scholarly journals Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study)

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e035672
Author(s):  
Xiaoqian Liu ◽  
Sarah Robbins ◽  
Jillian Eyles ◽  
Tatyana Fedorova ◽  
Sonika Virk ◽  
...  
Keyword(s):  
Adverse Events ◽  
Participatory Design ◽  
Controlled Trial ◽  
Symptomatic Relief ◽  
Joint Disease ◽  
Bark Extract ◽  
Hand Osteoarthritis ◽  
Scientific Publications ◽  
Boswellia Serrata ◽  
Double Blind

IntroductionHand osteoarthritis (HOA) is a highly prevalent disabling joint disease. The current management regimens are limited. Potentially as a consequence, many people turn to complementary and alternative medicines for symptomatic relief. A combination of two or more supplements is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to investigate the efficacy of a supplement combination for treating symptomatic HOA in comparison to placebo.Methods and analysisThe RADIANT study is an internet-based, parallel, superiority, double-blind, placebo-controlled, randomised, two-arm clinical trial. A participatory design is used to facilitate the study procedures. One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containingBoswellia serrataextract, pine bark extract and methylsulfonylmethane and (2) curcumin or placebo for 12 weeks. The primary outcome will be 12-week change in hand pain on a visual analogue scale (VAS). Main secondary outcomes include adverse events, change in hand function, patient global assessment of disease activity and quality of life. A range of additional measures will be recorded, and an individual patient placebo response will be performed. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored weekly throughout the study.Ethics and disseminationThis protocol has been approved by the University of Sydney Human Research Ethics Committee (HREC No. 2018/766). Dissemination will occur through conferences, social media, scientific publications and PhD thesis.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12619000835145); Pre-results

scholarly journals Topical corticosteroid for treatment of hand osteoarthritis: study protocol for a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yuanyuan Wang ◽  
Sultana Monira Hussain ◽  
Desmond Gan ◽  
Yuan Z. Lim ◽  
Mahnuma Mahfuz Estee ◽  
...  
Keyword(s):  
Topical Corticosteroid ◽  
Controlled Trial ◽  
Trial Registration ◽  
Joint Disease ◽  
Hand Osteoarthritis ◽  
Primary Analysis ◽  
Public Health Importance ◽  
Double Blind ◽  
Intention To Treat ◽  
Randomised Controlled

Abstract Background Hand osteoarthritis is a common and disabling chronic joint disease with a lack of effective therapies. Emerging evidence suggests the role of local inflammation in causing pain in hand osteoarthritis. Corticosteroids are potent anti-inflammatory drugs used in many rheumatic diseases. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether topical corticosteroid reduces pain over 6 weeks in patients with hand osteoarthritis. Methods One hundred participants with hand osteoarthritis will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either topical Diprosone OV or placebo ointment administered 3 times daily on the painful hand joints for 6 weeks. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 weeks. The secondary outcomes include changes in pain and function assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Michigan Hand Outcomes Questionnaire, and tender and swollen joint count at 6 weeks. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups. Discussion This study will provide high-quality evidence to determine whether topical corticosteroid reduces pain over 6 weeks in patients with hand osteoarthritis, with major clinical and public health importance by informing clinical practice guidelines for the management of hand osteoarthritis and reducing the burden of the disabling disease. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000599976. Registered 22 May 2020.

scholarly journals FRI0419 LOW DOSE OF GLUCOCORTICOIDS FOR PAIN CONTROL IN THE ESTROGEN-DEPENDENT PRIMARY POLYARTICULAR OSTEOARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 807.2-808
Author(s):  
G. Puerta ◽  
M. Bautista ◽  
M. Urbano ◽  
F. Bonilla ◽  
C. Cañas
Keyword(s):  
Bone Scintigraphy ◽  
Pain Control ◽  
Controlled Trial ◽  
Case Series ◽  
Tender Joint Count ◽  
Hand Osteoarthritis ◽  
Average Dose ◽  
Tender Joint ◽  
Double Blind ◽  
Clinical Records

