Current best evidence for clinical care (more info)
BACKGROUND: Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza.
PURPOSE: To determine the safety and efficacy of LH capsule in patients with Covid-19.
METHODS: We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery.
RESULTS: We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, p = 0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, p < 0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all p < 0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, p < 0.001) and clinical cure (78.9% vs. 66.2%, p = 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both p > 0.05). No serious adverse events were reported.
CONCLUSION: In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.
|Discipline / Specialty Area||Score|
|General Internal Medicine-Primary Care(US)||
|Family Medicine (FM)/General Practice (GP)||
This is a randomized controlled trial of Lianhuaqingwen (LH), a Chinese herbal medication for treating COCID-19 patients. LH benefited the patients in rate of symptom recovery at day 14 (number needed to treat [NNT] = 11), rate of clinical cure (NNT = 8) but there was no difference in the rate of conversion to severe cases. LH shortened the median time to symptom recovery by about 3 days. However, the trial excluded patients with severe pneumonia needing mechanical ventilation. No mortality results were reported. Bias could have been introduced because the study was not blinded. LH may be useful for treating COVID-19 patients, but it is disappointing that long term benefit (particularly mortality in the sicker patients) was not studied.
This interesting study has one main limitation: it is not double-blinded. Also, the demographics in the control and treatment group display some important differences that can bias the findings –mainly the proportion of subjects 45 years old or older. Nevertheless, it is a study with interesting results in favour of a LH capsule that can help in the recovery time of patients with Covid-19 and is, at least according to the results of the paper, harmless.
Clearly, new information so I doubt anyone in the West has heard of this. The study had small numbers, lots of exclusions, and did not appear to affect sever disease nor progression to severe disease. It is unclear how this works, if it does. Since no one has a reliable therapy for Covid-19, it may be worth looking at this in a well controlled blinded study in the West in a large cohort. obviously, not for current clinical use, but anything is interesting in the current climate.
We find some difficulties since this is an open label study. This results from the clinicians giving the treatment at discretion, an action that modifies the end result. The exploratory data analysis, with the box-plot, doesn’t show much variation between the variables. However, the statistic proofs do show a statistic significance in the recovery rate that was higher in the treatment group as compared with the control group. The median time to recovery of fever (2 vs. 3 days). Fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was shorter in the treatment group. The improvement in chest computed tomographic was higher in the treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings. In light of the apparent efficacy, safety profiles and no serious adverse events reported, the LH capsules could be considered for further studies in the symptomatic treatment of Covid-19 in a much larger scale.
Like most Western physicians, I have no experience with this treatment. It may be effective but the biologic basis is unclear and the differences, although statistically significant, may be more of a symptom abbreviation. It would be extremely useful to see corroboration in another setting.
The study demonstrates that lianhuaqingwen provides symptomatic therapy for less severe COVID-19 cases. This is expected given similar effect in patients with influenza. There is, however, no effect on prevention of disease progression. This argues against the pharmacologic properties of lianhuaqingwen.
This open-label trial with subjective endpoints is of limited value regarding the potential efficacy of the studied compound.
This article needs more summarising and discussion.
I am bothered by the lack of blinding of subjects and persons assessing results (except the radiologist) and believe the rationale for not blinding was not adequate.
There are some problems with the open label design of the study, as there was no systematic method to collect symptoms or to conceal treatment to the observers, except for TC. Some of the outcomes, however, seem robust and suggest a mild anti-inflammatory effect.
I cast serious doubt on the results of this article. No one knows what kind of “medicine” it is.