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Declarations | PMC10176668 | |||
Ethics approval and consent to participate | Informed consent form was required to be signed by the subject and caregiver or study partner before exposure to any study-related procedure, including screening tests for eligibility. The Institutional Review Board (IRB; Advarra IRB, Columbia, MD) reviewed the protocol and informed consent form. The Investigators were required to conduct all the study aspects in accordance with applicable Regulatory national, state and local laws. | PMC10176668 | ||
Consent to publication | Not applicable. | PMC10176668 | ||
Competing interests | Nordisk, ABH, BBS, NJI, Dementia, LSS | BRAIN | Current/former employees of Cognition Therapeutics (Cognition): NJI, KML, RY, LW, MEH, SMC, AOC. Cognition paid consultants: CMY, JRC, RJG, CSD, MG, RM. LSS grants/fees: Eli Lilly, Merck, Roche/Genentech, Avraham, Boehringer Ingelheim, Neurim, Neuronix, Cognition, Eisai, Takeda, vTv, Abbott, Biogen, Novartis, Biohaven, outside this work. SD Chair of: Acumen Medical Scientific Advisory Board, Biogen Drug Monitoring Committee, Cognition Medical Advisory Board, DSMB for Prevail Pharmaceuticals and for pepinemab (Vaccinex, Inc.), Associate Editor of Neurotherapeutics, Editor for Dementia for UpToDate. HZ: SABs/as consultant for Abbvie, Acumen, Alector, Alzinova, ALZPath, Annexon, Apellis, Artery Therapeutics, AZTherapies, Cognition, Denali, Eisai, Nervgen, Novo Nordisk, Optoceutics, Passage Bio, Pinteon Therapeutics, Prothena, Red Abbey Labs, reMYND, Roche, Samumed, Siemens Healthineers, Triplet Therapeutics, Wave, has given lectures in symposia sponsored by Cellectricon, Fujirebio, Alzecure, Biogen, Roche, is co-founder of Brain Biomarker Solutions (BBS, of GU Ventures Incubator; outside this work). KB: consultant, advisory boards, data monitoring committees Abcam, Axon, Biogen, Cognition, Julius Clinical, Lilly, MagQu, Novartis, Siemens Healthineers, Roche Diagnostics, is co-founder of BBS. International Patent WO 15/116923 pertains to this paper. YIS received a grant to the University of Pennsylvania supporting this research. ABH has lectured or served at SABs for Abbvie, Alector, BioArctic, Biogen, Eisai, Janssen, Novo Nordisk, Roche. | PMC10176668 |
References | PMC10176668 | |||
Subject terms | desaturation, apnea | OBSTRUCTIVE SLEEP APNEA, EVENTS, SECONDARY, EVENT | Nasal pressure signal is commonly used to evaluate obstructive sleep apnea. This study aimed to assess its safety for respiratory monitoring during sedation. A total of 45 adult patients undergoing sedation with propofol and fentanyl for invasive endoscopic procedures were enrolled. While both nasal pressure and capnograph signals were continuously recorded, only the nasal pressure signal was displayed. The primary outcome was the incidence of oxygen desaturation below 90%. The secondary outcomes were the ability to predict the desaturation and incidence of harmful events and false alarms, defined as an apnea waveform lasting more than 3 min without desaturation. Of the 45 participants, 43 completed the study. At least one desaturation event occurred in 12 patients (27.9%; 95% confidence interval 15.3–43.7%). In these 12 patients, more than half of the desaturation events were predictable in 9 patients by capnography and 11 patients by nasal pressure monitoring ( | PMC9871023 |
Introduction | overdose, airway obstruction, hypoxemia, respiratory disorder, respiratory depression | AIRWAY OBSTRUCTION, HEMODYNAMIC INSTABILITY, RESPIRATORY DISORDER, EVENTS, RESPIRATORY DEPRESSION | The upper interventional endoscopy procedures of endoscopic submucosal dissection (ESD), endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and double-balloon enteroscopy (DBE) are currently performed under sedation with sedative agents, including propofol, dexmedetomidine, and benzodiazepine, and analgesics, including fentanyl, pentazocine, and pethidine, to reduce patient distress and achieve successful completion. However, hypoxemia associated with respiratory depression or hemodynamic instability is well known to occur frequently during sedation. Furthermore, cardiopulmonary events during endoscopy are described to be the most important fatal complicationsThe European Society of Gastrointestinal Endoscopy recommended that capnography be considered during the administration of propofol in specific situations, including high-risk patients, intended deep sedation, and long procedure durationA nasal pressure monitor is a simple and easy-to-use tool for assessing airflow and is commonly used during polysomnography, whereas a pneumotachograph, the gold standard method for measuring airflow, is inconvenient for use in daily clinical practice due to the requirement for a well-fitting maskFor these reasons, a nasal pressure monitor can distinguish between the central respiratory disorder due to drug overdose and the airway obstruction that requires management by its waveform | PMC9871023 |
Materials and methods | PMC9871023 | |||
Study population | CRF | CRF | Patients scheduled for ERCP, ESD, EUS-FNA, or DBE under sedation at Chiba University Hospital between December 2019 and April 2020 were enrolled. The inclusion criteria included age ≥ 20 years, SpOAll cases were registered centrally at the data center (Chiba University Hospital). All data were collected using case report forms (CRFs), and all CRFs were submitted to the data center. The data center used a system with which it was possible to acquire access logs and validation, enter the CRF data, and create data sets. The database was locked after verification by the principal investigator. This study was approved by the Research Ethics Committee of the Graduate School of Medicine, Chiba University (approval number 3180015). This trial was registered in the Japan Registry of Clinical Trials (identifier jRCTs032190146) on November 29, 2019. All methods were performed in accordance with the relevant guidelines and regulations of the Declaration of Helsinki. Written informed consent was obtained from all participants. | PMC9871023 |
Study design | This was a prospective, single-center, single-arm phase II trial to confirm the safety of the nasal pressure monitor as a novel approach to monitoring during invasive endoscopic procedures with non-anesthesiologist administration of propofol and fentanyl sedation. All patients were placed in the treatment position after both the capnography sensor (CO | PMC9871023 | ||
Procedure (intervention) | respiratory abnormality, obstructive sleep apnea, respiratory abnormalities, apnea, SpOAll adverse | ADVERSE EVENTS, BLOOD, EVENTS, OBSTRUCTIVE SLEEP APNEA | All patients underwent standard monitoring with continuous pulse oximetry. Blood pressure was monitored every 2.5 min for the first 15 min and then every 5 min, and clinical observation, including the Ramsay Sedation Scale, was performed every 5 min with electrocardiogram monitoring. Bispectral Index waveforms were also continuously recorded on the monitor. The information recorded on the monitor was later reviewed.The patients were sedated with propofol and fentanyl by an anesthesiologist-trained endoscopist, and the drug amount was appropriately adjusted according to the protocol for sedation during an invasive endoscopic procedure developed by the Anesthesiology Department of our hospital. When oxygen desaturation of SpOAll adverse events that occurred on day 1 after treatment were documented, and all serious adverse events within 1 week were also recorded, in addition to adverse events suspected of being related to the testing device.Following the procedure, the monitor records for both capnography and the nasal pressure monitor were reviewed by three physicians, including an expert on waveform analysis for the nasal pressure monitor. The incidence of oxygen desaturation below 95% or 90% was evaluated and compared with the existence of respiratory abnormalities and the type of respiratory abnormality based on the waveforms of the nasal pressure monitor and capnography at the point at which oxygen desaturation occurred. The respiratory abnormalities that occurred within 1 min before hypoxemic events were considered with reference to a previous report in which hypoxemic events could be delayed by 45–60 s after an apnea episode in patients with obstructive sleep apnea | PMC9871023 |
Study outcomes | desaturation | EVENTS | The primary outcome was the incidence of desaturation events, defined as a fall of SpO | PMC9871023 |
Statistical analysis | hypoxemia, respiratory abnormalities | REGRESSION | Using propofol-based sedation, the hypoxemia rate during invasive endoscopic procedures under sedation was reported to range from 12 to 50%Continuous data were expressed as the mean and standard deviation. Categorical data were presented as numbers and percentages. Categorical variables were compared using Fisher’s exact test. Logistic regression analysis was used for univariate analysis, and the OR and 95% CI were calculated. The CI for the percentage of two values was calculated using the Clopper–Pearson interval. A two-tailed p-value < 0.05 was considered statistically significant. For comparison of multiple items, a p-value < 0.05/α (α indicating the number of multiplicities) was considered significant using the Bonferroni correction. When comparing respiratory abnormalities, a p-value < 0.0125 was set as the significance level because there were four variables. All data analyses were performed using SAS (version 9.4, SAS Institute, Cary, NC, USA). | PMC9871023 |
Ethics statement | This study was approved by the Research Ethics Committee of the Graduate School of Medicine, Chiba University (approval number 3180015). Written informed consent was obtained from all participants. | PMC9871023 | ||
Results | PMC9871023 | |||
Analysis population | A total of 45 adult patients were assessed for eligibility, and all the patients were enrolled. Of the 45 patients, two patients dropped out before treatment: one had the procedure canceled, and the other’s respiratory waveform was not displayed from the start due to an equipment malfunction. Thus, we analyzed data from both monitoring waveforms during the treatment of 43 patients. Figure Study population and patient enrollment for analysis. | PMC9871023 | ||
Primary outcome | oxygen desaturation | Of the 43 patients who underwent endoscopic treatment, 12 patients had oxygen desaturation of SpO | PMC9871023 | |
Respiratory abnormality detectability | During treatment, oxygen desaturation of SpO | PMC9871023 | ||
Representative cases | Figure Waveform examples. Top, capnography; bottom, nasal pressure monitoring. Arrows (black) indicate the point of SpO | PMC9871023 | ||
Discussion | respiratory abnormality, obstructive disorders, respiratory abnormalities, allergies | OXYGEN DEFICIENCY, ADVERSE EVENTS, EVENT, HYPOXIC, ALLERGIES, EVENTS | In this phase II study, no major safety issues were observed with the nasal pressure monitor as a novel approach to monitoring during invasive endoscopic procedures under sedation with propofol and fentanyl. SpOOf the 45 patients, two cases dropped out: one due to the cancellation of the endoscopic procedure itself and the other due to the non-display of the monitor due to the occlusion of the cannula by the patient’s body, causing inhibition of pressure transmission. No similar event had occurred since then by taking care not to press the cannula. Two adverse events clearly related to endoscopic procedures were observed, but they had no effect on the primary goal of this phase II study, that is, confirming the safety of nasal pressure monitoring. Furthermore, waveform analysis revealed that the nasal pressure monitoring system could detect respiratory abnormalities when oxygen desaturation episodes occurred. Therefore, nasal pressure monitoring can be used as a respiratory monitor during the endoscopic procedure under sedation to detect respiratory abnormalities before SpOAccording to waveform analysis, there were more patients with high detectability of respiratory abnormalities at oxygen desaturation by the nasal pressure monitor than by capnography. However, no significant differences were observed. As previously reported, even if capnography did not display respiratory abnormalities, hypoxic events occurred in this study. The nasal pressure monitor also could not detect respiratory abnormalities before all hypoxic eventsThis study also thoroughly examined respiratory abnormalities during oxygen deficiency, demonstrating that only the nasal pressure monitor could detect obstructive disorders, which capnography did not (Table In this study, ASA class I and allergies were risk factors associated with a decrease in SpOThis study has several limitations. First, this was a single-center study conducted at Chiba University. Second, waveform analysis may be biased due to physician subjectivity, even though waveform analysis was performed by three physicians, one of whom was an expert in waveform analysis, and each respiratory abnormality was defined in detail. Third, a waveform analyst examined respiratory abnormalities at the point of oxygen desaturation a few weeks after the procedure to compare the two monitoring systems, even though it is critical that the physician in charge of sedation be able to make a decision regarding respiratory abnormalities during the procedure. This point should be investigated further in future research. Fourth, since the trial was planned as a phase II pilot trial to evaluate the safety and feasibility of nasal pressure monitoring compared to capnography, sample size and event size were low even though the statistically demanded size was reached. Therefore, the study was underpowered to find differences in hypoxic event rates and false alarms for nasal pressure monitoring and capnography. Fifth, since the Japanese guidelines for sedation in gastroenterological endoscopy describe the effectiveness of the combined use of propofol and fentanyl for ERCPIn conclusion, this study confirmed the safety of the nasal pressure monitor to proceed to a phase III trial. This monitoring method during an endoscopic procedure that requires sedation may be useful in detecting respiratory abnormalities before SpO | PMC9871023 |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-28213-y. | PMC9871023 | ||
Acknowledgements | We would like to thank Masayuki Yokoyama, Kosho Asano, Miyuki Sensui, Yukiko Shima, Satomi Nakamura, Ryoko Arai, and Yuka Izumi for supporting this research. This study would not have been possible without them. | PMC9871023 | ||
Author contributions | T.M., H.N. | H.N. and R.M. wrote the paper. H.N., R.M., S.I., and S.O. designed the study. R.T. and Y.S. analyzed the data. H.S., I.O., S.Y., T.M., K.K., Y.K., Y.M., M.K., S.M., and T.Y. performed endoscopy and collected the data. J.K. and N.K. supervised the study. All authors reviewed the manuscript. | PMC9871023 | |
