Efficacy and safety of traditional Chinese medicine nursing intervention in postoperative patients after gastrectomy
- Authors:
- Published online on: October 31, 2023 https://doi.org/10.3892/ol.2023.14124
- Article Number: 537
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Copyright: © Fan et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
Abstract
Introduction
Gastric cancer is one of the leading causes of cancer death and a malignant tumor with a high global incidence (11.7%) (1). Gastric cancer is also a common gastrointestinal tumor, and the 5-year survival rate is very low (<15.0%) (2). In China, gastric cancer has a rapid annual increase in incidence, and was responsible for 8.2% of all deaths from cancer in 2018 (3–5). Clinically, gastrectomy is the main treatment for patients with non-metastatic gastric cancer, and early surgery can reduce the incidence of cancer-related mortality and tumor metastasis (6,7). Although the prognosis of advanced gastric cancer has been improved by the use of gastrectomy with adjuvant therapy (radiotherapy, chemotherapy, immunotherapy and other therapies), the 5-year overall survival rate is still low (8). In addition, patients with gastric cancer who undergo gastrectomy frequently experience postoperative complications (POCs), with a reported range of 20–46% of cases affected (9). The most common POCs of patients with gastric cancer who undergo gastrectomy are gastric hemorrhage, duodenal stump rupture, gastrointestinal anastomotic fistula and postoperative obstruction (10). Furthermore, POCs may increase the risk of metal health issues and decrease the quality of life in the perioperative period (11).
Traditional Chinese medicine (TCM) has antitumor potential, with the characteristics of access to multiple targets, a low number of side effects and good therapeutic effects (12). TCM nursing intervention is frequently used in clinical care, including for postoperative care for malignant tumor resections and percutaneous coronary intervention (13). In recent years, TCM has been shown to be effective in treating patients with gastric cancer, with its main advantages being that it is a comprehensive intervention with multiple approaches and multiple targets for tumor cells (14–16). Clinically, TCM nursing can prolong the survival time and improve the quality of life for patients with cancer due to less side effects (17). Perioperative TCM nursing intervention can improve an unhealthy mental state and reduces the occurrence of POCs in patients with gastric cancer (18). Treatment with TCM regulates both innate immunity (dendritic cells, myeloid-derived suppressor cells, natural killer cells and macrophages) and adaptive immunity (regulatory T and B cells, and CD4/CD8 T lymphocytes) (19). Combining early chemotherapy with TCM (Zhipu Liujunzi decoction) nursing intervention can improve the function of the immune system and the quality of life in patients with gastric cancer after surgery (20). More recently, the understanding of the targets and mechanisms of TCM involved in the consequent alterations in tumor parameters has expanded (16,21). Notably, when used as an adjuvant therapy TCM has been indicated to extend the median survival time and improve the overall survival rate of patients with gastric cancer (22). However, further studies and clinical trials are required in order to assess the efficiency and safety of TCM in patients with gastric cancer after gastrectomy.
Nursing intervention is an effective approach to aid patients with gastric cancer who suffer from psychological disorders during the perioperative period (23). Although postoperative TCM nursing interventional therapy should be integrated for patients across all stages of gastric cancer, most nursing intervention has focused on patients with metastatic disease (24). It has been shown that Jianpi Yangzheng Xiaozheng decoction can reduce the incidence of adverse drug reactions and improve the quality of life of patients with gastric cancer (25). Jianpi Yangzheng Xiaozheng decoction comprises Dangshen (Campanulaceae), Baizhu (Composite), Fuling (Polyporaceae), Shengyiren (Composite), Danggui (Grass family), Shanyao (Dioscoreaceae), Muxiang (Composite), Baishao (Asclepiadaceae), Chenpi (Rutaceae), Baqia (Liliaceae), Shijianchuan (Lamiaceae) and Zhigancao (Leguminosae), which decrease the toxic effects of chemotherapy, regulate immune function and improve macrophage cell activity in patients with gastric cancer (26). Jianpi Yangzheng Xiaozheng decoction considerably improves the quality of life of patients, relieving pain and prolonging survival time for patients with advanced-stage gastric cancer in China (25). However, there is limited knowledge on the potential effects of Jianpi Yangzheng Xiaozheng decoction nursing intervention on patients with gastric cancer after gastrectomy.
