Efficacy and safety of Pien Tze Huang capsules in patients with herpes zoster: A multicenter, randomized, double-blinded, and placebo-controlled trial.

Autor: Wu W; The Second Clinical School of Guangzhou University of Chinese Medicine, Guangzhou, PR China; Department of Dermatology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, PR China., Yang D; Department of Dermatology, CHINA-JAPAN Friendship Hospital, Beijing, PR China., Sui D; Department of Dermatology, The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, PR China., Zhu M; Department of Dermatology, The Guangdong Second Provincial Traditional Chinese Medicine Hospital, Guangzhou, PR China., Luo G; Department of Dermatology, The Dermatology Hospital of Southern Medical University, Guangzhou, PR China., Yang Z; Department of Dermatology, The Jiangmen Wuyi Hospital of Traditional Chinese Medicine, Jiangmen, PR China., Wang Y; Department of Dermatology, The Affiliated Hospital of Shanxi University of Chinese Medicine, Xianyang, PR China., Luo H; Department of Dermatology, The First Hospital of Changsha, Changsha, PR China; Department of Dermatology, The Third People's Hospital of Shenzhen, Shenzhen, PR China., Ling L; Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, PR China., Zhang Z; The Second Clinical School of Guangzhou University of Chinese Medicine, Guangzhou, PR China., Wu Y; Guangzhou Evidence-Based Medicine Tech Co. Ltd, Guangzhou, PR China., Feng G; Guangzhou Evidence-Based Medicine Tech Co. Ltd, Guangzhou, PR China., Li H; Department of Dermatology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, PR China. Electronic address: lihongyi@gzucm.edu.can.
Jazyk: angličtina
Zdroj: Phytomedicine : international journal of phytotherapy and phytopharmacology [Phytomedicine] 2024 May; Vol. 127, pp. 155453. Date of Electronic Publication: 2024 Feb 17.
DOI: 10.1016/j.phymed.2024.155453
Abstrakt: Background: Herpes zoster (HZ) is a common medical condition accompanied by several distressing symptoms, including acute pain. Pien Tze Huang (PZH) is a well-known traditional Chinese medicine (TCM) with numerous pharmacological effects, including antiviral properties, neuroprotection, and immunity regulation.
Purpose: To investigate the efficacy and safety of PZH capsules in patients with HZ.
Study Design: A multicenter, double-blinded, randomized, and placebo-controlled trial from 8 hospitals in 5 cities of China.
Methods: Eligible participants were randomly assigned to the PZH capsule and placebo group at a 1:1 ratio. Treatment was conducted for 14 days with a window period of no more than 2 days. For the first 7 days, participants received antiviral drugs combined with PZH capsules (0.6 g/time, 3 times a day) or placebos. For the remaining 7 days, they were only treated with PZH capsules (0.6 g/time, 3 times a day) or placebos.
Results: We included 222 patients in the full analysis set (FAS), and 187 patients in the per protocol set (PPS). The change of numeric rating scale pain scores from baseline to the seventh day (±1 day) after treatment in the PZH capsule group was statistically superior to the placebo group (FAS: 2.33 vs. 1.71, 97.5%CI: 0.03 ∼ 1.19; PPS: 2.29 vs. 1.51, 97.5%CI: 0.18 ∼ 1.38). In the PPS, there was a significant difference in the time (days) of pain relief between the placebo group and the PZH capsule group (Mean (SD): 5.71 (3.76) vs. 4.69 (3.57), p = 0.046). On the seventh day (±1 day) after treatment, the level of CD8+ cells in the PZH capsule group were higher than those of the placebo group (FAS: Mean (SD): 24.08 (6.81) vs. 21.93 (8.19), p = 0.007; PPS: Mean (SD): 24.26 (6.93) vs. 22.15 (8.51), p = 0.012). The level of cytotoxic lymphocyte cells found similar results on the seventh day (±1 day) (FAS: Mean (SD): 12.17 (4.65) vs. 10.55 (4.15), p = 0.018; PPS: Mean (SD): 12.25 (4.65) vs. 10.11 (3.93), p = 0.002). No serious adverse events were noted and PZH capsules were well tolerated.
Conclusion: PZH capsules confer therapeutic effects on HZ with the TCM symptom of stagnated heat of liver channel by substantially reducing the pain intensity, shortening the time of pain relief as well as regulating the immune function. On the basis of the efficacy and safety profiles, PZH capsules may be a promising complementary therapy for the treatment of HZ.
Competing Interests: Declaration of competing interest We declare that we have no conflicts of interest associated with this publication. The medications were supplied by Zhangzhou Pien Tze Huang Pharmaceutical Co.,Ltd (Fujian, China), however Zhangzhou Pien Tze Huang Pharmaceutical was not involved in any aspect of this study including study design, collection, data analysis, interpretation of results, and manuscript preparation.
(Copyright © 2024. Published by Elsevier GmbH.)
Databáze: MEDLINE
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