Double-blind Randomized Clinical Trial Research Articles

The effectiveness of a poly-herbal formulation from traditional Persian medicine (TPM) in gastroesophageal reflux disease (GERD), a double-blinded randomized clinical trial

INTRODUCTION: Gastroesophageal reflux disease (GERD) leads to increased contact of the acidic refluxate with the esophageal mucosa. Nearly 10- 20 % of the world's population is affected by GERD. Due to the complications associated with GERD, as well as complications of long-term treatment with current medications, and global demand toward Complementary and Alternative Medicine (CAM), this study evaluated the efficacy of a poly-herbal formulation known as Mastic pill (Habb-e-Mastaki) from traditional Persian medicine (TPM), previously reformulated and standardized, in a double-blinded randomized clinical trial. METHODS: 34 patients in the drug group received 4 capsules of Mastic pill plus Omeprazole capsule 20 mg daily. 34 patients in the placebo group received the same dosing of Omeprazole and placebo. The medication was given to patients for a total duration of 4 weeks. All patients were requested to fill out the modified GERD-HRQL questionnaire at the beginning and every two weeks for a total duration of six weeks. RESULT: Reflux, and heartburn severity score as well as disruption of personal life score significantly reduced in both groups, but it was more remarkable in the drug group (P-value = 0.0001). Dysphagia, early satiation, and nausea significantly reduced in the drug group while the placebo group showed no improvement. Our results suggest that constipation, bloating, belching, and odynophagia did not significantly improve in none of the groups. CONCLUSION: This study showed that Habb-e-Mastaki is effective against GERD. Further detailed in vitro and in vivo studies aimed at discovering the mechanism of action of this formulation and clinical studies involving a larger population will be necessary to explain and confirm the results obtained in the present study.

Resting-state electroencephalography theta predicts neurofeedback treatment 4-month follow-up response in nicotine addiction

BackgroundThe high rate of long-term relapse is a major cause of smoking cessation failure. Recently, neurofeedback training has been widely used in the treatment of nicotine addiction; however, approximately 30%...

The effect of low-dose aspirin on aspirin triggered lipoxin, interleukin 1 beta, and prostaglandin E2 levels in periapical fluid: a double-blind randomized clinical trial

BackgroundThe role of pro-resolving mediators in inflammation is a new concern in research. The effect of low-dose aspirin on production of a special kind of these mediators named aspirin triggered lipoxin (ATL) has been studied on different tissues. This randomized clinical trial evaluated the effect of low-dose aspirin on ATL and pro-inflammatory mediators’ level in periapical fluid of necrotic teeth with large lesions.MethodsTwenty-four patients with necrotic pulp and periapical lesion were randomly assigned to low-dose aspirin and placebo groups. In the first appointment, canals were shaped up to F3 size and #40 K-file and cleaned with 10 milliliters 2.5% sodium hypochlorite and 17% Ethylenediaminetetraacetic acid. Periapical fluid was sampled by a paper cone. The tooth was temporized without any intracanal medication. Tablets were administered for 7 days, then the teeth were re-opened and the sampling were repeated. Interleukin-1 beta (IL-1β), prostaglandin E2 (PGE2) and ATL were analyzed by enzyme-linked immunosorbent assay. Data were analyzed with paired t-test using SPSS statistical software, version 21 (α = 0.05).ResultsA significant reduction in PGE2 and IL-1β was noted in the aspirin-treated group while an increase in ATL was observed (P < 0.001). There was no significant difference in the mediator scores before and after in the placebo-treated group (P > 0.05).ConclusionLow-dose aspirin can influence the inflammatory process by reducing pro-inflammatory mediators such as PGE2 and IL-1β, as well as increasing the pro-resolving mediators such as ATL.Trial registrationIRCT20191211045702N1.

