Meta AnalysisID 539
山金车在外科手术中的应用——系统评价与Meta分析
CRD42020131300
The aim of the planned analysis is to systematically review the literature on clinical studies on homeopathic Arnica in surgery and to evaluate by meta-analytical means whether the clinical effects of potentized Arnica m
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Record Fields
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- Meta Analysis Id
- 539
- Evidence Id
- 9097
- Core Evidence Id
- 9097
- Source Meta Analysis Id
- 517
- Herb2 Meta Analysis Id
- HBMA000517
- Crd Id
- CRD42020131300
- Title
- Arnica in surgery - a systematic review and meta-analysis
- Review Question
- The aim of the planned analysis is to systematically review the literature on clinical studies on homeopathic Arnica in surgery and to evaluate by meta-analytical means whether the clinical effects of potentized Arnica montana are different from control. Additionally, we aim to identify quality of trials and to investigate whether the effect of using homeopathic Arnica differs between the type of surgery performed or the homeopathic potency used. In contrast to former meta-analyses, and in order to consider both, internal and external validity, not only RCTs but also controlled observational studies will be taken into account.
- Study Type Included
- RCTs and controlled observational studies will be included. All other study designs will be excluded.
- Condition Being Studied
- Any type of surgical procedure in which potentized Arnica montana was applied in order to assess its clinical effects on the included patients in comparison to control. Studies should be able to be coded into the ICD-10 categories: Z98.8 und Z48.8 surgical follow-up and the ICF-category b280 “pain” or b430 “haematological functions”.
- Participant
- Only studies on human organisms will be included. Participants must have been eligible for various types of surgery.
- Animal
- Human Disease Modelled
- Intervention
- Homoeopathic Arnica montana applied either pre- or postoperatively. Arnica Montana should have been homeopathically processed by trituration and succussion. Any Q-potency will be included. Studies analyzing mother tinctures only will not be included.
- Comparator Control
- The clinical effects of potentized Arnica will be compared 1) to placebo, and 2) to conventional treatments that have shown effectiveness for the respective condition and waiting-list controls, as long as they received standard care. Studies with other types of control (e.g., waiting list without standard care, other complementary medicine methods) will not be included.
- Main Outcome
- As the homeopathic preparation Arnica is a multipurpose drug, indicated in all cases where bleeding, swelling or pain is present as a consequence of trauma, operation, surgery, or injury, the respective studies have different scopes and outcome parameters. There are studies which measure swelling and edema using various measures, such as circumference measures or analogue measures, edema, reduction of blood dripping through canules and subjective measures of pain relief and irritation. Defining one major outcome would reduce the number of potential studies and would result in at least 5 different meta-analyses and in single meta-analysis with less power and smaller scope. Hence our proposal to deal with this heterogeneous situation is the following: Whereever it is defined we use the main outcome measure proposed (ecchymosis, edema, pain relief, circumference or extension measures, etc.) and calculate the standardized mean difference, defined as the difference in pre-post scores standardized by the pooled standard deviation. This metric is going to be the main outcome measure per study and across studies. Wherever there is an array of parameters, those parameters are averaged into one outcome measure per study, treated the same way as above. This will yield once outcome measure per study, the standardized mean difference across various outcome domains. As all outcome measures employed in this paradigm are continuous, for instance square cm, cm, pain VAS, extension of ecchymosis, etc., standardized mean difference is the best measure to combine these various metrics into one standardized metric. Measures of effect Pain measurements will be considered as reported in the original studies. If there should be multiple measurements, the last reported follow-up (measured from the start of the intervention) will be considered as primary endpoint to include.
- Outcome Measure
- Additional Outcome
- Wound healing, swelling/edema, hematoma Measures of effect Pain measurements will be considered as reported in the original studies. If there should be multiple measurements, the last reported follow-up (measured from the start of the intervention) will be considered as primary endpoint to include.
- Study Method
- Intervention, Meta-analysis, Systematic review
- Keyword
- Arnica; Flower Essences; Humans; Plant Extracts
- Contact
- Katharina Gaertner [email protected]
- Organisational Affiliation
- University of Witten, Faculty of health Sciences
- Funding Source
- The Tiedemann Foundation for Classical Homeopathy, the Homeopathy foundation of the Association of homeopathic Doctors in Germany (DZVhÄ) and the Pierre Schmidt Foundation in Switzerland supported the principle investigator and assistants financially, but did not have any role in the design of the protocol nor will it be involved in any other aspect of the project, such as collection of the primary studies, analyses of the data or interpretation of results.
- Other Selection Criteria
- Final Publication
- https://www.frontiersin.org/articles/10.3389/fsurg.2021.680930/full
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Germany
- Review Stage
- Review Completed published
- First Submission Date
- 2019-04-08
- Registration Date
- 2020-04-28
- Anticipated Start Date
- 2019-06-03
- Anticipated Completion Date
- 2020-03-30
- Title Cn
- 山金车在外科手术中的应用——系统评价与Meta分析
- Title En
- Arnica in surgery - a systematic review and meta-analysis
- Bilingual Status
- complete