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. 2024 Mar 8;103(10):e37226. doi: 10.1097/MD.0000000000037226

Efficacy and safety of Xiaoyao Pill combined with Western medicine in the treatment of schizophrenia: A Meta-analysis and Systematic review

Lili Cai a,*, Lianqi Liu a,b, Zhibing Jiang a, Zhongxing Liang a, Yuehua Yang a
PMCID: PMC10919496  PMID: 38457544

Abstract

Background:

The efficacy and safety of Xiaoyao Pill combined with Western medicine in the treatment of schizophrenia are still inconclusive. This meta-analysis summarized relevant studies to compare the efficacy and safety of Xiaoyao Pill combined with Western medicine and Western medicine alone in the treatment of schizophrenia, aiming to provide guidance for clinical treatment.

Methods:

In this meta-analysis, we searched PubMed, Embase, Cochrane Library, CNKI, Wanfang, CQVIP, and CBM databases from the establishment of the databases to August 2023. The study proposed to include studies that reported combination of Xiaoyao Pill with Western medicine and Western medicine alone in the treatment of schizophrenia, excluding published literature, unpublished literature, literature with incomplete or inadequate information, animal experiments, literature reviews and systematic studies. Data were analyzed using Review manager 5.3.

Results:

About 9 studies (6 RCTs and 3 case–control studies) were included in this meta-analysis. The sample size ranged from 60 to 128, with a total of 779 patients, including 395 in the combined treatment group and 384 in the control group. Pooled results showed that the total effective rate of combined treatment group was significantly higher than that of Western medicine alone (OR = 4.21, 95% CI: 1.50–11.83, P = .006). Positive and Negative Syndrome Scale (PANSS) (−) (MD = −2.30, 95% CI: −3.72 ~ −0.89, P = .001) and PANSS (+) (MD = −2.60, 95% CI: −3.34 ~ −1.86, P < .00001) of combined treatment group were all significantly lower than that of Western medicine alone. Additionally, PRL levels of combined treatment group was significantly lower than that of Western medicine alone (MD = −28.78, 95% CI: −42.20 ~ −15.35, P < .0001). However, there was no significant difference in BPRS and total PANSS between combined treatment group and Western medicine alone group. Notably, pooled results showed that there was no significant difference in incidence of adverse events between combined treatment group and Western medicine alone group.

Conclusion:

The effective rate of Xiaoyao Pill combined with Western medicine in the treatment of schizophrenia is higher than that of Western medicine alone, which can effectively relieve the positive and negative symptoms of schizophrenia, and can significantly reduce the level of PRL. In the treatment of schizophrenia, clinicians can give priority to Xiaoyao Pill combined with Western medicine therapy.

Keywords: efficacy and safety, meta-analysis and systematic review, Schizophrenia, Western medicine, Xiaoyao Pill

1. Introduction

Schizophrenia is a common mental disorder, and its specific causes are not yet fully understood. Its clinical features primarily include behavioral, emotional, and cognitive inconsistencies, as well as detachment from the real environment.[1,2] In recent years, the incidence of schizophrenia has been steadily increasing, often recurring with symptoms gradually worsening, leading to a decline in patients’ social functioning, and possibly even mental deterioration, significantly impacting their quality of life.[3,4] Assessment of symptoms associated with schizophrenia relied on the Brief Psychiatric Rating Scale (BPRS) and Positive and Negative Syndrome Scale (PANSS).[5,6] Hyperprolactinemia (HPRL) is a common adverse effect of antipsychotic drugs in clinical practice.[7,8] Given its high occurrence, HPRL becomes a pivotal consideration in our study, potentially influencing the treatment and quality of life for individuals with schizophrenia.

