Effectiveness of combining Qingyanyin formulated granules with press needles in treating abdominal obesity: a multicenter randomized controlled trial.

Abstract

Objective: To assess the efficacy and safety of the Qingyanyin formulated granules (, 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.