Across the world, researchers are frantically trying to find a treatment for COVID-19. Thus many trials have been initiated – and some are better than others.
The aim of this study was to develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.
A putative ARDS-suppressing drug Keguan-1 was evaluated in a randomized, controlled two-arm trial. The two groups were:
- A control therapy receiving alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively.
- The experimental group receiving the control therapy plus Keguan-1 19.4 g twice daily. The new formula was derived from 3 different formulae, Yinqiao Powder (银翘散), Sangju Drink (桑菊饮), and Sanren Decoction (三仁汤), named “Keguan-1” (meaning anti-coronavirus 1 in Chinese) with 7 components: Lonicera japonica Thunb. (Jinyinhua, lot. 19040301) 30 g, Forsythia suspensa (Thunb.) Vahl, (Lianqiao, lot. 19040221) 30 g, Morus alba L. (Sangye, lot. 19045321) 15 g, Chrysanthemum morifolium Ramat. (Juhua, lot. 19040811) 10 g,
Coix lacryma-jobi L. var. mayuen (Roman.) Stapf, Yiyiren, lot. 19025161) 30 g, Fritillaria thunbergii Miq. (Zhebeimu, lot. 19041161) 15 g, and Prunus armeniaca L. var. ansu Maxim. (Kuxingren, lot. 19045591) 9 g. The powder versions of the drugs for the 7 components of Keguan-1 were obtained from Beijing Tcmages Pharmaceutical Co. Ltd. (Beijing, China) and mixed in the defined ratio.
After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.
An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm).
The results show that, compared with the control arm, the experimental group exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
The authors (who almost out-number the patients in the study) concluded that Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients.
The mixture used in this trial is adventurous, to put it mildly (although the authors state that they report the development of a TCM-medicine “We have reported here the development of Keguan-1, a new CM drug that was specifically designed for suppressing ARDS development in patients of COVID-19 and/or of other RDI” they actually do nothing of the sort). The trial design is flimsy, to put it politely. And the conclusion is unjustified, to put it scientifically.
One might even say that – pandemic or not – it is irresponsible to conclude from a sample size of 2 x 24 on the safety and efficacy of any therapy – TCM or not.