Currently, schizophrenia is primarily treated with Western medicine, but due to various adverse reactions associated with Western medicine, it can affect patient treatment compliance.[9] Recognizing these limitations, there is a growing interest in embracing traditional Chinese medicine (TCM) as a complementary approach. Within the TCM framework, which classifies schizophrenia as “dian zheng” and “kuang zheng,” the integration of TCM with Western medicine has demonstrated notable efficacy and safety.[10,11] This combined approach not only enhances therapeutic outcomes but also ensures good safety profiles for the medications employed. Among these interventions, Xiaoyao Pill, a TCM, is gaining prominence in the treatment of patients with schizophrenia.[12,13] However, the efficacy and safety of Xiaoyao Pill combined with Western medicine in the treatment of schizophrenia are still inconclusive. This meta-analysis aims to address this gap in knowledge by summarizing relevant studies and comparing the efficacy and safety of Xiaoyao Pill combined with Western medicine vs Western medicine alone in treating schizophrenia. The goal is to provide valuable insights that can guide clinical treatment decisions and contribute to a more comprehensive understanding of optimal therapeutic approaches for schizophrenia.

2. Methods

2.1. Literature inclusion and exclusion criteria

2.1.1. Inclusion criteria.

  1. Subjects: patients with schizophrenia.

  2. Interventions: Combination of Xiaoyao Pill and Western medicine in the treatment of schizophrenia.

  3. Control: The control group exclusively receives TCM treatment for schizophrenia.

  4. Outcome indicators: Total effective rate, BPRS (a widely used professional rating scale in psychiatry), PANSS (a scale in psychiatry used to assess the severity of symptoms in patients with psychosis), Prolactin (PRL) levels and incidence of adverse events including extra pyramidal symptoms (EPS), headache, hydrostomia, dizziness, gastrointestinal sympotms, and sleepness. When it comes to selecting outcome indicators, this study initially extracted various outcome indicators aligned with the study’s objectives. Subsequently, the study retained those indicators that were consistently present in at least 2 literature sources.

  5. Study design: randomized controlled trial and observational study.

2.1.2. Exclusion criteria.

Duplicate publications; studies for which full text was not available or for which data extraction was not possible; studies using animal studies; reviews and systematic reviews.

2.2. Search strategy

In this meta-analysis, we searched PubMed, Embase, Cochrane Library, CNKI, Wanfang, CQVIP, and CBM databases from the establishment of the databases to August 2023. The mesh terms used were: (((((((“Schizophrenia”[Mesh]) OR (Schizophrenias [Title/Abstract])) OR (Schizophrenic Disorders [Title/Abstract])) OR (Disorder, Schizophrenic [Title/Abstract])) OR (Disorders, Schizophrenic [Title/Abstract])) OR (Schizophrenic Disorder [Title/Abstract])) OR (Dementia Praecox [Title/Abstract])) AND ((Xiaoyao Pill [Title/Abstract]) OR (Xiaoyao Pills [Title/Abstract])).

2.3. Literature screening and data extraction

Two researchers conducted the search for information, the screening of information and the capture of information respectively. Any questions or disagreements were made after consultation with a third party. Information was collected by author, year, study design, number of cases, and outcome indicators.

2.4. Literature quality assessment

Two researchers carried out separate independent evaluations of the quality of the literature, using the Review Manager 5.3 software risk assessment tool to evaluate the included literature according to random sequence generation, allocation concealment, blinding, whether research results were blinded to review, completeness of outcome data, using the Cochrane Risk Assessment Scale, and gender, selection of reported research outcomes, other biases, etc., and in cases of disagreement, through discussion or consultation with third parties. The Meta-analysis was performed in accordance with the relevant items in the Preferred Reporting Items for Systematic Reviews and Meta Analysis (PRISMA) statement.[14]

2.5. Data synthesis and statistical analysis

Data were analyzed using Review Manager 5.3. Mean differences with 95% CI were used as continuous variables. I2 was used to evaluate cell heterogeneity. If the test for heterogeneity was P ≥ .1 and I2 ≤ 50%, homogeneity between studies was indicated and the studies were analyzed together using a fixed effects model; if P < .1 and I2 > 50%, significant heterogeneity between this group was indicated; if there was a difference, the source of the difference was identified using sensitivity analysis. If the differences were still large, the random-effects model was used or the results of the combined study were discarded in favor of descriptive analysis. Publication bias was analyzed using funnel plots (funnel plots were examined for symmetry, where the presence of publication bias might be indicated by an asymmetrical distribution of data points. Typically, a symmetric funnel plot suggests a lower likelihood of publication bias).

