|Year : 2019 | Volume
| Issue : 4 | Page : 228-235
Therapeutic effect of jianpi decoction combined with chemotherapy on postoperative treatment of colorectal cancer: A systematic review and meta-analysis
Wen-Jun Zhou1, Bin Wei1, Fei-Fei Cai1, Meng-Die Yang1, Xiao-Le Chen1, Qi-Long Chen1, Ming Zhao2, Shi-Bing Su1
1 Research Center for Traditional Chinese Medicine Complexity System, Institute of Interdisciplinary Integrative Medicine Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China
2 AntiCancer, Inc., San Diego, 92111, USA
|Date of Submission||31-Jan-2019|
|Date of Decision||03-May-2019|
|Date of Acceptance||08-Jul-2019|
|Date of Web Publication||03-Dec-2019|
Prof. Shi-Bing Su
Research Center for Traditional Chinese Medicine Complexity System, 1200 Road Cailun, Shanghai
Source of Support: None, Conflict of Interest: None
Objective: The purpose of this systematic review is to assess the therapeutic effect of Jianpi decoctions in Chinese herbal medicines (CHM) combined with chemotherapy on the postoperative treatment of colorectal cancer. Methods: Literatures were obtained from Wanfang database, CNKI, PubMed, Cqvip, MEDLINE, Cochrane, CBM, and Springer LINK as well as other conference papers and theses. The search included all documents in English or Chinese published before September 2018. We selected randomized controlled trials based on specific criteria and the most important criteria were that Jianpi decoction should be applied in combination with chemotherapy on the postoperative treatment of colorectal cancer. Results: Publications in eight electronic databases were extensively searched and 20 trials were included for analysis eventually. A total of 1652 patients in total were enrolled in these studies. Among them, 879 patients received CHM and Western medicine combination therapy and another 773 participants only got Western medicine therapy. Compared with those patients receiving Western medicine alone, the survival rate of 1-year (odds ratio [OR] = 2.35, 95% confidence limit [Cl] = 1.30–4.28,P < 0.05), 3-year (OR = 2.02, 95% Cl = 1.49–2.73,P < 0.001), and 5-year survival rate (OR = 2.32, 95% Cl = 1.56–3.45,P < 0.001) of patients in the group of Jianpi decoctions in CHM and chemotherapy combination has significantly increased. Moreover, results also showed positive effects on immunoregulation such as CD3+ (OR = 0.68, 95% confidence interval [CI] = 0.52–0.85,P < 0.0001), CD4+/CD8+ (OR = 0.77, 95% CI = 0.29–1.26,P < 0.05). Side effects caused by chemotherapy such as nausea (OR = 0.35, 95% CI = 0.25–0.50,P < 0.0001) and vomiting (OR = 0.32, 95% CI = 0.22–0.46,P < 0.0001), diarrhea (OR = 0.42, 95% CI = 0.30–0.60,P < 0.0001), as well as metastasis and recurrence (OR = 0.38, 95% CI = 0.24–0.61,P < 0.001) were remarkably reduced. The quality of life (OR = 4.40, 95% Cl = 2.86–6.77,P < 0.0001) has been improved. Moreover, there was no statistically significant bias in the overall studies. Conclusion: This systematic review suggests that Jianpi decoction in CHM can reduce the chemotherapy toxicity, enhance the patient's immunity, prolong their survival rate, improve their quality of life as well as prevent metastasis, and recurrence for patients in postoperative treatment of colorectal cancer.
