Moreover, analyzing recurrence rate, statistical difference was found between
SPr and SP in the average percentages of recurrences after first dosing. The evaluation of tolerability in the patients’ report demonstrated an equivalence of AE profile for each study RAD001 supplier group. However, significant higher percentage of migraineurs with extrapyramidal side-effects and nausea was reported in SPr and SP group, respectively. The AEs correlated with therapeutic use of promethazine include extrapyramidal reactions such as dystonia and tardive dyskinesia. In consistent with a previous randomized, double-blind, placebo-controlled trial, only nausea, vomiting (which often accompany migraine), and malaise were reported in the SP treatment. The only FK866 price drug-related AEs reported in patients receiving sumatriptan 50 mg were nausea, vomiting, chest symptoms, malaise, and fatigue. In terms of safety analysis of promethazine, some adverse effects such as QT interval prolongation were unlikely to show up in promethazine study
arm. This medication as an antiemetic drug with great function at controlling nausea and vomiting can induce arrhythmogenic effect including QT interval prolongation, potentially provoking ventricular arrhythmias.[56, 57] Although this adverse reaction rarely occurs particularly when the oral route of promethazine administration is used, its safety profile should be interpreted with consideration of all common and rare complications. Additionally, a longer Osimertinib order follow-up period and repeated administration of the study medications would allow analysis of long-term infrequent complications which was improbable to be picked up in a study of this design. Moreover, the potential impact of several AEs of this combination therapy on performance of daily activities should be considered in analyzing tolerability profile of the drugs.
The objective of our trial was to evaluate the efficacy and safety of the pharmaceutical modalities for treatment of migraine headache. We assessed concomitant use of a phenothiazine medication in addition to a commonly used triptan in migraine treatment. Although our study was unique in its focus, it has limitations that warrant mention. The interpretation of our findings is limited by lack of placebo-controlled groups including promethazine plus placebo and placebo plus placebo arms. Inclusion of these study groups could support assay sensitivity of the trial. Therefore, future evaluations must consider comparison of the combination therapies with several placebo-controlled groups to improve validity of the resulting comparison. Another limitation is that corrections for multiple comparisons were not applied to the study outcome measures. Therefore, the findings need to be interpreted cautiously.