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Findings
BPD, death
SECONDARY
In this secondary analysis of a randomized clinical trial including 799 extremely preterm infants, baseline risk for grades 2 to 3 BPD or death estimated using infants’ gestational age, birth weight, sex, respiratory support, and fraction of inspired oxygen was not associated with either benefit or harm from hydrocorti...
PMC10233424
Meaning
BPD, death, neurodevelopmental impairment
BRONCHOPULMONARY DYSPLASIA, SECONDARY
Differences in the association of hydrocortisone with death, BPD, or neurodevelopmental impairment were not identified when analyzed by infants’ baseline risk for BPD or death.This secondary analysis of a randomized clinical trial investigated whether estimated risk for grades 2 to 3 bronchopulmonary dysplasia or death...
PMC10233424
Importance
BPD, death, neurodevelopmental impairment, NDI
BRONCHOPULMONARY DYSPLASIA (BPD)
Extremely preterm infants who develop bronchopulmonary dysplasia (BPD) are at a higher risk for adverse pulmonary and neurodevelopmental outcomes. In the National Institute of Child Health and Human Development Neonatal Research Network (NICHD NRN) Hydrocortisone Trial, hydrocortisone neither reduced rates of BPD or de...
PMC10233424
Objective
BPD, death, NDI
To determine whether estimated risk for grades 2 to 3 BPD or death is associated with the effect of hydrocortisone on the composite outcomes of (1) grades 2 to 3 BPD or death and (2) moderate or severe NDI or death.
PMC10233424
Design, Setting, and Participants
SECONDARY
This secondary post hoc analysis used data from the NICHD NRN Hydrocortisone Trial, which was a double-masked, placebo-controlled, randomized clinical trial conducted in 19 US academic centers. The NICHD HRN Hydrocortisone Trial enrolled infants born at a gestational age of less than 30 weeks who received mechanical ve...
PMC10233424
Intervention
Infants were randomized to 10 days of hydrocortisone or placebo treatment.
PMC10233424
Main Outcomes and Measures
BPD, death, NDI
Infants’ baseline risk of grades 2 to 3 BPD or death was estimated using the NICHD Neonatal BPD Outcome Estimator. Differences in absolute and relative treatment effects by baseline risk were evaluated using interaction terms in models fitted to the efficacy outcome of grades 2 to 3 BPD or death and the safety outcome ...
PMC10233424
Results
BPD, death, NDI
Among the 799 infants included in the analysis (421 boys [52.7%]), the mean (SD) gestational age was 24.9 (1.5) weeks, and the mean (SD) birth weight was 715 (167) g. The mean estimated baseline risk for grades 2 to 3 BPD or death was 54% (range, 18%-84%) in the study population. The interaction between treatment group...
PMC10233424
Conclusions and Relevance
BPD, death
SECONDARY
In this secondary analysis of a randomized clinical trial, the effect of hydrocortisone vs placebo was not appreciably modified by baseline risk for grades 2 to 3 BPD or death.
PMC10233424
Trial Registration
ClinicalTrials.gov Identifier:
PMC10233424
Introduction
BPD, death, prematurity
BRONCHOPULMONARY DYSPLASIA (BPD)
Bronchopulmonary dysplasia (BPD) remains the most common serious morbidity of extreme prematurity,The recently conducted National Institute of Child Health and Human Development Neonatal Research Network (NICHD NRN) Hydrocortisone Trial compared hydrocortisone with placebo in extremely preterm infants receiving mechani...
PMC10233424
Methods
BPD
SECONDARY
We performed a secondary post hoc analysis of the NICHD NRN Hydrocortisone Trial, which was a double-masked, placebo-controlled, randomized clinical trial that enrolled 800 infants from 19 academic centers in the US. Participants were enrolled between August 22, 2011, and February 4, 2018, with follow-up between 22 and...
PMC10233424
Results
A total of 800 infants were enrolled in the NICHD NRN Hydrocortisone Trial (421 boys [52.7%] and 379 girls [47.3%]) (eFigure 1 in Compared with infants within lower quartiles of baseline risk, infants in the higher quartiles had a lower median birth weight (800 [IQR, 690-925] g in quartile 1 vs 630 [IQR, 530-710] g in ...
PMC10233424
Demographic and Clinical Characteristics Used for Risk Estimates by Quartile of Baseline Risk for Grades 2 to 3 BPD or Death
BPD, death
BRONCHOPULMONARY DYSPLASIA
Abbreviations: BPD, bronchopulmonary dysplasia; FIn the primary analysis for heterogeneity of treatment effect in the efficacy outcome of grades 2 to 3 BPD or death, there was no significant interaction between baseline risk for grades 2 to 3 BPD or death and treatment on a relative or absolute scale (
PMC10233424
Efficacy Outcome
BPD, death
BRONCHOPULMONARY DYSPLASIA (BPD)
The observed frequency (A), relative risk (B), and risk reduction (C) of grades 2 to 3 bronchopulmonary dysplasia (BPD) or death in the hydrocortisone vs placebo treatment groups are shown by quartile (Q) of baseline estimated risk of grades 2 to 3 BPD or death. Symbols (circles, squares, and triangles) represent estim...
PMC10233424
Outcomes by Quartile of Baseline Risk for Grades 2 to 3 BPD or Death
BPD, death, NDI
BRONCHOPULMONARY DYSPLASIA
Abbreviations: BPD, bronchopulmonary dysplasia; PMA, postmenstrual age.In the analysis of the safety outcome of moderate or severe NDI or death, there was no significant interaction between baseline risk for grades 2 to 3 BPD or death and treatment on a relative or absolute scale (
PMC10233424
Safety Outcome
BPD, neurodevelopmental impairment, death, NDI
BRONCHOPULMONARY DYSPLASIA (BPD)
The observed frequency (A), relative risk (B), and risk reduction (C) of moderate or severe neurodevelopmental impairment (NDI) or death in the hydrocortisone vs placebo treatment groups by quartile (Q) of baseline estimated risk of grades 2 to 3 bronchopulmonary dysplasia (BPD) or death. Symbols (circles, squares, and...
PMC10233424
Outcomes by Quartile of Baseline Risk for Moderate or Severe NDI or Death Between Birth and Follow-up
neurodevelopmental impairment
Abbreviation: NDI, neurodevelopmental impairment.
PMC10233424
Discussion
BPD, death, NDI
LUNG DISEASE
In this analysis for heterogeneity of treatment effect in infants enrolled in the NICHD NRN Hydrocortisone Trial, baseline estimated risk for grades 2 to 3 BPD or death was not associated with the effect of hydrocortisone on observed grades 2 to 3 BPD or moderate or severe NDI or death. These findings are consistent wi...
PMC10233424
Strengths and Limitations
BPD, death, NDI
Our analysis has several strengths, including being the first analysis, to our knowledge, of heterogeneity of treatment effect in a randomized clinical trial of corticosteroid exposure in extremely preterm infants. Moreover, this analysis assessed heterogeneity of treatment effect for both efficacy (BPD or death) and s...
PMC10233424
Conclusions
BPD, death, NDI
SECONDARY
In this secondary analysis for heterogeneity of treatment effect in infants enrolled in the NICHD NRN Hydrocortisone Trial, baseline risk for grades 2 or 3 BPD or death did not modify the treatment effect of hydrocortisone for either observed grades 2 or 3 BPD or death or moderate or severe NDI or death. Similar analys...
PMC10233424
Background and Objectives
headache disability, disability, pain
CHRONIC HEADACHES, HEADACHE DISORDERS
Go to This Null Hypothesis article is published as part of a collaborative effort between NeurologyThe Article Processing Charge was funded by the authors.Submitted and externally peer reviewed. The handling editor was Associate Editor Rebecca Burch, MD.Chronic headache disorders are a major cause of pain and disabilit...
PMC10065208
Methods
migraine, Headache, type headache, headache
MIGRAINE, MEDICATION OVERUSE HEADACHE
This was a pragmatic randomized controlled trial. Participants were aged 18 years or older with chronic migraine or chronic tension–type headache, with or without medication overuse headache. We primarily recruited from general practices. Participants were assigned to either a 2-day group education and self-management ...
PMC10065208
Results
migraine, headache
MIGRAINE, TENSION-TYPE HEADACHE, CHRONIC HEADACHE
Between April 2017 and March 2019, we randomized 736 participants. Because only 9 participants just had tension-type headache, our main analyses were on the 727 participants with migraine. Of them, 376 were allocated to the self-management intervention and 351 to usual care. Data from 586 (81%) participants were analyz...
PMC10065208
Discussion
migraine, type headache, headache
MIGRAINE
These findings conclusively show a lack of benefit for quality of life or monthly headache days from a brief group education and supportive self-management program for people living with chronic migraine or chronic tension–type headache with episodic migraine.
PMC10065208
Trial Registration Information
Registered on the International Standard Randomized Controlled Trial Number registry, ISRCTN79708100 16th December 2015
PMC10065208
Classification of Evidence
migraine, disability, headaches, pain
MIGRAINE
This study provides Class III evidence that a brief group education and self-management program does not increase the probability of improvement in headache-related quality of life in people with chronic migraine.Globally, headaches are second only to back pain as a cause of years lived with disability.
PMC10065208
Methods
PMC10065208
Study Design
CHRONIC HEADACHE
The Chronic Headache Education and Self-management Study (CHESS) was a randomized controlled trial conducted in 2 localities in the United Kingdom: Greater London and the Midlands. The protocol for this trial has been published.
PMC10065208
Study Population
fits, headaches, ICHD-3, headache, migraine, type headache
TENSION-TYPE HEADACHES, SECONDARY, CHRONIC HEADACHES, MIGRAINE, CLUSTER HEADACHES
We primarily recruited from general practices, but people could self-refer. Participating general practices ran computer searches to identify people who had, in the previous 2 years, consulted with headaches or who had been given a prescription for a migraine-specific drug (triptans/pizotifen). After screening for thos...
PMC10065208
Randomization and Masking
migraine, type headache, headache
MIGRAINE, MEDICATION OVERUSE HEADACHE
We used block minimization to randomize individual participants in batches of approximately 20 to ensure we could populate the self-management groups in a timely manner. We stratified by geographical locality (Midlands and Greater London) and 6 headache types (chronic migraine, chronic tension–type headache and episodi...
PMC10065208
Intervention
pain
Our intervention development process has been published,Sessions were co-led by a nurse and another registered allied health professional (nurse, health psychologist, physiotherapist, chiropractor, or occupational therapist) and just once by a research assistant. All facilitators attended 2 consecutive days of training...
PMC10065208
Outcomes
Headache, pains, headache
Our primary outcome was headache-related quality of life measured using the Headache Impact Test (HIT)-6 at 12 monthsWe collected data on total headache days, average duration of headache, and headache severity from participants weekly for 6 months and then monthly, starting from the initial eligibility call to ensure ...
PMC10065208
Statistical Analysis
Headache, anxiety, headache, migraine, depression, type headache
MIGRAINE, EVENTS, SECONDARY, ADVERSE EVENTS
Our analyses followed the prespecified statistical analysis plan available in the Supplement (For primary and secondary analyses, treatment effects were estimated using linear mixed-effects models with partial clustering to account for clustering in the self-management arm. Analyses were adjusted for age, gender, and t...
PMC10065208
Standard Protocol Approvals, Registrations, and Patient Consents
WEST
North West—Greater Manchester East Research Ethics Committee approved the trial (REC REF: 16/NW/0890). Participants provided written consent. The trial was registered on the International Standard Randomized Controlled Trial Number registry, ISRCTN79708100. The trial protocol is available in the Supplement (
PMC10065208
Data Availability
Individual participant data and a data dictionary will be available, subject to a data sharing agreement, for further prespecified analyses on request through Warwick Clinical Trials Unit (
PMC10065208
Results
We approached 31,020 people from 166 general practices across London and the Midlands (combined list size = 1,529,684); 2,220 expressed an interest in the trial and 41 people self-referred. Of them, 1,912 (85%) were contactable, and 1,159 (61%) of them were eligible. We randomized 736 (64%) of these people between 24 A...
