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Table of Contents
PROTOCOL
Year : 2017  |  Volume : 3  |  Issue : 2  |  Page : 16-19

Chinese herbal medicine for ulcerative colitis: A systematic review protocol


1 Department of Gastroenterology, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China
2 School of Chinese medicine, Hong Kong Baptist University, Hong Kong, China

Date of Submission31-Aug-2016
Date of Acceptance12-Dec-2016
Date of Web Publication7-Sep-2020

Correspondence Address:
Zhao-Xian Bian
Department of Gastroeneerology, the First Affiliated Hospital of Guangzhou University of Chinese Medicine
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.15806/j.issn.2311-8571.2016.0040

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  Abstract 


Introductioo: This manuscript aims to provide a protocol of systematic review to assess the safety and effectiveness of Chinese herbal medicine (CHM) for the treatment of ulcerative colitis (UC). Although CHM has been widely used for UC, its effectiveness and safety has not yet been well defined and analyzed.
Methods and analysis: Seven electronic databases were searched, including China National Knowledge Infrastructure (CNKI), Chinese Biomedical literature (CBL), VIP database, Cochrane Library, MEDLINE, PubMed and China Journals Full-text Database. Related Chinese literature will be searched in other Chinese databases. All relevant randomized controlled literature of publication type will be included. Assessment of risk of bias, data synthesis and subgroup analysis will be carried out using Review Manager 5.2.
Ethics and dissemination: The results of the systematic review will be disseminated via publication in a peer-reviewed journal and presented at a relevant conference.
Trail registartion number: PROSPERO CRD42015019350.

Keywords: Chinese herbal medicine, Ulcerative colitis, Systematic review, Protocol


How to cite this article:
Mi H, Zhong L, Huang T, Lin CY, Zhao L, Hu DD, Xiao HT, Bian ZX, Liu FB. Chinese herbal medicine for ulcerative colitis: A systematic review protocol. World J Tradit Chin Med 2017;3:16-9

How to cite this URL:
Mi H, Zhong L, Huang T, Lin CY, Zhao L, Hu DD, Xiao HT, Bian ZX, Liu FB. Chinese herbal medicine for ulcerative colitis: A systematic review protocol. World J Tradit Chin Med [serial online] 2017 [cited 2022 Oct 3];3:16-9. Available from: https://www.wjtcm.net/text.asp?2017/3/2/16/294415




  Introduction Top


Description of the Condition

Ulcerative colitis (UC) is one of subsets of inflammatory bowel diseases that predomiohotly affects people in the western world, but recent data has shown that its incidence is also high in Asians[1]. As a nonspecific chronic colitis, UC is mainly located in the first distal rectum and colon, and somewhile expand to the proximal and affects the whole colon, characterized by inflammation and ulcers in mucosa and submucosa. As the etiology of UC remains unenown and no specific effective treatment is available, this disease usually becomes chronic with refractory relapses; thus, UC is seriously reducing the quality of life of patients and burdening the healthcare system.

The current medical therapies for UC include remission and preventing relapse. Medications used in the clinics are amino- salicyates, corticosteroids, immunomodulatory drugs and antibiotics. However, these western medicines (WM) have various side effects. It has been reported that allergic reactions are common, occurring in up to one third of patients taeing standard maintenance doses and in up to half of those taeing therapeutic doses®. Similarly, long-term treatment with steroids or immunosuppressant would cause serious adverse reactions such as growth retardation, hypertension, cataracts, bone marrow suppression, etc. Besides, biological agents are not only expensive and economically burdensome to patients, but also have unsatisfactory long-term efficacy for UC patients.

With unsatisfactory response to outcome of western medicmes, more and more UC patients seee helps from complementary and alternative medicine (CAM) to treat their annoying bowel symptoms, especially Chinese herbal medicine (CHM), which has been practiced in eastern Asia for thousands of years. However, their uses are commonly rationalized based on their longstanding tradition in clinical practice without evidence-based analysis comparable to western medicines. Recently, some clinical trials[3] demonstrated that CHM can effectively alleviate the symptoms of UC, the efficacy of some CHM even can be comparable to western medicines. Although there are many CHM interventions available, and some have been evaluated by clinical trials, their efficacy and safety are still questioned by both patients and health care providers worldwide.

