Meta AnalysisID 320

人参及人参复方制剂对症管理疲劳：系统评价和Meta分析的研究方案

CRD42021247021

This systematic review aims to assess the efficacy and safety of ginseng and ginseng herbal formulas on symptomatic management of fatigue.

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Meta Analysis Id: 320
Evidence Id: 8878
Core Evidence Id: 8878
Source Meta Analysis Id: 300
Herb2 Meta Analysis Id: HBMA000300
Crd Id: CRD42021247021
Title: Ginseng and ginseng herbal formulas for symptomatic management of fatigue: Study protocol of a systematic review and meta-analysis
Review Question: This systematic review aims to assess the efficacy and safety of ginseng and ginseng herbal formulas on symptomatic management of fatigue.
Study Type Included: Only randomized controlled trials (RCTs) will be included.
Condition Being Studied: Fatigue is a complex construct which has no standardized definition. In most of literatures, fatigue was defined as a symptom, indicative of physical or mental disease, reduced ability or desire to perform physical, mental or cognitive tasks, or a consequence of the treatment of diseases. Fatigue is also one of the most common presenting complaints in individuals with a variety of chronic health conditions such as neurological diseases, epidemic diseases and cancer, and may persist for years even after treatment completion. Patients with fatigue are at a risk of unpleasant physical symptoms or disability, psychological problems, treatment discontinuation and even premature death, which significantly influenced patients’ life quality.
Participant: Inclusion criteria: Trials including participants who present symptoms of fatigue will be included, regardless of the primary diagnosis, cause of the symptom and duration. Fatigue in healthy subject who engages in work or sport is eligible. Exclusion criteria: No restrictions were placed on the geographic, socioeconomic or ethnic backgrounds of any of the participants. There are no other limitations set for the exclusion of participants.
Animal
Human Disease Modelled
Intervention: Inclusion criteria: The intervention is ginseng and ginseng herbal formulas. 3 types of ginseng (Chinese ginseng, Korea ginseng and American ginseng) and their processed products will be included. 14 ginseng containing herbal formulas used as classical prescriptions of Traditional Chinese Medicine will be included. Exclusion criteria: Trials of ginseng and ginseng herbal formulas used as an independent treatment or in combination with other treatment or placebo will be considered eligible. However, other unsubstantiated therapies such as tuina, and the compounds or extractive of ginseng and ginseng herbal formulas will be excluded. Studies that compare the efficacy of different doses of ginseng will be excluded as dose-response curve is not a focus of this review.
Comparator Control: The following control groups will be considered: 1. placebo； 2. usual care/no treatment; 3. conventional drugs/treatment. Three arm RCTs with both placebo and active treatment controls will also be considered.
Main Outcome: Fatigue measured by validated instruments including general fatigue instruments such as Brief fatigue inventory (BFI), Fatigue assessment instrument (FAI), etc. and disease specific fatigue instruments such as Fatigue Symptoms and Impact Questionnaire Relapsing Multiple Sclerosis (FSIQ-RMS) and Multidimensional Assessment of Fatigue (MAF), etc. (All the instruments mainly include three types as following: 1. Single-item screening instruments such as Visual analog scale (VAS) for fatigue and NCCN intensity tool. 2. Multi-item, unidimensional validated instruments such as BFI, FAI，Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(13 items) 3. Multi-item, multidimensional instruments such as Multidimensional Fatigue Inventory (MFI), FACIT-F (40 items) and Revised Piper Fatigue Scale (PFS-R);) Measures of effect Dichotomous data will be analysed by using a risk ratio (RR) with 95% CIs. Continuous data will be analysed by using a weighted mean difference (WMD) or a standard mean difference (SMD) with 95% CIs. The WMD will be used for the same scale or same assessment instrument; SMD will be used for different assessment tools.
Outcome Measure
Additional Outcome: 1. Quality of life measured by validated instrument such as Short Form 36 (SF-36); 2. Reported adverse event. Measures of effect Dichotomous data will be analysed by using a risk ratio (RR) with 95% CIs. Continuous data will be analysed by using a weighted mean difference (WMD) or a standard mean difference (SMD) with 95% CIs. The WMD will be used for the same scale or same assessment instrument; SMD will be used for different assessment tools.
Study Method: Intervention, Meta-analysis, Systematic review
Keyword: Fatigue; Humans; Meta-Analysis as Topic; Panax; Phytotherapy; Systematic Reviews as Topic
Contact: Xiaotong Li [email protected]
Organisational Affiliation: Memorial Sloan Kettering Cancer Center https://www.mskcc.org
Funding Source: This work is supported in part by a grant from the National Institutes of Health/National Cancer Institute Cancer Center (P30 CA008748), and by the Laurance S. Rockefeller Fund and the Translational and Integrative Medicine Research Fund, both at Memorial Sloan Kettering Cancer Center.
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language: English
Country: United States of America
Review Stage: Review Ongoing
First Submission Date: 2021-05-07
Registration Date: 2021-06-07
Anticipated Start Date: 2021-04-05
Anticipated Completion Date: 2021-11-04
Title Cn: 人参及人参复方制剂对症管理疲劳：系统评价和Meta分析的研究方案
Title En: Ginseng and ginseng herbal formulas for symptomatic management of fatigue: Study protocol of a systematic review and meta-analysis
Bilingual Status: complete