Background:Low doses of glucocorticoids (GCs) can be useful in the management of osteoarthritis when it is related to hypoestrogenic states (estrogen-dependent primary polyarticular osteoarthritis [EDPOA]), that usually can appear after the menopause. Deflazacort is a GC that has similar anti-inflammatory effects than other steroids, but with fewer side effects.Objectives:To describe the average dose of GCs that best controlled articular pain, based on tender joint count in patients with EDPOA.Methods:The diagnosis of EDPOA was made in postmenopausal patients with polyarticular compromised (six or more joints affected), morning stiffness less than 30 minutes, erythrocyte sedimentation rate less than 45mm/hour and imaging studies with changes related to osteoarthritis (radiography, magnetic resonance imaging or bone scintigraphy). Patients with autoimmune diseases such as rheumatoid arthritis, lupus or Sjögren syndrome were excluded.The clinical records of patients diagnosed with EDPOA and treated between January 2015 and June 2019 at the Valle del Lili foundation Hospital were reviewed. The patients treated with deflazacort GC were included. Pain was assessed by the treating rheumatologist using the visual analog scale (VAS, possible score 0-10). Tender joints were those with VAS> 5. The count of compromised joints was compared with inflammatory findings on bone scintigraphy (Figure 1).Figure 1.Comparison between number of joints with inflammatory findings on bone scintigraphy and number of swollen joints in physical evaluationThe number of tender joints was recorded at the start of treatment, which was a dose of 6 mg/day of deflazacort for two months. Subsequently, the dose was reduced depending on the improvement of pain (items: intensity of pain and number of tender joints) until achieving a stabilization along the time with an improvement of 75% of the items evaluated. The number of painful joints was recorded again two months after the stabilization on pain control was achieved.Quantitative variables were described with medians and interquartile ranges because the absence of normal distribution of the sample size. To assess the presence of a significant decrease on the number of tender joints the Wilcoxon range test was used, a value of p<0.001 was considered statistically significant. The data were analyzed with Stata v.15.Results:Twenty-eight patients with EDPOA were included, with a median of age of 50 years (IQR 44-51), 56 years (IQR 52-66) and 61 years (IQR 54-69) at the time of menopause, onset of symptoms and the diagnosis of EDPOA respectively. A median of 18 tender joints (IQR 10-27) was obtained from the physical examination of the records reviewed. The dose of deflazacort that achieved stabilization on the improvement of the pain along the time was 21mg/week (IQR 12-21); after 8 weeks of treatment the number of tender joints was 2 (IQR 1-4), which implies a reduction of 14 (IQR 8-20; p<0.0001) on the tender joint count (Figure 2).Figure 2.Number of tender joints before and after eight weeks of treatment achieving with a stable pain control in patients with EDPOA treated with deflazacort with a media dose of 3mgr/day.Conclusion:In this case series a media dose of deflazacort of 21mg per week (3mg/day) was useful to significantly reduce the number of tender joints in patients with EDPOA.References:[1]Roman-Blas JA, Castañeda S, Largo R,et al. Osteoarthritis associated with estrogen deficiency. Arthritis Research & Therapy 2009;11:241.[2]Cvoro A, Yuan C, Paruthiyil S,et al. Crosstalk between glucocorticoid and estrogen receptors occurs at a subset of proinflammatory genes. The Journal of Immunology 2011;186:4354-4360.[3]Féline K, Marion K, Annelies B,et al. Results of a 6-week treatment with 10 mg prednisolone in patients with hand osteoarthritis (HOPE): a double-blind, randomised, placebo-controlled trial. Lancet 2019;394:1993-2001.Disclosure of Interests:None declared

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)

TOP-PRO study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

Cephalalgia ◽  
2021 ◽  
pp. 033310242110474
Author(s):  
Debashish Chowdhury ◽  
Luv Bansal ◽  
Ashish Duggal ◽  
Debabrata Datta ◽  
Ankit Mundra ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Virus Disease ◽  
Controlled Trial ◽  
Preventive Treatment ◽  
Point Estimate ◽  
Tolerability Profile ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean

Objective The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine. Background Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence. Methods Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed. Results As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was −5.3 ± 1.2 vs −7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of −1.99 with a 95% confidence interval of −5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups. Conclusion Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile. Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997)

Zao Ren An Shen capsule for insomnia: A double-blind, randomized, placebo-controlled trial

SLEEP ◽  
2021 ◽  
Author(s):  
Yoann Birling ◽  
Xiaoshu Zhu ◽  
Nicole Avard ◽  
Caterina Tannous ◽  
Paul P Fahey ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Adverse Events ◽  
Chinese Herbal Medicine ◽  
Controlled Trial ◽  
Double Blind ◽  
Subjective Sleep ◽  
Chinese Herbal ◽  
Cohen’S D ◽  
Cohen's D ◽  
Insomnia Severity

