scholarly journals Efficacy of an Anti-Cellulite Herbal Emgel: A Randomized Clinical Trial

2021 ◽  
Vol 14 (7) ◽  
pp. 683
Author(s):  
Ngamrayu Ngamdokmai ◽  
Neti Waranuch ◽  
Krongkarn Chootip ◽  
Katechan Jampachaisri ◽  
C. Norman Scholfield ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Subcutaneous Fat ◽  
Volatile Oils ◽  
Double Blind ◽  
Severity Scores ◽  
Secondary Outcomes ◽  
Cutaneous Blood ◽  
Time Point

Cellulite describes unsightly skin overlying subcutaneous fat around thighs and buttocks of post-pubescent females. A herbal ‘emgel’ containing volatile oils and extracts of A traditional Thai herbal compress was tested in a double-blind, placebo-controlled trial with 18 women aged 20–50 year with severe cellulite. Appearance of cellulite (primary outcome), thigh circumferences, skin firmness, and cutaneous blood flow (secondary outcomes) were assessed at baseline, 2, 4, 8 and 12 weeks with a 2-week follow-up. Herbal emgel applied onto the thigh skin twice daily reduced cellulite severity scores in every time point. The score was reduced from 13.4 ± 0.3 (baseline) to 12.1 ± 0.3 (week 2) and 9.9 ± 0.6 (week 12). All secondary outcomes improved with both placebo and herbal emgels suggesting that ingredients in the base-formulation might be responsible. Querying of participants, analysis of their diaries, and physical monthly inspections found no adverse events. The herbal emgel safely improved the appearance of cellulite, while the base emgel may play a role for other endpoints. Further studies on the active constituents and their mechanism of action are needed to further explore these factors.

Diclofenac Sodium Gel in Patients with Primary Hand Osteoarthritis: A Randomized, Double-blind, Placebo-controlled Trial

2009 ◽  
Vol 36 (9) ◽  
pp. 1991-1999 ◽  
Author(s):  
ROY D. ALTMAN ◽  
RENÉE-LILIANE DREISER ◽  
CHESTER L. FISHER ◽  
WALTER F. CHASE ◽  
DONATUS S. DREHER ◽  
...  
Keyword(s):  
Disease Activity ◽  
Pain Intensity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Diclofenac Sodium ◽  
Global Rating ◽  
Hand Osteoarthritis ◽  
Dominant Hand ◽  
Double Blind ◽  
Secondary Outcomes

Objective.To measure the efficacy and safety of diclofenac sodium gel in patients with primary hand osteoarthritis (OA).Methods.In a randomized, double-blind, placebo-controlled trial, men and women aged ≥ 40 years diagnosed with primary OA in the dominant hand were randomly assigned to self-apply topical 1% diclofenac sodium gel (Voltaren® Gel) (n = 198) or vehicle (n = 187) to both hands 4 times daily for 8 weeks. Primary outcome measures included OA pain intensity (100-mm visual analog scale), total Australian/Canadian Osteoarthritis Hand Index (AUSCAN) score, and global rating of disease activity at 4 and 6 weeks. Secondary outcomes included onset of efficacy in Weeks 1 and 2, durability of efficacy at 8 weeks, measures of disease activity in the dominant hand, pain intensity in the non-dominant hand, AUSCAN subindices, end of study rating of efficacy, and Osteoarthritis Research Society International response criteria.Results.Diclofenac sodium gel decreased pain intensity scores by 42%–45%, total AUSCAN scores by 35%–40%, and global rating of disease by 36%–40%. Significant differences favoring diclofenac sodium gel over vehicle were observed at Week 4 for pain intensity and AUSCAN, with a trend for global rating of disease activity. At Week 6, diclofenac sodium gel treatment significantly improved each primary outcome measure compared with vehicle. Secondary outcomes generally supported the primary outcomes. The most common treatment-related adverse event (AE) was application-site paresthesia. Most AE were mild. No cardiac events, gastrointestinal bleeding, or ulcers were reported.Conclusion.Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA. (NCT ID: NCT00171665)

scholarly journals Effect of Metformin on Cigarette Withdrawal Syndrome and Abstinence in Lung Cancer Patients; A Double-blind Placebo-controlled Trial

