Tongxinluo capsule was approved by the State Food and Drug Administration in 1996 for the treatment of angina pectoris and ischemic stroke, extracted, concentrated and freeze-dried from 7 plant and 5 animal products. Recent experimental studies in hyperlipidemia rabbits and ApoE−/- mice have shown that TXL can reduce and stabilize atherosclerotic plaques through its lipid-lowering, antioxidant, and anti-inflammatory effects 3,4,5. Several small clinical studies have shown that TXL capsules reduce blood lipid levels in patients with coronary heart disease (Tongxinluo Chinese medicine for heart disease), improve angina, and reduce the incidence of restenosis 6,7,8. ENLEAT showed that in 219 patients with ST-elevation myocardial infarction, TXL therapy combined with conventional drug therapy significantly reduced the incidence of no recirculation and the size of myocardial infarction after percutaneous coronary intervention9. These basic and clinical studies strongly suggest that TXL may have powerful anti-atherosclerotic effects, but evidence from large-scale clinical trials of TXL in patients with atherosclerosis is still lacking. 

Here, we report the results of the Tongxinluo Capsule (CAPITAL) Carotid Plaque Intervention trial, which was designed to examine the effects of TXL capsule on carotid IMT and plaque area over a 24-month period in Chinese patients with subclinical atherosclerosis.

TXL capsules used in this study contained ginseng (Araceae; Ginseng), Red peony (Paeoniaceae; Peony), Perilla seed (rhamnus family; Jujube) (roasted), yellow rosewood (Fabacee; Huanghualiwood (Huanghualiwood), Santali albi lignum, Burseraceae; Boswellia) (preparation), Haemopidae (leeches), Scorpions (bufoidae; The scorpion), Scolopendra (Scolopendrobspinipesmultilans l. och) and Cicadidae (Cicadidae; Steleophaga (Corydiidae; Woodlouse and Borneolusyntheticum. The quality standards of the herbs we use are in accordance with Chinese Pharmacopoeia 20, 2005. Detailed information on the quality control standards for TXL capsule ingredients and related studies can be found in Supplementary Appendix III. Eligible subjects were given TXL capsules, 6 tablets, twice daily, or placebo capsules, 6 tablets, twice daily, for 24 months (see Supplemental Appendix VI Figure S1). The study drugs were provided by Shijiazhuang Yiling Pharmaceutical Co., LTD., China.