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Discussion | cardiovascular disease, inflammation, asthma, typically impaired, airway inflammation | INFLAMMATORY RESPONSES, CARDIOVASCULAR DISEASE, INFLAMMATION, ASTHMA, ARTERIAL STIFFNESS | We investigated the link between asthma and cardiovascular disease risk in a controlled laboratory environment by assessing the impact of the mannitol and methacholine airway challenges on systemic inflammation and vascular function in young people with confirmed asthma and in controls. Despite sufficiently reducing FEVVascular markers of cardiovascular disease risk are typically impaired in asthma compared to controls [To normalize lung function after each challenge, and to minimize any discomfort from bronchoconstriction, each participant received 400°g salbutamol following each challenge irrespective of individual level of airway response. While salbutamol does not appear to have anti-inflammatory properties, salbutamol increases sympathetic activity [The risk of developing cardiovascular disease increases with age [A limitation of this study was the lack of confirmation of the pulmonary inflammatory responses to mannitol. While the EBC analysis did not yield detectable airway inflammation, other techniques such as induced sputum or bronchoscopy sampling would have likely confounded the vascular assessments. The mannitol inhalation challenge has previously been shown to increase markers of mast cell activation [In the current study, all follow-up measurements were done within the first hour following each challenge. Further assessments to evaluate changes over time were not feasible as the participants would have had to remain fasting and sedentary. Previous studies evaluating the effect of increased systemic inflammation on vascular function and arterial stiffness both observed detectable changes in inflammatory levels eight hours after the inflammatory insult [ | PMC10351735 |
Conclusion | inflammation, asthma exacerbations, airway inflammation | INFLAMMATION | Airway challenges that induce bronchoconstriction (methacholine) or inflammation and bronchoconstriction (mannitol) did not result in immediate measurable or clinically meaningful acute changes in systemic inflammation or vascular function. These findings suggest that airway inflammation and bronchoconstriction immediately following asthma exacerbations are unlikely to be the sole mechanisms for the increased cardiovascular risk and other factors such as the impact of inhaler medications on cardiovascular health and the real-world impacts of asthma exacerbations need to be further examined. | PMC10351735 |
Supporting information | PMC10351735 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file. | PMC10351735 | ||
Study dataset with anonymized data necessary to replicate study findings. | (XLSX)Click here for additional data file. | PMC10351735 | ||
Study protocol. | (DOCX)Click here for additional data file.The authors of this study would like to thank Karishma Kapoor, Shelby Henry, Samira Roland, and Jenna Bertoncini at the University of Alberta for their assistance in data collection for this study. The authors thank Silvia Ortiz, MSc, at the University of Alberta for assistance in data analysis. | PMC10351735 | ||
References | PMC10351735 | |||
Abstract | PMC10338851 | |||
Purpose | To refine the currently used, weight‐grouped protocol for coronary computed tomography angiography (CCTA), in terms of the radiation and contrast medium dose, through clinical evaluation. | PMC10338851 | ||
Methods | coronary artery disease | CORONARY ARTERY DISEASE | Following the current routine setting that varies between three weight groups (group A: 55–65 kg, group B: 66–75 kg, group C: 76–85 kg), three additional reduction protocols were proposed to each group, with different combinations of lowered tube voltage (70–100 kVp), tube current (100–220 mAs), and iodine delivery rate (0.8–1.5 gI/s). A total of 321 patients scheduled for CCTA due to suspected coronary artery disease were enrolled, who were randomly assigned to one of the four subgroups of settings under the corresponding weight group. The resulting objective image quality was compared by measuring the contrast‐to‐noise ratio and signal‐to‐noise ratio. Subjective image quality was graded by two radiologists using a 4‐point Likert scale, on a total of 3848 segments. The optimal protocol for each weight group was determined with respect to the image quality and the applied radiation dose. | PMC10338851 |
Results | For all three groups, no significant difference was noticed in objective images quality between subgroups of dose settings (all | PMC10338851 | ||
Conclusion | It is feasible to refine the currently used, weight‐grouped protocol for CCTA in terms of radiation and contrast medium dose, by use of an optimization strategy where the balance between dose and image quality can be improved in a routine clinical setting.
Yan Zhang and Ying Wang contributed equally to this study. | PMC10338851 | ||
INTRODUCTION | coronary artery disease | CORONARY ARTERY DISEASE | Coronary computed tomography angiography (CCTA) is a non‐invasive imaging modality that is of great value for diagnosing coronary artery disease (CAD).Efforts have also been made in optimizing the vessel enhancement in order to improve the image quality of CCTA.The purpose of this study was to refine the currently used, body weight grouped protocol for CCTA in terms of the radiation and contrast medium dose, hopefully reducing the dose while improving or at least not affecting the image quality. To do so in a routine clinical setting, the reduction was restricted within an empirical extent that would not severely compromise the image quality and leave the diagnosis totally impossible. The search for optimal protocol was subject to comprehensive comparison of the resulting subjective and objective image quality as well as the applied radiation dose. | PMC10338851 |
METHODS | PMC10338851 | |||
Study design and participants | CAD | CORONARY ARTERY DISEASE, CAD | As illustrated in Figure Flowchart of the study design. CAD, coronary artery disease; CCTA, coronary computed tomography angiography.Radiation and Contrast medium dose parameters.This prospective study received ethical approval from the Institutional Ethics Committee. Patients scheduled for CCTA from February to December 2022 due to suspected or known CAD were enrolled in this study, who were first categorized by body weight and then randomly assigned to one of the corresponding subgroups. Patients with implanted coronary stents were excluded because metal artifacts may be involved, which is important but a separate issue beyond dose and vessel enhancement as considered in the present study. Aside from the current study design, investigation on patients < 55 or > 85 kg was additionally carried out with a small number of cases, where the consideration on optimization might be different. Written informed consent was obtained from each participant before the CT examination.To test whether there was a potentially better setting than the current one, and if so, to determine which the optimal setting was for each group, the process of balancing as well as the priority placed on dose or image quality may vary from case to case. On image quality, it must be noted that the aim was not to evaluate if the resulting images were acceptable for clinical diagnosis but to investigate, with respect to those routinely accepted, the possibility and the associated cost for improvement, which raised the baseline for comparison. | PMC10338851 |
