A retrospective study was conducted on 180 patients with gallstone disease who were admitted to the Department of Hepatobiliary Surgery at the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine (TCM) from July 2017 to July 2023. These patients were included in the study group. Additionally, 180 healthy individuals who underwent physical examinations at the Health Examination Center of the same hospital were selected as the normal control group.

1) Patients diagnosed with any of the following conditions related to gallstone disease: “gallbladder stones,” “intrahepatic bile duct stones,” or “extrahepatic bile duct stones.”

2) Diagnostic criteria for “gallbladder stones”: confirmed by ultrasound examination or other imaging methods, the presence of one or more solid components within the gallbladder cavity, which may be mobile or fixed.

3) Diagnostic criteria for “intrahepatic bile duct stones”: confirmed through abdominal ultrasound, CT, MRI, or ERCP (endoscopic retrograde cholangiopancreatography) that the stones are located within the bile duct system inside the liver.

4) Diagnostic criteria for “extrahepatic bile duct stones”: confirmed via abdominal ultrasound, CT, MRI, or ERCP that the stones are present in the extrahepatic bile duct from the liver to the duodenum.

5) Age: between 18 and 70 years old.

1) Age non-compliance: patients under 18 or over 70 years old.

2) Severe systemic diseases: patients with malignant tumors, systemic autoimmune diseases (such as lupus erythematosus, rheumatoid arthritis), or severe heart disease.

3) Surgical history: patients with cholangitis caused by intestinal fluid reflux due to surgery.

4) Non-compliance with medical advice: patients unable or unwilling to follow the prescribed treatment regimen and follow-up requirements of the study.

5) Pregnant or breastfeeding patients.

6) Drug allergy: patients with a history of allergy to traditional Chinese medicine or Western medicine used in this study.

7) Recent treatment: patients who have received other treatments within 1 week prior to enrollment.

8) Mental disorders: patients with mental disorders or psychological issues that affect their ability to cooperate with treatment.

In this study, δ = 0.1, σ = 3.63, α = 0.05, β = 0.10, and 1 − β = 0.90. Referring to the t-value table for degrees of freedom (∞), the one-sided t0.05 = 1.645 and t0.1 = 1.282. Substituting these values into the formula n = 2*[(α + β)σ/δ]², it is determined that at least 171 cases are required to meet the above requirements. Considering a dropout rate of 5% - 10%, each group needs a sample size of 180 cases.

The TCM Constitution Scale was established by Professor Wang Qi of Beijing University of TCM based on the conceptual framework of TCM constitution types. The development of sub-scales involved the collection of items, the formation of an item pool, the selection of items, the formulation of questions, and pilot testing. The scale consists of 60 items and is a well-performing standardized scale. It includes nine sub-scales: Balanced Constitution, Qi deficiency constitution, Yang deficiency constitution, Yin deficiency constitution, Phlegm-dampness constitution, Damp-heat constitution, Blood stasis constitution, Qi stagnation constitution, and Special endowment constitution.

The Eysenck Personality Questionnaire (EPQ) was developed by British psychologist H.J. Eysenck based on his three-dimensional theory of personality. It is used to assess personality traits such as introversion-extroversion and emotional stability. The EPQ consists of three personality dimensions and one validity scale: Psychoticism (P) dimension, Introversion-Extraversion (E) dimension, Neuroticism (N) dimension, and Lie (L) scale.

The Brief Coping Style Scale was compiled by Xie Yaning in 1998. It consists of 20 items, with the first 12 items forming the positive coping factor and the last 8 items forming the negative coping factor. The scale is self-administered and uses a multi-level rating system, with four options for each item: never used, occasionally used, sometimes used, and frequently used (corresponding scores are 0, 1, 2, and 3, respectively).

The Multidimensional Perceived Social Support Scale was developed by Zimet et al., introduced and revised by Jiang Qianjin et al. It is suitable for use in various populations and primarily investigates the subjective perception of social support among patients with psychosomatic disorders (PSD). The scale includes two dimensions: family support and external support, and consists of 12 self-rated items. It uses a 1 - 7 point scoring method, where 1 represents strongly disagree, 2 represents disagree, 3 represents slightly disagree, 4 represents neutral, 5 represents slightly agree, 6 represents agree, and 7 represents strongly agree. The total score ranges from 12 to 84 points, with the family support score ranging from 4 to 28 points and the external support score ranging from 8 to 56 points. Higher scores indicate better perceived social support.

