Naproxen Sodium in Menstrual Migraine Prophylaxis: A Double-Blind Placebo Controlled Study

In this study, the efficacy of Naproxen sodium (Nxs) in the prophylaxis of Menstrual Migraine (MM) was tested, versus Placebo (PL). Forty women suffering from MM were admitted to a double-blind treatment protocol with Nxs 550 mg twice each day by mouth or Placebo (PL), for 3 months; in the next 3 months all the women were treated with the active drug in an open study. The headache intensity and duration, as well as the number of days of headache and the analgesic consumption, were significantly reduced with Nxs compared to PL. The efficacy of Nxs, shown also in improving premenstrual pain, and its good tolerability, support the use of this drug in the prophylactic therapy of MM.     

Amitriptyline in the prophylactic treatment of migraine and chronic daily headache

(Headache 2011;51:33‐51) Objective and Background.— Amitriptyline is one of the most commonly used medications in migraine prophylaxis. There have been relatively few placebo‐controlled studies of amitriptyline in migraine prophylaxis or in treatment of chronic daily headache (CDH). This report deals with a large placebo‐controlled trial of amitriptyline vs placebo of 20 weeks duration that included subjects with intermittent migraine (IM) as well as CDH. The study was carried out between 1976 and 1979; however, results have never been fully reported. Methods.— Patients with a history of migraine as defined by the 1962 Ad Hoc Committee report were recruited for this study. Subjects had at least 2 headaches per month, and no limit was placed on the number of headaches per month that could be experienced. The study format included a 4‐week baseline period (Period A) in which all subjects received placebo in a dose of 2 pills per day for one week, 3 pills per day for one week and then 4 pills per day for 2 weeks. Subjects with at least 2 migraine headaches in this period were then entered into Period B and randomized into either amitriptyline or placebo tracks. Medication consisted of identical tablets containing either 25 mg amitriptyline or placebo. Period B was 4 weeks in duration with dose titration identical to Period A. The dose could be reduced if necessary to reduce side effects. The minimum dose was one pill per day. Period C was a 12‐week maintenance or stabilization period in which the patient continued the dose established by week 8 with visits at weeks 12, 16, and 20. Patients kept a headache calendar that was used for data collection. Headache frequency (per month), severity, and duration (hours) were the primary measurement parameters employed for data analysis. Results.— For the entire group, 391 subjects were entered into Period A, 338 were randomized into Period B, 317 (81%) subjects completed the first post‐randomization visit (8 weeks), 255 (65%) completed week 12, 210 (54%) completed week 16, and 186 (48%) completed week 20. Using headache frequency and evaluating parameters of (a) improvement, (b) no change, or (c) worsening relative to baseline, there was a significant improvement in headache frequency for amitriptyline over placebo at 8 weeks (P = .018) but not at 12, 16, or 20 weeks. When amitriptyline and placebo patients were compared for headache frequency at 8, 12, 16, and 20 weeks to their own placebo stabilization period at 4 weeks, statistically significant improvement vs worsening was seen in headache frequency at each evaluation point for both amitriptyline and placebo groups (P ≤ .01) reaching 50% reporting a decrease in frequency in each group and approximately 10% reporting worsening by week 20. There were no significant differences in headache severity or duration between amitriptyline and placebo groups at anytime during the study. Within the study sample, there were 36 amitriptyline and 22 placebo subjects who had headaches ≥17 days/month that fit the current definition of CDH by the Silberstein‐Lipton criteria. These were analyzed separately as a subgroup for comparison of amitriptyline vs placebo using a metric of (1) no change or worsening; (2) up to a 50% improvement; and (3) ≥50% improvement in headache frequency. Amitriptyline was superior to placebo in number with improvement in frequency of ≥50% at 8 weeks (25% vs 5% [P = .031]) and at 16 weeks (46% vs 9% [P = .043]). There was a trend for amitriptyline to be superior to placebo at 12 and 20 weeks but this did not reach significance. Conclusions.— In this study, using headache frequency as the primary metric, for the entire group, amitriptyline was superior to placebo in migraine prophylaxis at 8 weeks but, because of a robust placebo response, not at subsequent time points. For the subgroup with CDH, amitriptyline was statistically significantly superior to placebo at 8 weeks and 16 weeks with a similar but nonsignificant trend at 12 and 20 weeks. Compared with placebo amitriptyline is effective in CDH. Amitriptyline was also significantly effective in IM compared intragroup to its own baseline; however, placebo was equally effective in the same analysis. The reason for the robust placebo response in the IM group is not clear, but has been occasionally reported.     

