scholarly journals A Combination of Lactoplantibacillus plantarum Strains CECT7527, CECT7528 and CECT7529 Plus Monacolin K Reduces Blood Cholesterol: Results from a Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1206
Author(s):  
Rafael Guerrero-Bonmatty ◽  
Guadalupe Gil-Fernández ◽  
Francisco José Rodríguez-Velasco ◽  
Jordi Espadaler-Mazo
Keyword(s):  
Intervention Group ◽  
Study Groups ◽  
Statin Treatment ◽  
Blood Cholesterol ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Red Yeast Rice ◽  
Monacolin K ◽  
Double Blind ◽  
History Of

Background: Dietary supplements have been proposed to help manage blood cholesterol, including red yeast rice (RYR) extracts, plant sterols and stanols, beta-glucans, and some probiotics. This study was conducted to evaluate the efficacy of RYR (containing 10 mg of monacolin K) combined with 109 CFU of three Lactoplantibacillus plantarum strains (CECT7527, CECT7528, and CECT7529). Methods: A 12-week randomized, double-blinded, placebo-controlled clinical trial was conducted. In total, 39 adult patients were enrolled, having total cholesterol (TC) ≥200 mg/dL, and being statin-naïve or having recently stopped statin treatment because of intolerance. Active product or placebo were taken once daily, and subjects were evaluated at baseline, 6, and 12 weeks. Results: Study groups were comparable at baseline, except for history of recent hypercholesterolemia treatment (81% in active vs. 22% in placebo). Changes in LDL cholesterol and TC became significant compared to placebo (mean difference between groups and standard error of the mean = 23.6 ± 1.5 mg/dL, p = 0.023 and 31.4 ± 1.9 mg/dL, p = 0.011, respectively) upon adjusting for the baseline imbalance in hypercholesterolemia treatment. No adverse effects were noted during the study. Conclusion: This combination of 10 mg of monacolin K and L. plantarum strains was well tolerated and achieved a statistically significant greater reduction in LDL-C and TC in the intervention group compared to the placebo, once adjusting for recent history of hypercholesterolemia treatment.

scholarly journals A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUO®) on LDL Cholesterol Levels and Lipid Pattern in Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study)

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3127
Author(s):  
Arrigo F.G. Cicero ◽  
Sergio D’Addato ◽  
Claudio Borghi
Keyword(s):  
Ldl Cholesterol ◽  
Hdl Cholesterol ◽  
Blood Cholesterol ◽  
Controlled Clinical Trial ◽  
Red Yeast Rice ◽  
Double Blind ◽  
Cholesterol Levels ◽  
Red Yeast ◽  
Significant Difference ◽  
Double Blinded

Phytosterols and red yeast rice are largely studied cholesterol-lowering nutraceuticals, respectively inhibiting the bowel absorption and liver synthesis of cholesterol. Our aim was to test the effect of combined nutraceutical-containing phytosterols and red yeast rice vs. a placebo on the lipid profile. We performed a parallel arms, double-blind, placebo-controlled clinical trial, randomizing 88 moderately hypercholesterolemic subjects to treatment with a combined nutraceutical containing phytosterols (800 mg) and red yeast rice, standardized to contain 5 mg of monacolins from Monascus purpureus, with added niacin (27 mg) and policosanols (10 mg) (LEVELIP DUO®), or placebo. The mean LDL-Cholesterol (LDL-C) change at Week 8 was −32.5 ± 30.2 mg/dL (−19.8%) in the combined nutraceutical group and 2.5 ± 19.4 mg/dL (2.3%) in the placebo group. The estimated between-group difference of −39.2 mg/dL (95% CI: −48.6; −29.8) indicates a statistically significant difference between treatments in favor of the combined nutraceutical (p < 0.0001). Total Cholesterol (TC), non-HDL cholesterol (non-HDL-C), Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only. No significant changes in other clinical and laboratory parameters were observed. In conclusion, the tested combined nutraceutical was well tolerated, while significantly reducing the plasma levels of LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C and LDL-C/HDL-C ratios in mildly hypercholesterolemic patients. Trial registration (ClinicalTrials.gov): NCT03739242.

