scholarly journals DL-3-n-butylphthalide improves cerebral hypoperfusion in patients with large cerebral atherosclerotic stenosis. A single-center, randomized, double-blind, placebo-controlled study.

2020 ◽  
Author(s):  
Dawei Chen ◽  
Yanwei Yin ◽  
Jin Shi ◽  
Fen Yang ◽  
Kehua Wang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Single Photon ◽  
Photon Emission ◽  
Cerebral Hypoperfusion ◽  
Controlled Study ◽  
Emission Computed Tomography ◽  
Single Center ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Atherosclerotic Stenosis

Abstract Background: DL-3-n-butylphthalide (NBP) was demonstrated to increase the cerebral blood flow (CBF) in the animal models, but there are no clinic studies to verify this. We aimed to explore the effect of NBP on improving cerebral hypoperfusion caused by cerebral large-vessel stenosis. Methods: In this single-center, randomized, double-blind, placebo-controlled study, 120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) were included and randomly assigned into NBP or placebo group as 1:1 radio. Patients in NBP or placebo group received 200mg or 20mg of NBP capsules three times daily for four weeks respectively. Single photon emission computed tomography (SPECT) was used to assess regional CBF (rCBF) in four regions of interest (ROIs) corresponding to MCA before and 12 weeks after the treatment. After therapy, the rCBF change for every ROI and the whole CBF change in MCA territory for every patient were classified into amelioration, stabilization and deterioration respectively. Results: 48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis) completed the trial. Overall, both groups had 54 stenotic carotid arteries and 216 ROIs for rCBF change analysis. After therapy, the rCBF in ROIs increased in NBP group (83.5%±11.4% vs. 85.8%±12.5%, p=0.000), whereas no change was found in placebo group (86.9%±11.6% vs. 87.8%±11.7%, p=0.331). Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p=0.000). Furthermore, ordinal regression analysis showed that compared with placebo, NBP independently made more patients to have whole CBF amelioration in ipsilateral MCA (Wald-χ2=5.247, OR=3.31, p=0.022). Conclusions: NBP might improve the cerebral hypoperfusion in the patients with carotid artery atherosclerotic stenosis. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900028005, registered December 8th 2019- Retrospectively registered ( http://www.chictr.org.cn/index.aspx ).

scholarly journals DL-3-n-butylphthalide improves cerebral hypoperfusion in patients with large cerebral artherosclerotic stenosis. A single-center, randomized, double-blind, placebo-controlled study.

2020 ◽  
Author(s):  
dawei Chen ◽  
Jin Shi ◽  
Yanwei Yin ◽  
Fen Yang ◽  
Kehua Wang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Single Photon ◽  
Photon Emission ◽  
Cerebral Hypoperfusion ◽  
Controlled Study ◽  
Emission Computed Tomography ◽  
Single Center ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Atherosclerotic Stenosis

Abstract Background: DL-3-n-butylphthalide (NBP) was demonstrated to increase the cerebral blood flow (CBF) in the animal models, but there are no clinic studies to verify this. We aimed to explore the effect of NBP on improving cerebral hypoperfusion caused by cerebral large-vessel stenosis. Methods: In this single-center, randomized, double-blind, placebo-controlled study, 120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) were included and randomly assigned into the NBP or placebo group as 1:1 radio. Patients in NBP and placebo group received 200mg and 20mg of NBP capsules three times daily for four weeks respectively. Single photon emission computed tomography (SPECT) were used to assess regional CBF (rCBF) in four regions of interest (ROIs) corresponding to MCA before and 12 weeks after the treatment. The rC BF change for every ROI and the CBF change in whole MCA territory for every patient after therapy were classified into amelioration, stabilization and deterioration respectively. Results: 48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis) completed the trial. Both groups had 54 stenotic carotid arteries and 216 ROIs for rCBF change analysis. After therapy, the rCBF in ROIs increased in NBP group (83.5%±11.4% vs. 85.8%±12.5%, p=0.000), but had no change in placebo group (86.9%±11.6% vs. 87.8%±11.7%, p=0.331). There was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p=0.000). Ordinal regression analysis showed that NBP independently made more patients to have whole CBF amelioration in ipsilateral MCA than placebo (Wald-χ2=5.247, OR=3.31, p=0.022). Conclusions: NBP may improve the cerebral hypoperfusion in the patients with carotid artery atherosclerotic stenosis. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900028005, registered December 8th 2019- Retrospectively registered, http://www.chictr.org.cn/edit.aspx?pid=45490&htm=4.

scholarly journals DL-3-n-butylphthalide improves cerebral hypoperfusion in patients with large cerebral atherosclerotic stenosis. A single-center, randomized, double-blind, placebo-controlled study.

