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Drug Design, Development and Therapy 2024
Randomized Controlled Trial
Penehyclidine for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Gynecological Laparoscopic Surgery Under Combined Intravenous and Inhalation Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Trial [Letter].
Topics: Humans; Double-Blind Method; Laparoscopy; Female; Quinuclidines; Postoperative Nausea and Vomiting; Gynecologic Surgical Procedures; Anesthesia, Inhalation; Antiemetics; Randomized Controlled Trials as Topic; Anesthesia, Intravenous
PubMed: 38911028
DOI: 10.2147/DDDT.S482220 -
BMJ Open Jun 2024Fibromyalgia is associated with chronic widespread pain and disturbed sleep. Multidisciplinary, multimodal management often includes pharmacotherapy; however, current...
INTRODUCTION
Fibromyalgia is associated with chronic widespread pain and disturbed sleep. Multidisciplinary, multimodal management often includes pharmacotherapy; however, current drugs used to treat fibromyalgia provide meaningful benefit to only 30-60% of treated individuals. Combining two or more different drugs is common in clinical practice with the expectation of better efficacy, tolerability or both; however, further research is needed to identify which combinations actually provide added benefit. Thus, we are planning a clinical trial to evaluate melatonin (MLT)-pregabalin (PGB) combination in participants with fibromyalgia.
METHODS AND ANALYSIS
This will be a single-centre, double-blind, randomised, double-dummy, three-period, crossover trial comparing a MLT-PGB combination to each monotherapy in 54 adult participants satisfying the 2016 American College of Rheumatology criteria for fibromyalgia. Participants will receive maximally tolerated doses of MLT, PGB and MLT-PGB combination for 6 weeks. The primary outcome will be daily pain intensity (0-10); secondary outcomes will include the Fibromyalgia Impact Questionnaire, SF-36 survey, Medical Outcomes Study Sleep Scale, Beck Depression Inventory (BDI-II), adverse events and other measures. Analysis of the primary and secondary outcomes will involve a linear mixed model with sequence, period, treatment, the first-order carryover and baseline pain score as fixed effects and participant as a random effect to test whether there are any treatment differences among three treatments and to estimate the least square mean of the mean daily pain intensity for each treatment, adjusting for carryover as well as period effects (ie, stability of pain levels).
ETHICS AND DISSEMINATION
This trial has been registered with the International Standard Randomised Controlled Trial Number Registry, ISRCTN #18278231, has been granted ethical approval by the Queen's University Health Sciences Research Ethics Board (Queen's HSREB Protocol #6040998) and is currently under review for a Clinical Trial Application to Health Canada Natural and Non-prescription Health Products Directorate. All participants will provide written informed consent prior to trial participation. Following trial completion, results will be disseminated in one or more biomedical journal publications and presented at one or more scientific meetings.
TRIAL REGISTRATION NUMBER
This trial has been registered with the International Standard Randomised Controlled Trial Number Registry, ISRCTN18278231.
Topics: Humans; Fibromyalgia; Melatonin; Pregabalin; Double-Blind Method; Cross-Over Studies; Drug Therapy, Combination; Adult; Analgesics; Female; Middle Aged; Pain Management; Randomized Controlled Trials as Topic; Male; Pain Measurement; Chronic Pain; Treatment Outcome
PubMed: 38910006
DOI: 10.1136/bmjopen-2024-087180 -
BMJ Open Diabetes Research & Care Jun 2024To assess the efficacy of a chitosan-based gel (ChitoCare) for the treatment of non-healing diabetic foot ulcers (DFUs). (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
To assess the efficacy of a chitosan-based gel (ChitoCare) for the treatment of non-healing diabetic foot ulcers (DFUs).
RESEARCH DESIGN AND METHODS
Forty-two patients with chronic DFUs were randomized to the ChitoCare or placebo gel for a 10-week treatment period and 4-week follow-up. The primary study end point was the rate of complete wound closure at week 10, presented as relative rate.
