Head and Neck Research Group, Research Centre, Akershus University Hospital, 1478, Lørenskog, Oslo, Norway; Institute of Clinical Medicine, Campus Akershus University Hospital, University of Oslo, 1474, Nordbyhagen, Oslo, Norway.
Institute of Clinical Medicine, Campus Akershus University Hospital, University of Oslo, 1474, Nordbyhagen, Oslo, Norway; HØKH, Research Centre, Akershus University Hospital, 1478, Lørenskog, Oslo, Norway.
Musculoskelet Sci Pract. 2017 Jun;29:66-71. doi: 10.1016/j.msksp.2017.03.003. Epub 2017 Mar 14.
Unlike pharmacological randomized controlled trials (RCTs), manual-therapy RCTs do not always report adverse events (AEs). The few manual-therapy RCTs that provide information on AEs are frequently without details, such as the type and-, severity of the AE and reason for withdrawal.
To prospectively report all AEs in a chiropractic spinal manipulative therapy (CSMT) RCT.
A prospective 3-armed, single-blinded, placebo, RCT.
Seventy migraineurs were randomized to the CSMT or a placebo, with 12 intervention sessions over three months. The recommendations by CONSORT and the International Headache Society's Task Force on AEs in migraine RCTs were followed. A standardized reporting scheme designed for pharmacological RCTs was used, and the AEs were described as frequencies and percentages within each group. The 95% confidence intervals (CIs) for the percentages (absolute risk) of AEs in each group were calculated when possible. Attributable risk (%) and relative risk were calculated with the corresponding 95% CIs.
AEs were assessed in 703 sessions, with 355 in the CSMT group and 348 in the placebo group. Local tenderness was the most common AE, reported by 11.3% and 6.9% of the CSMT group and the placebo group, respectively, and tiredness on the intervention day was reported by 8.5% and 1.4% of CSMT group and the placebo group, respectively. The highest attributable risk was for tiredness on the treatment day, 7.0% (CI 3.9-10.2%) which presented a relative risk of 5.9 (CI 2.3-15.0).
AEs were mild and transient, and severe or serious AEs were not observed.
与药物随机对照试验（RCT）不同，手法治疗 RCT 并不总是报告不良事件（AEs）。少数提供 AEs 信息的手法治疗 RCT 通常缺乏细节，例如 AEs 的类型、严重程度以及退出的原因。
前瞻性报告一项脊椎指压疗法（CSMT）RCT 中的所有不良事件。
一项前瞻性的、三臂、单盲、安慰剂对照 RCT。
70 例偏头痛患者随机分为 CSMT 组或安慰剂组，接受 3 个月共 12 次干预。遵循 CONSORT 建议和国际头痛协会偏头痛 RCT 中 AEs 工作组的建议。使用专为药物 RCT 设计的标准化报告方案，按每组的频率和百分比描述 AEs。在可能的情况下，计算每组 AEs 的百分比（绝对风险）的 95%置信区间（CI）。计算归因风险（%）和相对风险及其相应的 95%CI。
在 703 次治疗中评估了不良事件，CSMT 组有 355 次，安慰剂组有 348 次。局部压痛是最常见的不良事件，CSMT 组和安慰剂组分别有 11.3%和 6.9%报告，干预日疲劳分别有 8.5%和 1.4%报告。治疗日疲劳的归因风险最高，为 7.0%（95%CI：3.9-10.2%），其相对风险为 5.9（95%CI：2.3-15.0）。
不良事件轻微且短暂，未观察到严重或严重的不良事件。
