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Comparison of 3 Treatment Strategies for Medication Overuse Headache: A Randomized Clinical Trial.
JAMA Neurology ( IF 29.0 ) Pub Date : 2020-09-01 , DOI: 10.1001/jamaneurol.2020.1179
Louise Ninett Carlsen 1, 2 , Signe Bruun Munksgaard 2 , Mia Nielsen 2 , Ida Maria Storm Engelstoft 2 , Maria Lurenda Westergaard 2 , Lars Bendtsen 2 , Rigmor Højland Jensen 2
Affiliation  

Importance Medication overuse headache (MOH) is a disabling, globally prevalent disorder representing a well-known and debated clinical problem. Evidence for the most effective treatment strategy is needed.

Objective To compare 3 treatment strategies for MOH.

Design, Setting, and Participants This open-label, randomized clinical trial with 6 months of follow-up was conducted in the tertiary sector at the Danish Headache Center, Glostrup, from October 25, 2016, to June 28, 2019. Of 483 patients with MOH referred during the inclusion period, 195 met the criteria consisting of migraine and/or tension-type headache, 18 years or older, eligibility for outpatient treatment, no severe physical or psychiatric disorder, no other addiction, and not pregnant or breastfeeding. Of these, 75 refused participation and 120 were included. Data were analyzed from July 3 to September 6, 2019.

Interventions Random assignment (1:1:1 allocation) to 1 of the 3 outpatient treatments consisting of (1) withdrawal plus preventive treatment, (2) preventive treatment without withdrawal, or (3) withdrawal with optional preventive treatment 2 months after withdrawal.

Main Outcomes and Measures The primary outcome was change in headache days per month after 6 months. Predefined secondary outcomes were change in monthly migraine days, use of short-term medication, pain intensity, number of responders, patients with remission to episodic headache, and cured MOH.

Results Of 120 patients, 102 (mean [SD] age, 43.9 [11.8] years; 81 women [79.4%]) completed the 6-month follow-up. Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20). No difference was found in reduction of migraine days per month, use of short-term medication, or headache intensity. In the withdrawal plus preventive group, 23 of 31 patients (74.2%) reverted to episodic headache, compared with 21 of 35 (60.0%) in the preventive group and 15 of 36 (41.7%) in the withdrawal group (P = .03). Moreover, 30 of 31 patients (96.8%) in the withdrawal plus preventive group were cured of MOH, compared with 26 of 35 (74.3%) in the preventive group and 32 of 36 (88.9%) in the withdrawal group (P = .03). These findings corresponded to a 30% (relative risk, 1.3; 95% CI, 1.1-1.6) increased chance of MOH cure in the withdrawal plus preventive group compared with the preventive group (P = .03).

Conclusion and Relevance All 3 treatment strategies were effective, but based on these findings, withdrawal therapy combined with preventive medication from the start of withdrawal is recommended as treatment for MOH.

Trial Registration ClinicalTrials.gov Identifier: NCT02993289



中文翻译:

药物过量头痛的3种治疗策略的比较:一项随机临床试验。

重要性 药物过度使用性头痛(MOH)是一种致残性疾病,在全球范围内普遍存在,代表着一个众所周知且争议较大的临床问题。需要最有效的治疗策略的证据。

目的 比较三种治疗MOH的策略。

设计,背景和参与者 这项开放标签,随机临床试验,为期6个月,于2016年10月25日至2019年6月28日在Glostrup的丹麦头痛中心的第三部门进行。共483例患者。在纳入期间转诊的MOH中,有195名符合以下标准:偏头痛和/或紧张型头痛,18岁或以上,有资格接受门诊治疗,没有严重的身体或精神疾病,没有其他成瘾症,没有怀孕或母乳喂养。其中,有75名拒绝参加,其中120名被拒绝参加。分析了2019年7月3日至9月6日的数据。

干预 随机分配(1:1:1分配)到3种门诊治疗中的1种,包括(1)停药加预防性治疗,(2)无停药的预防性治疗,或(3)停药后2个月停药并选择预防性治疗。

主要结果和措施 主要结果是6个月后每月头痛天数发生变化。预先定义的次要结局为每月偏头痛天数变化,短期药物的使用,疼痛强度,缓解人数,发作性头痛缓解的患者以及治愈的MOH。

结果 在120名患者中,有102名(平均[SD]年龄,43.9 [11.8]岁; 81名女性[79.4%])完成了6个月的随访。停药加预防组每月头痛天数减少了12.3(95%CI,9.3-15.3),预防组减少了9.9(95%CI,7.2-12.6),以及8.5(95%CI,5.6- 11.5)在戒断组(P  = 0.20)。每月偏头痛天数减少,使用短期药物或头痛强度无差异。在戒断加预防组中,31例患者中有23例(74.2%)恢复为发作性头痛,而在预防组中,有21例(35.6%)恢复为发作性头痛,在戒断组中有36例中的15例(41.7%)恢复为发作性头痛(P = .03)。此外,停药加预防组的31例患者中有30例(96.8%)治愈了MOH,而预防组的35例中有26例(74.3%),停药组中的32例中有32例(88.9%)(P  =。 03)。这些发现对应于戒断加预防组与预防组相比,MOH治愈的机会增加了30%(相对危险度; 1.3; 95%CI,1.1-1.6)(P  = .03)。

结论和相关性 这3种治疗策略均有效,但基于这些发现,建议从戒断开始就结合戒断治疗和预防药物作为MOH的治疗方法。

试验注册 ClinicalTrials.gov标识符:NCT02993289

更新日期:2020-09-14
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