2021 ◽  
Vol 14 (5) ◽  
Author(s):  
Bijan Pirnia ◽  
Raheleh Masoudi ◽  
Melika Sefidrood ◽  
Elham Zarghami ◽  
Kambiz Pirnia ◽  
...  
Keyword(s):  
Withdrawal Syndrome ◽  
Controlled Trial ◽  
Nicotine Withdrawal ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Urinary Cotinine ◽  
Metformin Group ◽  
Secondary Outcomes ◽  
Cigarette Withdrawal

Background: Lung cancer (LC) is a leading cause of cancer morbidity and mortality worldwide. One of the predisposing factors for LC is smoking. Metformin is the first line for diabetes treatment and is shown that it can be used for nicotine withdrawal syndrome reduction. Objectives: This study was conducted to evaluate the effects of metformin on reducing the nicotine withdrawal syndrome and increasing nicotine abstinence in patients with LC. Methods: In a randomized double-blind placebo-controlled trial from February 2018 to May 2019, 53 patients with LC were selected by respondent-driven sampling (RDS), and were assigned into two experimental and wait-list control (WLC) group through block randomization (BR). After 3 weeks of baseline assessment, metformin or placebo was prescribed in the form of escalating doses. Cigarette Withdrawal Scale (CWS-21), urinary cotinine levels, and exhaled carbon monoxide (eCO) levels were evaluated in 16 steps by the repeated measures. The primary outcomes include metformin efficacy on cigarette withdrawal syndrome and secondary outcomes include urinary cotinine levels and eCO level. The data were analyzed by generalized estimation equation (GEE), chi-square, and Atlas-Ti5. Results: The primary outcomes showed that the metformin group had significant effects on the improvement of depression, anxiety, craving, irritability, and appetite, difficulty in concentrating, appetite-weight, and insomnia during the 12-weeks treatment period (all P's < 0.05). In addition, only cravings scores remained constant until the 6-month follow-up (P < 0.05). Secondary outcomes demonstrated that urinary cotinine levels and eCO level significantly decreased in the metformin group (all P's < 0.05). However, this decrease did not remain constant at both levels until the 6-month follow-up (P > 0.05). Conclusions: Metformin had a clinical potential for reducing nicotine withdrawal. However, more studies are needed.

scholarly journals Efficacy of montelukast in the management of COVID-19: double blind randomized placebo controlled trial

2021 ◽  
Vol 10 (12) ◽  
pp. 1374
Author(s):  
Vijay Kumar ◽  
Avinash A. Ganapule ◽  
Sushmita Supriya ◽  
Divendu Bhushan ◽  
Pallavi Lohani ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Final Analysis ◽  
Standard Operating Procedure ◽  
Double Blind ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Double Blinded

Background: Objective of the study was to determine the efficacy of montelukast in reducing the severity of COVID-19 symptoms using a double blinded randomized controlled trial.Methods: Parallel, double-blinded randomized controlled trial (RCT) with placebo as comparison to montelukast. All patients above the age of 14 years both males and females, admitted with a diagnosis of mild or moderate COVID-19 (on the basis of a positive reverse transcriptase polymerase chain reaction (RT-PCR) report) at our facility during the study period from 01 September 2020-31 January 2021) and excluding those having adverse reaction to montelukast or those not willing to participate, and pregnant and lactating females. Patients in the intervention arm were given tablet montelukast 10 mg OD HS from the day of admission for 10 days. The patients in the placebo group were given an identical appearing placebo at bedtime for 10 days from the day of admission. The rest of the treatment was given as per the standard operating procedure (SOP) of the institute with minor adjustments as per the treating team’s judgement. Primary outcome was progression of the disease to severe grade and secondary outcomes were discharge on or before day 10 from admission, admission to ICU, need for mechanical ventilation and in-hospital mortality.Results: A total of 94 patients were enrolled for the study. 90 patients, 45 in each arm were included in the final analysis. The baseline characteristics of the two arms including age, sex, comorbidities, severity at admission and treatment given apart from montelukast or placebo, were comparable with respect to these variables. This study did not find any improvement in primary outcome of progression to severe disease and secondary outcomes of intensive care unit (ICU) admission, mortality or need of mechanical ventilation, discharge on or by day 10 with the use of montelukast as compared to placebo in mild to moderate cases of COVID-19.Conclusions: There was no difference in primary or secondary outcomes with the use of Montelukast compared to placebo.

scholarly journals Efficacy of Platelet-Rich Plasma and Plasma for Symptomatic Treatment of Knee Osteoarthritis: A Double-Blinded Placebo-Controlled Randomized Clinical Trial.

