scholarly journals Clinical Efficacy of a Spray Containing Hyaluronic Acid and Dexpanthenol after Surgery in the Nasal Cavity (Septoplasty, Simple Ethmoid Sinus Surgery, and Turbinate Surgery)

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Ina Gouteva ◽  
Kija Shah-Hosseini ◽  
Peter Meiser
Keyword(s):  
Hyaluronic Acid ◽  
Observational Study ◽  
Nasal Cavity ◽  
Intervention Group ◽  
Sinus Surgery ◽  
Control Group ◽  
Nasal Breathing ◽  
Double Blind ◽  
Mucosal Regeneration ◽  
Mean Values

Background. This prospective, controlled, parallel-group observational study investigated the efficacy of a spray containing hyaluronic acid and dexpanthenol to optimise regular treatment after nasal cavity surgery in 49 patients with chronic rhinosinusitis. Methods. The control group received standard therapy. Mucosal regeneration was determined using rhinoscopy sum score (RSS). Pre- and postoperative nasal patency was tested using anterior rhinomanometry. The participants were questioned about their symptoms. Results. Regarding all RSS parameters (dryness, dried nasal mucus, fibrin deposition, and obstruction), mucosal regeneration achieved good final results in both groups, tending to a better improvement through the spray application, without statistically significant differences during the whole assessment period, the mean values being 7.04, 5.00, 3.66, and 3.00 (intervention group) and 7.09, 5.14, 4.36, and 3.33 (control group). No statistically significant benefit was identified for nasal breathing, foreign body sensation, and average rhinomanometric volume flow, which improved by 12.31% (control group) and 11.24% (nasal spray group). Conclusion. The investigational product may have additional benefit on postoperative mucosal regeneration compared to standard cleaning procedures alone. However, no statistically significant advantage could be observed in this observational study. Double-blind, controlled studies with larger populations will be necessary to evaluate the efficacy of this treatment modality.

Optimization of postoperative management of patients undergoing functional endoscopic sinus surgery

2018 ◽  
pp. 26-31
Author(s):  
Sergey Bezshapochny ◽  
Andrey Loburets ◽  
Valery Loburets
Keyword(s):  
Nasal Cavity ◽  
Postoperative Period ◽  
Sodium Hyaluronate ◽  
Sinus Surgery ◽  
Control Group ◽  
Nasal Breathing ◽  
Traditional Therapy ◽  
Significant Difference ◽  
Water Salt ◽  
Experimental Group

Topicality: The result of surgical treatment depends largely on the chosen method of management of the postoperative period, the main purpose of which is to reduce the effects of surgical trauma. Despite the wide variety of drugs for local and systemic use, the question of pharmacotherapy of the operated sinus remains open to this day. The main properties that a modern drug should possess are safety and high clinical efficacy. Aim: to study the clinical efficacy of topical application of a complex preparation based on a saline solution containing sodium hyaluronate and dexpanthenol in patients with chronic sinusitis after functional endoscopic sinus surgery (FESS). Materials and Methods: Clinical and laboratory studies were conducted on 47 patients with chronic rhinosinusitis who underwent surgery using the FESS technique. Patients were divided into 2 groups according to the principle of the postoperative period. Patients of research group (n=21), except for traditional therapy, was used locally NASOMER (a preparation based on a water-salt solution containing sodium hyaluronate and dexpanthenol); to the control group (n=26) patients entered, in the postoperative period received traditional therapy. Traditional therapy included a toilet of the nasal cavity, the use of short-course topical decongestants, irrigation of the nasal cavity with water-salt solutions. Criteria of clinical effectiveness: data of endoscopy of the nasal cavity, rhinomanometry, activity of the mucociliary transport system. The effectiveness of functional research methods in the postoperative period was determined on the 7th and 14th day of treatment. Results: On the 3rd day of the study, an increase in the swelling of the nasal cavity was observed in patients of both clinical groups, correlated with difficulty in nasal breathing. On the 7th day, a decrease in edema was observed in patients of both groups, but in the experimental group, the index of nasal breathing, according to rhinomanometry, was significantly (p<0.05) different from the control group, and was respectively 1.54±0.14 and 2.04±0.19 kPa/l*s. On the 14th day of the study, no significant difference was observed between these indicators. When studying the activity of the ciliated epithelium of the mucous membrane of the nasal cavity, it was proved that patients of the experimental group on day 7 after surgery showed a statistically significant difference in this indicator compared to the control group (17.8±1.0 and 22.7±2.1 min. respectively). Conclusions: The use of NASOMER after surgical intervention in patients with chronic rhinosinusitis contributes to more effective treatment compared with traditional therapy, as evidenced by the rapid recovery of the main functional parameters according to active posterior rhinomanometry and mucociliary clearance. Based on the results of the studies performed, the use of NASOMER for pharmacotherapy in the postoperative period is recommended for patients who have undergone rhinosurgical interventions with the aim of reducing the period of postoperative rehabilitation as an effective anti-inflammatory and wound-healing agent.

