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Table of Contents
ORIGINAL ARTICLE
Year : 2020  |  Volume : 6  |  Issue : 1  |  Page : 74-89

A systematic review and meta-analysis of randomized controlled trials on treating ulcerative colitis by the integration method of heat-clearing, damp-excreting, spleen-strengthening, and stasis-removing of traditional chinese medicine with western medicine


1 Department of Gastroenterology, Clinical Medical College of China-Japan Friendship Hospital, Beijing University of Chinese Medicine; Department of Gastroenterology, China-Japan Friendship Hospital, Beijing, China
2 Department of Gastroenterology, Clinical Medical College of China-Japan Friendship Hospital, Beijing University of Chinese Medicine, Beijing, China
3 Department of Pharmacology of Integrated Chinese and Western Medicine, School of Preclinical Medicine, Beijing University of Chinese Medicine, Beijing, China
4 Department of Gastroenterology, Clinical Medical College of China-Japan Friendship Hospital, Beijing University of Chinese Medicine, Beijing, China
5 Department of Gastroenterology, China-Japan Friendship Hospital, Beijing, China
6 Department of Cardiovascular Medicine, Dongfang Hospital, The Second Clinical Medical College of Beijing University of Chinese Medicine, Beijing, China

Date of Submission01-Aug-2019
Date of Acceptance15-Nov-2019
Date of Web Publication13-Mar-2020

Correspondence Address:
Prof. Shu-Kun Yao
China-Japan Friendship Hospital, Beijing 100029
China
Prof. Yan Li
Department of Cardiovascular Medicine, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/wjtcm.wjtcm_1_20

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  Abstract 


Objective: The objective of this study was to systematically evaluate the clinical efficacy of the integration method of heat-clearing, dampness-excreting, spleen-strengthening, and stasis-removing from traditional Chinese medicine (TCM) combined with Western medicine for the treatment of ulcerative colitis (UC). Materials and Methods: The databases China National Knowledge Infrastructure, China Biology Medicine disc (CBMdisc), WANFANG, VIP, and PubMed were searched for randomized controlled trials investigating the integration of the TCM methods of clearing heat, draining dampness, invigorating the spleen, and removing stasis, combined with Western medicine to treat UC from January 2009 to March 2019. Two reviewers independently conducted literature searches, screenings, data extractions, and literature bias evaluations. A meta-analysis was conducted using RevMan 5.3 and Stata 13.0 software. Results: In total, 15 studies involving 1289 patients were included. The results of the meta-analysis showed that the total effective rate of treatment in the experimental groups was higher than that of the control groups (relative risk [RR] = 1.27, 95% confidence interval [CI]: 1.21, 1.35, Z = 8.74,P < 0.00001). In the subgroup analysis, the total effective rate of oral TCM combined with Western medicine was higher than that of the control groups (RR = 1.24, 95% CI: 1.15, 1.33, Z = 5.88,P < 0.00001). The total effective rate of oral TCM with enemas combined with Western medicine was higher than that of the control group (RR = 1.30, 95% CI: 1.12, 1.50, Z = 3.52,P= 0.0004). The comparison between Western medicine alone and oral TCM combined with enteroscopy and Western medicine showed that the effective rate of enteroscopy (RR = 1.18, 95% CI: 1.05, 1.33, Z = 2.86,P= 0.004) and the symptom scores before and after treatment all improved more in the combined treatment groups than in those of the Western medicine group alone, with statistically significant differences (RR = −4.23, 95% CI: −4.93, −3.53, Z = 11.84,P < 0.00001). Conclusion: The integration of the TCM methods of heat clearing, dampness excreting, spleen strengthening, and stasis removing combined with Western medicine can significantly improve the cure rate of UC, and is an effective method to treat UC.

