ArticleChinese medicine2026
Clinical efficacy and multi-omics analysis of Si-Ni-San for depression treatment in breast cancer patients: a randomized, double-blind, placebo-controlled, crossover trial.
Article in Chinese medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Modified sini powder for the management of postoperative depression in non-small cell lung cancer patients: a multicenter, randomized, double-blind, placebo-controlled trial protocol.Frontiers in pharmacology · 2026Article
- Diet, gut microbiota, and the gut-brain axis: mechanistic interactions and therapeutic implications in neuropsychiatric disorders.Frontiers in cellular and infection microbiology · 2026Review
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Authors and funding
14 authors.
Funding
Abstract
backgroundBreast cancer is a leading malignancy and a significant cause of mortality in women. The coexistence of depression has been associated with a more aggressive breast cancer progression. Si-Ni-San (SNS), a Traditional Chinese medicine (TCM) formula, has been traditionally used for the treatment of depression. This clinical trial aimed to evaluate the effectiveness and safety of SNS in relieving depression in breast cancer patients, and explore its molecular mechanism.
methodsA randomized, double-blind, placebo-controlled crossover trial was conducted in breast cancer patients with mild to moderate depression (MMD). Patients were asked to participate over a four-week SNS treatment and a four-week placebo intervention in randomized order, with a two-week washout period. The primary endpoint was the change of Hamilton Depression Scale-24 (HAMD-24) score. Secondary endpoints were the changes of Functional Assessment of Cancer Therapy-Breast (FACT-B) and syndrome score of Traditional Chinese medicine (TCMSS). Liver function test (LFT) and mental status examination (MSE) were conducted to ensure the safety. Gut microbiota, serum metabolomics, cytokine profiling and T lymphocyte subsets were tested to explore the molecular mechanisms.
resultsA total of 53 patients completed the trial. Compared to placebo intervention, SNS treatment significantly reduced HAMD-24 score (4.46 ± 4.403 (95% CI - 5.69, - 3.24) vs. 0.66 ± 4.463 (95% CI - 1.89, 0.57), P < 0.001), accompanied by the improved FACT-B scores (7.22 ± 13.77 (95% CI 3.66, 10.77) vs. - 0.78 ± 15.32 (95% CI - 4.74, 3.17), P = 0.09) and TCMSS scores (- 12.71 ± 12.88 (95% CI - 16.30, - 9.13) vs. - 5.60 ± 4.69 (95% CI - 9.42, - 1.79), P = 0.01). No obvious risk in LFT, MSE and fewer adverse events were observed. Exploratory multi-omics analyses revealed three key phenomenon including specific reduction in Lactobacillus abundance, decreased serum indole levels, and increased CD8
conclusionsSNS is efficacious for relieving depression in breast cancer patients with high safety, and Lactobacillus-Indole-CD8
trial registrationChiCTR, ChiCTR2200065009. Registered 25 October 2022.
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