PMC10065208
CONSORT Chart
migraine, Migraine, type headache, headache
MIGRAINE, SECONDARY, MIGRAINE, MEDICATION OVERUSE HEADACHE
Because of the nature of the group intervention (fixed dates and times), not everyone who completed eligibility assessment could access the intervention; thus, it was not possible to randomize all those eligible for the trial (Nine participants (1%) had chronic tension–type headache, so our main analyses were on the re...
PMC10065208
Treatment Differences and 95% CI for Secondary Outcomes, Adjusted for Age, Gender, Baseline Value of the Dependent Variable, Headache Type, and Geographical Locality at 4-, 8- and 12-Month Follow-ups
USD28,600, Anxiety
INTERACTIONS
Abbreviations: nC, number of participants from standard care; nSM, number of participants from self-management. Estimates and 95% CI rescaled to range from 0 to 100 for graphical representation purposes only. To obtain the estimated difference and its 95% CI in its original scale, the value from graph is multiplied by ...
PMC10065208
Cost-effectiveness Plane Displaying Incremental Costs and QALYs and Cost-effectiveness Acceptability Curves and Probability Estimate of the Intervention Compared With Usual Care at the Specified Willingness-to-Pay Thresholds
CHRONIC HEADACHE
(A) The graph shows the cost-effectiveness plane displaying 1,000 base-case ICERs simulated from the joint distribution of incremental costs and incremental QALYs. (B) Graph represents cost-effectiveness acceptability curves and gives a probability estimate of the CHESS intervention being cost-effective compared with u...
PMC10065208
Discussion
chronic headache disorders, pain, headache-related disability, headache, migraine
MIGRAINE, CHRONIC PAIN, SECONDARY, HEADACHE DISORDERS
There was no indication that the CHESS intervention had any important beneficial effects on clinically relevant outcomes. Only at 4 months was there an indication, on balance, that there was beneficial effect on the HIT-6, −1.0 (95% CI −1.91 to −0.006); In our secondary outcomes, only for pain self-efficacy was there a...
PMC10065208
Study Funding
ARC
This research was funded by the National Institute for Health Research (NIHR) Program Grants for Applied Research program (RP-PG-1212-20,018). S.J. Taylor is supported by the National Institute for Health Research ARC North Thames. The views expressed in this publication are those of the authors and not necessarily tho...
PMC10065208
Disclosure
Arthritis, Pain, pain
ARTHRITIS, CHRONIC HEADACHE
M. Underwood reports grants from NIHR during the conduct of the study; personal fees from National Institute for Health Research, grants from National Institute for Health Research, grants from vs Arthritis, other from Multiple professional conferences, grants from Stryker Ltd, grants from SERCO Ltd, other from Confede...
PMC10065208
Authors
PMC10065208
Glossary
Headache, Depression, Anxiety, Pain
adverse eventsComplier Averaged Causal EffectChronic Headache Education and Self-management Studydefined daily doseHospital Anxiety and Depression ScaleHeadache Impact Test Pain Self-Efficacy Questionnaireserious AE
PMC10065208
References
PMC10065208
Objective
To evaluate if daily oral 75 µg of Desogestrel (DSG) for 3 months prior to the insertion of etonogestrel-releasing contraceptive implant (ENG-IMPLANT) might help reduce its premature discontinuation.
PMC10010063
Results
bleeding
BLEEDING
A total of 66 women were randomized in the ENG-IMPLANT group (26) and in the DSG + ENG-IMPLANT group (40), respectively, in the Geneva University Hospitals and Basel University Hospital, from August 15th, 2016 through September 30th, 2019. In the DSG + ENG-IMPLANT group, patients were given a 3 months’ supply of 75 µg ...
