Spinks A B, Wasiak J, Villanueva E V, Bernath V
Cochrane Database Syst Rev. 2004(3):CD002851. doi: 10.1002/14651858.CD002851.pub2.
Motion sickness - the discomfort experienced when perceived motion disturbs the organs of balance - may include symptoms such as nausea, vomiting, pallor, cold sweats, hypersalivation, hyperventilation and headaches. The control and prevention of these symptoms have included pharmacological, behavioural and complementary therapies. Although scopolamine has been used in the treatment and prevention of motion sickness for decades, there have been no systematic reviews of its effectiveness.
To assess the effectiveness of scopolamine versus no therapy, placebo, other drugs, behavioural and complementary therapy or two or more of the above therapies in combination for motion sickness in persons (both adults and children) without known vestibular, visual or central nervous system pathology.
The Cochrane Ear, Nose and Throat Disorders Group Specialised Register, the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2003), MEDLINE (OVID, 1966 to March Week 1 2004), EMBASE (1974 to 2004) CINAHL (Ovid, 1982 to March Week 1 2004) and reference lists of retrieved studies were searched for relevant studies. No language restrictions were applied.
All parallel-arm, randomised controlled trials (RCTs) focusing on scopolamine versus no therapy, placebo, other drugs, behavioural and complementary therapy or two or more of the above therapies in combination were included. Outcomes relating to the prevention of onset or treatment of clinically-defined motion sickness, task ability and psychological tests, changes in physiological parameters and adverse effects were considered.
Data from the studies were extracted independently by two authors using standardised forms. Study quality was assessed. Dichotomous data were expressed as odds ratio (OR) and a pooled OR was calculated using the random effects model.
Of 27 studies considered potentially relevant, 12 studies enrolling 901 subjects met the entry criteria. Scopolamine was administered via transdermal patches, tablets or capsules, oral solutions or intravenously. Scopolamine was compared against placebo, calcium channel antagonists, antihistamine, meth-scopolamine or a combination of scopolamine and ephedrine. Studies were generally small in size and of varying quality. Scopolamine was more effective than placebo in the prevention of symptoms. Comparisons between scopolamine and other agents were few and suggested that scopolamine was superior (versus meth-scopolamine) or equivalent (versus antihistamines) as a preventative agent. Evidence comparing scopolamine to cinnarizine or combinations of scopolamine and ephedrine is equivocal or minimal. Although sample sizes were small, scopolamine was no more likely to induce drowsiness, blurring of vision or dizziness compared to other agents. Dry mouth was more likely with scopolamine than with meth-scopolamine or cinnarizine. No studies were available relating to the therapeutic effectiveness of scopolamine in the management of established symptoms of motion sickness.
REVIEWERS' CONCLUSIONS: The use of scopolamine versus placebo in preventing motion sickness has been shown to be effective. No conclusions can be made on the comparative effectiveness of scopolamine and other agents such as antihistamines and calcium channel antagonists. In addition, no randomised controlled trials were identified that examined the effectiveness of scopolamine in the treatment of established symptoms of motion sickness.
晕动病——当感知到的运动干扰平衡器官时所体验到的不适——可能包括恶心、呕吐、面色苍白、冷汗、唾液分泌过多、换气过度和头痛等症状。对这些症状的控制和预防包括药物治疗、行为疗法和辅助疗法。尽管东莨菪碱已用于晕动病的治疗和预防数十年,但尚未对其有效性进行系统评价。
评估东莨菪碱与不治疗、安慰剂、其他药物、行为疗法和辅助疗法或上述两种或更多疗法联合使用对无已知前庭、视觉或中枢神经系统病变的人群(包括成人和儿童)晕动病的有效性。
检索了Cochrane耳、鼻、喉疾病组专业注册库、Cochrane对照试验中心注册库(Cochrane图书馆,2003年第4期)、MEDLINE(OVID,1966年至2004年3月第1周)、EMBASE(1974年至2004年)、CINAHL(OVID,1982年至2004年3月第1周)以及检索到的研究的参考文献列表,以查找相关研究。未设语言限制。
纳入所有聚焦于东莨菪碱与不治疗、安慰剂、其他药物、行为疗法和辅助疗法或上述两种或更多疗法联合使用的平行组随机对照试验(RCT)。考虑与预防临床定义的晕动病发作或治疗、任务能力和心理测试、生理参数变化以及不良反应相关的结果。
两位作者使用标准化表格独立提取研究中的数据。评估研究质量。二分数据以比值比(OR)表示,并使用随机效应模型计算合并OR。
在27项被认为可能相关的研究中,12项纳入901名受试者的研究符合纳入标准。东莨菪碱通过透皮贴剂、片剂或胶囊、口服溶液或静脉注射给药。将东莨菪碱与安慰剂、钙通道拮抗剂、抗组胺药、甲基东莨菪碱或东莨菪碱与麻黄碱的组合进行比较。研究规模一般较小且质量参差不齐。东莨菪碱在预防症状方面比安慰剂更有效。东莨菪碱与其他药物的比较较少,表明东莨菪碱作为预防药物更优(与甲基东莨菪碱相比)或相当(与抗组胺药相比)。比较东莨菪碱与桂利嗪或东莨菪碱与麻黄碱组合的证据不明确或极少。尽管样本量较小,但与其他药物相比,东莨菪碱引起嗜睡、视力模糊或头晕的可能性并不更高。与甲基东莨菪碱或桂利嗪相比,东莨菪碱更易引起口干。尚无关于东莨菪碱治疗已确诊晕动病症状有效性的研究。
已证明使用东莨菪碱与安慰剂相比预防晕动病是有效的。关于东莨菪碱与其他药物如抗组胺药和钙通道拮抗剂的比较有效性无法得出结论。此外,未发现随机对照试验研究东莨菪碱治疗已确诊晕动病症状的有效性。