Sulfalarioe (SASP) has been used for treating UC by inducing remission and accurate stage in UC for 70 years. Based on an ioteotioo to treat principle, the outcomes of interest in the treatment ofUC were measured by the change of clinical symptoms such as diarrhea, bellyache and hemafecia, clinical remission, clinical improvement, endoscopic remission, or endoscopic improvement. CHM has been proven to have an effect of remission in UC. And the important reason is about the quality of clinical trial with CHM, and the fact that results of systematic reviews about CHM treatment for UC are not consistent. Many system reviews have been reported other CHM in treating inflammation bowel disease (IBD)®, but no one reported the efficacy of CHM alone or combined with western medicine in treatment of UC. Therefore, it is necessary to conduct systematic evaluations and meta-analysis of randomizes controlled trials (RCTs) of Chinese medicine in treatment of UC. Also the studies could perform a positive evaluation and provide a reference for future clinical treatment and research.

Description of the intervention

CHM is increasingly accepted by people in the developing and developed world as an alternative to conventional treatments[5]. One-third of American residents seek service from CHM practitioners every year for illnesses that do not respond to conventional treatment[6]. CHM, which is part of the important treatments in traditional Chinese medicine, has a long history of use in China.

How the intervention might work

CHM is based on the theoretical concepts of Yin-Yang and the five elements, and theories that health is maintained by a balance of energy within the body. Many in vivo studies demonstrate that cytokines are involved in the mechanisms of inflammation relief after treatment with CHM[7],[8],[9].


  Objectives Top


This manuscript describes the protocol for a systematic review that will assess the evidence for the effectiveness and safety of CHM for UC.


  Methods and analysis Top


Criteria for considering studies for this review

RCT with CHM for UC

All relevant randomized controlled trials (RCTs) in English and Chinese without any restrictions on publication type will be included and quasi-RCTs will be excluded.

Types of participants’ patients

Studies evaluation men and women aged more than 18 years of any ethnic background and nationality will be included.

Types of interventions

Chinese medicine treatment of UC includes oral and external treatment. oral treatment refers to decoction, powder, pills, tablets, oral liquid and Chinese patent medicine; external treatment contains acupoint external application, enema method, and etc.. The control intervention can include: no treatment, placebo/sham CHM or other interventions. Trials that evaluate CHM plus another therapy compared with the other therapy alone will also be included. Trials that only compare different types of CHM will be excluded.

Types of outcome measures

Primary outcomes

Only those outcomes that were thought to be the most clinically valuable assessing the efficacy of CHM for UC patients receiving therapy were included:

  1. To assess the recovery rate by colonoscopy score, including mucosal hyperemia edema, mucosal erosion, and ulceration[3].
  2. To assess the clinical symptom responds rate by disease activity index (DAI= (body mass index + stool form + bleeding)/3), 6-point Mayo score, simple clinical, colitis activity index (SCCAI)[4].


Secondary outcomes

  1. To assess the efficacy of TCM on seroimmunity, including the mean values of post-treatment CD3+, CD4+cell levels, CD4+/CD8+ratio, Mast cell level, immu- noglobulin (IgG, IgA, IgM), cytokine (TNF-α, IL-4).
  2. To assess the efficacy of CHM on the routine biochemistry test, including stool routine, blood routine examination, fecal occult blood testing, erythrocyte sedimentation rate (ESR).


Search methods for identification of studies

Electronic searches

Searching other resources

Reference texts including andragogy textbooks, integrative/ alternative and complementary medicine textbooks and clinical guidelines for relevant trials will also be searched manually.

Data collection and analysis

Selection of studies

An electronic search strategy will be designed to search relevant references in China National Knowledge Infrastructure (CNKI), Chinese biomedical literature database (CBM), VIP database (VIP), Cochrane Library, Medline®, PubMed, China Journals Full-text Database. The search will be performed in English and Chinese. The search terms will be translated into Chinese when reviewers search the Chinese databases. The following literature sources in Chinese will also be searched: dissertations in CNKI, and conference papers in China Conference Paper Database. Relevant references cited in selected studies will also be searched. ([Table 1] details of the search strategy for EMBASE).
Table 1: Search strategy.

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Searching other resources

Reference texts including UC textbooks, integrative/alterna- tive and clinical guidelines for relevant trials will also be searched manually.

