Abstract
sBackgroundInfluenza can fall into three categories according to severity: mild influenza, severe influenza, and critical influenza. Severe influenza can result in critical illness and sometimes death particularly in patients with comorbidities, advanced age, or pregnancy. Neuraminidase inhibitors (NAIs) are the only antiviral drugs in widespread use for influenza. However, the effectiveness of NAIs against severe influenza is uncertain. New effective drugs or regimens are therefore urgently needed. Qiangzhu-qinggan (QZQG) formula has been found to be effective against influenza virus infection during long-term application in China, which lacks support of evidence-based clinical trial till now. This study is designed to assess the efficacy and safety of QZQG formula as an adjuvant therapy in adult patients with severe influenza.MethodsThis protocol is drawn up in accordance with the SPIRIT guidelines and CONSORT Extension for Chinese herbal medicine formulas. This is a randomized, placebo-controlled, double-blind, multicenter trial. Two hundred twenty-eight adults with severe influenza are randomly assigned in a 1:1 ratio to QZQG or placebo for 7 days. All participants need to receive 1 day of screening before randomization, 7 days of intervention, and 21 days of observation after randomization. The primary outcome is the proportion of clinical improvement, defined as the proportion of patients who met the criteria of 3 points or less in the seven-category ordinal scale or 2 points or less in National Early Warning Score 2 within 7 days after randomization.DiscussionThis is the first randomized, controlled, parallel, double-blind clinical trial to evaluate the efficacy and safety of traditional Chinese herbal formula granules as an adjuvant therapy in adult patients with severe influenza. This study aims to redefine the value of traditional Chinese herbal medicines in the treatment of virus-related respiratory infectious diseases and serves as an example of evidence-based clinical trials of other Chinese herbal medicines.
Highlights
Background and rationale {6a} “Spanish flu” pandemic in 1918 was described as the most devastating viral pandemic in history caused by an H1N1 influenza A virus that infected over 500 million and killed between 50 and 100 million people [1]
A prospective, nonblinded, randomized controlled trial (RCT) in 2011 found that time to fever resolution was reduced by 19% (CI, 0.3% to 34%; P = 0.05) with oseltamivir plus maxingshigan–yinqiaosan compared with oseltamivir [13]
Severe influenza tends to result in critical illness and sometimes death compared with mild influenza [4, 6]
Summary
Background and rationale {6a} “Spanish flu” pandemic in 1918 was described as the most devastating viral pandemic in history caused by an H1N1 influenza A virus that infected over 500 million and killed between 50 and 100 million people [1]. The Centers for Disease Control and Prevention (CDC) estimated that influenza virus infection caused more than 35.5 million illnesses, more than 16.5 million medical visits, 490,600 hospitalizations, and 34,200 deaths during the 2018– 2019 influenza season in the USA [2]. Seasonal influenza worldwide is estimated to cause 291,243–645,832 influenza-associated respiratory deaths annually [4]. Severe influenza is one of the main causes of critical illness and death in patients with comorbidities, advanced age, or pregnancy [4]. Severe influenza can result in critical illness and sometimes death in patients with comorbidities, advanced age, or pregnancy. Qiangzhu-qinggan (QZQG) formula has been found to be effective against influenza virus infection during long-term application in China, which lacks support of evidencebased clinical trial till now. This study is designed to assess the efficacy and safety of QZQG formula as an adjuvant therapy in adult patients with severe influenza
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