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BACKGROUND@#Syndrome is one of the most important concepts in Chinese medicine (CM) theory. However, it was not well accounted in most of randomized controlled trials (RCTs).@*OBJECTIVES@#To determine whether CM syndrome differentiation affects the treatment results, functional constipation (FC) was selected as a target disease, and MaZiRenWan (, MZRW), a classic CM formula commonly used for constipation with excessive heat syndrome, was selected for study.@*METHODS@#It is an 18-week prospective double-blinded, doubledummy RCT, including 2-week run-in, 8-week treatment and 8-week post treatment follow-up. A total of 120 FC patients diagnosed as excessive heat syndrome will be recruited from the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and the Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine. Patients will be randomly allocated into fixed MZRW (f_MZRW) granule group, modified MZRW (m_MZRW) granule group or bisacodyl group. For m_MZRW group, no more than two herbal granules can be added according to the syndrome differentiation for individual participants. The primary end point is the mean of complete spontaneous bowel movements (CSBMs) per week during the treatment period. Secondary end points include mean of CSBMs per week during follow-up, stool form, global symptom improvement, constipation and constipation-related symptoms assessment, CM syndrome change, and reported adverse events.@*DISCUSSION@#This trial is designed to evaluate the effectiveness of these three interventions for FC patients with the CM syndrome of excessive heat, and to determine the change of CM syndrome and the progress of disease during the treatment course. The results are important to explore whether syndrome differentiation is important for the therapeutic effect of a formula on a disease. [Trial registration: Chinese Clinical Trial Registry (Reg No. ChiCTR-TRC-13003742); protocol version: MZRW/NSFC-81173363 (2015.05.04)].
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Humans , Constipation , Diagnosis , Drug Therapy , Double-Blind Method , Drugs, Chinese Herbal , Therapeutic Uses , Medicine, Chinese Traditional , Outcome Assessment, Health Care , Prospective Studies , Randomized Controlled Trials as TopicABSTRACT
Traditional Chinese Medicine (TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.
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Humans , Clinical Protocols , Clinical Trials as Topic , Medicine, Chinese Traditional , Research DesignABSTRACT
With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine (IM) and has become a new unique discipline. During almost 20 years, as one of the most important parts of evidence-based IM, systematic review (SR)/meta-analysis (MA) of IM have shown a good development momentum in the aspects of quantity, depth, breadth and influence, but also face the harsh situation of the uncontrolled quantity and quality, especially for SRs in Chinese. Therefore, how to supervise and standardize this area effectively becomes a problem to be solved. Based on the experience both at home and abroad, the authors put forward several kinds of solutions for laying the foundation for further development such as promoting the registration system of SR/MA of IM, effectively setting up the regulatory platform of quality and quantity, launching professional training for SR/MA reviewers, forming qualification registration, developing the data transfer and sharing platform to realize the transparency of evidence process.
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How to test the treatments of Chinese medicine (CM) and make them more widely accepted by practitioners of Western medicine and the international healthcare community is a major concern for practitioners and researchers of CM. For centuries, various approaches have been used to identify and measure the efficacy and safety of CM. However, the high-quality evidence related to CM that produced in China is still rare. Over the recent years, evidence-based medicine (EBM) has been increasingly applied to CM, strengthening its theoretical basis. This paper reviews the past and present state of CM, analyzes the status quo, challenges and opportunities of basic research, clinical trials, systematic reviews, clinical practice guidelines and clinical pathways and evidence-based education developed or conducted in China, pointing out how EBM can help to make CM more widely used and recognized worldwide.
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Humans , Critical Pathways , Evidence-Based Medicine , Medicine, Chinese Traditional , Practice Guidelines as Topic , Randomized Controlled Trials as TopicABSTRACT
Stomach pain in Chinese medicine (CM) is a very common disorder in clinical practice and it has been listed as one of the pilot three conditions in Hong Kong to develop evidence-based CM clinical practice guidelines (CM CPGs). The aim of this stomach Pain CPG is to summarize the treatment methods of stomach pain with CM and evaluate reasonably, then to guide local licensed CM practitioners and provide beneficial reference for social medical decision makers and patients. In this manuscript, we defined stomach pain in CM and the category of chronic gastritis in Western medicine. The clinical manifestation, CM pattern classification, and CM intervention including herbal medicine treatment based on pattern differentiation, symptomatic treatment, acupuncture treatment, regulation and nursing were illustrated.