Keywords: Clearing heat, draining dampness, invigorating spleen, meta-analysis, removing stasis, ulcerative colitis


How to cite this article:
Jia ZJ, Yanga ZH, Jia CX, Xiao KM, Niu YQ, Chen J, Duan SJ, Yao SK, Li Y. A systematic review and meta-analysis of randomized controlled trials on treating ulcerative colitis by the integration method of heat-clearing, damp-excreting, spleen-strengthening, and stasis-removing of traditional chinese medicine with western medicine. World J Tradit Chin Med 2020;6:74-89

How to cite this URL:
Jia ZJ, Yanga ZH, Jia CX, Xiao KM, Niu YQ, Chen J, Duan SJ, Yao SK, Li Y. A systematic review and meta-analysis of randomized controlled trials on treating ulcerative colitis by the integration method of heat-clearing, damp-excreting, spleen-strengthening, and stasis-removing of traditional chinese medicine with western medicine. World J Tradit Chin Med [serial online] 2020 [cited 2020 Apr 8];6:74-89. Available from: http://www.wjtcm.net/text.asp?2020/6/1/74/280620




  Introduction Top


Ulcerative colitis (UC) refers to a chronic nonspecific inflammatory disease involving lesions in the colon and rectum, mainly in the mucosa and submucosa. Although its pathogenesis remains unclear, many studies in recent years have suggested that UC develops due to factors related to the immune system, heredity, infection, the environment, and psychology.[1] UC is most common in young adults; according to China's statistics, its peak age of occurrence is 20–49 years, with little gender difference, and the male–female ratio of UC patients is 1–1.3:1. It is estimated that the prevalence of UC in China is 11.6/100,000. At present, there is no epidemiological data on large sample populations.[2] The clinical manifestations of UC are persistent or recurrent diarrhea with mucopurulent bloody stool accompanied by abdominal pain, tenesmus, and various degrees of systemic symptoms. The course of the disease is often 4–6 weeks or more, and may additionally affect the skin, mucous membrane, joints, eyes, or liver. Mucopurulent bloody stool is the most common symptom of UC. Diarrhea with a course <6 weeks is often distinguished from some infectious enteritis.[3]

Adverse reactions such as gastrointestinal discomfort, dizziness, headache, rash, and even severe adverse reactions such as anemia, bone marrow suppression, and respiratory tract infections often occur with commonly used treatments such as sulfasalazine, azathioprine, budesonide, and infliximab. Therefore, there is a search for more effective treatments of UC with fewer adverse reactions. Although there is no clear name of UC in ancient books of traditional Chinese medicine (TCM), according to the clinical symptoms such as mucopurulent bloody stool and the characteristics of recurrence, it can be summarized as “Liji” and “Jiuli.” By looking, listening, asking, and feeling the pulse, one could determine “Liji” as the excess of heat and dampness, blood stasis, and spleen deficiency. Therefore, when preparing treatments, it is important to clear heat and remove dampness, strengthen the spleen, and improve blood stasis, which are conducive to increasing the therapeutic effect of UC.[2]

At present, TCM is known to be very effective for treating UC. In order to provide evidence for the integration of the TCM methods of heat clearing, dampness excreting, spleen strengthening, and stasis removing combined with Western medicine in UC treatment, we performed a systematic review and meta-analysis of the current literature.


  Materials and Methods Top


Literature selection

To search the literature for relevant studies, key Chinese words used were “Qingre Lishi” (clearing heat and draining dampness), “Jianpi” (invigorating the spleen), “Yiqi” (tonifying qi), “Huoxue” (promoting blood circulation), “Huayu” (removing stasis), “Kuiyangxing Jiechangyan” (ulcerative colitis), “Zhongyao” (traditional Chinese medicine/Chinese herbs), “Suiji” (random), “Duizhao” (controlled), “Linchuang Shiyan” (clinical trials), and the English words: “heat-clearing,” “damp-excreting,” “spleen-strengthening,” “stasis-removing,” “ulcerative colitis,” and “UC.” The selected databases were China National Knowledge Infrastructure, China Biology Medicine (CBM), Wanfang database, VIP database, and PubMed. The literature was searched for publications between January 2009 and March 2019.

