Jamjoom Ammer M, Saeedi Rothaina J, Jamjoom Abdulhakim B
Department of Trauma and Orthopedics, Leeds General Infirmary, Leeds, UK.
Section of Neurosurgery, King Khalid National Guards Hospital and King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia.
J Pain Res. 2021 Sep 29;14:3057-3065. doi: 10.2147/JPR.S317697. eCollection 2021.
The literature lacks information about the characteristics of the placebo effect following sham spine procedures for chronic low back pain. We aim to evaluate the effect using pain score data from the sham arms of published trials.
Relevant trials were selected and reviewed. Baseline and post-procedure pain scores were collected. Each follow up pain score was considered an episode and compared to its baseline for significance. Patients and episodes were pooled and analyzed using three parameters: patient reported outcome measures (PROMs) (Oswestry Disability Index [ODI], Visual Analog Scale [VAS], Numerical Rating Scale [NRS] and Short Form-36 [SF]), anatomical targets (disc, facet, sacroiliac joint [SIJ], ramus communicans nerve [RCN], basivertebral nerve [BVN], and caudal) and follow up periods (early: 0-2, intermediate: >2-4 and late: >4-6) in months. The percentage of pooled patients in the episodes that had significant reduction in pain scores was termed placebo effect. The outcome was defining the magnitude of the placebo effect and determining if it was influenced by the three parameters.
Seventeen studies that reported 535 patients and 55 pain scoring episodes were considered eligible. Significant reduction in pain scores was reported in 21 episodes. The overall placebo effect among the patients during the studied period was 53.2%. The rate ranged according to PROMs from 42.4% to 72.1%, anatomical targets from 11.1% to 100% and follow up periods from 47.9% to 59%. The placebo effect differed significantly between the various domains in the three parameters.
Placebo effect was observed in nearly half of the patients during the first 6 months following a sham spine procedure. The effect was influenced by utilized PROMs, anatomical target and follow up period. The findings should be considered in the design of new sham spine procedure trials. Further research is required to delineate the effect of bias on the findings.
关于针对慢性下腰痛的假脊柱手术安慰剂效应的特征，文献中缺乏相关信息。我们旨在利用已发表试验中假手术组的疼痛评分数据来评估这种效应。
选择并回顾相关试验。收集基线和术后疼痛评分。每次随访疼痛评分被视为一个事件，并与其基线进行显著性比较。将患者和事件进行汇总，使用三个参数进行分析：患者报告结局测量指标（PROMs）（奥斯威斯利功能障碍指数[ODI]、视觉模拟量表[VAS]、数字评定量表[NRS]和简短健康调查简表[SF-36]）、解剖靶点（椎间盘、小关节、骶髂关节[SIJ]、交通支神经[RCN]、椎体静脉神经[BVN]和尾侧）以及随访期（早期：0 - 2个月，中期：>2 - 4个月，晚期：>4 - 6个月）。疼痛评分显著降低的事件中汇总患者的百分比被称为安慰剂效应。结果是确定安慰剂效应的大小，并确定其是否受这三个参数的影响。
17项报告了535例患者和55次疼痛评分事件的研究被认为符合条件。21次事件报告疼痛评分显著降低。研究期间患者的总体安慰剂效应为53.2%。该比率根据PROMs从42.4%到72.1%不等，根据解剖靶点从11.1%到100%不等，根据随访期从47.9%到59%不等。安慰剂效应在这三个参数的不同领域之间存在显著差异。
在假脊柱手术后的前6个月内，近一半患者观察到了安慰剂效应。该效应受所使用的PROMs、解剖靶点和随访期的影响。在设计新的假脊柱手术试验时应考虑这些发现。需要进一步研究来阐明偏倚对研究结果的影响。
