scholarly journals Colchicine in Patients With Acute Coronary Syndrome

Circulation ◽  
2020 ◽  
Vol 142 (20) ◽  
pp. 1890-1900 ◽  
Author(s):  
David C. Tong ◽  
Stephen Quinn ◽  
Arthur Nasis ◽  
Chin Hiew ◽  
Philip Roberts-Thomson ◽  
...  
Keyword(s):  
Placebo Group ◽  
Medical Therapy ◽  
Care Service ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Clinical Manifestations ◽  
Gastrointestinal Symptoms ◽  
Double Blind ◽  
Coronary Syndrome ◽  
Standard Medical Therapy

Background: Inflammation plays a crucial role in clinical manifestations and complications of acute coronary syndromes (ACS). Colchicine, a commonly used treatment for gout, has recently emerged as a novel therapeutic option in cardiovascular medicine owing to its anti-inflammatory properties. We sought to determine the potential usefulness of colchicine treatment in patients with ACS. Methods: This was a multicenter, randomized, double-blind, placebo-controlled trial involving 17 hospitals in Australia that provide acute cardiac care service. Eligible participants were adults (18–85 years) who presented with ACS and had evidence of coronary artery disease on coronary angiography managed with either percutaneous coronary intervention or medical therapy. Patients were assigned to receive either colchicine (0.5 mg twice daily for the first month, then 0.5 mg daily for 11 months) or placebo, in addition to standard secondary prevention pharmacotherapy, and were followed up for a minimum of 12 months. The primary outcome was a composite of all-cause mortality, ACS, ischemia-driven (unplanned) urgent revascularization, and noncardioembolic ischemic stroke in a time to event analysis. Results: A total of 795 patients were recruited between December 2015 and September 2018 (mean age, 59.8±10.3 years; 21% female), with 396 assigned to the colchicine group and 399 to the placebo group. Over the 12-month follow-up, there were 24 events in the colchicine group compared with 38 events in the placebo group ( P =0.09, log-rank). There was a higher rate of total death (8 versus 1; P =0.017, log-rank) and, in particular, noncardiovascular death in the colchicine group (5 versus 0; P =0.024, log-rank). The rates of reported adverse effects were not different (colchicine 23.0% versus placebo 24.3%), and they were predominantly gastrointestinal symptoms (colchicine, 23.0% versus placebo, 20.8%). Conclusions: The addition of colchicine to standard medical therapy did not significantly affect cardiovascular outcomes at 12 months in patients with ACS and was associated with a higher rate of mortality. Registration: URL: https://www.anzctr.org.au ; Unique identifier: ACTRN12615000861550.

scholarly journals Effects of colchicine on major adverse cardiac events in next 6-month period after acute coronary syndrome occurrence; a randomized placebo-control trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mehdi Akrami ◽  
Peyman Izadpanah ◽  
Mehdi Bazrafshan ◽  
Unes Hatamipour ◽  
Navid Nouraein ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Placebo Group ◽  
Survival Rate ◽  
Medical Therapy ◽  
Major Adverse Cardiac Events ◽  
Placebo Control ◽  
Cardiac Events ◽  
Coronary Syndrome ◽  
Standard Medical Therapy ◽  
Adverse Cardiac Events

Abstract Background Cardiovascular disease in particular acute coronary syndrome (ACS) is remained one of the most cause of morbidity and mortality, annually. Considering inflammatory pathway of atherosclerosis, colchicine as an anti-inflammatory drug is introduced to be effective in pathogenesis, prognosis and mortality rate of these patients. So in order to find out the effects of this drug we conducted this trial to know whether it reduces major adverse cardiac events (MACE) in ACS patients or not. Methods In a prospective randomized double-blinded placebo-controlled trial, we enrolled ACS patients (40–70 years) with recent ST-segment elevation myocardial infarction (STEMI) or NSTE-ACS diagnosed by coronary angiography and managed with either medical therapy or percutaneous coronary intervention. Patients were assigned to two groups either receiving colchicine 0.5 mg daily or placebo for 6 months. Both groups simultaneously received standard medical therapy as accessible guidelines. MACE occurrence consists of decompensated heart failure, ACS, stroke and survival rate compared between two groups. Results A total of 249 patients were recruited between October 2019-March 2020 with mean age of 56.89 ± 7.54, 69.5% males; 120 assigned to the colchicine group and 129 assigned to the placebo group. Over the 6 months’ period, 36 MACE occurred that were 8 events in the colchicine group compared with 28 events in the placebo group experiencing the event (P = 0.001). All of four deaths in the colchicine group and two in the placebo group were due to cardiovascular events. Evaluating adverse effects, gastrointestinal symptom was the most with the rate of 15 (12.5%) in the colchicine group and 3 (2.5%) in the controls. (P = 0.002). Conclusion The addition of colchicine to standard medical therapy in ACS patients significantly reduces MACE occurrence and improves survival rate over the time.