The present study investigated the ameliorative effects of TCM (Jianpi Yangzheng Xiaozheng decoction) nursing intervention on POCs and long-term survival in patients with gastric cancer after curative resection. The effects of TCM nursing intervention on postoperative gastrointestinal function, inflammatory index, physical capacity, quality of life, immune activity and recurrence were also systematically investigated.
Materials and methods
Patients
The present study is a prospective, randomized controlled trial that was performed in The First Hospital of Harbin (Harbin, China). The study protocol was approved by the Ethics Committee of The First Hospital of Harbin (approval no. 20150507TFHX1). A total of 1,032 eligible patients with gastric cancer who underwent gastrectomy were recruited between May 2015 and June 2017. All patients were diagnosed with gastric cancer using imaging and pathology assessments and met the indications for radical gastrectomy. The baseline clinicopathological characteristics, including hypoproteinemia, tumor size, tumor stage and American Society of Anesthesiologists grade (27) were analyzed and are shown in Table I. After gastrectomy, patients voluntarily chose to undergo postoperative treatment and all patients provided written informed consent. All the patients were randomly assigned into two groups: The TCM nursing intervention group (TCM group; n=520) and the routine nursing intervention group (control group; n=512). Patients were assigned into these two groups using a block randomization method based on the disease status of patients with cancer (28). No differences in treatment were applied between the two groups, with the exception of the Jianpi Yangzheng decoction. The TCM used in this study was Jianpi Yangzheng decoction, which is composed of 12 types of Chinese herbal medicine (15 g Dangshen, 10 g Baizhu, 10 g Fuling, 15 g Shengyiren, 10 g Danggui, 15 g Shanyao, 10 g Muxiang, 10 g Baishao, 6 g Chenpi, 10 g Baqia, 15 g Shijianchuan and 3 g Zhigancao) (26). The raw herbs for the Jianpi Yangzheng decoction were obtained from Heilongjiang Traditional Chinese Medicine Hospital (Harbin, China). All the herbs were mixed with 500 ml sterile water and boiled for 30 min, and then the patients drunk the leachate. One dose of Jianpi Yangzheng decoction was orally administrated to the TCM group every day after gastrectomy for at least 6 months. The study flowchart is shown in Fig. 1. The duration of the postoperative hospital stay for patients after gastrectomy was recorded.
 | Table I.Baseline clinicopathological characters of patients with gastric cancer who underwent a gastrectomy. |
Inclusion criteria and exclusion criteria
The inclusion criteria for the study were as follows: i) Patients diagnosed with gastric cancer; ii) patients aged from 25 to 70 years old; iii) patients with a life expectancy of at least 6 months; iv) patients underwent a gastrectomy; v) after gastrectomy, patients provided written informed consent to participate in the study according to the Good Clinical Practice criteria (29); and vi) a Karnofsky Performance Status score of >60 (30). The exclusion criteria were as follows: i) Patients with other cancer types; ii) pregnant or lactating women; iii) patients who were unable to swallow TCM; iv) patients with symptomatic brain metastasis or mental disorders; and v) patients with severe cardiovascular disease, chronic liver disease, kidney disease or blood disease.
Physical capacity
To assess physical capacity, the 6-min walk test (6-MWT) (31) was performed every 2 months in the patients of each group. The test was performed in a 50-meter corridor and all patients were instructed to walk as far as possible in 6 min.
Postoperative pain and POCs
After gastrectomy, the postoperative pain scores of the patients in the two groups were evaluated every 3 days during the hospital stay (on days 0, 3, 6, 9, 12 and 15) using the 0–10 Numeric Rating Scale, with 0 representing no pain and 10 representing the worst imaginable pain (32). POCs in the patients with gastric cancer after surgery were recorded and classified according to the Clavien-Dindo (C-D) classification grade (33).
