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ORIGINAL RESEARCH article

Front. Pharmacol.

Sec. Ethnopharmacology

Volume 16 - 2025 | doi: 10.3389/fphar.2025.1673112

The Effects of Chinese Botanical Lotion and Pimecrolimus Cream in the Treatment of Chronic Perianal Eczema: A Randomized Clinical Trial

Provisionally accepted
Lixia  LaiLixia Lai1Yanmei  WangYanmei Wang1Lvping  WenLvping Wen2Shaozhao  WangShaozhao Wang3Si  ChenSi Chen4Chao  GuChao Gu5*Zeye  ZhangZeye Zhang4*
  • 1Department of Proctology, China-Japan Friendship Hospital, Beijing, China
  • 2Anorectal Section, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
  • 3Department of Anorectal Word, Jinan Central Hospital, Jinan, China
  • 4Zhejiang Chinese Medical University School of Basic Medical Sciences, Hangzhou, China
  • 5Department of Anorectal Surgery, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China

The final, formatted version of the article will be published soon.

Background: Fumigation and sitz-bath therapy are traditional Chinese medicine (TCM) practices that offer unique benefits for managing chronic perianal eczema (CPE). This study aimed to investigate the clinical efficacy of the traditional Chinese herbal lotion (anal pruritus lotion, APL) combined with pimecrolimus cream in CPE treatment. Methods: Patients with CPE admitted between October 2019 and March 2022 were analyzed. The control group was given basic therapy with pimecrolimus cream, whereas the treatment group received pimecrolimus cream combined with APL under fumigation and sitz-bath therapy. We recorded and compared baseline patient information and clinical symptoms pre-and post-therapy, including clinical symptom scores, the eczema area and severity index (EASI), pruritus visual analogue scale (VAS) scores, dermatology life quality index (DLQI), and efficacy evaluations. Additionally, safety assessments and follow-up surveys were performed, as well. Results: Baseline data were comparable between the treatment and control groups. Post-therapy, the treatment group exhibited significantly improved outcomes compared to the control group in eczema severity, pruritus VAS scores, and dermatology life quality, with lower relapse rates (P < 0.05). Safety evaluations suggested that the treatments were safe and reliable. Conclusion: The combination of pimecrolimus cream and APL is more effective in the treatment of CPE than pimecrolimus cream alone, providing a promising new approach for the clinical management of perianal eczema. Trial registration: International Traditional Medicine Clinical Trial Registry, ITMCTR 2024000576. http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=58f1a168-bdf1-4e2a-a9bd-cf0f4a3ec06f

Keywords: chronic perianal eczema, Pimecrolimus cream, Chinese botanical lotion, fumigation and sitz-bath therapy, anal pruritus lotion

Received: 25 Jul 2025; Accepted: 23 Oct 2025.

Copyright: © 2025 Lai, Wang, Wen, Wang, Chen, Gu and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Chao Gu, guchao1983812@163.com
Zeye Zhang, 20210941110@bucm.edu.cn

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.