scholarly journals A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Rafal Kaminski ◽  
Krzysztof Kulinski ◽  
Katarzyna Kozar-Kaminska ◽  
Monika Wielgus ◽  
Maciej Langner ◽  
...  
Keyword(s):  
Platelet Rich Plasma ◽  
Meniscal Repair ◽  
International Knee Documentation Committee ◽  
Treated Group ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Parallel Group ◽  
Meniscus Healing ◽  
Ikdc Score

Objective. The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. Methods. This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. Results. After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P=0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. Conclusions. The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome.

scholarly journals Short-Term Outcomes of Percutaneous Trephination with a Platelet Rich Plasma Intrameniscal Injection for the Repair of Degenerative Meniscal Lesions. A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study

2019 ◽  
Vol 20 (4) ◽  
pp. 856 ◽  
Author(s):  
Rafal Kaminski ◽  
Marta Maksymowicz-Wleklik ◽  
Krzysztof Kulinski ◽  
Katarzyna Kozar-Kaminska ◽  
Agnieszka Dabrowska-Thing ◽  
...  
Keyword(s):  
Platelet Rich Plasma ◽  
Meniscal Tear ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Non Union ◽  
Parallel Group ◽  
Significant Difference ◽  
Clinically Significant ◽  
Patient Related Outcome

Meniscal tears are the most common orthopaedic injuries, with chronic lesions comprising up to 56% of cases. In these situations, no benefit with surgical treatment is observed. Thus, the purpose of this study was to investigate the effectiveness and safety of percutaneous intrameniscal platelet rich plasma (PRP) application to complement repair of a chronic meniscal lesion. This single centre, prospective, randomized, double-blind, placebo-controlled study included 72 patients. All subjects underwent meniscal trephination with or without concomitant PRP injection. Meniscal non-union observed in magnetic resonance arthrography or arthroscopy were considered as failures. Patient related outcome measures (PROMs) were assessed. The failure rate was significantly higher in the control group than in the PRP augmented group (70% vs. 48%, P = 0.04). Kaplan-Meyer analysis for arthroscopy-free survival showed significant reduction in the number of performed arthroscopies in the PRP augmented group. A notably higher percentage of patients treated with PRP achieved minimal clinically significant difference in visual analogue scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) symptom scores. Our trial indicates that percutaneous meniscal trephination augmented with PRP results in a significant improvement in the rate of chronic meniscal tear healing and this procedure decreases the necessity for arthroscopy in the future (8% vs. 28%, P = 0.032).

Is celecoxib a useful adjunct in the treatment of post-tonsillectomy pain in the adult population? A randomised, double-blind, placebo-controlled study

2017 ◽  
Vol 131 (S1) ◽  
pp. S18-S28 ◽  
Author(s):  
T-T Ng ◽  
D Diamantaras ◽  
J Priestley ◽  
J Redman ◽  
N De Silva ◽  
...  
Keyword(s):  
Adult Population ◽  
Treated Group ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Pain Scores ◽  
Parallel Group Design ◽  
Narcotic Analgesia ◽  
Parallel Group ◽  
Analgesia Requirement

AbstractObjective:To evaluate the efficacy and safety of celecoxib for pain management in post-tonsillectomy adult patients.Design:A randomised, double-blind, placebo-controlled, phase 3 clinical trial was conducted in an adult population (aged 18–55 years), with a parallel group design using an allocation ratio of 1:1.Methods:Eighty patients underwent elective tonsillectomy or adenotonsillectomy, operated on by one surgeon. They were discharged home with randomly assigned celecoxib or placebo, together with regular post-tonsillectomy medications (paracetamol and Endone). Pain scores were measured from post-operative days 1 to 10. All patients were assessed on post-operative days 5, 12 and 28.Results:There were no statistically significant differences in the daily or overall pain scores, the total intake of Endone, or the time taken to achieve freedom from pain after tonsillectomy between the study arms (n = 40 each arm). The celecoxib-treated group experienced significantly more vomiting (celecoxib vs placebo p < 0.001 (Mann–Whitney test), confidence interval = 0.57 to 0.76).Conclusion:Celecoxib usage was associated with significantly more vomiting and did not reduce narcotic analgesia requirement post-tonsillectomy.