The Effect of a Low Dose of Vitamin C in Patients With COVID-19: A Double-Blind Randomized Controlled Trial

Background: Vitamin C is a micronutrient with anti-inflammatory and free radical scavenging properties that can strengthen the body’s immune system. In this study, it was attempted to assess the clinical efficiency of oral vitamin C in treating COVID-19. Materials and Methods: This double-blind randomized clinical trial was conducted on 401 patients hospitalized in Taleghani hospital, Abadan, over 18 years of age and with confirmed COVID-19 infection, from November 2020 to May 2021. The patients were randomly assigned to intervention groups (201 people, two tablets per day, each containing 500 mg of vitamin C) and the control group (200 people, placebo, containing starch received for five days). Improvements in clinical symptoms, death from baseline to the 28-day follow-up after the intervention, hospital length of stay, and laboratory values of C-reactive protein (CRP) were some of the considered outcome variables. Results: No significant difference was observed between the two groups in terms of the daily improvement of clinical symptoms and the odds of healing from each symptom increased by about 48-50%. The difference in the length of hospital stay between the two groups was close to significant (P=0.051). There was no significant difference in mortality between the two groups (P=0.8). There was no difference between the two groups in the laboratory parameters, except for alkaline phosphatase (P=0.03). Conclusion: Vitamin C had no significant effect on improving patients’ clinical symptoms such as fatigue, fever, cough, and shortness of breath.

Treating hypersensitivity in older adults with silver diamine fluoride: A randomised clinical trial

ObjectiveThis study aimed to evaluate the desensitizing effect of topically applied 38% silver diamine fluoride (SDF) solution on the exposed root surface of hypersensitive teeth in older adults. MethodThis double-blind randomised clinical trial recruited healthy older adults with dentine hypersensitivity. A trained examiner tested the most hypersensitive tooth root surface with a blast of compressed cold air from a three-in-one syringe. The participants gave a sensitivity score (SS) in visual analogue scale from 0 (no pain) to 10 (agonizing) at the baseline visit. Then, they received 38% SDF or 5% potassium nitrate solution (control) as intervention on the root surface. After the intervention, they received a compressed cold air test and reported the SS again. The compressed cold air test followed by intervention was repeated at 4- and 8-week follow ups. The primary outcome was the reduction in SS at 8-week follow-up with reference to the SS at baseline before intervention. Shapiro–Wilk and Mann–Whitney U tests were performed for data analysis following a normality test of SS. ResultsThis trial recruited 148 participants, and 139 (94%) participants completed the trial. The median percentage reductions in SS in the SDF and potassium nitrate groups were 60% and 50%, respectively (p < 0.001). ConclusionAccording to the results, 38% SDF solution reduced hypersensitivity on the exposed root surface of older adults. In addition, 38% SDF was more effective than 5% potassium nitrate solution to reduce hypersensitivity on the exposed root surface of older adults. Clinical significanceDentin hypersensitivity is common amongst older adults and negatively affects their quality of life. To date, there is no gold standard professionally applied desensitizing therapy in treating hypersensitivity. Evidence from this clinical trial could aid clinical practice and improve oral health in older adults. Trial registrationThis study was registered at ClinicalTrials.gov (NCT05392868).

Investigation of the effects of intranasal desmopressin on the bleeding of the patients during open septorhinoplasty: A randomized double-blind clinical trial

ObjectivesRhinoplasty is one of the most common cosmetic surgeries in the world. Lack of adequate local homeostasis may lead to excessive bleeding during the operation, which increases the time of operation and recovery period, and the prevalence of complications. This study investigated the effects of nasal desmopressin on the quality of the surgical field and the volume of bleeding during rhinoplasty. Materials and methodsThis double-blind randomized clinical trial was performed on 120 patients aged 18–40 years who were candidates for rhinoplasty. Patients were randomly divided into three groups: low-dose desmopressin group and high-dose desmopressin group and placebo group. Hemodynamic changes and surgical field based on BOEZAART criteria, and the volume of bleeding were calculated. ResultsIn this study 115 women (95.8%) and 5 men (4.2%) participated. The mean age of patients was (27 ± 6.8). Bleeding volume in high dose desmopressin group was (21.7 cc ± 12.3), (27.7 cc ± 12.3) in low dose group, and (38.3 cc ± 12.3) in the placebo group, The difference in blood volume among the three groups was statistically significant with p < 0.005. Clean surgical field according to BOEZAART classification was marginally significant in both desmopressin groups. The differences in blood pressure, heart rate, blood and urine sodium, and hemoglobin before and after surgery between groups there not statistically significant. ConclusionBased on the results of the present study topical nasal spray desmopressin can reduce surgical field bleeding during rhinoplasty. To generalize the results to other surgeries in the ENT field it is recommended to conduct studies.

