Xiaoke Pill (消渴丸) and anti-diabetic drugs: A review on clinical evidence of possible herb-drug interactions

Objective: To critically analyze the clinically-based evidence of herb-drug interaction on Xiaoke Pill (消渴丸) and its concomitant use with anti-diabetic drugs. Methods: MEDLINE, EMBASE, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED), International Pharmaceutical Abstracts (IPA), Chinese BioMedical Literature Database (CBM), Traditional Chinese Medical Database System (TCMDS), China National Knowledge Infrastructure Database (CNKI) and Wangfang Databases were searched. Levels of Evidence and Severity Level of Interaction were used to evaluate the quality of the included studies. Results: A total of 27 studies published in Chinese, including 2 randomized controlled trials, 3 case series and 22 case reports, were included. Eighteen herbdrug interactions were reported involving Xiaoke Pill as monotherapy, while 6 herb-drug interactions occurred associated with Xiaoke Pill in combination with anti-diabetic drugs. The clinical results of herb-drug interaction of Xiaoke Pill were reported as additive blood glucose-lowering effects with anti-diabetic drugs, including benefifi cial and adverse hypoglycemic effects, anaphylactic shock and severe hair loss. Of these interactions 82.8% were reported to be associated with potential deterioration of the patients’ conditions including hypoglycemic coma, stroke, mental disorder and even death. Conclusions: This review helped establish the clinically-based evidence about herb-drug interaction of Xiaoke Pill and its concomitant use with anti-diabetic drugs. The fifi ndings would help arouse the awareness of both health professionals and the general public to avoid the adverse herb-drug interactions of Xiaoke Pill in healthcare and community settings