Meta AnalysisID 62
探讨口服地黄（RG）单独或复方制剂在人体随机对照试验中是否对炎症血液生物标志物水平产生显著差异
CRD42020198533
This systematic review will evaluate blood biomarkers of inflammation and where possible report the rate of adverse events related to oral intake of Rehmannia glutinosa in randomised controlled trials of healthy and clin
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Record Fields
Scalar fields from the final meta_analysis record.
- Meta Analysis Id
- 62
- Evidence Id
- 8620
- Core Evidence Id
- 8620
- Source Meta Analysis Id
- 58
- Herb2 Meta Analysis Id
- HBMA000058
- Crd Id
- CRD42020198533
- Title
- To investigate whether oral Rehmannia glutinosa (RG) intake in human RCTs, alone or in formulation, produces significant differences in inflammatory blood biomarker levels.
- Review Question
- This systematic review will evaluate blood biomarkers of inflammation and where possible report the rate of adverse events related to oral intake of Rehmannia glutinosa in randomised controlled trials of healthy and clinical populations.
- Study Type Included
- Study design for inclusion will be restricted to experimental designs so that all published, peer-reviewed, randomised controlled trials (RCTs) that meet the inclusion and exclusion criteria will be included. This will include both crossover, parallel and longitudinal experimental study designs.
- Condition Being Studied
- The change in systemic inflammation as assessed by biomarkers such as pro-inflammatory cytokines, chemokines and other proteins involved in the inflammatory response.
- Participant
- Inclusion criteria: • Healthy populations • Clinical populations • Human adults (>18years) Exclusion criteria: • Non-human subjects, • In vitro and human cell line studies, • Animal models • Children (<18 years)
- Animal
- Human Disease Modelled
- Intervention
- Any form of oral Rehmannia glutinosa administered either on its own, in an herbal mixture (R.glutinosa in a multi-ingredient formulation) or co-administered with pharmaceutical medicines. Examples of a multi-ingredient formulation that contains RG include:- Rehmannia/Lily Bulb formula (LBRD); or Liu Wei Di Huang (LWDH) formula that contains Shu Di Huang (Radix Rehmanniae Preparata), Shan Zhu Yu (Fructus Corni), Shan Yao (Rhizoma Dioscoreae), Ze Xie (Rhizoma Alismatis), Mu Dan Pi (Cortex Moutan), and Fu Ling (Poria). No limitation will be imposed concerning dosage, methods of dosing or duration of administration. Studies investigating different oral preparations of RG, e.g. liquid, tablet, capsule, raw/dried root, granule preparations, will also be included in this review.
- Comparator Control
- The comparator groups will have received either an inert or active placebo, and no additional intervention (not administered to the treatment group), other herbal remedies or pharmaceutical medicines.
- Main Outcome
- The primary outcome measure will be the mean difference in blood biomarkers of inflammation between the intervention group and control group. Primary outcome measures will include pro-inflammatory cytokines, chemokines, other proteins involved in the inflammatory response measured in full blood, plasma, or serum. Measures of effect The influence of the type of analyses used to assess treatment effects (e.g. intention to treat) will be investigated in sensitivity analyses and meta-regressions where possible. Timing of effect measures: Some studies may have used a repeated measures approach and will have different time points. If there is sufficient data available in the included trials, timings of measures will be documented at baseline and at the most appropriate follow-up data point, with commonly reported time points explored if warranted.
- Outcome Measure
- Additional Outcome
- Data reported on adverse events (AEs) or other safety data will also be investigated. This may include any anaphylactic, allergic reactions, hypersensitivity reactions, or complications directly attributable to RG. In addition, reports of rash, nausea, fatigue, or worsening of symptoms will be recorded. AEs due to interactions between RG in combination with other remedies, or potential interactions with other medicines will also be collected. Lastly, serious AEs that are considered life-threatening, lead to death, hospitalisation or a persistent/significant disability will also be collected. Measures of effect Timing of effect measures: Mean time to reported remission, symptom resolution, or reduction in pharmaceutical usage.
- Study Method
- Intervention, Meta-analysis, Systematic review
- Keyword
- Biomarkers; Chromatography, High Pressure Liquid; Humans; Rehmannia
- Contact
- Sarina Macklin [email protected]
- Organisational Affiliation
- The Australian National University https://rsph.anu.edu.au/research/groups/neuroimaging-brain-lab
- Funding Source
- Sarina Macklin is supported by Australian Government Research Training Program (AGRTP) Fee-Offset Scholarship.
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Australia
- Review Stage
- Review Ongoing
- First Submission Date
- 2020-07-24
- Registration Date
- 2020-08-24
- Anticipated Start Date
- 2020-07-20
- Anticipated Completion Date
- 2021-06-30
- Title Cn
- 探讨口服地黄（RG）单独或复方制剂在人体随机对照试验中是否对炎症血液生物标志物水平产生显著差异
- Title En
- To investigate whether oral Rehmannia glutinosa (RG) intake in human RCTs, alone or in formulation, produces significant differences in inflammatory blood biomarker levels.
- Bilingual Status
- complete