Meta AnalysisID 159

柴胡治疗无并发症的急性呼吸道感染：一项系统评价

CRD42021234066

To determine whether Radix bupleuri is effective and safe to be used in uncomplicated acute respiratory tract infections (ARTIs).

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Meta Analysis Id: 159
Evidence Id: 8717
Core Evidence Id: 8717
Source Meta Analysis Id: 145
Herb2 Meta Analysis Id: HBMA000145
Crd Id: CRD42021234066
Title: Radix bupleuri for uncomplicated acute respiratory tract infections: a systematic review
Review Question: To determine whether Radix bupleuri is effective and safe to be used in uncomplicated acute respiratory tract infections (ARTIs).
Study Type Included: All randomized controlled trials (RCTs) will be eligible for inclusion. We will include cross-over trials if they had pre-cross-over data.
Condition Being Studied: Acute respiratory tract infections are a major cause of global morbidity and mortality, with an estimation of 2.65 million deaths worldwide. Standard treatments for uncomplicated ARTIs are mainly symptomatic, including analgesics, antipyretics, mucolytics, expectorants, decongestants, and educational interventions. Despite research has suggested uncomplicated ARTIs are predominantly viral infections, antibiotics showed little benefit in symptom improvement for ARTIs such as colds, or acute laryngitis, antibiotics are frequently prescribed in primary care settings. Antimicrobial resistance (AMR) is an evolving major global threat to public health. The marginal benefit of antibiotics for ARTIs are outweighed by increasing AMR and common adverse reactions leading to unnecessary increases in healthcare costs. Research is warranted to explore other alternatives that may offered symptomatic relief and reduce unnecessary antibiotic prescribing.
Participant: Trials with patients of all ages, with either an ARTI diagnosis or appearance with symptoms of uncomplicated ARTIs (not necessitating antibiotic therapy). A clinical diagnosis of ARTIs was the main inclusion criteria. Diagnoses of upper or lower ARTIs include common cold, influenza, rhinosinusitis, laryngitis, tonsillitis, pharyngitis, croup, acute otitis media, and bronchitis, and acute exacerbations of chronic obstructive pulmonary disease (COPD). Symptoms of uncomplicated ARTIs are defined as having symptoms such as cough, sore throat, fever, runny nose and discoloured sputum for a duration of less than four weeks. We excluded any condition for which an antibiotic or other specific therapy was recommended, such as streptococcal infections, pneumonia, diphtheria, tuberculosis, infections in immunocompromised or elderly persons, or any life-threatening condition. Also, studies restricted to patients with underly ingchronic disease, such as asthma or chronic obstructive airways disease (COPD), or any other condition potentially impacting on the management and outcome of ARI were not included (Timmer A et al., 2013).
Animal
Human Disease Modelled
Intervention: Radix bupleuri for uncomplicated acute respiratory tract infections. Radix bupleuri (Chai Hu in Chinese) is believed to be one of the most important herb traditionally used in China. Preparations containing the roots of Bupleurum species have been prescribed for more than 2000 years in China where the first record about their use appeared in Shen Nong’s Herbal. Radix bupleuri's chemical constituents mainly comprising flavonoids, lignins, phenyl propanol derivatives, triterpenoid saponins, and volatile oils. It shows a wide range of pharmacological activities, such as anti-inflammatory, antipyretic, antimicrobial and antiviral. Radix bupleuri is widely used in China, Korea and Japan for the treatment of fever, pain and inflammation associated with respiratory tract infections. Radix bupleuri, any form of preparation e.g. oral preparation, herbal injection or topical use, as a sole intervention will be included.
Comparator Control: No intervention, placebo; usual care such as antipyretics, antivirals, antibiotics, anti-inflammatories, steroids or corticosteroids will be included. Radix bupleuri combined with other interventions compared with other interventions alone will be included. Radix bupleuri combined with other TCM therapies such as herbs will be excluded.
Main Outcome: 1. Time to complete resolution of all symptoms (in days), or number of patients resolved at a predefined time. 2. Time to complete resolution of key symptoms (in days), or number of patients with key symptoms resolved at a predefined time. The following symptoms were expected to be of primary interest (key symptoms): fever, cough and sore throat. Measures of effect Where possible, the analyses will be based on intention to treat (ITT) data on each outcome provided for every randomised participant from the individual trials. Where possible, for continuous outcomes, the end of treatment scores rather than change from baseline scores will be extracted. For continuous data, because of the anticipated variability in the populations and interventions of included trials, a generic inverse variance random effects model will be used to pool the mean differences (MD) with 95% confidence intervals (CI) to incorporate heterogeneity. If the units of the outcome measures used across studies were not consistent, the effects as standardised mean differences (SMD) will be reported. An overall effect size of 0.2-0.5 was regarded as small, 0.5-0.8 as moderate and more than 0.8 as large. For dichotomous data, a random-effects method will be used to pool the summary risk ratio (RR) with 95% CI. Where standard deviation has not been reported with means, it will be calculated from the information reported such as confidence intervals (CI), p-values, or F-values.
Outcome Measure
Additional Outcome: 1. Need for antibiotics at follow-up. 2. Days off work or school. 3. Length of hospitalization. 4. Adverse events (AEs): This included any anaphylactic, allergic reactions, hypersensitivity reactions, or complications of taking Radix bupleuri. Information regarding AEs due to interactions among Radix bupleuri in combination with other remedies, or potential interactions with medications patients had for their comorbidities will also be collected. We defined serious AEs according to the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines as any event that leads to death, is life-threatening, requires hospitalisation or leads to persistent or significant disability; biochemistry results such as electrolytes, liver and kidney function tests (alanine aminotransferase and creatinine). Measures of effect These will be the same as for the main outcomes.
Study Method: Intervention, Systematic review
Keyword: Bupleurum; Drugs, Chinese Herbal; Humans; Medicine, Chinese Traditional; Patient Safety; Phytotherapy; Plant Roots; Respiratory Tract Infections; Signs and Symptoms, Respiratory; Treatment Outcome
Contact: Lijiao Yan [email protected]
Organisational Affiliation: Beijing University of Chinese Medicine
Funding Source: This review is funded by Innovate UK (grant no. 104287-610239) and the National Key Research and Development Project (grant no. 2018YFE0102300)
Other Selection Criteria
Final Publication: Accepted by Frontiers Pharmacology https://www.frontiersin.org/articles/10.3389/fphar.2021.787084/abstract
Same Topic Review
Published Protocol
Review Type
Language: English
Country: China, England
Review Stage: Review Completed published
First Submission Date: 2021-02-05
Registration Date: 2021-02-08
Anticipated Start Date: 2020-10-30
Anticipated Completion Date: 2021-10-30
Title Cn: 柴胡治疗无并发症的急性呼吸道感染：一项系统评价
Title En: Radix bupleuri for uncomplicated acute respiratory tract infections: a systematic review
Bilingual Status: complete