Botulinum Toxin to Improve Lower Blepharoplasty Scar: A Double-Blinded, Randomized, Vehicle-Controlled Clinical Trial

2021 ◽  
Author(s):  
Yau-Li Huang ◽  
Christopher Glenn Wallace ◽  
Yen-Chang Hsiao ◽  
Mei-Ching Lee ◽  
Jung-Ju Huang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Botulinum Toxin ◽  
Visual Analogue Scale ◽  
Analogue Scale ◽  
Vehicle Control ◽  
Reference Points ◽  
Lower Blepharoplasty ◽  
Scar Quality ◽  
Double Blinded ◽  
Transcutaneous Lower Blepharoplasty

Abstract Background Lower blepharoplasty is a common cosmetic operation that relies on minimal postoperative scarring, but Asian patients are at higher risk than Caucasians for hypertrophic and/or widened scars. Botulinum toxin type A (BTX) injections are widely employed to alleviate dynamic facial rhytids and also can improve scar quality by reducing scar tension. The authors assessed whether simultaneous transcutaneous lower blepharoplasty and BTX injections could improve subciliary scar quality. Objectives The objective of this study was to assess whether simultaneous transcutaneous lower blepharoplasty and BTX injections could improve subciliary scar quality. Methods This is a prospective, randomized, vehicle-controlled, double-blinded clinical trial. Between May 2015 and May 2018, 40 adults who underwent bilateral transcutaneous lower blepharoplasties were randomized to receive BTX (n = 20) or vehicle (normal saline; n = 20) injections into the lateral orbicularis oculi muscle immediately after wound closure. Vancouver Scar Scale, Visual Analogue Scale, and photographic scar width measurements at 3 reference points were recorded at the final clinical follow-up. Results Thirty-seven patients completed the trial. Vancouver Scar Scale and Visual Analogue Scale scores in the experimental and vehicle control groups were similar, but scar widths in the experimental group at all measured points were significantly narrower than in the vehicle control group (P < 0.001, P = 0.027, and P < 0.001 at each measured point, respectively). Conclusions Transcutaneous lower blepharoplasty scars in Asians can be significantly narrowed by simultaneous BTX injections without additional complications. Level of Evidence 4

Checkmate 577:Health-related quality of life (HRQoL) in a randomized, double-blind phase III study of nivolumab (NIVO) versus placebo (PBO) as adjuvant treatment in patients (pts) with resected esophageal or gastroesophageal junction cancer (EC/GEJC).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 167-167
Author(s):  
Eric Van Cutsem ◽  
Prianka Singh ◽  
James M. Cleary ◽  
Ronan Joseph Kelly ◽  
Markus H. Moehler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Analogue Scale ◽  
Repeated Measures ◽  
Analogue Scale ◽  
Gastroesophageal Junction ◽  
Neoadjuvant Chemoradiotherapy ◽  
Phase Iii ◽  
Meaningful Improvement ◽  
Utility Index ◽  
Patient Reported

167 Background: NIVO is the first adjuvant therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus PBO in resected EC/GEJC following neoadjuvant chemoradiotherapy as demonstrated by CheckMate 577. NIVO was well tolerated with an acceptable safety profile. This analysis provides additional information on the exploratory HRQoL endpoints in this clinical trial. Methods: The effect of NIVO versus PBO on HRQoL, including general and disease-related symptoms, functioning, disease burden, and overall QoL, was assessed using FACT-E and EQ-5D-3L patient-reported outcome (PRO) questionnaires administered at baseline (BL), every 4 weeks during the 12-month treatment period, and at post-treatment follow-up visits (up to 2 years after last dose). Longitudinal change from BL in PRO scores over 12 months was assessed using descriptive statistics. Additionally, mixed model for repeated measures and time to deterioration analyses evaluated the difference between treatment with NIVO and PBO (data not shown). Results: 794 pts with EC/GEJC were randomized 2:1 to NIVO (n = 532) or PBO (n = 262). PRO completion rates were ≥ 95% at BL and ~ 90% at 12 months on treatment. Mean (SD) BL HRQoL scores were similar between treatment arms for the FACT-E total score (NIVO: 133.40 [20.97]; PBO: 134.03 [20.40]); esophageal cancer subscale (ECS; NIVO: 50.2 [9.3]; PBO: 50.1 [8.9]); EQ-5D Visual Analogue Scale (NIVO: 70.4 [22.3]; PBO: 69.1 [24.1]); and EQ-5D Utility Index (NIVO: 0.820 [0.179]; PBO: 0.831 [0.163]) based on the UK value set. Descriptive analyses showed a trend for increases from baseline at most time points through week 49 for both NIVO and PBO treatment groups for FACT-E total score, ECS, and EQ-5D Visual Analogue Scale and Utility Index. Conclusions: Preliminary results from CheckMate 577 demonstrated that pts on NIVO treatment showed trends of improvement in both esophageal-specific and general HRQoL. Similar trends were also observed in pts treated with PBO over 1 year. Pts treated with NIVO did not experience a reduction in HRQoL, further supporting clinical data to demonstrate treatment benefit and tolerability for adjuvant NIVO in pts with resected EC/GEJC. Clinical trial information: NCT02743494.

scholarly journals Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Anna Hansson ◽  
Thomas Rasmussen ◽  
Roland Perfekt ◽  
Elin Hall ◽  
Holger Kraiczi
Keyword(s):  
Clinical Trial ◽  
Smoking Cessation ◽  
Clinical Study ◽  
Visual Analogue Scale ◽  
Replacement Therapy ◽  
Success Rate ◽  
Analogue Scale ◽  
Healthy Adult ◽  
Nicotine Gum ◽  
Search Query

Abstract Background Ability to manage urges to smoke is fundamental to maximizing the chances of success in smoking cessation. Previous studies have linked a higher dose of nicotine in nicotine replacement therapy to a higher success rate for smoking cessation. Thus, this study was performed to compare relief of urges to smoke, up until 5 h following treatment with a new 6 mg nicotine gum versus currently marketed 4 mg nicotine gum. Methods This was a randomized crossover clinical study. Following 12 h of abstinence from smoking, either one 6 mg or one 4 mg nicotine gum was given to 240 healthy adult smokers. Thereafter, urges to smoke were scored on a 100 mm Visual Analogue Scale repeatedly over 5 h. Results The reductions in urges to smoke over the first 1 and 3 h after administration were statistically significantly greater with 6 mg than 4 mg gum, (p < 0.005). A 50% reduction in perceived urges to smoke was reached in 9.4 min with 6 mg gum compared to 16.2 min with 4 mg gum (median values). The median duration of a 50% or more reduction in VAS urges to smoke score was 111 min with the 6 mg gum, versus 74 min for the 4 mg gum. Conclusion This study provides evidence that the 6 mg nicotine gum provided a greater reduction, faster and longer relief of urges to smoke than the 4 mg nicotine gum. Trial registration EudraCT Number: 2010–023268-42. Study was first entered in EudraCT 2011-02-23.

scholarly journals The Evaluation of the Clinical Effects of Botulinum Toxin on Nocturnal Bruxism

2017 ◽  
Vol 2017 ◽  
pp. 1-5 ◽  
Author(s):  
Fatih Asutay ◽  
Yusuf Atalay ◽  
Hilal Asutay ◽  
Ahmet Hüseyin Acar
Keyword(s):  
Retrospective Study ◽  
Botulinum Toxin ◽  
Visual Analogue Scale ◽  
Conservative Treatment ◽  
Analogue Scale ◽  
Single Injection ◽  
Botulinum Toxin A ◽  
Clinical Effects ◽  
Pain Scores ◽  
The Right

Objectives. Nocturnal bruxism can be managed by botulinum toxin (Botox®) in patients who have not responded to conservative treatment. The aim of this study was to evaluate the efficacy of botulinum toxin A (BTXA) in the treatment of nocturnal bruxism. Material and Methods. The retrospective study comprised 25 female patients, aged 23–55 years (mean 35.84±8.41 years). All patients received a single injection of BTXA in the right and left masseters. Evaluation was made by Visual Analogue Scale (VAS) values, complaint duration, onset of effect, and duration of effectiveness. Results. BTXA produced significant improvements in pain scores. Only 2 adverse events (8%) were recorded. Conclusion. BTX-A is effective in the treatment of nocturnal bruxism.