PMC10010063
Supplementary Information
The online version contains supplementary material available at 10.1186/s13104-023-06304-3.
PMC10010063
Keywords
PMC10010063
Introduction
abdominal pain, vaginal infection, weight gain, mastodynia, acne, headache
SIDE EFFECT, VAGINAL BLEEDING, VAGINAL INFECTION, ACNE
Etonogestrel-releasing contraceptive implant (ENG-IMPLANT) is a single rod implant containing 68 mg of etonogestrel which is user independent and can be used for three years. Main side effects of ENG-IMPLANT are related to irregular vaginal bleeding. Other side effects such as weight gain, headache, acne, mastodynia, a...
PMC10010063
Main text
PMC10010063
Materials and methods
PMC10010063
Setting and study population
vaginal bleeding, gynaecological cancer, metabolic diseases, venous thromboembolism, hypersensitivity, diabetes
VAGINAL BLEEDING, COAGULATION DISORDERS, HEPATIC DISORDER, RECRUITMENT, METABOLIC DISEASES, HYPERTENSION, HYPERSENSITIVITY, DIABETES
Between August 15th, 2016 and September 30th, 2019, we conducted a randomized prospective open-label study of women aged 18 to 42 years who were interested in using ENG-IMPLANT and were willing to have 90 days of pre-treatment with DSG. The study was conducted in the family planning clinic of the Geneva University Hosp...
PMC10010063
Study procedure
bleeding
BLEEDING
Once consent was obtained, women were randomized either to the ENG-IMPLANT group or the DSG + ENG-IMPLANT group. In the ENG-IMPLANT group, the implant was inserted immediately. In the DSG + ENG-IMPLANT group, patients were given a 3 months’ supply of DSG to be started immediately after which insertion of ENG-IMPLANT wa...
PMC10010063
Measurement of outcomes and other variables of interest
bleeding, headaches, irregular vaginal bleeding, breast pain, Weight gain
BLEEDING
Socio-demographic characteristics were collected. Data collectors recorded the date of implant insertion or the date of DSG initiation. The main outcome variable for this study was method discontinuation. Secondary outcomes were the side effects, tolerance and satisfaction 3 months after inclusion and 12 months after E...
PMC10010063
Randomization and statistical analysis
Statistical analysis was performed using the Stata program version 13 (StataCorp LP: College Station, TX, USA); the significance level for all tests was p < 0.05. To detect a mean difference of 0.5 standard deviation on the numerical tolerance scale, with a power of 0.85 and type 1 error rate of 0.05, we needed 2 group...
PMC10010063
Results
PMC10010063
Study population
Among the 67 women assessed for eligibility, 66 (98.5%) were included in the study and were allocated either to the ENG-IMPLANT group (26, 39.4%) or the DSG + ENG-IMPLANT group (40, 60.6%) (Fig. Flowchart of study participants
PMC10010063
Participants' characteristics
Additional file
PMC10010063
Discussion
PMC10010063
Findings, their interpretation and comparison to other studies
There have been numerous studies evaluating ENG-IMPLANT side effects but no trial, to our knowledge, who evaluate whether the practice of 3 months oral intake of DSG prior to ENG-IMPLANT insertion improves its continuation rate at-1-year.There was no statistically significant difference regarding overall satisfaction o...
PMC10010063
Conclusion
In conclusion, although our small sample size, it seems that the use of DSG prior to ENG-IMPLANT insertion does not help in predicting the continuation rate of the implant at one year.
PMC10010063
Limitations
The main limitation of our study is the small number of patients included and the high rate of loss at follow-up. Therefore, no definitive conclusions can be drawn to enforce change in attitude.
PMC10010063
Acknowledgements
Not applicable.
PMC10010063
Author contributions
SC and MY conceived the protocol object of the study. VL and MB executed the literature search and performed the data collection with FT and SG. SC, VL, RC and MY conceived and oversaw the conduction of the study. RC performed data review, methodology and statistical analysis. The manuscript was drafted by VL and criti...