Postoperative inflammation
Blood samples were collected from each patient every 3 days (on days 0, 3, 6, 9, 12 and 15) to measure serum inflammatory cytokine levels. Postoperative inflammation score was determined by inflammation score, as described previously (34). Postoperative serum levels of C-reactive protein (CRP) (cat. no. ab260058), IL-1β (cat. no. ab214025), IL-6 (cat. no. ab178013), IL-8 (cat. no. ab214030), IL-10 (cat. no. ab185986) and TNF-α (cat. no. ab181421) were measured using ELISA kits (all Abcam) according to the manufacturer's instructions. CD3+, CD4+, CD8+, CD16+, CD19+ and CD45+ expression levels in peripheral T lymphocytes were analyzed using a FACS Canto II flow cytometer and FACS Diva software (BD Biosciences).
Analysis of gastrointestinal function, abdominal pain and abdominal distention
The clinical outcomes were standard measures of gastrointestinal function and included the time from the operation to the first passage of flatus, the time from the operation to the passage of the first defecation, and the number of patients who were comfortable with the intake of a semi-fluid diet as measured every 3 days (on days 0, 3, 6, 9, 12 and 15 days) during the hospitalization. The abdominal pain of each patient from the two groups was evaluated using Prince Henry Pain Scale scoring (35) (0, no pain when coughing; 1, pain only when coughing; 2, no pain when quiet, but pain with deep breathing; 3, mild and bearable pain when resting; 4, severe and unbearable pain). Abdominal distension (36) was evaluated using the following scale: 0, no sense of abdominal distension; 1, mild distension; 2, moderate abdominal distention; and 3, severe abdominal distention.
Postoperative metal status
Postoperative mental status was evaluated in patients every 2 months post-surgery by clinicians for a total of 12 months. Quality of life after surgery was evaluated using the 36-Item Short Form Health Survey (SF-36) questionnaire (37). Scores in the SF-36 range from 0 to 100 (0 representing the worst and 100 the best). The Beck Depression Inventory (38) was used to assess the depression level in the patients after surgery. The Beck Depression Inventory includes 21 clinical symptoms of depression and the scores range from 5 to 63 (5–9, normal; 10–18, mild-to-moderate depression; 19–29, moderate-to-severe depression; 30–63, severe depression). Anxiety in patients with gastric cancer after surgery was determined by the State-Trait Anxiety Inventory (STAI) (39). The STAI includes separate measures of state- and trait-anxiety, which are scored as a minimum of 20 to a maximum of 80 (20–29, without anxiety; 20–30, the presence of anxiety; 31–49, an intermediate level of anxiety; 50–80, a high degree of anxiety).
Postoperative survival, recurrence and follow-up
Patients were followed up every 3 months during the 60-month follow up period. The overall survival time of the patients with gastric cancer after surgery was recorded from the date of surgery to death or the last follow-up. Recurrence time was defined as the time from surgery to recurrence or the last follow-up.
Safety of TCM
The safety of the TCM used in this study was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (40).
Statistical analysis
Data are expressed as the mean ± standard deviation or n (%). Data were analyzed using SPSS version 21.0 (SPSS Inc.; IBM Corp.). Unpaired Student's t-test was used to compare the data between two groups. Qualitative data were calculated using the χ2 test or Fisher's test. Overall survival and recurrence were analyzed using Kaplan-Meier analysis. P<0.05 was considered to indicate a statistically significant difference.
Results
Characteristic of patients with gastric cancer
A total of 1,032 patients with gastric cancer who underwent a gastrectomy were recruited to the present study. Patients with a mean age of 57.5 years (range, 53.2–62.8 years) were assigned into two groups: The TCM group (n=520) and the control group (n=512). There were 560 male and 472 female patients with gastric cancer. The surgical outcomes of the patients are shown in Table I. All patients received the same anesthetic drugs during the operation and underwent a gastrectomy. There were no significant differences between the two groups (all P>0.05). The study follow-up time was 60 months.