scholarly journals Effectiveness of acromioclavicular joint mobilization and physical therapy vs physical therapy alone in patients with frozen shoulder: A randomized clinical trial

2021 ◽  
pp. 026921552110704
Author(s):  
Mohammad Rahbar ◽  
Sepideh Ranjbar Kiyakalayeh ◽  
Reza Mirzajani ◽  
Bina Eftekharsadat ◽  
Neda Dolatkhah
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Visual Analogue Scale ◽  
Range Of Motion ◽  
Analogue Scale ◽  
Acromioclavicular Joint ◽  
Therapy Group ◽  
Frozen Shoulder ◽  
Joint Mobilization ◽  
Active Abduction

Objectives The objective of this trial was to compare the efficacy of acromioclavicular joint mobilization and standard physical-therapy versus physical-therapy alone in the treatment of the frozen shoulder. Design Single-blind randomized clinical trial. Setting Outpatient setting. Subjects Patients with frozen shoulder. Intervention Participants were randomly allocated into mobilization + physical-therapy (n = 28), and physical-therapy alone (n = 28) groups for one month. Main Measures The primary outcomes were the shoulder pain and disability index and the shoulder range of motion. The secondary outcome was the visual analogue scale. Measures were performed at the baseline, immediately and one month after the beginning of the treatment. Results Visual analogue scale and the shoulder pain and disability index improved more significantly in the mobilization group compared to the physical-therapy group immediately [−4.63 (−5.58–−3.67) vs. −2.22 (−2.96–−1.47), P < 0.001 and −23.08 (−28.63–−17.53) vs. −13.04 (−17.93–−8.16), P = 0.008, respectively] and one month after the beginning of the treatment [−5.58 (−6.45–−4.72) vs. −3.61 (−4.60–−2.62), P < 0.001 and −33.43 (−40.85–−26.01) vs. −20.03 (−26.00–−14.07), P = 0.001, respectively]. Active abduction range of motion was also improved more significantly immediately after the treatment in the mobilization group compared to the physical-therapy group [25.83 (11.45–40.13) vs. 10.17 (1.02–19.15), P = 0.025], however there were no significant differences between two groups concerning other measured range of motions. Conclusions Adding acromioclavicular mobilization to standard physical-therapy was more efficient in decreasing pain and disability and improving active abduction range of motion compared to standard physical-therapy in frozen shoulder patients.

scholarly journals Botulinum Toxin to Improve Results in Cleft Lip Repair: A Double-Blinded, Randomized, Vehicle-Controlled Clinical Trial

PLoS ONE ◽  
2014 ◽  
Vol 9 (12) ◽  
pp. e115690 ◽  
Author(s):  
Chun-Shin Chang ◽  
Christopher Glenn Wallace ◽  
Yen-Chang Hsiao ◽  
Chee-Jen Chang ◽  
Philip Kuo-Ting Chen
Keyword(s):  
Clinical Trial ◽  
Botulinum Toxin ◽  
Cleft Lip ◽  
Controlled Clinical Trial ◽  
Cleft Lip Repair ◽  
Double Blinded

scholarly journals Load monitoring on Pilates training: a study protocol for a randomized clinical trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Allysiê Priscilla de Souza Cavina ◽  
Eduardo Pizzo Junior ◽  
Aryane Flauzino Machado ◽  
Taíse Mendes Biral ◽  
Carlos Marcelo Pastre ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Visual Analogue Scale ◽  
Randomized Clinical Trial ◽  
Analogue Scale ◽  
Scientific Evidence ◽  
Training Session ◽  
Preventive Measure ◽  
Training Load ◽  
Subjective Perception

