Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial.

Current pharmacologic treatments offer limited efficacy and carry substantial risks, warranting the development of safe and effective alternatives.

目前的药物治疗效果有限，并且存在重大风险，这促使了安全有效替代疗法的开发。

This multicenter, randomized, placebo-controlledphase 3 trial evaluated the efficacy and safety of VER-01 in CLBP.

这项多中心、随机、安慰剂对照的III期临床试验评估了VER-01在慢性腰背痛（CLBP）中的疗效和安全性。

It enrolled 820 adults with CLBP (VER-01, n = 394; placebo, n = 426) and included a double-blind12-week treatment phase (phase A), a 6-month open-label extension (phase B), followed by either a 6-month continuation (phase C) or randomized withdrawal (phase D).

该试验招募了820名患有慢性腰背痛的成年人（VER-01组394人；安慰剂组426人），包括一个为期12周的双盲治疗阶段（A阶段），一个为期6个月的开放标签扩展阶段（B阶段），随后是为期6个月的继续治疗（C阶段）或随机撤药（D阶段）。

The primary endpoint of phase A was a change in mean numeric rating scale (NRS) pain intensity, with a change in total neuropathic pain symptom inventory (NPSI) score as a key secondary endpoint in participants with a neuropathic pain component (PainDETECT > 18).

阶段A的主要终点是平均数值评分量表（NRS）疼痛强度的变化，对于有神经性疼痛成分（PainDETECT > 18）的参与者，总神经性疼痛症状清单（NPSI）评分的变化作为关键次要终点。

The primary endpoint for phase D was time to treatment failure.

阶段D的主要终点是治疗失败的时间。

The study met its primary endpoint in phase A, with a mean pain reduction of -1.9 NRS points in the VER-01 group (mean difference (MD) versus placebo = -0.6, 95% confidence interval(CI) = -0.9 to -0.3; P < 0.001).

该研究在A阶段达到了主要终点，VER-01组的平均疼痛减轻了-1.9 NRS分（与安慰剂相比的平均差异（MD）= -0.6，95%置信区间（CI）= -0.9至-0.3；P < 0.001）。

Pain further decreased to -2.9 NRS points in phase B, with effects sustained through phase C.

在B阶段，疼痛进一步减轻至-2.9 NRS分，并且效果持续到C阶段。

The study also met its key secondary endpoint of phase A, with a mean NPSI decrease of -14.4 (standard error, 3.3) points from baseline in the VER-01 arm (MD versus placebo = -7.3, 95% CI = -13.2 to -1.3; P = 0.017).

该研究也达到了A阶段的关键次要终点，VER-01组从基线开始的平均NPSI降低了-14.4（标准误，3.3）分（与安慰剂相比的平均差异为-7.3，95%置信区间为-13.2至-1.3；P = 0.017）。

Although phase D did not meet its primary endpoint (hazard ratio= 0.75, 95% CI = 0.44-1.27; P = 0.288), pain increased significantly more with placebo upon withdrawal (MD = 0.5, 95% CI = 0.0-1.0; P = 0.034).

尽管D阶段没有达到其主要终点（风险比=0.75，95%置信区间=0.44-1.27；P = 0.288），但在停药后，与安慰剂相比，疼痛显著增加更多（平均差异=0.5，95%置信区间=0.0-1.0；P = 0.034）。

In phase A, the incidenceof adverse events-mostly mild to moderate and transient-was higher with VER-01 than with placebo (83.3% versus 67.3%; P < 0.001).

在A阶段，与安慰剂相比，VER-01的不良事件发生率更高，这些不良事件主要是轻度至中度且短暂的（83.3%对比67.3%；P<0.001）。

VER-01 was well-tolerated, with no signs of dependence or withdrawal. VER-01 shows potential as a new, safe and effective treatment for CLBP.

VER-01耐受性良好，未见依赖或撤药迹象。VER-01作为一种新的、安全有效的慢性腰背痛（CLBP）治疗方法具有潜力。

ClinicalTrials.gov registration: NCT04940741 .

临床试验注册：NCT04940741 .