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Case reports are valuable clinical evidence in traditional Chinese medicine (TCM). However, the general reporting quality is suboptimal. A working group comprising 20 members was set up to develop systematic recommendations on case report in Chinese medicine (CARC). The working group (CARC group) developed a primary checklist based on reviewing the general reporting quality of case reports in TCM and thorough internal discussion. Two-round consensus process had been carried out among clinical experts, evidence-based medicine methodologists, medical journal editors and clinical practitioners with designated questionnaire embedded with the primary checklist. In total, 118 participants from 17 provinces of China and Korea completed the questionnaires. Their feedback was analyzed and discussed by the CARC group. The checklist was amended accordingly, and the final version, comprising 16-item, is presented here. Under the framework of CARC recommendations, the reporting quality of case reports in TCM can be improved.
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Female , Humans , Male , Consensus , Health Planning Guidelines , Medical Records , Medicine, Chinese Traditional , Research ReportABSTRACT
An international brainstorming session on standardizing pattern identification (PI) was held at the Korea Institute of Oriental Medicine on October 1, 2013 in Daejeon, South Korea. This brainstorming session was convened to gather insights from international traditional East Asian medicine specialists regarding PI standardization. With eight presentations and discussion sessions, the meeting allowed participants to discuss research methods and diagnostic systems used in traditional medicine for PI. One speaker presented a talk titled "The diagnostic criteria for blood stasis syndrome: implications for standardization of PI". Four speakers presented on future strategies and objective measurement tools that could be used in PI research. Later, participants shared information and methodology for accurate diagnosis and PI. They also discussed the necessity for standardizing PI and methods for international collaborations in pattern research.
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Internationality , Medicine, Chinese Traditional , Reference Standards , Reference Standards , ResearchABSTRACT
A symposium on pattern identification (PI) was held at the Korea Institute of Oriental Medicine (KIOM) on October 2, 2013, in Daejeon, South Korea. This symposium was convened to provide information on the current research in PI as well as suggest future research directions. The participants discussed the nature of PI, possible research questions, strategies and future international collaborations in pattern research. With eight presentations and an extensive panel discussion, the symposium allowed participants to discuss research methods in traditional medicine for PI. One speaker presented the topic, 'Clinical pattern differentiation and contemporary research in PI.' Two speakers presented current trends in research on blood stasis while the remaining five other delegates discussed the research methods and future directions of PI research. The participants engaged in in-depth discussions regarding the nature of PI, potential research questions, strategies and future international collaborations in pattern research.
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Humans , Internationality , Medicine, Chinese Traditional , Research , SyndromeABSTRACT
<p><b>OBJECTIVE</b>To assess the efficacy and safety of Moluodan () in treating dysplasia in chronic atrophic gastritis (CAG) patients.</p><p><b>METHODS</b>This was a multi-centered, double-blind, randomized controlled trial. The total of 196 subjects were assigned to receive either Moluodan or folic acid in a 2:1 ratio by blocked randomization. Mucosa marking targeting biopsy (MTB) was used to insure the accuracy and consistency between baseline and after 6-month treatment. Primary outcomes were histological score, response rate of pathological lesions and dysplasia disappearance rate. Secondary endpoints included gastroscopic findings, clinical symptom and patient reported outcome (PRO) instrument.</p><p><b>RESULTS</b>Dysplasia score decreased in Moluodan group (P =0.002), significance was found between groups (P =0.045). Dysplasia disappearance rates were 24.6% and 15.2% in Moluodan and folic acid groups respectively, no significant differences were found (P =0.127). The response rate of atrophy and intestinal metaplasia were 34.6% and 23.0% in Moluodan group, 24.3% and 13.6% in folic acid group. Moluodan could improve erythema (P =0.044), and bile reflux (P =0.059), no significance between groups. Moluodan was better than folic acid in improving epigastric pain, epigastric suffocation, belching and decreased appetite (P <0.05), with symptom disappearance rates of 37% to 83%.</p><p><b>CONCLUSIONS</b>Moluodan improved dysplasia score in histopathology, and erythema and bile reflux score in endoscopy, and superior to folic acid in improving epigastric pain, epigastric suffocation, belching and decreased appetite. [ChiCTR-TRC-00000169].</p>