Abstract Background Currently there are campaigns to raise the awareness of the need to practice physical exercise with several objectives, mainly as a preventive measure. The Pilates method is a form of therapeutic exercise for maintaining and improving health. However, despite being popular, there is still no scientific evidence on the standardization and progression of the method. Therefore, the purpose of this study was to develop a protocol to monitor the progression of daily Pilates loads between the basic, intermediate, and advanced levels, as well as to analyze the effects of the method on psychometric, cardiorespiratory, and autonomic measures. Methods/design In total, 54 healthy men underwent 36 sessions of Pilates mat work. Before each training session, cardiorespiratory measures, pain (visual analogue scale), and a psychometric questionnaire were collected. Heart rate (HR), subjective perception of effort (SPE), and RR intervals were measured during the sessions and used later in the analysis of the progression of training load by monitoring the internal training load and heart rate variability. At the end of the sessions, cardiorespiratory measures, the visual analogue scale, and the psychometric questionnaire were measured again. After 15 min of rest, the final HR measurement was made and the participants noted the effort on the SPE scale. The psychometric, cardiorespiratory, and autonomic measures were evaluated before and after each of the 36 training sessions. Discussion This is a parallel randomized clinical trial of standardized Pilates training, with the aim of estimating training loads and measuring the efficacy of Pilates through clinical, cardiorespiratory, and autonomic outcomes. The protocol can easily be reproduced and could be used to support professionals in prescribing the method. Trial registration ClinicalTrials.gov, NCT03232866. Registered on 28 July 2017.

scholarly journals Design and implementation of botulinum toxin on cricopharyngeal dysfunction guided by a combination of catheter balloon, ultrasound, and electromyography (BECURE) in patients with stroke: study protocol for a randomized, double-blinded, placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mengshu Xie ◽  
Zulin Dou ◽  
Guifang Wan ◽  
Peishan Zeng ◽  
Hongmei Wen
Keyword(s):  
Clinical Trial ◽  
Botulinum Toxin ◽  
Controlled Trial ◽  
Second Phase ◽  
Residual Pressure ◽  
Efficacy And Safety ◽  
Cricopharyngeal Muscle ◽  
Significant Difference ◽  
Cricopharyngeal Dysfunction ◽  
Double Blinded

Abstract Background Cricopharyngeal dysfunction (CPD) occurs in various neurological disorders, especially stroke. The treatment approaches of CPD include swallowing training, cricopharyngeal dilation, botulinum toxin (BTX) injection, and cricopharyngeal myotomy. BTX injection into the cricopharyngeal muscle is effective and safe for some patients with dysphagia, with a success rate between 43 and 100% (mean = 76%). However, well-designed randomized controlled clinical trials are needed to verify its efficacy and safety for the treatment of CPD. The objective of this study is to explore the efficacy and safety of BTX for neurogenic cricopharyngeal achalasia, when administering an injection into the cricopharyngeal muscle guided by a novel precise positioning method, that combines ultrasound, catheter balloon, and electromyography (BECURE). Methods BECURE is a single-center randomized, placebo controlled, double-blinded, superiority clinical trial. To detect a significant difference between the 2 groups, a sample size of 44 patients is estimated. The intervention is BTX versus placebo, with 1:1 randomization. The randomization sequence from 1 to 44 was generated using the Statistical Package for Social Sciences. The study is divided into two phases. In the first phase, patients will be injected with BTX or the placebo. In the second phase, patients who received a placebo injection and those who did not respond to the first BTX injection will receive an injection of BTX. The primary outcome is the score of the Functional Oral Intake Scale (FOIS). The secondary outcomes are as follows: upper esophageal sphincter (UES) residual pressure, UES resting pressure, duration of UES relaxation, velopharyngeal and laryngopharyngeal peak pressure, UES opening, pharyngeal construction ratio, residue of bolus in the epiglottis valley or piriform sinus, and penetration and aspiration. Discussion Dysphagia is a common complication of stroke. There is lack of high-quality evidence for the efficacy of BTX in treating neurogenic CPD. This study will clarify whether BTX injection into the cricopharyngeal muscle can be effective and safe for patients with stroke and CPD. Trial registration Chinese Clinical Trial Register (ChiCTR1900025562). Registered on September 1, 2019.

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