scholarly journals EFFECTS OF ONCE-DAILY VERSUS TWICE DAILY DOSING OF CALCIUM FRUCTOBORATE ON KNEE DISCOMFORT. A 90 DAY, DOUBLE-BLIND, PLACEBO CONTROLLED RANDOMIZED CLINICAL STUDY

2018 ◽  
pp. 1-6
Author(s):  
Z. Pietrzkowski ◽  
A. Roldán Mercado-Sesma ◽  
R. Argumedo ◽  
M. Cervantes ◽  
B. Nemzer ◽  
...  
Keyword(s):  
Randomized Study ◽  
Control Group ◽  
Mcgill Pain Questionnaire ◽  
Double Blind ◽  
Test Analysis ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Randomized Clinical Study ◽  
Supplementation Period ◽  
Calcium Fructoborate

Importance: Previous research showed that a twice-daily 108 mg dose of calcium fructoborate (CFB) improved knee discomfort during a 2-week supplementation period. This current double-blind, placebo-controlled randomized study investigates the effects of CFB supplementation on knee discomfort during 90 days of supplementation. Purpose: To evaluate the comparative effects of once-daily and twice-daily dosing of calcium fructoborate on knee joint discomfort for ninety days. Design: 120 participants with self-reported knee discomfort were recruited and randomized into three groups (each N=40). Participants received: 108 mg CFB twice per day (CFB-G1); or, 216 mg CFB in a single dose (CFB-G2); or, placebo. Setting: Subjects were recruited through advertisement in local papers. The researchers assessed intake and within-study levels of knee discomfort by using the McGill Pain Questionnaire (MPQ) and the Western Ontario and McMaster University Arthritis Index (WOMAC). Results: 62 female and 59 male subjects completed the study. Subjects’ average age was (52.84 ± 8.19 years) and average BMI was (26.76 ± 2.50 kg/m2). Statistical differences between groups were calculated using a two-sided, two-sample t-test. Analysis of variance (ANOVA) was used to estimate within-group changes in mean WOMAC and MPQ scores as well as against the control group. When compared to placebo, CFB-G1 showed a significant decrease in reported discomfort on day 14 (P=0.02,) day 30 (P=0.003), day 60 (P<0.0001) and day 90 (P<0.0001) according to WOMAC Scores. A similar decrease was observed for CFB-G2 WOMAC Scores on day 14 (P=0.02), day 30 (P=0.0003), day 60 (P<0.0001) and day 90 (P<0.0001). When compared to placebo, the MPQ score for CFB-G1 group decreased on day 7 (P=0.002), day 14 (P=0.001), day 30 (P<0.0001), day 60 (P<0.0001) and day 90 (P<0.0001). MPQ score decreases were also observed for CFB-G2 group on day 7 (P=0.02), day 14 (P=0.01), day 30 (P<0.0001), day 60 (P<0.0001) and day 90 (P<0.0001). When comparing CFB-G1 and CFB-G2, no significant differences were observed. Importantly, no changes were observed in the WOMAC and MPQ scores within the placebo group. Conclusion: Both CFB groups showed early and significantly improved levels of knee comfort. Knee comfort continued to significantly improve throughout the duration of this 90-day study. No significant differences were observed between the once-daily and the twice–daily doses of CFB.

Effect of Cilostazol on Cerebral Vasospasm and Outcome in Patients with Aneurysmal Subarachnoid Hemorrhage: A Randomized, Double-Blind, Placebo-Controlled Trial

2016 ◽  
Vol 42 (1-2) ◽  
pp. 97-105 ◽  
Author(s):  
Naoya Matsuda ◽  
Masato Naraoka ◽  
Hiroki Ohkuma ◽  
Norihito Shimamura ◽  
Katsuhiro Ito ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Cerebral Infarction ◽  
Cerebral Vasospasm ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Control Group ◽  
Independent Factor ◽  
Double Blind ◽  
End Points ◽  
Double Blind Placebo ◽  
Poor Outcome

Background: Several clinical studies have indicated the efficacy of cilostazol, a selective inhibitor of phosphodiesterase 3, in preventing cerebral vasospasm after aneurysmal subarachnoid hemorrhage (SAH). They were not double-blinded trial resulting in disunited results on assessment of end points among the studies. The randomized, double-blind, placebo-controlled study was performed to assess the effectiveness of cilostazol on cerebral vasospasm. Methods: Patients with aneurysmal SAH admitted within 24 h after the ictus who met the following criteria were enrolled in this study: SAH on CT scan was diffuse thick, diffuse thin, or local thick, Hunt and Hess score was less than 4, administration of cilostazol or placebo could be started within 48 h of SAH. Patients were randomly allocated to placebo or cilostazol after repair of a ruptured saccular aneurysm by aneurysmal neck clipping or endovascular coiling, and the administration of cilostazol or placebo was continued up to 14 days after initiation of treatment. The primary end point was the occurrence of symptomatic vasospasm (sVS), and secondary end points were angiographic vasospasm (aVS) evaluated on digital subtraction angiography, vasospasm-related new cerebral infarction evaluated on CT scan or MRI, and clinical outcome at 3 months of SAH as assessed by Glasgow Outcome Scale, in which poor outcome was defined as severe disability, vegetative state, and death. All end points were evaluated with blinded assessment. Results: One hundred forty eight patients were randomly allocated to the cilostazol group (n = 74) or the control group (n = 74). The occurrence of sVS was significantly lower in the cilostazol group than in the control group (10.8 vs. 24.3%, p = 0.031), and multiple logistic analysis showed that cilostazol use was an independent factor reducing sVS (OR 0.293, 95% CI 0.099-0.568, p = 0.027). The incidence of aVS and vasospasm-related cerebral infarction were not significantly different between the groups. Poor outcome was significantly lower in the cilostazol group than in the control group (5.4 vs. 17.6%, p = 0.011), and multiple logistic analyses demonstrated that cilostazol use was an independent factor that reduced the incidence of poor outcome (OR 0.221, 95% CI 0.054-0.903, p = 0.035). Severe adverse events due to cilostazol administration did not occur during the study period. Conclusions: Cilostazol administration is effective in preventing sVS and improving outcomes without severe adverse events. A larger-scale study including more cases was necessary to confirm this efficacy of cilostazol.

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.

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