Efficacy and safety of a centrally acting analgesic flupirtine in primary knee osteoarthritis in comparison to tramadol: a randomized controlled trial

Background: Osteoarthritis (OA) is a chronic, degenerative joint disorder responsible for considerable morbidity, particularly in old age. Flupirtine, a new centrally acting analgesic, is devoid of the adverse effects of NSAIDs and opioid analgesics. In this study author compared the effectiveness and safety of flupirtine with tramadol in knee OA.Methods: An open label, randomized, controlled trial was done with patients of primary knee OA of both sexes, age >50 years. Patients were recruited from Rheumatology OPD of SSKM Hospital. A minimum WOMAC score of 35 was essential for recruitment. Patients with serious comorbidities were excluded. They were treated orally with either flupirtine (100mg thrice daily) or tramadol (50mg thrice daily) for 12 weeks.Results: Ninety patients were recruited and data of 42 on flupirtine and 41 on tramadol were analysed. There was significant improvement in pain, stiffness and physical function compared to baseline in both the groups. However, there was no significant difference between groups at 4, 8 and 12 weeks. Responder rate (50% reduction in pain score from baseline) was 66.67% with flupirtine and 48.78% with tramadol (p = 0.122). Flupirtine caused 4 adverse events compared to 16 with tramadol. However, both the drugs were well-tolerated.Conclusions: The effectiveness of flupirtine in knee OA is comparable to tramadol, while causing minimal adverse effects. Long-term benefits need to be explored.

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AYUSH-64 as an adjunct to Standard Care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India

10.31219/osf.io/xyuas ◽

2021 ◽

Author(s):

Harbans Singh ◽

Sumit Shrivastva ◽

Babita Yadav ◽

Amit Kumar Rai ◽

Sophia Jameela ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Inflammatory Markers ◽

Standard Care ◽

Controlled Trial ◽

Control Group ◽

Rt Pcr ◽

Open Label ◽

Clinical Recovery ◽

Randomized Controlled ◽

Significant Difference

Background: There is limited evidence on the safety and efficacy of administering Ayurveda interventions as add-on to the standard care for COVID-19. Objective: To explore the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in the management of mild to moderate stage COVID-19.Design, setting, participants and interventions: This was an open-label randomized controlled trial with 80 patients of mild to moderate stage COVID-19. Participants in the AYUSH-64 add-on group received two tablets (500 mg each) three times daily for 30 days along with conventional standard care (Paracetamol, Cetirizine, Vitamin C, and Azithromycin). The control group received standard care alone. Main outcome measures: The primary outcome assessed was the proportion of participants with clinical recovery and negative RT-PCR assay for COVID-19 on day 7, 15, 23, and 30. Additionally, change in pro-inflammatory markers, metabolic functions, HRCT chest and incidence of Adverse Drug Reaction (ADR) / Serious Adverse Event (SAE) were assessed.Results: Statistically significant difference was observed in the proportion of participants with clinical recovery in the AYUSH-64 add-on group (p<0.001) at each of the scheduled follow-up visits. All the participants in the AYUSH-64 add-on group clinically recovered by day 23 compared to 32.4 per cent in the control group. The mean duration for clinical recovery in AYUSH-64 add-on group (5.8 ± 2.67 days) was less as compared to control group (10.0 ± 4.06 days). The proportion of participants who turned RT-PCR negative for COVID-19 on day 7, 15, and 23 were 81.8, 94.5, and 100 per cent in AYUSH-64 add-on group, and 79.4, 94.5, and 97.2 per cent in control group, however, the difference observed was statistically not significant (p=0.314). The proportion of participants with improvement in HRCT chest was statistically significant in AYUSH-64 add-on group (p=0.031) unlike in control group (p=0.210). Similar reductions in most inflammatory markers measured (IL-6, CRP, Serum ferritin, and LDH) on day 30 (p<0.05) were observed in both groups. Conclusion: AYUSH-64 as adjunct to standard conventional care is safe and hastens clinical recovery in adult patients with mild to moderate COVID-19.