Evaluation of Lactobacillus Coryniformis K8 Consumption by Health Care Workers Exposed to COVID-19 (LactoCor2 Project): Protocol for a Randomized Controlled Trial.

Lactobacillus coryniformis K8 CECT5711 has immune-modulating properties, enhances the immune response to viral antigens leading to the production of specific antibodies, and has anti-inflammatory activity, which may help to prevent uncontrolled inflammatory processes leading to respiratory and other organ failures. The purpose of this study is to evaluate the effect of the consumption of a probiotic strain on the incidence and severity of COVID-19 in health personnel who carry out their professional work among patients with infection or suspected infection by SARS-CoV-2. This is a double-blind randomized clinical trial in which the experimental group will receive a capsule of L coryniformis K8 per day (3×109 colony former units/day), and the control group will receive a daily placebo capsule consisting of maltodextrin. A sample size of 314 volunteers was calculated. Volunteers must meet the following inclusion criteria: older than 20 years and active health personnel caring for patients with COVID-19, including all professionals such as medical doctors, nurses, and caretakers at the 2 referral hospitals that treat patients with COVID-19. The main outcome of the clinical trial will be the incidence of symptomatic infection by SARS-CoV-2 in personnel who care for patients with suspected or confirmed COVID-19. The study had to be extended to the 2 referral hospitals that treat patients with COVID-19 in the province of Granada (Andalusia, Spain); Hospital San Cecilio and Hospital Virgen de las Nieves. A total of 255 individuals met the inclusion criteria and were randomly assigned to one of the 2 groups. The results of this randomized controlled trial will provide valuable information regarding the administration of L coryniformis K8 against COVID-19, including whether there are fewer infectious processes due to this virus or, in case of occurrence, whether the disease is milder in participants taking the probiotic strain. ClinicalTrials.gov NCT04366180; http://www.clinicaltrials.gov/ct2/show/NCT04366180. RR1-10.2196/37857.

Perbandingan Efektivitas antara Ivabradin 5 mg dengan Bisoprolol 5 mg dalam Menjaga Kestabilan Hemodinamik pada Tindakan Laringoskopi Intubasi

Background: Laryngoscopy intubation can cause complications in the form of increased blood pressure and heart rate. This can be detrimental to patients with cardiovascular complications, increased intracranial pressure, and vascular anomalies. Various procedures are performed to stabilize hemodynamic fluctuations during laryngoscopy intubation, one of which is the administration of beta-blocking agents (Bisoprolol). In some studies, the administration of Bisoprolol can cause side effects such as hypotension and bradycardia. One drug considered to maintain hemodynamic stability in laryngoscopy intubation with minimal effects is the administration of Ivabradine, which works by regulating diastolic depolarization.&#x0D; Objective: To compare the effectiveness of Ivabradine 5 mg and Bisoprolol 5 mg in maintaining hemodynamic stability in laryngoscopy intubation.&#x0D; Methods: This double-blind randomized clinical trial was conducted at RSUP Dr. Wahidin Sudirohusodo Makassar in July-August 2022 with ethical qualifications from the Ethics Committee for Biomedical Research in Humans from the Faculty of Medicine, Hasanuddin University. The sample was the entire population that met the inclusion and exclusion criteria. The data were processed using SPSS 25. The analysis used paired T-test, Mann-Whitney, and Wilcoxon with a 95% confidence level (p&lt;0.005).&#x0D; Result: There was a significant decrease in the mean arterial pressure and decrease in heart rate after induction (T2-T0) in the Bisoprolol group (p&lt;0.05). The mean arterial pressure at T1-T0, T3-T0, T3-T2 did not statistically significant.&#x0D; Conclusion: Ivabradine 5 mg was more effective than Bisoprolol 5 mg in maintaining the stability of mean arterial pressure and heart rate in laryngoscopy intubation.

