Journal Article

Xiaoketongbi Formula vs pregabalin for painful diabetic neuropathy: A single‐center, randomized, single‐blind, double‐dummy, and parallel controlled clinical trial

Liu, Yunyi, Luo, Lulu, Li, Anxiang, Chen, Benjian, Lu, Jiayan, Ouyang, Wenwei, Liu, Zhenjie, Wu, Liyan, Lu, Qiyun, Liang, Qingshun, Fan, Guanjie, Wen, Zehuai, Liu, Yunwei

2022

Overview

Background We assessed the efficacy and safety of the Xiaoketongbi Formula (XF) vs. pregabalin in patients with painful diabetic neuropathy (PDN). Methods Patients with PDN (n = 68) were included in a single‐center, randomized, single‐blind, double‐dummy, parallel controlled clinical trial. The primary outcome was the change in the Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI‐DPN). Secondary outcomes evaluated included the reduction of BPI‐DPN >50%, changes in the numeric rating scale‐11 (NRS‐11) score for pain, Daily Sleep Interference Diary (DSID), Patient Global Impression of Change (PGIC), nerve conduction velocity (NCV), and adverse events. Results After 10 weeks of treatment, the BPI‐DPN score reduced from 42.44 ± 17.56 to 26.47 ± 22.22 and from 52.03 ± 14.30 to 37.85 ± 17.23 in the XF and pregabalin group (Ps < 0.001), respectively. The difference in the absolute change in BPI‐DPN score between both groups was −1.79 (95% CI: −9.09, 5.50; p = 0.625). In the XF and pregabalin groups, 44.1% (15/34) and 20.6% (7/34) of patients reported a BPI‐DPN reduction >50% (p = 0.038), respectively. There were no significant differences between groups in NRS‐11 and DSID (Ps > 0.05). A significantly greater number of patients in the XF group felt “significantly improved” or “improved” than in the pregabalin group (35.3% (12/34) vs. 11.8% (4/34), p = 0.045). The absolute change in motor nerve conduction velocity of the right median nerve was significantly different between both groups (XF group 0.7 ± 2.3 vs. pregabalin group −2.2 ± 4.1, p = 0.004). No serious adverse events were reported in either group. Conclusions XF is equivalent to pregabalin in reducing pain symptoms and improves the quality of life in patients with PDN. In addition, XF has the potential to improve nerve function by increasing NCV. 摘要 目的 比较消渴通痹方(XF)与普瑞巴林治疗痛性糖尿病神经病变(PDN)的疗效和安全性。 方法 对68例PDN患者进行单中心, 随机, 单盲, 双模拟, 平行对照临床试验。主要结果是糖尿病周围神经病变的简明疼痛问卷(BPI‐DPN)的变化。次要结果包括BPI‐DPN下降>50%, 疼痛数字评定量表‐11(NRS‐11)评分的变化, 日常睡眠干预日记(DSID), 患者总体变化印象(PGIC), 神经传导速度(NCV)和不良事件。 结果 治疗10周后, XF组和普瑞巴林组的BPI‐DPN评分分别从42.44±17.56降至26.47±22.22和52.03±14.30降至37.85±17.23(P<0.001)。两组间BPI‐DPN评分绝对值变化差异为‐1.79(95%CI:‐9.09, 5.50, P=0.625)。XF组和普瑞巴林组分别有44.1%(15/34)和20.6%(7/34)的患者报告BPI‐DPN下降>50%(P=0.038)。两组间NRS‐11和DSID评分差异无统计学意义(P>0.05)。与普瑞巴林组相比, XF组有显著改善或改善的患者数量显著增加(35.3%(12/34)比11.8%(4/34), P=0.045)。两组右侧正中神经运动传导速度绝对值变化差异有统计学意义(XF组0.70±2.3vs.普瑞巴林组‐2.2±4.1, P=0.004)。两组均未报告严重不良事件。 结论 XF在减轻PDN患者疼痛症状, 提高生活质量方面与普瑞巴林相当。此外, XF还有可能通过增加神经传导速度来改善神经功能。 Highlights This is the first randomized, single‐blind, double‐dummy, parallel controlled clinical trial collecting data on the efficacy and safety of Chinese herbal medicines compared to that of pregabalin in patients with painful diabetic neuropathy. The Xiaoketongbi Formula is an effective treatment that can relieve pain symptoms, improve quality of life, and potentially improve nerve conduction velocity in patients suffering from painful diabetic neuropathy.

• Publisher: Wiley Publishing Asia Pty Ltd,John Wiley & Sons, Inc
• Subject: Analgesics - therapeutic use / Chinese herbal medicine / Clinical trials / Diabetes / Diabetes Mellitus - drug therapy / Diabetic Neuropathies / Diabetic neuropathy / Double-Blind Method / gamma-Aminobutyric Acid - therapeutic use / Humans / Original / Pain / Pain management / Pain Measurement / pain therapy / painful diabetic neuropathy / pregabalin / Pregabalin - therapeutic use / Quality of Life / Single-Blind Method / Traditional Chinese medicine / Treatment Outcome / 中草药 / 普瑞巴林 / 疼痛疗法 / 痛性糖尿病神经病变