Low Dose Flunarizine in the Prophylaxis of Migraine

In a period of one year (1990) we selected 40 patients suffering from migraine. For an open randomized study there were 2 groups of patients: the first were treated with 10mg of flunarizine per day and the second with 3 mg per day. The patients were treated for 4 months consecutively. There were 11 drop outs (27.5%): nine for poor compliance and 2 due to side effects. The efficacy of flunarizine in the prophylaxis of migraine was essentially identical in the two dosage groups while the incidence of side effects was considerably reduced in the patients treated with the lower dose.     

米氮平治疗阿尔茨海默病所致抑郁的随机对照研究

目的：比较米氮平与阿米替林治疗阿尔茨海默病（AD）所致抑郁患者的临床疗效和安全性。方法：诊断为AD抑郁患者60例，随机分为A、B2组各30例，分别采用米氮平与阿米替林治疗8周。采用汉密尔顿抑郁量表（HAMD）和副反应量表（TESS）于治疗前和治疗后2、4、6、8周末时分别评定疗效和副反应。结果：A组和B组显效率分别为83．0％和70．0％，疗效相仿；HAMD评分，A组在治疗2周末即显著下降（P〈0．01），B组在第4周才明显下降（P〈0．05）；8周末2组差异无显著性意义。副反应A组明显少于和轻于B组（P〈0．01）。结论：米氮平治疗AD抑郁安全性高、副反应轻微，且见效快。     

Migraine: preventive treatment

Migraine is a common episodic headache disorder. A comprehensive headache treatment plan includes acute attack treatment to relieve pain and impairment and long-term preventive therapy to reduce attack frequency, severity, and duration. Circumstances that might warrant preventive treatment include: (i) migraine that significantly interferes with the patient's daily routine despite acute treatment; (ii) failure, contraindication to, or troublesome side-effects from acute medications; (iii) overuse of acute medications; (iv) special circumstances, such as hemiplegic migraine; (v) very frequent headaches (more than two a week); or (vi) patient preference. Start the drug at a low dose. Give each treatment an adequate trial. Avoid interfering, overused, and contraindicated drugs. Re-evaluate therapy. Be sure that a woman of childbearing potential is aware of any potential risks. Involve patients in their care to maximize compliance. Consider co-morbidity. Choose a drug based on its proven efficacy, the patient's preferences and headache profile, the drug's side-effects, and the presence or absence of coexisting or co-morbid disease. Drugs that have documented high efficacy and mild to moderate adverse events (AEs) include beta-blockers, amitriptyline, and divalproex. Drugs that have lower documented efficacy and mild to moderate AEs include selective serotonin reuptake inhibitors (SSRIs), calcium channel antagonists, gabapentin, topiramate, riboflavin, and non-steroidal anti-inflammatory drugs.     

Migraine Disability Awareness Campaign in Asia: Migraine Assessment for Prophylaxis

