Meta AnalysisID 6902

30种妊娠相关中草药的妊娠风险：系统评价与风险评估

CRD42023403863

What is the current evidence from human, animal and in vitro data for potential risks regarding clinically relevant endpoint variables associated with the use of 30 pregnancy-related Chinese herbs during pregnancy compar

Back to Browse

Relationship Network

Interactive first-hop connections across herbs, ingredients, formulas, targets, diseases, symptoms, syndromes, evidence, and monographs.

Click a node to open it in a new tab

Herb: 1Meta-analysis: 1Links: 1

Arranging relationship network...

Record Fields

Scalar fields from the final meta_analysis record.

Meta Analysis Id: 6902
Evidence Id: 15460
Core Evidence Id: 15460
Source Meta Analysis Id: 6888
Herb2 Meta Analysis Id: HBMA006888
Crd Id: CRD42023403863
Title: Pregnancy risks of 30 pregnancy-related Chinese herbs: A systematic review and risk evaluation
Review Question: What is the current evidence from human, animal and in vitro data for potential risks regarding clinically relevant endpoint variables associated with the use of 30 pregnancy-related Chinese herbs during pregnancy compared with no exposure or exposure with an intervention of known risk? Context and rationale Pregnancy risks of Chinese herbal medicine set out in textbooks and relevant clinical texts are contradictory and do not reflect the current state of knowledge. For ethical reasons clinical trials during pregnancy are only possible in exceptional cases and have rarely been carried out. Where there are studies of Chinese medicines during pregnancy, they usually use combinations of medicines (formulae). In the routine use of Chinese medicine during pregnancy, hardly any adverse effects have been documented. For these reasons, animal studies on this question are of particular importance. In order to spare the lives of animals, in vitro methods have been developed in recent decades, which also have a significance for pregnancy-related risk evaluation. For the assessment of mutagenicity or genotoxicity, they are well established.
Study Type Included: Inclusion criteria: Human studies: Randomized controlled trials, controlled clinical trials, cohort studies, case-control studies, each with a separate control group; case series. Animal and in vitro studies: Controlled studies with a suitable control standard. Exclusion criteria: Human studies: Only reports on single cases are excluded. Animal and in vitro studies: Non-controlled studies without a suitable control standard.
Condition Being Studied
Participant
Animal: Inclusion criteria: Human studies: females, embryos, fetuses, neonates, infants Animal studies: all kinds of animals, embryos, fetuses In vitro studies: embryos, tissue samples; embryonic stem cells, cells Exclusion criteria: Human/animal/in vitro studies: There are no exclusions.
Human Disease Modelled: Possible harm from the use of relevant Chinese herbal medicines during pregnancy.
Intervention: Inclusion criteria: Human studies: P.o. exposure during pregnancy to one of 30 Chinese herbal medicines as a single drug and as whole drug or whole drug extract. The herbal medicines are: Amomi Fructus (Sharen), Angelicae Sinensis Radix (Danggui), Astragali Radix (Huangqi), Atractylodis Macrocephalae Rhizoma (Baizhu), Bupleuri Radix (Chaihu), Chuanxiong Rhizoma (Chuanxiong), Citri Reticulatae Pericarpium (Chenpi), Codonopsis Radix (Dangshen), Coicis Semen (Yiyiren), Corni Fructus (Shanzhuyu), Cuscutae Semen (Tusizi), Dioscoreae Rhizoma (Shanyao), Dipsaci Radix (Xuduan), Ecliptae Herba (Mohanlian), Eucommiae Cortex (Duzhong), Ginseng Radix (Renshen), Glycyrrhizae Radix et Rhizoma (Gancao), Ligustri Lucidi Fructus (Nuzhenzi), Lycii Fructus (Gouqizi), Ophiopogonis Radix (Maidong), Pinelliae Rhizoma Praeparata (Zhibanxia), Paeoniae Radix Alba (Baishao), Poria (Fuling), Rehmanniae Radix (Dihuang), Rehmanniae Radix Praeparata (Shudihuang), Schisandrae Fructus (Wuweizi), Scutellariae Radix (Huangqin), Taxilli Herba (Sangjisheng), Zingiberis Rhizoma Recens (Shengjiang), Ziziphi Spinosae Semen (Suanzaoren). Animal studies: P.o. or parenteral exposure during pregnancy to one of 30 Chinese herbal medicines (see above) as a single drug and as whole drug or whole drug extract. In vitro studies: In vitro exposure to one of 30 Chinese herbal medicines (see above) as a single drug and as whole drug or whole drug extract. Exclusion criteria: Human, animal and in vitro studies: No exposure to one of the above medicines; exposure to non-officinal plant species or non-officinal plant parts according to the Chinese Pharmacopeia (2015); exposure to isolated compounds or fractions of the medicines; exposure to combinations of medicines (formulae). Human and animal studies: Topical application of medicines.
Comparator Control: Inclusion criteria: Human studies: No exposure to an active substance or exposure to another intervention with known effect on pregnancy; a historical comparative group without exposure to an intervention. Inclusion of case series without control group is possible, but their significance has to be adequately considered. Animal studies: No exposure to an active substance or exposure to another substance with known effect; a positive control group may be included. In vitro studies: No exposure to an active substance or exposure to a substance with known effect; a positive control group may be included. Exclusion criteria: Human studies: Exposure to an active substance or to an intervention with unknown effect. Animal and in vitro studies: Exposure to an active substance with unknown effect.
Main Outcome
Outcome Measure: Inclusion criteria: Human and animal studies: An actual or possible risk or lack of risk that is relevant to the p.o. clinical use of the respective Chinese medicine during pregnancy. Examples include abortion, absorption, teratogenicity, embryotoxicity, fetotoxicity, stillbirth, preterm birth, developmental toxicity, mutagenicity, genotoxicity or carcinogenicity. In vitro studies: (1) A harmful activity/cellular damage or the absence of a harmful activity/cellular damage, respectively, related to pregnancy or (2) mutagenicity/genotoxicity or the absence of mutagenicity/genotoxicity. Examples include contraction of myometrium, inhibition of cell differentiation, cytotoxicity, mutagenicity or genotoxicity. Exclusion criteria: Human and animal studies: Studies that do not test for an actual or possible risk or lack of risk that is relevant to the p.o. clinical use of the respective Chinese medicine during pregnancy; studies only demonstrating beneficial or preventing effects. In vitro studies: Studies that (1) do not test for a harmful activity/cellular damage or the absence of a harmful activity/cellular damage related to pregnancy; (2) do not test for mutagenicity/genotoxicity or the absence of mutagenicity/genotoxicity; studies only testing for mechanisms of action or beneficial or preventing effects or for anti-mutagenic, anti-genotoxic or anti-carcinogenic effects.
Additional Outcome
Study Method
Keyword: Animals; DNA Damage; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Iatrogenic Disease; Mutagenesis; Mutagens; Pregnancy
Contact: Axel Wiebrecht [email protected]
Organisational Affiliation
Funding Source: Societas Medicinae Sinensis, Munich, Germany (SMS) and German Medical Association for Acupuncture (DÄGfA), Munich, Germany – requested –
Other Selection Criteria: Human, animal and in vitro studies: Reviews, meta-analyses, commentaries, abstracts not providing detailed information, study protocols. (But reference lists will be retrieved.) There are no language restrictions.
Final Publication
Same Topic Review
Published Protocol
Review Type: Pre-clinical animal intervention review
Language: English
Country: Germany, Switzerland
Review Stage: Review Ongoing
First Submission Date: 2023-03-03
Registration Date: 2023-05-09
Anticipated Start Date: 2023-03-13
Anticipated Completion Date: 2024-03-31
Title Cn: 30种妊娠相关中草药的妊娠风险：系统评价与风险评估
Title En: Pregnancy risks of 30 pregnancy-related Chinese herbs: A systematic review and risk evaluation
Bilingual Status: complete