2021 ◽  
Author(s):  
Murillo Dório ◽  
Rosa Maria Rodrigues Pereira ◽  
Alexandre Galeno Branco Luz ◽  
Leticia Alle Deveza ◽  
Ricardo Manoel Oliveira ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Primary Outcome ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Symptomatic Treatment ◽  
Treatment Alternative ◽  
Double Blind ◽  
Secondary Outcomes ◽  
Double Blinded ◽  
And Function

Abstract Background: Platelet-rich plasma (PRP) has a still conflicting efficacy for knee osteoarthritis (KOA) and might be a minimally invasive and safe treatment alternative. The potential benefit of only plasma (non-enriched) has never been investigated. Our aim was to evaluate the efficacy of intra-articular platelet-rich plasma (PRP) and plasma to improve pain and function in participants with KOA over 24 weeks. Methods: Randomized, double-blind, placebo-controlled trial with 3 groups (n = 62): PRP (n = 20), plasma (n = 21) and saline (n = 21). Two ultrasound-guided knee injections were performed with a 2-week interval. The primary outcome was visual analog scale 0-10 cm (VAS) for overall pain at week 24, with intermediate assessments at weeks 6 and 12. Main secondary outcomes were: KOOS, OMERACT-OARSI criteria and TUGT. Results: At baseline, 92% of participants were female, with a mean age of 65 years, mean BMI of 28.0 Kg/m2and mean VAS pain of 6.2 cm. Change in pain from baseline at week 24 were -2.9 (SD 2.5), -2.4 (SD 2.5) and -3.5 cm (SD 3.3) for PRP, plasma and saline, respectively (p intergroup = 0.499). There were no differences between the three groups at weeks 6 and 12. Similarly, there were no differences between groups regarding secondary outcomes. The PRP group showed higher frequency of adverse events (65% versus 24% and 33% for plasma and saline, respectively, p = 0.02), mostly mild transitory increase in pain.Conclusions: PRP and plasma were not superior to placebo for pain and function improvement in KOA over 24 weeks. The PRP group had a higher frequency of mild transitory increase in pain.Trial registration: ClinicalTrials.gov, NCT03138317, 03/05/2017.

scholarly journals The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015111 ◽  
Author(s):  
Mohamed Abdel-Fattah ◽  
Graeme MacLennan ◽  
Mary Kilonzo ◽  
R Phil Assassa ◽  
Kirsty McCormick ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Single Incision ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Female Stress Urinary Incontinence ◽  
Midurethral Slings ◽  
Secondary Outcomes ◽  
Randomised Controlled

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.

Benefit-Finding Intervention Delivered Individually to Alzheimer Family Caregivers: Longer-Term Outcomes of a Randomized Double-Blind Controlled Trial

2019 ◽  
Vol 75 (9) ◽  
pp. 1884-1893 ◽  
Author(s):  
Sheung-Tak Cheng ◽  
Emily P M Mak ◽  
Timothy Kwok ◽  
Helene Fung ◽  
Linda C W Lam
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Well Being ◽  
Benefit Finding ◽  
Post Intervention ◽  
Double Blind ◽  
Interaction Terms ◽  
Positive Aspects Of Caregiving ◽  
Secondary Outcomes

