Pharmacologic class for lithobid iol in migraine and other headache disorders was recently explored (3, 6). However, we report here for the first time on efficacy of an oral formulation ketoflavone in alleviating migraine attacks; no additional side effects were observed, although two subjects developed mild gastrointestinal disturbances during the treatment period. No adverse effects were reported.
Twenty-nine migraine patients and 16 control subjects (20 females and 9 males, aged 33 ± 8 years) were recruited from the department of neurology and pain medicine at a university hospital in Berlin, Germany, from April 1998 through July 1999. All subjects underwent a medical history, physical exam, and assessment of pain, disability, nausea, and vomiting before enrollment. Two of our subjects enrolled at random, despite being excluded from analysis. They had received ketoflavones in a previous study, but they had not responded to treatment. The remainder were recruited according to screening criteria: 1) having received either a ketoflavone formulation (Ketofast; GSK) or a placebo, and 2) having pain ≤ 60 mm on the VAS. All subjects had received oral corticosteroids within the past year or were receiving at least 1 month of where to buy valium in usa treatment with Valium 5mg 90 pills US$ 290.00 US$ 3.22 a beta 1-adrenergic receptor agonist or a low-dose beta-blocker. All patients were also taking 2 or more anti–seizure medications.
The study was reviewed and approved by the ethics committee of university hospital, and written informed consent was provided. A double-blind, random design was used, with treatment assigned to each subject in accordance with the clinical trial protocol and study schedule.
Subjects received an oral dose of 3 g ketoflavone in 100-milliliters of water (mean ± SD [range] of 10 g daily; 15 daily in the ketoflavone, placebo condition) on 1 day (morning and noon) within 5 to 7 days following dosing. They were to take the dose 1 hour before breakfast on the 2nd day and a 3- to 5-day supply of the capsule. Three consecutive days of a single daily dose followed by an unscheduled morning dose were allowed.
The drug was available to be taken orally in the morning by patients during and immediately post-dose but was stopped within 1 to 2 hours after the final dose. patients were excluded if they had more than 6 migraine attacks in the previous week or if they reported taking drugs like antidepressants (e.g., venlafaxine or amitriptyline). The protocol was in compliance with the recommendations of International Conference Headache Disorders. Compliance was monitored by monitoring the medication dosage, compliance, and elimination of ketoflavone by monitoring the clinical picture physical examination and, if necessary, neuropsychologic testing.
Outcomes and primary measures.
The primary outcome was number of attacks, categorized as "light" (less than 60 mm on the visual analog scale, with buy valium in northern ireland use of the Visual Analog System [VAS]). VAS is the most widely used clinical measure for visual analog scale rating pain (17). Light attacks during the study period were distinguished by the absence or minimization of VAS scores more than or equal to 60 mm. Other primary outcome measures were the proportion of attacks rated by the VAS as "very light," "fair," "moderate," "mild," and "very severe."
Data for assessing efficacy were based on a computerized data-analytic program (Medical Statistical Tools, software package version 2.1, Lassen Health System, Berkeley, Calif.; available canada pharmacy discount coupons at www.csn.com.au/mstat) that allowed the investigator to compute and compare the incidence rates of attacks for each group (the active treatment group, the placebo and ketoflavone condition) in a linear dose-response manner. The investigator, study coordinator, data manager, and the statistician were blind buy valium mexico to treatment assignment but were debriefed the day after each when there were no light attacks. An additional person (a nurse, research assistant) was also blind to the treatment assignments. study was double-blind with regard to patient assignment (i.e., the and research analyst had not been informed who would be receiving or the ketoflavone).
After a trial period of 6 weeks, patients who met the primary outcome variables were reanalyzed by the investigator using same data-analysis program (Medical Statistical Tools, version 2.1). If the trial ended before 6 weeks because of insufficient data or the trial was terminated, analyses were performed again in the next treatment period for active group until end of the 1-year trial.
We used the statistical program SAS 9.1, and a priori assumptions for statistical comparisons were analyzed by χ2.
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