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Effects of Neuromuscular Electrical Stimulation Combined with Exercises versus an Exercise Program on the Pain and the Function in Patients with Knee Osteoarthritis: A Randomized Controlled Trial

BioMed Research International ◽

10.1155/2013/272018 ◽

2013 ◽

Vol 2013 ◽

pp. 1-7 ◽

Cited By ~ 6

Author(s):

Aline Mizusaki Imoto ◽

Stella Peccin ◽

Kelson Nonato Gomes da Silva ◽

Lucas Emmanuel Pedro de Paiva Teixeira ◽

Marcelo Ismael Abrahão ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Electrical Stimulation ◽

Knee Osteoarthritis ◽

Rating Scale ◽

Controlled Trial ◽

Neuromuscular Electrical Stimulation ◽

Functional Improvement ◽

Knee Oa ◽

Randomized Controlled ◽

Significant Difference

Objectives. To investigate the effect of 8 weeks of NMES + Ex (neuromuscular electrical stimulation combined with exercises) on pain and functional improvement in patients with knee osteoarthritis (OA) compared to exercise (Ex) alone.Design. Randomized controlled trial.Setting. A specialty outpatient clinic.Participants. Patients (N=100; women = 86, men = 14; age range, 50–75 years) with knee OA.Interventions. Participants were randomly assigned to NMES + Ex or Ex group.Outcome Measures. Numerical Rating Scale 0 to 10 (NRS) and the Timed Up and Go (TUG) test were the primary outcomes. The secondary outcomes used were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).Results. Following the interventions, a statistically significant improvement in both groups was observed in all outcomes assessed. For the comparison between the groups, no statistically significant difference was found between the NMES + Ex and the Ex groups in NRS (P=0.52), TUG test (P=0.12), and aspects of WOMAC: pain (P=0.26), function (P=0.23), and stiffness (P=0.63).Conclusion. The addition of NMES to exercise did not improve the outcomes assessed in knee OA patients. This study was registered at the Australian Clinical Trials Registry (ACTRN012607000357459).

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Effect of rhG-CSF Combined With Decitabine Prophylaxis on Relapse of Patients With High-Risk MRD-Negative AML After HSCT: An Open-Label, Multicenter, Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.19.03277 ◽

2020 ◽

Vol 38 (36) ◽

pp. 4249-4259

Author(s):

Lei Gao ◽

Yanqi Zhang ◽

Sanbin Wang ◽

Peiyan Kong ◽

Yi Su ◽

...

Keyword(s):

Randomized Controlled Trial ◽

High Risk ◽

Cumulative Incidence ◽

Controlled Trial ◽

Open Label ◽

Hematopoietic Stem ◽

Randomized Controlled ◽

Minimal Dose ◽

Significant Difference ◽

Multicenter Randomized Controlled Trial

PURPOSE Relapse is a major cause of treatment failure after allogeneic hematopoietic stem-cell transplantation (allo-HSCT) for high-risk acute myeloid leukemia (HR-AML). The aim of this study was to explore the effect of recombinant human granulocyte colony-stimulating factor (rhG-CSF) combined with minimal-dose decitabine (Dec) on the prevention of HR-AML relapse after allo-HSCT. PATIENTS AND METHODS We conducted a phase II, open-label, multicenter, randomized controlled trial. Two hundred four patients with HR-AML who had received allo-HSCT 60-100 days before randomization and who were minimal residual disease negative were randomly assigned 1:1 to either rhG-CSF combined with minimal-dose Dec (G-Dec group: 100 µg/m2 of rhG-CSF on days 0-5 and 5 mg/m2 of Dec on days 1-5) or no intervention (non–G-Dec group). The primary outcome was relapse after transplantation, and the secondary outcomes were chronic graft-versus-host disease (cGVHD), safety of the treatment, and survival. RESULTS The estimated 2-year cumulative incidence of relapse in the G-Dec group was 15.0% (95% CI, 8.0% to 22.1%), compared with 38.3% (95% CI, 28.8% to 47.9%) in the non–G-Dec group ( P < .01), with a hazard ratio (HR) of 0.32 (95% CI, 0.18 to 0.57; P < .01). There was no statistically significant difference between the G-Dec and non–G-Dec groups in the 2-year cumulative incidence of cGVHD without relapse (23.0% [95% CI, 14.7% to 31.3%] and 21.7% [95% CI, 13.6% to 29.7%], respectively; P = .82), with an HR of 1.07 (95% CI, 0.60 to 1.92; P = .81). After rhG-CSF combined with minimal-dose Dec maintenance, increasing numbers of natural killer, CD8+ T, and regulatory T cells were observed. CONCLUSION Our findings suggest that rhG-CSF combined with minimal-dose Dec maintenance after allo-HSCT can reduce the incidence of relapse, accompanied by changes in the number of lymphocyte subtypes.

