Search

Objectives: To evaluate the advantages of adding acupuncture to standard postoperative pain management for open radical prostatectomy (RP). Materials and methods: A randomized controlled trial (1:1:1) comparing routine postoperative analgesic care (control [CON]) vs the addition of press tack needle acupuncture (ACU) or press tack placebo acupressure (SHAM) for pain management after open RP was performed. A total of 126 patients were enrolled between February 2020 and April 2021. After open RP, the CON group received standard postoperative analgesia, the ACU group received long‐term acupuncture with press tacks at specific points (P‐6, Shenmen and SP‐6) along with standard analgesia, and the SHAM group received placebo press tacks at the same acupuncture points alongside standard analgesia. The primary endpoint was postoperative pain measured on a numeric rating scale, the NRS‐11, calculated as the area under the curve. The cumulative use of routine postoperative analgesics, time to first defaecation, and quality of life were analysed using the Kruskal–Wallis rank sum test, Fisher's exact test, and Pearson's chi‐squared test. Results: The ACU group reported significantly less postoperative pain compared to the SHAM (P = 0.007) and CON groups (P = 0.02). There were no significant difference in median (interquartile range) cumulative pain medication usage, time to first defaecation (CON: 37 [33, 44] h; SHAM: 37 [33, 42] h; ACU: 37 [33, 41] h; P > 0.9), or health status at discharge (EuroQol five‐dimension, five‐level general health assessment questionnaire: CON: 70 [65–83]; SHAM: 70 [60–80]; ACU: 70 [50–80]). Conclusion: Incorporating acupuncture into postoperative pain management can improve patient postoperative outcomes. [ABSTRACT FROM AUTHOR]

Background: Amyotrophic lateral sclerosis (ALS) is a chronic neurodegenerative disease characterized by gradually increasing damage to the upper and lower motor neurons. However, definitive and efficacious treatment for ALS is not available, and oral intake in ALS patients with bulbar involvement is complicated due to swallowing difficulties. Hypothesis/purpose: This study investigated whether the external plaster application of the herbal composition Ji-Wu-Li efficiently slows ALS progression because prior studies obtained promising evidence with oral herbal applications. Study design: The randomized, triple-blinded study compared the efficacy, safety, and tolerability of the application of Ji-Wu-Li plaster (JWLP) with placebo plaster (PLAP). Methods: In total, 120 patients with definite ALS, clinically probable ALS, or clinically probable laboratory-supported ALS were randomized in a 1:1 ratio to receive JWLP or PLAP. Patients were treated and observed for 20 weeks. The primary outcome was the ALSFRS-R score, while the secondary outcomes were the ALS-SSIT score and weight loss. Results: The mean±SD decrease in the ALSFRS-R over 20 weeks differed by 0.84 points in a group comparison (JWLP, -4.44 ± 1.15; PLAP, -5.28 ± 1.98; p = 0.005). The mean increase in the ALS-SSIT over 20 weeks differed by 2.7 points in a group comparison (JWLP, 5.361.15; PLAP, 8.06 ± 1.72; p < 0.001). Themean weight loss over 20 weeks differed by 1.65 kg in a group comparison (JWLP, -3.98 ± 2.61; PLAP, -5.63 ± 3.17; p = 0.002). Local allergic dermatitis suspected as causal to the intervention occurred in 10 of 60 participants in the JWLP group and 9 of 60 participants in the PLAP group. Systemic adverse events were mild, temporary, and considered unrelated to the intervention. Conclusion: The JWLP showed clinical efficacy in the progression of ALS, as measured by the ALSFRS-R, ALS-SSIT, and weight loss in a randomized, placebo-controlled trial. Because skin reactions occurred in both groups, the covering material needs improvement. All of the Ji Wu Li herbal ingredients regulatemultiplemechanisms of neurodegeneration in ALS. Hence, JWLPmay offer a promising and safe add-on therapy for ALS, particularly in patients with bulbar involvement, but a confirmative long-termmulticentre study is required. [ABSTRACT FROM AUTHOR]

A sample of 75 area vocational-technical (AVT) students and 90 inmates in Oklahoma vo-tech skills centers completed tests in 3 occupational areas. AVT students had higher scores in word processing; inmates had significantly higher scores on the horticulture greenhouse worker test. No significant differences resulted for the automobile cluster. (SK)

