scholarly journals Monitoring the Clinical Response to an Innovative Transdermal Delivery System for Ibuprofen

Pharmaceutics ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 664 ◽  
Author(s):  
Anthony Wright ◽  
Heather A. E. Benson ◽  
Penny Moss ◽  
Rob Will
Keyword(s):  
Transdermal Delivery ◽  
Controlled Trial ◽  
Phase 1 ◽  
Womac Pain ◽  
Number Needed To Treat ◽  
Womac Pain Score ◽  
Patch Application ◽  
Knee Oa ◽  
Randomised Controlled ◽  
And Function

We present a phase 1 study that utilizes a crossover design that provides a rapid and relatively inexpensive methodology for evaluating a new transdermal product. The treatment for osteoarthritis (OA) aims to reduce pain and improve function. An innovative magnetophoresis technology has been developed that facilitates transdermal delivery of ibuprofen. The study used measures that were taken over a relatively short time period to monitor the pharmacodynamic response to ibuprofen. Each participant received magnetophoresis-enhanced transdermal ibuprofen or placebo in randomised order, with a five-day washout period. The participants were 24 volunteers with medically diagnosed, painful knee OA. The primary outcome measures were VAS rating of pain on movement and Western Ontario and McMaster Universities (WOMAC) pain and function scores. VAS for pain on movement (p < 0.001), WOMAC pain score (p = 0.004), and WOMAC function score (p = 0.004) were all significantly improved. There was a significant reduction in movement-related pain (p < 0.05) during the first patch application and for the remainder of the study period. The number needed to treat for a 50% reduction in movement related pain was 2.2. The study showed a rapid and significant analgesic effect in response to transdermal ibuprofen. A short trial of this nature can be used for informing the parameters that are required for a major randomised controlled trial.

scholarly journals The Role of PRP and Its Platelet Concentration in Improving WOMAC Score on Early-Stage Knee Osteoarthritis (OA) Patients

2020 ◽  
Vol 8 (5_suppl5) ◽  
pp. 2325967120S0010
Author(s):  
Basuki Supartono ◽  
Salma Rahmadati ◽  
Diana Agustini
Keyword(s):  
Early Stage ◽  
Platelet Rich Plasma ◽  
Womac Score ◽  
Bivariate Analysis ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Knee Oa ◽  
Significant Difference ◽  
Platelet Concentration ◽  
And Function

Platelet concentration is one of the important factors in OA treatment with platelet-rich plasma (PRP). The purpose of this study was to determine the effect of PRP quality, which was determined by its platelet concentration, on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores in early-stage knee OA patients. This study involved 50 patients diagnosed with early-stage knee OA (stage I to III). Twenty-five patients received PRP with moderate platelet concentration (1× to 4×), another twenty-five patients received PRP with high platelet concentration (>4× to 6×). Patients were evaluated using WOMAC questionnaire before and three months after injection with PRP. Bivariate analysis showed that there was a significant improvement of three WOMAC score subscales (pain, stiffness, and function) in both group (p<0.05) and a significant difference in the differences between WOMAC pain scores between the two groups (p<0.05), meanwhile, significant differences in the differences between WOMAC stiffness and function scores between the two groups weren’t found (p>0.05). The conclusions of this study was, PRP with moderate and high platelet concentration had been shown to improve the three WOMAC score subscales of early-stage knee OA patients, but the effect of PRP’s platelet concentration was only significant in the improvement of WOMAC pain score.

scholarly journals Assessment of the Response Profile to Hyaluronic Acid Plus Sorbitol Injection in Patients with Knee Osteoarthritis: Post-Hoc Analysis of a 6-Month Randomized Controlled Trial

Biomolecules ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 1498
Author(s):  
Olivier Bruyère ◽  
Germain Honvo ◽  
Eduard Vidovic ◽  
Bernard Cortet
Keyword(s):  
Hyaluronic Acid ◽  
Physical Function ◽  
Response Rate ◽  
Controlled Trial ◽  
Womac Pain ◽  
Knee Oa ◽  
Intention To Treat ◽  
Womac Questionnaire ◽  
Double Blinded ◽  
And Function

In a previous randomized trial, the non-inferiority of two hyaluronic acid injections (Synolis VA versus Synvisc-One) was assessed in patients with knee OA, with a response rate of 79% for Synolis VA. To assess whether a responder profile could be established for this treatment modality, we used the Synolis VA arm of a published 6-month prospective, multicenter, comparative, randomized, double-blinded trial. At baseline and during the study, pain and function were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. Ninety-six subjects from the intention-to-treat trial were included in the analysis. The 6-month change of WOMAC Pain with Synolis VA was not associated with any baseline clinical data. However, the change in WOMAC Function was significantly associated with its baseline level, even after adjustment for potential confounding variables (p = 0.028), i.e., a poorer physical function at baseline was associated with a better response. In conclusion, in addition to the high absolute response rate to Synolis VA, the probability of success is even increased if administered in patients with more limited physical function at baseline. Further research with other potential confounding clinical variables is warranted in order to better applicate the concept of personalized medicine.

