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Cochrane Database Syst Rev. 2013 Sep 9;(9):CD007510. doi: 10.1002/14651858.CD007510.pub3.

Botulinum toxin for masseter hypertrophy.

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UKCC (Bahrain Branch), The Cochrane Collaboration, Box 25438, Awali, Bahrain.



Benign masseter muscle hypertrophy is an uncommon clinical phenomenon of uncertain aetiology which is characterised by a soft swelling near the angle of the mandible. The swelling may on occasion be associated with facial pain and can be prominent enough to be considered cosmetically disfiguring. Varying degrees of success have been reported for some of the treatment options for masseter hypertrophy, which range from simple pharmacotherapy to more invasive surgical reduction. Injection of botulinum toxin type A into the masseter muscle is generally considered a less invasive modality and has been advocated for cosmetic sculpting of the lower face. Botulinum toxin type A is a powerful neurotoxin which is produced by the anaerobic organism Clostridium botulinum and when injected into a muscle causes interference with the neurotransmitter mechanism producing selective paralysis and subsequent atrophy of the muscle.This review is an update of a previously published Cochrane review.


To assess the efficacy and safety of botulinum toxin type A compared to placebo or no treatment, for the management of benign bilateral masseter hypertrophy.


We searched the following databases from inception to April 2013: the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (via PubMed); EMBASE (via; Web of Science; CINAHL; Academic Search Premier (via EBSCOhost); ScienceDirect; LILACS (via BIREME); PubMed Central and Google Scholar (from 1700 to 19 April 2013). We searched two bibliographic databases of regional journals (IndMED and Iranmedex) which were expected to contain relevant trials. We also searched reference lists of relevant articles and contacted investigators to identify additional published and unpublished studies.


Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing intra-masseteric injections of botulinum toxin versus placebo administered for cosmetic facial sculpting in individuals of any age with bilateral benign masseter hypertrophy, which had been self-evaluated and confirmed by clinical and radiological examination were considered for inclusion. We excluded participants with unilateral or compensatory contralateral masseter hypertrophy resulting from head and neck radiotherapy.


Two review authors independently screened the search results. For future updates, two authors will independently extract data and assess trial quality using the Cochrane risk of bias tool. Risk ratios (RR) and corresponding 95% confidence intervals (CI) will be calculated for all dichotomous outcomes and the mean difference (MD) and 95% CI will be calculated for continuous outcomes.


We retrieved 683 unique references to studies. After screening these references 660 were excluded for being non-applicable. We assessed 23 full text articles for eligibility and all of these studies were excluded from the review.


We were unable to identify any RCTs or CCTs assessing the efficacy and safety of intra-masseteric injections of botulinum toxin for people with bilateral benign masseter hypertrophy. The absence of high level evidence for the effectiveness of this intervention emphasises the need for well-designed, adequately powered RCTs.

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