Haloperidol in the acute treatment of migraine: A randomized, double-blind, placebo-controlled study
Haloperidol in the acute treatment of migraine: A randomized, double-blind, placebo-controlled study
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DOI：
10.1111/j.1526-4610.2006.00438.x
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发表时间：
2006-05-01
期刊：
影响因子：
5
通讯作者：
Sulavuori, S
中科院分区：
文献类型：
--
作者：
Honkaniemi, J;Liimatainen, S;Sulavuori, S
客观。-在一项双盲、随机、安慰剂对照研究设计中评估静脉注射氟哌啶醇治疗急性偏头痛的疗效和安全性。抗精神病药主要用作急性偏头痛的止吐药。在以前的开放试验氟哌啶醇是有效的缓解偏头痛。将患者随机分为2组，分别静脉注射5 mg氟哌啶醇溶于500 mL生理盐水或单独注射500 mL生理盐水。在输注前和输注后1至3小时通过视觉模拟评分（VAS）评估疼痛。如果患者在输注后1 - 3小时未感觉疼痛强度缓解且已接受安慰剂，则他/她接受氟哌啶醇输注作为开放试验。开放试验还包括7名拒绝接受安慰剂对照试验的患者。输注后约1个月，通过电话联系患者并就治疗的副作用进行采访。40例患者入组了双盲、安慰剂对照研究。输注前，氟哌啶醇组的VAS值为7.7，安慰剂组为7.2。输注后，氟哌啶醇组的VAS值为2.2，安慰剂组为6.3（P < .0001）。氟哌啶醇组80%的患者疼痛明显缓解，而安慰剂组仅3例（15%）有反应（P <0.0001）。17例接受安慰剂治疗无应答的患者以及7例拒绝参加安慰剂对照研究的患者参加了开放试验。在该组中，VAS从6.7降至2.4，79%的患者感到疼痛显著缓解。氟哌啶醇最常见的副作用是镇静和静坐不能，后者更麻烦。这些影响在参加双盲（80%）和开放（88%）试验的患者中非常常见。16%的患者认为这种副作用无法忍受，并且不希望将来用氟哌啶醇治疗偏头痛发作。三名患者（7%）返回急诊病房，因为复发。这项研究表明，静脉注射氟哌啶醇对缓解偏头痛相关疼痛非常有效。由于大多数患者服用其他药物无反应，即使其他类型的治疗失败，氟哌啶醇似乎也是一种有效的补救药物。复发是罕见的，但副作用是常见的，限制了氟哌啶醇在一些患者中的使用。
Objective.-To assess the efficacy and safety of IV haloperidol in treatment of acute migraine headache in a double-blind, randomized, placebo-controlled study design.Background.-Neuroleptics are mainly used as antiemetics in acute migraine. In a previous open trial haloperidol was effective in relieving migraine pain.Design.-Patients were randomized into 2 groups receiving intravenously either 5 mg haloperidol in 500 mL of normal saline or 500 mL of normal saline alone. Pain was assessed by visual analogue scale (VAS) before and 1 to 3 hours after the infusion. If the patient felt no relief in pain intensity 1 to 3 hours after the infusion and had received placebo, he/she then received haloperidol infusion as an open trial. The open trial also included 7 patients who refused from the placebo-controlled trial. About 1 month after the infusion the patients were contacted by telephone and interviewed about the side effects of the treatment.Results.-Forty patients were enrolled into the double-blind, placebo-controlled study. Before the infusion the VAS values were 7.7 in the haloperidol and 7.2 in the placebo group. After the infusion the VAS values were 2.2 in the haloperidol and 6.3 in the placebo group (P < .0001). Significant pain relief was achieved in 80% of the patients treated with haloperidol, whereas only 3 patients (15%) responded to placebo (P < .0001). Seventeen patients treated with placebo without response together with 7 patients who refused from the placebo-controlled study participated in the open trial. In this group VAS declined from 6.7 to 2.4 and 79% of these patients felt significant pain relief. The most common side effects caused by haloperidol were sedation and akathisia, the latter being more troublesome. These effects were very common in patients participating in the double-blind (80%) and open (88%) trials. Sixteen percent of the patients considered the side effects intolerable and would not like the migraine attacks to be treated with haloperidol in the future. Three patients (7%) returned to the emergency ward because of a relapse.Conclusions.-This study shows that IV haloperidol is very effective in relieving migraine-associated pain. Because the majority of the patients had taken other medication without response, haloperidol appears to be an effective rescue medication even when other types of treatment have failed. Relapses are rare, but side effects are common, limiting the use of haloperidol in some patients.