Could Anise decrease the intensity of premenstrual syndrome symptoms in comparison to placebo? A double-blind randomized clinical trial

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Maryam Farahmand ◽  
Davood Khalili ◽  
Fahimeh Ramezani Tehrani ◽  
Gholamreza Amin ◽  
Reza Negarandeh
Keyword(s):  
College Students ◽  
Clinical Trial ◽  
Premenstrual Syndrome ◽  
Intervention Group ◽  
Study Groups ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Double Blind ◽  
High Prevalence

AbstractBackgroundPremenstrual syndrome (PMS) has a high prevalence among women of reproductive ages but despite its high prevalence, it has no determined and absolute treatment, so far. So, the aim of the present study was to compare the effect Pimpinella Anisum (Anise) with placebo on the intensity of the symptoms of PMS.MethodsThe present study was a randomized double-blind controlled clinical trial. College students who were suffering from PMS and had the inclusion criteria were selected and randomly assigned into two groups of intervention (Anise) and control (placebo). Participants in the intervention group, received 110 mg capsules of Anise three times day (a total dose of 330 mg per day); the control group received similar capsules with the same dosing that contained starch. Consumption of the capsules was started 7 days before the start of the menstruation and continued until 3 days after, which was a total of 10 days during two consecutive menstruation cycles. The intensity of the symptoms of premenstrual syndrome was measured using Premenstrual Symptoms Screening Tool (PSST). To compare the intensity of the symptoms between the two study groups, generalized estimating equation statistical method was used.ResultsEventually, sixty-seven 18–35 year old college students who were suffering from premenstrual syndrome were enrolled in the study. Comparing the mean score of the intensity of the syndrome between the two groups after the first and the second menstruation cycles showed a decrease in the intervention group to 13.9 (p-value<0.001; 95% CI: 16.5,−11.4) and 9.8 (p-value<0.001; 95% CI: 12.4,−7.3), respectively.ConclusionResults of the study showed that, in general, Anise was effective in decreasing the symptoms of premenstrual syndrome in comparison to placebo.

scholarly journals Interactions of Oxysterols with Atherosclerosis Biomarkers in Subjects with Moderate Hypercholesterolemia and Effects of a Nutraceutical Combination (Bifidobacterium longum BB536, Red Yeast Rice Extract) (Randomized, Double-Blind, Placebo-Controlled Study)

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 427
Author(s):  
Stefania Cicolari ◽  
Chiara Pavanello ◽  
Elena Olmastroni ◽  
Marina Del Puppo ◽  
Marco Bertolotti ◽  
...  
Keyword(s):  
Bifidobacterium Longum ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Mass Spectrometry Analysis ◽  
Abdominal Circumference ◽  
Controlled Study ◽  
Red Yeast Rice ◽  
Double Blind ◽  
Red Yeast ◽  
The Impact

Background: Oxysterol relationship with cardiovascular (CV) risk factors is poorly explored, especially in moderately hypercholesterolaemic subjects. Moreover, the impact of nutraceuticals controlling hypercholesterolaemia on plasma levels of 24-, 25- and 27-hydroxycholesterol (24-OHC, 25-OHC, 27-OHC) is unknown. Methods: Subjects (n = 33; 18–70 years) with moderate hypercholesterolaemia (low-density lipoprotein cholesterol (LDL-C:): 130–200 mg/dL), in primary CV prevention as well as low CV risk were studied cross-sectionally. Moreover, they were evaluated after treatment with a nutraceutical combination (Bifidobacterium longum BB536, red yeast rice extract (10 mg/dose monacolin K)), following a double-blind, randomized, placebo-controlled design. We evaluated 24-OHC, 25-OHC and 27-OHC levels by gas chromatography/mass spectrometry analysis. Results: 24-OHC and 25-OHC were significantly correlated, 24-OHC was correlated with apoB. 27-OHC and 27-OHC/total cholesterol (TC) were higher in men (median 209 ng/mL and 77 ng/mg, respectively) vs. women (median 168 ng/mL and 56 ng/mg, respectively); 27-OHC/TC was significantly correlated with abdominal circumference, visceral fat and, negatively, with high-density lipoprotein cholesterol (HDL-C). Triglycerides were significantly correlated with 24-OHC, 25-OHC and 27-OHC and with 24-OHC/TC and 25-OHC/TC. After intervention, 27-OHC levels were significantly reduced by 10.4% in the nutraceutical group Levels of 24-OHC, 24-OHC/TC, 25-OHC, 25-OHC/TC and 27-OHC/TC were unchanged. Conclusions: In this study, conducted in moderate hypercholesterolemic subjects, we observed novel relationships between 24-OHC, 25-OHC and 27-OHC and CV risk biomarkers. In addition, no adverse changes of OHC levels upon nutraceutical treatment were found.