Keywords: Chemotherapy, Chinese herbal medicine, colorectal cancer, jianpi decoction, postoperation
|How to cite this article:|
Zhou WJ, Wei B, Cai FF, Yang MD, Chen XL, Chen QL, Zhao M, Su SB. Therapeutic effect of jianpi decoction combined with chemotherapy on postoperative treatment of colorectal cancer: A systematic review and meta-analysis. World J Tradit Chin Med 2019;5:228-35
|How to cite this URL:|
Zhou WJ, Wei B, Cai FF, Yang MD, Chen XL, Chen QL, Zhao M, Su SB. Therapeutic effect of jianpi decoction combined with chemotherapy on postoperative treatment of colorectal cancer: A systematic review and meta-analysis. World J Tradit Chin Med [serial online] 2019 [cited 2020 Apr 2];5:228-35. Available from: http://www.wjtcm.net/text.asp?2019/5/4/228/271965
| Introduction|| |
Colorectal cancer ranked the third of diagnosed cancer and the fourth of death among the most common malignant tumors worldwide. Statistics showed that the incidence and mortality of colorectal cancer have declined in the past few years., Unfortunately, approximately 1.1 million people were diagnosed with colorectal cancer and 551,000 died in 2018, accounting for 6% of all cancers. The current treatments of colorectal cancer are surgery and the postoperative chemotherapy and radiotherapy should be followed. In general, the operation resection rate was 50%–70%. Patients usually receive chemotherapy after radical surgery, as the chemotherapy may increase 20% patients' 3-year survival rate and 10% patients' 5-year survival rate. However, the side effects induced by chemotherapy cannot be neglected.
Chinese herbal medicines (CHM) therapy in Traditional Chinese medicine (TCM) is a kind of adjuvant treatment, which can bring the body back to normal. Based on TCM syndrome differentiation, CHM therapy combined with chemotherapy or radiotherapy plays an important role in the treatments on postoperative colorectal cancer, mainly through strengthening the healthy Qi and removing pathogenic factors. These theories and practice of CHM therapy are still important in treating and preventing colorectal cancer. It has been reported that CHM combined with chemotherapy or radiation therapy, can enhance the action of chemotherapy and radiotherapy, sensitize cancer cells to chemotherapy and also can reduce their side effects and colorectal cancer recurrence and metastasis rate, improve the patient's quality of life.
Jianpi decoction, a kind of CHM formula, plays an important role in the treatment of postoperative colorectal cancer with the syndrome of the spleen and/or stomach Qi deficiency. Moreover, some CHM formulae were also used in the postoperative treatment of colorectal cancer such as Fuzheng Qudu decoction, Addie injection, Shengyang Yiwei decoction, Xiangshaliujunzi decoction, and Jianpi decoction, but these CHM formulae have not been proved to achieve good and definite effect. Therefore, seeking safer and more effective formulae is an urgent task for the postoperative care of patients with colorectal cancer to reduce chemotherapy toxicity, prolong survival rate, enhance immunity, and prevent recurrence. This study was carried out to confirm the therapeutic effect of Jianpi decoctions combined with chemotherapy through constructing a comprehensive review of surgery and postoperative treatment of colorectal cancer.
| Methods|| |
To ensure the accuracy of our systemic review and meta-analysis, we designed and reported our results by employing a checklist of items that was as consistent as possible with the Preferred Reporting Items for Systemic Review and Meta-Analyses statement.
Clinical trials were retrieved from eight databases including Wanfang date, CNKI, Pubmed, Cqvip, MEDLINE, Cochrane, CBM, and Springer LINK as well as from conference papers and theses. Terms retrieved in databases were as the following: postoperative colon cancer, rectal cancer, rectum cancer, colorectal cancer or large bowel cancer, and herb, herbal medicine, Zhong Yao, Zhong Cao Yao, Zhong Yi Yao, Chinese medicine, TCM or complementary and alternative medicine.
In this study, we examined whether Jianpi decoction in combination with chemotherapy reduced chemotherapy toxicity, enhanced immunity, prolonged survival rate, and prevented recurrence. Only the studies which satisfied the criteria were included in the meta-analysis. All the databases were searched from their available date of inception to the latest issue (September-2018).
Studies included in the meta-analysis had to meet all of the following inclusion criteria: (1) Participants: postoperative colorectal cancer is the single main disease; (2) type of intervention: studies compared TCM with Western medicine; (3) type of studies: only clinical randomized controlled trials were included; (4) type of outcome measurements: overall survival rate, chemotherapy toxicity, and immunoregulation were the main outcome measurements.
Clinical trials were excluded if they did not meet the above criteria: (1) Studies involved in animals orin vitro experiments; (2) Jianpi decoction was used in both intervention group and control group; (3) studies did not use the invention of investigate the outcome.