Post-traumatic stress and awareness in patient with traumatic lower limb surgery by neuraxial anesthesia: A randomized clinical trial

Aim of the studyAnesthesia decreases brain cognitive function, memory and pain, and also leads to the loss of consciousness. In this study, midazolam and propofol-sedated trauma patients undergoing lower limb surgery were evaluated for stress levels after neuraxial anesthesia.Subject or material and methodsThis double-blind randomized clinical trial was conducted on patients with lower extremity fractures due to trauma, who were candidates of elective lower extremity orthopedic surgery. Patients were randomly divided into two groups of propofol-sedated patients (n=110) and midazolam-sedated patients (n=110) after neuraxial anesthesia. Then, all patients underwent spinal anesthesia using 3 ml of 0.5% bupivacaine (3 mg/kg). Propofol (25-75 µg/kg/minute) was infused, and 1-2 mg of midazolam was injected PRN until patients reached the score of 3 on the Modified Observers' Assessment of Alertness/ Sedation Scale (MOAA/S).ResultsPreoperative sedation/alertness scores of patients in the two groups did not differ significantly from one another. Penetrating memories in the midazolam group was higher than the propofol group (P&lt;0.05). Personal relationship problem was more significant in the midazolam group than the propofol group (P&lt;0.05). Inability in controlling emotional feelings was higher in the midazolam group compared to the propofol group (P&lt;0.001).DiscussionOur findings indicated that a sub-hypnotic dose of propofol provided superior sedation and amnesia compared to midazolam. Aspects of stress, including penetrating memories, personal relationship problems, inability to control emotional feelings, and lack of depression during spinal anesthesia were better managed by propofol compared to midazolam.ConclusionsPropofol infusion was better in decreasing stress levels after surgery compared to midazolam.

Marginal and Para-Marginal Technique in Late Germectomy of Lower Third Molars.

Third molar surgery can cause post-operative complications to the patient due to the presence of a wound from the incision. This study aimed to compare marginal flap with para-marginal flap on postoperative complications by the measurements on pre and post-surgical plaque index (PI), bleeding on probing (BoP), maximum opening of the mouth (MOM), pain perception (PP) and post-surgical tumefaction (PT). In this double-blind randomized clinical trial, 40 patients were recruited and randomly allocated in two groups. In Group 1, third molar extraction was carried out after a marginal flap design was performed, while in Group 2 a para-marginal flap was performed. Plaque index, bleeding on probing, maximum mouth opening, and distal probing were assessed right before and one week after surgery, while post-operative pain perception and post-operative swelling were accounted one week following surgery. Statistically significant differences were reported between treatment groups, as the para-marginal flap led to better outcomes for all the measured indexes. The para-marginal flap design may decrease the occurrence of post-operative complications and discomforts after mandibular third molar surgery, compared to marginal flap design.

Effect of Mifepristone vs Placebo for Treatment of Adenomyosis With Pain Symptoms