Oral mucositis is a common adverse reaction of radiotherapy used for head and neck cancers. Our research investigates the therapeutic effect and potential mechanisms of ecdysterone, a compound which was used as a functional food additive, isolated from the root of medicine-food herbs Achyranthes bidentata (Blume), on radiation-induced oral mucositis in rats during the early development stages of mucositis. In this study, male Sprague-Dawley rats received a single 20 Gy X-ray dose to the head and neck after placement of each animal in a specially-constructed 5-mm lead jig. At 24 h postirradiation, ecdysterone was administrated orally. Therapeutic effects of ecdysterone were investigated by observing weight changes and development of mucositis on days 5 and 10 after treatment. Determination of superoxide dismutase and malondialdehyde concentration was performed 5 days after treatment. H&E and leukocyte common antigen staining and TUNEL assays were performed 10 days after treatment. After 10 days of treatment, total protein from the tongue samples was extracted and Western blot analysis was performed to evaluate changes in protein expression. The results of this study showed that ecdysterone prevented the development of radiation-induced oral mucositis in rats during the early stages. Ecdysterone significantly attenuated radiation-induced decrease in cellular superoxide dismutase concentration and increase in malondialdehyde concentration. Ecdysterone was also linked to up-regulation of anti-apoptotic protein Bcl-2 and down-regulation of pro-apoptotic proteins Bax and cleaved caspase-3. In conclusion, these findings suggest that orally administrated ecdysterone alleviates the development of radiation-induced oral mucositis in rats with remarkable anti-oxidant and anti-apoptotic activities at early stages after irradiation. [ABSTRACT FROM AUTHOR]

Background: Acupuncture is commonly used in Traditional Chinese Medicine for treatment of diabetic peripheral neuropathy (DPN), but data from randomized controlled trials are rare. Methods: This randomized, placebo‐controlled, partially double‐blinded clinical trial randomly assigned adults with confirmed type 2 diabetes‐induced DPN to receive 10 sessions of needle acupuncture, laser acupuncture, or placebo laser acupuncture for 10 consecutive weeks. Treatment was provided at bilateral acupoints Ex‐LE‐10 (Bafeng), Ex‐LE‐12 (Qiduan), and ST‐34 (Lianqiu). Neurological assessments, including nerve conduction studies (NCS) of sural and tibial nerves, were performed at baseline and weeks 6 and 15. Primary outcome was delta of sural sensory nerve action potential (SNAP). Secondary outcomes included further NCS values, clinical scores, and patient‐reported outcome measures (PROMs). Results: Of 180 participants, 172 completed the study. Sural SNAP and sural and tibial nerve conduction velocities improved significantly after 10 treatments when comparing needle acupuncture to placebo. Needle acupuncture showed earlier onset of action than laser acupuncture. PROMs showed larger improvements following needle and laser acupuncture than placebo, reaching significant differences for hyperesthesia and cramps following needle acupuncture and for heat sensation following laser acupuncture. Conclusions: Classical needle acupuncture had significant effects on DPN. Improvement in NCS values presumably indicates structural neuroregeneration following acupuncture. [ABSTRACT FROM AUTHOR]

Background The course of disease in mild and moderate COVID-19 has many implications for mobile patients, such as the risk of spread of the infection, precautions taken, and investigations targeted at preventing transmission. Methods Three hundred thirty-one adults were hospitalized from January 21 to February 22, 2020, and classified as severe (10%) or critical (4.8%) cases; 1.5% died. Two hundred eighty-two (85.2%) mild or moderate cases were admitted to regular wards. Epidemiological, demographic, clinical, chest computed tomography (CT) scan, laboratory, treatment, and outcome data from patient records were analyzed retrospectively. Results Patients were symptomatic for 9.82±5.75 (1–37) days. Pulmonary involvement was demonstrated on a chest CT scan in 97.9% of cases. It took 16.81±8.54 (3–49) days from the appearance of the first symptom until 274 patients tested virus-negative in naso- and oropharyngeal (NP) swabs, blood, urine, and stool, and 234 (83%) patients were asymptomatic for 9.09±7.82 (1–44) days. Subsequently, 131 patients were discharged. One hundred sixty-nine remained in the hospital; these patients tested virus-free and were clinically asymptomatic because of widespread persisting or increasing pulmonary infiltrates. Hospitalization took 16.24±7.57 (2–47) days; the time interval from the first symptom to discharge was 21.37±7.85 (3–52) days. Conclusions With an asymptomatic phase, disease courses are unexpectedly long until the stage of virus negativity. NP swabs are not reliable in the later stages of COVID-19. Pneumonia outlasts virus-positive tests if sputum is not acquired. Imminent pulmonary fibrosis in high-risk groups demands follow-up examinations. Investigation of promising antiviral agents should heed the specific needs of mild and moderate COVID-19 patients. [ABSTRACT FROM AUTHOR]