Funding | The authors received no specific funding for this work. | PMC9871023 | ||
Data availability | All data generated or analysed during this study are included in this published article (and its Supplementary Information files). | PMC9871023 | ||
Competing interests | Shiroh Isono is one of the inventors of the nasal pressure monitoring system tested in this study. Shiroh Isono received scholarship donations and consultant fees from Nihon Kohden Inc. The other authors declare no conflicts of interest. | PMC9871023 | ||
References | PMC9871023 | |||
Introduction | COPD | COPD, DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease characterized by persistent and progressive restrictions on air circulationPulmonary rehabilitation (PR) is an essential component of COPD management and has been proven to improve the physical and psychological ability of patientsTherefore, the aim of this study was to develop a PA intervention for stable COPD patients in China based on the BCW and to evaluate the feasibility and effectiveness of the method in the hope of providing guidance for the treatment of such patients, with the results reported as follows. | PMC10739839 |
Methods | PMC10739839 | |||
Study design | COPD | COPD | This study adopted a quasi-experiment design (nonequivalent control group and non-synchronized, pretest–posttest design). Due to it is difficult to achieve double-blind intervention in this study, non-randomized controlled trials were selected. We used a convenient sampling method to select COPD patients in the outpatient and ward of the Department of Respiratory Medicine of the First Affiliated Hospital of Zhejiang University and Haining People's Hospital. In order to better control the confounding variables, this study used a coin toss method for inpatients and outpatients. The patients in the first ward of respiratory medicine were taken as the experimental group, and the patients in the second ward of respiratory medicine were taken as the control group. The study was approved by the Institutional Research Committee of the First Affiliated Hospital of Zhejiang University and registered on ClinicalTrials.gov (ChiCTR2200060590). All participants provided written informed consent, and all ethical considerations were observed according to the Helsinki Declaration. | PMC10739839 |
Participants | COPD | MAY, COPD | Participants were recruited from May 2022 to July 2022. Inclusion criteria were as follows: (1) the diagnosis of stable COPD patients according to the GOLD (2022) guidelines, with a postbronchodilator ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) < 0.70, and absence of exacerbation in the 4 weeks before collection | PMC10739839 |
Sample size calculation | We calculated sample size based on the assumption that patients who received a behavior-change intervention improved the primary outcome (physical activity levle). Sample size was calculated using the formula: n1 = n2 = (Zα + Zβ)2 * 2σ2/δ2. The two-group sample size ratio was 1:1, statistical power of 90%, and a 2-sided significance level of 0.05. According to the pilot study, σ = 210.56 and δ = 154.08 were substituted into the formula. Allowing for an 15% loss to follow-up, we planned to recruit 92 participants (46 per group). | PMC10739839 | ||
Intervention | COPD | COPD, DISEASE | This study is mainly divided into two groups, experimental group and control group. Both the experimental and control groups received standard medical care provided in the hospital. The control group was given routine intervention and health education guidance, including basic knowledge of the disease, smoking cessation, self-management skills, an action plan for COPD acute exacerbations, exercise training guidance (respiratory training), social psychological guidance and nutritional support. After discharge, telephone follow-up was conducted once a week for 15–20 min for 12 weeks. The main contents of follow-up included asking patients about their current health status, informing patients to seek medical treatment in time if their condition worsened, and answering patients' common health questions. In the experimental group, a PA program based on BCW theory was implemented on the basis of routine nursing, as follows. A flowchart of the intervention for the protocol is provided in Fig. Flowchart of the intervention for the protocol. | PMC10739839 |
Building the intervention team | A nurse-led multidisciplinary team was established before the intervention. There were 13 members in the group, including 1 director of the nursing department, 2 head nurses, 2 chief physicians of respiratory medicine, 1 rehabilitation therapist, 4 nurses of respiratory medicine and 3 postgraduates of nursing. Among them, the director of the nursing department was responsible for the overall control and quality control of the research to ensure the rigor and rationality of the research; the head nurse was responsible for personnel arrangement and organization of training; respiratory physicians were responsible for the supervision and guidance of research programs; the rehabilitation therapist was responsible for prephysical activity assessment and safety monitoring during exercise; respiratory nurses were responsible for the implementation of intervention programs, health education and follow-up; and master’s students were mainly responsible for literature retrieval and quality evaluation, construction of scheme and data collection. | PMC10739839 | ||
Develop a physical activity plan | COPD | COPD, DISEASE | At the beginning of this phase, a literature review and expert consultation were used to formulate the components and steps of the intervention. Then, combined with the disease demands of COPD patients in China, we initially constructed the first draft of a PA intervention program for COPD patients under the guidance of BCW theory. The full scoping review has been published previously | PMC10739839 |
Implementing the intervention | nausea, dyspnea, PA behavior, chest pain, dizziness, bad emotions, TTM, COPD | COPD, DISEASE, BEND |
Motivational interviewOn the first day of admission, the nurse introduced the ward environment and the purpose of the study to the patient and her family, obtained the patient’s consent and cooperation, and signed the informed consent form. The patient’s medical history, PA status and other information related to the disease were inquired. Subsequently, patients were provided with customized health education manuals, including the epidemiology, risk factors, disease symptoms and clinical manifestations of COPD. We assessed the stages of PA behavior change in COPD patients according to the Transtheoretical Model model (TTM). TTM stages include Precontemplation, Contemplation, Preparation, Action, Maintenance. TTM is a successful framework for guiding behavior change programs for several health behaviors. The type, duration, and intensity of the PA should be geared towards which stage the individual finds themselves in at the time. One-on-one motivational interview was used to assess the patients' current behavior change stage: in the pre-intention/intention stage, the health education of PA knowledge should be continued to be strengthened; in the preparation/action phase, nurses should help patients develop an action plan and provide information support.