PMC10010063
Funding
Funding for DSG and ENG-IMPLANT were provided for the study by MSD Switzerland.
PMC10010063
Availability of data and materials
According to Institutional Policies the database will be available upon request.
PMC10010063
Declarations
PMC10010063
Ethics approval and consent to partcipate
Approved by the Ethics Committee of Geneva on 12.04.2017 (CCER 2016-00972).The trial was retrospectively registered on
PMC10010063
Consent for publication
All the authors have approved the manuscript for publication.
PMC10010063
Competing interests
There are no disclosures of interest regarding financial, personal, intellectual, or religious interests. Completed disclosure of interests are available to view online as supporting information.
PMC10010063
References
PMC10010063
BACKGROUND:
pain, knee osteoarthritis, KOA
ADVERSE EFFECTS, KNEE OSTEOARTHRITIS
These authors contributed equally to this paper. In the treatment of knee osteoarthritis (KOA), there is a need for the long-term use of therapeutic drugs that reduce joint pain and have fewer adverse effects.
PMC10357135
OBJECTIVE:
KOA pain
This study aimed to investigate the therapeutic effect of bean pressing on ear points on early KOA pain.
PMC10357135
METHODS:
KOA
MAY
One hundred patients with KOA recruited at the Wenzhou Hospital of Traditional Chinese Medicine between February 2019 and May 2022 were divided randomly into a treatment group (
PMC10357135
RESULTS:
On day 5 following the start of treatment, the visual analog scale (VAS) and WOMAC scores of the treatment group were significantly lower than those of the control group (
PMC10357135
CONCLUSIONS:
KOA pain, KOA swelling
Auricular bean-pressing therapy had an analgesic effect and could also alleviate mild to moderate KOA swelling, joint stiffness, and other symptoms, effectively reducing the demand for NSAIDs and improving both knee function and quality of life. The results suggested that auricular bean-pressing therapy has promising ...
PMC10357135
Introduction
bone hyperplasia, knee disability, swelling, pain, KOA, Knee osteoarthritis
SEPTIC SYNOVITIS, KNEE OSTEOARTHRITIS, DEGENERATION
Knee osteoarthritis (KOA) is pathologically characterized by cartilage destruction, degeneration, bone hyperplasia, aseptic synovitis, and ligament degeneration. Its clinical manifestations include pain, swelling, and limited mobility, and in severe cases, it may lead to knee disability, which more frequently occurs in...
PMC10357135
Materials and methods
PMC10357135
Clinical data
eczema, KOA
MAY, ECZEMA
This was a randomized controlled trial. One hundred participants were selected from patients with KOA who were treated at the Department of Orthopedics of Wenzhou Hospital of Traditional Chinese Medicine between February 2019 and May 2022. The standard follow-up for all treated patients lasted 4 weeks. The study was ap...
PMC10357135
Therapeutic methods
pain
SEPARATION
Auricular bean-pressing process. (A) Disinfection; (B) Selected auricular acupoints; (C) Fixed Cowherb seeds: (D) Finished.The control group received routine rehabilitation treatment. In both groups, the patients required NSAIDs during treatment and follow-up; this was prescribed as oral celecoxib (Pfizer Inc., USA) a...
PMC10357135
Treatment indexes
KOA, fasting venous blood, pain
INFLAMMATION, CHRONIC DISEASES
To assess the efficacy of treatment on knee function and pain, the WOMAC index scores [The WOMAC is used mainly to evaluate the degree of KOA in patients. The scale includes three dimensions: pain, stiffness, and joint function, with 24 evaluation items. A five-grade scoring method was adopted, and each item was scored...
PMC10357135
Statistical analysis
We used SPSS™ Statistics v25.0 software (IBM, Chicago, USA) for all data processing. The data with normal or approximately normal distribution were expressed as mean
PMC10357135
Results
PMC10357135
General information statistics
Comparison of general data of patients between two groups Sample size determination. Notes: The map summarizes the number of the retrospectively selected patients, patients excluded, and the final sample size obtained. Of the 107 patients sampled in this study, 7 did not meet the inclusion criteria, and 3 were exclude...