CT image acquisition | All CT examinations were performed on a 320‐row CT scanner (uCT 960+; United Imaging Healthcare; Shanghai; China) with prospective electrocardiography (ECG)‐gating in axial scan mode, where the acquisition was completed in one single heartbeat. As in the majority of routine cases, beta‐blockers were not used. All patients were trained for breath‐holding.The scan range covered the entire heart, from 1 cm below the carina up to the diaphragm, corresponding to a z‐coverage of 12 , 14 , or 16 cm depending on the patient's heart size. The gantry rotation time was 0.25 s. Contrast medium with an iodine concentration of 350 mg/mL (Ioversol, Bayer) was used for all patients with 10‐s injection time, followed by 40 mL of saline solution. Data acquisition was triggered using a bolus tracking technique, which the region of interest (ROI) was set on the descending aorta at 1 cm below the tracheal bifurcation, with a triggering threshold of 100 Hounsfield Units (HU) and 6 s delay time. The optimal cardiac phase was automatically selected based on the measured ECG signal (ePhase; United Imaging Healthcare; Shanghai; China).After scan, an artificial intelligence (AI)‐based software algorithm (CardioCapture; United Imaging Healthcare; Shanghai; China) was used for motion correction. | PMC10338851 | ||
Objective image quality | One radiologist with over 7 years of experience in cardiovascular radiology sketched the ROIs for evaluating the objective image quality. The mean CT number and the noise were measured on the proximal segment of the left anterior descending (LAD) artery, the distal segment of the right coronary artery (RCA), as well as the adjacent pericardial fat. The ROI size on the pericardial fat was 12 mm | PMC10338851 | ||
Subjective image quality | BLIND | Two radiologists, one with 5 years and the other with 10 years of experience in CCTA diagnosis, were asked to assess the subjective image quality independently, where the cases were randomized and the observers were kept blind to the scanning protocol. The evaluation was performed for vessels with a diameter > 1.5 mm on MIP reconstruction images according to the 18‐segment classification system.Coronary CT angiography: examples of different levels of image quality. Right coronary artery (RCA) with score of 2−4 (a‐c); Left anterior descending (LAD) coronary artery with score of 2−4 (d‐f). | PMC10338851 | |
Statistical analysis | ±, SD | Statistical analysis was performed using the SPSS software Version 26.0 (IBM Corp., Armonk, New York, USA). All data were expressed as means ± SD. The SNR, CNR, CTDI | PMC10338851 | |
RESULTS | PMC10338851 | |||
Patient characteristics | A total of 321 patients (female/male: 126/195) were enrolled in the study, with 108, 108, and 105 cases in groups A, B, and C, respectively. Detailed information for each group i shown in Table Patient characteristics for three weight groups. | PMC10338851 | ||
Objective image quality | The results of objective image quality scores are shown in Figure Comparison of objective image quality. SNRs, signal‐to‐noise ratios; CNRs, contrast‐to‐noise ratios; LAD, left anterior descending; RCA, right coronary artery. | PMC10338851 | ||
Subjective image quality | Table Subjective image quality scores for each subgroup. | PMC10338851 | ||
Determination of the optimal setting | All other subgroups of protocols SNR and CNR measurement have no difference in image quality from conventional scanning protocols (Subgroups A(a‐c) VR and CPR images of a 73‐year woman (weight, 60 kg; BMI, 22.58 kg/m | PMC10338851 | ||
DISCUSSION | coronary artery stenosis | CORONARY ARTERY STENOSIS | In this study, we refined the currently used weight grouped protocol for CCTA in terms of the radiation and contrast medium dose through clinical evaluation. Given that no significant difference was found in objective image quality between subgroups, the optimal setting for each weight group was determined by the subjective image quality in combination with the applied radiation dose, where the subjective image quality was compared in terms of the percentage of cases being graded excellent, that is, receiving a score of 4. The detailed and comprehensive optimal scanning protocol was obtained by using the tentative approach in each body weight group, which provided diagnostically sufficient image quality for clinical diagnosis while reducing radiation dose and iodine intake.The patients < 55 or > 85 kg was additionally carried out with a small number of cases. Two scanning protocols, one routine protocol (In this study, the applied radiation dose was represented by the planned volume CT dose index (CTDIBody mass index (BMI) has been used in prior studies as the grouping factor for patients. Yuan et al. explored the feasibility of low tube voltage and IDR determined by patients’ BMI in CCTA.The present study had several limitations. First, the left circumflex artery was not considered in the objective image quality evaluation since the individual difference on circumflex artery is naturally quite large, which might complicate the evaluation of image quality. Second, while focused on image quality, the coronary artery stenosis found on CCTA images was not used, either as an extra grouping factor for image quality analysis or as a task for detectability test. This was in part due to the lack of gold standard of the diagnostic results. Third, this study considered only the hybrid iterative reconstruction that has been widely available with current commercial CT systems. It is of interest to investigate the same topic with emerging CT algorithms, such as deep‐learning based reconstruction, where the findings might be surprisingly different. Fourth, the automated exposure control (AEC) technique was not considered in this study, which would also be a reasonable starting point for optimization and worth comparing with the obtained parameter settings. Finally, the CCTA protocol refined in this study was only one scanner‐specific implementation. Care must be taken when translating the findings in this study to other CT models. The most determining factors are tube output, scanning geometry, and the image reconstruction method. Direct translation or scaling without a separate investigation is hardly reliable, even for those with similar wide detectors allowing volumetric CCTA in axial mode. However, the demonstrated investigative strategy for determining the optimal setting should be directly applicable to other scenarios, which is more essential than the exact value of the parameters. | PMC10338851 |
CONCLUSION | It is feasible to refine the currently used, weight‐grouped protocol for CCTA in terms of radiation and contrast medium dose, by use of an optimization strategy where the balance between dose and image quality can be improved in a routine clinical setting. Apart from the optimal protocol as found for each of the weight group, the strategy is directly extensible to more detailed categorization of patient characteristics. | PMC10338851 | ||
AUTHOR CONTRIBUTION | Conceptualization and study design: Huishu Yuan and Guozhi Zhang; Data collection, analysis, and interpretation: Yan Zhang, Ying Wang, Jing Li, and Aihui Di; Manuscript preparation: Yan Zhang, Jing Li, and Guozhi Zhang; All authors contributed to the work and approved the submitted version. | PMC10338851 | ||
CONFLICT OF INTEREST STATEMENT | The authors report no conflicts of interest. | PMC10338851 | ||
ACKNOWLEDGMENTS | To the anonymous reviewers. | PMC10338851 | ||
REFERENCES | PMC10338851 | |||
Background | hyper-inflammatory, hypoxic respiratory illness | SARS-COV-2 INFECTION | SARS-CoV-2 infections caused mild-to-moderate illness. However, a sizable portion of infected people experience a rapid progression of hyper-inflammatory and hypoxic respiratory illness that necessitates an effective and safer remedy to combat COVID-19. | PMC10696694 |
Methods | A total of 150 COVID-19-positive patients with no to mild symptoms, between the age groups 19–65 years were enrolled in this randomized, open-labeled three-armed clinical trial. Among them, 136 patients completed the study with RT-PCR negative reports. The patients received herbal drugs orally (Group A ( | PMC10696694 | ||
