Table 12Migraine prevention (50% or more reduction) with off-label pharmacologic treatments versus placebo in adults with episodic migraine, results from individual randomized controlled clinical trials

Active Drug, Weeks From Randomization to Time to Measure OutcomeReferenceSample% With Outcome With Active Drug [Placebo]Relative Risk (95% CI)Absolute Risk Difference (95% CI)Number Needed to Treat (95% CI)Attributable Events per 1,000 Treated (95% CI)Risk of BiasDirectConsistencyPrecisionStrength of Evidence
Acetazolamide
12 weeks
Vahedi, 20021175330.8 [33.3]0.9 (0.4 to 2.0)−0.03 (−0.28 to 0.23)NSNSLowYesNAImpreciseLow
Carbamazepin
6 weeks
Rompel, 19701189654.2 [10.4]5.2 (2.2 to 12.4)0.44 (0.27 to 0.60)2 (2 to 4)438 (272 to 603)MediumYesNAImpreciseLow
Lamotrigine
20 weeks
Gupta, 20079912046.0 [34.0]1.4 (0.9 to 2.2)0.13 (−0.04 to 0.31)NSNSLowYesNAImpreciseLow
Oxcarbazepine
15 weeks
Silberstein, 200811917032.9 [36.5]0.9 (0.6 to 1.4)−0.04 (−0.18 to 0.11)NSNSLowYesNAImpreciseLow
Valproate
12 weeks
Jensen, 19941208639.5 [14.0]2.8 (1.2 to 6.5)0.26 (0.08 to 0.43)4 (2 to 13)256 (77 to 435)MediumYesNAImpreciseLow
Acebutolol
12 weeks
Nanda, 19781218630.2 [4.7]6.5 (1.6 to 27.1)0.26 (0.10 to 0.41)4 (2 to 10)256 (105 to 407)MediumYesNAImpreciseLow
Alprenolol
6 weeks
Ekbom, 19751226633.3 [36.4]0.9 (0.5 to 1.8)−0.03 (−0.26 to 0.20)NSNSMediumYesNAImpreciseLow
Atenolol
12 weeks
Forssman, 19831234833.3 [0.0]17.0 (1.0 to 278.9)0.33 (0.14 to 0.53)3 (2 to 7)333 (140 to 527)MediumYesNAImpreciseLow
Nadolol
12 weeks
Freitag, 19841243225.0 [0.0]4.7 (0.3 to 75.0)0.25 (0.02 to 0.48)4 (2 to 45)250 (22 to 478)LowYesNAImpreciseLow
Amitriptyline
16 weeks
Couch, 201112539124.2 [24.4]1.0 (0.7 to 1.4)0.00 (−0.09 to 0.08)NSNSMediumYesNAImpreciseLow
Amitriptyline
4 weeks (≥75% improvement in headache)
Couch, 19761267343.2 [19.4]2.2 (1.0 to 4.8)0.24 (0.03 to 0.44)4 (2 to 31)238 (33 to 443)MediumYesNAImpreciseLow
Tonabersat
12 weeks
Goadsby, 200912712440.7 [36.9]1.1 (0.7 to 1.7)0.04 (−0.13 to 0.21)NSNSLowYesNAImpreciseLow
Lisinopril
12 weeks
Schrader, 200112812023.3 [0.0]29.0 (1.8 to 475.4)0.23 (0.12 to 0.34)4 (3 to 8)233 (124 to 343)LowYesNAImpreciseLow
Candesartan
12 weeks
Tronvik, 200312912038.3 [3.3]11.5 (2.8 to 46.6)0.35 (0.22 to 0.48)3 (2 to 5)350 (219 to 481)LowYesNAImpreciseLow
Nifedipine
4 weeks
Shukla, 19951307255.6 [11.1]5.0 (1.9 to 13.2)0.44 (0.25 to 0.64)2 (2 to 4)444 (252 to 637)MediumYesNAImpreciseLow
Dihydroergotamine
20 weeks
Pradalier, 20049038460.9 [56.0]1.1 (0.9 to 1.3)0.05 (−0.05 to 0.15)NSNSLowYesNAImpreciseLow
Lisuride
12 weeks
Somerville, 197613115037.3 [25.3]1.5 (0.9 to 2.4)0.12 (−0.03 to 0.27)NSNSMediumYesNAImpreciseLow
Flurbiprofen
8 weeks
Solomon, 19931324669.6 [30.4]2.3 (1.2 to 4.5)0.39 (0.13 to 0.66)3 (2 to 8)391 (125 to 657)MediumYesNAImpreciseLow
Indomethacin
4 weeks
Anthony, 1968913831.6 [26.3]1.2 (0.4 to 3.3)0.05 (−0.24 to 0.34)NSNSMediumYesNAImpreciseLow
Rofecoxib
12 weeks
Visser, 200413317522.0 [9.5]2.3 (1.1 to 5.0)0.12 (0.02 to 0.23)8 (4 to 53)125 (19 to 230)MediumYesNAImpreciseLow
Tolfenamic Acid
10 weeks
Mikkelsen, 19821346245.2 [6.5]7.0 (1.7 to 28.3)0.39 (0.19 to 0.58)3 (2 to 5)387 (192 to 582)MediumYesNAImpreciseLow
Aspirin
240 weeks (ever having migraine attack)
Buring, 1990135220716.0 [7.4]0.8 (0.7 to 0.9)−0.01 (−0.02 to −0.01)−70 (48 to 131)−14 (8 to 21)LowYesNAImpreciseLow
Montelukast
12 weeks
Brandes, 200413617724.2 [21.8]1.2 (0.7 to 2.0)0.0 (−0.09 to 0.16)NSNSLowYesNAImpreciseLow

CI = confidence interval; NA = Not applicable; NS= not significant

Number needed to treat and number of attributable events were calculated for statistically significant differences

Bold = significant differences when 95% CI of absolute risk difference do not include 0.

From: Results

Cover of Migraine in Adults: Preventive Pharmacologic Treatments
Migraine in Adults: Preventive Pharmacologic Treatments [Internet].
Comparative Effectiveness Reviews, No. 103.
Shamliyan TA, Kane RL, Taylor FR.

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