scholarly journals Study of the therapeutic efficacy and safety of intralesional tranexamic acid (25 mg/ml) for the treatment of melasma in male patients: A single centered “before-after” observational study

Author(s):  
Yog R. Verma ◽  
Karaninder S. Mehta ◽  
Pushpinder S. Chauhan ◽  
Vikram K. Mahajan ◽  
Monika Chandel ◽  
...  

<p class="abstract"><strong>Background:</strong> Melasma is a common and difficult to treat hypermelanosis of poorly understood etiopathogenesis with great tendency to relapse. Tranexamic acid (TA) has been used in various formulations for its treatment, but there is paucity of studies/data and no consensus on the optimum dosage of intradermal TA, especially among the male patients. To study the efficacy and safety of intralesional TA 25 mg/ml for the treatment of melasma in male patients.</p><p class="abstract"><strong>Methods: </strong>Total 58 males were enrolled for study from July 2019 to June 2020. TA in 25 mg/ml strength injection and about 0.05 ml was injected intradermally at 1 cm apart on the entire melasma lesion, not exceeding 50 mg per visit and repeated every 4 weekly for 12 weeks. The percentage reduction in MASI was the primary outcome measure. It was determined every 4th week till 12 weeks and finally at 24 weeks for recurrence.</p><p class="abstract"><strong>Results: </strong>Mean MASI decreased from baseline score of 8.42±5.63 to 6.71±4.65, 5.09±3.59 and 3.41±3.06 at the follow up week 4, 8 and 12 respectively with a significant decrease from 8th week onwards. Majority of the patients were satisfied with their improvement after treatment (67.2%) without any significant adverse effects.</p><p class="abstract"><strong>Conclusions:</strong> However, the TA was found to effective in all the three histopathological types of melasma but the dermal melasma was least responsive as well as earliest to relapse. We recommend monthly therapy at 25 mg/ml as more efficacious, time saving and cost effective to all the three types of melasma.</p><p class="abstract"> </p>

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.


2001 ◽  
Vol 178 (1) ◽  
pp. 36-41 ◽  
Author(s):  
James Warner ◽  
Chris Metcalfe ◽  
Michael King

BackgroundThere is no evidence to support current advice not to use benzodiazepines after bereavement.AimsTo determine the role of benzodiazepines in the management of bereavement.MethodWe conducted a randomised, double-blind, placebo-controlled evaluation of the use of diazepam after recent bereavement. Participants were randomised to either 2 mg diazepam or identically packaged placebo up to three times daily. The primary outcome measure was the Bereavement Phenomenology Questionnaire.ResultsThirty subjects were randomised. No evidence was found of an effect of benzodiazepines on the course of the first 6 months of bereavement (estimated mean difference of combined follow-up assessments=0.3 in favour of placebo; 95% CI –6.2 to +6.7).ConclusionWe found no evidence of a positive or negative effect of benzodiazepines on the course of bereavement.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H Yaku ◽  
T Kato ◽  
T Morimoto ◽  
Y Inuzuka ◽  
Y Tamaki ◽  
...  

Abstract Background The favourable effect of mineralocorticoid receptor antagonists (MRAs) on mortality was established in patients with stable heart failure (HF) with reduced ejection fraction (EF). However, its prognostic effect of MRAs in acute decompensated heart failure (ADHF) including HF with preserved EF (HFpEF) was unclear. Purpose This study sought to investigate the long-term impact of MRA on the post-discharge outcomes in patients with ADHF. Methods From the consecutive 3717 patients hospitalized for ADHF and discharged alive in the KCHF registry, we developed the propensity score (PS) for MRA use and constructed the PS-matched cohort. We compared the effect of MRA use on the primary outcome measure of all-cause death or HF hospitalization. Results A total of 1678 patients (45%) received MRA at discharge from the index hospitalization. Median follow-up was 470 days with 96% 1-year follow-up rate. In the PS-matched cohort (N=1034 in each group), the cumulative 1-year incidence of the primary outcome measure was significantly lower in the MRA group than in the no MRA group (28.4% vs. 33.9%, P=0.003) (Figure 1). The cumulative 1-year incidence of HF hospitalization was significantly lower in the MRA group than in the no MRA group (18.7% vs. 24.8%, P<0.001), while there was no difference in mortality between the 2 groups (15.6% vs. 15.8%, P=0.85). There was no interaction between the effect of MRA and the 3 subgroups stratified by EF (EF <40%, EF 40–49%, EF ≥50%) (interaction P=0.12). Figure 1 Conclusion The use of MRA was associated with lower risk for the primary composite outcome of all-cause death or HF hospitalization in patients hospitalized for ADHF including HFpEF, which was mainly driven by the lower risk for HF hospitalization.


