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NCT Number: NCT02299739

Liver Enzyme Abnormalities and Risk Factors in Taking Herbal Medicine

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Hospital of Korean Medicine

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

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).

Other names: 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.

Primary outcomes

  1. Alanine aminotransferase (ALT)

    Time frame: 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.

  2. Aspartate aminotransferase (AST)

    Time frame: 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.

  3. Alkaline phosphatase (ALP)

    Time frame: 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.

  4. Total bilirubin (TB)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jaseng Hospital of Korean Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Nov 24, 2014
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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