Application of Nasomer in surgical treatment of patients with polyposis rhinosinusitis

2018 ◽  
pp. 39-42
Author(s):  
Vladimir Bereznyuk ◽  
Alexander Chernokur ◽  
Oleg Gospod
Keyword(s):  
Nasal Cavity ◽  
Postoperative Period ◽  
Paranasal Sinuses ◽  
Standard Treatment ◽  
Surgical Intervention ◽  
Sodium Hyaluronate ◽  
Main Group ◽  
Control Group ◽  
Nasal Breathing ◽  
Minimal Invasiveness

Relevance: Modern endonasal surgery allows to remove polyps from all affected paranasal sinuses, following the principles of minimal invasiveness. Minimal traumatic of surgical intervention gives the best results, accompanied by less progression of the disease. Minimal invasiveness of surgical intervention and its obligatory combination with postoperative medical treatment are common practice in many countries. One of the drugs that actively effect the restoration of the mucous membrane of the nasal cavity and paranasal sinuses in the early postoperative period is Nazomer, which includes sodium hyaluronate and dexpanthenol in saline solution. The purpose of the study is to investigate the effectiveness of the drug Nazomer in patients with polyposis rhinosinusitis after endoscopic polyposynosotomy. Results and discussion: The main group consisted of 30 patients with polyposis rhinosinusitis, who were prescribed Nasomer in addition to standard treatment in the postoperative period. The control group included 30 patients who underwent standard treatment in the postoperative period. As criteria for clinical efficacy, data from endoscopic examination of the nasal cavity and indicators of anterior rhinomatometry, measured by the «Optimus» device, were selected. In the main group, the index of nasal breathing according to rhinomatometry was better than the results of patients in the control group on the 3rd and 5th day of the postoperative period by 26% and 24%, respectively. Conclusion: The use of the drug Nazomer in the postoperative period in patients with polyposis rhinosinusitis contributes to more active restoration of respiratory function of the nasal cavity compared with the control group, according to rhinomatometry, up to 26%. Based on the results obtained, the drug Nazomer is an effective anti-inflammatory and regenerative agent in the postoperative period in patients with polyposis rhinosinusitis.

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

2021 ◽  
pp. 2100752
Author(s):  
Pradeesh Sivapalan ◽  
Charlotte Suppli Ulrik ◽  
Therese Sophie Lapperre ◽  
Rasmus Dahlin Bojesen ◽  
Josefin Eklöf ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Safety Outcome ◽  
Hospitalised Patients ◽  
Double Blinded ◽  
Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

Hyaluronic acid for post sinus surgery care: systematic review and meta-analysis

2017 ◽  
Vol 131 (S1) ◽  
pp. S2-S11 ◽  
Author(s):  
E Fong ◽  
M Garcia ◽  
C M Woods ◽  
E Ooi
Keyword(s):  
Systematic Review ◽  
Hyaluronic Acid ◽  
Endoscopic Sinus Surgery ◽  
Meta Analysis ◽  
Adhesion Formation ◽  
Sinus Surgery ◽  
Current Evidence ◽  
Secondary Outcome ◽  
Control Group ◽  
Patient Reported