• Robust methodology design was applied in Chinese herbal patent medicine for COVID-19. • Efficacy of Shufeng Jiedu capsules will be verified by randomized controlled trial. • Decentralized methods will be applied to collect patients reported outcomes in this trial. Most current Coronavirus disease (COVID-19) infected cases are now diagnosed as mild to moderate. Symptoms such as sore throat, headache, nasal congestion, cough, etc. lack effective treatment for their relief. The registered Chinese herbal medicine Shufeng Jiedu Capsule (SFJD) has been used to treat different epidemics like influenza A virus subtype H1N, and has been shown to improve symptoms such as fever, sore throat, headache, nasal congestion and cough. It has also been widely used to treat COVID-19 in China. This study aims to verify the efficacy and safety of SFJD in patients with mild and moderate COVID-19 infection. This study is designed as a randomized, blind, placebo control trial. A total of 220 patients in each group will receive either SFJD or placebo three times a day for five days, in addition to standard medical care. Participants will be assessed at baseline, during the treatment period, during the period of isolation in hospital and after hospital discharge on day 7 and 14. The primary outcome is time to alleviation of all COVID-19 related symptoms, including cough, stuffy nose, sore throat, fever or chills, muscle/joint pain, headache, fatigue, etc. Secondary outcomes are time to alleviation of individual COVID-19 related symptoms, time to SARS-CoV-2 virus reverse transcription polymerase chain reaction (RT-PCR) turning to negativity, changes in inflammatory parameters (leukocyte, lymphocyte, C-reactive protein (CRP), serum procalcitonin (PCT), inflammatory factor (Interleukin-6), CD4/CD8 cells), the amount of lung inflammation as ascertained by chest CT and adverse events. The study is expected to provide evidence to explore indications and usage of SFJD for COVID-19. The design and methodology could be relevant to research on Chinese herbal medicine for other infectious diseases. Additionally, the results from the follow-up period will provide information on potential longer term symptom alleviation (14 days post COVID-19). ISRCTN14236594, Registered on 3 May 2022. [ABSTRACT FROM AUTHOR]

Traditional medicines have developed independently in every region and are currently used under the regulation of each country based on the historical and cultural background. At present, various channels for the international standardization of traditional Chinese medicine have been opened, creating conditions for accelerating the globalization of traditional Chinese medicine and providing new opportunities. The following presentations show how the globalization of traditional medicines is considered in Europe, China, Japan, and Korea. [Extracted from the article]

Background: Shufeng Jiedu capsule (SFJDC) has been widely used as a conventional Chinese pharmaceutical agent for various upper respiratory infections, including acute lung injury, acute respiratory distress syndrome and allergic rhinitis (AR). However, its mechanism in AR remains unclear.Purpose: The present study aimed to decipher the antiallergic inflammatory effect of SFJDC in an AR model with olfactory dysfunction. Specifically, we wanted to explore whether SFJDC can improve the olfactory abnormality in AR mice and reduce the levels of inflammatory factors in the olfactory epithelium (OE) and olfactory bulb (OB).Methods: To address the above issues, we constructed an AR model using C57BL/6 mice, which were sensitised and challenged with ovalbumin (OVA) by intraperitoneal injection. SFJDC (0.045 or 0.18 g/kg) was delivered by gavage administration 1 h prior to the intraperitoneal injection of OVA. The control mice received saline alone. Then, the animals were assessed according to the presence of nasal symptoms and nasal inflammation, and a buried food test was used to evaluate olfactory function. The levels of proteins involved in the AMPK/mTOR autophagy pathway in the OE and OB were investigated by western blotting and fluorescence staining.Results: After OVA induction of AR and drug administration, we found that SFJDC significantly ameliorated the nasal symptoms and allergic inflammatory reaction of the nasal mucosa superior to cetirizine. A behavioural test indicated that the mice with AR had olfactory dysfunction, and SFJDC can ameliorate this behavior deficiency. Meanwhile, SFJDC clearly reduced the neuroinflammation level in OE tissue. In addition, SFJDC increased p-mTOR and decreased p-AMPK, beclin1, LC3 and cleaved caspase-3 levels in the OE.Conclusions: In addition to antibacterial and antiviral activities, SFJDC has marked anti-inflammatory effects in AR mice. Its mechanism of action in the nasal cavity involves inhibition of upregulated anti-inflammatory cytokines, modulation of autophagy and apoptosis levels and regulation of autophagy through the AMPK/mTOR pathway in the OE tissue of AR mice. Hence, SFJDC is a promising drug for AR, and clinical trials should further validate the therapeutic impact of SFJDC on AR with olfactory dysfunction. [ABSTRACT FROM AUTHOR]