Effects of TCM nursing intervention on hospital stay, postoperative pain and frequency of postoperative symptoms
To verify the efficacy of TCM nursing intervention, hospital stay, postoperative pain and frequency of postoperative symptoms in patients were evaluated between the two groups. Patients in the TCM nursing intervention group had a shorter hospital stay and lower postoperative pain scores compared with those in the control group (both P<0.05; Fig. 2). It was observed that TCM nursing intervention decreased the use rate of opioids compared with the control group (P<0.05; Table II). Compared with the control, TCM nursing intervention significantly decreased the frequency of postoperative dizziness, vomiting, nausea, distention, diarrhea and comfort of intake of a semi-fluid diet during the hospital stay (all P<0.05; Table II).
| Table II.Effect of TCM nursing intervention on hospital stay, postoperative pain and frequency of postoperative symptoms. |
Effects of TCM nursing intervention on postoperative gastrointestinal dysfunction
Postoperative gastrointestinal dysfunction can cause the accumulation of secretions and gas, which will result in postoperative symptoms of gastrointestinal discomfort after gastrectomy (41). Thus, the differences in postoperative gastrointestinal dysfunction were compared between the two groups of patients with gastric cancer who underwent gastrectomy (Table III). The data revealed that TCM nursing intervention significantly decreased the time to first postoperative flatus and defecation, and the fasting time (all P<0.05). Postoperative patients in the TCM group were more comfortable with the intake of a semi-fluid diet than patients in the control group at 15 days post-surgery. Compared with the control, TCM nursing intervention significantly decreased the occurrence of abdominal pain and abdominal distension in the patients after gastrectomy (all P<0.05; Table III).
| Table III.Effect of TCM nursing intervention on postoperative gastrointestinal dysfunction in gastric cancer patients after surgery. |
Effects of TCM nursing intervention on postoperative inflammation index in gastric cancer patients
The effects of TCM nursing intervention on postoperative inflammation index were analyzed in the patients with gastric cancer who underwent gastrectomy. As shown in Fig. 3A, the patients in the TCM group exhibited lower inflammation scores than those in the control group at 6 days post-surgery. TCM nursing intervention also decreased the inflammatory cytokines levels of CRP, IL-1β, IL-6, TNF-α, IL-8 and IL-10 after gastrectomy compared with the control group during the hospital stay (Fig. 3B-G).
Effects of TCM nursing intervention on POCs in patients with gastric cancer who underwent gastrectomy
POCs in each patient with gastric cancer were recorded, classified according to the C-D classification grade and compared between the two groups. The characteristics of the patients in each C-D grade in the propensity score-matched cohorts are shown in Table IV. Grade I complications were present in 403 (77.5%) and 368 (71.9%) patients in the TCM and control groups, respectively. Grade II complications were recorded in 67 (13.1%) and 42 (8.1%) patients in the TCM and control groups, respectively. It was also demonstrated that 14 (2.7%) and 25 (4.9%) patients experienced grade III complications in the TCM and control groups, respectively, while patients with grade IV–VIII complications accounted for 36 (6.9%) and 77 (15.0%) patients at 12 months after surgery in the TCM and control groups, respectively.
| Table IV.Effect of TCM nursing intervention on postoperative complications in patients with gastric cancer who underwent surgery. |
Effect of TCM nursing intervention on physical capacity and metal status
Physical capacity and metal status were evaluated at the time of hospitalization and discharge for the two groups of patients with gastric cancer who underwent gastrectomy. The results data showed that TCM nursing intervention significantly improved clinician-rated measures of depression and anxiety during hospitalization compared with the control (all P<0.05). The quality of life of the patients after gastrectomy also increased in the TCM nursing intervention group when compared with that of the control group (all P<0.05). After 12-month discharge, the patients in the TCM group experienced less depression and anxiety, and a higher quality of life than those in the control group (all P<0.05) (Fig. 4). TCM nursing intervention also improved the postoperative physical capacity, as determined by 6-MWT (Table V). TCM nursing intervention increased the physical capacity of gastric cancer patients at 2, 4 and 6 months compared with the control (Fig. 5). After 6 months of follow-up, no significant difference in postoperative physical capacity was observed between the two groups.