Abstract Study Objectives The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia. Methods We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for four weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events. Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability. Results A non-significant (p &gt; 0.05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with adverse events was not significantly different (p &gt; 0.05) between the two groups. Except for subjective sleep onset latency, which had a non-significant (p &gt; 0.05) medium effect (Cohen’s d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen’s d &lt; 0.4) and non-significant (p &gt; 0.05). The acceptability and tolerability were high in the active group. Conclusions ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.

scholarly journals Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial

2021 ◽  
Author(s):  
Kathryn E. Stephenson ◽  
Boris Julg ◽  
C. Sabrina Tan ◽  
Rebecca Zash ◽  
Stephen R. Walsh ◽  
...  
Keyword(s):  
Viral Load ◽  
T Cell ◽  
Adverse Events ◽  
Antiviral Activity ◽  
Controlled Trial ◽  
Phase 1 ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Cell Counts ◽  
Hiv 1

AbstractHuman immunodeficiency virus (HIV)-1-specific broadly neutralizing monoclonal antibodies are currently under development to treat and prevent HIV-1 infection. We performed a single-center, randomized, double-blind, dose-escalation, placebo-controlled trial of a single administration of the HIV-1 V3-glycan-specific antibody PGT121 at 3, 10 and 30 mg kg–1 in HIV-uninfected adults and HIV-infected adults on antiretroviral therapy (ART), as well as a multicenter, open-label trial of one infusion of PGT121 at 30 mg kg–1 in viremic HIV-infected adults not on ART (no. NCT02960581). The primary endpoints were safety and tolerability, pharmacokinetics (PK) and antiviral activity in viremic HIV-infected adults not on ART. The secondary endpoints were changes in anti-PGT121 antibody titers and CD4+ T-cell count, and development of HIV-1 sequence variations associated with PGT121 resistance. Among 48 participants enrolled, no treatment-related serious adverse events, potential immune-mediated diseases or Grade 3 or higher adverse events were reported. The most common reactions among PGT121 recipients were intravenous/injection site tenderness, pain and headache. Absolute and relative CD4+ T-cell counts did not change following PGT121 infusion in HIV-infected participants. Neutralizing anti-drug antibodies were not elicited. PGT121 reduced plasma HIV RNA levels by a median of 1.77 log in viremic participants, with a viral load nadir at a median of 8.5 days. Two individuals with low baseline viral loads experienced ART-free viral suppression for ≥168 days following antibody infusion, and rebound viruses in these individuals demonstrated full or partial PGT121 sensitivity. The trial met the prespecified endpoints. These data suggest that further investigation of the potential of antibody-based therapeutic strategies for long-term suppression of HIV is warranted, including in individuals off ART and with low viral load.

A Controlled Trial of Extended-Release Guanfacine and Psychostimulants on Executive Function and ADHD

2018 ◽  
Vol 24 (2) ◽  
pp. 318-325 ◽  
Author(s):  
Judy P. M. van Stralen
Keyword(s):  
Executive Function ◽  
Adverse Events ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
P Value ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Stimulant Therapy

Objective: To evaluate the effectiveness of guanfacine extended-release (GXR) versus placebo as adjunct therapy to usual care stimulant therapy in improving executive function in children aged 6 to 12 years diagnosed with ADHD. Method: In this single center, double-blind placebo-controlled crossover trial, subjects continued to take their psychostimulant and were randomly assigned at baseline to receive active treatment or placebo first. Efficacy measures included Behavioural Rating Inventory of Executive Function (BRIEF-P), ADHD Rating Scale IV (ADHD-RS IV), and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety measures included adverse events and vital signs. Results: Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p value = .0392), ADHD-RS-IV ( p < .0001), CGI-S ( p = .0007), and CGI-I ( p = .003). There were no serious adverse events and no new safety signals. Conclusion: Use of GXR as adjunctive therapy to stimulant therapy significantly improves executive function in children with ADHD.