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Efficacy of Valganciclovir Versus Ganciclovir in Treatment of Symptomatic Cytomegalovirus Infection in Infants: An Open- Labeled Randomized Controlled Trial

Journal of the International Child Neurology Association ◽

10.17724/jicna.2019.133 ◽

2020 ◽

Author(s):

Kanij Fatema ◽

Md Mizanur Rahman ◽

Shaheen Akhtar ◽

Jannatara Shefa

Keyword(s):

Randomized Controlled Trial ◽

Side Effects ◽

Controlled Trial ◽

Cortical Blindness ◽

Neonatal Seizure ◽

Cmv Infection ◽

Open Label ◽

Randomized Controlled ◽

Significant Difference ◽

Congenital Cmv

Introduction: Congenital cytomegalovirus (CMV) infection is the most common viral infection transmitted via the placenta, causing significant neurodevelopmental impairment in infants and children. Gancyclovir and Valgancyclovir are two drugs used in the treatment of symptomatic CMV infected case which have limited comparative study. This study compared the efficacy and tolerability of these two drugs on symptomatic CMV infected infants.Methodology: This was an open-label randomized controlled trial done to compare oral valganciclovir(VGCV) with injectable ganciclovir (GCV) in the treatment of symptomatic congenital CMV infected infants. A total of 72 patients were included; 12 patients discontinued the treatment due to noncompliance or side effects. Pre and post-treatment CMV virus levels and adverse effects were monitored. Psychological, visual, and hearing assessments were performed at baseline and six months post-treatment.Results: The mean age of the infants in VGCV and GCV group was 7.10±3.58 and 7.50±3.99 months, respectively. Nineteen infants presented with developmental delay, 13 with seizure, 4 with a movement disorder. Twenty-one percent of the infants were preterm, and 38% were low birth weight. Eighteen infants had a neonatal seizure. Twenty-eight infants of VGCV and 24 infants of the GCV group showed clearance of the virus after six weeks of treatment. No statistical difference was found in virus clearance. Regarding ophthalmological assessment, infants had chorioretinitis, optic atrophy, squint, and cortical blindness. On hearing assessment, none of the infants deteriorated after drug administration, while some showed improved hearing. None of the infants showed deterioration of cognition, while some of the infants showedimprovement in cognitive assessment, but there was no significant difference in two groups. The side effects of GCV were significantly greater than VGCV (P<0.05). Conclusion: In symptomatic congenital CMV infection in infants, VGCV is as efficient as GCV, and the former has fewer side effects.

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Prospective Single-Blinded Randomized Controlled Trial Comparing Pericapsular Injection Versus Lumbar Plexus Peripheral Nerve Block for Hip Arthroscopy

The American Journal of Sports Medicine ◽

10.1177/0363546520943580 ◽

2020 ◽

Vol 48 (11) ◽

pp. 2740-2746

Author(s):

John P. Scanaliato ◽

Daniel Christensen ◽

Michael M. Polmear ◽

Catherine Salfiti ◽

Patrick S. Gaspar ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Postoperative Pain ◽