| Table V.Effect of TCM nursing intervention on postoperative physical capacity in patients with gastric cancer who underwent surgery. |
Effects of TCM nursing intervention on postoperative immune activity
It is now known that altered immune cell expression may be responsible for the low survival and poor prognosis in patients with gastric cancer after surgery (42). Thus, the immune function in patients with gastric cancer who underwent gastrectomy was compared between the two treatment groups in the present study. As shown in Table VI, CD3+, CD4+, CD8+, CD16+, CD19+ and CD45+ expression levels were recorded in peripheral T lymphocytes, and were higher in patients in the TCM group compared with those in the control group (all P<0.05). Compared with that in the control group, a significant increase in the concentration of natural killer cells and T cells was observed in patients in the TCM group (both P<0.05) (Table VI).
| Table VI.Effect of TCM nursing intervention on survival and recurrence in patients with gastric cancer who underwent surgery. |
Effects of TCM nursing intervention on survival and recurrence
The survival and recurrence times in the patients with gastric cancer were recorded and compared between the two groups. The data revealed that TCM nursing intervention prolonged the survival after gastrectomy compared with the control during the 60-month follow-up period (Fig. 6A). Furthermore, the mortality rate of gastric cancer was also decreased in the patients in the TCM nursing intervention group (Fig. 6B). During the 5-year follow-up period, 65 (12.7%) patients in the control group died and 142 (27.7%) patients experienced recurrence or tumor metastasis, while only 30 (5.8%) patients died in the TCM nursing intervention group, and 88 (16.9%) patients experienced recurrence or tumor metastasis (Table VII).
| Table VII.Effect of TCM nursing intervention on survival and recurrence in patients with gastric cancer who underwent surgery. |
Cancer treatment-related adverse events of TCM nursing intervention in patients with gastric cancer who underwent gastrectomy
The treatment-related adverse events were recorded after gastrectomy in the TCM nursing intervention group. Most of the TCM treatment-related adverse events were grade 1 or 2 according to National Cancer Institute Common Terminology Criteria (Table VIII). The cancer treatment-related adverse events of TCM included vomiting, pruritus, gastrointestinal reaction, increased alanine transaminase (ALT)/aspartate transaminase (AST) levels, fatigue, hypertension and diarrhea. No toxin-induced death was observed in any patient in the TCM nursing intervention group. Of the 55 patients affected, 20 (3.8%) had grade 3 diarrhea, 12 (2.3%) had grade 3 hypertension and 33 (6.3%) had a gastrointestinal reaction, and these patients were forced to reduce the dose of TCM.
| Table VIII.Cancer treatment-related adverse events of traditional Chinese medicine nursing intervention in patients with gastric cancer who underwent surgery. |
Discussion
In general, gastric cancer is the malignant tumor of the digestive tract with the highest incidence, prevalence and mortality rates (43). An increasing number of young individuals are being affected by the condition due to changes in lifestyle and dietary structure in China (44). Despite the treatment strategies that have been applied in patients with gastric cancer, the overall survival rate and prognosis are still poor (45). Clinically, TCM has been proven effective in treating gastric cancer, acting as a comprehensive interventional method that has multiple approaches and targets (14). In addition, TCM nursing intervention can markedly decrease POCs, improve the quality of sleep, relieve postoperative pain, and improve the mental status and quality of life of patients who have received gastric cancer surgery (46). The present study investigated the effects of TCM nursing intervention on POCs, survival and recurrence rate in patients with gastric cancer who underwent gastrectomy. Outcomes showed that TCM nursing intervention significantly improved depression and anxiety, suggesting that postoperative mental state in individuals with gastric cancer may be improved by TMC nursing intervention, with a basis of routine nursing. Results in the current study also pointed out that TCM nursing intervention was extremely effective in decreasing POCs, inflammation and numbers of deaths, and improving the postoperative gastrointestinal dysfunction, physical capacity, quality of life and survival of patients with gastric cancer after gastrectomy.