RESULTS
Thirty patients completed the 10-week treatment and 28 completed the 4-week follow-up. The ChitoCare arm achieved 16.7% complete wound closure at week 10 vs 4.2% in the placebo arm (p=0.297), 92.0% vs 37.0% median relative reduction in wound surface area from baseline at week 10 (p=0.008), and 4.62-fold higher likelihood of achieving 75% wound closure at week 10 (p=0.012). Based on the results of the Bates-Jensen Wound Assessment Tool, the wound state at week 10 and the relative improvement from the baseline were significantly better (median 20 vs 24 points, p=0.018, and median 29.8% vs 3.6%, p=0.010, respectively).
CONCLUSIONS
ChitoCare gel increased the rate of the DFU healing process. Several secondary end points significantly favored ChitoCare gel.
TRIAL REGISTRATION NUMBER
NCT04178525.
Topics: Humans; Chitosan; Diabetic Foot; Female; Male; Middle Aged; Gels; Wound Healing; Aged; Follow-Up Studies; Treatment Outcome; Chronic Disease; Double-Blind Method; Prognosis
PubMed: 38909998
DOI: 10.1136/bmjdrc-2024-004195 -
BMC Neurology Jun 2024Parkinson's disease (PD) is a neurodegenerative disease for which no disease-modifying therapies exist. Preclinical and clinical evidence suggest that repeated exposure... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Parkinson's disease (PD) is a neurodegenerative disease for which no disease-modifying therapies exist. Preclinical and clinical evidence suggest that repeated exposure to intermittent hypoxia might have short- and long-term benefits in PD. In a previous exploratory phase I trial, we demonstrated that in-clinic intermittent hypoxia exposure is safe and feasible with short-term symptomatic effects on PD symptoms. The current study aims to explore the safety, tolerability, feasibility, and net symptomatic effects of a four-week intermittent hypoxia protocol, administered at home, in individuals with PD.
METHODS/DESIGN
This is a two-armed double-blinded randomized controlled trial involving 40 individuals with mild to moderate PD. Participants will receive 45 min of normobaric intermittent hypoxia (fraction of inspired oxygen 0.16 for 5 min interspersed with 5 min normoxia), 3 times a week for 4 weeks. Co-primary endpoints include nature and total number of adverse events, and a feasibility-tolerability questionnaire. Secondary endpoints include Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II and III scores, gait tests and biomarkers indicative of hypoxic dose and neuroprotective pathway induction.
DISCUSSION
This trial builds on the previous phase I trial and aims to investigate the safety, tolerability, feasibility, and net symptomatic effects of intermittent hypoxia in individuals with PD. Additionally, the study aims to explore induction of relevant neuroprotective pathways as measured in plasma. The results of this trial could provide further insight into the potential of hypoxia-based therapy as a novel treatment approach for PD.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT05948761 (registered June 20th, 2023).
Topics: Humans; Parkinson Disease; Hypoxia; Double-Blind Method; Male; Middle Aged; Female; Aged; Adult
PubMed: 38909201
DOI: 10.1186/s12883-024-03702-3 -
BMJ Open Jun 2024Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), currently marketed for type 2 diabetes and obesity, may offer novel mechanisms to delay or prevent neurotoxicity... (Randomized Controlled Trial)
Randomized Controlled Trial
Protocol for a double-blind placebo-controlled randomised controlled trial assessing the impact of oral semaglutide in amyloid positivity (ISAP) in community dwelling UK adults.
INTRODUCTION
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), currently marketed for type 2 diabetes and obesity, may offer novel mechanisms to delay or prevent neurotoxicity associated with Alzheimer's disease (AD). The impact of semaglutide in amyloid positivity (ISAP) trial is investigating whether the GLP-1 RA semaglutide reduces accumulation in the brain of cortical tau protein and neuroinflammation in individuals with preclinical/prodromal AD.