Objectives.— This study aimed to survey the headache diagnoses and consequences among outpatients attending neurological services in 8 Asian countries. Methods.— This survey recruited patients who consulted neurologists for the first time with the chief complaint of headache. Patients suffering from headaches for 15 or more days per month were excluded. Patients answered a self‐administered questionnaire, and their physicians independently completed a separate questionnaire. In this study, the migraine diagnosis given by the neurologists was used for analysis. The headache symptoms collected in the physician questionnaire were based on the diagnostic criteria of migraine proposed by the International Classification of Headache Disorders, second edition (ICHD‐2). Results.— A total of 2782 patients (72% females; mean age 38.1 ± 15.1 years) finished the study. Of them, 66.6% of patients were diagnosed by the neurologists to have migraine, ranging from 50.9% to 85.8% across different countries. Taken as a group, 41.4% of those patients diagnosed with migraine had not been previously diagnosed to have migraine prior to this consultation. On average, patients with migraine had 4.9 severe headaches per month with 65% of patients missing school, work, or household chores. Most (87.5%) patients with migraine took medications for acute treatment. Thirty‐six percent of the patients had at least one emergency room consultation within one year. Only 29.2% were on prophylactic medications. Neurologists recommended pharmacological prophylaxis in 68.2% of patients not on preventive treatment. In comparison, migraine prevalence was the highest with ICHD‐2 “any migraine” (ie, migraine with or without migraine and probable migraine) (73.3%) followed by neurologist‐diagnosed migraine (66.6%) and ICHD‐2 “strict migraine” (ie, migraine with or without aura only) (51.3%). About 88.6% patients with neurologist‐diagnosed migraine fulfilled ICHD‐2 any migraine but only 67.1% fulfilled the criteria of ICHD‐2 strict migraine. Conclusions.— Migraine is the most common headache diagnosis in neurological services in Asia. The prevalence of migraine was higher in countries with higher referral rates of patients to neurological services. Migraine remains under‐diagnosed and under‐treated in this region even though a high disability was found in patients with migraine. Probable migraine was adopted into the migraine diagnostic spectrum by neurologists in this study.     

Flunarizine Versus Metoprolol in Migraine Prophylaxis: A Double-Blind, Randomized Parallel Group Study of Efficacy and Tolerability

The prophylactic effect of flunarizine and metoprolol was studied in a multi-center randomized, double-blind trial of 149 patients with migraine with or without aura. After a 4-week placebo run-in period, patients were randomly allocated to treatment with flunarizine 10 mg daily or metoprolol 200 mg daily for 16 weeks (parallel group design). Both drugs reduced the number of migraine days per month by 37% (95% confidence interval 21-53%) compared with the placebo run-in period. All efficacy parameters were significantly reduced by both drugs and no significant difference was found between the two drugs at any time of the treatment period. However, calculation of the 95% confidence limits showed that each drug may have a superiority of more than 100% on a single main effect parameter. The most common adverse experiences were day-time sedation (both drugs) and weight gain (flunarizine). Depression was the most serious side-effect occurring in 8% on flunarizine and 3% on metoprolol. We conclude that both drugs are effective in the prevention of migraine attacks but a higher number of dropouts occurred on flunarizine because of depression or weight gain.     

A Comparative Study of Naproxen Sodium, Pizotyline and Placebo in Migraine Prophylaxis

SYNOPSIS
318 patients satisfying the Ad Hoc Committee's criteria for common or classical migraine were entered into an 8 week single-blind placebo recording phase to establish, by diary cards, the frequency and severity of their attacks. 176 patients completed this and had records indicating 4–8 episodes in the 8 week period, with sufficient severity to reduce activity and/or work; these patients wore randomized by a predetermined code, into three double-blinded groups: naproxen sodium 550 mg bid (60 patients), pizotyline 0.5 mg tid (59 patients), or placebo (57 patients). The patients wore followed at monthly intervals for 12 weeks, with 25 dropping out (3 on naproxen sodium, and 2 each on pizotyline and placebo because of "side effects;" the remaining 18 because of noncompliance or reasons unrelated to therapy). Approximately 25% of patients in each of the 3 groups complained of side effects.
Statistical analysis showed that both naproxen sodium and pizotyline were better than placebo, and of overall equivalent (i.e. equal) efficacy in the prophylaxis of migraine. In some respects, naproxen sodium was slightly more effective than pizotyline in the first month of treatment.     

