Clinical trial NCT02299739: Liver Enzyme Abnormalities and Risk Factors in Taking Herbal Medicine
Official title: Liver Enzyme Abnormalities and Its Risk Factors in Taking Traditional Herbal Medicine in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug-Induced Liver Injury
Musculoskeletal Diseases
Keywords: Herbal Medicine
Complementary Therapies
Liver Function Tests
Risk Factors
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 6894
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: Alanine aminotransferase (ALT)
timeFrame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
measure: Aspartate aminotransferase (AST)
timeFrame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
measure: Alkaline phosphatase (ALP)
timeFrame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
measure: Total bilirubin (TB)
timeFrame: Change from baseline (admission) in liver function test up to discharge (average 4 wks)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Jinho Lee, Masters
role: PRINCIPAL_INVESTIGATOR
References: