Effect and Tolerability of a Nutritional Supplement Based on a Synergistic Combination of β-Glucans and Selenium- and Zinc-Enriched Saccharomyces cerevisiae (ABB C1®) in Volunteers Receiving the Influenza or the COVID-19 Vaccine: A Randomized, Double-Blind, Placebo-Controlled Study

A single-center, randomized, double-blind, placebo-controlled study was conducted in 72 volunteers who received a synergistic combination of yeast-based ingredients with a unique β-1,3/1,6-glucan complex and a consortium of heat-treated probiotic Saccharomyces cerevisiae rich in selenium and zinc (ABB C1®) or placebo on the next day after getting vaccinated against influenza (Chiromas®) (n = 34) or the COVID-19 (Comirnaty®) (n = 38). The duration of treatment was 30 and 35 days for the influenza and COVID-19 vaccine groups, respectively. Mean levels of CD4+T cells increased from 910.7 at baseline to 1000.2 cells/µL after the second dose of the COVID-19 vaccine in the ABB C1® group, whereas there was a decrease from 1055.1 to 929.8 cells/µL in the placebo group. Changes of CD3+T and CD8+T lymphocytes showed a similar trend. In the COVID-19 cohort, the increases in both IgG and IgM were higher in the ABB C1® supplement than in the placebo group. Serum levels of selenium and zinc showed a higher increase in subjects treated with the active product than in those receiving placebo. No serious adverse events related to ABB C1® or tolerance issues were reported. The study findings validate the capacity of the ABB C1® product to stimulate trained immunity.

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Supplementation with a Highly Concentrated Docosahexaenoic Acid (DHA) in Non-Proliferative Diabetic Retinopathy: A 2-Year Randomized Double-Blind Placebo-Controlled Study

Antioxidants ◽

10.3390/antiox11010116 ◽

2022 ◽

Vol 11 (1) ◽

pp. 116

Author(s):

Purificación Piñas García ◽

Francisco Javier Hernández Martínez ◽

Núria Aznárez López ◽

Luis Castillón Torre ◽

Mª Eugenia Tena Sempere

Keyword(s):

Diabetic Retinopathy ◽

Placebo Group ◽

Docosahexaenoic Acid ◽

Proliferative Diabetic Retinopathy ◽

Serum Levels ◽

Nutritional Supplement ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Patients With Diabetes

We assessed the effect of a 2-year supplementation with a highly concentrated docosahexaenoic acid (DHA) product with antioxidant activity on non-proliferative diabetic retinopathy (NPDR) in a randomized double-blind placebo-controlled study. A total of 170 patients with diabetes were randomly assigned to the DHA group (n = 83) or the placebo group (n = 87). NPDR was diagnosed using non-contact slit lamp biomicroscopy examination, and classified into mild, moderate, and severe stages. Patients in the DHA group received a high rich DHA triglyceride (1050 mg/day) nutritional supplement, and those in the placebo group received olive oil capsules. The percentages of mild NPDR increased from 61.7% at baseline to 75.7% at the end of the study in the DHA group, and from 61.9% to 73.1% in the placebo group. Moderate NPDR stages decreased from 35.1% at baseline to 18.7% at the end of the study in the DHA group, and from 36.8% to 26.0% in the placebo group. In the DHA group, there were five eyes with severe NPDR at baseline, which increased to one more at the end of the study. In the placebo group, of two eyes with severe NPDR at baseline, one eye remained at the end of the study. Changes in visual acuity were not found. There were improvements in the serum levels of HbA1c in both groups, but significant differences between the DHA and the placebo groups were not found. In this study, the use of a DHA triglyceride nutraceutical supplement for 2 years did not appear to influence the slowing of the progression of NPDR.

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Abstract 4420: Results of A Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of PS433540 in Human Subjects with Hypertension

Circulation ◽

10.1161/circ.118.suppl_18.s_886 ◽

2008 ◽

Vol 118 (suppl_18) ◽

Author(s):

Joel M Neutel ◽

Wilford F Germino ◽

Henry Punzi ◽

Mark McBride ◽

Catherine C Bryson ◽

...

