Active Ingredients: Gabapentin
Patients were to be called every other week by study nurses to confirm their current dosing, answer questions, and encourage compliance.
As in the initial study, patients were given a questionnaire booklet with instructions, a set of daily hot flash diaries, weekly symptom experience diaries, and a POMS-B, the latter for completion at the end of the eight-week period. Also included on the weekly questionnaires were queries about quality of life and satisfaction with hot flash control.
These questions were scaled from 0—10, with 10 being most severe. Data analysis Efficacy measures calculated from the hot flash diaries included hot flash frequency, as well as a hot flash score.
Hot flash frequency was simply the number of hot flashes reported in each 24-hour period. The total hot flash score was a combination of the frequency and severity of the hot flashes.
A number was assigned for each level of hot flash severity: 1 for mild, 2 for moderate, 3 for severe, and 4 for very severe. Summary statistics were compiled for baseline characteristics of this population and Kruskal-Wallis methodology was employed to compare study endpoints between the study arms assigned during the double-blind portion.
Change from baseline in patient reported side effects were calculated and ANOVA and Bonferoni techniques employed to identify any significant differences.For permissions, please email: journals significant problem in men undergoing androgen deprivation therapy. Abstract Introduction: Hot flashes represent a.
Frequency counts and chi-square tests were conducted to determine relationships in study endpoints over time.
All patients provided written informed consent for participating in this trial, monitored by local Internal Review Boards as mandated by United States Federal regulations.
Patients were then randomized, using a dynamic allocation method that balances the marginal distributions of the stratification factors, to receive one of four treatment schedules: gabapentin 300 mg at bedtime for 28 days, versus gabapentin 300 mg at bedtime for 7 days and then 300 mg twice daily for 21 days, versus gabapentin 300 mg at bedtime for 7 days then 300 mg twice daily for 7 days and then 300 mg three times daily for 14 days, versus a placebo for 28 days.
Patients receiving placebo were divided into three groups so that one group received one tablet at bedtime for 28 days, a second group received one tablet at bedtime for 7 days then one tablet b.
All treatment assignments were blinded to the patients and clinical investigators, with only the North Central Cancer Treatment Group NCCTG randomization office, the pharmacists, and the study statisticians having access to the drug assignments for individual patients.
Gabapentin and matching placebo tablets were provided by Pfizer Corporation, New York. At study entry, the patient was given a booklet that contained patient instructions, hot flash definitions, hot flash diary questionnaires to be completed daily for 5 weeks, symptom experience diaries to be completed weekly for 5 weeks, and the 30-item Profile of Mood States-Brief POMS-B form to be completed at the end of the baseline week and then at the end of 4 weeks of treatment.
Hot flash definitions were provided to each patient, derived from other men who had participated in a previous hot flash trial. This diary questionnaire inquired regarding the numbers of mild, moderate, severe, and very severe hot flashes per 24-hour period.
It also inquired about hot flash distress, satisfaction with hot flash control, quality of life QoL, and how much hot flashes affected QoL, each on a 0—10 scale. Throughout the presented results, all patient-reported outcomes have been transformed onto a 0—100 scale with 0 indicating the most negative outcome and 100 indicating the most positive outcome, for ease of comparability.
On the last day of each treatment week, patients were asked about their compliance with taking the study medication by asking them how many tablets they were taking per day.
Each patient was to be contacted by telephone weekly for the first 5 weeks to document compliance, encourage completion of the questionnaires, and address questions.
On the last scheduled day of the randomized double-blind treatment, each patient, after assuring that he had completed his questionnaires, was allowed to be told which dose of gabapentin he received and was subsequently given the choice of whether he would like to continue with gabapentin or to start active drug if he was on the placebo.
The primary end point in this current study was change from baseline in hot flash score after 4 weeks of treatment.