Propranolol is more effective at reducing temporomandibular disorder (TMD) pain in people with migraines than in people without. This comes from a study published in Cephalalgia.
Building on the data from the SOPPRANO study (ClinicalTrials.gov identifier NCT02437383), the researchers wanted to evaluate the two objectives of the study: firstly, whether the effectiveness of propranolol is higher in people with comorbid migraines than in people without and, secondly, whether propranolol die Effectiveness for TMD pain is mediated by a decrease in headache or a change in heart rate as a result of using propranolol.
SOPPRANO was a double-blind, placebo-controlled, phase 2b, multi-site, parallel group study evaluating the analgesic efficacy of propranolol in patients with painful TMD. A total of 200 participants with chronic myogenic TMD with or without arthralgia were enrolled and then randomly assigned 1: 1 to receive either 60 mg extended-release propranolol or placebo over the course of the study period.
The primary study result was the mean weekly facial pain index results as the 7-day average of the product of mean facial pain intensity multiplied by pain duration.
Within the cohort, 87% of participants (mostly young white women) completed the follow-up at week 9; 52% met the criteria for a specific or probable migraine, and 29% and 30% of the migraineurs met the criteria for chronic migraines or migraines with aura. Demographics were generally similar between groups, except for the time since the onset of TMD – 12 years for people with migraines and 9 years for people without migraines.
Researchers analyzed efficacy as the difference between the groups in the facial pain index at week 9 and found a small difference in people with migraines (adjusted mean, -3.6; 95% confidence limit) [CL], -9.7 to 2.4), but no difference for people without. The migraines by treatment group were not statistically significant.
Another analysis of a 30% or more reduction in facial pain intensity at week 9 found that propranolol was more effective in people with migraines (adjusted odds ratio) [aOR]3.3; 95% CL, 1.4-8.1; P = 0.009; Number needed to handle [NTT]3.7) compared to people without migraines (aOR 1.3; 95% CL 0.5-3.2; P = 0.631; NNT 18.7).
The researchers observed a similar tendency for facial pain intensity to decrease by 50% or more, and found an NNT of 3.9 versus 12.5 for people with migraines versus people without (P = 0.260 for interaction). People with migraines were more likely to decrease their HIT-6 score by 6 points or more at week 9 than people without (aOR, 2.8 vs. 1.2).
The researchers identified a “negligible correlation” between the change in facial pain index and the change in HIT-6 at week 6 and week 9 (Kendall’s tau ranged from 0.09 to 0.27). Results of a causal mediation analysis with HIT-6 as a potential mediator showed a weak indirect effect of treatment on reducing the facial pain index by 50% or more (OR, 1.05; 95% CL, 0.91-1.19); Only 9% of the total effect was mediated by reducing HIT-6. In comparison, a mediation analysis using the heart rate as a potential mediator showed a stronger indirect effect (OR 1.30; 95% CL 0.86-1.74).
The limitations of the study include the lack of a daily headache diary due to the focus on TMD, the assessment of the effect of propranolol via the HIT-6 questionnaire, and results of mediation analyzes that did not reach statistical significance.
“This [randomized controlled trial] of patients with chronic myofascial TMD showed that propranolol’s effectiveness in reducing TMD pain was improved in the presence of comorbid migraine, ”the researchers concluded. “Therefore, propranolol appears to be the drug of choice for treating painful TMD [people with migraines]. ”
Tchivileva IE, Ohrbach R., Filingim RB, et al. Effect of comorbid migraines on the effectiveness of propranolol in painful TMD in a randomized controlled trial. Cephalalgia. Published online February 9, 2021. doi: 10.1177.0333102241989268
This article originally appeared on Clinical Pain Advisor