Traditional Chinese medicine for sepsis: advancing from evidence to innovative drug discovery

Ji, Yun; Song, Hongyun; Li, Libin

doi:10.1186/s13054-025-05441-4

Critical Care

Table 1 Clinical efficacy and safety of TCM for the treatment of sepsis

From: Traditional Chinese medicine for sepsis: advancing from evidence to innovative drug discovery

TCM products	Comparison	Patients	Design	Phase^a	Mortality outcome	SOFA outcome	Other outcomes	References
Astragalus injection	Astragalus injection + RT vs. RT	50 patients with sepsis	RCT	II	Improved	Not assessed	Improve immune function, improve APACHE II score	[17]
Astragalus injection	Astragalus injection + RT vs. RT	60 patients with sepsis	RCT	II	No effect	No effect	Improve immune function, good safety profile	[18]
Banxia Xiexin Decoction	Banxia Xiexin Decoction + RT vs. RT	850 patients with sepsis (9 RCTs)	Meta	All phase II RCTs	Not assessed	Not assessed	Reduce gastrointestinal dysfunction score and APACHE II score	[19]
Dachaihu Decoction	Dachaihu Decoction + RT vs. RT	70 patients with sepsis	RCT	II	No effect	Improved	Improve APACHE II score, improve liver, renal, gastrointestinal function, inflammation, and coagulation, with fewer adverse events	[20]
Dachengqi Decoction	Dachengqi Decoction + RT vs. RT	68 sepsis patients with acute respiratory distress syndrome	RCT	II	No effect	Improved	Reduce inflammation markers, improve APACHE II score, shorten mechanical ventilation time, no significant difference in ICU stay	[21]
Dahuang Fuzi Decoction	Dahuang Fuzi Decoction + RT vs. RT	518 patients with sepsis (6 RCTs)	Meta	All phase II RCTs	No effect	Not assessed	Improve gastrointestinal function	[22]
Fusu Mixture	Fusu Mixture + RT vs. RT	81 patients with septic shock	RCT	II	No effect	Not assessed	Improve microcirculation parameters, shorten ICU stay	[23]
Hongyu Peizhen Formula	Hongyu Peizhen Formula + RT vs. RT	62 patients with sepsis	RCT	II	Not assessed	Improved	Improve cardiac function	[24]
HuangLian JieDu Decoction	HuangLian JieDu Decoction + RT vs. RT	115 patients with sepsis	RCT	II	Not assessed	Not assessed	Reduce inflammatory factors and APACHE II score, with no significant difference in adverse events	[25]
Jiawei Yiyi Fuzi Baijiang Powder	Jiawei Yiyi Fuzi Baijiang Powder + RT vs. RT treatment	160 patients with sepsis	RCT	II	Not assessed	Not assessed	Improve gastrointestinal function, enhance immunity, and improve nutritional status	[26]
JinHong Formula	JinHong Formula + RT vs. RT	114 patients with sepsis	RCT	II	Improved	Improved	Improve APACHE II score, reduce inflammatory markers and oxidative stress	[27]
Modified Huanglian Jiedu Decoction	Modified Huanglian Jiedu Decoction + RT vs. RT	86 patients with sepsis	RCT	II	No effect	Not assessed	Shorten length of mechanical ventilation and ICU stay, reduce incidence of hyperglycemia and gastric retention	[28]
Modified Liangge Powder	Modified Liangge Powder + RT vs. RT	143 patients with sepsis	RCT	II	Improved	Improved	Improve APACHE II score, decrease inflammatory markers	[29]
Pogejiuxin Decoction	Pogejiuxin Decoction + RT vs. RT	92 patients with septic shock	RCT	II	No effect	Improved	Reduce inflammation markers, improve lactate clearance rate, improve APACHE II score	[30]
Qiguiyin Granule	Qiguiyin Granule + RT vs. RT	60 sepsis patients with acute kidney injury	RCT	II	No effect	Not assessed	Increase renal injury recovery rate, shorten CRRT duration	[31]
