This systematic review investigated the effectiveness and safety of
botulinum toxin type A (BTX-A) for painful
temporomandibular disorders. We searched for randomized controlled trials (RCTs) in 10 databases, from inception to February 12, 2019 (MEDLINE, EMBASE, CENTRAL, LILACS, BBO, Web of Science, Scopus, ClinicalTrials.gov, WHO and OpenGrey). We included 12 RCTs that compared BTX-A versus inactive or active interventions. BTX-A was slightly more effective than placebo for
pain reduction at 1 month: mean difference -1.74 points (0-10 scale), 95% confidence interval -2.94 to -.54, 3 RCTs, 60 participants, I-square (I2) = 0%. However, there were no significant differences at 3 and 6 months. BTX-A was similar to no treatment for
pain reduction at 3 and 6 months. BTX-A was more effective than conventional treatment and
low-level laser therapy for
pain reduction at 1, 6, and 12 months, but less effective than facial manipulation for
pain reduction at 3 months. BTX-A was not associated with a significant increase in the risk of adverse events. The quality of the evidence was low, and results are insufficient to support the use of BTX-A for painful
temporomandibular disorders. High-quality RCTs are needed to increase confidence in effect estimates. PERSPECTIVE: BTX-A for painful
temporomandibular disorders appears to be well tolerated. For
pain reduction, BTX-A is slightly more effective than placebo only at 1 month; conventional treatment and low-level
laser at 1, 6, and 12 months. Low-quality evidence limits the applicability of these findings and precludes recommendations for practice.