Journal
FRONTIERS OF MEDICINE
Volume 15, Issue 5, Pages 704-717Publisher
SPRINGER
DOI: 10.1007/s11684-021-0853-6
Keywords
COVID-19; SARS-CoV-2; Shuanghuanglian oral liquid; clinical trial
Categories
Funding
- National Key R&D Program of China [2020YFC0841400]
- Tongji Hospital Clinical Research Project [XXGZBDYJ009, 2019YBKY019]
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The study showed that the combination of Shuanghuanglian (SHL) and standard care was safe and partially effective for treating COVID-19, with higher negative conversion rates of SARS-CoV-2 and promoted absorption of pneumonia inflammatory focus. No serious adverse events were reported in the SHL groups.
We conducted a randomized, open-label, parallel-controlled, multicenter trial on the use of Shuanghuanglian (SHL), a traditional Chinese patent medicine, in treating cases of COVID-19. A total of 176 patients received SHL by three doses (56 in low dose, 61 in middle dose, and 59 in high dose) in addition to standard care. The control group was composed of 59 patients who received standard therapy alone. Treatment with SHL was not associated with a difference from standard care in the time to disease recovery. Patients with 14-day SHL treatment had significantly higher rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests than the patients from the control group (93.4% vs. 73.9%, P = 0.006). Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), -46.39 (-86.83 to -5.94) HU; P = 0.025) and day 14 (mean difference (95% CI), -74.21 (-133.35 to -15.08) HU; P = 0.014). No serious adverse events occurred in the SHL groups. This study illustrated that SHL in combination with standard care was safe and partially effective for the treatment of COVID-19.
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