Bilateral mandibular block improves pain relief and morphine consumption in mandibular osteotomies: a prospective, randomized, double-blind, placebo-controlled clinical trial

2021 ◽  
Vol 46 (4) ◽  
pp. 322-327
Author(s):  
Marina Bertuit ◽  
Francesca Rapido ◽  
Habib Ly ◽  
Charlotte Vannucci ◽  
Jérôme Ridolfo ◽  
...  
Keyword(s):  
Postoperative Analgesia ◽  
Severe Pain ◽  
Postoperative Nausea And Vomiting ◽  
Sensory Innervation ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Block Group ◽  
Double Blind ◽  
Double Blind Placebo

BackgroundThe sensory innervation of the lower jaw mainly depends on the third root of the trigeminal nerve, the mandibular nerve (V3). The aim of this single-center, prospective, randomized, double-blind, placebo-controlled study was to evaluate the effectiveness of bilateral V3 block for postoperative analgesia management in mandibular osteotomies.Methods107 patients undergoing mandibular surgery (75 scheduled osteotomies and 32 mandible fractures) were randomized in two groups. A bilateral V3 block was performed in each group, either with ropivacaine 0.75% (block group, n=50) or with a placebo (placebo group, n=57). A postoperative multimodal analgesia was equally provided to both groups. The primary outcome was the cumulative morphine consumption at 24 hours. Secondary outcomes were the occurrence of severe pain and the incidence of postoperative nausea and vomiting (PONV) in the first 24 hours. Data were analyzed on an intention-to-treat basis.ResultsThe cumulative morphine consumption at 24 hours was significantly lower in the block group (median 8.0 mg (IQR 2.0–21.3) vs 12.0 mg (IQR 8.0–22.0), p=0.03), as well as the incidence of severe pain during the 24 hours of follow-up (4.0% vs 22.8%, p<0.01). The mandibular block had no impact on the incidence of PONV.ConclusionBilateral V3 block for mandibular osteotomies is an effective opioid-sparing procedure. It provided better postoperative analgesia in the first 24 hours, and it did not affect PONV incidence.Trial registration numberNCT02618993.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Effect of a food supplement containing berberine, monacolin K, hydroxytyrosol and coenzyme Q10 on lipid levels: a randomized, double-blind, placebo controlled study

2017 ◽  
Vol Volume 11 ◽  
pp. 1585-1592 ◽  
Author(s):  
Sergio D'Addato ◽  
Luciana Scandiani ◽  
Giuliana Mombelli ◽  
Francesca Focanti ◽  
Federica Pelacchi ◽  
...  
Keyword(s):  
Coenzyme Q ◽  
Food Supplement ◽  
Controlled Study ◽  
Monacolin K ◽  
Lipid Levels ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Evaluating the Effect of Intraoperative Dextrose 10% Administration on Reducing Postoperative Nausea and Vomiting after Laparoscopic Surgery

2019 ◽  
Vol 13 (1) ◽  
pp. 78-85
Author(s):  
Ashraf Nabil Saleh ◽  
Dalia Fahmy Emam ◽  
Mohamed Mohamed Kamal
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Study Groups ◽  
Primary Objective ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Double Blind ◽  
Female Patients ◽  
Medication Consumption

Background: Although PONV is usually self-limiting or is treated without sequelae, the incidence of PONV could be as high as 70% to 80% in high-risk populations such as female sex, obese patients, age younger than 40 years, nonsmoker patients, history of PONV or motion sickness. Objectives: The study aimed to investigate whether dextrose 10% decreases the incidence of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy Materials and Methods: This prospective, double-blind randomized placebo-controlled study comprised 130 ASA physical status I and II nonsmoker female patients, 20-40 years of age, scheduled for laparoscopic cholecystectomy at Ain Sham University – Assembled operating theater from August 2018 to October 2018. Patients were arbitrarily divided into two study groups of 65 patients each. Group LR received lactated Ringer’s solution and group D received 10% dextrose. The primary objective of this study was to compare the incidence of PONV in the study treatment groups. The secondary outcomes included measurement of antiemetic medication consumption as well as blood glucose changes between groups. Results: 50 from a total of 65 participants (76.9%) in Lactated Ringer (LR) group experienced nausea. On the other hand, 30 participants only (46.2%) in dextrose (D) group were nauseated. This dissimilarity was statistically highly significant (P= 0.0003). Conclusion: In this study, dextrose 10% administration resulted in improved postoperative emesis management as explained by the lower incidence of nausea and rescue antiemetic consumption.

