Wenxin keli on treating ventricular premature beats

The Chinese herb extract Wenxin Keli is made by a mixture of several different herbs. A study published in early 2012 investigated claims that the Chinese herb Wenxin Keli was effective in suppressing AFib. It now holds the title of the first state-sanctioned traditional Chinese medicine-based antiarrhythmic drug.

wenxin keli,the first state-sanctioned traditional Chinese medicine-based antiarrhythmic drug.

Citation
Liu Fu, He Mei, Lv Zhan, Zhou Chunyang, Huang Jiuling. A systematic review of the herbal medicinal extract Wenxin keli on treating ventricular premature beats. PROSPERO 2013:CRD42013003200 Available fromhttp://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013003200
Review question(s)

To investigate both the benifit and safety of Wenxin Keli for participants with ventricular premature beats.Specifically, its use for the following indications will be assessed:

1. Participants without organic heart disease but who had been suffered from symptoms of ventricular premature beats;

2. Ventricular premature beats with prognostic significance in participants following nonfatal organic cardiac disease.

Searches

We will search the following databases with no restriction on language or publication status:

Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, Science Direct, Chinese BioMedical literature Database (CBMdisc), China National Knowledge Infrastructure (CNKI), Chinese VIP Information (VIP), WanFang Data.

In addition, ongoing trials will be retrieved from The WHO ICTRP Search Portal, The Chinese Clinical Trial Register and The Clinical Trials Register.

Link to search strategy
Types of study to be included

Randomized controlled trials (RCTs) and quasi-RCTs will be included in this review. We wil call or email the included study authors for the details of study design in case of false RCTs.

Condition or domain being studied

Ventricular premature beats (VPBs), a type of cardiac arrhythmia with premature contractions of the heart ventricles, which are commonly identified in daily clinical practice, either in symptomatic or asymptomatic subjects. Among middle-aged healthy men, the prevalence of VPBs on an ECG was found to be 4 – 5%. Considerably higher age-adjusted prevalence of VPBs was observed though reported data were varyiable. Affected groups include patients without structural heart disease and those with any form of cardiac disease, independent of severity. There are occasions where the presence of VPBs implies a susceptibility towards more sinister arrhythmias. Some studies have found that repetitive VPBs, increased frequency of VPBs, VPBs after acute myocardial infarction, are associated with an increased mortality risk, while their presence alone is usually of little importance. Therefore, assessments of symptoms and potential organic heart disease before initiating treatment are neceessary.

Considering the potential prognostic importance of VPBs, two goals in the treatment are to reduce symptoms and to prolong life. Antiarrhythmic medications remain the primary treatment modality for most mild-to-moderate VPBs, but a balance needs to be struck between the level of symptoms and the possibility of side effects, given that the long term use of these medications may be accompanied by severe proarrhythmic activity. The development of safe and effective drugs for the treatment of VPBs remains a high priority.

Wenxin keli is a herbal medicinal extract with licensable indication for VPBs in China, which was included in the 2009 revision of the National Reimbursement Drug List. In contrast to other oral herbal medicine extracts, there a consumption record of wenxin keli achieved more than one billion in 2011 in China. The extract comprises five components: Nardostachys chinensis batal extract (NcBe), Codonopsis, Notoginseng, Amber, and Rhizoma polygonati, with action of blocking sodium and potassium channel, depression of peak and late Na. Furthermore, there is vast clinical evidence that such exact appears to be a replacement therapy for certain conventional antiarrhythmic drugs, including propafenone, mexileine and metoprolol, in relieving both the symptoms and documented ECG of benign VPBs, in the absence of sinister side effects. Some of this evidence is from well-designed, randomized, placebo-controlled, multi-center trials. It should be borne in mind that these benign arrhythmias were the target for therapy in the CAST study, where it was demonstrated that drug therapy with potentially arrhythmic effect can degrade prognosis in patients with ischaemic heart disease. Hence a rigorous systematic review or Meta analysis on the effectiveness and safety of wenxin keli for VPBs is necessary.

Participants/ population

Inclusion criteria: Participants aged 18-75, diagnosised VPBs by the criteria of Cardiovascular Physiology (9th ed), regardless of gender, race, with or without organic heart disease will be included.