Adverse Effects ◽

Hip Arthroscopy ◽

Controlled Trial ◽

Arthroscopic Surgery ◽

Lumbar Plexus ◽

Postanesthesia Care Unit ◽

Randomized Controlled ◽

Significant Difference

Background: Hip arthroscopy has become the standard for the operative treatment of symptomatic femoroacetabular impingement. Given the high levels of postoperative pain associated with hip arthroscopy, optimal analgesia is critical to ensure patient comfort and safety after discharge. Purpose/Hypothesis: Our purpose was to perform a single-blinded randomized controlled trial comparing the use of pericapsular injection versus lumbar plexus blockade for postoperative pain control after arthroscopic surgery on the hip. We hypothesized that pericapsular injection would provide equivalent pain relief to that of lumbar plexus blockade while minimizing adverse effects and alleviating the dependence on a qualified individual to administer. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 64 consecutive patients undergoing hip arthroscopy were prospectively assessed over a 6-month period between 2017 and 2018. Patients were randomly allocated to 1 of 2 groups: 32 patients received a lumbar plexus blockade by a single anesthesiologist, while 32 patients received a pericapsular injection of 30 mL of ropivacaine and 12 mg of morphine. Postoperative pain in the postanesthesia care unit (PACU) as measured using the numeric rating scale, time to discharge, PACU morphine equivalents, and adverse effects were collected by PACU staff. Postoperative day 1 and 2 narcotic use was obtained through a telephone call with the patient on postoperative day 3. Results: We found no statistically significant difference in PACU pain scores at all time points, although there was a trend toward lower pain for patients receiving a pericapsular injection. PACU and short-term narcotic demand did not vary across the 2 arms. Time to discharge from the PACU did not differ. There were no major adverse events reported for either intervention. Conclusion: Pericapsular injection provides equivalent analgesia when compared with lumbar plexus blockade. It is a safe intervention that allows for efficient postoperative analgesia for patients undergoing hip arthroscopy. Registration: ClinicalTrials.gov ID: NCT03244631.

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The Effectiveness of Mometasone Spray and Triamcinolone Acetonide Gel in Preventing Sore Throat, Cough, and Hoarse after Intubation

Journal of Anesthesiology and Clinical Research ◽

10.37275/jacr.v2i1.144 ◽

2021 ◽

Vol 2 (1) ◽

pp. 135-147

Author(s):

Zentika. I. Fajri ◽

Fredi Heru Irwanto ◽

A Miarta ◽

Theodorus

Keyword(s):

Randomized Controlled Trial ◽

General Anesthesia ◽

Sore Throat ◽

Triamcinolone Acetonide ◽

Endotracheal Intubation ◽

Controlled Trial ◽

Inclusion Criteria ◽

Open Label ◽

Randomized Controlled ◽

Significant Difference

Background: Endotracheal intubation is a procedure performed by inserting an endotracheal tube into the airway. With endotracheal intubation, there can be several complications ranging from mild to severe. Sore throat, coughing, and hoarseness were several endotracheal intbation complications. From several studies, it was found that the incidence of POST was 21-65%. This study aimed to determine the efficacy between 0.1% triamcinolone acetonide gel and 100 mcg mometasone spray in reducing sore throat, cough, and hoarseness due to endotracheal intubation. Method: A Randomized Controlled Trial, Open-Label was carried out on patients undergoing endotracheal intubation with general anesthesia in RSMH operating room from September 2020 - November 2020. Seventy-two study subjects met the inclusion criteria and were divided into two groups, namely the triamcinolone acetonide gel group, and the mometasone spray group. Analyzing data was SPSS version 23. Result: There were no difference between age, sex, ASA PS classification, and length of operation between the two groups (p> 0.05). Mometasone spray 100 mcg and triamcinolone acetonide gel 0.1% had the same effectiveness to reduce endotracheal intubation such as sore throat, cough, and hoarseness within 24 hours of endotracheal intubation (p> 0.05). There was a significant difference in the incidence of sore throat between two groups in the first hour (p = 0.039). Conclusion: There was no statistically significant difference between the efficiency of mometasone spray 100 mcg and triamcinolone acetonide gel 0.1% on a sore throat, cough, and hoarseness within 24 hours of endotracheal intubation (p > 0.05).

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