Efficacy of Acupuncture Combined With Pharmacotherapy for Depression: A Randomized Controlled Clinical Trial.

Background: Depression is frequently accompanied by comorbid symptoms such as anxiety, insomnia, and cognitive impairment, which complicate treatment and adversely affect clinical outcomes. Acupuncture has shown promise as a complementary therapy; however, the efficacy of acupuncture combined with selective serotonin reuptake inhibitors (SSRIs) requires further investigation. Methods: This single-center, randomized clinical trial enrolled 213 inpatients with depression and comorbid symptoms. Participants were randomly assigned to receive either SSRIs treatment or antidepressant treatment combined with acupuncture for two weeks. Clinical outcomes were assessed using the Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), Mini-Mental State Examination (MMSE), Pittsburgh Sleep Quality Index (PSQI), and Beck Scale for Suicide Ideation (BSI). The primary outcome was the change in the HAMD reduction rate. Results: Both groups demonstrated significant clinical improvement after two weeks of treatment. However, analysis of covariance (ANCOVA) revealed that the acupuncture group achieved significantly greater reductions in HAMD, HAMA, and PSQI scores, as well as significantly higher MMSE scores, compared with the control group (all adjusted Conclusions: When used as an adjunct to antidepressant therapy, acupuncture provides rapid and broad therapeutic benefits for patients with depression. Compared with SSRI monotherapy, the combined treatment was associated with greater improvements in depressive and anxiety symptoms, sleep quality, and cognitive performance. These findings support the integration of acupuncture into multimodal treatment strategies for managing the complex symptom profile of major depressive disorder. Clinical Trial Registration: The study has been registered on https://itmctr.ccebtcm.org.cn/en/index.html (registration number: ITMCTR2025001802; registration link: https://trialsearch.who.int/Trial2.aspx?TrialID=ITMCTR2025001802).