Subject(s)
Female , Humans , Male , Middle Aged , Chronic Disease , Double-Blind Method , Drugs, Chinese Herbal , Pharmacology , Therapeutic Uses , Gastritis, Atrophic , Drug Therapy , Microbiology , Pathology , Gastroscopy , Helicobacter pylori , Treatment OutcomeABSTRACT
<p><b>OBJECTIVE</b>To systematically review the clinical practice guidelines (CPGs) for ischemic stroke in Chinese medicine (CM) with the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument.</p><p><b>METHODS</b>CM CPGs for ischemic stroke were searched in 5 online databases and hand-searches in CPGrelated handbooks published from January 1990 to December 2012. The CPGs were categorized into evidence based (EB) guideline, consensus based with no explicit consideration of evidence based (CB-EB) guideline and consensus based (CB) guideline according to the development method. Three reviewers independently appraised the CPGs based on AGREE II instrument, and compared the CPGs' recommendations on CM pattern classification and treatment.</p><p><b>RESULTS</b>Five CM CPGs for ischemic stroke were identified and included. Among them, one CPG was EB guideline, two were CB guidelines and two were CB-EB guidelines. The quality score of the EB guideline was higher than those of the CB-EB and CB guidelines. Five CM patterns in the CPGs were recommended in the EB CPG. The comprehensive protocol of integrative Chinese and Western medicine recommended in the EB CPG was mostly recommended for ischemic stroke in the CPGs. The recommendations varied based on the CM patterns.</p><p><b>CONCLUSION</b>The quality of EB CPG was higher than those of CB and CB-EB CPGs in CM for ischemic stroke and integrative approaches were included in CPGs as major interventions.</p>
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Humans , Biomedical Research , Brain Ischemia , Therapeutics , Health Planning Guidelines , Medicine, Chinese Traditional , Practice Guidelines as Topic , Stroke , TherapeuticsABSTRACT
<p><b>OBJECTIVE</b>To explore the effect of Chang'an No. I Recipe (CA) on 5-hydroxytryptamine signal system and mRNA expression levels of hippocampal brain derived neurotrophic factor (BDNF) in visceral hypersensitivity model rats with irritable bowel syndrome (IBS).</p><p><b>METHODS</b>IBS visceral hypersensitivity rat models were established by combined chronic restraint stress and forced swimming. Successfully modeled rats were randomly divided into the model group, the Dicetelgroup (27 mg/kg) , the Fluoxetine group (3.6 mg/kg), the high dose CA group (22.6 mg/kg), the medium dose CA group (11.3 mg/kg), and the low dose CA group (5.7 mg/kg) according to body weight, 9 in each group. Besides, a normal control group with 10 rats was set up. Corresponding medication was administered to rats in each treatment group. Equal volume of physiological saline was administered to rats in the model group by gastrogavage. All medication was performed once per day for a total of 14 days. Pain threshold was determined by abdominal withdrawal reflex (AWR). Changes of colon 5-HT levels were determined by immunohistochemical assay. mRNA expression levels of hippocampal 5-hydroxytryptamine 1A receptor (5-HT1a) and BDNF were detected by immunofluorescent RT-PCR.</p><p><b>RESULTS</b>Compared with the normal control group before treatment, pain threshold was obviously lowered in proctectasia rats of each group (P < 0.01). Compared with the normal control group after treatment, pain threshold was obviously lowered in rats of the model group; colon 5-HT levels, mRNA expression levels of hippocampal 5-HT1a and BDNF were obviously elevated (P < 0.01). Compared with the model group, pain threshold was obviously elevated in the Fluoxetine group and all CA groups; colon 5-HT levels were obviously reduced in the Dicetel group, high and medium dose CA groups (P < 0.05, P < 0.01); mRNA expression levels of hippocampal 5-HT1a and BDNF were obviously reduced in each CA group (P < 0.01); mRNA expression levels of hippocampal BDNF were obviously reduced in the Fluoxetine group (P < 0.01).</p><p><b>CONCLUSIONS</b>The target points of CA were involved in brain and gut. CA could reduce pain threshold of proctectasia rats, down-regulate colon mucosal 5-HT levels, and lower mRNA expression levels of BDNF and 5-HT1a in rat hippocampus.</p>