Abstract Objectives To examine the longer-term effects of benefit-finding on caregivers’ depressive symptoms (primary outcome), and global burden, role overload, psychological well-being, and positive aspects of caregiving (secondary outcomes). Method Ninety-six Hong Kong Chinese caregivers of relatives with Alzheimer’s disease were randomly assigned to receive the benefit-finding intervention (BFT) or one of the two control conditions, namely, simplified psychoeducation (lectures only; SIM-PE) or standard psychoeducation (STD-PE). Caregivers received four biweekly one-to-one interventions of 3 hours each at their own homes. We focused on outcomes measured at 4- and 10-month follow-ups. The trajectories of intervention effects were modeled by BFT × time and BFT × time2 interaction terms. Results Mixed-effects regression showed significant BFT × time2 interaction effects on depressive symptoms against both control conditions, suggesting diminishing BFT effects over time. Z tests showed that, compared with controls, BFT participants reported substantial reductions in depressive symptoms at 4-month follow-up (d = −0.85 and −0.75 vs. SIM-PE and STD-PE, respectively). For depressive symptoms measured at 10-month follow-up, BFT was indistinguishable from STD-PE, whereas a moderate effect was observed in comparison with SIM-PE (d = −0.52). Moreover, positive aspects of caregiving, but not other secondary outcomes, continued to show intervention effect up to 10-month follow-up. Discussion Benefit-finding is an efficacious intervention for depressive symptoms in Alzheimer caregivers, with strong effects in the medium-term post-intervention and possible moderate effects in the longer-term post-intervention.

scholarly journals Efficacy of Acupuncture in Improving Symptoms and Quality of Life of Patients With Acne Vulgaris: a Randomized Sham Acupuncture-controlled Trial

2021 ◽  
Author(s):  
Ruimin Jiao ◽  
Xu Zhai ◽  
Xuecheng Zhang ◽  
Zhiyi Xiong ◽  
Zhishun Liu
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Acne Vulgaris ◽  
Inflammatory Lesion ◽  
Sham Acupuncture ◽  
Lesion Count ◽  
Serious Adverse Events ◽  
Scale Total Score ◽  
Secondary Outcomes

Abstract Objective: The aim of this study was to examine the effectiveness of acupuncture in treating the symptoms and QoL of patients with moderate or severe AV. Methods: Participants were randomly assigned (1:1) to receive 12 treatment sessions of acupuncture or sham acupuncture over 4 weeks with 24 weeks of follow-up. The primary outcome was the change from baseline in the Skindex-16 scale total score at treatment completion. Secondary outcomes included Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, and visual analogue scale scores for itch and pain evaluation. Results: There is no statistically significant between-group difference for the primary outcome and any secondary outcomes after 4 weeks of treatment and at 16 weeks and 28 weeks of follow-up, except for the Skindex-16 subscale (the emotions of participants with AV) at week 4 (P = 0.026). No serious adverse events occurred in two group. Conclusion: Acupuncture and sham acupuncture might both relieve the symptoms of patients with moderate or severe AV, reduce the number and degree of inflammatory lesion counts, and improve QoL. Trial registration number: ChiCTR-1900023649 Chinese Clinical Trial Registry

Verbal Contingencies in the Lidcombe Program: A Noninferiority Trial

2020 ◽  
Vol 63 (10) ◽  
pp. 3419-3431
Author(s):  
Michelle Donaghy ◽  
Sue O'Brian ◽  
Mark Onslow ◽  
Robyn Lowe ◽  
Mark Jones ◽  
...  
Keyword(s):  
Treatment Effect ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Applications ◽  
Verbal Response ◽  
Randomized Controlled ◽  
Open Plan ◽  
Secondary Outcomes ◽  
Present Trial

Purpose The Lidcombe Program is an efficacious and effective intervention for early stuttering. The treatment is based on parent verbal response contingent stimulation procedures, which are assumed to be responsible for treatment effect. The present trial tested this assumption. Method The design was a parallel, open plan, noninferiority randomized controlled trial. In the experimental arm, the five Lidcombe Program verbal contingencies were removed from parent instruction. The primary outcome was beyond-clinic percentage syllables stuttered at 18-month follow-up. Seventy-four children and their parents were randomized to one of the two treatment arms. Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered. Conclusions The inconclusive finding of noninferiority means it is possible that verbal contingencies make some contribution to the Lidcombe Program treatment effect. However, considering all primary and secondary outcomes, an overriding impression from the trial is a similarity of outcomes between the control and experimental arms. The clinical applications of the trial are discussed, along with further research that is needed.