Results | hypoxia | HYPOXIA, GROUP B | We found that the mean viral clearance time was 13.92 days (95% confidence interval [CI] 12.85–14.99) in Group A, 13.44 days (95% confidence interval [CI] 12.14–14.74) in Group B, and 11.86 days (95% confidence interval [CI] 10.62–13.11) days in Group C. Over a period of 14 days, the mean temperature in Groups A, and B significantly decreased linearly. In Group A, during the trial period, eosinophils, and PT/INR increased significantly, while monocytes, SGOT, globulin, serum ferritin, and HIF-1α, a marker of hypoxia reduced significantly. On the other hand, in Group B hsCRP decreased at mid-treatment. Eosinophil levels increased in Group C during the treatment, while MCP-3 levels were significantly reduced. | PMC10696694 |
Graphical Abstract | PMC10696694 | |||
Supplementary Information | The online version contains supplementary material available at 10.1186/s40001-023-01507-7. | PMC10696694 | ||
Keywords | PMC10696694 | |||
Methods | PMC10696694 | |||
Study design, participants, and ethics | ARI, OPD | ACUTE RESPIRATORY INFECTION, RECRUITMENT, DELHI, GROUP B | A three-armed, open-labeled, randomized clinical trial was undertaken from November 2020 to September 2021. A total of 150 patients were recruited at the screening OPD and COVID health centre of All India Institute of Ayurveda (AIIA), New Delhi and ARI (acute respiratory infection) OPD and Corona Ward, ESIC Medical College and Hospital, Faridabad, Haryana. The inclusion criteria were (1) diagnosis of COVID-19 positive based on RAT and RT-PCR results; (2) age 19–65 years; (3) presenting with no or mild symptoms (SpOThe 150 random numbers were generated using 3-digit random numbers tables and allocation to 3 groups was done: Group A (even number), Group B (odd number) and Group C (number multiple of 3). As per this, 52 patients in Group A, 51 patients in Group B and 47 patients in Group C were enrolled in the study. This study was carried out in accordance with the recommendations of the Indian Council of Medical Research, India guidelines for biomedical research, with written informed consent from all subjects. The study protocol was approved by the Institutional Human Ethics Committee of CSIR-Institute of Genomics and Integrative Biology (IGIB), New Delhi, All India Institute of Ayurveda (AIIA), New Delhi and ESIC Medical College and Hospital, Faridabad, Haryana, India. The study was registered in the Clinical Trials Database with Registration no. CTRI/2020/09/028043. The trial drug capsules of extracts of At the time of enrollment, patients were provided information on how to record their vitals and report their clinical symptoms daily such as temperature, pulse, blood pressure (BP), respiratory rate (RR) and oxygen saturation levels. They were provided pulse oximeters to facilitate accurate reporting of SpOAfter enrollment in the intervention, 14 patients (two, eight, and four from AV, TC, and AV + TC, respectively) were lost to follow-up. Among these, eleven individuals did not provide any information about medication taken/ not and no follow-up/tests could be done after enrollment. Two patients were enrolled based on RAT, however they turned negative on RT-PCR, hence did not initiate the treatment. One patient took intervention and provided clinical follow-up for the recovery of symptoms but did not come for final blood/RT-PCR tests, hence the data were not included in the final analysis. A total of 136 patients completed the study with RT-PCR negative, out of which 67 subjects gave their blood samples at the three time points (Fig. Recruitment and randomization of the patients. 150 COVID-19 positive patients were enrolled in the clinical trial. We randomized 150 patients who met the inclusion criteria into Group A ( | PMC10696694 |
Outcomes | PMC10696694 | |||
Primary outcomes | sore throat, myalgia, dyspnea, fever, fatigue, diarrhea, pain, cough, nasal congestion, headache, nausea, | SORE THROAT | The amount of time taken for RT-PCR to turn negative served as a primary outcome of viral clearance. Clinical symptoms such as fever, cough, difficulty breathing, dyspnea, sore throat, headache, joint pain, fatigue, running nose, nasal congestion, loss of sense of smell, loss of sense of taste, myalgia, nausea, vomiting, and diarrhea surveilled two times a day, i.e., morning and evening along with other vital parameters like temperature, heart rate (HR), blood pressure (BP), respiratory rate (RR), and oxygen saturation (SpO | PMC10696694 |
Secondary outcomes | Tecan | DISEASE PROGRESSION, DISEASE, PULMONARY INVOLVEMENT, SECONDARY, BLOOD | Blood tests planned to be conducted in the study were mainly of two types: (1) for assessment, monitoring the disease progression markers (PT-INR, Hs CRP, D-dimer, ferritin, cytokines, and other molecular markers) and observing the effect of trial medicines on them; (2) for identifying systemic effects of the disease as well as the effect of trial medication on the general safety of these parameters such as CBC, LFT, KFT, lipid profile. To evaluate these blood parameters, 16 ml venous blood was collected at three time points before the start of treatment, midway through treatment, and at the end of treatment. Hematological parameters, CBC, and ESR were analyzed on a 6-part hematology autoanalyzer (Sysmex XN 1000), and ESR analyzer (Vesmatic 80), respectively. Coagulation parameters (PT/INR/D-dimer) were analyzed by a fully automated coagulation analyzer (STAGO startmax). Biochemical parameters (LFT, KFT, lipid profile, ferritin, and hsCRP) were analyzed on a fully automated analyzer (Vitros XT 7600).Further serum samples were isolated and stored to measure 15 pro-inflammatory and anti-inflammatory cytokines (IFN-α2, IFN-γ, IL-1β, IL-1RA, IL-4, IL-6, IL-7, IL-8, IL-13, IL-18, IP-10, MCP-1, MCP-3, TNF-α, and VEGFA) levels through multiplexing (MILLIPLEX® MAP KIT; Cat.#HCYTA-60K), and the plate was scanned using MAGPIX with xPONENT software and measuring biomarkers such as HIF-1α (ELISA kit-Elabscience®; E-EL-H6066), and vWF (ELISA kit-Elabscience®; E-EL-H2168) and the plate was scanned using Tecan i-control, 2.0.10.0. All the experiments were performed by following the manufacturer's protocols. 67 patients' data with three time points were considered for the analysis of secondary outcomes.X-rays were also done for patients at the time of enrollment and at the end of the intervention period, to rule out any pulmonary involvement or progression during the course of disease in patients on treatment. | PMC10696694 |
Statistical analysis | The data processing and statistical analysis were performed using IBM Statistical Package for Social Sciences Software (SPSS) for Windows, version 26 and R software (v.4.1.2). The data distribution was examined for each parameter using the Shapiro–Wilk test ( | PMC10696694 | ||
Results | A total of 150 patients diagnosed with COVID-19 using a RAT or RT-PCR positive test were enrolled among them 101 were males and 49 females with mean age 38.59 ± 11.74 years. Fourteen patients were considered to drop out of the trial. Among 136 patients, 50 patients were in Group A (All the groups had similar demographic and illness characteristics (Table Baseline demographics and clinical features of COVID-19 patients in each groupn, number of patients; no., number; %, percent; SD, standard deviation | PMC10696694 | ||
Viral clearance | Patients were mostly home quarantined and opted to come for follow-up RT-PCR at their convenience. Hence this is more indicative of the confirmation date rather than the actual time to negativity which could be earlier. The mean time taken to become COVID-19 negative was 13.92 days (95% confidence interval [CI] 12.85–14.99) in Group A (Kaplan–Meier survival analysis of the proportion of patients: | PMC10696694 | ||