3. Results

3.1. Literature search results

A total of 75 articles were collected for this study. After excluding duplicate trials, 26 patients were included in this study. A total of 21 articles were identified after reading their titles and abstracts. Finally, 9 studies were included in the meta-analysis (Fig. 1).

Figure 1.

Figure 1.

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Flow diagram for selection of studies.

3.2. Baseline characteristics and quality assessment of the included studies

Nine studies (6 RCTs and 3 case-control studies) were included in this meta-analysis. The sample size ranged from 60 to 128, with a total of 779 patients, including 395 in the Combined treatment group and 384 in the Control group. The age distribution of patients in the combined treatment group was 25.2–45.3, and the age distribution of patients in the control group was 24.2–44.8, suggesting that the ages were comparable. Western medicines used include Risperidone, Clozapine, and Olanzapine. The NOS scores used for quality assessment were all > 7 and met the requirements (Table 1). The quality assessment results of the 6 RCTs are shown in Figures 2 and 3. The findings showed that all studies included in this review described the formation of random sequences. However, none of the studies described “Allocation concealment” and whether blind methods were used (Figs. 2 and 3).

Table 1.

Baseline characteristics and quality assessment of the included studies.

Author Year Study design Sample size Sex (female/male) Age Duration of disease Measurements NOS score
Combined treatment group Control group Combined treatment group Control group Combined treatment group Control group Combined treatment group Control group Combined treatment group Control group
Xu[15] 2008 Case-control 30 30 30/0 30/0 34.58 ± 9.4 36.45 ± 10.2 48.0 ± 3.0 48.0 ± 3.0 Xiaoyao Pill + Risperidone and Clozapine Risperidone and Clozapine 7
Yu[16] 2009 RCT 58 62 58/0 62/0 32.68 ± 9.8 30.95 ± 9.2 42.0 ± 3.5 43.0 ± 2.6 Xiaoyao Pill + Risperidone and Clozapine Risperidone and Clozapine –
Xiong[17] 2011 Case-control 50 35 50/0 35/0 31.2 ± 7.5 34.8 ± 15.6 Xiaoyao Pill + Clozapine Clozapine 7
Sun[18] 2014 RCT 40 40 6/34 7/33 43.0 ± 5.9 44.0 ± 5.0 145.2 ± 66 140.4 ± 68.4 Xiaoyao Pill + Risperidone Risperidone –
Liu[12] 2015 RCT 36 36 36/0 36/0 25.2 ± 12.3 24.2 ± 13.5 / / Xiaoyao Pill + Risperidone Risperidone –
Zhan[19] 2016 Case-control 64 64 64/0 64/0 29.3 28.1 28.2 ± 23.6 31.1 ± 21.7 Xiaoyao Pill + Risperidone Risperidone 8
Su[20] 2017 RCT 30 30 30/0 30/0 25.3 ± 4.9 30.2 ± 7.6 27.6 ± 16.8 30.0 ± 12.0 Xiaoyao Pill + Risperidone Risperidone –
Huang[21] 2018 RCT 47 47 16/31 15/32 45.3 ± 4.2 44.8 ± 4.3 7.43 ± 1.26 7.69 ± 1.41 Xiaoyao Pill + Olanzapine Olanzapine –
Chen[22] 2023 RCT 40 40 17/23 18/22 31.8 ± 7.2 31.6 ± 7.3 51.5 ± 9.7 51.3 ± 9.7 Xiaoyao Pill + Olanzapine Olanzapine –
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Figure 2.

Figure 2.

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Risk of bias graph.

Figure 3.

Figure 3.

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Risk of bias summary.

3.3. Results of meta-analysis

3.3.1. Total effective rate.

Seven studies compared the total effective rate of Xiaoyao Pill combined with Western medicine and Western medicine alone in the treatment of schizophrenia. Since there was significant heterogeneity (I2 = 69%, P = .004), a random-effect model was used for the meta-analysis. The results showed that the total effective rate of combined treatment group was significantly higher than that of Western medicine alone (OR = 4.21, 95% CI: 1.50–11.83, P = .006) (Fig. 4).