The rhizome of Coptis chinensis is commonly used in traditional Chinese medicine alone or in combination with other herbs to treat diseases characterized by causing oxidative stress including inflammatory diseases, diabetes mellitus and neurodegenerative diseases. In particular, there is emerging evidence that Coptis chinensis is effective in the treatment of neurodegenerative diseases associated with oxidative stress. Hence, the aim of this study was to investigate the neuroprotective effect of Coptis chinensis in vitro and in vivo using MPP and MPTP models of Parkinson's disease. MPP treated human SH-SY5Y neuroblastoma cells were used as a cell model of Parkinson's disease. A 24h pre-treatment of the cells with the watery extract of Coptis chinensis significantly increased cell viability, as well as the intracellular ATP concentration and attenuated apoptosis compared to the MPP control. Further experiments with the main alkaloids of Coptidis chinensis, berberine, coptisine, jaterorrhizine and palmatine revealed that berberine and coptisine were the main active compounds responsible for the observed neuroprotective effect. However, the full extract of Coptis chinensis was more effective than the tested single alkaloids. In the MPTP-induced animal model of Parkinson's disease, Coptis chinensis dose-dependently improved motor functions and increased tyrosine hydroxylase-positive neurons in the substantia nigra compared to the MPTP control. Based on the results of this work, Coptis chinensis and its main alkaloids could be considered potential candidates for the development of new treatment options for Parkinson's disease. [ABSTRACT FROM AUTHOR]

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is recognized as the second commonest side effect after chemotherapy. Besides neurological deficits and pain, it is a potential reason for terminating chemotherapy. Effective curative treatments of neurodegeneration are lacking. Hitherto, no randomized controlled study used nerve conduction studies (NCS), the gold standard diagnostic tool for peripheral neuropathy, as the primary outcome parameter for evaluating acupuncture for CIPN, which can also measure structural changes.Methods: The study was carried out at the HanseMerkur Center for TCM at the University Medical Center, Hamburg-Eppendorf. Sixty patients with CIPN were included in the study after physical examination, subjective evaluation and quantitative evaluation by NCS. Subsequently, the patients were randomly assigned to Group 1 (30 patients), which received, in the first period, needle acupuncture and to Group 2 (30 patients), which was assigned to the waiting list in the first period. Group 1 received a standard 10-week bilateral treatment of ST34 (Liangqiu), EX-LE12 (Qiduan) and EX-LE8 (Bafeng). After 14 weeks, both groups were re-evaluated. Using a cross-over design, the patients of Group 2 received the same treatment procedure as Group 1 in the first period. Patients of Group 1 were assigned to the waiting list for the second period. After 28 weeks both groups were re-evaluated. Wilcoxon test was used as a pre-test to rule out carryover effects and to test for differences between acupuncture and the waiting list. Group assignment was not exposed to the statistician and the neurologist.Results: Sural sensory nerve amplitude, and sural nerve conduction velocity, were significantly improved (p < 0.01, effect size (f) 0.55 and 0.49) compared to measurements in the waiting period. Change of NCS of the tibial nerve did not significantly differ in group comparison. Patients reported subjective improvement during acupuncture treatment superior to the waiting period for burning pain, cramps, numbness, frequency of symptoms (all p < 0.01) and unsteadiness of gait (p < 0.05). On physical examination, blind walking, heel-to-toe walking, distal pallhypesthesia (both p < 0.01), and the neuropathy deficit score (p < 0.05) were significantly improved during acupuncture treatment compared to the waiting period.Conclusion: Acupuncture can enhance structural regeneration in CIPN as measured by NCS, which is manifested in subjective improvement and neurological findings. [ABSTRACT FROM AUTHOR]