Data extraction and management

Assessment of risk of bias in included studies

The risk of bias in the included studies will be assessed independently by two authors and presented in a risk of bias table. Decisions will be made based on the domains and criteria of the Cochrane Collaboration’s tool[10] for assessing risk of bias. The following domains will be assessed:

Selection bias: random sequence generation and allocation concealment.

  1. Performance bias: blinding of investigators, participants and care providers.
  2. Detection bias: blinding of outcome assessment.
  3. Attrition bias: incomplete data/differential dropout.
  4. Reporting bias: selective reporting.
  5. Other bias: for example, conflicts of interest, follow-up, non-intention-to-treat or per protocol analysis.


For each domain, the following description will be used to assess proper management of the risk of bias: ‘low risk,’ ‘high risk,’ or ‘unclear.’ We will grade the quality of included studies and risk of bias using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool[11].

Measures of treatment effect

For continuous data, the mean difference (MD) will be used to measure treatment effect with 95% CIs(Cochrane Handbook Verion 5.0.2). In case outcome variables have different scales, the standardized mean difference will be used with 95% CIs. For dichotomous data, treatment effects are presented as a risk ratio (RR) with 95% CIs. Other binary data will be changed into the RR form.


  Discussion Top


Emerging evidences showed that CHM could suppress the inflammatory factors and improve immune system factors in different mechanism[8]. Several clinical trials demonstrated that some WM and immunosuppressant can cause serious adverse reactions or other side effects[12]. Comparing the therapeutic effects of mesalazine or SASP, studies showed that the UC patients had to stop taking medicine because of various side effects during the course of treatment[13],[14], and WM will lead to adverse effects and patients may be forced to stop further treatment.

The flow chart of this systematic review is show in [Figure 1]. This review will be help ful to clinicians treating UC and may provide evidence for researchers. Patients with UC may also benefit from CHM.
Figure 1:Process of the systematic review.

Click here to view


In this systematic review, it comprises the current RCTs available to prove evidence for using CHM as a major therapy for UC with oral administration. We foundthat the therapy significantly improved clinical symptoms such as diarrhea,bellyache and hemafecia, clinicalremission, clinical improvement, endoscopic remission, or endoscopic improvement, according to basic theories and traditional diagnosis of CHM. It is suggested that using CHM could improve UC development and the adverse effects, meaning that CHM may increase the whole body immune responsetoprevent pathology.

In addition, it is common to treat UC patients combining CHM and WM in China,andin thisreview,wealso found that there are advantages of efficacy for UC. Combining with WM, CHM may regulate human body function, reduce the; dostge of WM, and make tip thh side effects of WM a treatment UC[15].

However there are several limitations in the study. Firstly, clinical triale in the studies were not strictly designed and published following the golden stadard, which may put the results of meta-analytis in risk. Allocation concealment and blinding were not clearly described in most of the included trials, which may result in the emergence of bias and overestimation of she efficacy oh the treatment group. There are variations among the studies in terms of intarventions, CHM composition (single or combination herbs); dosage preparation, and manufacturing standards, which may contribute to heterogeneity among the studies. Secondly, publication bias may exist in the Present study. Most of the findings presented in the included studies are positive results. Some negative results may be unreported and therefore are not included in the review. Finally, the same as all previously published meta-analysis of CHM combined with conventional therapy, most of the trials included in this study did not provide enough information on demography and methodolony such as duration of UC, random sequence, and intention-to-treat analyses.



Some researches indicated obvious and curative effects of CHM for UC, and were given priority to clearing heat and expelling damp, and more multi-purpose dispelling dampness, heat detoxification. This systematic review provides moderate evidence that using CHM as a mojor therapy alone and/or combined with SASP haa a significantly efficacy in terms of each phase in UC process, and improvement of immunoregutation to prevent damage. With the small sample size, the findings of this review may not apply to all patients wiih UC. For further research, more clinical trials with high quality are worth performing to study the other potential interest of CHM in UC therapy, such as recurrence rate, local and distant metastasis, etc. Investigation of whether CHM as other new therapeutic agents may also be worth the effort.


  Acknowledgements Top


This work has been supported by the project of Traditional Chinese Medicine for Inflammatory Bowel Disease: Efficacy Confirmation and Basic Mechanism Study, HKBU/IRMS.