Keyword(s):

Placebo Group ◽

Adverse Events ◽

Human Subjects ◽

Antihypertensive Agents ◽

Epidemiologic Studies ◽

Controlled Study ◽

Serious Adverse Events ◽

Double Blind ◽

Double Blind Placebo ◽

Link Type

Epidemiologic studies continue to demonstrate extremely disappointing blood pressure (BP) control rates. For this reason, the search for more effective antihypertensive agents continues. PS433540 is the first compound in a novel class of agents called Dual Acting Receptor Antagonists (DARA) which selectively block angiotensin (AT 1 ) and endothelin (ET A ) receptors. In this prospective, randomized, double blind, placebo controlled study, 234 men and women with a mean age of 56.0 years entered a 3– 4 week single blind placebo run-in period. Qualifying stage I or stage II hypertensive patients were randomized in a 1:1:1 ratio to either PS433540 200mg, 500mg or matching placebo for a period of 4 weeks. Ambulatory BP monitoring (ABPM) was performed at the start of the study and was repeated at the end of the treatment period. PS433540 lowered both 24HR Systolic BP (SBP) and Diastolic DBP (DBP) as well as mean office SBP and DBP to a greater extent than placebo, p<0.001. (see Table ) PS433540 was well tolerated with 2 reported serious adverse events in the placebo group and placebo lead-in period. Three patients (all from the placebo group) were discontinued from the study for adverse events. There were no significant laboratory abnormalities. This study demonstrates that PS433540 is an effective and well tolerated new class of antihypertensive agent that may prove to be a very important addition to our armamentarium for the management of hypertension.

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

10.21203/rs.2.23503/v2 ◽

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 ).

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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 ◽

10.3390/nu12123794 ◽

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.

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

Arquivos de Neuro-Psiquiatria ◽

10.1590/s0004-282x2001000100010 ◽

2001 ◽

Vol 59 (1) ◽

pp. 46-49 ◽

Cited By ~ 8

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.

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

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2018/4381205 ◽

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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Efficacy of Phenazone in the Treatment of Acute Migraine Attacks: A Double-Blind, Placebo-Controlled, Randomized Study

Cephalalgia ◽

10.1111/j.1468-2982.2004.00764.x ◽

2004 ◽

Vol 24 (10) ◽

pp. 888-893 ◽

Cited By ~ 15

Author(s):

H Göbel ◽

A Heinze ◽

U Niederberger ◽

T Witt ◽

V Zumbroich

Keyword(s):

Adverse Events ◽

Randomized Study ◽

Controlled Study ◽

Acute Migraine ◽

Serious Adverse Events ◽

Double Blind ◽

Double Blind Placebo ◽

Number Of Patients ◽

Significant Difference ◽

Main Target

In this study we compared the efficacy of 1000 mg phenazone with that of placebo in the treatment of acute migraine attacks in a randomized double-blind, placebo-controlled study of 208 patients. The main target criterion was the number of patients with a pain reduction from severe or moderate to slight or no pain 2 h after taking the pain medication. The percentage of patients satisfying the main target criterion was 48.6% for phenazone and 27.2% ( P < 0.05) for placebo. Freedom from pain after 2 h was reported by 27.6% with phenazone treatment and 13.6% ( P < 0.05) with placebo. Compared with placebo, the phenazone treatment also resulted in a significant improvement in the associated migraine symptoms of nausea, phonophobia and photophobia. Of patients treated with phenazone 11.4%, and 5.8% of those treated with placebo reported adverse events. There was no significant difference between the groups with regard to numbers of patients with adverse events. No serious adverse events occurred. The results show that phenazone at a dosage of 1000 mg is effective and well tolerated in the treatment of acute migraine attacks.

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ω-3 fatty acid differentially modulated serum levels of IGF1 and IGFBP3 in men with CVD: A randomized, double-blind placebo-controlled study

Nutrition ◽

10.1016/j.nut.2014.09.010 ◽

2015 ◽

Vol 31 (3) ◽

pp. 480-484 ◽

Cited By ~ 7

Author(s):

Sanaz Gholamhosseini ◽

Ebrahim Nematipour ◽

Abolghassem Djazayery ◽

Mohammad Hassan Javanbakht ◽

Fariba Koohdani ◽

...

Keyword(s):

Fatty Acid ◽

Serum Levels ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo

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Efficacy of Low-Dose Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

Journal of Clinical Medicine ◽

10.3390/jcm9010069 ◽

2019 ◽

Vol 9 (1) ◽

pp. 69

Author(s):

Youlim Kim ◽

Hyung-Sook Kim ◽

Jong Sun Park ◽

Young-Jae Cho ◽

Ho Il Yoon ◽

...