METHODS AND ANALYSIS
ISAP is an investigator-led, randomised, double-blind, superiority trial of oral semaglutide compared with placebo. Up to 88 individuals aged ≥55 years with brain amyloid positivity as assessed by positron emission tomography (PET) or cerebrospinal fluid, and no or mild cognitive impairment, will be randomised. People with the low-affinity binding variant of the rs6971 allele of the Translocator Protein 18 kDa (TSPO) gene, which can interfere with interpreting TSPO PET scans (a measure of neuroinflammation), will be excluded.At baseline, participants undergo tau, TSPO PET and MRI scanning, and provide data on physical activity and cognition. Eligible individuals are randomised in a 1:1 ratio to once-daily oral semaglutide or placebo, starting at 3 mg and up-titrating to 14 mg over 8 weeks. They will attend safety visits and provide blood samples to measure AD biomarkers at weeks 4, 8, 26 and 39. All cognitive assessments are repeated at week 26. The last study visit will be at week 52, when all baseline measurements will be repeated. The primary end point is the 1-year change in tau PET signal.
ETHICS AND DISSEMINATION
The study was approved by the West Midlands-Edgbaston Research Ethics Committee (22/WM/0013). The results of the study will be disseminated through scientific presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER
ISRCTN71283871.
Topics: Humans; Glucagon-Like Peptides; Double-Blind Method; Alzheimer Disease; Positron-Emission Tomography; United Kingdom; Administration, Oral; Male; Middle Aged; Female; tau Proteins; Aged; Brain; Randomized Controlled Trials as Topic
PubMed: 38908839
DOI: 10.1136/bmjopen-2023-081401 -
Asian Nursing Research Jun 2024To investigate the effects of honey-based oral care on the oral health of patients with stroke undergoing rehabilitation.
PURPOSE
To investigate the effects of honey-based oral care on the oral health of patients with stroke undergoing rehabilitation.
METHODS
In this randomized controlled trial, 44 stroke patients from a tertiary hospital's rehabilitation ward were assigned to receive either honey-based oral care or normal saline, with treatments administered twice daily for 2 weeks. The study, conducted from November 2021 to July 2022, employed a double-blind method, blinding both participants and evaluators to treatment allocations. Key outcomes measured included oral status, dental plaque index (DPI), and xerostomia. The final analysis included 13 patients in the experimental group and 16 in the control group.
RESULTS
The intervention significantly changed the oral status, DPI, and xerostomia between the groups. The experimental group showed significantly improved oral status (Z = -4.63, p=.001), DPI (Z = -4.58, p<.001), and xerostomia (t = -6.33, p<.001) compared to the control group. The experimental group showed significant improvements in oral status (Z=-3.27, p<.001), DPI (Z=-3.19, p=.001), and xerostomia (t=7.37, p<.001) after the intervention, confirming the efficacy of honey-based oral care.
CONCLUSIONS
Honey-based oral care effectively improves oral status and xerostomia, and reduces DPI in patients with stroke.
CLINICAL TRIAL REGISTRATION NUMBER
Trial registration. Clinical Research Information Service (CRIS), KCT0008201. Registered on 04 February 2023. The first patient was enrolled on November 16, 2021, at https://cris.nih.go.kr/cris/search/listDetail.do?searchWord=KCT0008201&search_yn=Y.
PubMed: 38908430
DOI: 10.1016/j.anr.2024.06.001 -
Medicina Oral, Patologia Oral Y Cirugia... Jul 2024Brain-derived neurotrophic factor (BDNF) is a factor that implicate in the pathophysiology and treatment of depression and anxiety. The aim of this study was to... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Brain-derived neurotrophic factor (BDNF) is a factor that implicate in the pathophysiology and treatment of depression and anxiety. The aim of this study was to determine the relationship between dental anxiety and BDNF serum level through impacted third molar surgery.
MATERIAL AND METHODS
In this randomized, double-blind, cross-sectional study, the sample included patients who had been admitted for the impacted third molar extraction under local anesthesia between January to November 2020. The primary predictor variable was serum BDNF level and the second predictor variable was dental anxiety scores before and after operation in patients. The primary outcome variable was the correlation between anxiety scores (APAIS, MDAS, STAI, VAS) and serum BDNF level. The sample included 55 patients (22 Male, 33 Female) aged 18 to 42 (24,2+5,55).