Efficacy and Safety of Hylan versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis

2018 ◽  
Vol 32 (03) ◽  
pp. 259-268 ◽  
Author(s):  
Wen-Li Dai ◽  
Ze-Ming Lin ◽  
Dong-Hong Guo ◽  
Zhan-Jun Shi ◽  
Jian Wang
Keyword(s):  
Meta Analysis ◽  
Womac Pain ◽  
Efficacy And Safety ◽  
Function Score ◽  
Womac Pain Score ◽  
Knee Oa ◽  
Womac Function ◽  
The Difference ◽  
Level I ◽  
And Function

AbstractThe purpose of this study was to use meta-analytic approach to compare the efficacy and safety of intraarticular hylan and hyaluronic acid (HA) for knee osteoarthritis (OA) treatment. We searched PubMed, Embase, and the Cochrane databases through July 2017 to identify Level I randomized controlled trials (RCTs) that evaluated clinical efficacy and safety of hylan compared with HA for knee OA. The primary outcomes were Visual Analogue Scale (VAS) for pain and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, and WOMAC function scores. In each study and for the outcome measures (VAS for pain, WOMAC pain, function and stiffness scores, and Lequesne score), we calculated the treatment effect from the difference between the preintervention and postintervention changes in the hylan and HA groups. Twenty-one RCTs involving 3,058 patients were included. Pooled analysis suggested that compared with HA, hylan was associated with similar pain relief and function improvement in patients with knee OA (VAS for pain: mean difference [MD], –3.04; 95% confidence interval [CI], –9.13 to 3.04; p = 0.33; I 2 = 76%. WOMAC pain score: MD, 0.23; 95% CI, –0.25 to 0.70; p = 0.35; I 2 = 0%. WOMAC function score: MD, –0.47; 95% CI, –6.81 to 5.88; p = 0.88; I 2 = 84%). No significant difference was found comparing the patients with treatment-related adverse events. The relationship was robust in sensitivity analysis and consistent in most of the subgroup analyses. As to the primary outcomes (WOMAC pain, function scores, VAS for pain), the difference between hylan and HA did not reach the previously reported minimum clinically important difference (MCID) values (–13.4 for VAS for pain, –2.0 for WOMAC pain score, –7.7 for WOMAC function score). Our meta-analysis showed that there were no statistically and clinically significant differences in pain relief and function improvement between hylan and HA injections for knee OA treatment. In view of its higher costs, we discourage the use of hylan in patients with knee OA in clinical practice. The level of evidence is I, meta-analysis of Level I studies.

scholarly journals Acupotomy Therapy for Knee Osteoarthritis Pain: Systematic Review and Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-17
Author(s):  
Jigao Sun ◽  
Yan Zhao ◽  
Ruizheng Zhu ◽  
Qianglong Chen ◽  
Mengge Song ◽  
...  
Keyword(s):  
Systematic Review ◽  
Knee Osteoarthritis ◽  
Pain Score ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Knee Oa ◽  
Effectiveness Rate ◽  
And Function