Adenomyosis is a common chronic gynecological disorder, and its treatment is an unmet need. New therapies need to be developed. Mifepristone is being tested for adenomyosis treatment. To determine whether mifepristone is effective and safe for adenomyosis treatment. This multicenter, placebo-controlled, double-blind randomized clinical trial was conducted in 10 hospitals in China. In total, 134 patients with adenomyosis pain symptoms were enrolled. Trial enrollment began in May 2018 and was completed in April 2019, and analyses were conducted from October 2019 to February 2020. Participants were randomized 1:1 to receive mifepristone 10 mg or placebo orally once a day for 12 weeks. The primary end point was the change in adenomyosis-associated dysmenorrhea intensity, evaluated by the visual analog scale (VAS) after 12 weeks of treatment. Secondary end points included the change in menstrual blood loss, increased level of hemoglobin in patients with anemia, CA125 level, platelet count, and uterine volume after 12 weeks of treatment. Safety was assessed according to adverse events, vital signs, gynecological examinations, and laboratory evaluations. In total, 134 patients with adenomyosis and dysmenorrhea were randomly assigned, and 126 patients were included in the efficacy analysis, including 61 patients (mean [SD] age, 40.2 [4.6] years) randomized to receive mifepristone and 65 patients (mean [SD] age, 41.7 [5.0] years) randomized to received the placebo. The characteristics of the included patients at baseline were similar between groups. The mean (SD) change in VAS score was -6.63 (1.92) in the mifepristone group and -0.95 (1.75) in the placebo group (P < .001). The total remission rates for dysmenorrhea in the mifepristone group were significantly better than those in the placebo group (effective remission: 56 patients [91.8%] vs 15 patients [23.1%]; complete remission: 54 patients [88.5%] vs 4 patients [6.2%]). All the secondary end points showed significant improvements after mifepristone treatment for menstrual blood loss, hemoglobin (mean [SD] change from baseline: 2.13 [1.38] g/dL vs 0.48 [0.97] g/dL; P < .001), CA125 (mean [SD] change from baseline: -62.23 [76.99] U/mL vs 26.89 [118.70] U/mL; P < .001), platelet count (mean [SD] change from baseline: -28.87 [54.30]×103/µL vs 2.06 [41.78]×103/µL; P < .001), and uterine volume (mean [SD] change from baseline: -29.32 [39.34] cm3 vs 18.39 [66.46] cm3; P < .001). Safety analysis revealed no significant difference between groups, and no serious adverse events were reported. This randomized clinical trial showed that mifepristone could be a new option for treating patients with adenomyosis, based on its efficacy and acceptable tolerability. ClinicalTrials.gov Identifier: NCT03520439.

Evaluation of Propolis Hydrogel for the Treatment of Dentinal Sensitivity: A Clinical Study.

Propolis is a natural resinous substance collected by honeybees, chiefly from buds and the leaves, branches, and bark of trees. Its role as a wound-healing gel has been studied, but the use of a propolis hydrogel in the treatment of dentinal hypersensitivity has not been evaluated. Dentin hypersensitivity (DH) is commonly treated via iontophoresis using fluoridated desensitizers. The aim of the present study was to compare and evaluate the effects of a 10% propolis hydrogel, 2% sodium fluoride (NaF), and 1.23% acidulated phosphate fluoride (APF) when used in conjunction with iontophoresis for the treatment of cervical dentin hypersensitivity (DH). Systemically healthy patients complaining of DH were selected for this single-centre, parallel, double-blind randomized clinical trial. Three substances were selected as desensitizers for study in the present trial: a 10% propolis hydrogel, 2% sodium fluoride, and 1.23% acidulated phosphate fluoride, all in conjunction with iontophoresis. Any decrease in DH following the application of specific stimuli was assessed at baseline, before and after application, on the 14th day following use, and on the 28th day following the intervention. Intra-group comparisons show diminished values of DH at maximum post-op follow-up intervals which were significantly trimmed down from the baseline (p < 0.05). The 2% NaF demonstrated a significant reduction in DH over 1.23% APF and the 10% propolis hydrogel (p < 0.05). However, there was no statistically significant difference in the mean difference between the APF and propolis hydrogel groups assessed via tactile, cold, and air tests (p > 0.05). All three desensitizers have proved to be useful when used in conjugation with iontophoresis. Within the limitations of this study, a 10% propolis hydrogel can be used as a naturally occurring alternative to commercially available fluoridated desensitizers.

Sodium Bicarbonate for Metabolic Acidosis in the ICU: Results of a Pilot Randomized Double-Blind Clinical Trial.