Assess physical activityAt the study visit, we used the International Physical Activity Questionnaire (IPAQ) to assess the past and current PA history of patients, including the type, intensity, time and frequency of activity, and to understand the daily activity level of the patients; introduce the definition of PA and SB, the benefits of PA to health and the dangers of prolonged sedentary behavior to patients and their families, correct their incorrect perception, and establish a correct concept of disease. In addition, we should pay more attention to the psychological nursing of patients, understand the possible concerns of patients and their families in activities, strengthen psychological counseling for their bad emotions, and guide patients to master the skills to relieve psychological stress, such as listening to soothing music, reasonable exercise, mindfulness meditation practice, and planting green flowers.
Make a planAccording to the PA assessment results and lung function status at baseline, COPD patients were divided into a moderate- and vigorous-intensity group and a low-intensity group. Individual PA levels were classified according to criteria developed by the IPAQ group (see Exercise prescription.
Set a goal(I) Short-term goal: patients in the low-PA group might start with low-intensity PA (for example, walking at a leisurely pace, riding a bike on flat ground and lifting light weights) and gradually increase the intensity of exercise; patients in the moderate- to high-intensity PA group recommended performing moderate-intensity exercise (brisk walking) at least 5 days a week. (II) Long-term goal: All patients’ daily walking time increased, sedentary time decreased, dyspnea improved, and cardiopulmonary function and quality of life improved.
Implement exercise prescriptionIn the first week after discharge, exercise guidance was provided by the exercise rehabilitation therapist, and the patients in the moderate and vigorous PA groups received comprehensive training combined with aerobic exercise and resistance exercise. Patients in the low PA group only performed aerobic exercise; both groups performed warm-up and relaxation training for 5–10 min before and after exercise. Walking was recommended as the main training method of aerobic exercise. The workout session should last between 25 and 60 min with a frequency of 3–5 times every week. Resistance exercise is recommended to use an elastic band, mainly for the upper limbs, including three movements: standing front horizontal lift, arm bend lift in the standing position and chest push in the sitting position. Each movement lasts approximately 3 s, repeated 10–15 times as a set, for a total of 2 sets. The interval between the sessions was 2 min and 3 times a week.
Exercise monitoring and safety precautions(I) Explain the safety precautions related to the activities to the patients and their families in detail. Stretching and relaxation training can be performed before and after exercise. The duration was 5–10 min, and a slight stretching sensation was dominant. If the patient is over 75 years old and has poor physical fitness, it is best to be accompanied by a family member. (II) Identify the signs of termination of exercise: once a patient has chest pain, dyspnea (modified Borg dyspnea scale > 5 points), dizziness, nausea and vomiting, pallor, sweating, resting heart rate above 120 beats per minute, systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure > 100 mmHg (1 mmHg = 0.133 kPa), SpO
Regular follow-upAfter discharge, the patients were followed up by telephone or WeChat (that is a smartphone application) every week for 15–20 min for 12 weeks. The main contents of follow-up included asking the patient about the activity history of the past week, assessing whether the patient's exercise goal had been completed, reminding the patient to continue exercising, recording the results on the follow-up form, and giving feedback in a timely manner. | PMC10739839 |
Assessments | PMC10739839 | |||
General data | COPD | COPD | The questionnaire was designed by researchers on the basis of reviewing the relevant literature. (I) Demographic data, including age, sex, weight, marital status, education level, smoking status, etc.; (II) disease-related data, including GOLD classification, year of COPD diagnosis, comorbidities, etc. | PMC10739839 |
International physical activity questionnaire, IPAQ | The questionnaire was developed by the World Health Organization in 1998. It includes both short and long versions and is recognized as one of the valid assessment questionnaires for measuring PA levels | PMC10739839 | ||
Pulmonary function tests | Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the FEV1/FVC ratio were measured by a computerized spirometer. The spirometer was calibrated before use to ensure that it worked properly. Before the examination, we understood the patient’s medical history and treatment in detail, determined whether the indication for spirometry was met, and paid attention to exclude relevant contraindications. Introduce the procedure and movement to the patient and guide the patient to practice to master the movement more quickly. The patient takes a sitting position with his chest straight, feet relaxed and the head naturally level or slightly tilted. According to the test curve and indicators, patients were guided to perform measurement procedures and corresponding actions. The measurement is repeated, and the best result is selected. | PMC10739839 | ||
Modified Medical Research Council scale (mMRC) | breathlessness, disability | The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 (no breathlessness except on strenuous exercise) to 4 (too breathless to leave the house or breathless when dressing or undressing) | PMC10739839 | |
Six minutes walking test, 6MWT | dyspnea, fatigue | BLOOD, THORACIC | The 6MWT was undertaken in accordance with the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. It was carried out by the team members in the corridor of the respiratory ward of the hospital, with a length of 30 m and red warning lines marked at both ends of the ground. Blood oxygen saturation and heart rate were monitored during the experiment using a portable oximeter. At the end of the experiment, walking distance was recorded, and the Borg scale was used to assess dyspnea and fatigue. | PMC10739839 |
Exercise Self-Regulatory Efficacy Scale, EX-SRES | COPD | COPD | This scale was developed by Davis et al. and can be used as an effective tool to assess exercise efficacy beliefs in COPD patients | PMC10739839 |
COPD assessment test, CAT | The scale was developed by Jones PW and can be used to assess the clinical symptoms and quality of life of patients | PMC10739839 | ||
Data collection | The general data and outcome indicators of this study were collected by two trained and qualified evaluators. The collection time of each indicator was as follows: (I) Baseline data: collected on the day of admission; (II) The outcome indicators included the main outcome indicators: physical activity, which was collected on the day of admission (T0), week 4 (T1), week 8 (T2) and week 12 (T3). Secondary outcome indicators: sedentary time, exercise ability, mMRC, exercise self-efficacy and CAT were collected at T0, T1, T2 and T3. Pulmonary function indexes were measured at T0 and T3. In addition to the baseline data collected in the hospital, the outcome indicators at the T1, T2 and T3 time points were mainly collected by telephone or WeChat. Electronic questionnaires were distributed to patients and filled in by the patients themselves. Questionnaires were collected on site. Vague questions or uncertain options should be checked with the patient before filling them in. | PMC10739839 | ||