AbstractBackground:Wound healing after endoscopic sinus surgery may result in adhesion formation. Hyaluronic acid may prevent synechiae development. A systematic review was performed to evaluate the current evidence on the clinical efficacy of hyaluronic acid applied to the nasal cavity after sinus surgery.Methods:Studies using hyaluronic acid as an adjunct treatment following endoscopic sinus surgery for chronic rhinosinusitis were identified. The primary outcome was adhesion formation rates. A meta-analysis was performed on adhesion event frequency. Secondary outcome measures included other endoscopic findings and patient-reported outcomes.Results:Thirteen studies (501 patients) met the selection criteria. A meta-analysis of adhesion formation frequency on endoscopy demonstrated a lower risk ratio in the hyaluronic acid intervention group (42 out of 283 cases) compared to the control group (81 out of 282) of 0.52 (95 per cent confidence interval = 0.37–0.72). Hyaluronic acid use was not associated with any significant adverse events.Conclusion:Hyaluronic acid appears to be clinically safe and well tolerated, and may be useful in the early stages after sinus surgery to limit adhesion rate. Further research, including larger randomised controlled trials, is required to evaluate patient- and clinician-reported outcomes of hyaluronic acid post sinus surgery.

The efficacy of multidisciplinary rehabilitation in stable multiple sclerosis patients

2006 ◽  
Vol 12 (2) ◽  
pp. 235-242 ◽  
Author(s):  
L K Storr ◽  
P S Sørensen ◽  
M Ravnborg
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Bodily Pain ◽  
Intervention Group ◽  
Inpatient Rehabilitation ◽  
Control Group ◽  
Double Blind ◽  
Multidisciplinary Rehabilitation ◽  
Upper Limb Function ◽  
Multiple Sclerosis Patients

Objective To evaluate the short-term efficacy of multidisciplinary, inpatient rehabilitation of multiple sclerosis (MS) patients. Methods A double-blind, randomized, parallel group design was used. The intervention group were offered comprehensive, multidisciplinary inpatient rehabilitation at the Haslev MS Hospital for an average of 35.5 days, while the control group received no treatment related to the study. All patients were examined in their homes twice with a 10-week interval. The rehabilitation of the intervention group started 2-3 weeks after the first examination and ended 2-3 weeks before the second examination. Impairment was assessed by the Multiple Sclerosis Impairment Scale and the Expanded Disability Status Scale. Disability was assessed by means of Guy’s Neurological Disability Scale. Two specific scales were used to assess upper limb function and ambulation: The Nine-Hole Peg Test and timed 10-metre walking. Patients’ own perception of bodily pain, bladder symptoms, spasticity, fatigue, impaired walking and transfers were recorded using visual analogue scales. Finally, quality of life was assessed using the Life Appreciation and Satisfaction Questionnaire and the Functional Assessment in Multiple Sclerosis. Patients Two hundred and thirty-three patients were screened and of those 38 were included for treatment and 52 as controls. Results We found no statistically significant differences between the two groups in any of the outcome measures. Conclusion Although the study was underpowered, the negative outcome exposes the difficulties in quantitative analyses of the efficacy of multidisciplinary rehabilitation, which is liable to confounding factors such as variation in the indication for treatment, in the placebo effect, and in the reliability and responsiveness of the outcome measures.

scholarly journals Effect of Oral Ingestion of Low-Molecular Collagen Peptides Derived from Skate (Raja Kenojei) Skin on Body Fat in Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Marine Drugs ◽  
2019 ◽  
Vol 17 (3) ◽  
pp. 157 ◽  
Author(s):  
Young Tak ◽  
Yun Kim ◽  
Jeong Lee ◽  
Yu-Hyun Yi ◽  
Young Cho ◽  
...  
Keyword(s):  
Body Fat ◽  
Animal Studies ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Collagen Peptides ◽  
Collagen Peptide ◽  
Skin Collagen ◽  
Overweight Adults

Recent animal studies found the potential of a collagen peptide derived from skate skin to have anti-obesity effects through the suppression of fat accumulation and regulation of lipid metabolism. However, no studies have yet been performed in humans. Here, this very first human randomized, placebo-controlled, and double-blinded study was designed to investigate the efficacy and tolerability of skate skin collagen peptides (SCP) for the reduction of body fat in overweight adults. Ninety healthy volunteers (17 men) aged 41.2 ± 10.4 years with a mean body mass index of 25.6 ± 1.9 kg/m2 were assigned to the intervention group (IG), which received 2000 mg of SCP per day or to the control group (CG) given the placebo for 12 weeks and 81 (90%) participants completed the study. Changes in body fat were evaluated using dual energy X-ray absorptiometry as a primary efficacy endpoint. After 12 weeks of the trial, the percentage of body fat and body fat mass (kg) in IG were found to be significantly better than those of subjects in CG (−1.2% vs. 2.7%, p = 0.024 and −1.2 kg vs. 0.3 kg, p = 0.025). Application of SCP was well tolerated and no notable adverse effect was reported from both groups. These results suggest the beneficial potential of SCP in the reduction of body fat in overweight adults.