Background and Purpose. Knee osteoarthritis (OA) is a major public health problem, and currently, few effective medical treatments exist. Chinese acupotomy therapy has been widely used for the treatment of knee OA in China. We conducted this systematic review and meta-analysis to evaluate the efficacy of Chinese acupotomy in treating knee OA to inform clinical practice. Methods. We performed a comprehensive search on PubMed, the Cochrane Library, EMBASE, and four Chinese databases for articles published prior to June 2020. We included only randomized controlled trials (RCTs) that used acupotomy therapy as the major intervention in adults with knee OA, were published in either Chinese and English, included more than 20 subjects in each group, and included pain and function in the outcome measures. Knee OA was defined by the American College of Rheumatology or Chinese Orthopedic Association criteria in all studies. We extracted the visual analogue scale (VAS) pain score, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, the total effectiveness rate, the modified Japanese Orthopedic Association (JOA) activities of daily living score, and Lysholm’s score. We calculated the mean difference (MD) or risk ratio (RR) for all relevant outcomes. Meta-analyses were conducted using random-effects models when appropriate. Results. We identified 1317 potentially relevant studies, thirty-two of which met the eligibility criteria and were conducted in China between 2007 and 2020. A total of 3021 knee OA patients (62.96% female, median age: 57 years, and median disease duration: 33 months) were included. The treatment duration ranged from 1 week to 5 weeks (median: 3 weeks). The typical acupotomy treatment involved releasing soft tissue adhesions and was performed once a week for 1–5 weeks until the pain was relieved. The control group treatments included acupuncture (8 studies), electroacupuncture (10 studies), sodium hyaluronate (8 studies), radiofrequency electrotherapy (1 study), and nonsteroidal anti-inflammatory drugs (NSAIDs, 5 studies). The results from the meta-analysis showed that acupotomy led to superior improvements in the VAS pain score (MD = −1.11; 95% confidence interval (CI), −1.51 to −0.71; p  < 0.00001) and WOMAC pain score (MD = −2.32; 95% CI, −2.94 to −1.69; p  < 0.00001), a higher total effectiveness rate (RR = 1.15; 95% CI, 1.09–1.21; p  < 0.00001), and superior improvements in the JOA score (MD = 6.39; 95% CI, 4.11–9.76; p  < 0.00001) and Lysholm’s score (MD = 12.75; 95% CI, 2.61–22.89; p  = 0.01) for overall pain and function. No serious adverse events were reported. Conclusion. Chinese acupotomy therapy may relieve pain and improve function in patients with knee OA. Furthermore, rigorously designed and well-controlled RCTs are warranted.

scholarly journals Nortriptyline for pain in knee osteoarthritis in general practice: a double blind randomised controlled trial

2021 ◽  
pp. BJGP.2020.0797
Author(s):  
Ben Hudson ◽  
Jonathan A Williman ◽  
Lisa K Stamp ◽  
John S Alchin ◽  
Gary J Hooper ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Subscale Score ◽  
Womac Pain ◽  
Double Blind ◽  
Knee Oa ◽  
Parallel Group ◽  
Pain Subscale ◽  
Secondary Outcomes ◽  
Randomised Controlled

Background: Osteoarthritis (OA) of the knee is a common cause of chronic pain. The currently available analgesics have limited efficacy and may be poorly tolerated. Aim: To investigate the analgesic efficacy of nortriptyline in people with knee OA. Design and setting: A two-arm parallel-group 1:1 double blind randomised placebo-controlled trial. Participants were recruited from orthopaedic outpatient clinics, primary care, and by public advertising. Method: Adults with knee OA and with pain rated as >20 points on the 50 point Western Ontario and McMaster University (WOMAC) pain sub-scale were randomised to receive either nortriptyline or identical placebo for 14 weeks. Primary outcome was knee pain at 14 weeks measured using the WOMAC pain sub-scale. Secondary outcomes included function, stiffness, non-steroidal anti-inflammatory drug, opioid and/or paracetamol use, participant global assessment, and adverse effects at 14 weeks. Results: Of the 205 randomised participants, 201 (98%) completed follow-up at 14 weeks. The baseline-adjusted mean WOMAC pain subscale score at week 14 was 6.15 points lower (95% CI -0.26 to 12.6, p = 0.06) in the nortriptyline vs. the placebo arm. Differences in secondary outcomes generally favoured the nortriptyline arm, but were small and unlikely to be clinically relevant. Dry mouth (87% vs. 51%, p < 0.001), constipation (69% vs. 30%, p < 0.001), and sweating (31% vs. 21%, p = 0.033) were all more commonly reported by participants taking nortriptyline. Conclusion: This study suggests nortriptyline does not significantly reduce pain in people with knee OA. Adverse effect profile was as expected.

scholarly journals Nutrigenetics-based intervention approach for adults with non-alcoholic fatty liver disease (NAFLD): study protocol for a randomised controlled feasibility trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e045922
Author(s):  
Laura Haigh ◽  
Stuart McPherson ◽  
John C Mathers ◽  
Quentin M Anstee
Keyword(s):  
Liver Disease ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Controlled Trial ◽  
Phase 1 ◽  
Feasibility Trial ◽  
Alcoholic Fatty Liver ◽  
Intervention Protocol ◽  
Randomised Controlled ◽  
Alcoholic Fatty Liver Disease

