Liver Enzyme Abnormalities and Risk Factors in Taking Herbal Medicine

NCT02299739 | Completed

• 1 other identifier: JS-CT-2013-02
• Study Type: observational
• Target: 6,894
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-Induced Liver Injury; Musculoskeletal Diseases

Keywords

Herbal Medicine; Complementary Therapies; Liver Function Tests; Risk Factors

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Interventions

Herbal medicine DRUG

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).

Also known as: Traditional herbal medicine

Acupuncture PROCEDURE

Acupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points.

Pharmacopuncture PROCEDURE

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 PROCEDURE

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 PROCEDURE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Jaseng Hospital of Korean Medicine: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury; Musculoskeletal Diseases

Interventions

Phytotherapy; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jinho Lee, Masters

  Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 24, 2014
• Study Start: December 1, 2005
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

KR (1)