Inclusion criteria

The inclusion criteria for this review were randomized controlled trials (RCTs); patients with UC diagnosis; publication between January and March 2019; and the integration of TCM through oral administration alone or combined with enteroclysis for heat clearing, dampness excreting, spleen strengthening, and stasis removing along with Western medicine in the experimental group against a control group treated with Western medicine alone. Specifically, Western medicine treatment had to be included in both groups, with identical types of medicine and course of treatment. In addition, primary outcome indicators included comprehensive treatment effectiveness, rate of reduction in clinical symptoms, and efficacy shown by endoscope, and secondary outcome indicators included TCM syndrome scores and the comparison of treatment effectiveness of different TCM syndromes.

Exclusion criteria

The exclusion criteria were any study that was not an RCT; treatment of UC with TCM herbs alone and Western medicine alone; RCTs with the integration of enteroclysis with TCM herbs with Western medicine and treatment with Western medicine alone; RCTs without the number of people in each group specified; and studies that did not treat UC with the TCM herbs for heat-clearing, dampness-excreting, spleen-strengthening, and stasis-removing functions.

Evaluation standard

The Cochrane Collaboration's tool for assessing the risk of bias[4] was used to evaluate the quality of the literature, including selection bias due to the inadequate generation of a randomized sequence or inadequate concealment of allocations before assignment; performance or detection bias due to lack of blinding; attrition bias due to the amount, nature, or handling of incomplete outcome data; reporting bias due to selective outcomes; and bias due to problems not covered elsewhere. For each study, “low-risk,” “unclear,” and “high-risk bias” were evaluated based on the Cochrane criteria.

Literature screening and data extraction

Two researchers screened the literature and extracted data according to the inclusion criteria independently. If there was disagreement, the two researchers would discuss it together or a third researcher would assist in making a decision. The main data extracted were general information such as the first author, the date of publication, and the source and title of the study; basic features of the studies such as the method of randomized grouping of the participants, male–female ratio, interventional methods used in each group, and follow-ups; and outcomes measured such as the effective rate and adverse reactions.

Statistical analysis

A meta-analysis was performed using RevMan 5.3 (Haymarket, London, SW1Y 4QX, UK) and Stata 13.0 (Texas, USA) software. The heterogeneity test was conducted using the Chi-square test on all the included study results with the standard level set at α = 0.1. When P ≥ 0.1 and I2 ≤ 50%, which indicates homogeneity of the results, the meta-analysis can be conducted using the fixed-effects model. When P < 0.1 and I2 < 50%, which indicates certain heterogeneity of the results, the heterogeneity is within the acceptable range, and the meta-analysis can be conducted using the fixed-effects model. When P < 0.1 and I2 > 50%, which indicates relatively significant heterogeneity among the results, further analysis of the source of the heterogeneity should be undertaken. When there is an absence of obvious clinical experimental indicators such as categorical variables, the relative risk (RR) should be taken as the effect size. When there is an absence of obvious clinical experimental indicators such as numerical variables, the weighted mean difference and the standard mean difference should be taken instead. The interval estimations were all set at a 95% confidence interval (CI). The existence of publication bias was analyzed using Begg's test and Egger's test.


  Results Top


Retrieval and screening process

After searching the Chinese databases for the keywords described previously, 2897 studies were retrieved. A primary screening of the titles and abstracts resulted in 279 studies meeting the inclusion criteria. After an extensive reading of the articles for secondary screening, the following articles were excluded: 74 were not RCTs; 62 did not involve the treatment of UC with the TCM herbs for functions of heat clearing, dampness excreting, spleen strengthening, and stasis removing; 31 involved the treatment of UC with enteroclysis of the TCM decoction; 92 compared the effects of TCM herbs alone to Western medicine; 1 had the total effectiveness rate as the only outcome; 1 used electro-acupuncture therapy; 1 did not specify the treatment course; and 2 did not specify the number of participants or the male–female ratio in each group. The final number of included studies was 15. Our screening process is shown in [Figure 1].
Figure 1: Literature selection process

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Basic features of the included studies

