Meta AnalysisID 462

槲寄生提取物治疗乳腺癌患者的生活质量:系统评价与Meta分析方案

CRD42023388900

Which impact does the supplementary treatment with mistletoe extracts have on quality of life in breast cancer patients compared to placebo, standard care, or other phytotherapeutic therapies?

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Record Fields

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Meta Analysis Id
462
Evidence Id
9020
Core Evidence Id
9020
Source Meta Analysis Id
437
Herb2 Meta Analysis Id
HBMA000437
Crd Id
CRD42023388900
Title
Quality of life in breast cancer patients treated with mistletoe extract: protocol for a systematic review and meta-analysis
Review Question
Which impact does the supplementary treatment with mistletoe extracts have on quality of life in breast cancer patients compared to placebo, standard care, or other phytotherapeutic therapies?
Study Type Included
We will include randomized controlled trials as well as non-randomized studies, both prospective and retrospective. Since individualized treatment regimens are frequent in mistletoe therapy, but are usually not assessed in randomized clinical trials (RCTs) [15, 16], we will also include real world data analysis in the form of non-randomized controlled studies. The studies must have at least one control group and one verum-group receiving mistletoe treatment assessing the global quality of life in breast cancer patients. We will select studies that apply a global instrument to measure the QoL or the self-regulation of cancer patients (see [17] for an overview) treated with mistletoe extracts. We will not limit our search to languages; however, the search itself will only comprise German and English terms.
Condition Being Studied
Breast cancer is the most common cancer in women worldwide with an incidence of more than two millions in 2020 [1]. Although the disease is not always fatal, it significantly decreases the quality of life [2]. QoL is a measure of the perceived well-being of an individual with a wide range of assessment tools. Although the measure of psychosomatic self-regulation (e.g. [3]) does not represent a global dimension of QoL, it has been shown to be correlated with QoL [4] and we will therefore include it in our search. While systemic treatment options focus on the survival [5], multiple approaches have been tested to support the QoL of cancer patients. For instance, stress management [6], physical activity [7] and yoga [8] have been reported to improve the quality of life in breast cancer patients. We plan to conduct a systematic review and meta-analysis to estimate the impact of mistletoe on QoL in breast cancer patients.
Participant
Breast cancer patients
Animal
Human Disease Modelled
Intervention
Mistletoe extracts (MEs) are extracts from the European mistletoe Viscum album L. and frequently used in cancer care [9, 10]. Mistletoe contains biologically active molecules including lectins, flavinoides, viscotoxins, oligo-/polysaccharides, alkaloids, membrane lipids and other substances [11]. The exact pharmacological mode of action of ME is not completely elucidated, but it has been reported to induce multiple impacts such as an increase in the antioxidant system [12] or immune system have [13]. The standard mistletoe treatment protocol, applied in most clinical investigations up to date, consists of subcutaneous injections of ME, three times a week. An adaptation to the patient is possible by increasing the ME-concentrations and by choosing from different host trees or manufacturing methods, leading to an individualized treatment regimen [14].
Comparator Control
Control groups can be, depending on the oncological setting, various. Control groups will include treatments with placebo, best supportive care only, treatment according to guidelines only, or supplementary treatment with a phytotherapeutic compound other than mistletoe.
Main Outcome
The main outcome is the global quality of life as measured by patient reported outcome measures and recorded by medical interviews.
Outcome Measure
Additional Outcome
none Measures of effect We opt for the standardized mean differences (post vs. pre) and standard deviations per treatment arm. If baseline mean and end point mean and the corresponding variances or categorical data with odds-ratios are presented, we will convert these numbers and calculate standardized mean differences and standard deviations by employing a validated imputation method [18-20].
Study Method
Meta-analysis, Systematic review
Keyword
Biological Products; Breast Neoplasms; Female; Humans; Meta-Analysis as Topic; Mistletoe; Plant Extracts; Quality of Life; Systematic Reviews as Topic
Contact
Martin Loef [email protected]
Organisational Affiliation
CHS-Institute
Funding Source
Stiftung Integrative Medizin & Pharmazie
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language
English
Country
Germany
Review Stage
Review Ongoing
First Submission Date
2023-01-03
Registration Date
2023-01-14
Anticipated Start Date
2023-01-03
Anticipated Completion Date
2023-04-15
Title Cn
槲寄生提取物治疗乳腺癌患者的生活质量:系统评价与Meta分析方案
Title En
Quality of life in breast cancer patients treated with mistletoe extract: protocol for a systematic review and meta-analysis
Bilingual Status
complete