Department of Surgery, School of Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA.
School of Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA.
Cephalalgia. 2023 Mar;43(3):3331024221150231. doi: 10.1177/03331024221150231.
A systematic and meta-analysis was conducted to examine the evidence of the effects of botulinum toxin A on chronic tension-type headache.
Cochrane, Embase, Ovid, ProQuest, PubMed, Scopus, Web-of-Science databases, and ClinicallTrials.gov registry were systematically searched for studies examining the effects of botulinum toxin A on tension-type headaches. The records were screened by two independent reviewers using pre-determined eligibility criteria. DerSimonian Liard random-effects meta-analyses were performed using the 'meta' package (5.2-0) in R (4.2.0). Risk of bias and quality of evidence were assessed using the Cochrane Collaboration's Tool RoB 2 and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. Clinical significance was determined using pre-defined minimal clinically important differences.
Eleven controlled trials were included (390 botulinum toxin A, 297 controls). Botulinum toxin A was associated with significant improvements in standardized headache intensity (-0.502 standard deviations [-0.945, -0.058]), headache frequency (-2.830 days/month [-4.082, -1.578]), daily headache duration (-0.965 [-1.860, -0.069]) and the frequency of acute pain medication use (-2.200 days/month [-3.485, -0.915]) vs controls. Botulinum toxin A-associated improvements exceeded minimal clinically important differences for headache intensity, frequency, and acute pain medication use. A 79% (28%, 150%) greater response rate was observed for botulinum toxin A vs controls in improving chronic tension-type headache. Treatment of eight chronic tension-type headache patients was sufficient to elicit a therapeutic response in one patient.
Corroborating the current mechanistic evidence, our meta-analysis supports the utility of botulinum toxin A for managing chronic tension-type headaches. However, due to limitations in the quality of evidence, adequately-powered high-quality controlled trials examining the effects of Botulinum toxin A on chronic tension-type headache are warranted.
Protocol preregistered in PROSPERO International Prospective Register of Systematic Reviews (CRD42020178616).
系统评价和荟萃分析旨在研究肉毒毒素 A 治疗慢性紧张型头痛的效果证据。
我们系统性检索了 Cochrane、Embase、Ovid、ProQuest、PubMed、Scopus、Web-of-Science 数据库和临床试验.gov 注册处，以寻找评估肉毒毒素 A 治疗紧张型头痛效果的研究。两名独立审查员使用预先确定的纳入标准筛选记录。使用 R（4.2.0）中的“meta”包（5.2-0）进行 DerSimonian Liard 随机效应荟萃分析。使用 Cochrane 协作工具 RoB 2 和推荐评估、制定与评价（GRADE）方法评估风险偏倚和证据质量。使用预先定义的最小临床重要差异来确定临床意义。
纳入了 11 项对照试验（390 例肉毒毒素 A，297 例对照组）。与对照组相比，肉毒毒素 A 可显著改善标准化头痛强度（-0.502 个标准差[-0.945，-0.058]）、头痛频率（-2.830 天/月[-4.082，-1.578]）、每日头痛持续时间（-0.965 [-1.860，-0.069]）和急性疼痛药物使用频率（-2.200 天/月[-3.485，-0.915]）。肉毒毒素 A 相关改善超过了头痛强度、频率和急性疼痛药物使用的最小临床重要差异。与对照组相比，肉毒毒素 A 治疗慢性紧张型头痛的反应率提高了 79%（28%，150%）。治疗 8 例慢性紧张型头痛患者，1 例患者可获得治疗反应。
本荟萃分析支持肉毒毒素 A 用于治疗慢性紧张型头痛，与当前的机制证据相符。然而，由于证据质量有限，需要进行足够数量和高质量的对照试验，以评估肉毒毒素 A 对慢性紧张型头痛的疗效。
本研究方案已在 PROSPERO 国际系统评价前瞻性注册库（CRD42020178616）预先注册。