Data analysis | All data were input into Excel 2017. After double-checking and verification, a database was established, and SPSS 26.0 statistical software was used for statistical analysis. To evaluate the normality of the data, the Shapiro–Wilk test was utilized. Data are presented as the mean ± standard deviation (SD) for continuous variables and frequencies and percentages for categorical variables. We used the difference-in-difference (DID) approach to evaluate the impact of our intervention because it allowed us to make comparisons before and after exposure to our intervention between the experimental and control groups. Two independent sample Repeated measures analysis of variance (ANOVA) was used to evaluate the change trend of the scale scores at different time points. The effect size of repeated measures ANOVA was calculated as partial et squared ( | PMC10739839 | ||
Results | PMC10739839 | |||
Discussion | dyspnea, COPD | COPD, DISEASE, DISEASE PROGRESSION | To the best of our knowledge, this is the first study to evaluate the effect of a PA program based on BCW theory on PA levels, sedentary time, dyspnea, exercise capacity, lung function and HRQoL among patients with COPD. The results showed that, compared to the control group, the PA of patients in the experimental group increased significantly and the sedentary time decreased after 12 weeks of intervention. The program increased the patient's exercise capacity and self-efficacy, and improved the patient's health-related quality of life. Due to the limited intervention time in this study, the pulmonary function of COPD patients may not be reversed in a short time, and the long-term effect of this program on the pulmonary function of patients needs to be further explored.PA and prolonged sitting are strongly associated with increased all-cause mortality in patients with COPDLung function is of great significance for monitoring disease progression in COPD patients. FEV1/FVC is a sensitive index to evaluate airflow limitation. Due to the complexity and long duration of COPD, lung function is impaired to varying degrees, leading to dyspnea and decreased exercise toleranceShortness of breath is one of the most common symptoms of COPD patients and a major predictor of hospitalization and mortalityThe 6MWT is an important marker of disease severity in patients with COPD, which has been shown to be related to lung function and HRQoL and can predict patient mortalityLow exercise self-efficacy in COPD patients was associated with low PA, self-reported health status, and exercise ability. The results of this study showed that there were statistically significant differences in the group effect, time effect and interaction effect of exercise self-efficacy between the two groups ( | PMC10739839 |
Limitations | COPD | COPD | Considering the factors of manpower, material resources and time, there are still some limitations in this study. First, compared with experimental studies, quasi-experimental studies are more feasible and practical in population intervention research. There are several limitations associated with quasi-experimental designs, which include lack of randomization, selection bias, performance bias and reporting bias. Large sample, multi-center, randomized controlled trials can be further carried out in the future. Second, we measured PA using a questionnaire but not using an accelerometer. Questionnaire-based surveys may be affected by recall bias, resulting in higher self-reported levels of PA. To obtain more accurate data, objective measurement tools such as accelerometers could be used to assess physical activity levels in the future. Third, the intervention and follow-up time of the project was only 12 weeks, which was relatively short. Exercise is a long-term process, and the health benefits of patients may be more significant with the increase in the duration of the intervention period. Therefore, we will continue to explore the lasting effects of this behavior change program on PA in COPD patients. | PMC10739839 |
Conclusions | COPD | COPD | In summary, our results showed that the BCW theory-based PA program increased PA levels, reduced sedentary time, enhanced exercise capacity and self-efficacy, and improved some lung function measures as well as HRQoL in patients with stable COPD. In the future, we can further explore the continuous effect of this program on lung function changes in COPD patients. | PMC10739839 |
Supplementary Information |
Supplementary Information 1.Supplementary Information 2. | PMC10739839 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-50099-z. | PMC10739839 | ||
Acknowledgements | COPD | COPD | We would like to thank all individuals with COPD who participated in this study and the staff who helped collect data. | PMC10739839 |
Author contributions | X.X.: Data curation, Data collection, Formal analysis, Writing-original draft. M.H.: Data curation, Data collection, Formal analysis. X.L. and X.L.: The study research design, Methodology, and interpretation. Y.Y: Investigation, Formal analysis. S.C.: Investigation, Formal analysis. L.H.: Conceptualization, Methodology, Validation, Formal analysis, Resources, Visualization, Supervision, Writing-review & editing, Project administration. | PMC10739839 | ||
Funding | This work was supported by two grants from the General Public Welfare Projects of Science and Technology Department of Zhejiang Province of China (LGF20G030009). The Medical and Health Science and Technology Department of Zhejiang Province (2023KY695). | PMC10739839 | ||
Data availability | Data from this study are available on request from the corresponding author (lihuahuang818@zju.edu.cn). | PMC10739839 | ||
Competing interests | The authors declare no competing interests. | PMC10739839 | ||
References | PMC10739839 | |||
Background | blood loss | BLOOD LOSS | This randomized controlled study was undertaken to investigate the efficacy of intravenous tranexamic acid (TXA) administration in reducing perioperative blood loss in patients undergoing medial opening-wedge distal tibial tuberosity osteotomy (MOWDTO). It was hypothesized that TXA would reduce perioperative blood loss in MOWDTO.
| PMC9996975 |
Methods | blood loss | BLOOD LOSS | A total of 61 knees in 59 patients who underwent MOWDTO during the study period were randomly assigned to either of the groups with intravenous TXA administration (TXA group) or without TXA administration (control group). In the TXA group, patients received 1000 mg of TXA intravenously before skin incision and 6 h after the first dose. The primary outcomes was the volume of perioperative total blood loss which calculated using the blood volume and hemoglobin (Hb) drop. The Hb drop was calculated as the difference between preoperative Hb and postoperative Hb at days 1, 3, and 7.