To identify the best population, design of the intervention, and to assess between-group biochemical separation, in preparation for a future phase III trial. Investigator-initiated, parallel-group, pilot randomized double-blind trial. Eight ICUs in Australia, New Zealand, and Japan, with participants recruited from April 2021 to August 2022. Thirty patients greater than or equal to 18 years, within 48 hours of admission to the ICU, receiving a vasopressor, and with metabolic acidosis (pH < 7.30, base excess [BE] < -4 mEq/L, and Paco2 < 45 mm Hg). Sodium bicarbonate or placebo (5% dextrose). The primary feasibility aim was to assess eligibility, recruitment rate, protocol compliance, and acid-base group separation. The primary clinical outcome was the number of hours alive and free of vasopressors on day 7. The recruitment rate and the enrollment-to-screening ratio were 1.9 patients per month and 0.13 patients, respectively. Time until BE correction (median difference, -45.86 [95% CI, -63.11 to -28.61] hr; p < 0.001) and pH correction (median difference, -10.69 [95% CI, -19.16 to -2.22] hr; p = 0.020) were shorter in the sodium bicarbonate group, and mean bicarbonate levels in the first 24 hours were higher (median difference, 6.50 [95% CI, 4.18 to 8.82] mmol/L; p < 0.001). Seven days after randomization, patients in the sodium bicarbonate and placebo group had a median of 132.2 (85.6-139.1) and 97.1 (69.3-132.4) hours alive and free of vasopressor, respectively (median difference, 35.07 [95% CI, -9.14 to 79.28]; p = 0.131). Recurrence of metabolic acidosis in the first 7 days of follow-up was lower in the sodium bicarbonate group (3 [20.0%] vs. 15 [100.0%]; p < 0.001). No adverse events were reported. The findings confirm the feasibility of a larger phase III sodium bicarbonate trial; eligibility criteria may require modification to facilitate recruitment.

Minocycline for sporadic and hereditary cerebral amyloid angiopathy (BATMAN): study protocol for a placebo-controlled randomized double-blind trial

BackgroundCerebral amyloid angiopathy (CAA) is a disease caused by the accumulation of the amyloid-beta protein and is a major cause of intracerebral hemorrhage (ICH) and vascular dementia in the elderly. The presence of the amyloid-beta protein in the vessel wall may induce a chronic state of cerebral inflammation by activating astrocytes, microglia, and pro-inflammatory substances. Minocycline, an antibiotic of the tetracycline family, is known to modulate inflammation, gelatinase activity, and angiogenesis. These processes are suggested to be key mechanisms in CAA pathology. Our aim is to show the target engagement of minocycline and investigate in a double-blind placebo-controlled randomized clinical trial whether treatment with minocycline for 3 months can decrease markers of neuroinflammation and of the gelatinase pathway in cerebrospinal fluid (CSF) in CAA patients.MethodsThe BATMAN study population consists of 60 persons: 30 persons with hereditary Dutch type CAA (D-CAA) and 30 persons with sporadic CAA. They will be randomized for either placebo or minocycline (15 sporadic CAA/15 D-CAA minocycline, 15 sporadic CAA/15 D-CAA placebo). At t = 0 and t = 3 months, we will collect CSF and blood samples, perform a 7-T MRI, and collect demographic characteristics.DiscussionThe results of this proof-of-principle study will be used to assess the potential of target engagement of minocycline for CAA. Therefore, our primary outcome measures are markers of neuroinflammation (IL-6, MCP-1, and IBA-1) and of the gelatinase pathway (MMP2/9 and VEGF) in CSF. Secondly, we will look at the progression of hemorrhagic markers on 7-T MRI before and after treatment and investigate serum biomarkers.Trial registrationClinicalTrials.gov NCT05680389. Registered on January 11, 2023

P-47 Double-blind placebo-controlled randomized clinical trial on the concurrent use of crocin during chemoradiation of esophageal squamous cell carcinoma

P-47 Double-blind placebo-controlled randomized clinical trial on the concurrent use of crocin during chemoradiation of esophageal squamous cell carcinoma

Use of probiotics in patients with chronic kidney disease on hemodialysis: a randomized clinical trial.

Supplementation with probiotics for patients with chronic kidney disease (CKD) may be associated with decreased systemic inflammation. To assess the impact of oral supplementation with probiotics for patients with CKD on hemodialysis. This double-blind randomized clinical trial included 70 patients on hemodialysis; 32 were given oral supplementation with probiotics and 38 were in the placebo group. Blood samples were collected at the start of the study and patients were given oral supplementation with probiotics or placebo for three months. The probiotic supplement comprised four strains of encapsulated Gram-positive bacteria: Lactobacillus Plantarum A87, Lactobacillus rhamnosus, Bifidobacterium bifidum A218 and Bifidobacterium longum A101. Patients were given one capsule per day for 3 months. Blood samples were taken throughout the study to check for inflammatory biomarkers. Non-traditional biomarkers Syndecan-1, IFN-y, NGAL, and cystatin C were measured using an ELISA kit, along with biochemical parameters CRP, calcium, phosphorus, potassium, PTH, GPT, hematocrit, hemoglobin, glucose, and urea. Patients given supplementation with probiotics had significant decreases in serum levels of syndecan-1 (239 ± 113 to 184 ± 106 ng/mL, p = 0.005); blood glucose levels also decreased significantly (162 ± 112 to 146 ± 74 mg/dL, p = 0.02). Administration of probiotics to patients with advanced CKD was associated with decreases in syndecan-1 and blood glucose levels, indicating potential improvements in metabolism and decreased systemic inflammation.

