Meta AnalysisID 125
巴西植物疗法中使用的各种波尔多叶的毒性：一项动物临床前研究的系统评价
CRD42020212281
Is there a difference in toxicity related to the internal administration in animals of the various types of boldo used in Brazilian folk medicine? Context and rationale Phytotherapy is a type of allopathic treatment char
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- Meta Analysis Id
- 125
- Evidence Id
- 8683
- Core Evidence Id
- 8683
- Source Meta Analysis Id
- 111
- Herb2 Meta Analysis Id
- HBMA000111
- Crd Id
- CRD42020212281
- Title
- Toxicity of various types boldo used in Brazilian phytotherapy: a systematic review of pre-clinical studies in animals.
- Review Question
- Is there a difference in toxicity related to the internal administration in animals of the various types of boldo used in Brazilian folk medicine? Context and rationale Phytotherapy is a type of allopathic treatment characterized by the use of medicinal plants in their various pharmaceutical forms, without the combination with any isolated drug in the same product, even whether from vegetable origin. The use of herbal products has been increasing worldwide, which is associated with the seek for alternative treatments that can be less aggressive, thence enhancing the patient compliance and submission. However, due to lack of robust scientific evidences regarding their safety and efficacy, in the majority of the cases herbal medicines are still not considered as feasible options in emergencies and chronic health impairments. Therefore, the usage of phytomedicines has been limited to both preventive care and complementarily to regular treatments, showing good performance in the amelioration of several diseases. In Brazil, due to several issues such as its wide botanical diversity and cultural aspects, over the last few decades it has been noticed a remarkable increase in the adepts for herbal treatments. Among the adapted native and exotic plants most used in Brazilian complementary medicine, several species popularly known as “boldo” are noteworthy. Although they share the same popular name, the different species of “boldo” have very distinct anatomical, histomorphological and phytochemical features, the latter being responsible for the difference in efficacy and toxicity of such herbs. The species that has been most frequently reported in ethnopharmacological and ethnotoxicological studies are Peumus boldus, Vernonia condensata, Plectranthus barbatus, Plectranthus ornatus and Plectranthus neochilus. Often extracts from the leaves of “boldo” species are used orally in the form of teas (infusions and decoctions) and alcoholic preparations (tinctures, macerates, bottles, etc.) as antimicrobial, laxative, digestive stimulant (cholagogue, choleretic, antispasmodic) and in the relief of stomachache (gastric hyposecretory), treatment of hepatitis and other symptoms caused by alcoholic intoxications, which suggests a possible hepatoprotective effect. Due to its acknowledged therapeutic value, in Brazil there are 19 boldo herbal medicines registered by the National Health Surveillance Agency (Anvisa). This ratifies the urgency for generating scientific evidences regarding the safety in the use of these species, since the majority of the phytopharmaceuticals are over-the-counter products and, therefore, may be used without proper professional guidance concerning self-medication issues, which can become a serious public health problem when considering the toxic potential of phytochemicals. The safety of the oral use of products based on “boldo” leaf extracts has been questioned by the academic community, mainly due to a case report, in which a patient who used a laxative herbal complex for several years had severe hepatotoxicity five months after the manufacturer has changed the composition of the product by adding boldo extract. Hence, a systematic review of boldo toxicity in experimental models would bring relevant information either to endorse the rationale use by the patients and to support the maintenance or renovation of the registration of such a phytomedicines by the Anvisa, once the outcomes arising from pre-clinical studies can be considered for the dose calculations when planning clinical trials and may do correlate with therapeutic effects in humans.
- Study Type Included
- Inclusion criteria: Animal preclinical controlled studies with separate treatment arms; Exclusion criteria: In vitro and ex vivo, in silico study designs, before-after studies without control group, observational studies, cross-over design, randomized study design, and non-randomized study designs.
- Condition Being Studied
- Participant
- Animal
- Inclusion criteria: All animal models, all sex, all age, and all species of animals Exclusion criteria: Studies in humans, animals with any co-morbid
- Human Disease Modelled
- adverse side effects; Oral intoxication; hepatotoxicity;
- Intervention
- Inclusion criteria: Treatment with boldo preparations in any dosing, given at any time and frequency of dosing Exclusion criteria: Treatment with polyherbal preparation of boldo or isolated pure compounds or boldo combined with standard oral toxicant agents
- Comparator Control
- Inclusion criteria: Animal models of intoxication treated with either vehicle/placebo, or health animal control Exclusion criteria: Animal models of intoxication treated with any other drug
- Main Outcome
- Outcome Measure
- Inclusion criteria: Primary: LD50; survival; and signs of intoxication or adverse effects (e.g., general behavior); Secundary: absloute body weight; results of organ analysis (weight measure and histolopathological analysis); Hematological analysis of red blood cells count (RBC), hemoglobin (Hb), hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets number, white blood cells count (WBC) and differential leukocyte count; Biochemical analysis of alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total proteins (PT) for hepatic function; urea nitrogen (BUN), uric acid (AUR) and creatinine (CRE) for renal function; and amylase (AMY) for pancreatic function; and results from locomotion and muscle tone evaluation (number of squares covered by the animals; number of rearing; and muscle strength of the animals). Exclusion criteria: None
- Additional Outcome
- Study Method
- Keyword
- Animals; Phytotherapy; Plant Extracts
- Contact
- Renê Couto [email protected]
- Organisational Affiliation
- Universidade Federal de São João del-Rei https://www.ufsj.edu.br/cco/
- Funding Source
- Brazilian National Council for Scientific and Technological Development (CNPq, Portuguese: Conselho Nacional de Desenvolvimento Científico e Tecnológico) Grant number(s) 21005
- Other Selection Criteria
- Original articles and short communications (published or ahead of print) will be considered. Case reports, review articles, editorials, letters to the editor, papers will be excluded. presented in scientific events, news, comments, dissertations and theses will not be included. No language restrictions are planned.
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Experimental animal exposure review
- Language
- English
- Country
- Brazil
- Review Stage
- Review Ongoing
- First Submission Date
- 2020-10-01
- Registration Date
- 2020-11-13
- Anticipated Start Date
- 2020-10-01
- Anticipated Completion Date
- 2021-08-31
- Title Cn
- 巴西植物疗法中使用的各种波尔多叶的毒性：一项动物临床前研究的系统评价
- Title En
- Toxicity of various types boldo used in Brazilian phytotherapy: a systematic review of pre-clinical studies in animals.
- Bilingual Status
- complete