Time to normal body temperature | RECRUITMENT, GROUP B | At the time of recruitment, 40% of patients had a temperature ≤ 98.6°F (normal body temperature) in Group A and < 50% of patients in Group B and C. Patients had higher body temperature recovered with the median day of 4 (95% confidence interval [CI] 3.86–6.72), 3 (95% confidence interval [CI] 2.66–4.41), 4 (95% confidence interval [CI] 2.86–5.94) in Group A, B, and C, respectively. On the 7th day, nearly 90% of patients had a temperature ≤ 98.6 °F in Group B, C, and A (Fig. | PMC10696694 | |
Primary clinical outcome | The average morning and evening data of each individual were assessed to compare the trend in their vital parameters for 14 consecutive days. There was a significant decline in mean temperature over 14 days from 98.92 ± 1.28 to 98.04 ± .80 in Group A; Trend in mean clinical symptoms in three study Groups over 14 days of observations: | PMC10696694 | ||
Secondary clinical outcome | PMC10696694 | |||
Pro-inflammatory and anti-inflammatory cytokines | GROUP B | A total of 15 pro-inflammatory and anti-inflammatory cytokines levels were examined using their serum samples. The cytokine levels in Group A (On the other hand, in Group B (In Group C ( | PMC10696694 | |
Molecular biomarkers for hypoxia and thrombosis | thrombosis, hypoxia | THROMBOSIS, HYPOXIA, GROUP B | The levels of hypoxia and thrombosis biomarkers, HIF-1α and vWF were tested. The level of HIF-1α significantly decreased in Group A after treatment (AT) (Table vWF, a molecular marker of thrombosis induced by HIF-1α, was undetectable in a large number of patients either before and/or after the treatment. The samples included in the analysis were Group A, Furthermore, to see the difference between groups we conducted a comparative analysis of the biochemical, hematological parameters, and molecular markers at baseline (referred to as "Before Treatment") and After Treatment. We observed that MCP-1 was significantly higher in Group C as compared to Group B at baseline (Table | PMC10696694 |
Management of complication | diabetes | GROUP B, DIABETES | One patient from Group A and another from Group B with diabetes were on oxygen supplementation for 4 days since their condition deteriorated from mild to moderate stage, antipyretic, and antibiotics were also given along with intervention drugs. One of them continued with the trial medication and hence included in the analysis, whereas the other discontinued the medication and was considered a dropout. However, both were followed up till recovery and tested negative for RT-PCR during the trial period only. | PMC10696694 |
Discussion | dyspnea, SARS-CoV-2 infection, hyper-inflammatory, infection, hypoxemia, systemic disorder | SARS-COV-2 INFECTION, GROUP B, SILENT HYPOXIA, INFLAMMATORY RESPONSES, DISEASE, HYPOXIC, INFECTION, INFLAMMATORY RESPONSE | The majority of SARS-CoV-2 infections had either no or mild symptoms. But there is also a significant proportion of infected individuals who suffer from a severe hyper-inflammatory and hypoxic response that entails the development of a potent and effective treatment for COVID-19. The result of this clinical trial demonstrated that the early-onset of oral treatment with In our study, the average viral clearance observed was 13.92 days (95% CI 12.85–14.99) in Group A, 13.44 days (95% CI 12.14–14.74) in Group B and 11.86 days (95% CI 10.62–13.11) days in Group C. Furthermore, we also observed the median time taken to normal body temperature was 4 days in Group A and C, and 3 days in Group C. On the 7th day, 88% of patients in Group A and 90% of patients in Groups B and C had achieved normal temperature below 98.6 °F after treatment. This observation is comparable with another study in which avifavir, an RNA polymerase inhibitor, the treated group had a median time of two days to normalize body temperature and 4 days in the standard of care group [Daily monitoring of oxygen saturation (SpOIn addition to the clinical symptoms and viral clearance, we wanted to test the effect of SARS-CoV-2 is a systemic disorder that involved multiorgan effects to some extent. To estimate the overall safety of these drugs, we evaluated systemic health parameters such as CBC, ESR, PT, PT/INR, liver function, kidney function, and lipid profile. In our patient’s group, most parameters were within normal limits and were largely unaffected or altered within normal limits in all three groups. Almost half of SARS-CoV-2 infected individuals showed some impairment in their liver function and elevated liver enzymes [The overall decline in the systemic health parameters has been observed and reported in literature during the course of the disease [It is reported that without any indications of respiratory discomfort or dyspnea, patients with COVID-19 are frequently shown to have life-threatening hypoxemia which is termed as Silent hypoxia. The viral ORF3a protein is shown to increase the production of HIF-1α during SARS-CoV-2 infection, which in turn promotes the inflammatory responses and subsequently the infection. Since HIF-1α is a critical promoter of both SARS-CoV-2 infection and inflammatory response, it is suggested as a viable therapeutic target for COVID-19 and virus-induced inflammatory infection [Although this analysis provided in-depth understanding of the clinical effects of tested formulation in COVID-19 patients, it has two limitations. One, due to the highly contagious nature of the disease, the patient's willingness to comply with blood sample collections was adversely affected. As a result, this left us with less than half of the patients from whom three-timepoint sample workups. Second, the study did not include a placebo control group. In the context of the COVID-19 pandemic, the absence of established therapeutic interventions necessitated the implementation of symptomatic management as the prevailing standard of care. The Government of India, Ministry of AYUSH, subsequently issued guidelines for the management of COVID-19, incorporating Ayurvedic medicines, with This study demonstrated the effects of | PMC10696694 |
Conclusions | hyper-inflammatory, viral pneumonia, AV herbal extract | VIRAL PNEUMONIA | Even though the alarmingly high number of SARS-CoV-2 cases are asymptomatic or mild, they can also manifest as severe viral pneumonia with hyper-inflammatory response, demanding the use of powerful and effective medication. We present the first clinical evidence of HIF-1 reduction in COVID-19 patients receiving AV herbal extract treatment. Our study concluded that the use of oral medication of | PMC10696694 |
Acknowledgements | DELHI | The authors thank the Covid Health Centers of AIIA, ESIC, and the testing and research facilities of IGIB for their steadfast assistance. The authors also acknowledge the patients for their participation in the study. J.L.N. Shastri, and National Medicinal Plants Board, R. Galib AIIA, New Delhi, acknowledged for helping in the procurement of trial drugs. The authors would like to thank Dr Mitali Mukerji from CSIR-IGIB, Delhi, Dr Vitthal G. Huddar from AIIA, Delhi and Dr Asim Das, ESIC for scientific discussions and Drs Sheetal Gandotra, Vivek Rao and Atish Gheware for helping with multiplexing experiments. We also thank Sanjay, Subhash Gujjar and Suman Mudila CSIR-IGIB and Pawan Kumar from ESIC for assistance in the lab. | PMC10696694 | |
Author contributions | MP | RECRUITMENT | BP, TN, and AA conceived and designed the study. BP, TN, AKP, MB, SR, MP, and RT prepared the protocol and implemented the study. TN did trial drug procurement. MV, NR, AT, SKr, MB, SR, MP, and AKP performed patient recruitment and clinical monitoring. MF, RT, MP, MK, and SA did COVID RT-PCR testing. SR, RT, MP, and SK performed hematological and biochemical blood tests. RR and AC performed the cytokines and molecular testing. BM, SK, MV, NR, MB, MS, and BP prepared eCRF and did data documentation and validation. AK, RR, MS, AC, and BP analyzed the data and wrote the manuscript. All authors have read and approved the manuscript. | PMC10696694 |
Funding | The work is supported by a Grant (GAP0183) from M/o AYUSH for CoE Applied development in Ayurveda, | PMC10696694 | ||
