Rad Reza Ebrahimi, Ghaffari Fatemeh, Fotokian Zahra, Ramezani Azadeh
M.D., Neurologist, Assistant Professor, Department of Medicine, Islamic Azad University, Tonekabon Branch, Tonekabon, Mazandaran, Iran.
Ph.D. of Nursing, Assistant Professor, Ramsar Nursing Care Research Center, School of Nursing and Midwifery, Babol University of Medical Sciences, Babol, Mazandaran, Iran.
Electron Physician. 2017 Mar 25;9(3):3912-3917. doi: 10.19082/3912. eCollection 2017 Mar.
Migraine is a common, episodic and debilitating disease. The migraineur not only suffers from pain, but also lives with a diminished to poor quality of life. Several medicinal therapies are used to abate the debilitating symptoms of this disease.
The present study was conducted to determine the effectiveness of Ibuprofen and Lorazepam combination therapy in treating the symptoms of acute migraine.
The present randomized clinical trial study used the pretest-posttest design with three comparison treatments, to examine 90 patients with an average of two to six attacks per month and an initial diagnosis of migraine based on the International Headache Society (HIS) criteria. The study was conducted on patients during the first half of 2014 with a diagnosis of acute migraine attack who were referred to Babol Ayatollah Rouhani Hospital in Iran. The patients were randomly divided into three groups of 30. The first group was administered 200 mg Ibuprofen capsules, the second group 400 mg Ibuprofen capsules and the third group a combination of 200 mg Ibuprofen capsules and 1 mg Lorazepam tablets. The medications were taken in the presence of the researcher. A checklist was used to assess the severity of headache and other migraine symptoms such as nausea, vomiting, photophobia and phonophobia in the patients, before and two hours after the intervention. Data were analyzed in SPSS-18 using the Mann-Whitney test, the McNemar test, Wilcoxon's test, the NOVA and the Chi-squared test at the significance level of p<0.05, and power analysis with 30 patients in each group to perform this study was 0.8(1-β).
The mean age of participants was reported as 52±8 years and the condition was more frequent in women (56%). All three treatment regimens reduced the severity of headache significantly in the patients (p<0.001); nevertheless, the combination therapy used, produced the lowest mean severity of headache (p<0.001). The highest reduction in nausea and vomiting was (3.3%). None of the patients in either of the three groups reported phonophobia after the intervention, but only the patients in the combination therapy group reported no instance of photophobia.
Given the greater effectiveness of combination therapy with Ibuprofen and Lorazepam in alleviating the symptoms of acute migraine compared to single-drug treatments with Ibuprofen, Lorazepam is recommended to be used as a first line treatment for acute migraine.
The trial was registered at the Thai Clinical Trials Registry (TCTR) (http://www.clinicaltrials.in.th/) with the ID: TCTR20160927003.
The authors received no financial support for the research, authorship, and/or publication of this article.
偏头痛是一种常见的、发作性的使人衰弱的疾病。偏头痛患者不仅遭受疼痛，而且生活质量下降甚至很差。有几种药物疗法用于减轻这种疾病使人衰弱的症状。
本研究旨在确定布洛芬和劳拉西泮联合治疗对急性偏头痛症状的疗效。
本随机临床试验采用前测-后测设计及三种对照治疗，对90例平均每月发作2至6次且根据国际头痛协会（HIS）标准初步诊断为偏头痛的患者进行研究。该研究于2014年上半年对诊断为急性偏头痛发作并转诊至伊朗巴博勒阿亚图拉·鲁哈尼医院的患者进行。患者被随机分为三组，每组30人。第一组服用200毫克布洛芬胶囊，第二组服用400毫克布洛芬胶囊，第三组服用200毫克布洛芬胶囊与1毫克劳拉西泮片的组合。药物在研究人员在场的情况下服用。使用一份清单在干预前和干预后两小时评估患者头痛的严重程度以及其他偏头痛症状，如恶心、呕吐、畏光和畏声。在SPSS - 18中使用曼 - 惠特尼检验、麦克尼马尔检验、威尔科克森检验、方差分析和卡方检验对数据进行分析，显著性水平为p<0.05，每组30名患者进行本研究的功效分析为0.8(1 - β)。
参与者的平均年龄报告为52±8岁，女性中这种情况更常见（56%）。所有三种治疗方案均显著降低了患者头痛的严重程度（p<0.001）；然而，所采用的联合治疗产生的头痛平均严重程度最低（p<0.001）。恶心和呕吐的最大降幅为（3.3%）。三组中任何一组在干预后均无患者报告畏声，但只有联合治疗组的患者报告没有畏光情况。
鉴于与布洛芬单药治疗相比，布洛芬和劳拉西泮联合治疗在缓解急性偏头痛症状方面效果更佳，建议将劳拉西泮用作急性偏头痛的一线治疗药物。
该试验在泰国临床试验注册中心（TCTR）（http://www.clinicaltrials.in.th/）注册，注册号：TCTR20160927003。
作者未获得本研究、撰写及/或发表本文的资金支持。