scholarly journals Postoperative Ileus after Stimulation with Probiotics before Ileostomy Closure

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 626
Author(s):  
Ángela Rodríguez-Padilla ◽  
Germán Morales-Martín ◽  
Rocío Pérez-Quintero ◽  
Juan Gómez-Salgado ◽  
Rafael Balongo-García ◽  
...  
Keyword(s):  
Colorectal Carcinoma ◽  
Postoperative Ileus ◽  
Loop Ileostomy ◽  
Bowel Function ◽  
Ileostomy Closure ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Colorectal Cancer Surgery ◽  
Stimulation Of

Loop ileostomy closure after colorectal surgery is often associated with Postoperative ileus, with an incidence between 13–20%. The aim of this study is to evaluate the efficacy and safety of preoperative stimulation of the efferent loop with probiotics prior to ileostomy closure in patients operated on for colorectal carcinoma. For this, a prospective, randomized, double-blind, controlled study is designed. All patients who underwent surgery for colorectal carcinoma with loop ileostomy were included. Randomized and divided into two groups, 34 cases and 35 controls were included in the study. Postoperative ileus, the need for nasogastric tube insertion, the time required to begin tolerating a diet, restoration of bowel function, and duration of hospital stay were evaluated. The incidence of Postoperative ileus was similar in both groups, 9/34 patients stimulated with probiotics and 10/35 in the control group (CG) with a p = 0.192. The comparative analysis showed a direct relationship between Postoperative ileus after oncological surgery and Postoperative ileus after reconstruction surgery, independently of stimulation. Postoperative ileus after closure ileostomy is independent of stimulation of the ileostomy with probiotics through the efferent loop. There seem to be a relationship between Postoperative ileus after reconstruction and the previous existence of Postoperative ileus after colorectal cancer surgery.

CHRONIC ASTHMA IN CHILDHOOD: DOUBLE-BLIND CONTROLLED STUDY OF TREATMENT WITH GAMMA-GLOBULIN

PEDIATRICS ◽  
1958 ◽  
Vol 21 (6) ◽  
pp. 980-993
Author(s):  
Rosalind S. Abernathy ◽  
Edward L. Strem ◽  
Robert A. Good
Keyword(s):  
Gamma Globulin ◽  
Normal Population ◽  
Physical Growth ◽  
Controlled Study ◽  
Control Group ◽  
Chronic Asthma ◽  
Blood Proteins ◽  
Double Blind ◽  
Chemical Determination ◽  
Complete Blood Counts

To evaluate the effect of injections of gamma-globulin upon the course of asthma, observations were made with 22 asthmatic children ranging in age from 1½ to 5½ years. They had suffered from asthma from 1 to 13 years and were selected as subjects because they had not made satisfactory improvement under allergic management over an average of 2.4 years. They were placed in two groups by random assignment, one of which received injections of gamma-globulin. Without knowledge of the treatment being given, one author examined each child at the time of each injection and one month after the last injection. Roentgenograms, vital capacity, complete blood counts and chemical determination of the blood proteins were performed at the initial and final visits. Fifteen of the twenty-two patients improved clinically, eight in the treatment group and seven in the control group. No significant differences between the groups were noted in the amount of asthma, physical growth, hemoglobin value or eosinophilia. The concentration of gamma-globulin in the serum increased in the treated patients. Nevertheless, there was no difference in the incidence of infection in the two groups and in both it was equal to that in a normal population. This double-blind controlled study offers no evidence to support the view that treatment with gamma-globulin has a beneficial effect on the course of chronic asthma in children.

scholarly journals Randomized, Double-Blind, Placebo-Controlled Study of Modified Erzhi Granules in the Treatment of Menopause-Related Vulvovaginal Atrophy

2018 ◽  
Vol 2018 ◽  
pp. 1-15
Author(s):  
Ranran Chen ◽  
Dianrong Song ◽  
Wei Zhang ◽  
Guanwei Fan ◽  
Yingqiang Zhao ◽  
...  
Keyword(s):  
Drug Withdrawal ◽  
Endometrial Thickness ◽  
Vaginal Epithelium ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Vulvovaginal Atrophy ◽  
Normal Ranges ◽  
And Control

