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Journal of Traditional Chinese Medicine >

2025 , Vol. 45 >Issue 1: 107 - 114

DOI: https://doi.org/10.19852/j.cnki.jtcm.2025.01.009

Effectiveness of combining Qingyanyin formulated granules (轻燕饮配方颗粒) with press needles in treating abdominal obesity: a multicenter randomized controlled trial

  • Wujie YE ,
  • Yawei YANG ,
  • Da ZHANG ,
  • Ling TANG ,
  • Minying CUI ,
  • Bin FU ,
  • Meng ZHANG ,
  • Xingang HU ,
  • Yan ZHAO
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  • 1 School of Chinese Medicine, Beijing University of Traditional Chinese Medicine, Beijing 100029, China
    2 Department of Dermatology, the Afiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University, Guangzhou 510100, China
    3 School of Life Sciences, Beijing University of Traditional Chinese Medicine, Beijing 100029, China
    4 Physical Examination Center, Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100078, China
    5 Gynecology Department, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing 100700, China
    6 Preventive Treatment Center, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, China
    7 Physical Examination Center, Beijing University of Chinese Medicine East Hospital, Zaozhuang 277101, China
    8 Internal Encephalopathy of Traditional Chinese Medicine, Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100078, China

Received date: 2023-12-22

  Accepted date: 2024-04-25

  Online published: 2025-01-10

Supported by

National Key Research and Development Project: Clinical Evaluation of the Interventional Techniques for Abdominal Obesity(2019YFC1710102)

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Abstract

OBJECTIVE: To assess the efficacy and safety of the Qingyanyin formulated granules (轻燕饮配方颗粒, QYY), press needles (PN), and their combined application in addressing abdominal obesity (AO). This trial aims to offer a more scientifically grounded therapeutic regimen for clinical interventions.

METHODS: From March 2021 to July 2021, a multicenter, triple －blind, randomized 2 × 2 factorial design clinical trial was conducted across 7 centers in 4 major cities within mainland China. The trial participants were patients diagnosed with AO. The trial followed a 1∶1∶1∶1 random allocation ratio, assigning participants to one of four groups: QYY placebo plus simulated press needles (SPN) (placebo + SPN), QYY plus SPN (QYY + SPN), QYY placebo plus PN (placebo + PN), and QYY plus PN (QYY + PN). The trial participants received treatment for 12 weeks. Observe the changes in waist circumference, body weight, body mass index (BMI), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) scores, and Pittsburgh Sleep Quality Index (PSQI) before and after treatment.

RESULTS: The QYY + PN group exhibited significant improvements in waist circumference compared to placebo + PN [Difference = －1.59, 95% CI (－3.03, －0.16)] and placebo + SPN groups [Difference = －2.01, 95% CI (－3.46, －0.57)]. QYY + PN demonstrated a significant advantage over placebo + SPN [Difference = －2.01, 95% CI (－3.46, －0.57)], and no statistically significant interaction was observed between the two interventions (P > 0.05). In terms of weight and BMI improvements, the QYY + PN, QYY + SPN, and the PN + placebo groups all experienced trending greater reductions in weight compared to the placebo group. In terms of the total scores of PSQI, BAI, and BDI, all four groups exhibited improvements compared to the baseline. Specifically, concerning the change in total PSQI scores, the QYY + PN group exhibited a greater reduction; Regarding the change in total BAI scores, the PN + placebo group demonstrated a greater decrease;As for the change in total BDI scores, the QYY + SPN group displayed a greater reduction.

CONCLUSION: This study confirmed that QYY + PN can effectively reduce the waist circumference of patients with AO. Furthermore, the combined approach offers greater benefits than either treatment alone, all without any reported serious adverse events.

Key words： obesity, abdominal; body mass index; press needle; randomized controlled trial; Qingyanyin formulated granules

Cite this article

Wujie YE , Yawei YANG , Da ZHANG , Ling TANG , Minying CUI , Bin FU , Meng ZHANG , Xingang HU , Yan ZHAO . Effectiveness of combining Qingyanyin formulated granules (轻燕饮配方颗粒) with press needles in treating abdominal obesity: a multicenter randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2025 , 45(1) : 107 -114 . DOI: 10.19852/j.cnki.jtcm.2025.01.009

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