The Effects of Wenxin Keli on Left Ventricular Ejection Fraction
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.
Objective. To evaluate the beneficial and adverse effects of Wenxin Keli (WXKL), either alone or in combination with Western medicine, on the left ventricular ejection fraction (LVEF) and plasma brain natriuretic peptide (BNP) in the treatment of heart failure (HF). Methods. Seven major electronic databases were searched to retrieve potential randomized controlled trials (RCTs) designed to evaluate the clinical effectiveness of WXKL, either alone or in combination with Western medicine, for HF, with the LVEF or BNP after eight weeks of treatment as main outcome measures. The methodological quality of the included studies was assessed using criteria from the Cochrane Handbook for Systematic Review of Interventions, Version 5.1.0, and analyzed using RevMan 5.1.0 software. Results. Eleven RCTs of WXKL were included. The methodological quality of the trials was generally evaluated as low. The risk of bias was high. The results of the meta-analysis showed that WXKL, either alone or in combination with Western medicine, was more effective in LVEF and BNP, compared with no medicine or Western medicine alone, in patients with HF or HF complicated by other diseases. Five of the trials reported adverse events, while the others did not mention them, indicating that the safety of WXKL remains uncertain. Conclusions. WXKL, either alone or in combination with Western medicine, appears to be more effective in improving the LVEF and BNP in patients with HF and HF complications.
After the primary search of the seven databases both in Chinese and English, 599 articles were retrieved: Cochrane Library (), PubMed (), Embase (), CNKI (), VIP (), CBMdisc (), and Wanfang (). The majority of these trials were excluded because some papers were found in more than one database and some included irrelevant titles and abstracts. Only 149 studies were retrieved. Following a review of the titles and abstracts, several studies were excluded, and only 126 studies remained. Five trials were excluded because of duplicated publications. Thirteen trials were excluded for being animal studies, and five trials were excluded for being nonclinical trials, including case reports and traditional reviews. One hundred and fifteen out of the remaining 126 articles were excluded based on the inclusion criteria, leaving eleven RCTs to be reviewed [8–18]. The screening process is summarized in a flow chart (Figure 1). All of the trials were conducted in China and published in Chinese. The characteristics of the eleven RCTs are summarized in Table 1.
The eleven RCTs involved a total of 907 patients with HF. Only five trials [10, 13, 16–18] specified the diagnostic criteria of HF. Of those, three [13, 16, 18] used the Chinese diagnosis and treatment of CHF guidelines (2007). One  used the guiding principle of the traditional Chinese medicine (TCM) treatment of CHF (1993). Another  used the ACC/AHA guidelines for the management of patients with HF without detailed information. The rest of the trials [8, 9, 11, 12, 14, 15] described patients with HF diagnoses by diagnostic criteria for CHF without detailed information.
The interventions of all eleven trials [8–18] included WXKL, either alone or combined with Western medicine, as shown in Table 1. The controls included Western medicine alone or no medicine use. The total treatment duration was eight weeks. Four trials [10, 13, 15, 17] specified the clinical standards of HF. All eleven trials [8–18] used the LVEF as the main outcome measure, and seven of the trials [12–18] used BNP as the main outcome measure. Five of the included trials [8, 12, 13, 16, 17] described the adverse effects in detail.
3.2. Methodological Quality of the Included Trials
The majority of the included RCTs were assessed as having low methodological quality. According to the predefined quality assessment criteria indicated above, none of the included trials were evaluated as having a low risk of bias, as is shown in Table 2. Only one  of the trials reported the methodology used to generate the allocation sequence. The trial stated the method was a table of random numbers method but did not provide detailed information; insufficient information was provided to allow for the quality assessment of the allocation method. Allocation concealment was not mentioned in all the included trials. The blinding of the participants, personnel, and outcome assessments was not detailed in all of the trials. Two trials [11, 13] reported dropouts or withdrawals. None of the trials calculated an estimation of the pretrial sample size, which indicated a lack of statistical power to ensure an appropriate estimation of the therapeutic effect. The results of the assessment of the risk of bias are presented in Table 2