A Double-Blind Placebo-Controlled Trial of Intranasal Capsaicin for Cluster Headache

Cephalalgia ◽  
1993 ◽  
Vol 13 (2) ◽  
pp. 114-116 ◽  
Author(s):  
David R Marks ◽  
Alan Rapoport ◽  
Dennis Padla ◽  
Randall Weeks ◽  
Robert Rosum ◽  
...  
Keyword(s):  
Placebo Group ◽  
Cluster Headache ◽  
Sensory Neurons ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Nerve Terminals ◽  
Double Blind ◽  
Headache Severity ◽  
Topical Capsaicin ◽  
To Receive

It has been suggested that treatment of cluster headache (CH) patients with topical capsaicin may desensitize sensory neurons by depleting the nerve terminals of substance P. We attempted to determine whether capsaicin is effective in aborting CH attacks. Patients in acute cluster were randomized to receive either capsaicin or placebo in the ipsilateral nostril for 7 days. Patients recorded the severity of each headache for 15 days. Headaches on days 8–15 of the study were significantly less severe in the capsaicin group vs the placebo group. There was also a significant decrease in headache severity in the capsaicin group on days 8–15 compared to days 1–7, but not in the placebo group. Episodic CH patients appeared to benefit more than chronic CH patients. These results indicate that intranasal capsaicin may provide a new therapeutic option for the treatment of this disease.

scholarly journals The Effect of Protein Supplementation versus Carbohydrate Supplementation on Muscle Damage Markers and Soreness Following a 15-km Road Race: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 858
Author(s):  
Dominique S. M. ten Haaf ◽  
Martin A. Flipsen ◽  
Astrid M. H. Horstman ◽  
Hans Timmerman ◽  
Monique A. H. Steegers ◽  
...  
Keyword(s):  
Placebo Group ◽  
Protein Intake ◽  
Muscle Soreness ◽  
Controlled Trial ◽  
Protein Supplementation ◽  
Group Differences ◽  
Double Blind ◽  
Carbohydrate Supplementation ◽  
Protein Group ◽  
Road Race

We assessed whether a protein supplementation protocol could attenuate running-induced muscle soreness and other muscle damage markers compared to iso-caloric placebo supplementation. A double-blind randomized controlled trial was performed among 323 recreational runners (age 44 ± 11 years, 56% men) participating in a 15-km road race. Participants received milk protein or carbohydrate supplementation, for three consecutive days post-race. Habitual protein intake was assessed using 24 h recalls. Race characteristics were determined and muscle soreness was assessed with the Brief Pain Inventory at baseline and 1–3 days post-race. In a subgroup (n = 149) muscle soreness was measured with a strain gauge algometer and creatine kinase (CK) and lactate dehydrogenase (LDH) concentrations were measured. At baseline, no group-differences were observed for habitual protein intake (protein group: 79.9 ± 26.5 g/d versus placebo group: 82.0 ± 26.8 g/d, p = 0.49) and muscle soreness (protein: 0.45 ± 1.08 versus placebo: 0.44 ± 1.14, p = 0.96). Subjects completed the race with a running speed of 12 ± 2 km/h. With the Intention-to-Treat analysis no between-group differences were observed in reported muscle soreness. With the per-protocol analysis, however, the protein group reported higher muscle soreness 24 h post-race compared to the placebo group (2.96 ± 2.27 versus 2.46 ± 2.38, p = 0.039) and a lower pressure muscle pain threshold in the protein group compared to the placebo group (71.8 ± 30.0 N versus 83.9 ± 27.9 N, p = 0.019). No differences were found in concentrations of CK and LDH post-race between groups. Post-exercise protein supplementation is not more preferable than carbohydrate supplementation to reduce muscle soreness or other damage markers in recreational athletes with mostly a sufficient baseline protein intake running a 15-km road race.

scholarly journals Efficacy and Safety of Divaza for the Correction of Oxidative Disturbances in Patients with Cerebral Atherosclerosis: A Randomized Controlled Trial

2021 ◽  
pp. 1-11
Author(s):  
Nataliia U. Lashch ◽  
Pavel R. Kamchatnov ◽  
Tatiana N. Fedorova ◽  
Olga A. Muzychuk ◽  
Kristina K. Khacheva ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Placebo Group ◽  
Study Design ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Prospective Trial ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Cerebral Atherosclerosis ◽  
Endogenous Antioxidant