Only those outcomes that were thought to be the most representative of the study were applied: (1) To assess the efficacy of Jianpi decoction in CHM according to the 1-, 3-, and 5-year survival rates of patients (2) to assess the efficacy of Jianpi decoction in CHM on immunostimulatory activity, i.e., the mean values of posttreatment CD3+ T-cell level, and CD4+/CD8+ ratio (3) to assess the efficacy of Jianpi decoction in CHM on relieving the adverse events of chemotherapy, including nausea and vomiting, diarrhea, and metastasis and recurrence.
The methodological quality of random control trials (RCTs) was assessed using the five-point Jadad scales. (1) Description of single- or double-blindness; (2) description of withdrawals and dropouts; (3) description of randomization; (4) assessors blinded to treatment conditions; (5) adequate and appropriate randomization method. All trials were reviewed by at least two reviewers and any disagreement was resolved through the involvement of a third reviewer in consensus conferences. In addition, the risk of bias for the included studies was also assessed.
The Stata 12.0 software (StataCorp LLC, 4905 Lakeway Drive, College Station, Texas 77845-4512, USA) was applied for data analysis. Dichotomous data were reported as odds ratio (OR), whereas continuous data were reported as mean difference ± standard deviation. If the heterogeneity exists in pooled studies (I2 > 50%), a random model was applied; otherwise, the fix model was applied. Statistically significant difference was considered as P < 0.05.
A funnel plot is a graph designed to check for the existence of publication bias in systematic reviews and meta-analysis. In the absence of publication bias, it assumes that the largest studies will be plotted near the average, and smaller studies will be spread evenly on both sides of the average, creating a roughly funnel-shaped distribution. A symmetric inverted funnel shape arises from a “well-behaved” data set, in which publication bias is unlikely.
| Results|| |
The process of the study selection is shown in [Figure 1]. According to the prespecified selection criteria defined in the methods section, 224 studies in total were retrieved in this review. 197 studies did not meet the included criteria, for example, they only investigated the Chinese medicine syndrome scales, and 11 studies were literature reviews, and hence, only 20 studies satisfied the selection criteria. Twenty studies,,,,,,,,,,,,,,,,,,, were included in this meta-analysis. The characteristics of the studies are summarized in [Table 1].
1-year survival, 3-year survival and 5-year survival were analyzed as shown in [Figure 2]a-c, respectively. 1-, 3-, and 5-year survival rate of patients in combination group is higher than that in the control group (OR = 2.35, 95% confidence limit [Cl] = 1.30–4.28, P < 0.05; OR = 2.02, 95% Cl = 1.49–2.73, P < 0.001; OR = 2.32, 95% Cl = 1.56–3.45, P < 0.001). The heterogeneity test indicated no significant difference among these studies.
|Figure 2: Forest plots of survival rate. (a) One-year survival after treatment. (b) Three-year survival after treatment. (c) Five-year survival after treatment. Experiment, Jianpi decoction combined with chemotherapy group; Control, chemotherapy group|
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Chemotherapy toxicity and side effects
Nausea and vomiting and diarrhea are common side effects of chemotherapy. In the 14 studies, nausea and vomiting were significantly reduced in combination group compared with western medicine therapy used alone (OR = 0.35, 95% confidence interval [CI] = 0.25–0.50, P < 0.0001; OR = 0.32, 95% CI = 0.22–0.46, P < 0.0001) [Figure 3]a and [Figure 3]b. However, the heterogeneity test indicated a significant difference among the pooled 14 studies, which might be due to different chemotherapy regimens used in different studies.
|Figure 3: Forest plots of survival quality. (a) Nausea after treatment. (b) Vomiting after treatment. (c) Diarrhea after treatment. Experiment, Jianpi decoction combined with chemotherapy group; Control, chemotherapy group|
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We further found that chemotherapy combined with Jianpi decoctions significantly reduced diarrhea with no heterogeneity found among studies (OR = 0.42, 95% CI = 0.30–0.60, P < 0.0001) [Figure 3]c. The study was not pooled due to the different data types.