Most gastric cancer patients need to undergo a gastrectomy, and postoperatively, patients frequently experience gastrointestinal dysfunction, POCs, inflammation and a decreased quality of life (47). A number of studies have indicated that parameters based solely on preoperative factors are able to identify the patients who are at the greatest risk of a POC. Appropriate postoperative care can then contribute to the improvement of the POC and gastrointestinal dysfunction (48,49). TCM formulae and chemical components isolated from some Chinese herbal medicines have been used to treat gastric cancer, and TCM has been proven effective in treating gastric cancer patients by inhibiting tumor growth (16). In the current study, it was observed that TCM nursing intervention shortened the time until first postoperative flatus, the regression time for epigastric distension symptoms, the time until first defecation and the recovery time until comfortable with semi-solid food for patients with gastric cancer, suggesting that the addition of TCM nursing intervention could improve the gastrointestinal dysfunction after gastrectomy compared with routine nursing. In addition, in another study, perioperative TCM nursing for patients with gastric cancer alleviated acute inflammation and improved the quality of life of 103 patients with gastric cancer (18). Consistent with this, the results in the present study demonstrated that TCM nursing intervention not only improved the quality of life and inflammation index, but also helped the mental status and postoperative physical capacity in the 1,032 patients with gastric cancer who underwent a gastrectomy. Different to other studies, TCM nursing intervention could effectively improve postoperative pain and the frequency of postoperative symptoms. Furthermore, another previous study found that enhanced recovery after gastrectomy could decrease inflammation perioperatively, improve nutrition postoperatively and decrease hospitalization time in patients with gastric carcinoma (50). In the present study, perioperative inflammation and inflammatory cytokines levels of CRP, IL-1β, IL-6, TNF-α, IL-8 and IL-10 in the patients with gastric cancer were significantly lower in the patients in the TCM group compared with those in the patients in the control group during hospitalization.
TCM combined with chemotherapy may extend the overall survival time and increase the survival rate and quality of life of patients with stage IV non-surgical gastric cancer (51). In addition, TCM plays an important role in decreasing inflammation and prolonging survival time in subjects with gastric cancer (52). TCM also has an important potential value for improving the prognosis of patients with advanced gastric cancer (53). The present study evaluated the efficacy of TCM nursing intervention for improving the postoperative POCs of patients after gastrectomy, and also investigated its effect on postoperative survival and prognosis. In a study on oral cancer, the clinical efficacy of TCM anticancer decoctions plus basic chemotherapy and nursing interventions as postoperative treatment was notable, with significant improvements in patient immunity and decreased tumor marker levels (54). Consistent with this, the results of the present study showed that immune activity, quality of life and the 5-year cumulative survival rate of patients in the TCM nursing intervention group were significantly higher than those in the control group. In addition, the recurrence rate for patients in the TCM nursing intervention group was significantly lower than that in the control group. Most patients with gastric cancer who undergo surgery develop recurrence and metastasis (55). In China, almost all patients want to choose aggressive treatment (56), and the present results identified that TCM nursing intervention was effective when compared with the control. Notably, the results showed that a limited number of patients in the TCM nursing intervention group experienced a low number of cancer treatment-related adverse events, such as vomiting, pruritus, gastrointestinal reaction, increased ALT/AST levels, fatigue, hypertension and diarrhea. However, the long-term efficacy of TCM on immune activity, quality of life and 5-year cumulative survival rate in patients with gastric cancer were not analyzed in this study.
In conclusion, TCM nursing intervention has an important value for improving the postoperative gastrointestinal dysfunction, metal status, POCs, inflammation, immune activity, survival, and prognosis of patients with gastric cancer who undergo gastrectomy. In addition, TCM nursing intervention could be effective, safe and well tolerated for patients with gastric cancer who undergo gastrectomy, which suggests its potential clinical application and deserves further research.
Acknowledgements
Not applicable.
Funding
Funding: No funding was received.
Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Authors' contributions
LF and YH conceived and designed the study. YL, XL and DL performed data analysis. RW analyzed the data, and wrote and revised the manuscript. All authors have read and approved the manuscript. LF and RW confirm the authenticity of all the raw data.
Ethics approval and consent to participate
This study was approved by the Ethics Review Committee of The First Hospital of Harbin (Harbin, China; approval no. 20150507TFHX1). Written informed consent was obtained from all subjects.
Patient consent for publication
Written informed consent was obtained from all patients, and all patients agreed to publication of their data.
Competing interests
The authors declare that they have no competing interests.
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