<b><i>Objective:</i></b> The objective of this study was to determine if Divaza, a drug with nootropic and antioxidant effects, was safe and effective for the correction of oxidative disturbances and to stabilize cognitive impairment in patients with cerebral atherosclerosis. <b><i>Study Design:</i></b> The study design consisted of a 12-week multicenter, randomized, double-blind, placebo-controlled, prospective trial in parallel groups. <b><i>Setting:</i></b> The setting in which the study was conducted comprised 10 clinical centers across the Russian Federation. <b><i>Interventions:</i></b> Patients were randomized into 2 groups and instructed to take either 2 tablets of the study drug or a placebo 3 times per day in conjunction with basic therapy. <b><i>Outcomes:</i></b> The primary outcome was a change in the average endogenous antioxidant potential after the completion of the study. The blood indicators of the oxidative stress (OS) were analyzed at the baseline and then after 12 weeks of therapy using iron-induced chemiluminescence analysis. The Montreal cognitive assessment test was used as a secondary outcome measure to evaluate cognitive impairment at the end of the study. <b><i>Results:</i></b> 124 outpatients with a mean age of 60.7 ± 7.6 years were enrolled and randomly assigned to receive Divaza (<i>n</i> = 65) or a placebo (<i>n</i> = 59). An improvement of cognitive function was observed in all patients of the Divaza group at the end of the treatment; this was significantly better than the placebo group (100 [100] vs. 89.5 [89.1]%, respectively, <i>p</i> = 0.0272 [<i>p</i> = 0.0128]). The administration of Divaza restored the activity of the endogenous antioxidant system. The change in the average level of lipoprotein resistance to oxidation after 12 weeks of therapy, compared to the baseline, was significantly higher in the Divaza group (14.8 ± 14.7 [14.8 ± 14.7] seconds latent period vs. 6.4 ± 16.9 [6.9 ± 16.7] seconds in the placebo group (<i>p</i> = 0.007 [<i>p</i> = 0.0107]). <b><i>Conclusions:</i></b> Divaza is a safe and effective therapeutic option for attenuating OS and recovery of cognitive impairment in patients with cerebral atherosclerosis.

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

scholarly journals Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

2021 ◽  
pp. svn-2021-000942
Author(s):  
Jingyi Liu ◽  
Ximing Nie ◽  
Hongqiu Gu ◽  
Qi Zhou ◽  
Haixin Sun ◽  
...  
Keyword(s):  
Placebo Group ◽  
Tranexamic Acid ◽  
Intracerebral Haemorrhage ◽  
Intracranial Haemorrhage ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intracerebral Haematoma ◽  
Spot Sign ◽  
Double Blind ◽  
Risk Of Death

BackgroundStudies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.MethodsWe did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days.ResultsOf the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth, death and dependency.ConclusionsAmong patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

scholarly journals Positive effect of polyprenol-containing drug on anxiety, depression and cognitive disorders in patients with acute coronary syndrome

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
EI Tsoi ◽  
EV Vyshlov ◽  
VV Ryabov
Keyword(s):  
Acute Coronary Syndrome ◽  
Cognitive Functions ◽  
Controlled Trial ◽  
Cognitive Disorders ◽  
Original Method ◽  
Study Group ◽  
Double Blind ◽  
Coronary Syndrome ◽  
Anxiety Depression ◽  
Positive Effect

