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Miorelaksansi za liječenje boli u reumatoidnom artritisu

Abstract

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Background

Pain management is a high priority for patients with rheumatoid arthritis (RA). Muscle relaxants include drugs that reduce muscle spasm (for example benzodiazepines such as diazepam (Valium), alprazolam (Xanax), lorazepam (Ativan) and non‐benzodiazepines such as metaxalone (Skelaxin) or a combination of paracetamol and orphenadrine (Muscol)) and drugs that prevent increased muscle tone (baclofen and dantrolene). Despite a paucity of evidence supporting their use, antispasmodic and antispasticity muscle relaxants have gained widespread clinical acceptance as adjuvants in the management of patients with chronic musculoskeletal pain.

Objectives

The aim of this review was to determine the efficacy and safety of muscle relaxants in pain management in patients with RA. The muscle relaxants that were included in this review are the antispasmodic benzodiazepines (alprazolam, bromazepam, chlordiazepoxide,cinolazepam, clonazepam, cloxazolam, clorazepate, diazepam, estazolam, flunitrazepam, flurazepam, flutoprazepam, halazepam, ketazolam, loprazolam, lorazepam, lormetazepam, medazepam, midazolam, nimetazepam, nitrazepam, nordazepam, oxazepam, pinazepam, prazepam, quazepam, temazepam, tetrazepam, triazolam), antispasmodic non‐benzodiazepines (cyclobenzaprine, carisoprodol, chlorzoxazone, meprobamate, methocarbamol, metaxalone, orphenadrine, tizanidine and zopiclone), and antispasticity drugs (baclofen and dantrolene sodium).

Search methods

We performed a search of the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 4th quarter 2010), MEDLINE (1950 to week 1 November 2010), EMBASE (Week 44 2010), and PsycINFO (1806 to week 2 November 2010). We also searched the 2008 to 2009 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) abstracts and performed a handsearch of reference lists of relevant articles.

Selection criteria

We included randomised controlled trials which compared a muscle relaxant to another therapy (active, including non‐pharmacological therapies, or placebo) in adult patients with RA and that reported at least one clinically relevant outcome.

Data collection and analysis

Two blinded review authors independently extracted data and assessed the risk of bias in the trials. Meta‐analyses were used to examine the efficacy of muscle relaxants on pain, depression, sleep and function, as well as their safety.

Main results

Six trials (126 participants) were included in this review. All trials were rated at high risk of bias. Five cross‐over trials evaluated a benzodiazepine, four assessed diazepam (n = 71) and one assessed triazolam (n = 15). The sixth trial assessed zopiclone (a non‐benzodiazepine) (n = 40) and was a parallel group study. No trial duration was longer than two weeks while three single dose trials assessed outcomes at 24 hours only. Overall the included trials failed to find evidence of a beneficial effect of muscle relaxants over placebo, alone (at 24 hrs, 1 or 2 weeks) or in addition to non‐steroidal anti‐inflammatory drugs (NSAIDs) (at 24 hrs), on pain intensity, function, or quality of life. Data from two trials of longer than 24 hours duration (n = 74) (diazepam and zopiclone) found that participants who received a muscle relaxant had significantly more adverse events compared with those who received placebo (number needed to harm (NNTH) 3, 95% CI 2 to 7). These were predominantly central nervous system side effects, including dizziness and drowsiness (NNTH 3, 95% CI 2 to 11). 

Authors' conclusions

Based upon the currently available evidence in patients with RA, benzodiazepines (diazepam and triazolam) do not appear to be beneficial in improving pain over 24 hours or one week. The non‐benzodiazepine agent zopiclone also did not significantly reduce pain over two weeks. However, even short term muscle relaxant use (24 hours to 2 weeks) is associated with significant adverse events, predominantly drowsiness and dizziness.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Plain language summary

Lijekovi za opuštanje mišića (miorelaksansi) za liječenje boli u reumatoidnom artritisu

Ovaj sažetak Cochrane sustavnog pregleda predstavlja nam rezultate istraživanja o učinku miorelaksansa na bol u pacijenata s reumatoidnim artritisom.