| PMC9996975 |
Results | blood loss | BLOOD LOSS | The perioperative total blood loss was significantly lower in the TXA group (543 ± 219 ml vs. 880 ± 268 ml | PMC9996975 |
Keywords | PMC9996975 | |||
Introduction | bleeding, blood loss, varus deformity, knee osteoarthritis, DVT | BLEEDING, BLOOD LOSS, POSTOPERATIVE BLEEDING, KNEE OSTEOARTHRITIS, POSTOPERATIVE DEEP VEIN THROMBOSIS, DVT | Osteotomy around the knee is a widely employed surgical option for medial compartment knee osteoarthritis exhibiting varus deformity [As a countermeasure for postoperative bleeding, tranexamic acid (TXA) administration plays a key role in various surgical fields [With the recent trend in joint preservation and biological reconstruction in surgical treatment of the knee, the number of types of osteotomy procedures being performed has been increasing in recent years [Postoperative three-dimensional computed tomography after medial opening-wedge distal tibial tuberosity osteotomy for right knee. The purpose of this study was to investigate the efficacy and safety of TXA administration in MOWDTO by examining the perioperative amount of bleeding and the incidence of postoperative deep vein thrombosis (DVT). The hypothesis of this study was that TXA would reduce perioperative total blood loss without increasing the risk of DVT. | PMC9996975 |
Materials and methods | PMC9996975 | |||
Study design | pulmonary embolism, allergy, knee osteoarthritis, DVT | PULMONARY EMBOLISM, ALLERGY, KNEE OSTEOARTHRITIS, DVT | This prospective, two-arm, parallel group, randomized-controlled, open-label trial with 1:1 treatment allocation was performed in a single university hospital. The study was approved by the institutional review board. (Registered on 26/02/2019, registration number 3136). Before participant enrollment, the trial was registered as a randomized controlled trial with the University Hospital Medical Information Network (Registered on 9/11/2018, registration number UMIN000034842).Patients were recruited between February 2019 and March 2021 from the patient population of a single university hospital, and eligible patients gave written informed consent. The inclusion criteria of this randomized controlled trial were patients older than 20 years with medial compartment knee osteoarthritis scheduled for MOWDTO. The exclusion criteria were as follows: previous history of DVT or pulmonary embolism (PE); patients who declared an allergy to TXA by the preoperative interview; patients scheduled for MOWDTO combined with other procedures such as implant removal, anterior cruciate ligament (ACL) reconstruction, osteochondral autograft transfer, and autologous chondrocyte implantation. | PMC9996975 |
Randomization | Each patient participating in the trial was randomly assigned to one of the two groups through simple random allocation. We generated randomized numbers ranging from 0 to 99 with a computer software (Excel 2010; Microsoft, Redmond, Washington, USA). Patients with even numbers were allocated to the group scheduled to receive intravenous TXA, and those with odd numbers were allocated to receive no TXA administration. | PMC9996975 | ||
Interventions | The study treatments were intravenous TXA administration (TXA group) or no administration of TXA (control group). In the TXA group, patients received 1000 mg of TXA diluted by 100 ml of saline intravenously (Transamin; Daiichi Sankyo, Tokyo, Japan) before skin incision and 6 h after the first dose. The patients allocated in the control group did not receive TXA. Other perioperative interventions, such as surgical technique, rehabilitation regimen, and perioperative medications were the same for all patients. | PMC9996975 | ||
Surgical procedure | Akiyama T | All surgical procedures were performed in a standardized manner under general anesthesia and performed by one of the four surgeons. No pneumatic tourniquet was used during the study period. The MOWDTO procedure performed in this study followed the triplane osteotomy technique described by Akiyama T [Postoperative radiograph of the right knee. | PMC9996975 | |
Postoperative care | postoperative thromboembolism, anemia, pain | ANEMIA | After surgery, elastic compression stockings and a mechanical compression device were applied to the lower limbs on both sides. For chemoprophylaxis for postoperative thromboembolism, 15 mg per day of edoxaban, an Xa-inhibitor, was orally administered until one week after surgery. At one week, ultrasonographic examination with pulsed Doppler, color Doppler (Toshiba Medical Systems, Japan) was performed for screening of DVT.Postoperative drainage volume was recorded separately on the first day and second day, and the suction drain was removed on the second day. From the day after surgery, patients were given oral 60 mg of loxoprofen three times a day and 75 mg of pregabalin once a day. For patients with severe pain, additional prescription of tramadol hydrochloride acetaminophen was allowed as needed.The postoperative rehabilitation regimens were the same for both groups, and range of motion exercise was initiated at postoperative day 1. Weight bearing of lower limbs on the surgical side was allowed at two weeks. We evaluated hemoglobin (Hb) at postoperative day 1, 3 and 7. Allogeneic blood transfusion was indicated for patients with Hb < 7.0 g/dl or those with Hb < 10.0 g/dl if they had symptoms related to anemia.
| PMC9996975 |
Outcome measures | PMC9996975 | |||
Primary outcome | blood loss, Hb loss | BLOOD LOSS | The primary outcome was the volume of perioperative total blood loss, which was calculated as follows.First, the blood volume of the patient was calculated in liters using the following formula according to Nadler et alSecond, Hb loss was calculated according to the following formula.Finally, the total blood loss was calculated as follows:In addition, Hb drop at postoperative days 1, 3 and 7 and the amount of postoperative drainage volume were measured and compared between two groups. | PMC9996975 |
Secondary outcomes | pain, DVT | SECONDARY, SOFT TISSUE INFECTIONS, COMPLICATIONS, DVT | The secondary outcomes were the overall incidence of DVT, rate of blood transfusion, the incidence of wound complications and superficial soft tissue infections, leg circumference and the visual analog scale (VAS) score. The circumference of the leg was measured before surgery and at postoperative day 7 by physiotherapists at the maximum circumference of the lower leg. The VAS score at rest was measured periodically from the following day to five days after surgery at 6:00 AM, 12:00 PM, and 8:00 PM. The VAS score during activity was defined as the strongest pain experienced during physical therapy. | PMC9996975 |
Statistical analyses and sample size | Statistical analyses were performed using the R software (The R Foundation for Statistical Computing). The comparisons between the two groups were performed using the Student’s | PMC9996975 | ||
Results | PMC9996975 | |||
Secondary outcomes | pain, DVT | DVT | The ultrasonographic examination at postoperative day 7 revealed DVT in the lower leg in two patients in the TXA group and two patients in the control group (Visual analog scale scores for pain at rest after surgeryVisual analog scale scores for pain during activity after surgery | PMC9996975 |