Investigators: Investigators must have a bachelor’s degree or higher in Traditional Chinese Medicine (TCM) or a non-TCM background with systematic training in TCM theory and clinical medical practice.

Training Methods: Qualified investigators will undergo centralized training to understand the content of the project and detailed implementation procedures.

Survey Methods: Surveys will be conducted directly with participants from both the study group and the control group in a quiet environment with natural lighting. Various scales will be administered, and questionnaires with a response rate of over 95% will be considered valid.

Participants from both the study group and the control group will be asked about their name, gender, age, occupation, educational level, living situation, marital status, and family medical history.

Participants will be asked about their sleep patterns, smoking and drinking history, dietary preferences, and daily routines.

The Eysenck Personality Questionnaire, Social Support Rating Scale, Coping Style Scale, and TCM Constitution Scale will be used to evaluate the psychological and personality characteristics and constitution of participants in both the study group and the control group.

The logistic regression analysis results will provide insights into how different constitutions influence the onset of gallstone disease. This section will detail the specific findings, including the odds ratios (OR) and confidence intervals (CI) for various constitutional types, and discuss the statistical significance of these findings. See Table 1 .

The independent variables selected for the model include gender, qi stagnation constitution, Balanced Constitution, scores of negative coping, scores of positive coping, and stressful life events. The OR values for Balanced Constitution, gender, positive coping style, and total social support are all less than 1, and the maximum value of the 95% confidence interval is also less than 1. See Table 2 .

The intercept was included in the model, and the model’s convergence status was satisfactory when the relative gradient convergence criterion was set at IE-8. The residual Chi-square (χ²) test result showed a χ² value of 110.570, with P ≤ 0.0001, indicating that the result is statistically significant. During the stepwise selection process of independent variables, negative coping scores and stressful life events were sequentially entered into the model. From the analysis of standardized regression coefficients, it was found that the negative coping score had a greater impact on the model. Stressful life events were highly associated with the incidence of gallstones, with individuals experiencing stressful life events having an incidence rate 59 times higher than that of the general population. The results are shown in Table 3 .

Compared to the normal group, the frequency of patients with Qi stagnation constitution in the study group was significantly increased, showing a notable difference (P < 0.001); the frequencies of Yin deficiency constitution and balanced constitution in the study group were significantly decreased compared to the normal group, with statistical differences (P < 0.05, P < 0.001). There were no significant differences in other constitution types between the study group and the normal group (P > 0.05). See Table 4 .

There were 102 cases in the youth group, 42 cases in the middle-aged group, and 36 cases in the elderly group. In the normal group, there were 48 cases in the youth group, 69 cases in the middle-aged group, and 63 cases in the elderly group. When comparing the youth group with the normal group, χ² = 11.109, P = 0.0009, indicating a significant difference (P < 0.01). In the analysis of the frequency of constitutional types in the youth and middle-aged groups of the study group, the chi-square test showed no significant differences; however, there were significant differences in the Yang deficiency constitution in the elderly group compared to the youth group and middle-aged group (P < 0.01, P < 0.05). See Table 5 .

There were 117 male patients and 63 female patients; in the normal group, there were 84 males and 69 females. A chi-square test showed χ² = 4.0890, P = 0.0432, indicating significant differences (P < 0.05). However, there were no significant differences in the distribution of physical constitution types between different genders (P > 0.05). See Table 6 .

In the study group, there were 111 intellectual laborers and 69 manual laborers; in the normal group, there were 93 intellectual laborers and 87 manual laborers. Compared between the two groups, there were no significant differences (P > 0.05). When comparing the Qi-Stagnation type among intellectual laborers and manual laborers in the study group, the result was χ² = 6.8467, P = 0.012, indicating significant differences (P < 0.05). See Table 7 .

Constitution refers to the relatively stable characteristics displayed by individuals in terms of morphology, physiological function, and psychological activity, determined by hereditary and acquired factors during their life process [4] . Traditional Chinese medicine theory posits that form and spirit are a unified whole; specific morphological structures consistently exhibit certain psychological tendencies, while the functional activities of different organs correspondingly manifest specific emotions, emotional responses, and cognitive activities. This study found that among 180 patients surveyed, there were 111 cases of Qi stagnation constitution, 21 cases of Qi deficiency constitution, 9 cases of blood stasis constitution, 3 cases of Yin deficiency constitution, 9 cases of Yang deficiency constitution, 12 cases of damp-heat constitution, and 6 cases of Balanced Constitution. The age distribution included 102 in the youth segment, 42 in the middle-aged segment, and 36 in the elderly segment; there were 117 males and 63 females, with 111 engaged in intellectual labor and 69 in physical labor. Compared to the normal control group, the frequency of Qi stagnation constitution in the research group was significantly higher (P < 0.001). The frequencies of Yin deficiency constitution and Balanced Constitution in the research group were significantly lower compared to the normal control group (P < 0.05, P < 0.001). No significant differences were found in other constitutional types between the research group and the normal control group (P > 0.05). These results suggest that Qi stagnation is a latent constitution in patients with gallbladder stone disease, while harmonious and Yin deficiency constitutions exhibit a lower tendency for disease onset.