Objective. To evaluate the clinical therapeutic efficacy and safety of modified Erzhi granules (MEG) in patients with menopause-related vulvovaginal atrophy (VVA). Methods. This randomized, double-blind, placebo-controlled study comprised two groups, including the treatment and control groups. Patients receive MEG and placebo for 12 weeks, respectively. Vaginal health score (VHS), vaginitis score, vaginal maturation index (VMI), female sexual function index (FSFI), and modified Kupperman Index (modified KI) were used as efficacy endpoints and assessed at baseline, 4, 8, and 12 weeks during administration, and 4 weeks after drug withdrawal. At baseline and 12 weeks, serum estradiol (E2), follicle stimulating hormone (FSH), pelvic ultrasound, breast ultrasound, and other safety parameters were measured, recording adverse events. Results. At 12 weeks, VHS, percentage of superficial cells in the vaginal epithelium and FSFI were significantly increased, while vaginitis score, percentage of basal cells in the vaginal epithelium, and modified KI were significantly decreased in comparison with baseline and control group (all P<0.05); these differences persisted for up to 4 weeks after drug withdrawal. The placebo group showed no significant change during treatment compared with baseline values (p>0.05). Serum E2 and FSH levels, endometrial thickness, and breast thickness in all patients were within the normal ranges before and after treatment, with no serious adverse reactions observed. Conclusion. MEG significantly alleviates menopause-related vulvovaginal atrophy, with no overt adverse effects on the endometrium, breast, hepatic, and renal functions.

Controlled Study of the Use of Local Steroid Injection in the Treatment of Trigger Finger and Thumb

1992 ◽  
Vol 17 (1) ◽  
pp. 69-70 ◽  
Author(s):  
M. A. LAMBERT ◽  
R. J. MORTON ◽  
J. P. SLOAN
Keyword(s):  
Local Anaesthetic ◽  
Steroid Injection ◽  
Controlled Trial ◽  
Trigger Finger ◽  
Controlled Study ◽  
Control Group ◽  
Methylprednisolone Acetate ◽  
Double Blind ◽  
Local Steroid Injection ◽  
Control Injection

A controlled double-blind prospective study of injection of methylprednisolone acetate plus local anaesthetic against a control injection of a local anaesthetic in the treatment of trigger finger and thumb has shown a 60% success rate for the steroid injection against 16% for the control group (p < 0.05). This is the first controlled trial of local steroid therapy in this condition.

Acetyl L-Carnitine Slows Decline in Younger Patients With Alzheimer's Disease: A Reanalysis of a Double-Blind, Placebo-Controlled Study Using the Trilinear Approach

1998 ◽  
Vol 10 (2) ◽  
pp. 193-203 ◽  
Author(s):  
John O. Brooks ◽  
Jerome A. Yesavage ◽  
Angelico Carta ◽  
Daniele Bravi
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Average Rate ◽  
The United States ◽  
Rate Of Change ◽  
Disease Assessment ◽  
Controlled Study ◽  
Double Blind ◽  
Parallel Group ◽  
Longitudinal Effects

Objectives: To assess the longitudinal effects of acetyl-L-carnitine (ALC) on patients diagnosed with Alzheimer's disease. Design: Longitudinal, double-blind, parallel-group, placebocontrolled. Setting: Twenty-four outpatient sites across the United States. Participants: A total of 334 subjects diagnosed with probable Alzheimer's disease by NINCDS-ADRDA criteria. These data were originally reported by Thal and colleagues (1996). Measurements: Cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS) given every 3 months for 1 year. Results: The average rate of change was estimated using the trilinear approach, which allows for periods of both change and stability. Both the ALC group and the placebo group exhibited the same mean rate of change on the ADAS (0.68 points/month). However, a multiple regression analysis revealed a statistically significant Age × Drug interaction characterized by younger subjects benefiting more from ALC treatment than older subjects. Further analyses suggested that the optimal, though not statistically significant, cutpoint for ALC benefit was 61 years of age. Conclusions: ALC slows the progression of Alzheimer's disease in younger subjects, and the use of the trilinear approach to estimate the average rate of change may prove valuable in pharmacological trials.

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