Coptis chinensis rhizomes (CR) are one important ingredient of traditional Chinese herbal formulas such as San-Huang-Xie-Xin-Tang which is used for treatment of cardiovascular and neurodegenerative diseases. Recent studies suggest that the extract of CR might be a potential therapeutic agent for amelioration of neurological disorders associated with oxidative stress. In the present study we aimed at revealing the main active compound(s) of the CR extract and at investigating the mechanism of action. Four main alkaloids of the CR extract (berberine, coptisine, jatrorrhizine, and palmatine) were selected for this study. Results showed that out of those alkaloids only pretreatment with coptisine significantly attenuated tert-butylhydroperoxide induced reduction of cell viability, increased rate of apoptosis, and declined mitochondrial membrane potential. Elisa assay and quantitative real-time PCR analyses revealed that thioredoxin-interacting protein (TXNIP) gene expression was downregulated by coptisine, which could explain the neuroprotective effect, hypothetically, by strengthening the thioredoxin defense system against oxidative stress and attenuation of apoptosis signal-regulating kinase (Ask1) mediated apoptotic signaling. A comparison between coptisine and CR extract identified coptisine as the main single component responsible for the neuroprotective effect. Based on the results the CR extract and coptisine are promising candidate agents for prevention or improvement of diabetic neuropathy and neurodegenerative disorders. [ABSTRACT FROM AUTHOR]

This document is a reply to a comment on a study titled "A randomized controlled study on acupuncture for peri-operative pain after open radical prostatectomy." The authors address the comment by discussing the complexity of pain experiences, the generalizability of their results, the choice of acupuncture points, and the impact of acupuncture on recovery parameters. They agree that their study opens up possibilities for non-pharmacological pain management in urology and encourage future research to expand patient diversity, include qualitative results, and deepen the understanding of the neurophysiological basis of acupuncture. The authors also emphasize the importance of considering safety, patient preference, and cost-effectiveness in implementing acupuncture in routine care. [Extracted from the article]

Ethnopharmacological relevance The dried rhizome of Coptis chinensis Franch. (family Ranunculaceae) is traditionally used in Chinese medicine for the treatment of inflammatory diseases and diabetes. Recent studies showed a variety of activities of Coptis chinensis Franch. alkaloids, including neuroprotective, neuroregenerative, anti-diabetic, anti-oxidative and anti-inflammatory effects. However, there is no report on the neuroprotective effect of Coptis chinensis Franch. watery extract against tert-butylhydroperoxide (t-BOOH) induced oxidative damage. The aim of the study is to investigate neuroprotective properties of Coptis chinensis Franch. rhizome watery extract (CRE) and to evaluate its potential mechanism of action. Materials and methods Neuroprotective properties on t-BOOH induced oxidative stress were investigated in SH-SY5Y human neuroblastoma cells. Cells were pretreated with CRE for 2 h or 24 h followed by 2 h of treatment with t-BOOH. To evaluate the neuroprotective effect of CRE, cell viability, cellular reactive oxygen species (ROS), mitochondrial membrane potential (MMP) and the apoptotic rate were determined and microarray analyses, as well as qRT-PCR analyses were conducted. Results Two hours of exposure to 100 µM t-BOOH resulted in a significant reduction of cell viability, increased apoptotic rate, declined mitochondrial membrane potential (MMP) and increased ROS production. Reduction of cell viability, increased apoptotic rate and declined mitochondrial membrane potential (MMP) could be significantly reduced in cells pretreated with CRE (100 µg/ml) for 2 h or 24 h ahead of t-BOOH exposure with the greatest effect after 24 h of pretreatment; however ROS production was not changed significantly. Furthermore, microarray analyses revealed that the expressions of 2 genes; thioredoxin-interacting protein (TXNIP) and mitochondrially encoded NADH dehydrogenase 1, were significantly regulated. Down regulation of TXNIP was confirmed by qRT-PCR. Conclusion Due to its neuroprotective properties CRE might be a potential therapeutic agent for the prevention or amelioration of diseases like diabetic neuropathy and neurodegenerative disorders like Alzheimer and Parkinsons disease. [ABSTRACT FROM AUTHOR]