Different physiological characteristics associated with various age stages also correspond to different constitutional traits. The researchers surveyed 100 adults and found that the balanced constitution was more prevalent among young adults, while imbalances in Yin and Yang were more common in middle-aged individuals, particularly with a predominance of Yin deficiency over Yang excess [5] . This study found that the youth stage (≤39 years) was the most frequent age for research, likely due to this age group being at the peak of their careers, facing significant work pressure and numerous life stressors, leading to frequent stressful life events. Physiologically, this age group has abundant Qi and blood, and strong righteous Qi, making them susceptible to developing a latent Qi stagnation constitution.

The Chi-square test on the frequency distribution of constitution types across different age groups indicated no significant differences in the distributions between youth and middle-aged groups, while the elderly group exhibited a significant difference in Yang deficiency compared to the youth and middle-aged groups (P < 0.01, P < 0.05), suggesting broader distribution of Yang deficiency constitution in elderly patients.

Due to differences in genetic traits, body morphology, organ structure, and other factors, men and women also exhibit distinct physiological functions and psychological characteristics, leading to gender differences in constitution. This affects emotional traits and directly influences the incidence, pathogenesis, and treatment of diseases. Wang Na analyzed the constitution characteristics of 2967 cases using clustering research and examined the differences between genders [6] . The findings indicated numerous differences in constitution between men and women, with women generally exhibiting more deficiency, imbalance, and disordered constitutions, particularly with deficiencies in essence and blood. Zhang Huimin and others surveyed 395 individuals aged over 16 in urban, town, and rural populations of Beijing regarding Qi deficiency constitution distribution. The results showed that women were more likely than men to exhibit Qi deficiency constitution.

This study suggests that in terms of incidence, men exhibit a higher prevalence than women, possibly due to greater societal responsibility and roles that are less favorable for psychological counseling, leading to the accumulation of negative emotions such as frustration and sadness, which contributes to Qi stagnation. The frequency distribution of constitution types between different genders showed no significant differences according to the Chi-square test, indicating that the distribution of constitution types in the research patients is basically the same across genders.

Different occupational groups have distinct working characteristics and psychological traits, resulting in relatively stable constitutions over time, which leads to varying disease susceptibility across people of different occupations and education levels. For instance, those engaged in manual labor with lower educational backgrounds may face exhaustion and economic challenges, leading to various health issues; conversely, those engaged in intellectual work and with higher education may become weakened due to excessive mental strain and lack of exercise.

This study indicates that in terms of incidence, occupational factors do not significantly correlate with the diseases under study. However, it was found that among intellectual laborers, the frequency of Qi stagnation constitution was significantly higher compared to physical laborers (P < 0.05), suggesting a broader distribution of Qi stagnation constitution among intellectual laborers.

In summary, the Qi stagnation constitution is a latent predisposition for gallstone disease, while the balanced constitution and Yin deficiency constitution have a lower tendency for onset; it is commonly found among young males engaged in mental labor.

Despite obtaining some meaningful results, the current study also has several limitations that may affect the reliability and applicability of the findings:

Selection Bias: The sample was sourced from a single healthcare institution, which may introduce selection bias. The representativeness of the sample is limited, and it may not fully reflect the distribution of constitutions among gallstone disease patients nationwide or in broader populations.

Recall and Information Bias: The data for this study were primarily collected through questionnaires and clinical records, which can introduce recall bias and information bias. Self-reported data, in particular, may be affected by the respondents’ memory and personal interpretation, potentially compromising the accuracy of the data.

Unidentified or Uncontrolled Confounding Factors: Although we attempted to control for some confounding factors in our analysis, there may still be unidentified or uncontrolled confounders such as dietary habits and living environment that could influence the study outcomes. These factors might confound the relationships observed in the study, affecting the validity of the conclusions.