Qingwen Baidu Decoction	Qingwen Baidu Decoction + RT vs. RT	86 patients with sepsis	RCT	II	Not assessed	Improved	Reduce inflammatory markers, improve endothelial function	[32]
Qingwen Baidu Decoction	Qingwen Baidu Decoction + RT vs. RT	80 patients with sepsis	RCT	II	Not assessed	Improved	Improve inflammation markers	[33]
Shenfu Injection	Shenfu Injection + RT vs. RT	4279 patients with septic shock (56 RCTs)	Meta	All phase II RCTs	Improved	Improved	Increase MAP, reduce lactate levels	[34]
Shenfu Injection	Shenfu Injection + RT vs. RT	2340 patients with sepsis and septic shock (32 RCTs)	Meta	All phase II RCTs	Improved	Improved	Increase MAP, reduce lactate levels	[35]
Shengjiang Powder	Shengjiang Powder + RT vs. RT	720 patients with sepsis (13 RCTs)	Meta	All phase II RCTs	Not assessed	Not assessed	Improve APACHE II score, decrease inflammation markers, good safety profile	[36]
Shenqi Fuzheng Injection	Shenqi Fuzheng Injection + RT vs. RT	60 patients with septic shock	RCT	II	No effect	Not assessed	Improve hemodynamics, improve APACHE II score	[37]
Shengmai Injection	Shengmai Injection + RT vs. RT	860 patients with septic shock (17 RCTs)	Meta	All phase II RCTs	No effect	Not assessed	Improve shock recovery, reduce serum lactate level	[38]
Shenmai Injection	Shenmai Injection + RT vs. RT	1469 patients with sepsis (21 RCTs)	Meta	All phase II RCTs	Improved	Not assessed	Reduce inflammatory markers, improve APACHE II score	[39]
Shenmai Injection	Shenmai Injection + RT vs. RT	583 patients with sepsis and septic shock (6 RCTs)	Meta	All phase II RCTs	Improved	Improved	Decrease lactate levels	[35]
Sini Decoction	Sini Decoction + RT vs. RT	60 patients with sepsis	RCT	II	No effect	Improved	Improve cardiac function, improved lactate clearance rate	[40]
Tuoli Xiaodu Powder	Tuoli Xiaodu Powder + RT vs. RT	57 patients with sepsis	RCT	II	No effect	Improved	Reduce inflammatory markers	[41]
Xinmailong Injection	Xinmailong Injection + RT vs. RT	192 patients with sepsis	RCT	II	No effect	Not assessed	Reduce incidence of diastolic sepsis-induced myocardial dysfunction	[42]
Xinmailong Injection	Xinmailong Injection + RT vs. RT	476 patients with sepsis (8 RCTs)	Meta	All phase II RCTs	No effect	Not assessed	Improve cardiac function, no significant effect on ICU stay, no significant adverse events reported	[43]
Xuebijing Injection	Xuebijing Injection + RT vs. RT	1817 patients with sepsis	RCT	III	Improved	Improved	Increase ICU-free days and mechanical ventilation-free days, similar adverse events	[14]
Xuebijing Injection	Xuebijing Injection + RT vs. RT	1144 patients with sepsis (16 RCTs)	Meta	All phase II RCTs	Improved	Not assessed	Improve APACHE II score, no serious adverse events	[44]
Yantiao Formula	Yantiao Formula + RT vs. RT	120 patients with sepsis	RCT	II	Not assessed	Improved	Improve gastrointestinal function	[45]
Zengye Chengqi Decoction	Zengye Chengqi Decoction + RT vs. RT	124 patients with sepsis	RCT	II	No effect	Not assessed	Reduce inflammation markers, shorten ICU stay	[46]

^a Phase II trials primarily aim to establish preliminary evidence of efficacy, whereas phase III trials require rigorous confirmation of clinical benefit
APACHE, Acute Physiology and Chronic Health Evaluation; CI, confidence interval; CRRT, continuous renal replacement therapy; ICU, intensive care unit; RT, regular treatment; SOFA, Sequential Organ Failure Assessment; TCM, traditional Chinese medicine

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