Liver Enzyme Abnormalities and Risk Factors in Taking Herbal Medicine

Musculoskeletal Diseases Clinical Trial

Official title:

Liver Enzyme Abnormalities and Its Risk Factors in Taking Traditional Herbal Medicine in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299739
• Other study ID #: JS-CT-2013-02
• Status: Completed
• Start date: December 2005
• Est. completion date: December 2013

Study information

• Verified date: November 2018
• Source: Jaseng Hospital of Korean Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6894
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury
• Drug-Induced Liver Injury
• Musculoskeletal Diseases

Intervention

Drug:
• Herbal medicine
Herbal medicine was taken 3 times daily in dried powder (2g) and water-base decoction form (120ml) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica).

Procedure:
• Acupuncture
Acupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points.
• Pharmacopuncture
Select ingredients similar to those included in the oral herbal medicine (Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica) were freeze dried into powder form after decoction, then diluted in normal saline and adjusted for acidity and pH to be used in injections. The pharmacopuncture injections were injected once daily to the amount of 1 cc and Ah-shi points and local acupuncture points (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
• Bee venom pharmacopuncture
Bee venom pharmacopuncture was applied after confirming a negative reaction to the hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) was injected at 4-5 acupoints at the physician's discretion. Each acupuncture point was injected with approximately 0.2 cc to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
• Chuna manipulation
Chuna was administered 3-5 times a week. Chuna is a Korean version of spinal manipulation that incorporates conventional spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul	Gangnam-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Hospital of Korean Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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