After screening, 15 RCTs from Chinese databases were included in this study. Within those 15 studies, 1289 UC patients were included. All the experimental groups were treated with the integration of the TCM methods of heat clearing, dampness excreting, spleen strengthening, and stasis removing combined with Western medicine. Of these, 645 patients were in experimental groups and 644 patients were in control groups. The age range and average age were described in all the included studies, with a minimum age of 18 years and a maximum age of 72 years. In terms of the number of male and female patients, apart from the two studies without this information, a total of 636 male patients and 522 female patients were included in the other 13 studies. In terms of the disease course, three studies did not mention any information, two studies only described the average disease course among all the included patients, and the other ten studies provided details of the longest and shortest disease courses in the study. Of those 11 studies, the shortest disease course was 3 days and the longest disease course was 20 years. The statistical analysis of the experimental group's baseline information was clearly described in all the 15 studies and the baselines between the two groups were similar and comparable.

All RCTs were published in medical journals. Experimental groups in all the studies were treated with the integration of the TCM methods for heat clearing, dampness excreting, spleen strengthening, and stasis removing combined with Western medicine, and control groups were treated with Western medicine alone. The treatments used in the experimental groups included eight studies[5],[6],[7],[8],[9],[10],[11],[12] with oral administration of TCM herbs and seven studies[13],[14],[15],[16],[17],[18],[19] with enteroclysis of TCM herbs. The overview of the studies are shown in [Table 1].
Table 1: Literature overview

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Quality evaluation of literature methodologies

For randomized sequence generation, four studies[7],[9],[10],[11] used a random number table, with a relatively low risk of bias. The other 11 studies[5],[6],[8],[12],[13],[14],[15],[16],[17],[18],[19] did not describe the specific method for randomization and only used the term “random,” so the risk of bias could not be judged. None of the studies used a blind method nor described the concealment of allocations, so the risk of bias could not be judged. All the studies were low-quality studies. [Figure 2] depict the results of the quality evaluation and analysis conducted on all the included RCTs according to the quality evaluation criteria.
Figure 2: Quality evaluation and analysis

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Statistical analysis results

Analysis of total clinical effective rate

The experimental groups were treated with TCM herbs based on previous Western medicine treatments. The success of treatment was divided into the following three levels: cured, improved, and ineffective. The number of effective cases was determined by adding the cured and improved cases together. The meta-analysis on the summarized data of the included studies demonstrated that of the 645 patients in the experimental groups, 586 were treated effectively, and of the 644 patients in the control groups, 459 were treated successfully. All studies described the total clinical effective rate, and there was no statistically significant heterogeneity between different studies (P = 0.07, I2 = 0% <50%). Considering that these studies were homogeneous, the meta-analysis was conducted using the fixed-effect model, and the difference was statistically significant (RR = 4.11, 95% CI: 2.98, 5.67, Z = 8.62, P < 0.00001), indicating that the effective rate of the experimental group was higher than that of the control group [Figure 3].
Figure 3: Total effective rate

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Subgroup analysis of total clinical effective rate

Seven studies used oral TCM and enemas combined with Western medicine to treat UC and compared that to Western medicine alone. Eight studies only used oral TCM combined with Western medicine. Therefore, a subgroup analysis was performed. All the studies were divided into an oral medicine group and an oral–enema group. Research statistics showed that the oral group and the control group had no obvious heterogeneity (P = 0.50, I2 = 0% <50%). Considering that these studies were homogeneous, the meta-analysis was conducted using the fixed-effect model, and the result showed an RR = 1.24, a 95% CI of 1.15, 1.33, a Z = 5.88, and a P < 0.00001. The oral–enema group and control group had no obvious heterogeneity between the groups (P = 0.0001, I2 = 73% >50%). Considering that these studies had homogeneity, the meta-analysis was conducted using the random effects model, and the result showed a statistically significant difference (RR = 1.30, 95% CI: 1.12, 1.50, Z = 3.52, P = 0.0004). The results showed that the comprehensive curative effect of the subgroup was better than that of the control group [Figure 4] and [Figure 5].
Figure 4: Total effective rate (oral group)

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Figure 5: Total effective rate (combined oral–enema group)