RESULTS
Comparison of pre-operative scores (APAIS, MDAS, STAI, VAS and BDNF) and post-operative scores were statistically significant (P < .05). Post-operatively, MDAS and VAS scores decreased, while BDNF levels and STAI scores increased compared to the preoperative scores. BDNF was not correlated with APAIS, MDAS, STAI, and VAS preoperatively and postoperatively.
CONCLUSIONS
There may be a relationship between serum BDNF level and dental anxiety scale, but, no correlation was found between them.
Topics: Humans; Brain-Derived Neurotrophic Factor; Female; Male; Cross-Sectional Studies; Adult; Tooth, Impacted; Molar, Third; Young Adult; Dental Anxiety; Double-Blind Method; Adolescent; Tooth Extraction; Preoperative Period
PubMed: 38907644
DOI: 10.4317/medoral.26558 -
Trials Jun 2024There are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found mirtazapine, a tetracyclic...
BACKGROUND
There are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found mirtazapine, a tetracyclic antidepressant, to be effective in reducing methamphetamine use. The proposed Tina Trial is the first phase 3 placebo-controlled randomised trial to examine the effectiveness and safety of mirtazapine as an outpatient pharmacotherapy for methamphetamine use disorder.
METHODS
This is a multi-site phase 3 randomised, double-blind, placebo-controlled parallel trial. Participants are randomly allocated (1:1) to receive either mirtazapine (30 mg/day for 12 weeks) or matched placebo, delivered as a take-home medication. The target population is 340 people aged 18-65 years who have moderate to severe methamphetamine use disorder. The trial is being conducted through outpatient alcohol and other drug treatment clinics in Australia. The primary outcome is measured as self-reported days of methamphetamine use in the past 4 weeks at week 12. Secondary outcomes are methamphetamine-negative oral fluid samples, depressive symptoms, sleep quality, HIV risk behaviour and quality of life. Other outcomes include safety (adverse events), tolerability, and health service use. Medication adherence is being monitored using MEMS® Smart Caps fitted to medication bottles.
DISCUSSION
This trial will provide information on the safety and effectiveness of mirtazapine as a pharmacotherapy for methamphetamine use disorder when delivered as an outpatient medication in routine clinical practice. If found to be safe and effective, this trial will support an application for methamphetamine use disorder to be included as a therapeutic indication for the prescription of mirtazapine.
TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Registry ACTRN12622000235707. Registered on February 9, 2022.
Topics: Humans; Mirtazapine; Double-Blind Method; Amphetamine-Related Disorders; Methamphetamine; Adult; Middle Aged; Adolescent; Clinical Trials, Phase III as Topic; Male; Young Adult; Randomized Controlled Trials as Topic; Aged; Female; Treatment Outcome; Multicenter Studies as Topic; Australia; Time Factors; Medication Adherence; Antidepressive Agents, Tricyclic
PubMed: 38907288
DOI: 10.1186/s13063-024-08238-y -
Chinese Journal of Integrative Medicine Jun 2024To confirm the efficacy and safety of Ganyushu Granule (GYSG) in treating premenstrual syndrome (PMS) in patients with Gan (Liver) depression and qi stagnation syndrome...
Efficacy and Safety of Ganyushu Granule in Treatment of Premenstrual Syndrome with Gan (Liver) Depression and Qi Stagnation Syndrome: A Randomized, Double-Blind, Multi-Center, Phase-II Clinical Trial.
OBJECTIVE
To confirm the efficacy and safety of Ganyushu Granule (GYSG) in treating premenstrual syndrome (PMS) in patients with Gan (Liver) depression and qi stagnation syndrome (GDQSS) and determine its effective dosage.
