A randomized, masked placebo-controlled crossover single-center trial was conducted to explore the safety and efficacy of topically applied timolol (β-blockers) maleate eyedrops in comparison with topically applied placebo eyedrops in treating attacks of acute migraine.
Timolol maleate ophthalmic solution is
effective in aborting acute migraine attacks.
A randomized, masked
placebo-controlled crossover single-center trial was conducted to explore
the safety and efficacy of topically applied timolol (β-blockers)
maleate eyedrops in comparison with topically applied placebo eyedrops in
treating attacks of acute migraine.
From 27 May 2015 to 28 August 2017, a trial was carried out that recruited 50 migraine patients [42 (84%) were females, mean age 27.3 years]. Participants were randomized to either timolol eyedrops 0.5% group, or a placebo eyedrop (carboxymethyl cellulose, 0.5%) group. Following a three-month treatment period, participants fulfilled a one-month washout period. Participants were crossed over and then received the opposite therapeutic regimen for a final three months.
On a modified intent-to-treat basis, the analysis was conducted. Following random allocation, the participants were given instructions to use one drop of the assigned medicine in each eye at the earliest migraine onset. The decline in pain score by four points, or to zero, 20 minutes after instilling the eyedrop was the primary study outcome.
Notably, out of 619 attacks, 284 (46%) attacks were managed with timolol, 271 (44%) attacks were managed with the placebo. The remaining 64 attacks (10%) occurred during the washout when no study medicines were utilized. Overall, seven patients (14%) withdrew from the study after randomization.
Overall, the timolol-managed attacks were linked with a substantial decline in pain score by four points, or to zero, at 20 minutes in comparison with placebo-treated attacks, as depicted below:
According to a generalized estimating equation analysis, the pain score decline at 20 minutes was higher in the timolol arm in comparison with the placebo group by a mean (Standard error) of 4.63 points (0.34).
Topically applied β-blockers display fewer noxious effects, and may an effective and inexpensive therapeutic to abort migraine attacks. Utilizing such agents can at least theoretically eradicate confounding factors such as elevated first-pass metabolism.
It holds the promise to be a welcome addition to existing therapeutics for abortive pharmacotherapy of acute migraine. Additional research should focus on assessing whether the improvements witnessed are sustained for a longer follow-up period and with larger groups at multiple sites.
For short-term acute treatment of migraine,
topical applied timolol maleate ophthalmic solution
(0.5%) eyedrops were found to be
effective in lowering pain scores 20 minutes
after instillation in comparison with placebo.
JAMA ophthalmology
Short-term Efficacy and Safety of Topical β-Blockers (Timolol Maleate Ophthalmic Solution, 0.5%) in Acute Migraine A Randomized Crossover Trial
Abraham Kurian et al.
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