Figure 4.

Figure 4.

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Comparing the differences in total effective rate between Xiaoyao Pill combined with Western medicine and Western medicine alone.

3.3.2. BPRS.

Two studies compared the BPRS of Xiaoyao Pill combined with Western medicine and Western medicine alone in the treatment of schizophrenia. Since there was no significant heterogeneity (I2 = 0%, P = .95), a fixed-effect model was used for the meta-analysis. The pooled results showed that there was no significant difference in BPRS between combined treatment group and Western medicine alone group (MD = −0.34, 95% CI: −2.16 ~ 1.47, P = .95) (Fig. 5).

Figure 5.

Figure 5.

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Comparing the differences in BPRS between Xiaoyao Pill combined with Western medicine and Western medicine alone.

3.3.3. Total PANSS.

Four studies compared the total PANSS of Xiaoyao Pill combined with Western medicine and Western medicine alone in the treatment of schizophrenia. Since there was significant heterogeneity (I2 = 87%, P < .0001), a random-effect model was used for the meta-analysis. The pooled results showed that there was no significant difference in total PANSS between combined treatment group and Western medicine alone group (MD =  −2.55, 95% CI: −7.14~2.04, P = .28) (Fig. 6).

Figure 6.

Figure 6.

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Comparing the differences in PANSS between Xiaoyao Pill combined with Western medicine and Western medicine alone.

3.3.4. PANSS (−).

Four studies compared the PANSS (-) of Xiaoyao Pill combined with Western medicine and Western medicine alone in the treatment of schizophrenia. There was significant heterogeneity (I2 = 72%, P = .01) (Fig. 7A) and sensitivity analysis found that the study of Sun et al had a great influence on the results. Heterogeneity was significantly reduced after this study was excluded (I2 = 55%, P = .11) and a random-effect model was used for the meta-analysis. The pooled results showed that PANSS (−) of combined treatment group was significantly lower than that of Western medicine alone (MD = −2.30, 95% CI: −3.72 ~ −0.89, P = .001) (Fig. 7B).

Figure 7.

Figure 7.

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(A) Comparing the differences in PANSS (−) between Xiaoyao Pill combined with Western medicine and Western medicine alone (before sensitivity analysis). (B) Comparing the differences in PANSS (−) between Xiaoyao Pill combined with Western medicine and Western medicine alone (after sensitivity analysis).

3.3.5. PANSS (+).

Four studies compared the PANSS (+) of Xiaoyao Pill combined with Western medicine and Western medicine alone in the treatment of schizophrenia. Since there was no significant heterogeneity (I2 = 0%, P = .82), a fixed-effect model was used for the meta-analysis. The pooled results showed that PANSS (+) of combined treatment group was significantly lower than that of Western medicine alone (MD = −2.60, 95% CI: −3.34 ~ −1.86, P < .00001) (Fig. 8).

Figure 8.

Figure 8.

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Comparing the differences in PANSS (+) between Xiaoyao Pill combined with Western medicine and Western medicine alone.

3.3.6. PRL.

Two studies compared the PRL of Xiaoyao Pill combined with Western medicine and Western medicine alone in the treatment of schizophrenia. Since there was significant heterogeneity (I2 = 94%, P < .0001), a random-effect model was used for the meta-analysis. The pooled results showed that PRL levels of combined treatment group was significantly lower than that of Western medicine alone (MD = −28.78, 95% CI: −42.20 ~ −15.35, P < .0001) (Fig. 9).

Figure 9.

Figure 9.

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Comparing the differences in PRL between Xiaoyao Pill combined with Western medicine and Western medicine alone.

