Laboratory of Neuropharmacological Studies, Department of Pharmaceutical Science, Federal University of Sergipe, São Cristóvão, Sergipe, Brazil.
Laboratory of Teaching and Research in Social Pharmacy (LEPFS), Department of Pharmaceutical Science, Federal University of Sergipe, São Cristóvão, Sergipe, Brazil.
Curr Rheumatol Rev. 2022;18(4):305-316. doi: 10.2174/1573397118666220318105002.
It is often unclear whether systematic reviews and primary studies are de-signed to elucidate the efficacy or effectiveness of interventions. This may compromise the use of the information in clinical or policy decisions.
This overview aimed to evaluate the methodological profiles of studies on fibromyalgia pharmacotherapy in terms of the quality and nature of the interventions (efficacy versus effective-ness).
The protocol was registered in the International Prospective Register of Systematic Re-views database. Seven databases were searched for relevant publications. Systematic reviews inves-tigating the effectiveness or efficacy of fibromyalgia pharmacotherapy were included. Methodolog-ical quality was investigated using A MeaSurement Tool to Assess Systematic Reviews (AM-STAR), and efficacy andeffectiveness were evaluated using Rating of Included Trials on the Effica-cy-effectiveness Spectrum (RITES).
In this overview, 4,107 studies were initially identified. 8 systematic reviews and 34 prima-ry studies remained after overlaps were removed. Of the eight systematic reviews, 4.76% (n=3) and 7.93% (n=5) were of moderate and high quality, respectively. An analysis of systematic reviews clearly showed the criteria "participants characteristics" and "trial setting" with the most frequent answers as scales 1 and 2 (strong emphasis on efficacy or rather strong emphasis on efficacy), re-spectively. RITES analysis revealed that the most frequent response was "strong emphasis on effi-cacy" in 68% (92/136) of primary studies.
This analysis showed, in both systematic reviews and primary studies, a predominantly strong emphasis on efficacy, suggesting the need for methodological quality improvement in future studies, especially those designed to provide evidence related to effectiveness. The protocol for this overview has been registered in the International Prospective Register of Sys-tematic Reviews (PROSPERO; CRD42018095943).
系统评价和原始研究的目的通常不清楚，是为了阐明干预措施的疗效还是效果。这可能会影响临床或决策中信息的使用。
本综述旨在评估纤维肌痛症药物治疗研究的方法学概况，特别是干预措施的质量和性质（疗效与效果）。
该方案在国际前瞻性系统评价注册库中进行了注册。检索了 7 个数据库以获取相关出版物。纳入了评估纤维肌痛症药物治疗有效性或效果的系统评价。使用评估系统评价的测量工具（AMSTAR）评估方法学质量，使用疗效-效果谱评估纳入试验的疗效-效果分级（RITES）评估疗效和效果。
在本综述中，最初确定了 4107 项研究。在去除重叠后，有 8 项系统评价和 34 项原始研究保留下来。在这 8 项系统评价中，有 4.76%（n=3）和 7.93%（n=5）的质量为中等和高。系统评价的分析清楚地表明，“参与者特征”和“试验环境”的标准最频繁的回答分别为 1 分和 2 分（强烈强调疗效或非常强调疗效）。RITES 分析显示，在 68%（92/136）的原始研究中，最常见的回答是“强烈强调疗效”。
本分析表明，在系统评价和原始研究中，都强烈强调疗效，这表明需要在未来的研究中提高方法学质量，特别是那些旨在提供与效果相关证据的研究。本综述的方案已在国际前瞻性系统评价注册库（PROSPERO；CRD42018095943）中进行了注册。
