[Show abstract][Hide abstract] ABSTRACT: Buyang Huanwu decoction (BHD) is a famous herbal prescription that has been used
to treat stroke for centuries. Recent studies reported that the use of BHD had been
extended to treat various kinds of disorders according to the TCM syndrome theory of
Treating Different Diseases with the Same Method (TDDSM). Here, an overview of
systematic reviews (SRs) of BHD for healthcare were conducted to interpret the TCM
theory of TDDSM and its target of vascularity in an evidence-based manner.
Literature searches were carried out in 5 databases to search SRs of BHD for any
indication up to August 2013. Thirteen eligible SRs were identified that reported a
wide range of vascular conditions. Based on the Overview Quality Assessment
Questionnaire scores, the quality of included SRs was varied, with an average score of
4 points. We found that there is premature evidence for the use of BHD for healthcare,
whereas BHD was well tolerable in all patients. BHD can be used to treat many
disorders with the same therapeutic principle of invigorating Qi to activate blood
circulation, which is essentially a manifestation of the TDDSM and is likely to
account for targeting the specific pathogenesis of vascular diseases.
Evidence-based Complementary and Alternative Medicine 06/2014; · 1.72 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The practice of traditional Chinese medicine (TCM) has a profound history in many Asian countries. TCM syndrome is a set of characteristic physical signs and symptoms shared by a group of patients. Syndrome diagnosis and treatment assignment according to the identified TCM syndrome is a long-held practice of Chinese medicine. Owing to its distinctive way of interpreting illness and administering care, medical practitioners not well educated in TCM theories and practices are generally incapable of giving out prescriptions for Chinese patent drugs. Currently, the existence of a multitude of Chinese patent drugs marked with largely identical indications is further complicating this situation.
In this multicenter, randomized, controlled, double-blind, double-dummy clinical trial, in which we will use the comparative effectiveness research method, we will compare the efficacy of two commonly used Chinese patent medicines for angina patients diagnosed with qi deficiency and blood stasis syndrome. A total of 160 patients will be recruited and randomly assigned to receive either (1) QiShenYiQi dripping pills, Tongxinluo placebo and routine medication or (2) Tongxinluo capsules, QiShenYiQi placebo and routine medication. These treatment regimens will be carried out for 4 weeks, followed by a 10-day washout period and a 4-week crossover phase in which the treatments in the two patient groups will be exchanged. Patients will be allowed to choose symptoms that matter most to them and will be grouped accordingly. Patient-reported outcomes such as the Seattle Angina Questionnaire score and the 15-point Likert scale score will be measured and reported. The minimally clinical important difference will be calculated and used for efficacy assessment, and correspondence analysis will be performed to identify the best indications for each drug.
The goal of the study is to establish a methodology for the precise identification of the characteristic indications for which a Chinese patent drug is most effective. The findings of this study will inform the practicality of the proposed evaluation method.Trial registration: Chinese clinical trials register Chi CTRTTRCC13003732.
[Show abstract][Hide abstract] ABSTRACT: Rhizoma Coptidis (Huang Lian in Chinese pinyin) is among the most widely used traditional Chinese herbal medicines and has a profound history of more than 2000 years of being used as a therapeutic herb. The antidiabetic effects of Rhizoma Coptidis have been extensively investigated in animal experiments and clinical trials and its efficacy as a promising antihyperglycemic agent has been widely discussed. In the meantime, findings from modern pharmacological studies have contributed the majority of its bioactivities to berberine, the isoquinoline alkaloids component of the herb, and a number of experiments testing the antidiabetic effects of berberine have been initiated. Therefore, we conducted a review of the current evidence profile of the antihyperglycemic effects of Rhizoma Coptidis as well as its main component berberine and the possible mechanism of actions, in order to summarize research evidence in this area and identify future research directions.
BioMed research international. 01/2014; 2014:798093.
[Show abstract][Hide abstract] ABSTRACT: At present, the design of an ideal placebo control in acupuncture studies challenges researchers. Previously devised sham acupuncture techniques have reported various imperfections; therefore, the specific effects of acupuncture cannot be accurately examined in clinical trials primarily because of interferences from the placebo effects.