PMC10357135
Comparison of the knee sign scores and C-reactive protein levels between the two groups before and after treatment
tenderness, knee joints, swelling, pain
Comparison of swelling, tenderness, range of motion, and CRP between the two groups (Compared with the same group before treatment, Comparison of WOMAC scores between the two groups (Compared with the same group before treatment, After 4 weeks of treatment, the swelling, pain, mobility score, and CRP of the knee join...
PMC10357135
Comparison of the Western Ontario and McMaster Universities osteoarthritis scores between the two groups before and after treatment
The comparison of the total WOMAC scores between the two groups before treatment was not statistically significant (After 4 weeks of treatment, the NSAID requirement of the treatment group was significantly lower than that of the control group (Fig.  The numbers of patients not requiring celecoxib treatment in both tre...
PMC10357135
Discussion
obesity, osteoarthritis, meniscus rupture, KOA, disability, periarticular fractures, KOA swelling, injuries
OBESITY, OSTEOARTHRITIS, JOINT DISEASES, DEGENERATIVE JOINT DISEASE, SECONDARY, PATHOGENESIS, COMPLICATIONS, CHRONIC DISEASE
In the present study, the VAS and WOMAC scores of the treatment group were significantly lower than those of the control group, demonstrating that auricular bean-pressing therapy possessed analgesic and discomfort relief effects, for example, relieving mild- to moderate-degree KOA swelling, joint stiffness, and other s...
PMC10357135
Conclusion
KOA pain, knee pain
ADVERSE REACTIONS
The present study demonstrated that compared with conventional rehabilitation, auricular point bean-pressing therapy combined with conventional rehabilitation treatment can further relieve knee pain, improve patients’ knee function, and reduce the demand for NSAIDs. This reduces adverse reactions caused by taking drugs...
PMC10357135
Ethical approval
The study was conducted in accordance with the Declaration of Helsinki (as was revised in 2013). The study was approved by the ethics committee of the Wenzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang University of Traditional Chinese Medicine (approval no. WTCM-H-KT-2019047).
PMC10357135
Funding
The study was supported by Wenzhou Basic Scientific Research Projects (No. Y20190732).
PMC10357135
Informed consent
All patients provided signed informed consent for their inclusion in the research.
PMC10357135
Author contributions
Conception and design of the research: Yeyan Lin, Xuelai Zhou.Acquisition of data: Yeyan Lin, Bin Shen.Analysis and interpretation of the data: Yeyan Lin, Cunxian Lv.Statistical analysis: Yeyan Lin, Yongqin Wu.Obtaining financing: Xuelai Zhou.Writing of the manuscript: Yeyan Lin.Critical revision of the manuscript for ...
PMC10357135
Acknowledgments
The authors are particularly grateful to everyone who helped them with the article.
PMC10357135
Conflict of interest
The authors declare that they have no competing interests.
PMC10357135
References
PMC10357135
Objectives
OSA
OBSTRUCTIVE SLEEP APNEA
To compare the effects of two types of titratable mandibular advancement devices (MADs), namely MAD-H (allowing limited vertical opening) and MAD-S (allowing free vertical opening), on respiratory parameters and upper airway dimensions in patients with mild to moderate obstructive sleep apnea (OSA).
PMC10160211
Materials and methods
OSA, apnea
Patients with mild to moderate OSA (5 ≤ apnea–hypopnea index (AHI) < 30 /h) were randomly assigned to two parallel MAD groups. All MADs were subjectively titrated according to a standardized protocol during a 3-month follow-up. Every patient underwent two polysomnographic recordings, and two cone beam computed tomograp...
PMC10160211
Results
A total of 49 patients were recruited, and 31 patients (21 men and 10 women) with a mean (± SD) age of 48.5 (± 13.9) years and a mean AHI of 16.6 (± 6.7) /h completed the study. In the per-protocol analysis, there was no significant difference between MAD-H (
PMC10160211