Abstract Funding Acknowledgements Type of funding sources: None. Introduction. Polyprenols (natural isoprenoid lipids) are precursors of dolichols which is present in every cell and involved in a dolicholphosphate pathway. It seems the polyprenols from plants can be used for a substitution therapy in dolicholphosphate pathway disorders. There is one polyprenol-containing drug in Russia – Ropren® which contains polyprenols isolated by the original method from needles of European spruce. In clinical trials hepatoprotective, hypolipidemic effects of Ropren® in patients with liver pathology and positive effect in alcoholic psychosis and Alzheimer"s disease were founded. Considering that the myocardial infarction is often accompanied by the phenomena of anxiety, depression and decreased cognitive functions that impair prognosis of the disease the search for a drug aimed at reducing the expression of these conditions is relevant. Purpose. To study the effects of Ropren® on anxiety-depressive condition and cognitive functions in patients with acute coronary syndrome. Methods. Our registered single-center, randomized, double-blind, placebo-controlled trial "POLYNCOR" were included patients (n = 68) with acute coronary syndrome hospitalized on the first day from the beginning of the symptoms. All patients received standard therapy (including atorvastatin 40 mg) and were randomized on 2 groups: the 1st group (n = 34) received Ropren® 8 drops during а meal 3 times a day (144 mg/day) for 3 weeks then 3 drops 3 times a day (90 mg/day) for 5 weeks; the 2nd group 2 (n = 34) received placebo with the same dosage regimen. On the 3rd, 10th days of hospitalization and after 2 months of therapy the following parameters were analyzed: the level of depression on the CES-D scale, anxiety on the Taylor and Sheehan scales, cognitive functions were assessed on the Montreal Cognitive Assessment Scale (MoCA). Statistical data processing was performed using the Statistica v.10.0 package using nonparametric analysis methods. The results are presented as Me (Q1; Q3). Results. At discharge there were no differences between groups and the majority of the patients had signs of anxiety, depression and decreased cognitive functions. After 2 months of therapy comparing with the 3rd day of hospitalization the decrease of anxiety score: 2.5 (1.5; 7.5) vs. 15.5 (9,5; 20,5) respectively (p&lt; 0.05) according to Taylor scale and 5.5 (5; 14) vs. 30 (17,5; 39) respectively (p&lt; 0.05) according to Sheehan scale, and depression score: 8 (6.5; 9.5) vs. 18 (15,5; 20,5) respectively (p&lt; 0.05) according to CES-D scale were founded in the study group. Also in the study group cognitive functions score were improved from 23 (21; 25) to 26.5 (25; 28) (p&lt; 0.05) according to MoCA scale. Conclusion. Polyprenol-containing drug Ropren® contributes to significant reduction of anxiety, depression and improving of cognitive functions in patients with acute coronary syndrome after 2 months of therapy.

A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

2011 ◽  
Vol 41 (10) ◽  
pp. 2159-2166 ◽  
Author(s):  
Y. Panahi ◽  
B. Rezazadeh Moghaddam ◽  
A. Sahebkar ◽  
M. Abbasi Nazari ◽  
F. Beiraghdar ◽  
...  
Keyword(s):  
Placebo Group ◽  
Post Traumatic Stress Disorder ◽  
Traumatic Stress ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Traumatic ◽  
The Mean

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

scholarly journals A double-blind randomized controlled trial of topical Curcuma xanthorrhiza Roxb. on mild psoriasis: clinical manifestations, histopathological features, and K6 expressions

2018 ◽  
Vol 27 (3) ◽  
pp. 178-84 ◽  
Author(s):  
Githa Rahmayunita ◽  
Tjut N.A. Jacoeb ◽  
Endi Novianto ◽  
Wresti Indriatmi ◽  
Rahadi Rihatmadja ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinical Manifestations ◽  
Effective Treatment Option ◽  
Psoriasis Area Severity Index ◽  
Double Blind ◽  
Old Patients ◽  
Mean Values ◽  
Significant Difference ◽  
Curcuma Xanthorrhiza ◽  
The Difference

Background: Curcuma xanthorrhiza Roxb. exerts its anti-inflammatory effects by reducing the concentration of IL-6, IL-8, and phosphorylase kinase, which has role in keratinocyte proliferation. Our study aimed to evaluate the efficacy of C. xanthorrhiza in psoriasis.Methods: From 18 to 59 year-old patients with mild psoriasis, 2 similar lesions were selected. The severity assessment was based on the psoriasis area severity index (PASI), Trozak score, and K6 expression. Using a double-blinded randomized method, lesion was treated with 1% C. xanthorrhiza ointment vs placebo for 4 weeks. The results were analyzed by the chi-square test using STATATM V.12 software (Stata Corp.).Results: The study was conducted in 2010 to 2012 with 17 subjects participated. The median of PASI score were reduced significantly in both lesions, either treated with 1% C. xanthorrhiza ointment vs placebo; however when compared between the group, it was not significant (p=0.520). The Trozak score were reduced in lesions treated with 1% C. xanthorrhiza ointment; but it was not significant (p = 0.306). In lesions treated with placebo, the Trozak score was increased significantly. The difference of Trozak score between lesions treated with C. xanthorrhiza and placebo was significant (p=0.024). There was no significant difference of K6 expression in lesions treated with 1% C. xanthorrhiza ointments or placebo as well as on the difference of mean values of K6 expression between the group (p=0.827).Conclusion: Based on the results, 1% C. xanthorrhiza ointment is effective treatment option for mild psoriasis, but longer follow-up period is suggested to confirm this results. C. xanthorrhiza ointment is safe for topical administration as there were no side effects reported in this study.

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