Efficacy and safety of electroacupuncture for overweight and obese patients with anxiety: a randomized sham-controlled trial

Anxiety is a common manifestation in obese patients, and is closely linked to the progression of obesity. While electroacupuncture (EA) has shown efficacy in treating anxiety or obesity, high-quality clinical evidence supporting its effectiveness in obese patients with anxiety is lacking. This study is to investigate the effectiveness and safety of real EA (R-EA) versus sham EA (S-EA) as an alternative therapy for overweight and obese patients with anxiety. This patient-and assessor-blinded, randomized, sham-controlled trial included 72 Chinese adults with a body mass index (BMI) over 25 kg/m 2 and anxiety symptoms. Participants were randomly assigned to the R-EA or S-EA groups in a 1:1 ratio. All participants received a total of 24 treatment sessions (administered three times per week for 8 weeks) and underwent a 4-week follow-up period. The primary outcomes were changes in Self-Rating Anxiety Scale (SAS) score and weight after treatment. The secondary outcomes included the State-Trait Anxiety Inventory (STAI), Pittsburgh Sleep Quality Index (PSQI), BMI, waist circumference, and serum levels of adrenocorticotropic hormone (ACTH), cortisol (CORT), fasting blood-glucose (FBG), triglycerides (TG), and total cholesterol (TC). Compared with the S-EA group, the R-EA group showed a significantly greater reduction in SAS score after treatment, with a mean difference (MD) of 7.66 (95% CI: 2.27 to 13.05, P = 0.006). No statistically significant between-group difference was observed for body weight (MD:3.6 kg, 95% CI: -0.86 to 8.06, P = 0.112). For secondary outcomes, the R-EA group showed significant improvements over the S-EA group in STAI-1 (MD:6.61, 95%CI: 1.06 to 12.16, P = 0.02), STAI-2 (MD: 5.51, 95%CI: 0.16 to 10.86, P = 0.044), PSQI (MD: 1.86, 95%CI: 0.55 to 3.17, P = 0.006), CORT (MD:1365.96,95%CI: 886.71 to 1864.21, P < 0.001) and ACTH (MD: 13.88, 95%CI: 4.03 to 23.74, P = 0.006), while BMI, waist, WHR, FBG, TG, TC did not differ significantly between groups (all P > 0.05) after treatment. The proportion of participants achieving the minimal clinically important difference (≥ 5% weight reduction from baseline) was higher in the R-EA group than in the S-EA group (13/36, 36.1% vs. 5/36, 13.9%; χ² = 4.74, P = 0.029). EA significantly improved anxiety and sleep quality in overweight/obese patients with comorbid anxiety after 8 weeks of treatment, while no significant between-group difference was observed for body weight reduction. Exploratory analyses indicated a potential for clinically meaningful weight loss in the R-EA group, which warrant further investigation. Chinese Clinical Trial Registry: ChiCTR2400083594. Registered April 29, 2024, https://www.chictr.org.cn/showproj.html?proj=220741 .