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Analysis on publication bias

The researchers conducted a Begg's test and an Egger's test using Stata software to determine if there was publication bias. The Begg's and Egger's test revealed P < 0.05, suggesting publication bias. After removing four studies[7],[15],[8],[18] with a relatively low total effective rate, the researchers conducted a Begg's and Egger's test again, with P > 0.05, suggesting that there was no publication bias [Figure 6].
Figure 6: Begg's test and Egger's test results

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Analysis of the enteroscope effective rate

Of the 15 included studies, four studies[7],[15],[8],[9] recorded the enteroscope effective rate. There was no significant heterogeneity between the different studies (P = 0.93, I2 = 0% <50%). Considering these studies were homogeneous, the meta-analysis was conducted using the fixed effect model, the result of which was an RR = 1.18, a 95% CI (1.05, 1.33), a Z = 2.86, and a P = 0.004, showing a statistically significant difference. This suggested that the enteroscope effective rate of treating UC by the integration of an enteroscope with the oral TCM treatment methods for heat-clearing, dampness-excreting, spleen-strengthening, and stasis-removing along with western medicine was higher than western medicine treatment alone [Figure 7].
Figure 7: Analysis on enteroscope effective rate of five studies

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Comparison of symptom scores before and after treatment

Of the 15 included studies, two studies[6],[12] applied the same evaluation standard of symptom scores: the grading and scoring of the severity of TCM symptoms according to “The Guiding Principles for Clinical Study of New Chinese Medicine in Treating Diarrhea.[20] Specifically, a score of 0 meant no symptoms, and score of 1, 2, and 3 meant slight, medium, and severe symptoms, respectively. There was no significant heterogeneity between the different studies (P = 0.65, I2 = 0% <50%). Considering these studies were homogeneous, the meta-analysis was conducted using the fixed effect model. The result showed a statistically significant difference (RR = −4.23, 95% CI [−4.93, −3.53], Z = 11.84, P < 0.00001). The symptom score after treating the experimental group was lower than that of the control group, indicating there was higher treatment success in the experimental group [Figure 8].
Figure 8: Comparison of symptom scores before and after treatment from two studies

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Of the 15 included studies, six studies[6],[14],[15],[16],[11],[18] used a basic treatment of oral sulfasalazine, so a subgroup analysis could be performed. There was no significant heterogeneity between the different studies (P = 0.88, I2 = 0% <50%). Considering these studies were homogeneous, the meta-analysis was conducted using the fixed effect model, the result of which showed a statistically significant difference (RR = 1.21, 95% CI [1.12, 1.32], Z = 4.67, P < 0.00001), which indicated that the total effective rate in the experimental group was better than that of the control group (oral sulfasalazine group) [Figure 9].
Figure 9: Total effective rate (subgroup)

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Evaluation of adverse reactions

Of the 15 included studies, five studies[6],[8],[9],[10],[17] described adverse reactions, among which two[10],[17] showed no significant adverse reactions in the control group or the treatment group. In the other three studies,[9],[10],[17] the 116 patients in the control group experienced nausea and vomiting in two cases, fatigue in four cases, and fever in one case. Of the 116 patients in the treatment group, three experienced nausea and vomiting, two experienced dizziness, and one patient had abdominal pain and diarrhea. However, all the adverse reaction symptoms were mild, and all the patients were able to complete the medication therapies. Due to the insufficient observation of adverse reactions in the other included studies, the safety of this regimen cannot be conclusively determined based on the existing evidence.


  Discussion Top


In Western medicine, 5-aminosalicylic acid (5-ASA) is commonly used to treat mild or moderate UC, and steroid pulse therapy is used to induce, relieve, and control the symptoms of severe active UC. After the symptoms are relieved, the dose of oral steroids is gradually reduced, and 5-ASA is administered simultaneously to maintain the effect. If the patient is steroid resistant or steroid dependent, immunosuppressants or biological agents can also be used. UC can also be treated with the integration of TCM and Western medicine, using methods to clear the intestines, resolve dampness, cool the blood, and remove toxins combined with glucocorticoids.[21] Glucocorticoid-resistant/dependent UC should be treated by integrating TCM syndrome differentiation and Western medicine. In terms of Western medicine, thiopurine drugs such as azathioprine and biological agents (anti-tumor necrosis factor monoclonal antibody or vedolizumab) can be used.