Availability of data and materials | The data sets used and analyzed during the current study are available from the corresponding author upon reasonable request. | PMC10696694 | ||
Declarations | PMC10696694 | |||
Ethics approval and consent to participate | DELHI | This study was carried out in accordance with the recommendations of the Indian Council of Medical Research, India guidelines for biomedical research, with written informed consent from all subjects. All subjects gave written informed consent in accordance with the Declaration of Helsinki. The study protocols were reviewed and approved by the Institutional Human Ethics Committee of CSIR-Institute of Genomics and Integrative Biology (IGIB), New Delhi, All India Institute of Ayurveda (AIIA), New Delhi, and ESIC Medical College and Hospital, Faridabad, Haryana, India. | PMC10696694 | |
Consent for publication | A consent for publication was obtained from all study participants at the time of consenting for participation in the study. | PMC10696694 | ||
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. | PMC10696694 | ||
References | PMC10696694 | |||
1. Introduction | RA | These authors contributed equally to this work.Background: Preschool children are in a period of rapid physical and psychological development, and improving their level of physical fitness is important for their health. To better develop the physical fitness of preschool children, it is very important to understand the behavioral attributes that promote the physical fitness of preschool children. This study aimed to determine the effectiveness of and the differences between different physical exercise programs in improving preschool children’s physical fitness. Methods: A total of 309 preschool children aged 4–5 years were recruited from 5 kindergartens to participate in the experiment. They were cluster-randomly allocated into five groups: basic movements (BM) group, rhythm activities (RA) group, ball games (BG) group, multiple activities (MA) group, and control (CG) group. The intervention groups received designed physical exercise programs with a duration of 30 min 3 times per week for 16 weeks. The CG group received unorganized physical activity (PA) with no interventions. The physical fitness of preschool children was measured using the PREFIT battery before and after the interventions. One-way analysis of variance, a nonparametric test; generalized linear models (GLM); and generalized linear mixed models (GLMM) were used to examine differences during the pre-experimental stage among groups and to assess the differential effects of the intervention conditions on all outcome indicators. The intervention condition models were adjusted for potential confounders (baseline test results, age, gender, height, weight, and body mass index) explaining the main outcome variance. Results: The final sample consisted of 253 participants (girls 46.3%) with an average age of 4.55 ± 0.28 years: the BG group (n = 55), the RA group (n = 52), the BM group (n = 45), the MA group (n = 44), and the CG group (n = 57). The results of the generalized linear mixed model and generalized linear model analyses indicated significant differences for all physical fitness tests between groups, except for the 20 m shuttle run test and the sit-and-reach test after the interventions. Grip strength was significantly higher in the BG and MA groups than in the BM group. The scores for standing long jump were significantly higher in the MA group than in the other groups. The scores for the 10 m shuttle run test were significantly lower in the BG and MA groups than in the CG, BM, and RA groups. The scores for skip jump were significantly lower in the BG and MA groups than in the RA group. The scores for balance beam were significantly lower in the BG and MA groups than in the RA group and significantly lower in the BG group than in the BM group. The scores for standing on one foot were significantly higher in the BG and MA groups than in the CG and RA groups and significantly higher in the BM group than in the CG group. Conclusions: Physical exercise programs designed for preschool physical education have positive effects on the physical fitness of preschool children. Compared with the exercise programs with a single project and action form, the comprehensive exercise programs with multiple action forms can better improve the physical fitness of preschool children.Physical fitness can be considered as the comprehensive performance of physical functions, such as muscular function, cardiovascular function, and metabolic function, effectively during daily physical activity (PA) or physical exercise [Physical activity has been proven to be one of the important factors promoting physical fitness and is an essential factor of a healthy lifestyle [However, research has indicated that focusing on just one sport can lead to a series of problems in the growth and development of young athletes [On that basis, we designed a study to compare different physical exercise programs that have been proven to effectively improve the physical fitness of preschool children and are expected to respond to the evidence gap. Therefore, this study aimed to investigate the effectiveness and differences among these physical exercise programs in improving the physical fitness of preschool children. | PMC10002293 | |
2. Methods | PMC10002293 | |||
2.1. Study Design and Participants | RA | This study was a single-blind, cluster-RCT study, with the kindergarten class as the cluster for the intervention. The data were sourced from the Physical Exercise on Fundamental Movement Skills and Physical Fitness of preschoolers (PEFP) project [In this study, a total of 309 preschool children aged 4 to 5 years were recruited from five kindergartens and cluster randomly assigned to 5 groups: basic movements (BM) group, rhythm activities (RA) group, ball games (BG) group, multiple activities (MA) group, and control (CG) group. The attendance rate of 30% of the participants exceed 4/5 of the total course, and all of the participants completed at least 2/3 of the total course. After preschool children with missing pretest or posttest data were excluded, the final sample consisted of 253 participants (girls 46.3%) with an average age of 4.55 ± 0.28 years: the BG group (n = 55), the RA group (n = 52), the BM group (n = 45), the MA group (n = 44), and the CG group (n = 57). The flow diagram of the research process is shown in | PMC10002293 | |
2.2. Intervention Procedures | RA, Preschool | The present study comprised four intervention groups: the BM, RA, BG, and MA groups. Preschool children in the control group participated in unorganized PA, and the details of the interventions have been described elsewhere [The intervention program consisted of structured lessons with a duration of 30 min performed three times a week for 16 weeks. Kindergarten teachers participated in the study and performed the physical exercise interventions after receiving 2 h of training at a local kindergarten. The structure of each lesson consisted of a warm-up period of 5 min, followed by a core exercise period of 20 min and a cool-down activity of 5 min. The study was performed in the winter, and precautions were taken to ensure the safety of the preschool children, such as starting with low-intensity physical activity (e.g., wrist rotations and leg swings), gradually increasing the intensity (e.g., arm rotations and knee-up walk to forceful swinging of arms and on-site running), and then slowly decreasing the intensity. To ensure comparability across the different programs, the core exercise period followed a consistent intensity control principle, whereby every 10 min of sports activities should include at least 5 min of moderate-to-high-intensity physical activity and 2 min of vigorous-intensity physical activity. The interventions were designed as games to increase the children’s interest, with the main differences being in the core exercise content. The interventions were performed within the existing physical activity plans of the kindergartens to avoid additional physical activity for the preschool children in the intervention groups. The intensity of PA was estimated by teachers on the basis of the active behavior of the preschool children and was determined using the “Compendium of Physical Activity” developed by Ainsworth et al. [Preschool children in the control group participated in unorganized PA. The PA schedules were arranged by the kindergarten without the guidance of teachers, and the types and intensity of activities were determined by the preschool children. | PMC10002293 | |
