A review article by Hao et al. [1] has attracted great attention among those familiar with traditional Chinese medicine (TCM) owing to a clinical evidence–based approach to this topic. It systematically and elegantly evaluated the efficacy and safety of TCM for cardiovascular disease, as well as the pharmacological effects and potential mechanisms of active TCM ingredients on the cardiovascular system [1]. We sincerely congratulate the authors since the article has had huge repercussions in the international academic community, and it will promote the application of TCM to the world. Meanwhile, we believe this article could have been more comprehensive if the following points had been addressed.
Firstly, there is no summary of nonpharmacotherapy in TCM, including acupuncture, moxibustion, Qigong, and Tai Chi. Recently, for instance, several large-scale randomized controlled trials (RCTs) of acupuncture proved its clinical effect on migraine [2], constipation [3], polycystic ovary syndrome [4], and urinary incontinence [5]. In the cardiovascular field, acupuncture has shown its efficacy and safety in the treatment of heart failure, hyperlipidemia, and hypertension [6–10]. We performed a meta-analysis to evaluate acupuncture for the treatment of arrhythmia compared with existing antiarrhythmic drugs [9]. In 13 trials with 797 patients enrolled, acupuncture, with or without use of an antiarrhythmic drug, displayed a clear benefit in treating ventricular premature beat and sinus tachycardia.
Secondly, arrhythmia-related RCTs were not included. In cardiac electrophysiology, several herbal components, such as Shenmai, acacetin, Shensong Yanxin, and Wenxin Keli, have been proposed as antiarrhythmic drugs. Similar to amiodarone, the latter two have been verified to have effects on multiple ion channels and to modulate cardiac autonomic nervous function. In 49 RCTs with 4610 patients enrolled, Wenxin Keli was shown to be more effective than other available treatments of arrhythmia, angina, and heart failure [10]. We selected Wenxin Keli for the treatment of ventricular premature beats. The characteristics of RCTs of Wenxin Keli are shown in Table 1 [11–19]. Shensong Yanxin is another well-known compound, first described in the 16th century, and recommended by two Chinese experts’ consensuses [20, 21]. In a meta-analysis of 22 trials involving 2347 paroxysmal atrial fibrillation patients, it appeared to be beneficial [22]. Another study showed that in 465 study participants, Shensong Yanxin had the benefits of ventricular premature beat suppression and cardiac function improvement with good adherence on a background of standard treatment for heart failure [23]. Shensong Yanxin also significantly increased the heart rate in patients with bradycardia without severe side effects [24].
Characteristics of Randomized Controlled Trials of Wenxin Keli for Treatment of Ventricular Premature Beats (VBP).
| Study | Sample size | Intervention | Course (weeks) | Outcome measure | Main result | |
|---|---|---|---|---|---|---|
| Experimental group | Control group | |||||
| Yu [11] | 44/40 | Wenxin Keli 9 g, tid | Mexiletine 150 mg, tid | 4 | VPB | The total effective rate in the experimental group for VPB was greater than that in the control group |
| Yang et al. [12] | 30/30 | Wenxin Keli 9 g +amiodarone 0.2 g, tid | Amiodarone 0.2 g, tid | 4 | VPB | The clinical efficacy of the combination of Wenxin Keli and amiodarone for the treatment of VPB in coronary heart disease was greater than that of amiodarone alone |
| Zhang et al. [13] | 60/30 | Wenxin Keli 9 g, tid | Propafenone 100 mg, tid | 4 | VPB | There was no significant difference in the total effective rate for Wenxin Keli in elderly patients with or without cardiovascular disease on 24 h ECG for VPB |
| Sun and Zhang [14] | 126/83 | Wenxin Keli 9–18 g, tid | Propafenone 100 mg, tid | 4 | VPB | The relief of clinical symptoms in the experimental group was obviously greater than that in the control group. There was no significant difference in improvement in the two groups on 24 h ECG for VPB |
| Jiang et al. [15] | 66/65 | Wenxin Keli 9 g, tid | Metoprolol 12.5–25 mg, bid | 4 | VPB | The effect of Wenxin Keli was similar to that of metoprolol in treating VPB, but Wenxin Keli had a greater effect in relieving clinical symptoms than metoprolol. The incidence of adverse reactions was lower than with metoprolol |
| He [16] | 41/40 | Wenxin Keli 9 g, tid | Metoprolol 25 mg, bid | 4 | VPB | The effect of Wenxin Keli was similar to that of metoprolol in the treatment of senile VPB, but the effect of Wenxin Keli in relieving conscious symptoms was more obvious |
| Lu et al. [17] | 42/44 | Wenxin Keli 5 g, tid | Placebo 5 g, tid | 2 | VPB | The effective rate in the experimental group for VPB was greater than that in the control group |
| Liang and Wang [18] | 90/90 | Wenxin Keli 9 g +amiodarone 0.2 g, tid | Amiodarone 0.2 g, tid | 4 | VPB | The clinical effect in the experimental group for VPB was greater than that in the control group |
| Hua et al. [19] | 565/552 | Wenxin Keli 9 g, tid | Placebo 9 g, tid | 4 | VPB | The experimental group demonstrated a significantly greater reduction in the frequency of VBP than the control group |
In addition, it is controversial that the active ingredients of TCM have been confined to TCM in recent decades. Many people believe that TCM should contain only Chinese herbal compounds and should be guided by the theory of syndrome differentiation, since TCM is usually prescribed as a complex formula by the practitioner on a personalized basis. With the development of modern biomedical technology, the pharmacological effects and the underlying mechanisms of some active ingredients of TCM have been elucidated or assessed. For instance, after reviewing 19 natural drug therapies for antiarrhythmic effects, we summarized 18 active ingredient therapies, such as alkaloids, flavonoids, saponins, quinones, and terpenes [25]. This gives us new concepts and challenges in the use of natural drug agents. Thus we support the view that the active ingredients of TCM are an intrinsic part of TCM, which will help to enrich and develop the practice of TCM in the future [1].