background (PICO-chu)
Name the type of study conducted
Randomized crossover trial (BONUS: describe what this means)
Was there an appropriate and clearly focused question? Name it
Yup, can topical beta blockers treat acute migraines?
What p-value indicates that the data is statistically significant?
p </= of .05
Will this study change your current practice?
You tell us...
Besides timolol eye drops, name 2 abortive therapies for migraine headaches.
NSAIDs, -triptans, dopamine antagonists, -ergotamines, opiods
What was the intervention studied?
timolol maleate 0.5% eyedrops vs artificial tears
(BONUS: intervention was administered at earliest onset of migraine, may repeat at 20 minutes if needed. If migraine with aura, administer at onset of aura.)
What was the number of patients in each group
25 patients randomized into each group; 20 analyzed in Group A and 23 in Group B
How many/What percent of the 284 patients treated with timolol had a reduction in pain score of 4 after 20 minutes?
233 (84%)
This study is relevant for which types of medical providers?
FM and neurology
Name 2 preventative therapies for migraine headaches
B Blockers, TCA, divalproex, topiramate, methysergide, flunarizine, MAOIs, CGRP calcitonin gene related peptide inhibitors, botox
List at least 2 inclusion criteria for the study AND 2 exclusion criteria
Inclusion: >12 years old, clinical diagnosis of migraine, no antimigraine medications for at least 1 month before study.
Exclusion: taking systemic beta-blockers at baseline; diagnosis of asthma, bradyarrhythmias, cardiac dysfunction
Were comparison groups randomly allocated and similar at the start of the trial? Explain
Yup, cross over trial so participants were in both treatment and comparison groups during the study
How many/What percent of the 271 patients who had a placebo had a reduction in pain score of 4 after 20 minutes?
38 (14%)
Was there bias in study funding?
Nope
What commonly prescribed medication for women is contraindicated in patients with migraines with aura?
Oral contraceptives
What was the length of follow up?
7 months; 3 months in each treatment group and 1 month washout between
7 participants were excluded due to no post-baseline measurements, is this likey to significantly impact results?
Not much because participants were crossed over
What was the p-value in our study?
.001 BONUS: Does this RCT study support the use of timolol in acute migraine attacks? Yes!
What are advantages of topical beta-blockers such as timolol?
Non-oral route of admission (if pt have nausea/vomiting), more affordable than some other abortive options
What does CGRP stand for?
Calcitonin gene related peptide inhibitors
BONUS: What are drugs in this class? - ubrogepant and rimegapant
What was the primary outcome measured?
Reduction on pain scale by 4 points or to 0 20 minutes after administration of eye drop
(BONUS: secondary endpoint was NOT using oral rescue medication)
Name 2 limitations of the study
Single center trial looking at a single region in India
Only migraines with headache were included
Trial only assessed treatment response at 20, unknown it pain relief lasted longer
Headaches that began >20 min after onset of aura were not evaluated
What is "intention to treat?" Was there an intention to treat analysis in this case?
Intention-to-treat analysis of results of RTC is based on the initial treatment assignment and not on the treatment eventually received, it is intended to minimize effects of patients lost to follow up. Yes, it was modified with only those who had post baseline analysis
What are limitations of using topical beta-blockers such as timolol?
Can have systemic effects - e.g., bradycardia, hypotension, drowsiness, bronchospasm
How do you treat migraines in pregnancy? Name 2 drugs
Acetaminophen, Aspirin, NSAIDS in 2nd trimester before 20 weeks
BONUS: What is absolutely contraindicated for migraines in pregnancy? Ergotamines (potential to induce hypertonic uterine contractions)