Recurrence and metastasis after resection
Data have shown that 50%~60% patients with colorectal cancer will be issued metastasis after sugery., In recent years, the application of Jianpi decoction has shown unique and obvious effects on preventing the metastasis of colorectal cancer. The metastasis and recurrence was significantly decreased in patients with Jianpi decoction in CHM therapy (OR = 0.38, 95% CI = 0.24–0.61, P < 0.001) [Figure 4]. However, the heterogeneity test indicated a significant difference among the pooled studies, which might be due to different chemotherapy regimens used in different studies.
|Figure 4: Forest plots of metastasis and recurrence after treatment. Experiment, Jianpi decoction combined with chemotherapy group; Control, chemotherapy group|
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A significant rise of CD3+ T cell level was reported in patients treated with chemotherapy and CHM (OR = 0.68, 95% CI = 0.52–0.85, P < 0.0001) [Figure 5]a. However, the heterogeneity test indicated a significant difference among the pooled 9 studies. In addition, significant effects on improving immunity were also observed in patients receiving chemotherapy with Jianpi decoction, such as CD4+/CD8+ (OR = 0.77, 95% CI = 0.29–1.26, P < 0.05) [Figure 5]b.
|Figure 5: Forest plots of immunoregulation. (a) CD3+ level after treatment. (b) CD4+/CD8 + level after treatment|
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Quality of life
The results from 10 studies showed that the postoperative treatment of colorectal cancer combined with Jianpi decoction was able to improve patients' quality of life significantly. Results from 10 studies that were examined on Karnofsky Performance Status (KPS) showed that 89% of patients (298/335) in the chemotherapy with Jianpi decoction were reported with improve or stable, which is after treatment than those before treatment 10 points in KPS score in the improvement and the KPS score of after treatment equal to before in the stable. Some patients' KPS scores were increased by 10 after treatment, whereas other patients' scores were same before and after treatment (OR = 4.40, 95% Cl = 2.86–6.77, P < 0.0001) [Figure 6].
|Figure 6: Forest plots of quality of life. The performance status was analyzed from Karnofsky Performance Status of 10 studies. Experiment, Jianpi decoction combined with chemotherapy group; Control, chemotherapy group|
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A funnel plot was a graph designed to check for the existence of Publication bias in systematic reviews and meta-analyses, according to the data involved in survival rate, chemotherapy toxicity and side effects, recurrence and metastasis after resection, immunoregulation, and quality of life [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]. The shape of the forest plots revealed the evidence of obvious asymmetry, indicating that bias was statistically significant in the studies. [Figure 7] shows the funnel plot of diarrhea after treatment [Figure 7]a and recurrence and metastasis after resection [Figure 7]b was a symmetric inverted funnel shape, suggesting Publication bias. The funnel plot of nausea and vomiting, immunoregulation, quality of life indicated that all of them had significant bias because an article is out of the funnel plot, for example the diarrhea after treatment. The survival of 5-year also had bias for uneven distribution in a funnel plot, like the quality of life. Fortunately, the survival of 1 and 3 years did not reveal any evidence of obvious asymmetry. The other details were referred to the attachment.
|Figure 7: Funnel plot of publication bias analysis. (a) Diarrhea after treatment. (b) Recurrence and metastasis after resection|
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| Discussion|| |
Recent studies showed that the use of TCM has gained increased recognition and usage among cancer patients., CHM is especially popular in complementary and alternative medicine as palliative care for cancer patients, but the efficacy of TCM cure on surgery and postoperative treatment of colorectal cancer remains to be explored due to regional limitations and language barrier in CHM application. Meta-analysis is a powerful statistical analysis, which summaries results from individual studies to increase the precision of assessing the therapeutic effect. It is a good way to settle controversies studies down. This systematic review contains current available RCTs to provide evidence for the use of Jianpi decoction in CHM therapy for postoperative treatment of colorectal cancer.
The pathogenesis of colorectal cancer in TCM is spleen deficiency and dampness evil stasis. Chemotherapy may damage the spleen and stomach after operation. Spleen deficiency is fundamental and damp congestion is the representation. Treatment with Jianpi decoction is applied to treat diseases with Qi deficiency of spleen and stomach and/or dampness exuberance. Moreover, blood stasis is also an important factor in cancer recurrence. Jianpi Huoxue recipe can improve the blood circulation of tumor patients, preventing tumor emboli, and even kill tumor cells to prevent tumor recurrence. Hence, the postoperative colorectal cancer should focus on bringing the dysfunction of the spleen and stomach back to normal by Jianpi treatment, which can restraint the generation of phlegm and blood stasis.