Discussion | blood loss, postoperative pain, arthroplasty, DVT | BLOOD LOSS, COMPLICATIONS, DVT | The most important finding of this study was that the intravenous administration of TXA reduced perioperative total blood loss in MOWDTO without increasing the incidence of DVT.This is the first randomized controlled study to examine the effectiveness of intravenous TXA administration in MOWDTO, which was developed as a modification of MOWHTO.Osteotomies around the knee are widely accepted surgical options for osteoarthritic knees and there are several modified procedures to cope with potential shortcomings of MOWHTO. However, some authors have reported that approximately 5 to 7% of patients who underwent MOWHTO experienced complications associated with wound problems [As for potential risks of the use of TXA, previous studies in patients undergoing total joint arthroplasty have shown that TXA administration is not associated with increased incidence of DVT and PE [Regarding the effectiveness of TXA administrations in decreasing postoperative pain, several reports have concluded that it could relieve postoperative pain [There are several limitations in this study. First, the surgical team and anesthesiologists were not blinded. On the other hand, the surgical approach was consistent in both groups, and the total blood loss as a primary outcome could not have been biased by the observer. Second, the control group did not receive placebo. Finally, in the present study, the obtained data are limited to only short-term outcomes and the effects of TXA administration on the clinical outcome or patient satisfaction were not subjected to analysis. | PMC9996975 |
Conclusion | blood loss, bleeding, DVT | BLOOD LOSS, BLEEDING, DVT | Intravenous TXA administration in MOWDTO reduced the perioperative blood loss without increasing the risk of DVT. These study results suggest that intravenous administration of TXA might be an effective and safe measure for control of perioperative bleeding in this modified osteotomy procedure. | PMC9996975 |
Acknowledgements | Not applicable. | PMC9996975 | ||
Author contributions | TI developed the study design and drafted manuscript. RK, TI, SO and HN performed surgeries. SY and TT supervised the study. All authors read and approved the final manuscript. | PMC9996975 | ||
Funding | There was no external source of funding for this study. | PMC9996975 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are not publicly available due to their containing information that could compromise the privacy of research participants. However, the data are available from the corresponding author on reasonable request. | PMC9996975 | ||
Declarations | PMC9996975 | |||
Ethics approval and consent to participate | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Each author certifies that his institutional approved the human protocol for this investigation and that all investigation was conducted in conformity with ethical principles of research. This study protocol was approved by the institutional review board of Hyogo College of Medicine (Registration Number 3136). All patients provided written informed consent to participate. | PMC9996975 | ||
Competing interests | All authors report no competing interests with regard to this study. | PMC9996975 | ||
References | PMC9996975 | |||
Background | Peripheral neuropathy, amputation, diabetic, peripheral neuropathy, disability, diabetes | PERIPHERAL NEUROPATHY, PERIPHERAL NEUROPATHY, FOOT ULCERATION, DIABETES | Peripheral neuropathy is not only the most prevalent consequence of diabetes but also the main reason for foot ulceration, disability, and amputation. Therefore, the current study aims to determine the effectiveness of oral clonidine and gabapentin on peripheral neuropathy in diabetic patients. | PMC10577942 |
Methods | peripheral neuropathy, diabetic | TYPE 2 DIABETES, PERIPHERAL NEUROPATHY | This 12-week, randomized, and parallel-group trial was conducted to compare the efficacy of oral clonidine and gabapentin with gabapentin alone in diabetic patients in southwest Iran during the first half of 2021. Thirty patients with type 2 diabetes with peripheral neuropathy as assessed by a visual analog scale (VAS) and divided into two groups of 15 patients, treated for up to three months. The data were analyzed using SPSS-21 software. In order to report the results, descriptive indices, independent t-test, one-way analysis of covariance (ANCOVA) and analysis of variance with repeated measures were used. | PMC10577942 |
Results | neuropathic pain | The mean and standard deviation of the age of the participants in the clonidine + gabapentin group was equal to 50.20 ± 7.44, and in the gabapentin group was equal to 50.47 ± 7.57 (t = 0.10, P-value = 0.923). This research showed a significant difference between the clonidine + gabapentin group and with gabapentin group in terms of neuropathic pain and the severity of neuropathic pain (P < 0.001). | PMC10577942 | |
Conclusions | diabetic, neuropathic pain, diabetes | DIABETES | According to this research results, clonidine + gabapentin can reduce neuropathic pain and the severity of neuropathic pain in diabetic patients. Therefore, it is recommended that healthcare professionals with diabetes expertise prescribe these medications to reduce neuropathic pain and its severity. | PMC10577942 |
Trial registration | This study was registered in the Iranian Clinical Trials System with the ID (IRCT20211106052983N1) on 14/01/2022. | PMC10577942 | ||
Keywords | PMC10577942 | |||
Background | DM, metabolic disorder, Diabetic Peripheral Neuropathy, amputation, Diabetes Mellitus, Diabetic Neuropathy, hyperglycemia, DPN, diabetic, disability, diabetes | METABOLIC DISORDER, DIABETES MELLITUS, DIABETIC NEUROPATHY, COMPLICATION, HYPERGLYCEMIA, FOOT ULCERATION, DIABETES | Diabetes Mellitus (DM) is a metabolic disorder caused by low insulin production or function, resulting in chronic hyperglycemia [As a significant cause of foot ulceration, disability, and amputation, Diabetic Peripheral Neuropathy (DPN) is the most prevalent complication resulting from diabetes. More than 50% of diabetic patients undergo Diabetic Neuropathy (DN), which affects their nervous system [Currently, there are few treatments for DN, most of which include many side effects. In previous investigations, the results of melatonin [ | PMC10577942 |
Methods | allergic, neuropathic pain, neuropathy, hyperthyroidism, psychiatric, diabetic, hypotension, cardiovascular, kidney disease, peripheral neuropathy, diabetes | NEUROPATHY, HYPERTHYROIDISM, DRUG INTERACTION, HYPOTHYROIDISM, PERIPHERAL NEUROPATHY, DIABETES | The current research is a randomized clinical trial on two groups with a pre-intervention phase and three post-intervention assessments (after two, four, and eight weeks). The population consisted of all diabetic patients with peripheral neuropathy who sought medication in the diabetes clinic of Yasuj during the first half of 2021. The inclusion criteria were: (1) Informed consent of all participants, (2) being diagnosed with diabetes and having symptoms of peripheral neuropathy, (3) being aged between 30 and 60, (4) being able to participate in the study, (5) not suffering from chronic (cardiovascular, kidney disease, and hyperthyroidism or hypothyroidism), neurological, and severe psychiatric illnesses, (6) not being pregnant or involved in breast-feeding, (7) no simultaneous use of medicines (antipsychotics, analgesics, or tricyclic antidepressants) which can affect neuropathic pain, and (8) not having hypotension (having + 11 blood pressure). Also, our exclusion criteria were (1) being highly allergic to clonidine, (2) being diagnosed with neuropathy for causes other than diabetes, (3) experiencing worsened symptoms due to taking the medicines, and (4) having a severe drop in blood pressure or drug interaction. | PMC10577942 |
