The diagnostic criteria used in this study were based on the diagnosis and treatment protocol for COVID-19 (Trial version 7) that was issued by the National Health Commission and the State Administration of Traditional Chinese Medicine . Adult patients were classified as having a ‘severe’ infection if they experienced any of the following criteria: (1) onset of shortness of breath, respiratory rates (RR) ≥ 30 times/min; (2) an oxygen saturation ≤ 93% at rest; (3) a partial pressure of blood oxygen (PaO2)/oxygen absorption concentration (FiO2) ≤ 300 mmHg; or (4) pulmonary imaging showing significant progression of lesions within 24 to 48 hours. In total, 50% of the patients recruited into this study were treated as severe. Adult patients were classified as having a ‘critical’ infection if they experienced any of the following criteria: (1) respiratory failure and the need for mechanical ventilation; (2) shock; or (3) the patient experienced other organ failure and needed to be monitored in the intensive care unit (ICU).
In order to be included in this study, patients needed to (1) meet all of the COVID-19 diagnostic criteria; (2) be clinically classified as severe or critical, based on clinical symptoms and laboratory test indicators; (3) show improvement following treatment involving a combination of TCM and western medicine treatment, and who had attained the indications for discharge indications; and (4) provide their signatures on informed consent forms and were able to cooperate with rehabilitation treatment in an active and diligent manner.
Patients were excluded from the present study for the following reasons: (1) severe liver and kidney function impairment (serum alanine aminotransferase was 3-fold higher than the normal upper limit and/or a serum creatinine level ≥ 265 µmol/L); (2) severe cerebrovascular diseases, disorders of the blood system, nervous system diseases, and malignant tumors; (3) combined acute myocardial infarction and cardiogenic shock; (4) pregnant or lactating women; (5) mental disorders or unwillingness to cooperate; and (6) patients involved in other research studies.
Patients were recruited after discharge from the hospital. All 72 patients (41 males and 31 females) who suffered from severe or critical COVID-19 during the experimental period were treated in four centralized centers in Chongqing, China, including 28 patients from the municipal public health center, 10 patients from the Yongchuan district treatment center, 32 patients from the Wanzhou District treatment center, and 2 patients from the Qianjiang District treatment center. Patient age ranged from 25 to 89 years, with a mean of 56 years, and a median age of 69 (56–79).
All of the patients included in this study were given comprehensive rehabilitation treatment based on TCM for four weeks after discharge from hospital care. TCM was taken orally once in the morning and evening and Baduanjin(a type exercise of traditional Chinese medicine) was applied once a day for 15 minutes each time. The points of application included the bilateral Dingchuan, bilateral Shenshu, Shenque, and Danzhong; these were treated once a week for four to six hours. Moxibustion was selected for Qi Hai, Guan Yuan, bilateral Zusanli, and bilateral yuji, each for 10-15 minutes once every week. A Chinese herbal medicine foot bath was used once a day for approximately 20-30 minutes but not less than 5 times a week. We considered the clinical manifestations of patients with severe and critical COVID-19 following discharge into Yin and Yang syndrome types (Qi and Yin deficiency: phlegm and blood stasis syndrome; Yang Qi deficiency: phlegm and blood stasis syndrome). Patients experiencing the Yin syndrome type were administered with the following decoction: Radix Astragali 15g, Codonopsis pilosula 15 g , Lily 15 g, Ophiopogon japonicas 15 g, Pinellia ternata 10 g, thunberg fritillary bulb 10 g, Angelica 10 g, red peony root 10 g, Ligusticum wallichii 10 g, Alisma 10 g, Zedoary turmeric 6 g, and licorice root 6 g. Patients experiencing the Yang syndrome were administered with the following decoction: Codonopsis pilosula 15 g, Epimedium 15 g, Fructus psoraleae 15 g, cuscuta 15 g, cinnamon 10 g, baked ginger 10 g, Pinellia ternata 10 g, Thunberg fritillary bulb 10 g, Angelica 10 g, red peony root 10 g, Zedoary turmeric 6 g, and licorice root 6 g.
Patients needed to be differentiated into one of the two syndromes before they were discharged from their hospital. This differentiation was carried out by two attending doctors. The patients were then given the decoction that corresponded to their respective syndrome type.
We acquired instructional videos relating to Baduanjin, Acupoint sticking therapy, Moxibustion therapy, and application of the Chinese herbal medicine foot bath. At the time of their discharge, our researchers gave each patient a "rehabilitation bag" that included including the relevant TCM decoction and videos on a USB flash drive.
Since COVID-19 is a highly infectious disease, the researchers conducted rehabilitation guidance with social distancing and via remote digital methods. We recorded the WeChat numbers and telephone numbers of all convalescent patients were prior to their discharge from hospital. The researchers conducted regular follow- ups regularly (once a week) using WeChat or mobile phones and provided instruction with regards to rehabilitation exercise.
Efficacy and safety evaluation
Efficacy was evaluated by administering a range of questionnaires. Patients were asked to complete the Traditional Chinese Medicine Syndrome curative effect score scale, the mMRC dyspnea scale, the St. George's respiratory questionnaire, the SF - 36 quality of life scale, and the 6-minute walking test a specific website (https://www.wjx.cn/jq/62881624.aspx.) We also carried out a chest CT scan, and laboratory tests for routine blood routine parameters, C-reactive protein, and erythrocyte sedimentation rate. These tests and the questionnaires were carried out two months after discharge.
With regards to patient safety, we acquired the following information: general condition, liver function, renal function, adverse reactions, and adverse events (two months after discharge).
Data were analyzed by IBM SPSS Statistical Software version 22.0 was used in this research. If measurement data were normally distributed with the K-S test, we carried out statistical comparisons using the student’s t-test and analysis of variance (ANOVA). However, if data was not normally distributed, we used non-parametric analyses (the rank sum test) for comparisons. The Chi-squared test was used to compare counting data while logistic regression analysis was conducted to compare indicators, mean scale values, and the chest CT-scans.