Efficacy and Safety of Ergoferon in Children from 6 Months to 6 Years Old with Acute Respiratory Viral Infections in Contemporary Outpatient Practice: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial

To evaluate the efficacy and safety of Ergoferon in combination with symptomatic therapy in children from 6 months to 6 years old with acute respiratory infections (ARI) in contemporary outpatient practice, an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial was performed. Derived by technological treatment of antibodies to interferon gamma, histamine, and CD4, Ergoferon was previously proved to modulate its molecular targets promoting effective antiviral protection. The data of 282 patients with oral temperature ≥38.0°C plus mild to moderate severity of flu-like nonspecific and nasal/throat/chest symptoms were included in intention-to-treat analysis (n = 140, Ergoferon group; n = 142, placebo group). Time to alleviation of all ARI symptoms was the primary endpoint, and 8 outcome measures were estimated as the secondary endpoints. Respiratory viruses were confirmed in 57.1% (Ergoferon) and 54.9% (Placebo) of patients. Compared to placebo, Ergoferon reduced time to alleviation of all ARI symptoms (4.5 ± 1.7 versus 5.2 ± 2.2 days in placebo; p = 0.026 ) including fever (2.8 ± 1.5 vs 3.4 ± 2.0; p = 0.031 ), flu-like nonspecific (4.0 ± 1.8 vs 4.7 ± 2.2, p = 0.022 ), and nasal/throat/chest (4.3 ± 2.0 versus 5.0 ± 2.3; p = 0.024 ) symptoms. Ergoferon add-on therapy decreased the mean total symptom severity score (according to 4-point scale for each symptom), ARI severity, frequency of antipyretic use, and percentage of complication requiring antibiotics and increased the percentage of recovered patients. The incidence of adverse events (AEs) in the Ergoferon group was significantly lower compared to the placebo group (7.0% versus 18.8%; p = 0.004 ) including infectious diseases (3.5% vs 12.5%; p = 0.008 ). In the Ergoferon group, AEs were mild or moderate. In 8 (57.1%) cases, AEs were unrelated to Ergoferon, in 5 (35.7%), the relationship was uncertain, and in 1 (7.1%), it was possible (mild rash on the face). Ergoferon treatment is beneficial for infants and young children with ARI in contemporary outpatient practice. Being well-tolerated, Ergoferon increases the symptomatic therapy effectiveness and improves the patient condition and disease outcomes.

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Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2015/201592 ◽

2015 ◽

Vol 2015 ◽

pp. 1-11 ◽

Cited By ~ 2

Author(s):

Tsuyoshi Miyaoka ◽

Motohide Furuya ◽

Jun Horiguchi ◽

Rei Wake ◽

Sadayuki Hashioka ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Controlled Study ◽

Efficacy And Safety ◽

Treatment Resistant ◽

Double Blind ◽

Double Blind Placebo ◽

Intention To Treat ◽

The Difference ◽

The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

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Prevention of acute respiratory viral infections and influenza in children during the peaks of seasonal morbidity: the results of the international double-blind placebo-controlled randomized clinical trial

Rossiyskiy Vestnik Perinatologii i Pediatrii (Russian Bulletin of Perinatology and Pediatrics) ◽

10.21508/1027-4065-2020-65-3-109-120 ◽

2020 ◽

Vol 65 (3) ◽

pp. 109-120

Author(s):

N. A. Geppe ◽

A. V. Gorelov ◽

O. V. Shamsheva ◽

I. G. Sitnikov ◽

E. P. Sitnikova ◽

...

Keyword(s):

Placebo Group ◽

Bacterial Infections ◽

Viral Infections ◽

Group Versus ◽

Study Drug ◽

Preventive Therapy ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Respiratory Viral Infections

The authors conducted an international multicenter double-blind, placebo-controlled clinical study to obtain additional data on the efficacy and safety of a 12-week course of Anaferon for children for the prevention of acute respiratory viral infections (ARVI), including influenza, in children during the rise in seasonal morbidity (RCT of the Ministry of Health of the Russian Federation: №356 dated June 29, 2017; ClinicalTrials.gov Identifier: NCT03301155).Materials and methods. The study involved 1,036 children (1 month – 6 years 11 months 29 days) during two epidemiological seasons. The patients were divided into 2 groups: 528 patients received Anaferon for children 1 tablet a day for 12 weeks, 508 patients received placebo according to Anaferon for children scheme. The primary end point was the duration of the period from the first dose of the drug until manifestation of ARVI/influenza. Additional end points were percentage of children not falling with ARVI/influenza during 4-, 8- and 12-week course of preventive therapy; percentage of children with respiratory or ear-nose-throat bacterial infections requiring antibiotics within 12 week; percentage of children hospitalized with ARVI/influenza or their complications within 12 week. To assess safety, the authors analyzed the presence and nature of the adverse events (AEs), their severity, connection with the medication, outcome. The authors used the following statistical methods: calculation of hazard ratio, median time to the manifestation of symptoms of ARVI / influenza, 95% confidence intervals.Results. The Intention-to-treat (ITT) and Per Protocol [РР] analysis included the data of 1,021 [975] patients: 520 [494] – Anaferon for children group and 501 [481] –Placebo group. The average duration of the period from the first dose of the drug to the development of ARVI/influenza symptoms obtained as a result of the analysis of the statistical model was 428.8 [434.1] days for Anaferon for children group, that is 1.5 times higher than in Placebo group (275.8 [274.9] days; p=0.001 [p=0.0009]). The percentage of children without ARVI/influenza was 99.2% [99.2%] in Anaferon for children group (versus 90.2% [90.0%] in Placebo group; p=0.0003 [p=0.0003]) within 4 weeks, 92.7% [92.3%] (versus 82.8% [82.7%]; p=0.0003 [p=0.0003]) within 8 weeks, and 81.5% [81.8%] (versus 73.4% [73.4%], respectively; p=0.0021 [p=0.0021]). None of the patients was hospitalized for ARVI/influenza or complications. The frequency of AEs in Anaferon for children and Placebo groups had no differ. No one AE definitely related to the study drug was registered.Conclusion. The results confirm the efficacy and safety of a 12-week course of Anaferon for children to prevent ARVI and influenza during seasonal rise of morbidity in children.