Guided by evidence-based medicine (EBM) theories, we have made an initial attempt to establish a set of control methods for use in acupuncture studies, which is named the target disease-guided placebo-controlled (TIGER) design. In a trial using the TIGER design, participants suffering simultaneously from a predefined target disease and a pseudo target disease will be recruited and randomized to receive identical acupuncture intervention measures. As a result, the interventions not only appear the same but also produce the same stimulations in both groups. The patients in the treatment group will be informed of the actual target disease that the treatment aims for, whereas patients in the control group will be informed that the treatment is for the pseudotarget disease. It is speculated that no psychological response will be aroused in the control group. During data analysis, changes in the outcome measures of the patients in the control groupreveal the real therapeutic effect of acupuncture, and those of patients in the treatment group show both the real and placebo acupuncture effect. In this article, we explain how to put this design into use in a planned randomized clinical trial of acupuncture for the treatment of migraine.
This approach can eliminate the acupuncture placebo effect in the control group that may confound trial results. It is possible to observe the specific and placebo effects of acupuncture for the target disease separately using the TIGER design.
The proposed TIGER design has limitations.It is designed for clinical studies focusing on the specific effects of acupuncture, and it needs to be tested and verified for practicality and feasibility in various clinical research settings.
[Show abstract][Hide abstract] ABSTRACT: Managing compliance in a clinical research, especially in a multi-centre randomized clinical trial (MRCT) is vital. We now feel the need to take a look at the once overlooked area of investigator compliance as it may provide resources necessary for producing satisfactory trial outcomes.
To analyze investigator performance and examine their adherence behavior using data collected and information gained from the MISPS-TCM, a Chinese national research project.
Four researchers were responsible for collecting relevant information and investigating the compliance behavior of participants in MISPS-TCM. The Data Management Committee of MISPS-TCM offered us the number of withdrawal at each site and other site information. Reports on investigator compliance events were provided by the Monitoring Committee. Records of any misconduct of or errors made by the investigator were collected from the Center's daily management diary. Other information sources included trial managers and investigators at the Center or at different sites of the study.
Investigator compliance can be an important determinant of trial outcomes and the degree of compliance may have detrimental effects on the reliability of findings of an MRCT, directly or indirectly.
Trial managers of future MRCTs should take a firm grip on investigator compliance from the following aspects. First, physicians should be provided with more opportunities. Second, we created and recommended the 'Five Step Method' for evaluating investigators. Third, measures must be taken to secure investigator compliance. Fourth, evaluation of investigator compliance in an MRCT needs to be made.
Journal of Evidence-Based Medicine 08/2013; 6(3):157-66.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Diabetic nephropathy (DN) is a major microvascular complication with diabetes. In China, an estimated 34.7 percent of people diagnosed with diabetes have renal complications and a further 50 percent die of renal failure. Hence, identification of alternative treatments for these patients should be given priority. The Shenyan Kangfu tablet (SYKFT) is a new formulation of an existing and widely acclaimed Chinese herbal tea for treating qi-yin deficiency syndrome. Because a considerable portion of DN patients presenting with symptoms of swelling, fatigue and weak limbs would be diagnosed with qi-yin deficiency syndrome according to the traditional Chinese medicine (TCM) diagnostic criteria, we hypothesize that SYKFT may represent a complementary drug for DN patients with the corresponding syndrome. In view of this, we have designed a trial to assess the efficacy and safety of SYKFT for patients with diabetic nephropathy exhibiting signs of qi and yin deficiency. METHODS: This is a multicenter, double-blind, randomized controlled trial (RCT). The total target sample size is planned at 80 participants, with a balanced (1:1) treatment allocation. The experimental intervention will be SYKFY plus irbesartan (SI regimen) and the control intervention will be a placebo plus irbesartan (PI regimen). Participants will receive two courses of medication treatment each lasting 8 weeks. The primary outcome will be the composite of the quantitative 24-hour urinary protein level and urinary albumin excretion rate (UAER). Changes in urine albumin-to-creatinine ratio (UACR) and DN staging, and TCM symptom improvement will be the secondary outcome measures. Adverse events (AEs) will be monitored throughout the trial DISCUSSION: This study will be the first placebo-controlled RCT to assess whether SYKFT plus irbesartan will have beneficial effects on enhancing overall response rate (ORR), changing DN staging, improving clinical symptoms, and reducing the frequency of AEs for DN patients with qi-yin deficiency syndrome. The results of this trial will help to provide evidence-based recommendations for clinicians.Trial registration: Chinese Clinical Trials Register, Identifier: ChiCTR-TRC-12002182.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Treatment of cardiac syndrome X with unknown pathological mechanism remains a big challenge for clinicians. Complementary and alternative medicine may bring a new choice for its management. The aim of this study is to evaluate the clinical effects of traditional Chinese medicine on cardiac syndrome X patients. METHODS: We systematically searched databases such as Cochrane CENTRAL, PubMed, EMBASE, CBM, Chinese National Knowledge Infrastructure (CNKI), WanFang and VIP, and handsearched relevant journals to identify randomized controlled trials. Following the steps of systematic review recommended by the Cochrane group, we assessed the quality of included studies, extracted valid data and undertook meta-analysis. RESULTS: Twenty one moderate-to low-quality randomized controlled trials involving 1143 patients were included. The results showed that traditional Chinese medicine could improve angina [OR=1.34, 95% CI: 1.2 to 1.50], electrocardiogram (ECG), endothelin-1 (ET-1) levels, prolong exercise duration in treadmill tests, and reduce angina frequency per week compared with routine treatment. No other side effect was reported except two cases of stomach pain. CONCLUSION: Compared with conventional treatment, traditional Chinese medicine shows the potential of optimizing symptomatic outcomes and improving ECG and exercise duration. The efficacy of TCM may find explanation in its pharmacological activity of adjusting the endothelial function. TCM, as a kind of alternative and complementary medicine, may provide another choice for CSX patients.
