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. 2020 Jan 28:17:100538.
doi: 10.1016/j.conctc.2020.100538. eCollection 2020 Mar.

The efficacy of honey and a Thai Herbal Oil preparation in the treatment of pressure ulcers based on Thai traditional medicine wound diagnosis versus standard practice: An open-label randomized controlled trial

Somtanuek Chotchoungchatchai  1 , Orapitchaya Krairit  2 , Pramote Tragulpiankit  3 , Sompop Prathanturarug  1
Affiliations

The efficacy of honey and a Thai Herbal Oil preparation in the treatment of pressure ulcers based on Thai traditional medicine wound diagnosis versus standard practice: An open-label randomized controlled trial

Somtanuek Chotchoungchatchai et al. Contemp Clin Trials Commun. .

Abstract

Background: 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.

Methods: 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 via minimization. A TTM practice group received honey or THO depending on the TTM diagnosis via 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).

Results: 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.

Keywords: BWAT, Bates-Jensen Wound Assessment Tool; Clinacanthus nutans; Decubitus; Diagnosis; Honey; ITT, intention-to-treat; NPUAP / EPUAP, National Pressure Ulcer Advisory Panel and the European Pressure Ulcer Advisory Panel; PP, per-protocol; PU, pressure ulcer; PUSH, Pressure Ulcer Scale for Healing; RCT, randomized controlled trials; TAMC, total aerobic microbial count; THO, Thai Herbal Oil preparation; TLC, thin layer chromatography; TTM, Thai traditional medicine; TTM-PUAT, Thai Traditional Medicine Pressure Ulcer Assessment Tool; TYMC, total combined yeasts and molds count; Traditional medicine; Zingiber montanum.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial profile, * primary analysis.
Fig. 2
Fig. 2
PUSH scores of the 6 approaches of statistical analysis.
Fig. 3
Fig. 3
Hybrid methodology for designing the RCT based on traditional medicine concept.
See this image and copyright information in PMC

References

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