3.3.7. Adverse events.

Pooled results showed that there was no significant difference in incidence of EPS (OR = 0.93, 95% CI: 0.53–1.64, P = .79), headache (OR = 0.94, 95% CI: 0.23–3.86, P = .94), hydrostomia (OR = 1.32, 95% CI: 0.52–3.35, P = .56), dizziness (OR = 0.41, 95% CI: 0.10–1.63, P = .21), gastrointestinal symptoms (OR = 0.71, 95% CI: 0.33–1.52, P = .38) and sleepness (OR = 0.38, 95% CI: 0.07–2.04, P = .26) between combined treatment group and Western medicine alone group (Fig. 10).

Figure 10.

Figure 10.

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Comparing the differences in incidence of adverse events between Xiaoyao Pill combined with Western medicine and Western medicine alone.

3.4. Sensitivity analysis

We performed a sensitivity analysis to exclude each trial individually, and then performed a combined analysis of the remaining trials. By performing a meta-analysis, we found that the study by Sun et al had a large impact on the results of the analysis of PANSS (−); no articles were found in the analyses of other outcomes that significantly impacted the results.

3.5. Publication bias

Figures 11 present the funnel plots. The funnel plots were symmetrical, indicating there was no obvious publication bias in this study.

Figure 11.

Figure 11.

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Funnel plot for evaluating the publication bias of this meta-analysis.

4. Discussion

Most of schizophrenia is in the absence of obvious causes of disease, the course of disease is relatively long, and the disease shows a chronic trend of gradual development.[23,24] The specific biochemical mechanism and pathogenesis of schizophrenia are not clear, and the etiology, course and prognosis of schizophrenia are still in a stage of exploration and research.[25] Risperidone, Clozapine, and olanzapine are common antipsychotic drugs, widely used in clinical practice, can effectively control negative and positive symptoms, but the adverse drug reactions are relatively obvious, limiting their clinical application.[26,27] As a classic TCM for soothing the liver and relieving depression, Xiaoyao Pills have minimal toxic side effects and are convenient to take. In clinical practice, they have been proven to be effective in treating mental issues caused by liver qi stagnation. Su Chunhua and others reported that the combination of Xiaoyao Pills and psychological therapy has a very good therapeutic effect on mild depression in college students.[28] This meta-analysis included 9 literatures, involving 779 patients, and analyzed the total effective rate, BPRS, PANSS, PRL levels and incidence of adverse events after Xiaoyao Pill combined with Western medicine in the treatment of schizophrenia. Pooled results showed that the total effective rate of combined treatment group was significantly higher than that of Western medicine alone. PANSS (−) and PANSS (+) of combined treatment group were all significantly lower than that of Western medicine alone. Additionally, PRL levels of combined treatment group was significantly lower than that of Western medicine alone.

The results showed that the total effective rate of combined treatment group was significantly higher than that of Western medicine alone. In addition, the positive and negative scores of PANSS after Xiaoyao Pill combined with Western medicine in the treatment of schizophrenia were lower than that of Western medicine alone. Therefore, the application effect and desirability of Xiaoyao Pill in patients with schizophrenia were confirmed. Analysis of the reason, Xiaoyao Pill has a good effect in clearing liver and expelling fire and qi, so it has a targeted effect on the category of “diankuang” disease.[29] However, the pooled results showed that there was no significant difference in total PANSS between combined treatment group and Western medicine alone group. The results of this study were inconsistent with the results of positive and negative PANSS scores alone. The reason may be due to the excessive heterogeneity of the literature. However, sensitivity analysis did not find any studies that had a great impact on the results. Therefore, the cause of heterogeneity may be related to the basic characteristics of the patients, however, the number of included literatures is not sufficient for subgroup analysis. HPRL is one of the most common adverse reactions to antipsychotics.[7] Our findings suggest that PRL levels of combined treatment group was significantly lower than that of Western medicine alone. Studies have indicated that while antipsychotic drugs block the antipsychotic effect of dopamine in the limbic system of the midbrain, they also antagonize D2 receptors in the tuberoinfundibular pathway, leading to hyperprolactinemia.[30] This suggests that Xiaoyao Pill may potentially inhibit the antagonistic effect of antipsychotic drugs on D2 receptors, thereby reducing prolactin production. The present study results further support the high efficacy of combining Xiaoyao Pill with Western medicine in the treatment of schizophrenia. This suggests a promising avenue for clinicians seeking to address not only symptoms but also physiological markers. The observed reduction in PRL levels may imply improved treatment efficacy and reduced side effects associated with antipsychotic medications. However, further research, including long-term studies and investigations into mechanistic understanding, is essential to validate these findings and ascertain their broader applicability in clinical practice.

