Liver Enzyme Abnormalities and Risk Factors in Taking Herbal Medicine

Completed

• Conditions: Drug-Induced Liver Injury; Musculoskeletal Diseases

• Registration Number: NCT02299739
• Lead Sponsor: Jaseng Hospital of Korean Medicine

Brief Summary

Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. We assessed the prevalence of liver injury of 6,894 musculoskeletal disease inpatients taking herbal medicine.

Detailed Description

Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. The objective of this study is to report on the incidence of liver injury from herbal medicine in musculoskeletal disease patients as large-scale studies are scarce.

Of 32,675 inpatients taking herbal medicine at 7 locations of a Korean medicine hospital between 2005 and 2013, we screened for liver injury in 6,894 patients with liver function tests (LFTs) at admission and discharge. LFTs included t-bilirubin, AST, ALT, and ALP. We assessed for risk factors for liver injury at discharge.

Participants received the most frequently used complementary and alternative medicine treatment contents (herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation) administered to musculoskeletal disease patients at this hospital.

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6894

Inclusion Criteria

• Patients admitted for at least one day who took herbal medicine and at least 2 LFTs during admittance.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alanine aminotransferase (ALT)	Change from baseline (admission) in liver function test up to discharge (average 4 wks)	Participants were followed for the duration of hospital stay, an average of 4 weeks.
Aspartate aminotransferase (AST)	Change from baseline (admission) in liver function test up to discharge (average 4 wks)	Participants were followed for the duration of hospital stay, an average of 4 weeks.
Alkaline phosphatase (ALP)	Change from baseline (admission) in liver function test up to discharge (average 4 wks)	Participants were followed for the duration of hospital stay, an average of 4 weeks.
Total bilirubin (TB)	Change from baseline (admission) in liver function test up to discharge (average 4 wks)	Participants were followed for the duration of hospital stay, an average of 4 weeks.

Trial Locations

Locations (1)

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, Gangnam-Gu, Korea, Republic of