Efficacy of Wenyang jieyu recipe on residual fatigue in major depressive disorder: a randomized double-blind controlled trial

doi:10.3969/j.issn.1006-7795.2026.03.018

Abstract

Abstract: Objective To investigate the clinical efficacy and safety of Wenyang Jieyu recipe in treating residual fatigue symptoms in patients with depressive disorder. Methods A randomized, double-blind, placebo-controlled trial was conducted. Patients with unipolar depressive episodes and residual fatigue symptoms (kidney deficiency and liver depression syndrome) who met the inclusion criteria were enrolled, with 111 patients completing the study. They were randomly assigned in a 1∶1 ratio to the experimental group (Wenyang Jieyu formula granules + maintenance dose of escitalopram oxalate, n=55) and the control group (Chinese herbal placebo + maintenance dose of escitalopram oxalate, n=56). Assessments were performed at baseline and at weeks 2, 4 and 8, including the Fatigue Scale-14 (FS-14), traditional Chinese medicine (TCM) symptom score, Hamilton Depression Scale-17 Item (HAMD-17) , Hamilton Anxiety Scale (HAMA), Clinical Global Impression (CGI) , Young Mania Rating Scale (YMRS) , Personal and Social Performance Scale-Chinese Version (PSP-CHN) , and Treatment Emergent Symptom Scale (TESS) . Inflammatory markers and brain-derived neurotrophic factor (BDNF) levels were measured at week 8. The primary outcome was the change in FS-14 score from baseline to week 8. Results Compared with the control group, the experimental group showed more obvious improvement in fatigue symptoms. Repeated-measures ANOVA revealed significant time (P<0.01) and group effects (P<0.01) for FS-14 scores. At weeks 4 and 8, the experimental group had lower FS-14 score than the control group (P<0.01 for both time points). For secondary outcomes, the experimental group also showed greater reductions in HAMD-17, HAMA, and TCM symptom scores (all P<0.01). There was no significant difference between the two groups in baseline YMRS score (P>0.05). At week 8, the experiment group had significantly lower YMRS score than the control group (P0.01), with no significant difference between the two groups at weeks 2 and 4. PSP scores also showed no statistical difference between groups. Patients tolerated the treatment well, and no increased risk of adverse events was observed. Conclusion Wenyang Jieyu recipe can improve residual fatigue symptoms in patients with depression, and it also provides additional benefits for depressive and anxiety symptoms as well as TCM patterned kidney deficiency and liver depression syndrome. This therapy does not increase the risk of mania with a favorable safety profile, and show potential for clinical application.

Key words: depression, residual fatigue symptoms, Wenyang Jieyu therapy, randomized controlled trial, double-blind method, traditional Chinese medicine therapy

CLC Number:

Xu Huanshu, Yin Dongqing, Jia Hongxiao. Efficacy of Wenyang jieyu recipe on residual fatigue in major depressive disorder: a randomized double-blind controlled trial[J]. Journal of Capital Medical University, 2026, 47(3): 549-557.

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