scholarly journals Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Sinus Surgery

2019 ◽  
Vol 10 ◽  
pp. 215265671882128 ◽  
Author(s):  
Ahmad Rezaeian ◽  
Seyed Mostafa Hashemi ◽  
Zeinab Sadat Dokhanchi
Keyword(s):  
Postoperative Pain ◽  
Endoscopic Sinus Surgery ◽  
Intervention Group ◽  
Sinus Surgery ◽  
Control Group ◽  
Sphenopalatine Ganglion ◽  
Ganglion Block ◽  
Rescue Analgesia ◽  
Sphenopalatine Ganglion Block ◽  
And Control

Background Postoperative pain is one of the most complications in endoscopic sinus surgery. We aimed to evaluate the effect of the sphenopalatine ganglion block (SPGB) with bupivacaine on postoperative pain in patients undergoing endoscopic sinus surgery. Methods and Materials: In this clinical trial, 40 patients who indicated functional endoscopic sinus surgery were selected and then divided into 2 parallel groups as intervention and control. The intervention group was received 1.5 mL of bupivacaine 0.5% (injected to sphenopalatine ganglion) and while control was injected 1.5 mL of normal saline at the same injection site. Also, the visual analogue scale (VAS) was recorded immediately after anesthesia, along with 6, 12, 24, 48 h, 7 days, and 21 days after the operation for all patients. Results Immediately after anesthesia, as well as 6, 12, and 24 h after the operation, VAS in the intervention group was significantly lower than in the control group ( P < .05, for all). However, there were no significant differences between the 2 groups regarding VAS 48 h as well as 7 and 21 days after surgery ( P > .05, for both). Also, the rescue analgesia in the intervention group was significantly lower than in the control group ( P = .01). Conclusion SPGB with bupivacaine 0.5% (1.5 mL) was a simple, effective, safe, and noninvasive method for the management of postoperative pain in the patients undergoing endoscopic sinus surgery.

scholarly journals Retrospective observational study of the impact on emergency admission of telehealth at scale delivered in community care in Liverpool, UK

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e028981
Author(s):  
Cees van Berkel ◽  
Peter Almond ◽  
Carol Hughes ◽  
Maurice Smith ◽  
Dave Horsfield ◽  
...  
Keyword(s):  
Observational Study ◽  
Subgroup Analysis ◽  
Intervention Group ◽  
Average Treatment Effect ◽  
Retrospective Observational Study ◽  
Control Group ◽  
Chronic Obstructive ◽  
Emergency Admissions ◽  
Percentage Decrease ◽  
The Impact

ObjectiveTo assess the effect of a real world, ongoing telehealth service on the use of secondary healthcare.DesignA retrospective observational study with anonymous matched controls.SettingPrimary and community healthcare. Patients were recruited over 4 years in 89 general practices in Liverpool, UK and remotely managed by a dedicated clinical team in Liverpool Community Health.Participants5154 patients with chronic obstructive pulmonary disease, heart failure or diabetes were enrolled in the programme, of whom 3562 satisfied the inclusion criteria of this study.InterventionAt least 9 weeks of telehealth including vital sign collection, questionnaires, education, support and informal coaching by clinical staff.Primary outcomeReduction in the number of emergency admissions in the 12 months after start, compared with the year before start. Secondary subgroup analysis to improve future targeting and personalisation of the service.ResultThe average number of emergency admissions for the intervention group at baseline is 0.35, 95% CI 0.32 to 0.38. The differential decrease in emergency admissions in the intervention group in comparison with the control group, the average treatment effect, is 0.08, 95 CI 0.05 to 0.11, corresponding to an average percentage decrease of 22.7%. In subgroup analysis, a score is calculated that can be used prospectively to predict individual benefit from the intervention. Patients with an above median score (37%) are predicted average reduction in emergency admissions of 0.15, 95% CI 0.09 to 0.2, corresponding to a percentage decrease in admissions of 25.3%.ConclusionThe telehealth intervention has a positive impact across a wide cohort of patients with different diseases. Prospective scoring of patients and allocation to targeted telehealth interventions is likely to improve the effectiveness and efficiency of the service.

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