Subject(s)
Animals , Rats , Brain-Derived Neurotrophic Factor , Metabolism , Disease Models, Animal , Drugs, Chinese Herbal , Pharmacology , Therapeutic Uses , Hippocampus , Hypersensitivity , Intestinal Mucosa , Irritable Bowel Syndrome , Drug Therapy , Metabolism , RNA, Messenger , Metabolism , Rats, Sprague-Dawley , Serotonin , MetabolismABSTRACT
Syndrome differentiation is a key feature of Chinese medicine (CM) system. With CM receiving more and more attention from the mainstream medical systems, researchers from both traditional medical systems and the Western medical system are putting more effort into studying why and how the CM system works, particularly about CM syndromes. This paper reviews the current status of syndrome study and its future development. The major aspects include: (1) Usage of syndrome differentiation in clinical practice; (2) Formalization of syndrome diagnostic criteria; (3) Evidence-based determination of the common syndrome(s) of a disease; (4) Systems biology study of syndromes; and (5) Usage of syndrome in randomized controlled trials. It is expected to integrate the syndrome concept into the main stream medical system, in terms of diagnosis, treatment and prevention.
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Humans , Medicine, Chinese Traditional , SyndromeABSTRACT
The STandards for Reporting Interventions in Clinical Trials Of Moxibustion (STRICTOM), in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.
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Humans , Clinical Trials as Topic , Methods , Reference Standards , Moxibustion , Methods , Reference Standards , Randomized Controlled Trials as Topic , Research Design , Reference StandardsABSTRACT
<p><b>OBJECTIVE</b>To establish a new disease-syndrome-symptom integrated diarrhea-predominant irritable bowel syndrome (IBS-D) rat model of Gan stagnation and Pi deficiency syndrome (GSPDS).</p><p><b>METHODS</b>(1) The model establishment method: We combined mother-infant separation, chronic restraint, and senna gavage to establish a new IBS-D model of GSPDS. Totally 48 experimental rats were divided into the normal group (Group A), the mother-infant separation group (Group B), the chronic restraint group (Group C), and the senna gavage group (Group D), the mother-infant separation + senna gavage group (Group E), and the mother-infant separation + chronic restraint + senna gavage group (Group F), 8 in each group. (2) The model evaluation method: We used pain threshold indicating colorectal distension to represent for the visceral sensitivity, thus evaluating the establishment of "disease" model; open field test and serum D-xylose levels to evaluate the establishment of GSPDS model; defecation numbers of grain and loose stool rate to evaluate the establishment of diarrhea symptom.</p><p><b>RESULTS</b>(1) Compared with Group A, the body weight gained less in Group F, showing statistical difference (P < 0.05). (2) The pain threshold significantly decreased in Group F, showing statistical difference when compared with Group A (P < 0.05). (3) Compared with Group A, the total cross number, the standing number, and the decoration number in Group F significantly decreased (P < 0.05). (4) Compared with Group A, the serum D-xylose level of Group F significantly decreased (P < 0.05). (5) Compared with Group A, the defecation numbers of grain and the loose stool rate significantly increased, showing statistical difference (P < 0.05).</p><p><b>CONCLUSIONS</b>A new disease-syndrome-symptom integrated IBS-D animal model of GSPDS successfully established might be a better animal model used for studying IBS by Chinese medicine. However, further studies are needed.</p>
Subject(s)
Animals , Female , Pregnancy , Rats , Animals, Newborn , Diarrhea , Diagnosis , Disease Models, Animal , Irritable Bowel Syndrome , Diagnosis , Medicine, Chinese Traditional , Rats, Sprague-DawleyABSTRACT
Being the unique core of traditional Chinese medicine (TCM), pattern classification exerts a direct effect on the efficacy and safety of herbal interventions. In this article, the authors integrated the pattern classification and disease diagnosis with many approaches from systems biology. Integration of pattern classification with biomedical diagnosis by systems biology is not only a new direction of personalized medicine development, but also provides a new drug development model. In the further study, the pattern classifications of major diseases will be the focus of research.