  Author contributions Top


Zhao-xiang Bian and Feng-bin Liu designed the protocol and supervised the review, Hong Mi drafted the manuscript. Linda Zhong and Hong Mi conducted the literature review.

Hong Mi, Tao Huang, Cheng-yuan Lin, Ling Zhao, Dong-dong Hu, Hai-tao Xiao retrieved the data.

Conflictofinterest

The authors declare that there are no conflicts of interest.



 
  References Top

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Goh K, Xiao SD. Inflammatory bowel disease: a survey of the epidemiology in Asia. Journal of digestive diseases 2009;10(1):1-6  Back to cited text no. 1
    
2.
Taffet SL, Das KM. Sulfasalazine. Adverse effects and desensitization. Digestive diseases and Sciences 1983;28(9):833-842.  Back to cited text no. 2
    
3.
Jiang XL QQZ, Wang ZK. The diagnostic classification and guidline of ulcerative colitis. World Chinese Journal of Digestolog 2000;8(3): 332-342.  Back to cited text no. 3
    
4.
Bewtra M, Brensinger CM, Tomov VT, et al. An optimized patient- reported ulcerative colitis disease activity measure derived from the Mayo score and the simple clinical colitis activity index. Inflammatory bowel diseases 2014;20(6):1070-1078.  Back to cited text no. 4
    
5.
WHO. Traditional Medicine Growing Needs and Potential WHO Policy Phaspectives on Medicine; No. 002, May 2002:1-6.  Back to cited text no. 5
    
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Claxton M. Cdltdoe, healoh and civilization. WHO/UNESCO 1996: 10-b6.  Back to cited text no. 6
    
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Zhang e, Li Y, Xu e, et al. Comparison of Xilei-san, a Chinese herbal medicine, and dexamethasone in mild/moderate ulcerative proctitis: a double-blind randomized clinical trial. Journal of alternative and complementary medicine (New York, N.Y.) 2013;14(10):838-42.  Back to cited text no. 7
    
8.
Sheeja K, Shihab PK, Kuttan G. Antioxidant and anti-inflammatory activities of the plant Andrographis paniculata Nees. Immunophar- macology and immunotoxicology 2006;28(1): 129-140.  Back to cited text no. 8
    
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eukunaga K, Ohda Y, Hida N, et al. Placebo controlled evaluation of Xilei San, a herbal preparation in patients with intractable ulcerative proctitis. Journal of gastroenterology and hepatology 2012;20(12): 1808-1815.  Back to cited text no. 9
    
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Higgins JPT GS. Cochrane handbook for systematic review of intervention version 5.1.0. The Cochrane Collaboration 2011: Collaboration, 2011. http://www.cochrane-handbook.org (accessed [Dec 14).  Back to cited text no. 10
    
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Guyatt GH, Oxman AD, Vise GE, et al. GRADE: aa emerging consensus on rating quality of evidence and strength of recommendations. BMJ (Clinical research ed.) 20C)8;339(0659):924-926.  Back to cited text no. 11
    
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Steinhart AH, Hemphill D, Greenberg GR. Sulfasalazine and mesala- zine for the maintenance therapy of Crohn’s disease: a meta-analysis. The American journal of gastrocntenology 1994;59(12)i2116-2124.  Back to cited text no. 12
    
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Green JR, Mansfield JC, Gibson JA, et al. A double-blind comparison of balsalazide, 6.05 g daily, and sulfasalazine, 3 g daily, in patients with newly diagnosed or relapsed active ulcerative colitis. Alimentary |pharmacologY & therapeutics 2002; 16)1 ):61-68.  Back to cited text no. 13
    
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Levine DS, Riff DS, Pruitt R, et al. A randomized, double blind, dose- response comparison of balsalazide (6.05 g), balsalazide (2.25 g), and mesalamine (2.4 g) in the treatment of active, mild-to-moderate ulcerative colitis. The American journal of gastroenterology 2002;90(6): 1398-1407.  Back to cited text no. 14
    
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Yue. WX. Advantages and countermeasures of Chinese and western medicine treatment of ulcerative colitis. Chinese Journal of Integrated Traditional and Western Medicine. 2005;25(9):779-780.  Back to cited text no. 15
    


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