2020 ◽  
Author(s):  
Dawei Chen ◽  
Yanwei Yin ◽  
Jin Shi ◽  
Fen Yang ◽  
Kehua Wang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Single Photon ◽  
Photon Emission ◽  
Cerebral Hypoperfusion ◽  
Controlled Study ◽  
Emission Computed Tomography ◽  
Single Center ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Atherosclerotic Stenosis

Abstract Background: DL-3-n-butylphthalide (NBP) was demonstrated to increase the cerebral blood flow (CBF) in the animal models, but there are no clinic studies to verify this. We aimed to explore the effect of NBP on improving cerebral hypoperfusion caused by cerebral large-vessel stenosis.Methods: In this single-center, randomized, double-blind, placebo-controlled study, 120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) were included and randomly assigned into NBP or placebo group as 1:1 radio. Patients in NBP or placebo group received 200mg or 20mg of NBP capsules three times daily for four weeks respectively. Single photon emission computed tomography (SPECT) was used to assess regional CBF (rCBF) in four regions of interest (ROIs) corresponding to MCA before and 12 weeks after the treatment. After therapy, the rCBF change for every ROI and the whole CBF change in MCA territory for every patient were classified into amelioration, stabilization and deterioration respectively.Results: 48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis) completed the trial. Overall, both groups had 54 stenotic carotid arteries and 216 ROIs for rCBF change analysis. After therapy, the rCBF in ROIs increased in NBP group (83.5%±11.4% vs. 85.8%±12.5%, p=0.000), whereas no change was found in placebo group (86.9%±11.6% vs. 87.8%±11.7%, p=0.331). Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p=0.000). Furthermore, ordinal regression analysis showed that compared with placebo, NBP independently made more patients to have whole CBF amelioration in ipsilateral MCA (Wald-χ2=5.247, OR=3.31, p=0.022).Conclusions: NBP might improve the cerebral hypoperfusion in the patients with carotid artery atherosclerotic stenosis.Trial registration: Chinese Clinical Trial Registry, ChiCTR1900028005, registered December 8th 2019- Retrospectively registered (http://www.chictr.org.cn/index.aspx).

Theta Burst Magnetic Stimulation Improves Parkinson’s-Related Cognitive Impairment: A Randomised Controlled Study

2021 ◽  
Vol 35 (11) ◽  
pp. 986-995
Author(s):  
Weijia He ◽  
Jia-Chi Wang ◽  
Po-Yi Tsai
Keyword(s):  
Cognitive Impairment ◽  
Magnetic Stimulation ◽  
Single Photon ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Photon Emission ◽  
Controlled Study ◽  
Emission Computed Tomography ◽  
Randomised Controlled ◽  
Theta Burst

Background. Evidence remains mixed as to the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in treating mild cognitive impairment (MCI) in patients with Parkinson’s disease (PD). Objective. In this study, we examined the short- and long-term effects of patterned rTMS. Methods. We randomly assigned 35 patients with PD with MCI to two groups. One group received intermittent theta burst stimulation (iTBS; n = 20), and the other received its sham counterpart (n = 15). The stimulations were applied over the left dorsolateral prefrontal cortex for 10 consecutive weekdays. Measurements based on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Montreal Cognitive Assessment (MoCA) were conducted at three time points: at baseline, immediately after the last intervention and at 3-month follow-up. Each patient received a 99mTc-TRODAT-1 single-photon emission computed tomography (SPECT) brain scan at baseline. Results. The iTBS group exhibited significantly greater improvement than the sham group did in total RBANS and MoCA scores ( p < .001 for both) immediately after intervention and at the 3-month follow-up. Radiotracer uptake in the bilateral basal ganglion in baseline SPECT was positively correlated with response to iTBS conditioning with respect to improvements in MoCA scores ( p = .021). Conclusion. This randomised controlled trial provides evidence that a consecutive iTBS protocol can achieve a persistent and wide-ranging therapeutic effect in patients with PD with MCI.

