Chotchoungchatchai Somtanuek, Krairit Orapitchaya, Tragulpiankit Pramote, Prathanturarug Sompop
Department of Pharmaceutical Botany, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.
Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Contemp Clin Trials Commun. 2020 Jan 28;17:100538. doi: 10.1016/j.conctc.2020.100538. eCollection 2020 Mar.
Scientific support for Thai traditional medicine (TTM) practice is warranted for reintroduction into modern healthcare systems. A promising TTM practice for treatment of pressure ulcers was selected to conduct a clinical trial. This study aimed to evaluate the efficacy of the TTM practice for the treatment of pressure ulcers using honey or a Thai Herbal Oil preparation (THO) based on the TTM wound diagnosis comparing with the standard practice.
The study design was an open-label randomized controlled trial. Sixty-six participants, with pressure ulcers at least stage II-IV or unstageable, were allocated to two groups minimization. A TTM practice group received honey or THO depending on the TTM diagnosis the Thai Traditional Medicine Pressure Ulcer Assessment Tool (TTM-PUAT). A standard practice group received advanced dressings, including hydrogel, alginate, silver-impregnated, or hydrocolloid dressings. The primary outcome was the Pressure Ulcer Scale for Healing (PUSH).
Both TTM practice and standard practice showed a significant reduction in PUSH scores after treatments. However, there was no significant difference in PUSH score reduction between the groups. The mean PUSH score reduction over the 6-week period was 2.58 ± 3.38 (95% CI 1.34-3.82) in the TTM practice group and 3.24 ± 3.49 (95% CI 1.91-4.57) in the standard practice group (p = 0.284). The TTM practice and standard practice accelerated pressure ulcer healing without statistically significant difference between the practices, during 6 weeks in a home-based care setting. This finding supported the TTM practice as an alternative treatment for pressure ulcer.
泰国传统医学（TTM）疗法重新引入现代医疗体系需要科学依据。我们选择了一种有前景的TTM疗法来治疗压疮，并开展了一项临床试验。本研究旨在基于TTM伤口诊断，比较使用蜂蜜或泰国草药油制剂（THO）的TTM疗法与标准疗法治疗压疮的疗效。
本研究设计为开放标签随机对照试验。66名患有至少II-IV期或不可分期压疮的参与者，按最小化原则分为两组。TTM疗法组根据TTM诊断（使用泰国传统医学压疮评估工具（TTM-PUAT））接受蜂蜜或THO治疗。标准疗法组接受高级敷料，包括水凝胶、藻酸盐、含银或水胶体敷料。主要结局指标为愈合压疮量表（PUSH）。
TTM疗法组和标准疗法组治疗后PUSH评分均显著降低。然而，两组间PUSH评分降低幅度无显著差异。在为期6周的家庭护理环境中，TTM疗法组6周内PUSH评分平均降低2.58±3.38（95%CI 1.34 - 3.82），标准疗法组为3.24±3.49（95%CI 1.91 - 4.57）（p = 0.284）。TTM疗法和标准疗法均加速了压疮愈合，两种疗法之间无统计学显著差异。这一发现支持TTM疗法可作为压疮的替代治疗方法。
