Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Aug 4:14:1209075.
doi: 10.3389/fphar.2023.1209075. eCollection 2023.

Efficacy and safety of total glucosides of paeony in the treatment of recurrent aphthous ulcers: a single-center, double-blind, randomized, placebo-controlled clinical trial

Zijian Liu  1   2 , Xiang Guo  3 , Shufang Li  1 , Mingxing Lu  1 , Qianyun Guo  1 , Xingyun Liu  1 , Yutian Wang  1 , Ying Han  1 , Hongwei Liu  1
Affiliations

Efficacy and safety of total glucosides of paeony in the treatment of recurrent aphthous ulcers: a single-center, double-blind, randomized, placebo-controlled clinical trial

Zijian Liu et al. Front Pharmacol. .

Abstract

Introduction: There has been a lack of treatments available to lower the frequency of recurrent aphthous ulcers (RAUs) until now. Total glucosides of paeony (TGP) is a botanical drug extracted from the dried roots of Paeonia lactiflora Pall. [Ranunculaceae; Paeoniae Radix Alba]. This study aims to evaluate the efficacy and safety of TGP in the treatment of RAU. Methods: This study was registered with the Chinese Clinical Trial Registry (ChiCTR1900025623). Patients were randomly assigned to the TGP or placebo group and treated with 1.8 g/day for 24 weeks. Participants were observed for a total of 36 weeks and were asked to record ulcer severity, medication, and adverse reactions in the form of diaries or apps every day. The primary outcome was the monthly ulcer-free interval. Results: A total of 79 individuals were enrolled, with 40 assigned to the TGP group and 39 to the placebo group. The dropout rate was 18.18%. In the TGP group, the monthly ulcer-free interval was significantly longer than baseline (median, 9.6 days) since weeks 13-24 (median, 18.5 days) (p < 0.05), and after discontinuation, it was further prolonged (median, 24.7 days) than in weeks 13-24 (p < 0.05). In addition, the monthly ulcer-free interval was longer in the TGP group than in the placebo group (median, 15.9 days) at weeks 25-36 (p < 0.001). There were better improvements in the monthly number of ulcers and monthly area of ulcers, and visual analog scoring in the TGP group at weeks 25-36 (p < 0.001). Conclusion: TGP had a good long-term therapeutic effect on RAU with frequent occurrence. Systematic Review Registration: www.chictr.org.cn, identifier ChiCTR1900025623.

Keywords: Paeonia lactiflora Pall.; efficacy; randomized controlled trial; recurrent aphthous ulcers; safety article types clinical trial; total glucosides of paeony.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Items for daily medication and ulcer records (through diary or app). Tid, three times per day; Bid, two times per day.
FIGURE 2
FIGURE 2
Chromatographic profile of TGP. HPLC conditions: C18 column (250 × 4.6 mm id, 5 μm). The flow rate and injection volume were 0.8 mL/min and 20 μL, and the detecting wavelength was 230 nm. Peak 1: gallic acid; 2: catechin; 3: alibiflorin; 4: paeoniflorin; 5: 1,2,3,4,6-penta-O-galloyl-β-D-glucose; 6: benzoylpaeoniflorin; and 7: benzoylalbiflorin.
FIGURE 3
FIGURE 3
Participant flowchart.
FIGURE 4
FIGURE 4
Comparison between total glucosides of paeony capsules and the placebo in the treatment of recurrent aphthous ulcers. (A) Monthly ulcer-free interval. (B) Monthly number of ulcers. (C) Monthly area of ulcers. (D) VAS, visual analog scoring. TGP, total glucosides of paeony capsules. w, week.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Amare G. G., Meharie B. G., Belayneh Y. M. (2021). A drug repositioning success: The repositioned therapeutic applications and mechanisms of action of thalidomide. J. Oncol. Pharm. Pract. 27 (3), 673–678. 10.1177/1078155220975825 - DOI - PubMed
    1. Blake M. R., Raker J. M., Whelan K. (2016). Validity and reliability of the Bristol Stool Form Scale in healthy adults and patients with diarrhoea-predominant irritable bowel syndrome. Aliment. Pharmacol. Ther. 44 (7), 693–703. 10.1111/apt.13746 - DOI - PubMed
    1. Bratel J., Hakeberg M. (2014). Anamnestic findings from patients with recurrent aphthous stomatitis. Swed. Dent. J. 38 (3), 143–149. - PubMed
    1. Chiang C. P., Yu-Fong Chang J., Wang Y. P., Wu Y. H., Wu Y. C., Sun A. (2019). Recurrent aphthous stomatitis - etiology, serum autoantibodies, anemia, hematinic deficiencies, and management. J. Formos. Med. Assoc. = Taiwan yi zhi. 118 (9), 1279–1289. 10.1016/j.jfma.2018.10.023 - DOI - PubMed
    1. Cui R. Z., Bruce A. J., Rogers R. S., 3rd (2016). Recurrent aphthous stomatitis. Clin. dermatology 34 (4), 475–481. 10.1016/j.clindermatol.2016.02.020 - DOI - PubMed