On the Relationship Between Pain Variability and Relief in Randomized Clinical Trials.
On the Relationship Between Pain Variability and Relief in Randomized Clinical Trials.
复制标题
DOI：
10.3389/fpain.2022.844309
复制
发表时间：
2022
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
先前的研究报告表明，在接受安慰剂的患者中，更大的基线变异性与更大的疼痛缓解相关。然而，证明这种关联的研究并没有控制回归到平均值和自然史的混杂效应。在本报告中，我们分析了来自两项随机临床试验（安慰剂I和安慰剂II，总N = 139）的数据，同时通过无治疗组调整了自然史和回归平均值的影响。每项研究中两个安慰剂组之间的结果一致：两个安慰剂组均显示基线变异性与校正后应答之间的半偏相关性可忽略不计[安慰剂I和II的rsp（CI 95%）分别= 0.22（0.03，0.42）和0（-0.07，0.07）]。安慰剂I中的无治疗组显示出负相关[-0.22（-0.43，-0.02）]，但安慰剂II中的无治疗组和药物组的相关性可忽略不计[无治疗组和药物组分别为-0.02（-0.08，0.02）和0.00（-0.10，0.12）]。当作为线性协变量建模时，两项研究中基线疼痛变异性占干预后疼痛方差的<1%。即使在调整基线疼痛和自然史后，基线疼痛变异性无法解释疼痛反应的实质性差异，这突出表明先前关于疼痛变异性和治疗反应的结果可能不一致。事实上，这种关系似乎对安慰剂组的改善既不一致也不敏感。需要更多的工作来理解和建立基线疼痛变异性的预后价值，特别是其安慰剂特异性和在患者人群中的普遍性。
Previous research reports suggest greater baseline variability is associated with greater pain relief in those who receive a placebo. However, studies that evidence this association do not control for confounding effects from regression to the mean and natural history. In this report, we analyzed data from two randomized clinical trials (Placebo I and Placebo II, total N = 139) while adjusting for the effects of natural history and regression to the mean via a no treatment group. Results agree between the two placebo groups in each study: both placebo groups showed negligible semi-partial correlations between baseline variability and adjusted response [rsp (CI95%) = 0.22 (0.03, 0.42) and 0 (−0.07, 0.07) for Placebo I and II, respectively]. The no treatment group in Placebo I showed a negative correlation [−0.22 (−0.43, −0.02)], but the no treatment and drug groups in Placebo II's correlations were negligible [−0.02 (−0.08, 0.02) and 0.00 (−0.10, 0.12) for the no treatment and drug groups, respectively]. When modeled as a linear covariate, baseline pain variability accounted for <1% of the variance in post-intervention pain across both studies. Even after adjusting for baseline pain and natural history, the inability of baseline pain variability to account for substantial variance in pain response highlights that previous results concerning pain variability and treatment response may be inconsistent. Indeed, the relationship appears to be neither consistently specific nor sensitive to improvements in the placebo group. More work is needed to understand and establish the prognostic value of baseline pain variability—especially its placebo specificity and generalizability across patient populations.
登录
查看更多内容
影响因子：
--
作者：
Harris, RE;Williams, DA;Clauw, DJ
通讯作者：
Clauw, DJ
影响因子：
9.9
作者：
Katz, Jennifer;Finnerup, Nanna B.;Dworkin, Robert H.
通讯作者：
Dworkin, Robert H.
影响因子：
3.7
作者：
Hall, Kathryn T.;Lembo, Anthony J.;Kaptchuk, Ted J.
通讯作者：
Kaptchuk, Ted J.
影响因子：
7.4
作者：
Farrar, John T.;Troxel, Andrea B.;Dworkin, Robert H.
通讯作者：
Dworkin, Robert H.
影响因子：
7.4
作者：
Tuttle, Alexander H.;Tohyama, Sarasa;Mogil, Jeffrey S.
通讯作者：
Mogil, Jeffrey S.