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已发表论文
灵舒颗粒与汤剂治疗多囊卵巢综合征伴胰岛素抵抗患者的有效性和安全性比较：一项多中心随机对照剂量探索试验方案
Authors Feng Y, Wen X , Li X, Luo Y
Received 21 July 2025
Accepted for publication 30 October 2025
Published 7 November 2025 Volume 2025:17 Pages 4301—4309
DOI https://doi.org/10.2147/IJWH.S555202
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Matteo Frigerio
Yueying Feng,1 Xiaoyu Wen,1 Xiaobin Li,1– 3 Yunyun Luo1– 3
1The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510000, People’s Republic of China; 2Department of Gynecology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510000, People’s Republic of China; 3Department of Gynecology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510000, People’s Republic of China
Correspondence: Yunyun Luo, Department of Gynecology, Guangdong Provincial Hospital of Chinese Medicine, 1st Fl. 261 Datong Road, Yuexiu District, Guangzhou, 510000, People’s Republic of China, Tel +8615920124853, Email yyluoo@gzucm.edu.cn
Introduction: Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age. Although multiple treatment strategies have been proposed, many patients still experience suboptimal outcomes. Our research team has developed the Lingshu formula, which is grounded in traditional Chinese medicine theory, focusing on kidney deficiency and phlegm dampness. Clinical and animal studies have demonstrated its efficacy in improving insulin resistance, regulating hormonal and lipid metabolism, and reducing obesity, which was non-inferior to metformin. However, Lingshu is traditionally prepared in formula decoction, with a complicated and time-consuming process. The granule preparations have offered the advantages of stable drug quality, convenient storage and administration, and high patient compliance. However, the efficacy, safety, and optimal dosage of the Lingshu formula granules compared to its traditional decoction in the treatment of PCOS patients with insulin resistance still require further investigation. Therefore, this study aims to determine whether the Lingshu formula granules are superior to the traditional decoction and to establish their optimal dosage.
Methods: We will conduct a multicenter, randomized, controlled clinical trial targeted to enroll 200 patients. Eligible participants will be randomly assigned, in a 1:1:1:1 ratio, to group A (low-dose Lingshu granules, − 20% from standard dose), group B (medium-dose Lingshu granules, standard dose), group C (high-dose Lingshu granules, +20% from standard dose), or group D (Lingshu decoction). Treatment will last 90 days. The primary outcome is the insulin resistance index, and secondary outcomes include body mass index, waist-to-hip ratio, and laboratory tests, which will be recorded and compared across these four groups. In addition, variations in symptoms related to the Chinese traditional medicine and adverse events will also be documented and compared.
Discussion: The findings are expected to provide a scientific basis for the clinical application of the Lingshu formula granules in PCOS patients with insulin resistance and promote widespread use of traditional Chinese medicine.
Keywords: Lingshu formula, granule, decoction, polycystic ovary syndrome, insulin resistance
1The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510000, People’s Republic of China; 2Department of Gynecology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510000, People’s Republic of China; 3Department of Gynecology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510000, People’s Republic of China
Correspondence: Yunyun Luo, Department of Gynecology, Guangdong Provincial Hospital of Chinese Medicine, 1st Fl. 261 Datong Road, Yuexiu District, Guangzhou, 510000, People’s Republic of China, Tel +8615920124853, Email yyluoo@gzucm.edu.cn
Introduction: Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age. Although multiple treatment strategies have been proposed, many patients still experience suboptimal outcomes. Our research team has developed the Lingshu formula, which is grounded in traditional Chinese medicine theory, focusing on kidney deficiency and phlegm dampness. Clinical and animal studies have demonstrated its efficacy in improving insulin resistance, regulating hormonal and lipid metabolism, and reducing obesity, which was non-inferior to metformin. However, Lingshu is traditionally prepared in formula decoction, with a complicated and time-consuming process. The granule preparations have offered the advantages of stable drug quality, convenient storage and administration, and high patient compliance. However, the efficacy, safety, and optimal dosage of the Lingshu formula granules compared to its traditional decoction in the treatment of PCOS patients with insulin resistance still require further investigation. Therefore, this study aims to determine whether the Lingshu formula granules are superior to the traditional decoction and to establish their optimal dosage.
Methods: We will conduct a multicenter, randomized, controlled clinical trial targeted to enroll 200 patients. Eligible participants will be randomly assigned, in a 1:1:1:1 ratio, to group A (low-dose Lingshu granules, − 20% from standard dose), group B (medium-dose Lingshu granules, standard dose), group C (high-dose Lingshu granules, +20% from standard dose), or group D (Lingshu decoction). Treatment will last 90 days. The primary outcome is the insulin resistance index, and secondary outcomes include body mass index, waist-to-hip ratio, and laboratory tests, which will be recorded and compared across these four groups. In addition, variations in symptoms related to the Chinese traditional medicine and adverse events will also be documented and compared.
Discussion: The findings are expected to provide a scientific basis for the clinical application of the Lingshu formula granules in PCOS patients with insulin resistance and promote widespread use of traditional Chinese medicine.
Keywords: Lingshu formula, granule, decoction, polycystic ovary syndrome, insulin resistance