At present, the etiology and pathogenesis of UC remain unclear. It is widely believed that UC is caused by many factors involving genetics; the environment; psychology; and diet. These lead to intestinal mucosal barrier damage, neuroendocrine dysfunction, and immune imbalance, causing local ulceration of the intestinal mucosa.[22],[23],[24],[25],[26] According to traditional medicine, the pathogenesis of UC is mainly related to six exogenous pathogens, namely improper diet; affect-mind dissatisfaction, and congenital deficiency of endowment, which leads to abnormal spleen and stomach movement; endogenous dampness and heat; block qi and blood; qi stagnation and blood stasis; and intestinal conduction loss. At present, most studies show that the most active UC is associated with dampness heat of the large intestine according to the TCM syndrome differentiation, which is an excessive syndrome, and its main pathogenesis is heat dampness accumulating in the large intestine and the imbalance of qi and the blood.[27] Many studies have shown that TCM plays a therapeutic role in UC by inhibiting inflammatory signaling pathways such as KF-κB, TLR4-MyD88-NF-κB, mitogen-activated protein kinase, JAK/STAT, and PI3K-AKT-mTOR, among others.[28] Therefore, TCM used to clear away heat and dampness, invigorate the spleen, and remove blood stasis can act on the gastrointestinal tract and heal ulcers, greatly improving patients' confidence in treatment and their quality of life.

Herein, a meta-analysis was conducted on 15 studies. Although these studies used different modified prescriptions based on TCM syndrome differentiation, all these modifications were based on the TCM method of heat clearing, dampness excreting, spleen strengthening, and stasis removing, and all studies showed that the curative effect of treating UC by the integration of these with Western medicine is better than using Western medicine alone. All studies were randomized, with clear interventions and comparable baselines. However, there was limited description of the study designs, randomization methods, and allocation concealments, so it is difficult to judge if they were scientific and reasonable, if there was publication bias, or if there was sufficient quality of methodology. In addition, only five studies[6],[8],[9],[10],[17] mentioned adverse events. The lack of a specific description of adverse events makes security analysis difficult to conduct. The number of studies included and the cases in this analysis were also relatively small, and the basic conditions such as the stage of the disease and the disease course, the age of the patients, and result indicators were not uniform. In addition, there was difference in the duration of treatment in the studies, and most studies did not mention the specific randomization methods, leading to low quality and credibility overall. The above deficiencies, therefore, affect the meta-analysis results and the strength of the argument.

Further scientific studies with prospective, multicentric, large-scale, randomized, and double-blind controlled trials should be conducted to draw conclusions that are more convincing. Future researchers should pay attention to different methods of treatment and prescriptions at different stages of the disease. Randomized Controlled Trial (RCT) should be double blinded with allocation concealment, and follow-ups should be recorded to ensure the credibility of the results. Selecting only high-quality studies would enhance the evidence that TCM is therapeutic through the theory of evidence-based medicine.


  Conclusion Top


Treating UC with Western medicine combined with TCM based on UC's features of internal retention of dampness and heat, blocked vessels, and meridians by blood stasis and qi stagnation caused by the accumulation of stasis could better address both symptoms and root causes with a relatively higher success rate compared to treatment with Western medicine alone. This review provides evidence for treating UC with both TCM methods and Western medicine combined.

Financial support and sponsorship

This study was financially supported by Project of China-Japanese Friendship Hospital, the study on the pathogenesis of UC with syndrome of retention of dampness heat in large intestine based on relevant pathways of “bacteria–intestine–brain axis” (2019-JYB-JS-020).

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9]
 
 
    Tables

  [Table 1]



 

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  In this article
Abstract
Introduction
Materials and Me...
Results
Discussion
Conclusion
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