0410 Lavender essential oil and sleep hygiene as therapeutic options for insomniac postmenopausal women: a randomized clinical trial

Abstract Introduction Menopausal transition and postmenopause often bring sleep complaints and insomnia, a common sleep disorder. In addition, women at this stage also experience vasomotor symptoms, which can compromise sleep maintenance and quality of life. This study aimed to observe the effect of an intervention with aromatherapy and sleep hygiene in the quality of life, self-related sleep pattern and hot flashes record in postmenopausal women with insomnia diagnosis. Methods This pilot study is a double-blind randomized clinical trial. Of the 135 women interested in participating in the study, 34 postmenopausal women met the inclusion criteria and completed the protocol. Volunteers were clinically diagnosed with insomnia and distributed in two groups: Aroma Group (Lavandula angustifolia essential oil) (n=17) and Placebo Group (sunflower oil) (n=17), both inhaled before bedtime for 29 days. The groups received sleep hygiene guidelines and were monitored weekly. To assess the effect of the intervention, the Menopause-Specific Quality-of-Life Questionnaire, intervention version (MENQOL-I), and Epworth Sleepiness Scale (ESS) were used. With data from the sleep diary, we evaluated sleep onset latency (SLO), total sleep time (TST) and sleep efficiency (SE) daily. Additionally, participants who complained of vasomotor symptoms were invited to fill out a hot flashes form, reporting the presence or absence of these symptoms, daily amount, and its intensity. Results The therapeutic approaches in this study benefited participants in both groups in almost all domains of quality of life and self-rated sleep patterns such as TST and SE. Particularly, the lavender essential oil intervention provided significant improvement in the overall quality of life score over time. No differences were observed considering the hot flashes record and sleepiness. Conclusion The aromatherapy intervention was effective in improving overall quality of life in the Aroma group. Furthermore, strategies such as sleep hygiene and a sleep diary helped participants to self-assess their sleep routine and improve it. Support (if any) This research was supported by fellowships from Associação Fundo de Incentivo à Pesquisa (AFIP), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) - Finance Code 001, and Conselho Nacional de Pesquisa (CNPq). Laszlo (essential oils, books, foods, and aromatherapy products) donated the necessary oils for this project.

The effect of lumbopelvic manipulation on electromyography parameters of gluteus medius and vastus medialis in patients with patellofemoral pain syndrome: A double-blind, placebo-controlled trial

BackgroundPatellofemoral Pain Syndrome is the most common cause of anterior knee pain, especially in active young people. This study aimed to evaluate the effect of lumbopelvic manipulation on electromyography parameters of gluteus medius and vastus medialis in patients with patellofemoral pain syndrome. MethodsIn this double-blind placebo-controlled randomized clinical trial study, 26 patients with a diagnosis of patellofemoral pain syndrome were randomly divided into two groups. The first group received Lumbopelvic manipulation and the second group was a control group that received placebo manipulation. Electromyography activity of vastus medialis and gluteus medius muscles were evaluated as primary outcomes during the single-leg squat; pain intensity during rest and functional tasks (step up, step down, single leg squat) were assessed by numerical pain rating scale. Functional status was evaluated by step-down test and the score of the Kujala patellofemoral questionnaire, as secondary outcomes. All evaluations were performed before and after the intervention, except pain intensity at rest and the Kujala patellofemoral questionnaire that were assessed before the intervention and one week after. ResultIn both groups, no significant difference was observed before and after the intervention in terms of average amplitude and the onset of gluteus medius and vastus medialis. However, in the lumbopelvic manipulation group, pain intensity during rest and functional tests significantly decreased compared to the control group. Functional status significantly improved in the lumbopelvic manipulation group, with no significant difference between group comparisons. ConclusionLumbopelvic manipulation caused a reduction in pain intensity and improvement of functional status in the rehabilitation of patients with patellofemoral Pain Syndrome. However, it seems that this method could not change the EMG activity of muscles in these patients. Implications for practice•The results of present study can help physiotherapists to understand the possible underlying pathomechanics of patellofemoral pain syndrome and more effective treatment of these group of patients.