Can Simvastatin reduce COPD Exacerbations? A Randomised Double Blind Controlled Study

2021 ◽  
pp. 2001798
Author(s):  
Peter Schenk ◽  
Alexander O. Spiel ◽  
Felix Hüttinger ◽  
Micheline Gmeiner ◽  
Josefine Fugger ◽  
...  
Keyword(s):  
Placebo Group ◽  
Lung Function ◽  
Tertiary Care ◽  
Controlled Study ◽  
Rank Test ◽  
Chronic Obstructive ◽  
Single Center ◽  
Double Blind ◽  
Exacerbation Rate ◽  
Simvastatin Group

Several studies have shown that statins have beneficial effects in chronic obstructive pulmonary disease (COPD) regarding lung function decline, rates and severity of exacerbations, hospitalisation and need for mechanical ventilation.We performed a randomised double-blind placebo-controlled single-center trial of simvastatin at a daily dose of 40 mg versus placebo in patients with Global Initiative for COPD criteria II-IV at a tertiary care pulmonology department in Austria. Scheduled treatment duration was 12 months and main outcome parameter was time to first exacerbation.Overall 209 patients were enrolled. In the 105 patients taking simvastatin, time to first exacerbation was significantly longer compared to the 104 patients taking placebo: median 341 versus 140 days, log-rank test p<0.001. Hazard ratio for risk of first exacerbation for the simvastatin group was 0.51 (95% CI 0.34–0.75; p=0.001). Rate of exacerbations was significantly lower with simvastatin: 103 (41%) versus 147 (59%), p=0.003. The annualised exacerbation rate was 1.45 per patient-year in the simvastatin group and 1.9 in the placebo group (IRR 0.77, 95% CI 0.60 to 0.99).We found no effect on quality of life, lung function, 6-minute walk test and high-sensitivity C-reactive protein. More patients dropped out in the simvastatin group compared to the placebo group (39 versus 29).In our single-center RCT, simvastatin at a dose of 40 mg daily significantly prolonged time to first COPD exacerbation and reduced exacerbation rate.

scholarly journals A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

scholarly journals Oral lysine clonixinate in the acute treatment of migraine: a double-blind placebo-controlled study

2001 ◽  
Vol 59 (1) ◽  
pp. 46-49 ◽  
Author(s):  
Abouch V. Krymchantowski ◽  
Jackeline S. Barbosa ◽  
Celia Cheim ◽  
Luiz A. Alves
Keyword(s):  
Placebo Group ◽  
Acute Treatment ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Pain Syndromes ◽  
Severe Intensity ◽  
Ihs Criteria ◽  
Lysine Clonixinate ◽  
Severe Migraine

Several oral nonsteroidal anti-inflammatory drugs (NSAIDs) are effective to treat migraine attacks. Lysine clonixinate (LC) is a NSAID derived from nicotinic acid that has proven to be effective in various pain syndromes such as renal colic and muscular pain. The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of oral LC compared to placebo in the acute treatment of migraine. Sixty four patients with the diagnosis of migraine, according to the IHS criteria, were studied prospectively. Patients received LC or placebo once the headache reached moderate or severe intensity for 6 consecutive attacks. With regard to the moderate attacks, LC was superior than placebo after 1, 2 and 4 hours. The consumption of other rescue medications after 4 hours was significantly higher in the placebo group. With regard to the severe attacks, there was no difference between the active drug group and the placebo group concerning headache intensity and consumption of other rescue medications. We conclude that the NSAID lysine clonixinate is effective in treating moderately severe migraine attacks. It is not superior than placebo in treating severe migraine attacks.

scholarly journals Antiangiogenic Herbal Composition Ob-X Reduces Abdominal Visceral Fat in Humans: A Randomized, Double-Blind, Placebo-Controlled Study

2018 ◽  
Vol 2018 ◽  
pp. 1-11
Author(s):  
Jae-Heon Kang ◽  
In Sun Jeong ◽  
Min-Young Kim
Keyword(s):  
Adipose Tissue ◽  
Placebo Group ◽  
Visceral Fat ◽  
Human Study ◽  
Angiogenesis Inhibitor ◽  
Tissue Growth ◽  
Controlled Study ◽  
Double Blind ◽  
Tissue Mass ◽  
Double Blind Placebo

Adipose tissue growth is angiogenesis-dependent, and angiogenesis inhibitors can regulate adipose tissue mass by cutting off the blood supply. We examined whether antiangiogenic herbal composition Ob-X can reduce fast-growing abdominal fat, especially visceral fat in humans by inhibiting angiogenesis. Eighty abdominally obese subjects (body mass index: 25-29.9 kg/m2, waist circumference: exceeding 90 cm for males and 85 cm for females) participated in a 12-week randomized, double-blind, placebo-controlled human study to evaluate the efficacy and safety of Ob-X. 690 mg of Ob-X was administered orally twice a day. The Ob-X group showed a noticeable reduction in visceral fat of 20.5% after the 12-week treatment as compared to baseline measured by computed tomography. The change in visceral fat in the Ob-X group was statistically significant as compared to the placebo group (p = 0.0495) and 1.9 times higher than in the placebo group. Therefore, angiogenesis inhibitor Ob-X has the potential to improve obesity-related metabolic syndrome by reducing dangerous visceral fat.

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