Evidence map›Paper›PMID 29085558›Full record

ArticleWorld journal of hepatology2017

Herbal Traditional Chinese Medicine and suspected liver injury: A prospective study.

Dieter Melchart, Stefan Hager, Sabine Albrecht, Jingzhang Dai, Wolfgang Weidenhammer, Rolf Teschke

Abstract read
In one paragraph

Article in World journal of hepatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Dieter MelchartInstitute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, CH-8091 Zurich, Switzerland.
Stefan HagerHospital for Traditional Chinese Medicine, D-93444 Bad Kötzting, Germany.
Sabine AlbrechtHospital for Traditional Chinese Medicine, D-93444 Bad Kötzting, Germany.
Jingzhang DaiHospital for Traditional Chinese Medicine, D-93444 Bad Kötzting, Germany.
Wolfgang WeidenhammerCompetence Centre for Complementary Medicine and Naturopathy (CoCoNat), University Hospital Munich rechts der Isar, Technical University of Munich, D-80801 Munich, Germany.
Rolf TeschkeDepartment of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Teaching Hospital of the Medical Faculty of the Goethe University, D-63450 Hanau, Frankfurt/Main, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo analyze liver tests before and following treatment with herbal Traditional Chinese Medicine (TCM) in order to evaluate the frequency of newly detected liver injury.

methodsPatients with normal values of alanine aminotransferase (ALT) as a diagnostic marker for ruling out pre-existing liver disease were enrolled in a prospective study of a safety program carried out at the First German Hospital of TCM from 1994 to 2015. All patients received herbal products, and their ALT values were reassessed 1-3 d prior to discharge. To verify or exclude causality for suspected TCM herbs, the Roussel Uclaf Causality Assessment Method (RUCAM) was used.

resultsThis report presents for the first time liver injury data derived from a prospective, hospital-based and large-scale study of 21470 patients who had no liver disease prior to treatment with herbal TCM. Among these, ALT ranged from 1 × to < 5 × upper limit normal (ULN) in 844 patients (3.93%) and suggested mild or moderate liver adaptive abnormalities. However, 26 patients (0.12%) experienced higher ALT values of ≥ 5 × ULN (300.0 ± 172.9 U/L, mean ± SD). Causality for TCM herbs was RUCAM-based probable in 8/26 patients, possible in 16/26, and excluded in 2/26 cases. Bupleuri radix and Scutellariae radix were the two TCM herbs most commonly implicated.

conclusionIn 26 (0.12%) of 21470 patients treated with herbal TCM, liver injury with ALT values of ≥ 5 × ULN was found, which normalized shortly following treatment cessation, also substantiating causality.

Indexed as

Herbal medicineHerb induced liver injuryLiver injuryRoussel Uclaf Causality Assessment MethodTraditional Chinese Medicine

Identifiers

PMID29085558
PMCPMC5648988

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