Procedure | diabetic | STILL | In the present study, 49 diabetic patients were included using a purposeful sampling method. Thirty-four people entered the research process based on the entry criteria. Still, in operation, in each of the research groups, according to the exit criteria, two people left the research process. Finally, analyzed the information from 30 participants. They were then assigned to the clonidine + gabapentin and gabapentin groups randomly (according to the random allocation law). 15 participants were assigned to each group. In the present study, the researcher and the participants did not have any information about the drugs received. The researcher had only assigned the participants to the groups and evaluated them in the evaluation stages, but he had no information about the drugs that the participants were taking. In addition, the participants had no knowledge about which group they were in. The participants had no information about the number and type of medication prescribed for the opposite group. However, the attending physician was aware of the type of prescription drugs for each group based on the inclusion criteria and control of their side effects (drugs). Therefore, since the researcher and the participants did not know about the treatment process, the current research was double-blind (for the researcher and the participants). The participants in the experimental group received a daily clonidine dosage of 0.10 milligrams (Clonidine tablets were used at night) and a gabapentin capsule (100 milligrams) for eight weeks. However, the individuals in the control group took only gabapentin capsules (100 milligrams) daily for eight weeks. The participants in both groups completed the demographic—background information forms and the study measurements at all stages of the investigation. | PMC10577942 |
Measurements | PMC10577942 | |||
Michigan Diabetic Neuropathy Symptom score (DNS) | 2-very, neuropathic pain, pain | DNS combines scores from a neurological examination and standard nerve conduction stimulation. A 128-hertz diapason generates vibration to calculate this variable, and pain is induced on the back of the examinee’s toe using a sharp tool. During this procedure, the examinee is asked yes/no questions and is expected to answer. Responses with seven or more correct answers and one to seven or no correct answers are interpreted as average, weak, or lack of sensation, respectively. In addition, muscular strength is also examined in the distal muscles and rated on ranges of 0-normal, 1-weak-medium, and 2-very weak. Score 3 is given when examinee’s are unable to contract their muscles deliberately. The current tendon reflexes requiring facilitation and having no reflexes are scored by 0, 1, and 2, providing a maximum total score of 46. Higher scores than six are associated with neuropathic pain [ | PMC10577942 | |
The pain visual analog scale (VAS) | pain | In the current investigation, the patients were asked to rate their pain on the visual analog scale (VAS). This measurement consists of a scoring system varying between 0 (no pain) to 10 (unbearable pain), being known as the pain ruler [ | PMC10577942 | |
Statistical analysis | neuropathic pain | In the current research, frequency, percentage, mean and standard deviation indicators were used to examine descriptive results. Also, to check the homogeneity of demographic and background variables, the Chi-square test, Fisher’s exact test, and independent t-test were used. In addition, an independent t-test was used to investigate the differences between groups of neuropathic pain variables and neuropathic pain severity in different stages of the research. Finally, in order to check the results of research hypotheses, univariate analysis of covariance (ANCOVA) and variance test with repeated measurements were used. | PMC10577942 | |
Results | neuropathic, neuropathic pain, pain | Table
The descriptive indexes result of homogeneity gender, and medications of the participants according to their groups* Chi-squared test; ** Fisher’s exact testAs can be seen in Table
The descriptive indexes and background information homogeneity of the patients suffering from neuropathic pain in pre-intervention and post-intervention stages (two, four, and eight weeks after the initiation of the intervention)NOTE: Fre = Frequency; Per = Percentage; * Chi-squared test; ** Fisher’s exact testAs shown in Table
The Descriptive indices and independent t-test results for neuropathic pain and neuropathic pain intensity of the participants based on the stages evaluation and their groups* P < 0.05; ** P < 0.01Note: M = Mean; SD = Standard deviationAs shown in Table Table
The ANCOVA results for comparing the neuropathic pain between the study groups in the second, third, and fourth assessment stages* Effect Size: A numerical value that determines the difference between data and a statistical hypothesisIt is demonstrated in Table
The results of multivariate test for severity of neuropathic painAs shown in Table
The Results of multivariate test effects for neuropathic pain severity (based on the pain visual analog scale scores) for each research groupAccording to Table According to the results of the Bonferroni posthoc test, in the experimental group (clonidine + gabapentin), there are significant differences in terms of neuropathic pain severity between the first assessment and the other three assessment stages (P < 0.001). Also, the second assessment stages significantly differ from the third and fourth stages in neuropathic pain severity (P < 0.005). However, stages three and four are not significantly different (P > 0.05). Also, based on the results of the Bonferroni test in the control group (gabapentin), a significant difference was shown between the first assessment and the rest of the assessment stages (P < 0.05) and between the second assessment and the third and fourth assessment (P < 0.05). Despite these findings, no significant difference was discovered between stages three and four (P > 0.05). Figure
The interactive effects of the assessment stages and the study groups in terms of neuropathic pain severityIn addition, based on the results of multivariate effects between groups, there is a significant difference between the research groups regarding the severity of neuropathic pain (F = 22.42, P < 0.001). In addition, eta squared demonstrates that compared to gabapentin, prescribing clonidine combined with gabapentin can explain 0.44 of the between-group variances of the severity of neuropathic pain. | PMC10577942 | |
Discussion | diabetic, peripheral neuropathy, diabetes | PERIPHERAL NEUROPATHY, HIGH BLOOD PRESSURE, DIABETES | The current research aimed to determine the effectiveness of oral clonidine and gabapentin on peripheral neuropathy in diabetic patients. The results indicated that combining clonidine and gabapentin significantly affected peripheral neuropathy more than a single gabapentin consumption. To the best of our knowledge, to date, no previous investigation has examined the effectiveness of a combined treatment of gabapentin and clonidine (oral solution) on peripheral neuropathy among individuals who have diabetes. Below is information from other studies with similar results. Fulas et al. [Clonidine is a high blood pressure medication that can affect the alpha-adrenergic receptors and imidazoline as an agonist [There were limitations in the present study, which include: not having a group that was prescribed only clonidine. In this regard, it is suggested to consider a group for clonidine alone in future research. Another limitation of the research was the use of a purposeful sampling method, which led to a reduction in the generalizability of the results. In this regard, it is suggested to use a random sampling method to select participants in future research. | PMC10577942 |
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