2.3. Measurement Procedures | Physical fitness and descriptive data (e.g., age, sex, height, and weight) of preschool children were tested at baseline and at the end of the interventions, and each test was completed within a week. The physical fitness assessment was primarily based on the PREFIT battery, which has demonstrated satisfactory reliability and validity in evaluating the physical fitness of 4–6-year-old children [The physical fitness of the preschool children was evaluated through a comprehensive test battery consisting of measures of cardiorespiratory fitness, musculoskeletal fitness, and motor fitness. The cardiorespiratory fitness of preschool children was assessed by testing the 20 m shuttle run. The musculoskeletal fitness of preschool children was assessed by testing grip strength and standing sit-and-reach. The motor fitness of preschool children was assessed by testing the 10 m shuttle run, balance beam walk, and standing on one foot and hoping. Additionally, anthropometric data, such as height and weight, were collected, and the body mass index (BMI) was calculated from these measurements. The standard testing procedures employed in this study have been described in detail elsewhere [ | PMC10002293 | ||
2.4. Statistical Analysis | RA | The data were first tested for normality using standardized skewness and kurtosis values. Normally distributed data were presented as the mean and standard deviation, while non-normally distributed data were presented as the interquartile range. One-way analysis of variance (ANOVA) and the Kruskal–Wallis H test were used to examine differences during the pre-experimental stage among groups. The matched samples t-test and Wilcoxon rank-sum test were used to examine the differences of the physical fitness tests in groups before and after intervention. Generalized Linear models (GLMs) were used to assess the differential impacts of the intervention conditions on all outcome indicators for normally distributed data. Generalized Linear mixed models (GLMMs) were used to assess the differential effects of the intervention conditions on all outcome indicators for non-normally distributed data. The intervention condition (CG, BM, RA, BG, and MA) models were adjusted for potential confounders explaining main outcome variance (baseline test results, age, gender, height, weight, and BMI). Bonferroni adjusted pairwise comparisons were employed to analyze differences among conditions, and | PMC10002293 | |
3. Results | PMC10002293 | |||
4. Discussion | RA | Preschool children undergo a period of rapid physical growth and maturation of the nervous system, requiring the development of corresponding physical fitness, such as agility, strength, and reaction speed [In terms of cardiorespiratory fitness, pre-post effect sizes exhibited significant improvements in the 20 m shuttle run test in the BM and RA groups, which is consistent with previous studies [The muscle strength (grip and standing long jump) of preschool children in all intervention groups, including the control group, obviously improved after the interventions, which is consistent with previous research findings [The motor fitness of preschoolers was obviously improved in all intervention groups after the 16-week interventions, and the intervention groups had certain advantages over the CG group. Previous research, and systematic review and meta-analysis also, indicated that the designed physical activity programs had a positive effect on the motor fitness of preschool children [In summary, the MA group had advantages over the BM, RA, and CG groups in terms of the improvement of the physical fitness of preschool children. In addition, in this study, the BM and RA groups had no advantages over the CG group with regard to improvement of cardiorespiratory fitness, musculoskeletal fitness, and motor fitness. These results are similar to those of another study that found that teacher-centered intervention granted preschool children no advantage over the control group in terms of motor fitness [There are several limitations that need to be addressed in this study. The first is in terms of sample representation; because of the scale and difficulty of the experiment, only 4–5-year-old preschoolers were included in this study. Therefore, the results of this study may not be applicable to all preschool children. Second, the baseline level of physical fitness in the experimental groups was not balanced. The improvement after the interventions will be greater if the baseline test level is low. In addition, the physical environments of the baseline test and post-intervention test were relatively different. Therefore, the significance of analyzing the improvement of physical fitness before and after the interventions is limited. However, we used a mixed-effects model to adjust the effect of the baseline test results, gender, and other factors in the intervention effect. In addition, all kindergartens participating in the experiment were in the same community, and the test environment was similar. Finally, the number of preschool children in each group included in the analysis was not balanced, but the minimum sample size that meets the statistical analysis was 30 children per group [ | PMC10002293 | |
5. Conclusions | Physical exercise programs designed for preschool physical education have positive effects on the physical fitness of preschool children. Compared with the exercise programs with a single project and action form, comprehensive exercise programs with multiple action forms can better improve the physical fitness of preschool children. | PMC10002293 | ||
Author Contributions | G.W. and D.Z. (Dan Zeng) had full access to all the data in the study, and they take responsibility for the integrity of the data and are responsible for the data analysis. D.Z. (Danqing Zhang) and S.Z. supervised the study data collection and analysis. G.W. and D.Z. (Dan Zeng) wrote the first draft of the manuscript and reviewed and edited it. Y.H. and D.Z. (Danqing Zhang) reviewed and edited the manuscript. Y.L. directed the structure and participated in the review and editing of the manuscript. All authors have read and agreed to the published version of the manuscript. | PMC10002293 | ||
Institutional Review Board Statement | The study was approved by the Ethics Committee at the Shanghai University of Sport (102772019RT034), with informed consent. | PMC10002293 | ||
Informed Consent Statement | The parents or guardians of the participants have signed a written informed consent form, which is kept by the Physical Exercise on Fundamental Movement Skills and Physical Fitness of preschoolers (PEFP) project data manager. | PMC10002293 | ||
Data Availability Statement | Data is unavailable due to privacy and ethical restrictions. | PMC10002293 | ||
Conflicts of Interest | The authors declare that they have no competing interests. | PMC10002293 | ||
References | Flow chart of research method.The results of the generalized linear mixed-model analyses for physical fitness tests after intervention. CG, Control group; BM, Basic movements group; RA, Rhythm activities group; BG, Ball games group; MA, Multiple activities group. The 20 m shuttle run test (Participant characteristics and Physical Fitness Test before each intervention.Normally distributed data are represented by mean ± standard deviation (Mean ± SD), and non-normal distribution data are represented by the median and interquartile range. Difference of Physical Fitness before and after intervention.Normally distributed data are represented by mean ± standard deviation (Mean ± SD), matched samples | PMC10002293 | ||
