Acupuncture for olfactory dysfunction in infected COVID-19 patients: Study protocol for a randomized, sham-controlled clinical trial

Background: Olfactory dysfunction (OD) is a common symptom of Corona Virus Disease 2019 (COVID-19). It is defined as the reduced or distorted ability to smell during sniffing (orthonasal olfaction) and represents one of the early symptoms in the clinical course of COVID-19 infection. A large online questionnaire-based survey has shown that some post-COVID-19 patients had no improvement 1 month after discharge from the hospital. Objective: To explore the efficacy of acupuncture for OD in COVID-19 infected patients and to determine whether acupuncture could have benefits over sham acupuncture for OD in post-COVID-19 patients. Methods: This is a single-blind, randomized controlled, cross-over trial. We plan to recruit 40 post-COVID-19 patients with smell loss or smell distortions lasting for more than 1 month. Qualified patients will be randomly allocated to the intervention group (real acupuncture) or the control group (sham acupuncture) at a 1:1 ratio. Each patient will receive 8 sessions of treatment over 4 weeks (Cycle 1) and a 2-week follow-up. After the follow-up, the control group will be subjected to real acupuncture for another 4 weeks (Cycle 2), and the real acupuncture group will undergo the 4-week sham acupuncture. The primary outcomes will be the score changes on the questionnaire of olfactory functioning and olfaction-related quality of life at week 6, 8, 12, and 14 from the baseline. The secondary outcomes will be the changes in the olfactory test score at week 6 and 12 from the baseline measured by using the Traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC). Discussion: The results of this trial will help to determine the effectiveness of acupuncture for OD in post-COVID-19 patients. This may provide a new treatment option for patients.

Improving the quality of clinical research for the prevention and treatment of COVID-19 with Traditional Chinese Medicine

The Coronavirus Disease 2019 (COVID-19) is spreading around the world, and there is still no widely recognized effective treatment. The emergence of vaccines brings hope to the global control of the epidemic, but there is still a long way to go. The Chinese government pays much attention to this epidemic, and uses the national strength to mobilize in all aspects to successfully control COVID-19. Its anti-epidemic results have attracted worldwide attention. In China's anti-epidemic practice, Traditional Chinese Medicine (TCM) has been successfully used to a large extent, and a series of clinical research results have been published. How to form an evidence-based clinical recommendation based on these clinical results and disseminate these results around the world thus to facilitate the control of this pandemic should be further discussed. Among many published clinical research evidence related to COVID-19, the level of evidence is one of the core issues in the COVID-19 management with TCM. The commentary analyzed this challenging problem and put forward a series of corresponding suggestions, hoping to provide a useful reference for clinical research on TCM. The main problems in clinical research of TCM included: (1) Incomplete registration information, especially lack features of TCM;(2) no precise targeted clinical problems, especially what kind of clinical questions will be tested in the trial;(3) no rigorous research design, especially about the randomization, blinding, outcome assessment, etc.;(4) insufficient report about the trial results;(5) no data sharing plan. For emergent, new, and major infectious diseases such as COVID-19, the high-quality research evidence from clinical trials can guide clinical practice through forming high-quality evidence. The high-quality evidence can help the front-line medical staff to make evidence-based decision, which is the cornerstone of improving the clinical treatment effect for such new disease, without previous management experience. Applause should be given to the medical staff due to their efforts in clinical trials under the tremendous clinical work for COVID-19 pandemic. Specific attention should be given to clinical trials with TCM research in COVID-19 with suggestions as follows: (1) Strictly follow international standards to design, register, implement, and report the clinical trials. Pioneers have developed the guidelines in this area, and Chinese scholars also developed the specific recommendations for TCM researches. Previous studies have demonstrated that these guidelines can improve the quality of clinical researches;(2) establish the clinical data sharing mechanisms in China, starting from COVID-19 trials. The mechanism can improve the transparency of the trial, reduce the duplication, and increase the dissemination of the trial results;(3) set up the national unit for the emergent, new, and major infectious diseases thus to coordinate the clinical practice as well as the clinical research for TCM and western medicine. These efforts will facilitate transforming the research and practice results to be recognized high-level evidence thus to improve the clinical efficacy and safety of TCM. The efforts will just affect the evidence quality of COVID-19, but also for the emergent, new, and major infectious diseases in the future. © 2021, Science Press. All right reserved.

Epidemiological Investigation of OHCWs with COVID-19.

During the coronavirus disease 2019 (COVID-19) pandemic, there is an important risk of infection in health care workers, including oral health care workers (OHCWs), due to the characteristics of dental practice. In this retrospective study, data pertaining to the 31 OHCWs diagnosed with COVID-19 in Wuhan, Hubei Province, were retrieved and analyzed. Questionnaires were administered to the subjects over the Internet and telephone. Clinical and epidemiological characteristics and information on the use of personal protective equipment (PPE) were collected. There were 22 females and 9 males, with a median age of 39 y. Although the severity of most cases of COVID-19 (93.5%) was mild or moderate, 1 case was severe, and another case was critical, resulting in death. Fever was the main first symptom of COVID-19, followed by fatigue and myalgia. Most of the OHCWs routinely used PPE such as medical masks, gloves, caps, and work clothes while performing clinical work. N95 or KN95 masks were rarely available because of the scarcity of PPE during the outbreak. Nineteen OHCWs reported a contact history, among whom 7 worked in a fever clinic, 5 reported contact with dental patients suspected of having COVID-19, and 7 reported contact with family members with COVID-19-related symptoms at least 1 d earlier. Our findings indicated that there were few clusters of COVID-19 in dental settings. Since the outbreak, the Hospital of Stomatology, Wuhan University, has provided emergency dental treatment, and none of their staff were infected while providing dental service, which indicates that comprehensive measures such as the use of advanced PPE and environmental disinfection can prevent cross-infection in dental practice. The analysis of the procedures followed during the emergency treatments indicated that OHCWs preferred to recommend conservative treatment to patients, suggesting that attention should be paid to the psychological impact of COVID-19 on dental practitioners.

Coronavirus Disease 2019 (COVID-19): Emerging and Future Challenges for Dental and Oral Medicine.

The epidemic of coronavirus disease 2019 (COVID-19), originating in Wuhan, China, has become a major public health challenge for not only China but also countries around the world. The World Health Organization announced that the outbreaks of the novel coronavirus have constituted a public health emergency of international concern. As of February 26, 2020, COVID-19 has been recognized in 34 countries, with a total of 80,239 laboratory-confirmed cases and 2,700 deaths. Infection control measures are necessary to prevent the virus from further spreading and to help control the epidemic situation. Due to the characteristics of dental settings, the risk of cross infection can be high between patients and dental practitioners. For dental practices and hospitals in areas that are (potentially) affected with COVID-19, strict and effective infection control protocols are urgently needed. This article, based on our experience and relevant guidelines and research, introduces essential knowledge about COVID-19 and nosocomial infection in dental settings and provides recommended management protocols for dental practitioners and students in (potentially) affected areas.