Viglione Valentina, Boffa Angelo, Previtali Davide, Vannini Francesca, Faldini Cesare, Filardo Giuseppe
Clinica Ortopedica e Traumatologica 1 IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Applied and Translational Research (ATR) Center, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
EFORT Open Rev. 2023 Oct 3;8(10):719-730. doi: 10.1530/EOR-23-0082.
The study of the placebo effect is key to elucidate the 'real effect' of conservative interventions for plantar fasciitis. The aim of this meta-analysis was to quantify the impact of placebo in the different conservative treatments of plantar fasciitis.
A systematic literature review was performed on double-blind placebo-controlled trials (RCTs) according to PRISMA guidelines on PubMed, Embase, and Web of Science. The meta-analysis primary outcome was the 0-10 pain variation after placebo treatments analyzed at 1 week, 1, 3, 6, and 12 months. The risk of bias was assessed using the RoB 2.0 tool, while the overall quality of evidence was graded according to the GRADE guidelines.
The placebo effect for conservative treatments was studied in 42 double-blind RCTs on 1724 patients. The meta-analysis of VAS pain showed a statistically significant improvement after placebo administration of 2.13/10 points (P < 0.001), being highest at 12 months with 2.79/10 points (P < 0.001). The improvement of the placebo groups was higher in the extracorporeal shock wave therapy studies compared to the injection studies (2.59 vs 1.78; P = 0.05). Eight studies had a low risk of bias, 23 studies had 'some concerns,' and 4 studies had a high risk of bias. The GRADE evaluation showed an overall high quality of evidence.
This systematic review and meta-analysis demonstrated that the placebo effect represents an important component of all conservative approaches to treat plantar fasciitis. This effect is statistically and clinically significant, increases over time, and depends on the type of conservative treatment applied to address plantar fasciitis.
安慰剂效应的研究是阐明足底筋膜炎保守治疗“真实效果”的关键。本荟萃分析的目的是量化安慰剂在足底筋膜炎不同保守治疗中的影响。
根据PRISMA指南，在PubMed、Embase和科学网对双盲安慰剂对照试验（RCT）进行系统的文献综述。荟萃分析的主要结局是安慰剂治疗后1周、1个月、3个月、6个月和12个月分析的0至10分疼痛变化。使用RoB 2.0工具评估偏倚风险，同时根据GRADE指南对证据的总体质量进行分级。
在42项针对1724例患者的双盲RCT中研究了保守治疗的安慰剂效应。VAS疼痛的荟萃分析显示，安慰剂给药后疼痛有统计学意义的改善，改善了2.13/10分（P<0.001），在12个月时最高，为2.79/10分（P<0.001）。与注射研究相比，体外冲击波治疗研究中安慰剂组的改善更高（2.59对1.78；P=0.05）。八项研究偏倚风险低，23项研究“有些担忧”，四项研究偏倚风险高。GRADE评估显示证据总体质量高。
这项系统评价和荟萃分析表明，安慰剂效应是治疗足底筋膜炎的所有保守方法的重要组成部分。这种效应在统计学和临床上都具有显著意义，随时间增加，并且取决于用于治疗足底筋膜炎的保守治疗类型。
