Dersch Rick, Freitag Michael H, Schmidt Stefanie, Sommer Harriet, Rücker Gerta, Rauer Sebastian, Meerpohl Joerg J
German Cochrane Centre, Medical Center-University of Freiburg, Berliner Allee 29, 79110 Freiburg, Germany.
Syst Rev. 2014 Oct 21;3:117. doi: 10.1186/2046-4053-3-117.
Neuroborreliosis is a tick-borne infectious disease of the nervous system caused by Borrelia burgdorferi. Common clinical manifestations of neuroborreliosis are cranial nerve dysfunctions, polyradiculoneuritis, and meningitis. Diagnosis is usually based on clinical presentation, serologic testing, and analysis of cerebrospinal fluid. Many aspects of pharmacological treatment, such as choice of drug, dosage, and duration are subject of intense debate, leading to uncertainties in patients and healthcare providers alike. To approach the questions regarding pharmacological treatment of neuroborreliosis, we will perform a systematic review.
We will perform a comprehensive systematic literature search for potentially eligible studies that report outcomes after pharmacological interventions. To adequately consider the wealth of research that has been conducted so far, this review will evaluate randomized controlled trials (RCTs) and non-randomized studies on treatment of neuroborreliosis. We will assess potential risk of bias for each RCT meeting our selection criteria using the Cochrane risk of bias tool for RCTs. For non-randomized studies, we will use the Newcastle-Ottawa Scale and the recently piloted Cochrane risk of bias tool for non-randomized studies. Our primary outcome of interest will be neurological symptoms and the secondary outcomes will be disability, patient-reported outcomes (quality of life, and, if reported separately from other neurological symptoms, pain, fatigue, depression, cognition, and sleep), adverse events, and cerebrospinal fluid pleocytosis. Pooling of data and meta-analysis will only be deemed justified between studies with similar design (e.g., RCTs are only combined with other RCTs), characteristics (e.g., similar populations), and of acceptable heterogeneity (I2 < 80%). Pooled estimates will be calculated using RevMan software. Prespecified subgroup analyses will evaluate groups of antibiotics, length of antibiotic treatment, and different doses of doxycycline. We will assess the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
This systematic review will summarize the available evidence from RCTs and non-randomized studies regarding pharmacological treatment of neuroborreliosis. The available evidence will be summarized and discussed to provide a basis for decision-making for patients and healthcare professionals.
PROSPERO registration number: CRD42014008839.
神经莱姆病是一种由伯氏疏螺旋体引起的蜱传神经系统感染性疾病。神经莱姆病常见的临床表现为颅神经功能障碍、多发性神经根神经炎和脑膜炎。诊断通常基于临床表现、血清学检测以及脑脊液分析。药物治疗的许多方面，如药物选择、剂量和疗程等，都存在激烈争论，这使得患者和医疗服务提供者都感到不确定。为解决神经莱姆病药物治疗的相关问题，我们将进行一项系统评价。
我们将对报告药物干预后结局的潜在合格研究进行全面的系统文献检索。为充分考虑到目前已开展的大量研究，本评价将评估治疗神经莱姆病的随机对照试验（RCT）和非随机研究。我们将使用Cochrane随机对照试验偏倚风险工具，对每项符合我们选择标准的随机对照试验评估潜在的偏倚风险。对于非随机研究，我们将使用纽卡斯尔-渥太华量表以及最近试点的Cochrane非随机研究偏倚风险工具。我们感兴趣的主要结局将是神经症状，次要结局将是残疾、患者报告的结局（生活质量，如果与其他神经症状分开报告，还包括疼痛、疲劳抑郁、认知和睡眠）、不良事件以及脑脊液细胞增多。仅在设计相似（例如，随机对照试验仅与其他随机对照试验合并）、特征相似（例如，人群相似）且异质性可接受（I²＜80%）的研究之间进行数据合并和荟萃分析。将使用RevMan软件计算合并估计值。预先设定的亚组分析将评估抗生素组、抗生素治疗时长以及不同剂量的多西环素。我们将使用推荐分级的评估、制定与评价（GRADE）方法评估证据质量。
本系统评价将总结随机对照试验和非随机研究中有关神经莱姆病药物治疗的现有证据。将总结并讨论现有证据，为患者和医疗专业人员的决策提供依据。
PROSPERO注册号：CRD42014008839。
