS, CGI, QoL | |
| BI 248.616, 200825 | 376 | 6 weeks | 0.25 | IRLS, CGI, PGI | |
| Pergolide | Earley et al., 199826 | 16 | 18 days | 0.65 | MPM, ES, SA |
| Pieta et al., 199827 | 8 | 10 days | 2.5 | PLM, SE, SA | |
| Trenkwalder et al., 200411 | 83 | 48 weeks | 0.75 | IRLS, PLM, SE, PGI | |
| Wetter et al. 199928 | 28 | 4 weeks | 0.75 | MPM, TTS, AS | |
| Bromocriptine | Walters et al., 198829 | 6 | 4 weeks | 7.5 | SA, PLM, TST |
| Lisuride | Benes et al., 200514 | 153 | 12 weeks | 10 mg/48h | IRLS, CGI, MPM |
| Benes et al., 200817 | 231 | 12 weeks | 7.5mg/48h** | IRLS, CGI, PLM | |
| Cabergoline | Stiasny-Kolster et al., 200430 | 80 | 5 weeks | 0.5–2 | IRLS |
| Oertel et al., 200631 | 43 | 5 weeks | 2.0 | IRLS, PLM, QoL | |
| Trenkwalder et al., 200732 | 204 | 30 weeks | 2–3## | IRLS, CGI, QoL |
| Drug | Recommended |
|---|---|
| Pramipexole | Recommended |
| Piribedil | Optional |
| Bromocriptine | Contraindicated |
| Cabergoline | Optional |
| Pergolide | Contraindicated |
| Lisuride | Optional |
| Treatment | Selected articles | Number of patients/controls | Doses (mg) | Recomendations |
|---|---|---|---|---|
| Gabapentin | 2 | 30/22 | 300-2,400 | I B |
| Garcia-Borreguero D et al., 2002 | 22/22 | 600-2,400 | ||
| Svenja H, et al., 2003 | 8/0 | 300 | ||
| Gabapentin (IRC) | 2 | 31/16 | 125-300 | I B |
| Thorp ML et al., 2001 | 16/16 | 200-300 | ||
| Micozkadioglu H et al., 2004 | 15/0 | 125-200 | ||
| Pregabalin | 3 | 144/51 | 50-450 | I B |
| Allen R et al., 2010 | 114/23 | 50-450 | ||
| Garcia-Borreguero D et al., 2010 | 30/28 | 150-450 | ||
| Pregabalin (neuropathy) | 1 | 16/0 | 150-600 | I B |
| Sommer M et al., 2007 | 16/0 | 150-600 |
| Treatment | Original articles | n pat/control | Total dose (mg) | Recomendation |
|---|---|---|---|---|
| Lauerma H & Markkula J., 1999 | 12 | Tramadol (50-150) | III C | |
| Walters A et al., 1993 | 11 (x-over) | Oxycodone (5-20) | II B | |
| Walters A et al., 2001* | 36/0 | Codeíne (30-120) Di-hidrocodeíne (60-240) Methadone (10-40) Oxycodone (5-20) Tilidine (25-100) Propoxyphene (65-260) | IV C | |
| Ondo WO, 2005 | 27/0 | Methadone (5-40) | IV C | |
| Silver et al., 2011* | 76/0 | Methadone (5-40) | IV C |
| Opioids | Total dose (mg) 1-4 x day | Adverse effects |
|---|---|---|
| Codeine | 30-1204 | constipation, sedation, possible risk for development or worsening of sleep respiratory disturbances, risk of abuse in predisposed patients4 (lower risk of augmentation than dopaminergic agents6,7). |
| Di-hidrocodeine | 60-2404 | |
| Metadone | 5-405,6 | |
| Oxicodone | 5-203,4 | |
| Propoxifen | 65-2604 | |
| Tilidine | 25-1004 | |
| Tramadol | 50-1501 | |
| 100-4002 |
| Place and date | Authors | Number | Age | Prevalence (%) | GIESPI criteria | Pain growth | Girls predominance | Quality of life | Sleep quality |
|---|---|---|---|---|---|---|---|---|---|
| Canada, 2000 | Laberge et al. | 1353 | 6-16 | 31.7 | Adults | NFF | Yes | Anxiety | Normal |
| Germany, 2003 | Kinkelbur et al. | 084 | 6-17 | 1.3 | No | NFF | No | No | No |
| USA, 2004 | Kotagal & Silber | 38 | < 18 yo | 5.9 | Yes | Yes | No | Chronic fatigue | Insomnia |
| USA and UK, 2007 | Pichietti et al. | 0523 | 8-17 | 2 | Yes | Yes | No | Bad humor, lack of energy, attention deficit | Insomnia |
| Brazil, 2009 | Sander et al. | 83 | 5-16 | 6.3 | Yes | No | Yes | Peds QL | QCS |
| Turkey, 2011 | Yilmaz et al. | 304 | 15-18 | 3.6 | Yes | NFF | Yes | Yes | Yes |
| Turkey, 2011 | Turkdogan et al. | 346 | 10-19 | 2.7 | Yes | Yes | No | Yes | Yes |
| Drug | Dose | Level of evidence | Main indication |
|---|---|---|---|
| Iron replacement | 50-60 ng of iron 1-2x/day | IIb | Primary RLS; ferritin lower than 50 ng/dl |
| Sodium valproate | 30-60 mg/kg/d | IIb | Comorbidity with epilepsy |
| Carbamazepine | 10-30 mg/kg/d | IIb | Comorbidity with epilepsy |
| Gabapentin | 100-500 mg | IIb | Comorbidity with epilepsy and chronic pain |
| Clonazepan | 0.01 mg/kg | IIb | Comorbidity with epilepsy or parassomnia |
| Clonidine | 0.05-0.3 mg | IIb | Comorbidity with ADHD |
| Levodopa | 25/100mg | IIb | Primary RLS with risk of augmentation |
| Pramipexole | 0.125-0.75 mg | IIb | Primary RLS with risk of augmentation |
| Opioids | III |
