Objective  To explore the clinical efficacy and safety of Lactobacillus acidophilus complex as adjuvant therapy for generalized anxiety disorder (GAD), and preliminarily explore its mechanism of action from the perspectives of neurotransmitters and inflammatory factors.

Methods  The clinical data of GAD patients diagnosed and treated in the Sleep Medical Center of Huzhou Third People's Hospital from September 2021 to August 2023 were retrospectively collected in this study. According to whether probiotics were used in combination, the patients were divided into the combination group (probiotics combined with duloxetine or paroxetine) and the monotherapy group (duloxetine or paroxetine). The primary efficacy indicator of this study was the clinical response rate after 8-week treatment. The secondary observation indicators were the changes in Self-Rating Anxiety Scale (SAS) scores, Hamilton Anxiety Rating Scale (HAMA) scores, Pittsburgh Sleep Quality Index (PSQI) scores, serum neurotransmitter levels [norepinephrine (NE), 5-hydroxytryptamine (5-HT), glutamate (Glu)] and serum inflammatory factor levels [C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL- 6)] before and after treatment. In addition, the occurrence of adverse reactions during treatment in the two groups was evaluated.

Results  A total of 105 GAD patients were included in this study, with 40 in the combination group and 65 in the monotherapy group. After 8-week treatment, the clinical response rate of the combination group was significantly higher than that of the monotherapy group (95.00% vs. 80.00%, P<0.05). Compared with those before treatment, the SAS scores, HAMA scores, PSQI scores, and the levels of NE, Glu, CRP, TNF-α and IL-6 in both the combination group and the monotherapy group decreased significantly (P<0.05), while the 5-HT level increased significantly (P<0.05). In addition, after treatment, the SAS scores, HAMA scores, PSQI scores, and the levels of NE, Glu, CRP, TNF-α and IL-6 in the combination group were significantly lower than those in the monotherapy group (P<0.05), while the 5-HT level was significantly higher than that in the monotherapy group (P<0.05). In terms of adverse reactions, the incidence of adverse reactions in the combination group was lower than that in the monotherapy group, but there was no statistical difference (P>0.05).

Conclusion  Probiotic adjuvant therapy can improve the efficacy after 8 weeks, alleviate anxiety symptoms and sleep quality. It may exert its effects by regulating neurotransmitter and inflammatory balance.

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