BMC Complementary and Alternative Medicine 03/2013; 13(1):62. · 2.08 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Pancreatic fibrosis, a prominent histopathological feature of chronic pancreatitis (CP) and pancreatic ductal adenocarcinoma, is essentially a dynamic process that leads to irreversible scarring of parenchymal tissues of the pancreas. Though the exact mechanisms of its initiation and development are poorly understood, recent studies suggested that the activation of pancreatic stellate cells (PSCs) plays a critical role in eliciting such active course of fibrogenesis. Anthraquinone compounds possess anti-inflammatory bioactivities whereas its natural derivative rhein has been shown to effectively reduce tissue edema and free-radical production in rat models of inflammatory conditions. Apart from its anti-inflammatory properties, rhein actually exerts strong anti-fibrotic effects in our current in-vivo and in-vitro experiments. In the mouse model of cerulein-induced CP, prolonged administration of rhein at 50 mg/kg/day significantly decreased immunoreactivities of the principal fibrotic activators alpha-smooth muscle actin (α-SMA) and transforming growth factor-beta (TGF-β) on pancreatic sections implicating the activation of PSCs, which is the central tread to fibrogenesis, was attenuated. Consequently, the overwhelmed deposition of extracellular matrix proteins fibronectin 1 (FN1) and type I collagen (COL I-α1) in exocrine parenchyma was found accordingly reduced. In addition, the expression levels of sonic hedgehog (SHH), which plays important roles in molecular modulation of various fibrotic processes, and its immediate effector GLI1 in pancreatic tissues were positively correlated to the degree of cerulein-induced fibrosis. Such up-regulation of SHH signaling was restrained in rhein-treated CP mice. In cultured PSCs, we demonstrated that the expression levels of TGF-β-stimulated fibrogenic markers including α-SMA, FN1 and COL I-α1 as well as SHH were all notably suppressed by the application of rhein at 10 μM. The present study firstly reported that rhein attenuates PSC activation and suppresses SHH/GLI1 signaling in pancreatic fibrosis. With strong anti-fibrotic effects provided, rhein can be a potential remedy for fibrotic and/or PSC-related pathologies in the pancreas.
PLoS ONE 01/2013; 8(12):e82201. · 3.53 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background. Several types of drugs have been recommended for the secondary prevention of myocardial infarction (MI). However, these conventional strategies have several limitations, such as low adherence, high cost, and side effects during long time use. Novel approaches to this problem are still needed. This trial aimed to test the effectiveness and safety of Qi-Shen-Yi-Qi Dripping Pills (QSYQ), a multi-ingredient Chinese patent medicine, for the secondary prevention of MI. Methods and Findings. A total of 3505 eligible patients were randomly assigned to QSYQ group (1746 patients) or aspirin group (1759). Patients took their treatments for 12 months. The final follow-up visit took place 6 months after the end of the trial drugs. The 12-month and 18-month estimated incidences of the primary outcome were 2.98% and 3.67%, respectively, in the QSYQ group. The figures were 2.96% and 3.81% in the aspirin group. No significant difference was identified between the groups. Conclusions. This trial did not show significant difference of primary and secondary outcomes between aspirin and QSYQ in patients who have had an MI. Though inconclusive, the result suggests that QSYQ has similar effects to aspirin in the secondary prevention of MI.