While balancing yin and yang is one basic principle of Chinese medicine, balancing methods for combination of meridians and acupoints had been described throughout the history of Chinese medicine. We have identified six historical systems for combinations of acupuncture points in historical writings. All of them represent symmetrical combinations which are defined by the steps in the Chinese Clock. Taking the historical systems as a basis, we calculated the possible combinations that fit into these systems they revealed, leading to a total of 19 systems offering new balancing combinations. Merging the data of these 19 systems, there are 7 combinatorial options for every meridian. On the basis of this data, we calculated 4-meridian combinations with an ideal balance pattern, which is given when all meridians balance each other. We identified 5 of these patterns for every meridian, so we end up with 60 patterns for all the 12 meridians but we find multiple overlapping. Finally, 15 distinct patterns remain. By combining this theoretical concept with the Image and Mirror Concept, we developed an acupuncture research protocol. This protocol potentially solves some problems of acupuncture trials because it represents a rational reproducible procedure independent of examiner experience, but the resulting treatment is individualized. [ABSTRACT FROM AUTHOR]

Chemotherapy-induced neuropathy (CIPN) has a relevant impact on the quality of life of cancer patients. There are no curative conventional treatments, so further options have to be investigated. We conducted a systematic review in English and Chinese language databases to illuminate the role of medical herbs. 26 relevant studies on 5 single herbs, one extract, one receptor-agonist, and 8 combinations of herbs were identified focusing on the single herbs Acorus calamus rhizoma, Cannabis sativa fructus, Chamomilla matricaria, Ginkgo biloba, Salvia officinalis, Sweet bee venom, Fritillaria cirrhosae bulbus, and the herbal combinations Bu Yang Huan Wu, modified Bu Yang Huan Wu plus Liuwei Di Huang, modified Chai Hu Long Gu Mu Li Wan, Geranii herba plus Aconiti lateralispraeparata radix, Niu Che Sen QiWan (Goshajinkigan), GuiZhi Jia Shu Fu Tang (Keishikajutsubuto), Huang QiWu Wu Tang (Ogikeishigomotsuto), and Shao Yao Gan Cao Tang (Shakuyakukanzoto). The knowledge of mechanism of action is still limited, the quality of clinical trials needs further improvement, and studies have not yielded enough evidence to establish a standard practice, but a lot of promising substances have been identified. While CIPN has multiple mechanisms of neuronal degeneration, a combination of herbs or substances might deal with multiple targets for the aim of neuroprotection or neuroregeneration in CIPN. [ABSTRACT FROM AUTHOR]

The meridian system is a systematic order of empirical knowledge functioning as a rational ground for a balanced treatment by combining meridians. In TC M theory, a continuous circulation of Qi through 12 meridians is postulated, described as the Chinese clock (CC). On this basis, combinations of meridians and acupoints had been described in historical writings. The most common is the interior/exterior system beside the neighbouring system, the opposite clock system, and three systems, developed out of the theory of the six stages. All of these represent symmetrical combinations, which were defined by the steps in the CC.We calculated the possible combinations that fit into the systematics of the historical descriptions, leading to 19 systems. Merging the data of the 19 systems, possible steps in the CC clock for balancing a meridian are 1, 2, 3, and 6. Step 4 is not possible. Step 5 is a combinatory possibility but has no widespread tradition except for activating the yin extraordinary vessels. These possibilities can be plotted on the CC as a powerful tool for daily practice. Only two meridians might be excluded as potentially balancing meridians, so it seems almost impossible to define noneffective acupuncture points as controls in clinical trials. [ABSTRACT FROM AUTHOR]