Background | chronic neck pain | This study aimed to evaluate the cost utility of pharmacopuncture in comparison with usual care for patients with chronic neck pain. | PMC10666315 | |
Methods | chronic neck pain | A 12-week, multicenter, pragmatic randomized controlled trial was conducted, and 101 patients suffering from chronic neck pain for more than six months were randomly placed into the pharmacopuncture and usual care groups to receive four weeks of treatment and 12 weeks of follow-up observations. The quality-adjusted life year (QALY) was calculated using EQ-5D and SF-6D. Concerning costs in 2019, a primary analysis was performed on societal perspective cost, and an additional analysis was performed on healthcare perspective cost. | PMC10666315 | |
Results | Compared to usual care, pharmacopuncture was superior as it showed a slightly higher QALY and a lower incremental cost of $1,157 from a societal perspective. The probability that pharmacopuncture would be more cost-effective at a willingness-to-pay (WTP) of $26,374 was 100%. Pharmacopuncture was also superior from a healthcare perspective, with a lower incremental cost of $26. The probability that pharmacopuncture would be more cost-effective at a WTP of $26,374 was 83.7%. | PMC10666315 | ||
Conclusions | neck pain, chronic neck pain | Overall, pharmacopuncture for chronic neck pain was found to be more cost-effective compared to usual care, implying that clinicians and policy makers should consider new treatment options for neck pain. | PMC10666315 | |
Trial registration | Number NCT04035018 (29/07/2019) Clinicaltrials.gov; Number KCT0004243 (26/08/2019) Clinical Research Information Service. | PMC10666315 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12913-023-10325-w. | PMC10666315 | ||
Keywords | PMC10666315 | |||
Background | neck pain, musculoskeletal disorder, pain | MUSCULOSKELETAL DISORDER, CERVICAL SPONDYLOSIS, DYSFUNCTION | Neck pain is a common musculoskeletal disorder among the general population, with a one-year prevalence of 15.8% [Despite various treatment options for neck pain, many patients seek complementary and alternative medicine (CAM) treatment approaches [However, high-quality evidence of the efficacy of pharmacopuncture is still lacking. According to a systematic review that analyzed the efficacy of pharmacopuncture for cervical spondylosis, pharmacopuncture was found to be more effective in managing pain levels and dysfunction than other controls such as acupuncture and physical therapy (PT); however, the quality of evidence was assessed to be low or very low [Therefore, a pragmatic RCT was conducted to identify the pharmacopuncture’s efficacy for neck pain [ | PMC10666315 |
Methods | PMC10666315 | |||
Design | A cost-effectiveness analysis was conducted with a 12-week pragmatic RCT [Schedule of the participants is shown in Supplementary Table A1 (see Additional file | PMC10666315 | ||
Participants | cancer, rheumatoid arthritis, neurologic deficits, stroke, cancer metastasis or fracture, neck pain | STROKE, DISORDERS | Eligible patients were aged 17–70, had been experiencing neck pain for more than six months, and had a VAS score of more than five for their neck pain. The exclusion criteria for participation were as follows: having cancer metastasis or fracture in the spine; having progressive or severe neurologic deficits or other disorders that may have affected the results; suffering from other types of cancer, rheumatoid arthritis, or stroke; taking medications, such as steroids; being pregnant; having had cervical surgery during the last three months; and facing difficulties participating in the trial as determined by the researcher. The specific inclusion and exclusion criteria can be found in the study conducted by Park et al. [ | PMC10666315 |
Intervention | HEAT | The general rule for pharmacopuncture treatment was undergoing two sessions per week for four weeks; however, one to three sessions per week were permitted depending on the patient’s condition and the physician’s determination. The type of pharmacopuncture solution and treatment points were determined by the physician. All intervention-related matters were recorded in the patient’s electronic medical records (EMR) and case report form (CRF).The general rules for usual care were similar to those for pharmacopuncture treatment. A Korean Health Insurance Review and Assessment’s (HIRA) analysis claimed that data in a previous study showed that combinations of various types of PT (e.g., superficial heat therapy, deep heat therapy, traction, and electrotherapy) were prescribed [ | PMC10666315 | |
Randomization and blinding | Participants who were determined to be eligible based on the inclusion and exclusion criteria and signed the Informed consent form for this clinical study were assigned to two groups at a ratio of 1:1 using a randomization table. The randomization table was created in advance by a statistician using R studio 1.1.463 (© 2009–2018 RStudio, Inc., Boston, Massachusetts, United States). The random sequence was generated by block randomization, and the size of one block was randomly set between 2, 4 and 6.The randomization results were sealed in an opaque envelope and delivered to each institution for storage under a double lock. Randomization and assignment of registration numbers for eligible participants was done by opening sealed envelopes. A random number assigned to each participant was recorded on an electronic chart. Due to the nature of our intervention, only evaluators were blinded to group assignments. The evaluator performed outcome evaluation in a separate space before intervention. | PMC10666315 | ||
Tools | Both EQ-5D and SF-12 scores were measured at baseline and at intervals of 5, 8, and 12 weeks after randomization. The Korean version of the EQ-5D with verified validity was used, and utility was calculated by applying the tariffs used by Kim et al. [ | PMC10666315 | ||
Unit costs | Supplementary Table A2 (see Additional file | PMC10666315 | ||
Resource use measurement | neck pain, cervicalgia | DISEASES | In addition to the intervention used in the trial, healthcare services used personally by the patients for neck pain were investigated at baseline and at 5, 8, and 12 weeks using a questionnaire. The questionnaire was used to survey the non-reimbursement and copayments made by the patients as well as the frequency of use. Payer reimbursement was calculated by gender and age by analyzing the records for cervicalgia (Korean Standard Classification of Diseases code: M54.2) in the 2018 HIRA-National Patient Samples (HIRA-NPS) data [The transportation costs were determined through a questionnaire survey. The time spent by patients to receive treatment was surveyed, and the time cost was calculated using the time spent by each individual based on the standard wages for their corresponding gender and age given in the 2019 Survey Report on Labor Conditions by Employment Type [Productivity loss was investigated using the Work Productivity and Activity Impairment – Specific Health Problem (WPAI-SHP) questionnaire [As the total study period was 12 weeks, a discount rate was not applied. Moreover, an inflation rate of 0.46% for change in the consumer price index for medical care was applied to the costs estimated using the 2018 HIRA-NPS data to derive the costs for 2019. An exchange rate of 1156.4 won/dollars (as of 2019) was applied to derive values in US dollars [ | PMC10666315 |