Evidence-based Complementary and Alternative Medicine 01/2013; 2013:738391. · 1.72 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards.
Evidence-based Complementary and Alternative Medicine 01/2013; 2013:202703. · 1.72 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective. To define patient values, identify their manifestations in a randomized clinical trial, and investigate the possible implications for clinical research of traditional Chinese medicine. Methods. We categorized patient values manifestations into patient choice, preference, compliance, and patient-reported outcomes and summarized the underlying personal values through purposeful electronic searches for relevant reports. By hypothesizing a set of positive versus negative circumstances occurring in the enrollment, intervention allocation, treatment, and the follow-up stage of a trial, it is possible to discuss the potential implications of patient values manifestation on a trial with traditional Chinese medicine. Results. Patient values and its manifestations are ubiquitous in the process of clinical research with traditional Chinese medicine. These values may provide motivation for participation or engender the internal and external validity of the study. Conclusions. Trialists should attach sufficient importance to the needs and concerns of individual participant. To incorporate patient values into the design and conduct of a clinical study with traditional Chinese medicine, researchers are recommended to adopt participant-friendly design and use patient-reported outcomes, take convenience-for-patients measures, and help foster rational beliefs and behaviors of trial participants.
Evidence-based Complementary and Alternative Medicine 01/2013; 2013:847273. · 1.72 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The popularity of herbal medicines has risen worldwide. This increase in usage renders safety issues important. Many adverse events of herbal medicines can be attributed to the poor quality of the raw materials or the finished products. Different types of herbal medicines are associated with different problems. Quality issues of herbal medicines can be classified into two categories: external and internal. In this review, external issues including contamination (e.g. toxic metals, pesticides residues and microbes), adulteration and misidentification are detailed. Complexity and non-uniformity of the ingredients in herbal medicines are the internal issues affecting the quality of herbal medicines. Solutions to the raised problems are discussed. The rigorous implementation of Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) would undoubtedly reduce the risk of external issues. Through the use of modern analytical methods and pharmaceutical techniques, previously unsolved internal issues have become solvable. Standard herbal products can be manufactured from the standard herbal extracts.
Complementary therapies in medicine 02/2012; 20(1-2):100-6. · 1.95 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The reporting standards for randomized controlled trials were first published in 1996 by a group of scientists under the name "CONSORT," which means consolidated standards of reporting trials. Revisions followed in 2001 and 2010. A draft of the CONSORT for traditional Chinese medicine (TCM) was published in both Chinese and English in 2007. After publication of the draft, comments were solicited from the medical community. Some papers did raise concerns about which items should be included in the CONSORT for TCM such as the rationale of the trial design, intervention, outcome assessment, and adverse events. We have now reached the next step which is the finalization of the CONSORT for TCM. Three tasks remain. First, the major changes in CONSORT statement 2010 should be integrated into the CONSORT for TCM. Second, Chinese drugs from minerals and animals should be included in the guidelines. Finally, agreement must be reached among the working groups. Once the draft is finalized, wide dissemination and co-publication will be considered.
[Show abstract][Hide abstract] ABSTRACT: our study had two objectives: a) to systematically identify all existing systematic reviews of Chinese herbal medicines (CHM) published in Cochrane Library; b) to assess the methodological quality of included reviews.
We performed a systematic search of the Cochrane Database of Systematic Reviews (CDSR, Issue 5, 2010) to identify all reviews of CHM. A total of fifty-eight reviews were eligible for our study. Twenty-one of the included reviews had at least one Traditional Chinese Medicine (TCM) practitioner as its co-author. 7 reviews didn't include any primary study, the remaining reviews (n = 51) included a median of 9 studies and 936 participants. 50% of reviews were last assessed as up-to-date prior to 2008. The questions addressed by 39 reviews were broad in scope, in which 9 reviews combined studies with different herbal medicines. For OQAQ, the mean of overall quality score (item 10) was 5.05 (95% CI; 4.58-5.52). All reviews assessed the methodological quality of primary studies, 16% of included primary studies used adequate sequence generation and 7% used adequate allocation concealment. Of the 51 nonempty reviews, 23 reviews were reported as being inconclusive, while 27 concluded that there might be benefit of CHM, which was limited by the poor quality or inadequate quantity of included studies. 58 reviews reported searching a median of seven electronic databases, while 10 reviews did not search any Chinese database.
