This study aimed to assess the outcome of topiramate in migraine prophylaxis in adult Sudanese covered 32 study participants; three quarters of them 24(75%) were below 40 years in age and none above 55, with female predominance by 27(84%). Similarly, to previously describe by Kjersti Grøtta Vetvik etal that Migraine prevalence initially increases with age, with peak prevalence between 30–39 years, followed by gradual decline over subsequent years in both sexes. After puberty, the sex ratio increases, and women are two to three times more likely to have migraines than men. (4) And by also similar to K´atia M. Martins Etal were Migraineurs were mainly women (81.6%). Just 18.4% were men. (5) Nearly third of the participants were housewives 10(31%) and 6(19%) were employee. And almost half of them 15(47%) were married. Corresponding to Twadud Ali study finding in A total of 40 Sudanese patients with migraine ((75%) as females and (25%) as males, the majority of them 18(45%) were found in age group 30 – 39 years and (62%) were married .(6)
Concerning the factors triggers their headache the study found that nearly half of them 15(47%) triggered by weather changes, 13(41%) menstruation, 12(38%) missing meal, 10(31%) stress, 6(19%) exercise, 3(9%) computer use. While food content factor such as 8(25%) cheese, 5(16%) caffeine and 4(13%) chocolate. similar results was by J. Holzhammer etal : The most common trigger factors experienced by the patients were weather (82.5%), stress (66.7%), menstruation (51.4%) and relaxation after stress (50%) (7) and Fukui etal: The most common triggers for patients are stress/tension, premature eating, fatigue and lack of sleep; triggers are weather, smell, smoke and light. (8) And While Variable results was in a study of triggers factors of migraine which list: at least one dietary trigger, fasting was the most frequent one, followed by alcohol and chocolate. Hormonal factors accounted for 53%, of which premenstrual period was the most common trigger, 13% of physical activity caused migraine, 2.5% of sexual activity and 64% of emotional stress as triggers. 81% cited some sleep problems as triggers. Regarding environmental factors, smells were reported by 36.5%.(9) Regarding family history of migraine headache among the participants; 13(41%) of them has a positive family history. The role of heredity in migraine has been a major focus of clinical and research interest for years. Because minimal data are available and contradictory findings as well as methodological inadequacies characterize most of the genetic studies, the genetic assumption is tentative at best. (10) Migraine without aura seems to be caused by a combination of genetic and environmental factors, while migraine without aura may be primarily or entirely genetic.(11) In more detailed history about the characteristics of headache; our study found more than half of the participants 17(53%) was suffer from headache > 24 months, 7(22%) 12-24 months, 6(19%) 6-12 months and the rest 2(6%) <6months. most of them 26 (81%) used the OTC medications in the acute pain headache. While there are many daily activities inhibited by the migraine pain, the most common was affected in almost three quarter of them 23(72%) sleep, followed by 17(53%) relationships, 16(50%) both work and eating. similarly A survey has shown that among the millions of Canadians suffering from headaches adverse effects on relationships with family, friends and colleagues are common. Headaches also result in significant limitations in activity and lead to avoidance behaviors. (12) And Worldwide studies have shown that more than 50% of patients report disability severe enough to lead to decreased productivity in some of the most important aspects of life – work, school, and home.(13)
Regarding details of topiramate dosage the study found that 25(78%) was on 50 mg daily, 7(22%) was on 100 mg daily. While their period of topiramate usage was distributed as follow: 10(31%) 3months,9 (28%) 6months, 7(22%) 4month and 6(19%) 5months. According Pharmacological management of migraine guidelines issued in February 2018 Topiramate (50–100 mg daily) is recommended as a prophylactic treatment for patients with episodic or chronic migraine and should be used for at least three months at the maximum tolerated dose before deciding if it is effective or not. (14)
The aim of prophylaxis is to reduce the frequency, severity and duration of migraine attacks and to prevent the development of medication overuse.(15) In our study the overall reduction rate in frequency was (48%), while the Mean of frequency of attacks was (6.1 at baseline to 3.2) per month, in severity mean was 6.9 turn to 5. A result is very close to Mei, D. et al where given at the dose of 100 mg/day, in the prophylactic treatment of recorded a significant reduction in the frequency of migraine crises (from 5.26 at base-line to 2.60)in 4 weeks duration.(16)
Reduction in of attacks was as follow reduction ≥50% was in 17(53%) , Frequency Reduction 25% - 49% 13( 41%) and only in 2(6%) Reduction was less than < 25%. As Migraine can have considerable impact on quality of life and daily function. Modest improvements in the frequency or severity of migraine headaches may provide considerable benefits. Within trials, a reduction in migraine headache severity and/or frequency of 30–50% is regarded as a successful outcome.(14) Paired Samples Test used for difference in frequency in attacks was (p value < 0000) and for severity before and after topiramate was also (p value < 0000) indicating that torpiramate is effective in migraine prophylaxis. similar to Von Seggern etal, study in which frequency of headaches at the start of topiramate (baseline) and at all subsequent visits up to 24 weeks, declined significantly from baseline to end of treatment (10.68.4 to 7.47.7, respectively; P0.0004). (17)
In Adverse effect frequency, our study found that (15.6%) didn’t complain of any adverse effect, while the biggest shares (43.8%) have only one adverse effect. While Concerning Adverse effects by study participants due to topiramate ; more than third (38%)experienced weight loss , (22%) both Abdominal/GIT symptoms and Dizziness, (16%) mood changes, 4(13%) both parathesia and decreased memory, 3(9%) both Anorexia and sleepiness and only 1(3%) Taste changes. Linde M etal conducted a systematic review in trials of topiramate against placebo, seven adverse events (AEs) were reported by at least three studies. These were usually mild and of a non-serious nature. Except for dysgeusia and weight loss, there were no significant differences in the total AE or the incidence of 7 specific AEs between placebo and topiramate 50 mg. The frequency of AEs in general and all specific AEs except nausea is significantly higher on Topiramate 100.(18) Moreover other study reveled that Topiramate 100 mg daily was associated with a higher rate of adverse events than placebo, although these were mild to moderate. Side effects include nausea, paresthesias, anorexia, and weight loss. Cognitive side effects are common, vary in severity, are usually dose-dependent, and usually determine drug tolerability. Depression is also a common side effect. (14) James Adelman et al. % Placebo group]). Fatigue (5%), nausea (2%) and difficulty concentrating (2%). Compared with placebo, the average body weight of patients treated with topiramate was significantly lower.(19)
The study had some limitations. The relatively limited number of study participant (32 study participants from one study area only) may affect negatively the probability of found more significant outcome among patient receiving topiramate for migraine in other Sudanese hospitals. Another limitation, follow up. Some outcomes – such as long term outcome or the presence of long term effect and / or adverse effect - may need to be followed overtime for longer period. So, a long term prospective cohort follow up design may be useful for more detailed description for the confirmatory practices.