According to TCM theory, illness is caused by the disharmony of Yin and Yang, or cold and heat or deficiency and excess. TCM treatment aims to regulate the imbalance of Yin and Yang or cold and heat or deficiency and excess to restore to normal balanced state by CHMs, acupuncture and moxibustion, massage and Qigong, etc. The CHM therapy has been commonly used in Asia for thousands of years. It attaches importance to regulate the self-healing ability such as immune system of human body to remove pathogenic factors. Previous studies revealed that CHM therapy may help to improve the immune function in colorectal cancer patients.,,, In this study, our data also revealed that Jianpi decoctions regulated the levels of CD3+ and CD4+/CD8+, and remarkably enhanced immunoregulation in colorectal cancer patients after operation.
Survival rate, immunoregulation, quality of life, metastasis and recurrence, and chemo-toxicity are major outcomes to assess the therapeutic effect of the postoperative treatment of colorectal cancer. Previous studies have reported that Janpi decoctions improved immune function and reduced the toxicity of chemotherapy in the treatment of patients with colorectal cancer after operation. However, systematic review was lacked to analyze synthetically all of previous studies in the postoperative treatment of colorectal cancer. This study revealed that the Jianpi decoctions combined with chemotherapy significantly improved the survival rate and the quality of life, enhanced the immunoregulation, reduce the chemotherapy, induced toxicity, and metastasis and recurrence in colorectal cancer after operation.
The evaluation of literature methodological quality showed that a few literature reports random sequence generation, allocation mechanism, blinded, missing data and other information, the use of the absolute most of the literature research bias risk cannot be sure or higher. The quality of the literature can be concluded the important factors have clinical guiding significance conclusion of the meta-analysis. Research has shown that, mixed-method design and experiment is not rigorous documentation, will exaggerate 30%–50% treatment effect. There are randomization misuse and abuse phenomenon in clinical experiment report of TCM. In the meta-analysis, uses literature reflects this problem. Research has shown that experiments without allocation concealment are more easily to get meaningful results than that with allocation concealment experiments. The blinding method can avoid much bias, so blinding involves trial quality clinical trials. Research has shown that the treatment without blinding method can exaggerate 15% of effects than those with blinding method. Based on the above reasons, 20 studies were included in this meta-analysis.
However, some limitations of this meta-analysis are notable. First, there were few articles about Jianpi decoction combined with chemotherapy drugs in China, and those studies more likely reported positive results, which would be influenced by publication bias. Second, most of the studies about Jianpi decoction combined with chemotherapy drugs in Chinese were published in journals of poor quality. Third, the P values of Begger and Egger analysis are <0.05, indicating publication bias. A limited number of patients and articles could be an important factor. Fourth, high-quality studies were lacked such as clinical randomized controlled test with double-blind and the strict eligibility criteria. Fifth, some indicators were statistics in different ways, causing great difficulties to our work and may even cause the publication bias, such as quality of life. It suggested the actuality and the insufficient of Jianpi decoction combined with chemotherapy on the postoperative treatment of colorectal cancer in clinical researches.
| Conclusion|| |
The evidence from the meta-analysis on the included studies showed that Jianpi decoctions combined with chemotherapy has such advantages as improving survival rate and quality of life of patients, enhancing immunoregulation and alleviating chemo-toxicity, reducing metastasis and recurrence in postoperative treatment of colorectal cancer. However, due to the complex mechanisms of CHM interventions, particular attention should be paid to appropriate and rigorous research methodologies to investigate CHM as a holistic system. Therefore, a large scale RCT integrated with TCM-specialized methodology on syndrome differentiation and treatment is warranted for further study.
Financial support and sponsorship
The study was financially supported by Key Program of National Science Foundation of China (81330084) and National Key Research and Development: Special Project for Research on the Modernization of Traditional Chinese Medicine (2018YFC1704204).
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]