Now CDSR has included large numbers of CHM reviews, our study identified some areas which could be improved, such as almost half of included reviews did not have the participation of TCM practitioners and were not up-to-date according to Cochrane criteria, some reviews pooled the results of different herbal medicines and ignored the searching of Chinese databases.
PLoS ONE 01/2011; 6(12):e28696. · 3.53 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Chronic heart failure (CHF) is a global public health problem. Therefore, novel and effective drugs that show few side-effects are needed. Early literature studies indicated that Huangqi injection is one of the most commonly used traditional Chinese patent medicines for CHF in China. As a large number of clinical studies has been carried out and published, it is essential to evaluate the effectiveness and safety of Huangqi injection. Therefore, we carried out this systematic review under the support of the framework of the Joint Sino-Italian Laboratory (JoSIL).
To evaluate the efficacy and safety of Huangqi injection for CHF according to the available scientific knowledge.
An extensive search including PubMed, EMBASE, CBM, the Cochrane Library and Chinese literature databases was performed up to July 2008. Clinical trials regarding Huangqi injection for the treatment of CHF were searched for, irrespective of languages. The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0, and RevMan 5.0 provided by the Cochrane Collaboration and STATA 9.2 were used for data analysis.
After selection of 1,205 articles, 62 RCTs and quasi-RCTs conducted in China and published in Chinese journals were included in the review. The methodological quality of the trials was low. In most trials inclusion and exclusion criteria were not specified. Furthermore, only one study evaluated the outcomes for drug efficacy after an adequate period of time. For these reasons and because of the different baseline characteristics we did not conduct a meta-analysis.
Although available studies are not adequate to draw a conclusion on the efficacy and safety of Huangqi injection (a traditional Chinese patent medicine), we hope that our work could provide useful experience on further studies on Huangqi injections. The overall level of TCM clinical research needs to be improved so that the efficacy of TCM can be evaluated by the international community and possibly some TCM can enter into the international market.
PLoS ONE 01/2011; 6(5):e19604. · 3.53 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: to systematically review the Chinese-language literature on acupuncture-related adverse events.
we searched three Chinese databases (the Chinese Biomedical Literature Database, 1980-2009; the Chinese Journal Full-Text Database, 1980-2009; and the Weipu Journal Database, 1989-2009) to identify Chinese-language articles about the safety of traditional needle acupuncture. Case reports, case series, surveys and other observational studies were included if they reported factual data, but review articles, translations and clinical trials were excluded.
the inclusion criteria were met by 115 articles (98 case reports and 17 case series) that in total reported on 479 cases of adverse events after acupuncture. Fourteen patients died. Acupuncture-related adverse events were classified into three categories: traumatic, infectious and "other". The most frequent adverse events were pneumothorax, fainting, subarachnoid haemorrhage and infection, while the most serious ones were cardiovascular injuries, subarachnoid haemorrhage, pneumothorax and recurrent cerebral haemorrhage.
many acupuncture-related adverse events, most of them owing to improper technique, have been described in the published Chinese literature. Efforts should be made to find effective ways of monitoring and minimizing the risks related to acupuncture.
Bulletin of the World Health Organisation 12/2010; 88(12):915-921C. · 5.25 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To analyze adverse drug reactions (ADRs) associated with Shenmai injection and possible contributing factors.
We searched all clinical studies and ADR reports of Shenmai injection from the China National Knowledge Infrastructure (CNKI) database, the Data Bank of Chinese Scientific Journals (VIP), and Chinese Biomedical (CBM) database. We collected relevant information such as gender, age, allergic history, and diseases treated in ADR cases; types, occurrence times, and severity of ADRs; and menstruum and compatibility of Shenmai injection.
Of the 1828 clinical studies of Shenmai injection, 146 (7.99%) mentioned 576 ADR cases; 181 ADR reports mentioned 246 ADR cases. The most commonly affected age group was 40 to 69 (57.32%). In 36 (14.63%) cases, patients were described as having an allergic history. The diseases treated in ADR cases were principally heart failure and coronary artery heart disease. Thirty-eight (15.45%) of the 246 ADR cases in ADR reports described anaphylactic shock, while the most common ADR reported in clinical studies was headache/dizziness. Of the 822 total reported ADR cases, 99 (12.04%) were class III, and 637 (77.50%) were class IV, and there were no fatalities. The menstruum of most Shenmai injections was 5% glucose. Incompatible drugs were given in 68 ADR cases. In ADR cases, the most common dosage of Shenmai injection was 40 to 60 ml; 215 (80.90%) ADR cases occurred in first time medication, mainly in the first 30 minutes after injection.