IntroductionLifestyle interventions targeting weight loss and improved dietary patterns are the recommended treatment for non-alcoholic fatty liver disease (NAFLD). However, the effectiveness of current established diet therapies is suboptimal. The patatin‐like phospholipase domain containing 3 (PNPLA3) gene modifies disease outcome and hepatic lipid handling, but the role of PNPLA3 variants in modulating responsiveness to different diet therapies is unknown.Methods and analysisThis project aims to assess the feasibility of conducting a genotype-driven randomised controlled trial (RCT) investigating the differential response to a Mediterranean diet (MD) intervention of NAFLD patients according to genotype for the rs738409 (I148M) variant of PNPLA3. A single-centre randomised controlled feasibility trial will be undertaken. We will recruit 60 adults with NAFLD from a tertiary hepatology centre in England. In a cross-over design, participants will undertake Diet 1 (MD) and Diet 2 (control) for 4 weeks, in random order (1:1 allocation), separated by a 4 weeks washout period. Participants will complete one-to-one diet and lifestyle consultations at baseline, end of diet phase 1, end of washout and end of diet phase 2. Participants will be advised to maintain baseline levels of physical activity and body weight. The primary outcome is the acceptability and feasibility of the intervention protocol. Secondary outcomes include exploratory assessment of liver fibrosis biomarkers and lipid biomarkers.Ethics and disseminationEthical approval was granted by East of Scotland Research Ethics Service REC 1 (19/ES/0112). Results will be disseminated through peer-reviewed journals and presented at local, national and international meetings and conferences. The findings of this trial will lay the foundation for a future definitive RCT by informing trial design and optimising the intervention diets, instruments and procedures.Trial registration numberISRCTN93410321.

Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis

2012 ◽  
Vol 50 (4) ◽  
pp. 417-426
Author(s):  
R. Jund ◽  
M. Mondigler ◽  
H. Steindl ◽  
H. Stammer ◽  
P. Stierna ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Symptom Relief ◽  
Secondary Outcome ◽  
Number Needed To Treat ◽  
Symptom Duration ◽  
Serious Adverse Events ◽  
Dry Extract ◽  
End Of Treatment ◽  
Bno 1016 ◽  
Randomised Controlled

Objective: A herbal drug combination (Dry Extract BNO 1016) has been assessed for efficacy and tolerability in patients with acute viral rhinosinusitis. Methodology: In this randomised, controlled trial patients with symptom duration of up to 3 days, mild to moderate facial pain and a Major Symptom Score (MSS) between 8 and 12 were treated for 15 days with BNO 1016 or placebo (coated tablets administered orally). Primary efficacy endpoint was mean MSS at end of treatment. Secondary outcome measures included treatment response and changes in paranasal sinuses assessed by ultrasonography. Results: Treatment resulted in clinically relevant, significant differences in mean MSS for BNO 1016 versus placebo. BNO 1016 provided symptom relief two days earlier than placebo. The number needed to treat for healing is 8. BNO 1016 was superior regarding responder rates at Day 10 and Day 14 and percentage of patients without signs of acute viral rhinosinusitis assessed by ultrasonography at end of treatment. BNO 1016 was well tolerated; no serious adverse events were reported. Conclusion: The herbal dry extract BNO 1016 is efficacious and well tolerated in patients with acute viral rhinosinusitis. Trial registration: ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT01146860; EudraCT: 2009-016682-28).

scholarly journals Email-based promotion of self-help for subthreshold depression: Mood Memos randomised controlled trial

2012 ◽  
Vol 200 (5) ◽  
pp. 412-418 ◽  
Author(s):  
Amy J. Morgan ◽  
Anthony F. Jorm ◽  
Andrew J. Mackinnon
Keyword(s):  
Major Depression ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Active Group ◽  
Depression Symptoms ◽  
Number Needed To Treat ◽  
Subthreshold Depression ◽  
Self Help ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundSubthreshold depression is common, impairs functioning and increases the risk of major depression. Improving self-help coping strategies could help subthreshold depression and prevent major depression.AimsTo test the effectiveness of an automated email-based campaign promoting self-help behaviours.MethodA randomised controlled trial was conducted through the website: www.moodmemos.com. Participants received automated emails twice weekly for 6 weeks containing advice about self-help strategies. Emails containing general information about depression served as a control. The principal outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9) (trial registration: ACTRN12609000925246).ResultsThe study recruited 1326 adults with subthreshold depression. There was a small significant difference in depression symptoms at post-intervention, favouring the active group (d = 0.17, 95% CI 0.01–0.34). There was a lower, although non-significant, risk of major depression in the active group (number needed to treat (NNT) 25, 95% CI 11 to ∞ to NNT(harm) 57).ConclusionsEmails promoting self-help strategies were beneficial. Internet delivery of self-help messages affords a low-cost, easily disseminated and highly automated approach for indicated prevention of depression.

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