Keyword(s):

Placebo Group ◽

Critically Ill ◽

Critically Ill Patients ◽

Low Dose ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Icu Discharge ◽

Tertiary Teaching ◽

Delirium Prevention

Purpose: To evaluate the efficacy of short-term low-dose quetiapine for delirium prevention in critically ill patients. Methods: In this prospective, a single-center, randomized, double-blind, placebo-controlled trial, adult patients who were admitted from July 2015 to July 2017 to a medical intensive care unit (ICU) of a tertiary teaching hospital affiliated to Seoul National University were included. Quetiapine (12.5 mg or 25 mg oral at night; N = 16) or placebo (N = 21) was administered according to randomization until ICU discharge or the 10th ICU day. The primary endpoint was the incidence of delirium within the first 10 ICU days. Secondary endpoints included the rate of positive Confusion Assessment Method for the ICU (CAM-ICU) (the number of positive CAM-ICU counts/the number of total CAM-ICU counts), delirium duration, successful extubation, and overall mortality. Result: The incidence of delirium during the 10 days after ICU admission was 46.7% (7/15) in the quetiapine group and 55.0% (11/20) in the placebo group (p = 0.442). In the quetiapine group, the rate of positive CAM-ICU was significantly lower than in the placebo group (14.4% vs. 37.4%, p = 0.048), delirium duration during the study period was significantly shorter (0.28 day vs. 1.83 days, p = 0.018), and more patients in the quetiapine than in the placebo group were weaned from mechanical ventilation successfully (84.6% vs. 47.1%, p = 0.040). Conclusions: Our study suggests that prophylactic use of low-dose quetiapine could be helpful for preventing delirium in critically ill patients. A further large-scale prospective study is needed.

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Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin alfa Every 3 Weeks for the Treatment of Chemotherapy-Induced Anemia.

Blood ◽

10.1182/blood.v106.11.3556.3556 ◽

2005 ◽

Vol 106 (11) ◽

pp. 3556-3556 ◽

Cited By ~ 10

Author(s):

Kerry Taylor ◽

Peter Ganly ◽

Veena Charu ◽

Joseph DiBenedetto ◽

Karolyn Kracht ◽

...

Keyword(s):

Placebo Group ◽

Primary Endpoint ◽

Darbepoetin Alfa ◽

Dose Adjustment ◽

Nonsmall Cell Lung Cancer ◽

Target Range ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Hb Concentration

Abstract Background: Darbepoetin alfa (Aranesp®; DA) has been shown to be safe and effective for treating chemotherapy-induced anemia (CIA). The ability to administer darbepoetin alfa every 3 weeks (Q3W) (coincident with chemotherapy) would simplify the treatment of CIA. We report results from the first multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial evaluating efficacy and safety of fixed Q3W administration of an erythropoietic agent. Methods: This study enrolled subjects ≥18 years, diagnosed with anemia (hemoglobin [Hb]<11g/dL) and a nonmyeloid malignancy with ≥12 weeks of planned chemotherapy. Patients (N=391) were randomized 1:1 to receive DA 300 μg or placebo Q3W for 15 weeks. Dose adjustment rules included: increase (to 500 μg Q3W) if Hb concentration was <9 g/dL at week 4 or <10 g/dL (and had <1-g/dL increase) at week 7, or decrease (dependent on previous dose) if Hb concentration was ≥13 g/dL or had ≥1-g/dL increase in any 2-week period. Efficacy was assessed by incidence of red blood cell (RBC) transfusions and achievement of target Hb of ≥11 g/dL (not exceeding 13 g/dL), consistent with ASH/ASCO, NCCN, EORTC evidence-based practice guidelines. Results: A total of 386 randomized patients were included in the analysis. Demographic characteristics were similar between the 2 groups. Mean (SD) Hb levels at baseline were 10.03 (0.86) and 10.05 (0.92) g/dL in the placebo and DA groups, respectively. The most common tumor types were breast (23%), colon (11%), nonsmall-cell-lung cancer (10%), and hematologic malignancies (11%; 8% Non-Hodgkin’s Lymphoma). The incidence of RBC transfusions from week 5 to the end of treatment phase (EOTP) (the primary endpoint) was significantly lower for the DA group than for the placebo group (P<0.001) (see Table). Hb levels rose steadily in the DA group through approximately week 9, increasing by a mean (SD) of 1.08 (1.28) g/dL from baseline, and then remained relatively stable (see Figure). The proportion of patients achieving Hb target range from week 5 to EOTP was significantly higher for the DA group than for the placebo group (P<0.001). Dose adjustment rules helped to maintain Hb levels within target range. The safety profile of DA was consistent with that observed in previous studies. Rapid increases in Hb concentration or increases to ≥13 g/dL were not associated with adverse events. Conclusions: Fixed Q3W administration of DA is well tolerated and effective for the treatment of CIA. Summary of Results Placebo Darbepoetin alfa KM = Kaplan-Meier estimate Week 5 to EOTP N=185 N=181 Transfusions, KM (95% CL) (primary endpoint) 41% (34, 49) 24% (18, 30) Achievement of target Hb, KM (95% CL) 48% (41, 56) 82% (76, 88) Week 1 to EOTP N=193 N=193 Transfusions, KM (95% CL) 47% (40, 54) 30% (23, 36) Median time to target Hb, weeks (95% CL) 12 (9, 16) 6 (3, 7) Figure Figure

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