• Adriana Soares, Régis B Andriolo, Alvaro N Atallah, and Edina M K da Silva.
• Department of Medicine, Universidade Federal de São Paulo, Belo Horizonte, Brazil. adrianapacosoares@hotmail.com.
• Cochrane Db Syst Rev. 2012 Jan 1;4:CD007533.

BackgroundMyofascial pain syndrome (MPS) is a regional muscular pain syndrome characterised by the presence of trigger points, which are painful points in one or more muscles. The pain can be felt at the site where the trigger point is located or it can be felt away from that place when the muscle is pressed (referred pain). Botulinum toxin is a protein produced by the bacterium Clostridium botulinum and is a potent neurotoxin that eventually inhibits muscle contractions. It is capable of selectively weakening painful muscles and interrupting the pain cycle.ObjectivesTo assess the effectiveness and safety of botulinum toxin in treating MPS, excluding MPS in neck and head muscles.Search MethodsThe search strategy was composed of terms for myofascial pain and botulinum toxin. We searched the Cochrane Pain, Palliative and Supportive Care (PaPaS) Review Group's Specialised Register until December 2011, CENTRAL (Cochrane Database of Systematic Reviews 2011, Issue 4), PUBMED (from 1966 to 2011), EMBASE (from 1980 to 2011) and LILACS (from 1982 to 2011). There was no language restriction.Selection CriteriaWe included randomised controlled trials (RCTs) involving botulinum toxin for treating participants with MPS. We excluded studies with MPS of the neck and head from this review, as they have already been assessed in existing systematic reviews. We considered a diagnosis of MPS to be based on the identification of trigger points in the taut band through palpation of sensitive nodules, local twitch response and specific patterns of referred pain associated with each trigger point.Data Collection And AnalysisTwo review authors independently screened identified studies, extracted data, assessed trial quality and analysed results using the Cochrane PaPaS Review Group criteria.Main ResultsFour studies with a total of 233 participants, comparing botulinum toxin A (BTXA) with placebo, met the inclusion criteria. In one study with 145 participants, a significant improvement rate of pain intensity scores, as shown by the mean difference (MD) of -0.23 (95% confidence interval (CI) -0.26 to -0.20; P value < 0.00001) and duration of daily pain (MD -1.11; 95% CI -1.37 to -0.85; P value < 0.00001), was demonstrated when comparing BTXA with placebo. The three other studies showed that there was no statistically significant difference between BTXA and placebo in pain intensity.Authors' ConclusionsThere is inconclusive evidence to support the use of botulinum toxin in the treatment of MPS based on data from four studies with a total of 233 participants, which we considered adequate to be included in this review. Meta-analyses were not possible due to the heterogeneity between studies. We suggest that in future studies the same methodology to assess pain, a standardised dose of treatment, follow-up of at least four months (to observe the maximum/minimum curve of the drug effect) and appropriate data presentation should be used. More high-quality RCTs of botulinum toxin for treating MPS need to be conducted before firm conclusions on its effectiveness and safety can be drawn.

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