Economic perspective | neck pain, pain | Two perspectives were considered, and the primary analysis was conducted from a societal perspective, reflecting productivity loss due to neck pain. The societal perspective includes direct medical costs, direct non-medical costs, and costs associated with productivity loss. The analysis from a healthcare perspective included only direct medical costs and direct non-medical costs. Direct medical costs include the cost of intervention applied during the trial and the costs of informal care incurred during the trial period, such as the cost of treatment for neck pain from other Western medicine or KM institutions, the cost of analgesics, including over-the-counter drugs, and medical devices or exercise therapy. Direct non-medical costs include time and transportation costs. | PMC10666315 | |
Data analysis | A primary analysis examining incremental cost utility from a societal perspective was performed to calculate the incremental cost-effectiveness ratio (ICER) by comparing the differential mean costs and QALY between the pharmacopuncture and usual care groups. ICERs were calculated by dividing the difference in total costs by the difference in effects.Intention-to-treat (ITT) analysis was performed, and the missing values were imputed with multiple imputations (MI) using the Markov Chain Monte Carlo method and predictive mean matching. Twenty imputed datasets were generated; the covariates for imputation were treatment allocation, gender, age, and other correlated variables. Correlated variables (≥ 0.4) were included in the imputation model. The missing values for EQ-5D and SF-6D were 2–3%. The mice package in R version 4.0.1 was used for the imputation of missing values.The significance level was set to 0.05 for all statistical analyses, and SAS 9.4 (© SAS Institute, Inc., Cary, NC, USA) and R studio 1.1.463 (© 2009–2018 RStudio, Inc., Boston, Massachusetts, United States) were used for the statistical analyses. | PMC10666315 | ||
Uncertainty | neck pain, Neck Disability, pain | The uncertainty of ICER and costs was estimated using the bootstrap residual technique [Three sensitivity analyses were conducted. First, a per-protocol analysis was performed only on patients who had received six or more treatments. Second, the method for calculating the productivity loss was altered. In the primary analysis, overall work impairment was calculated by including all patients and not just waged workers. Because it was assumed that only employed patients would have time and productivity loss in the sensitivity analysis, the loss of patients other than waged workers was processed as zero. Third, pharmacopuncture fees may vary from one hospital to another as they are not reimbursed. Accordingly, pharmacopuncture fees were assumed to be 1.5 and 2 times the pharmacopuncture cost in the primary analysis while performing the cost-effectiveness analysis. Finally, a cost-effectiveness analysis was performed on the Numerical rating scale(NRS) score for neck pain and Neck Disability Index (NDI). The VAS is a numeric pain scale that can be used for an objective assessment of subjective pain felt by patients. The patient selects the appropriate point along a 100 mm-long line with one end labeled 0, indicating no pain, and the other end labeled 10, indicating the worst pain possible [ | PMC10666315 | |
Results | PMC10666315 | |||
Participants | Between September 2019 and June 2020, 263 patients were screened, of which 101 were randomly allocated to the pharmacopuncture and usual care groups. One participant from each group withdrew their consent before receiving the treatment; moreover, one participant from the PT group was dismissed by the investigator due to an administrative error in the random allocation process. Ultimately, 98 patients (49 each in the pharmacopuncture and usual care groups each) who received at least one treatment session were included in the ITT analysis. The flow chart of the study is shown in Supplementary Figure A2 (see Additional file | PMC10666315 | ||
QALY | REGRESSION | The pharmacopuncture group showed a significantly lower EQ-5D-5 L score at baseline; however, the score was similar to those of the control group after 12 weeks. There were no significant differences between the two groups’ SF6D scores. The QALY was calculated using regression analyses adjusted for baseline values (Table
Distribution of utilities according to EQ-5D-5L and SF-6D by pharmacopuncture and usual care. *EQ-5D-5L : Questionnaire valuing health-related Quality of Life, SF-6D : An equipment evaluating healthThe adjusted QALY of the pharmacopuncture group for 12 weeks was 0.168 (95% confidence interval [CI], 0.165–0.171), while that of the control group was 0.166 (95% CI, 0.163–0.169). Accordingly, the adjusted differential QALY calculated based on the EQ-5D was 0.002. The adjusted QALY calculated based on SF-6D was 0.159 (95% CI, 0.155–0.164) in the pharmacopuncture group and 0.156 (95% CI, 0.151–0.160) in the control group, with an adjusted differential QALY of 0.003.
Utility and quality of life years (QALY) after randomization by pharmacopuncture and usual careNote.
| PMC10666315 | |
Costs | From a healthcare perspective, the combination of medical costs and direct non-medical costs were similar between the pharmacopuncture and control groups during the treatment period, whereas the cost was lower by $26 (95% CI, -123 to 64) in the pharmacopuncture group during the entire period. Regarding direct non-medical costs, the time cost was significantly lower in the pharmacopuncture group ($201; 95% CI, 186–217) than in the control group ($236; 95% CI, 210–263). Specifically, the time cost was significantly lower in the pharmacopuncture group because they spent less time being treated than the control group (Supplementary Table A5 (see Additional file
Cost comparisons between pharmacopuncture and usual care
***** | PMC10666315 | ||
Cost-utility analysis | chronic neck pain, NRS, includedSensitivity | SENSITIVITY | From a societal perspective, pharmacopuncture was superior as it showed a slightly higher QALY and a lower cost of $1,157 compared to usual care. Based on $26,375 as the WTP among the Korean public, the probability of being cost-effective from a societal perspective was 100% based on both EQ-5D and SF-6D (Table
Cost-effectiveness plane and cost-effectiveness acceptability curves of pharmacopuncture compared with usual careAn analysis from a healthcare perspective also showed a cost difference of $26, confirming that pharmacopuncture was better than usual care. Based on $26,375 as the WTP, the probability of cost-effectiveness from a societal perspective was 83.7% and 89.6% based on EQ-5D and SF-6D, respectively.
The results of cost-effective analysis for pharmacopuncture compared with usual careFor the base case analysis, QALY was calculated with EQ-5D in societal perspectives. The incremental cost was divided by the incremental QALY to calculate the incremental cost-effectiveness ratio (ICER). The distribution of cost and QALY was calculated by non-parametric bootstrapIn the main analysis, patients assigned to each group were followed-up up to 12 weeks, and missing values were imputed with multiple imputation. The costs from the healthcare system perspective include the costs of formal and informal healthcare involved in chronic neck pain treatment and the transportation and time costs. For the costs in the societal perspective, productivity costs from chronic neck pain are includedSensitivity analysis. 1 was a per-protocol analysis, which included patients who received at least six treatment sessions (47 in the pharmacopuncture group and 45 in the physical therapy group). Sensitivity analysis 2. Assuming that only employed patients suffered income loss due to time and productivity losses. Sensitivity analysis 3. We applied $26 by multiplying 1.5 with the pharmacopuncture cost in the base case analysis. Sensitivity analysis 4. We applied $35 by multiplying 2 with the pharmacopuncture cost in the base-case analysis. Sensitivity analysis 5. Cost effectiveness analysis based on NRS and NDI
| PMC10666315 |
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