2018 ◽  
Vol 100-B (2) ◽  
pp. 152-160 ◽  
Author(s):  
K. N. Subramanyam ◽  
P. Khanchandani ◽  
P. V. Tulajaprasad ◽  
J. Jaipuria ◽  
A. V. Mundargi

Aims The aims of this study were to compare the efficacy and safety of intra-articular and intravenous (IV) tranexamic acid (TXA) in controlling perioperative blood loss in total knee arthroplasty (TKA) using a randomized, double-blinded equivalence trial. Patients and Methods A total of 182 patients aged between 45 and 75 years undergoing unilateral TKA at a tertiary centre were randomized to receive TXA, either 1.5 g intra-articularly after closure of the wound (n = 91) or two doses of 10 mg/kg IV (n = 91). The primary outcome measure was the reduction in the level of haemoglobin (Hb) in the blood on the fifth postoperative day. Secondary outcome measures were the total, visible, and hidden blood losses (TBL, VBL, HBL). We assumed equivalence of the primary outcome in both routes with a margin of ± 0.35gm/dl. Block randomization using computer-generated random numbers was used. The patients and the assessor of outcome were blinded. Results All patients completed the study. The mean difference in the reduction of the level of Hb between the two groups was -0.0055 gm/dl, with two-sided 95% confidence interval (CI) being -0.29 to 0.27, well within the predefined equivalence margin of ± 0.35gm/dl. The groups were comparable with regard to TBL, VBL, HBL, and complications. No patient needed a blood transfusion. Conclusion A single intra-articular dose and two IV doses of TXA give equivalent efficacy and safety in the management of blood loss at TKA. Cite this article: Bone Joint J 2018;100-B:152–60.


2018 ◽  
Author(s):  
Per Andrén ◽  
Kristina Aspvall ◽  
Lorena Fernández de la Cruz ◽  
Paulina Wiktor ◽  
Sofia Romano ◽  
...  

Objective: Behaviour therapy (BT) for Tourette’s Disorder (TD) and Persistent Motor or Vocal Tic Disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training [HRT] and exposure and response prevention [ERP]) into a therapist- and parent-guided online self-help format.Design: A pilot, single-blind, parallel group randomised controlled trial.Setting: A university hospital in Sweden.Participants: Twenty-three young people with TD/PTD, aged 8-16.Interventions: Two 10-week therapist- and parent-guided Internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).Outcome: The primary outcome measure was the Yale Global Tic Severity Scale (YGTSS). Blinded evaluators rated symptoms at baseline, post-treatment, and 3-month follow-up (primary endpoint). All participants were naturalistically followed-up to 12 months after treatment.Results: Patients and parents rated the interventions as highly acceptable, credible, and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity, and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 minutes per participant per week.Conclusions: Internet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration number: NCT02864589 (ClinicalTrials.gov).Funding: The trial was supported by the Stockholm County Council (PPG project 2016-0108).


2019 ◽  
Vol 101-B (12) ◽  
pp. 1498-1505 ◽  
Author(s):  
Jesper Sonntag ◽  
Linn Woythal ◽  
Per Rasmussen ◽  
Ulrik Branner ◽  
Per Hølmer ◽  
...  