METHODS
From June 2018 to March 2021, a total of 240 PMS women with GDQSS were included and randomly divided into 3 groups in a 1:1:1 ratio using central block randomization: high-dose GYSG group (n=78, GYSG 2 packs/time), low-dose GYSG group (n=82, GYSG and its simulant 1 pack/time), and placebo group (n=80, GYSG simulant 2 packs/time). Treatment with GYSG or placebo was given thrice daily and for up to 3 menstrual cycles. Primary outcomes were PMS diary (PMSD) score and premenstrual tension syndrome self-rating scale (PMTS). Secondary outcomes were Chinese medicine (CM) syndrome efficacy. PMSD, PMTS, and efficacy of CM were evaluated with menstrual cycles during the treatment period. Outcome indicators were analyzed after each menstrual cycle. All analyses were performed using an intention-to-treat method, and clinical safety was assessed.
RESULTS
Of the 216 patients included in the effectiveness analysis, 70, 75, and 71 patients were in the high-, low-dose GYSG, and placebo groups, respectively. From the 2nd treatment cycle, the change in PMSD scores in the high- and low-dose groups was lower than that in the placebo group (P<0.05). PMTS scores in the high-dose GYSG group after the 1st treatment cycle was lower than that in the placebo group (P<0.05), while after the 3rd treatment cycle, that in the low-dose group was lower than that in the placebo group (P<0.05). After the 2nd treatment cycle, the high-dose GYSG group had the best CM syndrome efficacy (P<0.05). No serious adverse reactions were reported.
CONCLUSIONS
GYSG was safe and well-tolerated at both doses for treating PMS patients with GDQSS. High-dose GYSG might be the optimal dose for a phase III trial. (Registration No. ChiCTR1800016595).
PubMed: 38907069
DOI: 10.1007/s11655-024-3755-z -
Scientific Reports Jun 2024Within intensive care units (ICU), the administration of peptide-based formulas (PBF) may confer nutritional advantages for critically ill patients identified with... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
Within intensive care units (ICU), the administration of peptide-based formulas (PBF) may confer nutritional advantages for critically ill patients identified with heightened nutritional risk. This investigation aimed to ascertain the efficacy of PBF in comparison to standard polymeric formulas (SPF) among this patient cohort. A double-blind, randomized controlled trial was conducted across three ICUs, encompassing 63 adult patients characterized by elevated modified Nutrition Risk in Critically Ill (mNUTRIC) scores. Enrollment occurred promptly subsequent to ICU admission, with participants allocated to receive either PBF or SPF. Primary outcome was the duration to achieve caloric targets. Secondary outcomes involved the evaluation of mean daily gastric residual volume, mechanical ventilation period, infection rates within the ICU, length of hospitalization, mortality rates, nutritional status and inflammatory markers, specifically serum albumin and interleukin-6 levels. Patients in the PBF group reached their caloric targets more expeditiously compared to the SPF group (2.06 ± 0.43 days versus 2.39 ± 0.79 days; p = 0.03). No significant differences were discernible between the groups regarding gastric residual volume, duration of mechanical ventilation, ICU length of stay, mortality, or infection rates. Both cohorts exhibited minimal adverse effects and were devoid of any instances of abdominal distension. While not reaching statistical significance, the observed trends in albumin and interleukin-6 levels suggest a potential advantage of PBF utilization. The implementation of PBF enabled swifter attainment of caloric goals in ICU patients at high nutritional risk without adversely impacting other clinical parameters. Given its favorable tolerance profile and potential immunomodulatory properties, PBF may be considered a valuable nutritional intervention in this setting.Thai Clinical Trials Registry TCTR20220221006. Registered 21 February 2022, https://www.thaiclinicaltrials.org/show/TCTR20220221006 .
Topics: Humans; Enteral Nutrition; Male; Female; Intensive Care Units; Middle Aged; Critical Illness; Aged; Double-Blind Method; Peptides; Nutritional Status; Length of Stay; Respiration, Artificial; Adult; Treatment Outcome; Polymers
PubMed: 38906990
DOI: 10.1038/s41598-024-65277-w