Ovaj pregled pokazuje da u osoba s reumatoidnim artritisom:

‐ Miorelaksansi vjerojatno neće smanjiti bol ako sa uzimaju jednokratno ili u periodu do dva tjedna

‐ Zbog loše kvalitete podataka ne zna se utječu li miorelaksansi na funkciju

‐ Nije nađena nijedna studija koja procjenjuje učinak miorelaksansa na kvalitetu života

‐ Nije nađena ni jedna studija koja procjenjuje učinak antidepresiva na spavanje

‐ Zbog niske kvalitete dokaza nije sigurno utječu li miorelaksansi na raspoloženje

Nisu dostupne točne informacije o nuspojavama i komplikacijama. To osobito vrijedi za rijetke, ali ozbiljne nuspojave. Moguće nuspojave uključuju umor, mučninu, glavobolje, zamagljen vid, suhoću usta, seksualnu disfunkciju, vrtoglavicu i zatvor.Rijetke komplikacije uključuju samoubilačke (suicidalne) misli, upalu jetre i smanjen broj leukocita.

Što je reumatoidni artritis i što su miorelaksansi?

Reumatoidni artritis je stanje u kojem vlastiti imunološki sustav , koji se obično bori protiv infekcija, napada ovojnicu zglobova. Zbog toga su zglobovi otečeni, ukočeni i bolni. Obično su prvo pogođeni mali zglobovi u rukama i nogama. Trenutačno ne postoji lijek za reumatoidni artritis te je cilj terapije olakšanje boli i ukočenosti zglobova i povećati pokretljivost.

Miorelaksansi se mogu koristiti za liječenje anksioznosti i problema sa spavanjem, i neki vjeruju da mogu smanjiti bol djelujući na živce koji je uzrokuju, no to je kontroverzno pitanje. Miorelaksansi uključuju lijekove koji smanjuju grčeve mišića, na primjer benzodiazepini kao diazepam (Normabel), Xanax, Lorsilan i ne‐benzodiazepini, i lijekove koji smanjuju pojačan tonus mišića (baklofen i dantrolen).

Najbolje procjene onoga što se događa osobama s reumatoidnim artritisom koje uzimaju miorelaksanse:

Bol nakon 24 sata:

‐ Beznačajan rezultat

Bol nakon 1‐2 tjedna:

‐ Beznačajan rezultat

Prestanak terapije zbog štetnih nuspojava, nakon 2 tjedna:

‐ Beznačajan rezultat

Nuspojave:

‐ 49 od 100 osoba razvilo je nuspojave, nakon 1 do 2 tjedna od uzimanja miorelaksansa (apsolutna razlika 49%),

‐ 52 od 100 osoba koje su uzimale miorelaksanse doživjele su nuspojave,

‐ 3 od 100 ososba koje su uzele placebo doživjele su nuspojavu

Nuspojave središnjeg živčanog sustava (SŽS):

‐ 33 od 100 osoba doživjelo je nuspojavu SŽS, nakon 1 do 2 tjedna od uzimanja miorelaksansa (apsolutna razlika 33%),

‐ 39 od 100 osoba koja su uzele miorelaksanas doživjelo je nuspojavu SŽS,

‐ 6 od 100 osoba koje su uzele placebo doživjelo je nuspojavu SŽS.

Ovaj zapis treba citirati na ovaj način:

Ovo je Cochrane sustavni pregled i sažetak, koji je pripremila organizacija Cochrane, i koji je objavljen u Cochrane knjižnici, u bazi Cochrane sustavnih pregleda. Izdavač: John Wiley and Sons, Ltd. Cijeli tekst ovog pregleda dostupan je u Cochrane knjižnici (ISSN 1464‐780X).