Department of Medical Pharmacology, Faculty of Medicine, Assiut University, Assiut, Egypt.
Department of Internal Medicine, Faculty of Medicine, Sohag University, Sohag, Egypt.
Inflammopharmacology. 2022 Apr;30(2):477-486. doi: 10.1007/s10787-022-00939-7. Epub 2022 Mar 1.
Recent evidence points to a potential therapeutic role for glycyrrhizin(GR) and boswellic acids (BA) in the treatment of COVID-19 but conclusive evidence is lacking. Our aim is to investigate the efficacy of GR + BA versus placebo for the treatment of hospitalized patients with moderate SARS-CoV-2 or COVID-19 variants infection. The current study is a randomized, double-blind, placebo-controlled, single-center trial. Patients with SARS-CoV-2 or COVID-19 variants diagnosed by PCR test who were admitted to Sohag University hospital were eligible if they were at least 18 years of age and had moderate symptoms. Patients were randomly assigned to receive oral GR capsule (60 mg) and BA (200 mg) twice daily for 14 days or a matching placebo. All patients also received treatment with the institutional protocol for COVID-19. The primary outcome was mortality and time to recovery. Secondary outcome was clinical status score, 14 days after receiving study drugs. Adverse events from use of study drugs have been evaluated for up to 14 days. The trial is registered at ClinicalTrials.gov (Identifier NCT04487964). During the 6-month enrollment period (June-November, 2021) only 50 patients (54% women; median age 60 years, IQR 54-65) met eligibility and were randomly assigned. Evaluation of the primary outcome at 14 days showed that there were five deaths in the placebo group and no deaths in the GR + BA group. With regard to recovery time, it was significantly shorter (p = 0.0001) in the group receiving GR + BA capsule compared to the placebo group (median 7.0; IQR 6.0-8.0 days vs. median 12.5; IQR 12-20 days). Clinical status on the ordinal score scale as a secondary outcome showed a significant difference between the GR + BA group (median (IQR) score, 2 [2-3]) and placebo groups (mean (IQR) score, 3 [3-5.5]). There was a significant decrease in CRB (p = 0.000041) in GR + BA compared with the placebo group. In conclusion, this safe, inexpensive, antiviral, immunomodulating and anti-inflammatory combination may be considered for use in mild to moderate infections of SARS-CoV-2 or COVID-19 variants. The study is limited by the small sample size; therefore, larger randomized trials are required.
最近的证据表明，甘草酸（GR）和乳香酸（BA）在治疗 COVID-19 方面可能具有潜在的治疗作用，但缺乏确凿的证据。我们的目的是研究 GR+BA 与安慰剂在治疗住院的中度 SARS-CoV-2 或 COVID-19 变体感染患者中的疗效。本研究为一项随机、双盲、安慰剂对照、单中心试验。通过 PCR 检测诊断为 SARS-CoV-2 或 COVID-19 变体且至少 18 岁且有中度症状的住院患者符合条件。患者被随机分配接受口服 GR 胶囊（60mg）和 BA（200mg），每日两次，共 14 天，或接受匹配的安慰剂。所有患者还接受了医院 COVID-19 治疗方案的治疗。主要结局是死亡率和恢复时间。次要结局是接受研究药物治疗后 14 天的临床状态评分。研究药物使用的不良事件已评估了 14 天。该试验在 ClinicalTrials.gov（标识符 NCT04487964）上注册。在 6 个月的入组期间（2021 年 6 月至 11 月），只有 50 名患者（54%为女性；中位年龄 60 岁，IQR 54-65）符合入选标准并被随机分配。在第 14 天评估主要结局时，安慰剂组有 5 例死亡，GR+BA 组无死亡。至于恢复时间，GR+BA 胶囊组明显短于安慰剂组（p=0.0001）（中位数 7.0；IQR 6.0-8.0 天 vs. 中位数 12.5；IQR 12-20 天）。次要结局为序贯评分量表上的临床状态显示 GR+BA 组（中位数（IQR）评分 2 [2-3]）与安慰剂组（平均（IQR）评分 3 [3-5.5]）之间存在显著差异。与安慰剂组相比，GR+BA 组的 CRB 显著下降（p=0.000041）。总之，这种安全、廉价、抗病毒、免疫调节和抗炎的联合用药可能可考虑用于轻度至中度 SARS-CoV-2 或 COVID-19 变体感染。该研究受到样本量小的限制，因此需要更大规模的随机试验。