Current evidence shows that Shenmai injection had lower ADR occurrence, but some potential factors such as irrational compatibility, dosages may lead to a high risk of ADR. In future, clinicians should follow indications or functions to promote rational use of Chinese Medicine Injections .
Journal of Evidence-Based Medicine 08/2010; 3(3):177-82.
[Show abstract][Hide abstract] ABSTRACT: To systematically assess the main clinical features of Houttuynia injection-associated adverse drug reactions (ADRs), as described in published reports, and to contribute to the post-marketing re-evaluation and clinical practices of Houttuynia injection.
We searched the electronic databases- PubMed, EMBASE, the Chinese National Knowledge Infrastructure (CNKI), the Chinese Science and Technology Journal Full-text Database (VIP) and the Chinese Biomedical Disc (CBMdisc), for articles published through June 2010. We then extracted and analyzed the data.
A total of 645 articles were included, with a total of 1232 ADR cases reported. Respiratory diseases accounted for 52.44% of all cases of Houttuynia injection ADRs, followed by reproductive system diseases (4.30%) and urinary system diseases (3.73%). Multiple systems or organs were involved in the ADRs, the top five were: respiratory system (37.42%), skin (34.66%), digestive system (25.49%), circulatory system (25.41%), and nervous system (23.96%). Serious systemic adverse reactions accounted for 22.56% of total ADRs. Of the reported 1,232 ADR cases, 286 ADR cases reported previous allergies in detail; allergy to penicillin accounted for 15.03% of the total cases with the allergic history, followed by unknown drugs (8.05%), and sulfonamides (3.15%). Among the ADR cases, Houttuynia injection was commonly used together with cephalosporins, penicillins, and macrolides. Macrolides combined with Houttuynia injection showed higher ADR risk than Houttuynia injection used alone (RR = 8.80, 95% CI 6.12 to 12.65, P < 0.0001). The ADR risk for intravenous injection of Houttuynia injection was higher than that of intramuscular injection (OR = 6.86, 95% CI 1.88 to 56.95, P= 0.0016). We used the WHO ADR Classification Criteria to divide the ADR cases into four grades. There were 22.56%, 36.28%, 16.48%, and 24.68% cases of Grade I, II, III, and IV, respectively. Anaphylactic shock accounted for 58.99% of the most serious ADRs (Grade I). All cases of death were caused by allergic shock, except one, who died of multiple organ failure caused by anaphylactic purpura. The fastest-onset three ADR cases occurred in one minute after injection.
The respiratory system was the most common system treated in Houttuynia injection ADR cases. It was also the most common site of ADR symptoms. The ADRs of Houttuynia injection were serious. The precautions should be taken to prevent the anaphylactic shock. Intravenous injection and the combination with with cephalosporins, penicillins, and macrolides increased the ADR risk of Houttuynia injection.
Journal of Evidence-Based Medicine 08/2010; 3(3):168-76.
[Show abstract][Hide abstract] ABSTRACT: Using Chinese Materia Medica (CM) as injections is an innovation that is proving effective in extensive clinical use in Mainland China. However, recent reports have focused on adverse reactions, ignoring the considerable successes of these preparations. In order to achieve balance in the media and in the minds of the public, we suggest the first step is to clarify the concepts of and differences between adverse drug reactions (ADR) and adverse events (AE) for all concerned-the public, medical practitioners, government officials, and lawmakers. Second, the State Food and Drug Administration should raise the requirements for Chinese Materia Medica Injection (CMI) registration and license approval and emphasize the importance of evidence-based CMI development and evidence-based CMI license approval. Thirdly, drug companies and institutions should reinforce basic research about the quality control of herbs and CMI-drug interactions. Fourth, the Government should clarify the legal responsibilities for CMI approval agencies, CMI developers, medical doctors, and patients. Fifth, the medical association and Government should enhance training for health care professionals concerning the usage of CMIs. And finally sixth, State Food and Drug Administration should monitor the content and quality of the directions for use of CMI.
Journal of Evidence-Based Medicine 05/2010; 3(2):88-94.