Aims The aim of this study was to investigate the difference in functional outcome after repair and non-repair of the pronator quadratus muscle in patients undergoing surgical treatment for a distal radial fracture with volar plating. Patients and Methods A total of 72 patients with a distal radial fracture were included in this randomized clinical trial. They were allocated to have the pronator quadratus muscle repaired or not, after volar locked plating of a distal radial fracture. The patients, the assessor, the primary investigator, and the statistician were blinded to the allocation. Randomization was irreversibly performed using a web application that guaranteed a secure and tamper-free assignment. The primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) after 12 months. Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH) score, pronation strength, grip strength, the range of pronation and supination, complications, and the operating time. Results Of the 72 patients, 63 (87.5%) completed follow-up for the primary outcome measure: 31 (86.1%) from the non-repair group and 32 (88.9%) from the repair group. At the 12-month follow-up, the mean difference in PRWE of 5.47 (95% confidence interval (CI) -4.02 to 14.96) between the repair (mean 18.38 (95% CI 10.34 to 26.41)) and non-repair group (mean 12.90 (95% CI 7.55 to 18.25)) was not statistically significant (p = 0.253). There was a statistically significant difference between pronation strength, favouring non-repair. We found no difference in the other secondary outcomes. Conclusion We found that repairing pronator quadratus made no difference to the clinical outcome, 12 months after volar plating of a distal radial fracture. We conclude that there is no functional advantage in repairing this muscle under these circumstances and advise against it. Cite this article: Bone Joint J 2019;101-B:1498–1505


BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024685 ◽  
Author(s):  
Per Andrén ◽  
Kristina Aspvall ◽  
Lorena Fernández de la Cruz ◽  
Paulina Wiktor ◽  
Sofia Romano ◽  
...  

ObjectiveBehaviour therapy (BT) for Tourette’s disorder (TD) and persistent (chronic) motor or vocal tic disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training (HRT) and exposure and response prevention (ERP)) into a therapist-guided and parent-guided online self-help format.DesignA pilot, single-blind, parallel group randomised controlled trial.SettingA specialist outpatient clinic in Sweden.ParticipantsTwenty-three young people with TD/PTD, aged 8–16.InterventionsTwo 10-week therapist-guided and parent-guided internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).OutcomeThe primary outcome measure was the Yale Global Tic Severity Scale. Blinded evaluators rated symptoms at baseline, post-treatment and 3-month follow-up (primary endpoint). All participants were naturalistically followed up to 12 months after treatment.ResultsPatients and parents rated the interventions as highly acceptable, credible and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 min per participant per week.ConclusionsInternet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration numberNCT02864589; Pre-results.


BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015111 ◽  
Author(s):  
Mohamed Abdel-Fattah ◽  
Graeme MacLennan ◽  
Mary Kilonzo ◽  
R Phil Assassa ◽  
Kirsty McCormick ◽  
...  

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.


2013 ◽  
Vol 38 (7) ◽  
pp. 767-773 ◽  
Author(s):  
P. C. Rhee ◽  
A. Y. Shin

The purpose of this study is to evaluate the rate of union after four-corner arthrodesis with a locking, dorsal circular plate comprised of polyether-ether-ketone. A retrospective review was conducted of all patients who underwent four-corner arthrodesis with a locking, dorsal circular plate at our institution from January 2005 to May 2009. The primary outcome measure was radiographic and clinical union. During the study period, 26 consecutive wrists underwent four-corner arthrodesis with a locking, dorsal circular plate. Twenty-three wrists were included. The mean clinical follow-up was 16 months (range 3–37). Union was achieved in 22 of 23 wrists at a mean time of 3 months (range 1–12). There was one partial union that underwent successful revision arthrodesis. In summary, four-corner fusion with a polyether-ether-ketone locking, dorsal circular plate results in high union rates. The use of a radiolucent plate allows for more accurate assessment of union with the biomechanical advantages of a fixed angle construct.


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