scholarly journals Efficacy and safety of galcanezumab for prevention of migraine headache in Japanese patients with episodic migraine: A phase 2 randomized controlled clinical trial

2020 ◽  
Vol 3 ◽  
pp. 251581632093257 ◽  
Author(s):  
Fumihiko Sakai ◽  
Akichika Ozeki ◽  
Vladimir Skljarevski
Keyword(s):  
Migraine Headache ◽  
Japanese Patients ◽  
Episodic Migraine ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Secondary Endpoints

Objective: This study was designed to assess the efficacy and safety of galcanezumab in comparison with placebo for the prevention of migraine in Japanese patients with episodic migraine. Methods: In this double-blind, placebo-controlled study, which was conducted over 6 months, randomized adult patients received subcutaneous injections of galcanezumab (120 mg n = 115, 240 mg n = 114) or placebo ( n = 230) once monthly. The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days. The key secondary outcome measures were response rates (≥50%, ≥75%, and 100%); the Migraine-Specific Quality-of-Life Questionnaire Role Function-Restrictive score; monthly migraine headache days requiring acute treatment; and Patient Global Impression of Severity (PGI-S). Results: The mean change from baseline in monthly migraine headache days over months 1–6 was significantly ( p < 0.001) greater for the 120-mg galcanezumab dose (−3.60 days) and the 240-mg galcanezumab dose (−3.36 days) compared with placebo (−0.59 days). Both the 120-mg and 240-mg doses of galcanezumab were superior compared with placebo for each of the key secondary endpoints except for PGI-S (only the 240-mg dose was superior). The most commonly reported treatment-emergent adverse events were local injection-site reactions; erythema, swelling, pruritus, and pain were more commonly reported by patients who were treated with galcanezumab than those treated with placebo. Conclusion: The number of monthly migraine headache days was reduced with both doses of galcanezumab, and both doses were safe and well tolerated in Japanese patients with episodic migraine.

Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial.

1998 ◽  
Vol 16 (4) ◽  
pp. 1574-1581 ◽  
Author(s):  
A N Serafini ◽  
S J Houston ◽  
I Resche ◽  
D P Quick ◽  
F M Grund ◽  
...  
Keyword(s):  
Pain Relief ◽  
Bone Metastases ◽  
Active Drug ◽  
Opioid Analgesic ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Complete Relief ◽  
Double Blind ◽  
Double Blind Placebo ◽  
To Receive

PURPOSE To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study. PATIENTS AND METHODS Patients with painful bone metastases secondary to a variety of primary malignancies were randomized to receive 153Sm-EDTMP 0.5 or 1.0 mCi/kg, or placebo. Treatment was unblinded for patients who did not respond by week 4, with those who had received placebo eligible to receive 1.0 mCi/kg of active drug in an open-label manner. Patient and physician evaluations were used to assess pain relief, as was concurrent change in opioid analgesia. RESULTS One hundred eighteen patients were enrolled onto the study. Patients who received 1.0 mCi/kg of active drug had significant reductions in pain during each of the first 4 weeks in both patient-rated and physician-rated evaluations. Pain relief was observed in 62% to 72% of those who received the 1.O-mCi/kg dose during the first 4 weeks, with marked or complete relief noted in 31% by week 4. Persistence of pain relief was seen through week 16 in 43% of patients who received 1.0 mCi/kg, of active drug. A significant correlation (P = .01) was observed between reductions in opioid analgesic use and pain scores only for those patients who received 1.0 mCi/kg 153Sm-EDTMP. Bone marrow suppression was mild, reversible, and not associated with grade 4 toxicity. CONCLUSION A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration and persisted until at least week 16 in the majority of patients who responded.

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