Evaluation and Comparison of Two Different Combined Regimens for Prophylaxis of Nausea and Vomiting After Laparoscopic Bariatric Surgery: A Double-Blinded Randomized Clinical Trial

Postoperative Nausea and vomiting (PONV) are the most complications after laparoscopic surgeries, especially laparoscopic bariatric surgeries. The incidence of PONV has been estimated in over two-thirds of patients undergoing laparoscopic bariatric surgeries. Prophylactic combined antiemetic therapy is recommended for patients undergoing these surgeries. This is a double-blinded randomized clinical trial. Eighty-three patients of ASA physical status I and II undergoing elective bariatric laparoscopic surgery were enrolled in this clinical trial and divided into two equal groups through simple randomization using a random number table. One group (group A) received a combination of ondansetron, dexamethasone, and haloperidol (ODH); and the other group (group B) received a combination of ondansetron, dexamethasone, and promethazine (ODP). The ODP group received promethazine 25 mg IM 30 minutes before extubation and ODH group received haloperidol 2 mg IM at the beginning of the surgery. Nausea and vomiting were assessed in terms of severity and frequency in the recovery room, 6, and 24 hours postoperatively in both groups using the Numeric Verbal Rating Scale (NVRS). The frequency of PONV was significantly lower in the ODH group compared to the ODP group in the recovery room (20% versus 40%). PONV severity was lower in the ODH group compared to the ODP group. The time to first rescue antiemetic prescription in the ODP group was more than in the ODH group (7.2 h versus 2.6 h). In morbidly obese patients undergoing laparoscopic bariatric surgery, both antiemetic combinations decreased the incidence of PONV, but the combination of haloperidol, dexamethasone, and ondansetron was more effective than promethazine, dexamethasone, and ondansetron.

Comparison of alignment efficacy and arch dimensions changes with superelastic-, heat-activated-, and seven stranded coaxial nickel-titanium archwires during fixed orthodontic treatment – A double-blind randomized clinical trial

Objectives: The objectives of this study were to compare the alignment efficacy, changes in arch dimensions, and pain experience with three different nickel-titanium (NiTi) archwires. Material and Methods: Forty-five subjects were subjected to indirect bonding in the mandibular arch, and allocated to three groups using block randomization; Group 1 (0.014” Superelastic NiTi), Group 2 (0.014” 27° Copper NiTi), and Group 3 (0.016” seven stranded coaxial NiTi archwire). The mandibular study models were retrieved periodically at 4-week intervals for 12 weeks, which were blinded to measure the change in Little’s irregularity index (LII) and dental arch dimensions. Pain and discomfort were recorded with visual analog scale at five different time intervals, namely, immediately after bonding (0) and at 1-, 4-, 8-, and 12-h for initial 7 days. Repeated analysis of variance, Wilcoxon Signed-Rank test, post hoc Bonferroni test, and Friedman’s test was applied for the comparison and was used for data analysis. Results: A significant reduction of LII score and increase inarch length, intercanine, interpremolar, and intermolar width (P ≤ 0.001) were observed after 12 weeks among all groups. However, intergroup comparison showed significant mean changes only for intercanine width (Group 1 versus 3) and interpremolar width (Groups 1 and 3; Groups 2 and 3). All other variables were found to be insignificant at all-time intervals when compared among each group. The increase in pain score was maximum with Group 1and least with Group 3. Conclusion: All archwires were found to be effective in reducing the LII score. Nevertheless, Group 3 archwire could achieve reduction of LII to zero in 14% of subjects than Groups 1 and 2.