Exclusion criteria:

1. Arrhythmia caused by drugs, electrolyte or acid-base balance disorders and other factors;

2. Removal of incentives (such as fatigue, nervousness, mood swings, alcoholism, etc.) can relieve symptoms significantly;

3. Patients accompanied with severe disease, such as slow arrhythmia (Including sick sinus syndrome and II degree atrioventricular block), Have a pacemaker or PCI surgery, severe hypotension, congestive heart failure, cardiogenic shock, cerebrovascular diseases, impairment of liver, kidney and hematopoietic system (ALT and AST, BUN, higher than 2 times the upper limit of normal, or Cr higher than the upper limit of normal);

4. allergic to the test drug allergy;

5. Pregnancy and lactating women, recently prepared pregnancy.

Intervention(s), exposure(s)

Three specific comparisons including wenxin keli will be taken into account:

1. Wenxin keli compared with placebo;

2. Wenxin keli compared with conventional Western antiarrhythmic drugs;

3. Wenxin keli combined with any Western drugs compared with the same western drugs alone.

Comparator(s)/ control

Placebo, no treatment, or any Western medicine

Context

No setting restriction.

Outcome(s)

Primary outcomes

Electrocardiograph(ECG) changes: numbers of the ventricular premature beats detected by 24-hour Holter ECG record.

Secondary outcomes

1. Change in symptoms

2. Unplanned cardiovascular hospitalization;

3. Adverse Events (Proarrhythmic activity, Liver and kidney function, Lipids, Blood sugar level, etc.).

Data extraction, (selection and coding)

Two reviewers (Liu F, He M) will independently extract data with prespecified selection criteria. Any disagreement will be resolved by face-to-face discussion or by consultation with a third reviewer (Lv Z). Further more, in consideration of false “RCTs”, publication authors will be contacted if any details about study design and outcomes are unclear. Also, in cases of author non-response, a consensus will be reached based on available information. Overall, a summary table of data extraction will be formed, which is mainly comprised of items such as: public information, participant characteristics, type of intervention, outcomes, results.

Risk of bias (quality) assessment

Two reviewers (Liu F, He M) will use the Cochrane tool to assess the risk of bias for individual studies as follows: random sequence generation (selection bias); allocation concealment (selection bias); blinding (performance bias and detection bias); incomplete outcome data (attrition bias); selective outcome reporting (reporting bias); Other bias.

Strategy for data synthesis

We will conduct statistical analysis using RevMan (version 5.1) . Standardized mean difference(SMD) with 95% confidence intervals (CI) will be used to analyse continuous data, and risk ratios (RR) with 95% CI for dichotomous data. If possible, an intention-to-treat (ITT) analysis will be carried out for each outcomes. It should be noted that, for cross-over trials, only the first intervention will be included.

Initial subgroup setting will be made in accordance with the outcomes and interventions. Heterogeneity of every group/subgroup will be assessed by using both Chi-squared test and the I-squared statistic. An I-squared value greater than 50% will considered to be indicative of significant heterogeneity, further analysis including sensitivity and subgroup analysis will be conducted, in order to explore the possible sources of heterogeneity.

If high levels of heterogeneity (I-squared>75%) are still detected after exploration, which indicate considerable heterogeneity, we will simply carry out descriptive analyses. At the other end of the spectrum, we will perform a fixed-effect (I-squared<50%) or random-effects (75%>I-squared>50%) meta-analysis.

Analysis of subgroups or subsets

We plan to perform subgroup analyses as follows:

1.With or without organic heart disease;

2.Time frame of treatment :4 weeks and longer than 4 weeks;

3.Different interventions mentioned above.

Contact details for further information

Fu Liu

pharmacyhm430@163.com

Organisational affiliation of the review

Affiliated Hospital of North Sichuan Medical College

http://www.hospital-nsmc.com.cn/

Review team

Professor Liu Fu, Department of pharmacy, Affiliated Hospital of North Sichuan Medical College, Nanchong, China
Ms He Mei, Department of pharmacy, Affiliated Hospital of North Sichuan Medical College, Nanchong, China
Dr Lv Zhan, West China hospital, Sichuan University, Nanchong, China
Professor Zhou Chunyang, Research institute of North Sichuan Medical College, Nanchong, China
Dr Huang Jiuling, Department of Traditional Chinese Medicine, Affiliated Hospital of North Sichuan Medical College, Nanchong, China

Anticipated or actual start date

14 January 2013

Anticipated completion date

11 August 2013

Funding sources/sponsors

This review is conducted by the team members without any funding sources or sponsors

Conflicts of interest

None known

Language

English

Country

China

Subject index terms status

Subject indexing assigned by CRD

Subject index terms

Drugs, Chinese Herbal; Humans; Ventricular Premature Complexes

Stage of review

Completed but not published

Date of registration in PROSPERO

28 January 2013

Date of publication of this revision

12 August 2013

Stage of review at time of this submission Started   Completed
Preliminary searches No  
Piloting of the study selection process  
Formal screening of search results against eligibility criteria  
Data extraction  
Risk of bias (quality) assessment  
Data analysis  

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