Efficacy of a carrageenan gel in preventing anal human papillomavirus (HPV) infection: interim analysis of the Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV) randomised controlled trial

2021 ◽  
pp. sextrans-2021-055009
Author(s):  
Cassandra Laurie ◽  
Mariam El-Zein ◽  
Joseph E Tota ◽  
Farzin Khosrow-Khavar ◽  
Pierre-Paul Tellier ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Interim Analysis ◽  
Controlled Trial ◽  
Hpv Infection ◽  
Gelling Agent ◽  
Receptive Anal Intercourse ◽  
Double Blind ◽  
Randomised Controlled

BackgroundCarrageenan, a non-toxic gelling agent derived from red algae, has potent anti-human papillomavirus (HPV) activity in in vitro and animal studies. We assessed, in an interim analysis, the efficacy of a carrageenan-based gel in reducing the risk of new detections of anal HPV among gay, bisexual and other men who have sex with men (gbMSM).MethodsThe LIMIT-HPV study (Lubricant Investigation in Men to Inhibit Transmission of HPV Infection) is a phase IIb, double-blind, placebo-controlled randomised controlled trial conducted in Montreal, Canada. gbMSM were randomly assigned (1:1) to receive a carrageenan-based or placebo gel. Participants were instructed to apply the gel to the anus, condom and/or partners’ penis before and—as required—during receptive anal intercourse. Questionnaire data and anal samples were collected at 0, 1, 2, 3, 6, 9 and 12 months. We estimated new detections of anal HPV infection(s) detected via Linear Array using Cox proportional hazards models.ResultsParticipants recruited from February 2016 to December 2019 were randomly assigned to the carrageenan (n=127) or placebo (n=128) arm. The efficacy and safety analyses included 201 and 210 participants. The median follow-up time was 7.6 months (range: 0–28.5) in the carrageenan group and 9.3 months (range: 0–40.7) in the placebo group. The HR for new detections was 1.21 (95% CI 0.86 to 1.70): 69.4% and 65.1% new detections of HPV in the carrageenan and placebo arms, respectively. More adverse events were reported in the carrageenan (59.8%) compared with the placebo (39.8%) arm.ConclusionsThe interim analysis did not demonstrate a protective effect of carrageenan on the risk of new detections of anal HPV infection among gbMSM. Carrageenan gel use was associated with a higher proportion of adverse events. Given these findings and the (assumed) low probability that a beneficial effect would be found by the study’s end, the trial was terminated as recommended by the Data Safety and Monitoring Board.Trial registration numberNCT02354144.

scholarly journals Efficacy and Safety of Bushenjiangya-Optimized Granule for Left Ventricular Diastolic Dysfunction in Hypertensive Patients: A Double-Blind, Randomized, Placebo-Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Qun Gao ◽  
Xiao-yun Cui ◽  
Fei Dong ◽  
Wen-ying Fan ◽  
Pin-hui Li ◽  
...  
Keyword(s):  
Adverse Events ◽  
Diastolic Dysfunction ◽  
Controlled Trial ◽  
Left Ventricular Diastolic Dysfunction ◽  
Left Ventricular ◽  
Major Adverse Cardiovascular Events ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Effective Response ◽  
Ventricular Diastolic Dysfunction

Objective. The study aimed to evaluate the efficacy and safety of Bushenjiangya-optimized (BSJYO) granule on left ventricular diastolic dysfunction (LVDD) in hypertensive (HTN) patients. Methods. 120 patients diagnosed with HTN plus LVDD were randomly assigned to the BSJYO granule group and placebo group, and all patients received basal western medicine (WM) treatment. After eight weeks of treatment, we evaluated echocardiography, traditional Chinese medicine (TCM) syndromes, 24-hour ambulatory blood pressure, liver and kidney functions, and adverse events. Major adverse cardiovascular events (MACEs) were collected at 6-month follow-up. Results. Compared with pretreatment, E/Ea (Doppler-derived index of filling pressure and worsening LVDD) significantly decreased significantly after 8 weeks of treatment in the BSJYO granule plus basal WM group (10.52 ± 1.87 vs. 9.49 ± 1.49, P<0.01), alongside reductions in significantly effective response (SER), effective response (ER), and total effective response (TER = SER + ER) in TCM symptom scores (21.59% vs. 71.70%, P<0.01). There were no differences between treatment groups in kidney and liver function, early adverse events, or MACE. Conclusion. BSJYO granule plus basal WM is an effective and safe therapy for HTN patients with LVDD.

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