Selaphum Hospital, Selaphum District, Roi Et, 45120, Thailand.
Social Medicine, Khon Kaen Hospital, Muang District, Khon Kaen, 40000, Thailand.
F1000Res. 2023 Nov 13;12:334. doi: 10.12688/f1000research.131344.2. eCollection 2023.
Plai or Roxb. was registered into the Thai Traditional Medicine list since 2011. However, there is limited evidence regarding Plai as a treatment in painful diabetic neuropathy (PDN). Therefore, this study aimed to evaluate the efficacy of topical
A RCT was conducted in patients with PDN during February to March 2019. All participants received oral gabapentin 300 mg before bed as a standard regimen. The intervention group (n=16) received Plai balm 15%w/w 0.5 gram to apply on their feet three times a day and the control group (n=15) received placebo balm to similarly apply. Pain score at baseline, 2 and 4 weeks were assessed and compared. Patients' quality of life, and adverse events, were collected. Mean pain scores before and after treatment in each group and between groups were also analyzed.
At the end of week two and week four, the Plai group showed statistically significant lesser mean pain scores than the placebo group by -1.47 (95%CI: -1.96 to -1.30, p-value < 0.001), and by -1.51 (95%CI: -1.92 to -0.13, p-value = 0.027), respectively. Moreover, the Plai group had more cases number/ percentages with at least 50% pain score reduction than the placebo group [12/16 (75%) vs 3/15 (20%), p-value = 0.004]. However, there was no statistically significant difference in quality of life between the two groups (overall p-value = 0.366). Adverse event was not found in any groups.
balm (Plai) was efficacious for pain reduction in painful diabetic neuropathy.
Registered with the Thai Clinical Trials Registry; TCTR20200221001.
Plai 或 Roxb. 自 2011 年起被列入泰国传统医学名录。然而，关于 Plai 治疗糖尿病性周围神经痛（PDN）的证据有限。因此，本研究旨在评估局部应用 Plai 的疗效。
2019 年 2 月至 3 月期间，对 PDN 患者进行了一项 RCT。所有参与者均在睡前接受标准方案的口服加巴喷丁 300mg。干预组（n=16）接受 15%w/w Plai 香脂 0.5 克，每天三次涂于足部，对照组（n=15）接受安慰剂香脂同样涂抹。在基线、2 周和 4 周时评估并比较疼痛评分。收集患者的生活质量和不良反应。还分析了每组治疗前后以及组间的平均疼痛评分。
在第 2 周和第 4 周结束时，Plai 组的平均疼痛评分明显低于安慰剂组，分别为-1.47（95%CI：-1.96 至-1.30，p 值<0.001）和-1.51（95%CI：-1.92 至-0.13，p 值=0.027）。此外，Plai 组至少有 50%疼痛评分减轻的病例数/百分比高于安慰剂组[12/16（75%）比 3/15（20%），p 值=0.004]。然而，两组的生活质量无统计学差异（总体 p 值=0.366）。两组均未发现不良反应。
香脂（Plai）对糖尿病性周围神经痛的疼痛缓解有效。
在泰国临床试验注册处注册；TCTR20200221001。