In addition, we analyzed the adverse events difference between the combination treatment group and Western medicine alone in the treatment of schizophrenia. Pooled results showed that there was no significant difference in incidence of EPS, headache, hydrostomia, dizziness, gastrointestinal sympotms, and sleepness between combined treatment group and Western medicine alone group. This shows that the safety of the 2 therapies is consistent, and doctors do not need to consider the safety of drugs in the clinical selection of treatment. In terms of the impact on clinical practice, these findings provide reassurance regarding the safety of the combined treatment approach compared to using Western medicine alone in schizophrenia treatment. Clinicians can potentially consider the combination therapy without an increased risk of adverse events. However, it is essential to acknowledge certain limitations, such as the need for further investigation to validate these results in diverse patient populations and over extended periods. To enhance the applicability of these results to a broader patient demographic, future research could focus on conducting large-scale, multicenter studies. Additionally, long-term follow-up studies may be warranted to assess the sustainability of the safety profile over an extended treatment duration. Such efforts would contribute to a more comprehensive understanding of the treatment’s safety and effectiveness, ultimately influencing and guiding clinical decision-making.

This meta-analysis had several limitations. First, the included studies had small sample sizes. Therefore, the objectivity of our meta-analysis results may have suffered from challenges despite data pooling. Future research efforts should focus on enlarging sample sizes to enhance statistical power and reliability. Consideration can be given to merging multiple studies or conducting larger-scale multicenter studies. Second, studies on total PANSS have large heterogeneity, which reduces the objectivity of study results. Heterogeneity may arise from the fact that the subjects involved in the study may have different baseline characteristics, such as age, gender, medical history, etc. These differences may introduce heterogeneity in the study results. In the future, meta-analysis can attempt to incorporate more studies and conduct different subgroup analyses based on patients’ baseline characteristics to reduce the presence of heterogeneity. This will contribute to a more precise understanding of differences among various subgroups.

5. Conclusion

The effective rate of Xiaoyao Pill combined with Western medicine in the treatment of schizophrenia is higher than that of Western medicine alone, which can effectively relieve the positive and negative symptoms of schizophrenia, and can significantly reduce the level of PRL. In the treatment of schizophrenia, clinicians can give priority to Xiaoyao Pill combined with Western medicine therapy.

Author Contributions

Conceptualization: Lili Cai.

Writing—original draft: Lili Cai.

Writing—review & editing: Lili Cai.

Methodology: Lianqi Liu.

Data curation: Zhibing Jiang, Zhongxing Liang, Yuehua Yang.

Abbreviations:

BPRS
Brief Psychiatric Rating Scale
EPS
extra pyramidal symptoms
HPRL
hyperprolactinemia
PANSS
Positive And Negative Syndrome Scale
PRISMA
Preferred Reporting Items for Systematic Reviews and Meta-Analysis
PRL
Prolactin
RCT
randomized controlled trial
TCM
traditional Chinese medicine.

Funded by Traditional Chinese Medicine Research Project of Guangdong Provincial Bureau of Traditional Chinese Medicine 2023 (NO.20232135).

Ethics approval and consent to participate is not applicable for this paper.

The authors declare that they have no competing interests.

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

How to cite this article: Cai L, Liu L, Jiang Z, Liang Z, Yang Y. Efficacy and safety of Xiaoyao Pill combined with Western medicine in the treatment of schizophrenia: A Meta-analysis and Systematic review. Medicine 2024;103:10(e37226).

Contributor Information

Lianqi Liu, Email: lcliulqi@163.com.

Zhibing Jiang, Email: 837484811@qq.com.

Zhongxing Liang, Email: 1597669609@qq.com.

Yuehua Yang, Email: 1462267431@qq.com.

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