A Randomized Double‐Blind Placebo‐Controlled Trial to Evaluate Prophylactic Effect of Traditional Chinese Medicine Supplementing Qi and Hemostasis Formula on Gastrointestinal Bleeding after Percutaneous Coronary Intervention in Patients at High Risks

Abstract

Objective To evaluate the clinical efficacy of traditional Chinese medicine (TCM) supplementing Qi and hemostasis formula on gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) and thus find out the optimal therapeutic regimen to reduce incidence of GI bleeding without increase of major adverse cardiovascular events (MACEs). Methods In the randomized, double-blinded, controlled trial, 117 participants who underwent PCI were enrolled and evenly distributed into treatment arm (59) and control arm (58). Numerous end points were assessed including the primary endpoint of GI bleeding and MACEs and secondary endpoint of thromboelastogram (TEG) (mainly MAadp, inhibition of ADP, and inhibition of AA) and TCM syndrome score during the follow-up phase of 90 days. Results Incidence of bleeding including GI bleeding and MACE did not differ significantly between two arms (28.82% in treatment arm versus 24.44% in control). However, on both days 30 and 90, TCM treatment remarkably reduced the TCM syndrome total score with notable alteration (P<0.05) except for some parameters such as pulse manifestation. When it came to TEG, however, MAADP increased significantly on day 30 in control arm, accompanied by a notable descending in inhibition rate of ADP pathway (both P<0.01). Conclusion (1) Supplementing Qi and hemostasis formula is equal to Pantoprazole Sodium Enteric-Coated Capsule in hemostasis and gastric mucosal protection; (2) supplementing Qi and hemostasis formula is superior to Pantoprazole Sodium Enteric-Coated Capsule in improving TCM syndrome manifestation possibly through the multitarget mechanism; (3) interference on clopidogrel of supplementing Qi and hemostasis formula might be much less than Pantoprazole Sodium Enteric-Coated Capsule due to the potential CYP450-independent mechanism. This trial is registered with ChiCTR1800014485.

Study on the Effect of Antiplatelet and Gastric Mucosal Protection of Traditional Chinese Medicine Invigorating Qi and Hemostasis

“…Existing studies found that TCM invigorating qi and hemostasis helped to reduce the incidence of gastrointestinal bleeding in high-risk groups while inhibiting platelet aggregation. 10 The gastric mucosal protection effect of TCM invigorating qi and hemostasis may be related to the regulation of gastric mucosal protective hormones. Additionally, MTL and GAS are crucial gastrointestinal hormones.…”

“…The TCM prescription of tonifying qi and achieving hemostasis has been established for this pathogenesis and primarily comprises Astragalus membranaceus, Radix Pseudostellaria heterophylla root, rhubarb charcoal, Baihe powder, cuttlefish bone, and Panax notoginseng . A randomized controlled study 10 found that the Chinese herbal ingredients of yiqi and hemostasis had some preventive effect on gastrointestinal bleeding after PCI, while the results of a thromboelastic diagram suggested that intervention using Chinese herbal medicine in this context as a result of clopidogrel’s antiplatelet effect was less likely compared with using pantoprazole. Pharmacological studies 8 , 9 suggest that the main components of Chinese herbal medicine for replenishing qi and achieving hemostasis can interfere with gastric mucosal injury, and concurrently, effect a degree of influence on platelet activation.…”

Combined Therapy with Traditional Chinese Medicine and Antiplatelet Drugs for Ischemic Heart Disease: Mechanism, Efficacy, and Safety

“…Further studies confirmed the inhibitory effect of Panax notoginseng saponins on the activity of platelet COX-1 and the downregulation of TXB2, PGD2, and PGE2 expressions [ 67 ]. A randomized controlled study of 117 patients with gastrointestinal bleeding after percutaneous coronary intervention has also shown that the protective effect of traditional Chinese medicines on the gastric mucosa is equivalent to that of pantoprazole sodium enteric-coated capsules [ 69 ]. Overall, PBCRBSCMs can regulate inflammation pathways and AA/COX/PG pathways, exert a protective effect on gastric mucosal epithelial cells, inhibit the occurrence of ulcers, and reduce gastric mucosal damage induced by conventional antiplatelet drugs.…”

Chinese Herbal Medicine Dingji Fumai Decoction for Ventricular Premature Contraction: A Real-World Trial

“…But overall, DFD works, which is encouraging. TSS is widely used in TCM clinical research (33,34). We innovatively applied TSS to this study, which was not found in other related studies (26,27,30,31).…”