针刺预防性治疗偏头痛的文献质量评价

目的对针刺预防性治疗偏头痛的随机对照研究进行文献质量评价。方法以针刺、偏头痛和预防为检索词，检索Cochrane图书馆（2007年第4期），MEDLINE（1966～2007），EMbase（1966～2007）等英文数据库和CBM（1978～2007），CMCC（1994～2007），CNKI（1994～2007）等中文数据库。手工检索《中国针灸》（1981～2007）等中医杂志及有关学术会议论文汇编。对纳入文献的方法学、诊断及纳入／排除标准、针刺／对照组干预措施、疗效评价标准及随访等方面进行评价。结果共纳入12篇随机对照研究，其中9篇高质量研究均为国外研究，3篇国内研究为低质量研究，国外研究多采用偏头痛每月发作频率、天数及SF-36／SF-12等量表作为疗效评价标准，国内则采用头痛指数计分作为疗效评价标准。9篇研究有随访记录，8篇研究报告了不良反应。结论目前国内尚无高质量的针刺预防性治疗偏头痛的临床研究报告，迄今所发表研究采用的疗效评价方法不能恰当评价针刺预防性治疗偏头痛的疗效。从试验设计及实施角度，今后应多借鉴国外同类研究的长处；从临床角度，针灸医师应认清偏头痛缓解期预防性治疗及急性期镇痛治疗的目的和意义的不同，设计出更科学的针刺预防性治疗偏头痛的试验方案。     

Divalproex ER Prophylaxis in Migraineurs with Probable Chronic Migraine and Probable Medication-Overuse Headache: A Case Series

Abstract:   This case series prospectively evaluated divalproex ER in 15 headache clinic migraine patients fulfilling International Headache Society criteria for probable chronic migraine and probable medication-overuse headache. Divalproex ER was initiated at 500 mg QHS and increased after Week 2 to 1000 mg QHS for a total treatment period of 2 months. Mean headache days per month dropped from 21.6 to 10.4 at month 1 and 8.9 at month 2. All 10 patients who completed the study rated their satisfaction with treatment as changed from unsatisfied at baseline to satisfied at study completion. The results of this study support the prophylactic efficacy of divalproex ER in migraine patients with probable chronic migraine and probable medication-overuse headache.     

Atenolol Prophylaxis in Migraine Secondary to an Arteriovenous Malformation

The migrainous syndrome secondary to a parieto-occipital arteriovenous malformation usually presents as unilateral headache with visual aura of progressive severity. We report successful prevention by atenolol of migraine with visual aura associated with an occipital vascular malformation. Effectively preventing migraine delayed specific therapeutic measures, thereby exposing the patient to the risk of an intracranial hemorrhage. The authors consider that prophylactic therapy should not be started whenever such an association is suspected.     

氟伏沙明治疗抑郁症对照研究

目的 探讨氟伏沙明治疗抑郁症的临床疗效和安全性.方法 将80例抑郁症患者随机分为两组,每组40例,研究组口服氟伏沙明治疗,对照组口服阿米替林治疗,观察8周.于治疗前及治疗第1周、2周、4周、8周末采用汉密顿抑郁量表、汉密顿焦虑量表及副反应量表评定临床疗效和不良反应.结果 治疗后两组汉密顿抑郁量表、汉密顿焦虑量表评分均较...     

Flunarizine in Migraine: A Minireview

Flunarizine is a non-selective calcium antagonist. It distributes preferentially in the adipose tissue and passes the blood brain barrier. Numerous controlled clinical studies have established that flunarizine is efficacious in migraine prophylaxis, including double-blind studies in which the drug was compared with placebo or other antimigraine drugs. To avoid side effects a special schedule or administration is necessary. Flunarizine has no myogenic effect on smooth muscle cells of the vessles. It is said to be the only calcium antagonist able to protect brain cells against hypoxic damage. In addition, the considerable body of information which shows flunarizine capable of directly influencing the central nervous system, suggests that the drug's anti-migraine action may depend on its ability to influence central phenomena.     

氟西汀治疗老年抑郁症的疗效观察

目的:探讨氟西汀治疗老年抑郁症的疗效及安全性。方法:56例老年抑郁症患者随机分为两组:A组和B组,每组各28例。A组采用氟西汀治疗,B组采用阿米替林治疗,两组疗程均为6周。两组疗效评定采用汉密顿抑郁量表(HAMD),两组副反应评定采用副反应量表(TESS)。结果:A组治疗后第2、4、6周末HAMD评分与B组比较,无显著性差异(P>0.05),A组治疗后第2、4、6周末TESS评分明显低于B组(P<0.05)。A组总有效率为78.57%,B组总有效率为71.43%,两组比较,无显著性差异(P>0.05)。结论:氟西汀可作为治疗老年抑郁症的首选药物。