scholarly journals A 10-year follow-up of tailored behavioural treatment and exercise-based physiotherapy for persistent musculoskeletal pain

2016 ◽  
Vol 31 (2) ◽  
pp. 186-196 ◽  
Author(s):  
Christina Emilson ◽  
Ingrid Demmelmaier ◽  
Stefan Bergman ◽  
Per Lindberg ◽  
Eva Denison ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Behavioural Medicine ◽  
Behavioural Treatment ◽  
Beneficial Effects ◽  
Maximum Pain ◽  
Secondary Outcomes ◽  
Randomised Controlled

Objective: To study the long-term outcomes of two interventions targeting patients with sub-acute and persistent pain in a primary care physiotherapy setting. Design: A 10-year follow-up of a two-armed randomised controlled trial, initially including 97 participants. Interventions: Tailored behavioural medicine treatment, applied in a physiotherapy context (experimental condition), and exercise-based physiotherapy (control condition). Main measures: Pain-related disability was the primary outcome. The maximum pain intensity, pain control, fear of movement, sickness-related absence (register data) and perceived benefit and confidence in coping with future pain problems were the secondary outcomes. Results: Forty-three (44%) participants responded to the follow-up survey, 20 in the tailored behavioural medicine treatment group and 23 in the exercise-based physiotherapy group. The groups did not differ in terms of the change in the scores for the primary outcome ( p=0.17) of pain-related disability between the experimental group (median: 2.5, Q1-Q3: -2.5-14.25), and the control group (median: 0, Q1-Q3: -5-6). Further, there were also no significant differences found for the secondary outcomes except for sickness-related absence, where the exercise-based physiotherapy group had more days of sickness-related absence three months before treatment ( p= 0.02), and at the 10-year follow-up ( p=0.03). Discussion: The beneficial effects favouring tailored behavioural medicine treatment that observed post-treatment and at the two-year follow-up were not maintained 10 years after treatment.

scholarly journals O002 Medical therapy for sleep disordered breathing in children: a randomised, double-blind placebo-controlled trial

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A1-A1
Author(s):  
A Baker ◽  
A Grobler ◽  
K Davies ◽  
A Griffiths ◽  
H Hiscock ◽  
...  
Keyword(s):  
Sleep Disordered Breathing ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Parent Satisfaction ◽  
Saline Group ◽  
Outcome Data ◽  
Healthy Children ◽  
Double Blind ◽  
Secondary Outcomes ◽  
Disordered Breathing

Abstract Background Sleep Disordered Breathing (SDB) in children is characterised by snoring and breathing difficulties during sleep. Small clinical trials suggest intranasal corticosteroids reduce SDB severity as defined by polysomnography. We assessed the efficacy of intranasal corticosteroid for improving symptoms and quality of life (QOL) in children with SDB. Methods This is a double-blind, randomised, placebo-controlled trial of healthy children 3-12y referred to a specialist with SDB symptoms. Exclusions were previous adenotonsillectomy, obesity or severe SDB. Participants received daily intranasal mometasone furoate 50micrograms or normal saline for 6 weeks. The primary outcome was resolution of symptoms measured by SDB score. Secondary outcomes were SDB symptom scores, QOL, behaviour, parent and surgeon perceived need for surgery, and parent satisfaction with treatment. Results 276 participants were recruited; 138 in each group. 127 and 123 participants had primary outcome data at 6 weeks in the mometasone and saline groups respectively. Baseline age, atopic history, symptom severity and QOL were similar between groups. Resolution of SDB symptoms occurred in 44% [95%CI 35–53] of the mometasone group and 40% [95%CI 32–49] of the saline group; risk difference 4% [95%CI -0.8–16] p=0.511. Secondary outcomes were not different between groups. Discussion This large RCT, using clinical rather than polysomnographic outcomes to investigate the efficacy of mometasone on symptoms of SDB, found substantial rates of symptom resolution after 6 weeks in both groups. However, we found no difference in treatment effect between 6 weeks of intranasal mometasone over saline, for management of SDB symptoms in childhood.

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