Background: Shufeng Jiedu capsules (SFJDC), a patented herbal drug composed of eight medicinal plants, is used for the treatment of different viral respiratory tract infectious diseases. Based on its antiviral, anti-inflammatory and immunoregulatory activity in acute lung injury, SFJDC might be a promising candidate for the treatment of COVID-19.Purpose: To evaluate the antiviral and anti-inflammatory properties and to discover the mechanism of action of SFJDC as a potential drug for the treatment of COVID-19. Furthermore, the study should determine the clinical effectiveness of SFJDC for the treatment of COVID-19.Design: We analyzed the antiviral and anti-inflammatory effects of SFJDC in a HCoV-229E mouse model on lung index, virus load in the lung, the release of cytokines, and on T- and B-lymphocytes. The mechanism of action was further investigated by network analysis. Additionally, we investigated data from a clinical pragmatic real-world study for patients with confirmed COVID-19, to evaluate the clinical effect of SFJDC and to determine the best time to start the treatment.Results: SFJDC significantly reduced the virus load in the lung of HCoV-229E mice (from 1109.29 ± 696.75 to 0 ± 0 copies/ml), decreased inflammatory factors IL-6, IL-10, TNF-α, and IFN-γ in the lung, and increased the amount of CD4+ and CD8+ cells in the blood compared to the model group. Network analysis revealed that SFJDC reduces the activity of NFκB via several signaling pathways. Quercetin, wogonin, and polydatin bind directly to the main protease (Mpro) of SARS-CoV-2. Clinical data showed that SFJDC, added to standard antiviral therapy (AVD), significantly reduced the clinical recovery time of COVID-19 and fatigue (from 3.55 ± 4.09 to 1.19 ± 2.28 days) as well as cough (from 5.67 ± 5.64 to 3.47 ± 3.75) days compared to AVD alone. SFJDC therapy was significantly more effective when used within the first 8 days after the onset of symptoms.Conclusion: SFJDC might be a promising drug for the treatment of COVID-19, but large-scale randomized, double-blinded, placebo-controlled clinical trials are needed to complement the real-world evidence. It might be beneficial to start SFJDC treatment as early as possible in suspected cases of COVID-19. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has had a profound global impact, although the majority of recently infected cases have presented with mild to moderate symptoms. Previous clinical studies have demonstrated that Shufeng Jiedu (SFJD) capsule, a Chinese herbal patent medicine, effectively alleviates symptoms associated with the common cold, H1N1 influenza, and COVID-19. This study aimed to assess the efficacy and safety of SFJD capsules in managing symptoms of mild to moderate COVID-19 infection. Methods: A randomized, double-blind, placebo-controlled trial was conducted from May to December 2022 at two hospitals in China. Mild and moderate COVID-19-infected patients presenting respiratory symptoms within 3 days from onset were randomly assigned to either the SFJD or placebo groups in a 1:1 ratio. Individuals received SFJD capsules or a placebo three times daily for five consecutive days. Participants were followed up for more than 14 days after their RT-PCR nucleoid acid test for SARS-CoV-2 turned negative. The primary outcome measure was time to alleviate COVID-19 symptoms from baseline until the end of follow-up. Results: A total of 478 participants were screened; ultimately, 407 completed the trial after randomization (SFJD, n = 203; placebo, n = 204). No statistically significant difference in baseline parameters was observed between the two groups. The median time to alleviate all symptoms was 7 days in the SFJD group compared to 8 days in the placebo group ( p = 0.037). Notably, the SFJD group significantly attenuated fever/chills ( p = 0.04) and headache ( p = 0.016) compared to the placebo group. Furthermore, the median time taken to reach normal body temperature within 24 h was reduced by 7 hours in the SFJD group compared to the placebo group ( p = 0.033). No deaths or instances of serious or critical conditions occurred during this trial period; moreover, no serious adverse events were reported. Conclusion: The trial was conducted in a unique controlled hospital setting, and the 5-day treatment with SFJD capsules resulted in a 1-day reduction in overall symptoms, particularly headache and fever/chills, among COVID-19-infected participants with mild or moderate symptoms. Compared to placebo, SFJD capsules were found to be safe with fewer side effects. SFJD capsules could potentially serve as an effective treatment for alleviating mild to moderate symptoms of COVID-19. Clinical Trial Registration : https://www.isrctn.com/, identifier ISRCTN14236594., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Lu, Yang, Jin, Friedemann, Li, Liu, Chen, Zou, Zhang, Wang, Lin, Tang, Cao, Jiang, Gao, Liu, Tao, Robinson, Schröder, Liu and Lu.)