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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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The assessment of the rationality of the pharmacotherapy of acute respiratory viral infection in the outpatient practice

Socìalʹna farmacìâ v ohoronì zdorov â ◽

10.24959/sphhcj.21.208 ◽

2021 ◽

Vol 7 (1) ◽

pp. 36-41

Author(s):

O. P. Balitska ◽

Yu. M. Hryhoruk ◽

M. A. Artemchuk ◽

V. S. Zlahoda V. S.

Keyword(s):

Viral Infections ◽

Respiratory Infections ◽

Family Doctor ◽

Evidence Base ◽

The State ◽

Symptomatic Therapy ◽

Clinical Protocol ◽

Family Doctors ◽

Respiratory Viral Infections ◽

Outpatient Practice

Acute respiratory viral infections (ARI) and influenza occupy a leading place in the structure of the overall morbidity of the population in most countries. Aim. To assess the rational prescription of drugs for etiotropic therapy of ARI in the outpatient practice. Materials and methods. The following materials for research were used: case histories; treatment sheets; the Unified clinical protocol of primary care for adults and children “Acute respiratory infections”; data of the State Formulary of Medicines as of January 2021; the Register of wholesale prices; the weekly “Apteka” (Pharmacy). The methods of retrospective, descriptive, frequency, and VEN-analysis were applied. Results. According to the research results, using patient histories, it was found that family doctors prescribed 67 drugs by trade names. For etiotropic therapy, 24 drugs were used; it was 37 % of the total number, and 63 % – for symptomatic therapy. Such drugs as Amizon, Aflubin, Amixin, Resistol, Umkalor were for etiotropic therapy (more than 5 prescriptions). None of these drugs is included in the State Formulary of Medicines and the Unified clinical protocol for the treatment of influenza and SARS. Thus, these drugs are without the proven efficiency, safety and cost-effective use. Conclusions. The study conducted has shown that the drugs prescribed most often do not have an evidence base of efficacy and safety; none of the most frequently prescribed drugs is included in the State Formulary of Medicines and the Unified clinical protocol. A direct relationship between an increase in the number of prescriptions and an increase in price has been proven. Key words: acute respiratory viral infections; influenza; frequency analysis; VEN-analysis; family doctor.

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Treatment of acute respiratory viral infections: results of a multicenter, double-blind, placebo-controlled, randomized clinical trial

Infekcionnye bolezni ◽

10.20953/1729-9225-2020-3-178-189 ◽

2020 ◽

Vol 18 (3) ◽

pp. 178-189

Author(s):

V.V. Rafalsky ◽

◽

R.F. Khamitov ◽

T.I. Martynenko ◽

M.V. Chernogorova ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Viral Infections ◽

Wilcoxon Test ◽

Controlled Study ◽

Control Group ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Respiratory Viral Infections

This multicenter, double-blind, placebo-controlled clinical trial was conducted to obtain additional data on the efficacy and safety of Anaferon for the treatment of acute respiratory viral infections (ARVI) during seasonal increase in their incidence (RCT of the Ministry of Health of Russia No 356 dated 24.07.2018; ClinicalTrials.gov Identifier: NCT03707912). Patients and methods. Between October 2018 and March 2019, a total of 204 patients aged 18 to 70 years with ARVI symptoms were included in this study within the first 24 hours of symptom onset. Patients were randomized into 2 groups: 104 individuals received oral Anaferon (should be kept in the mouth until completely dissolved and without food) according to the following scheme: 1 tablet every 30 minutes during the first 2 hours; then 3 more doses at regular intervals during the first day; then 1 tablet 3 times a day on days 2–5; 100 individuals received placebo according to the same scheme. The primary endpoint was time to resolution of symptoms of clinically diagnosed and/or PCR (polymerase chain reaction) – confirmed ARVI. Addithional endpoints included: time to resolution of symptoms of ARVI confirmed by PCR; proportion of patients with resolution of symptoms of clinically diagnosed and/or PCR-confirmed ARVI and separately PCR-confirmed ARVI; severity of clinically diagnosed and/or PCR-confirmed ARVI (assessed by ‘area under the curve’ for the total severity index); the number of antipyretic doses taken according to indications on days 1–3 of treatment (checked in the patient's diary); proportion of patients who required antibiotic treatment on days 4–7 of follow-up. To assess safety, we analyzed the incidence and type of adverse events (AEs), their severity, association with drug use, and treatment outcome. The following statistical methods were used: Fisher's exact test, Cochran–Mantel–Haenszel test, Wilcoxon test, and repeated measures ANOVA, PROC MIXED. Results. A total of 203 patients were included in the intention-to-treat (ITT) and per protocol (РР) analysis: 103 [95] individuals in the Anaferon arm and 100 [93] individuals in the Placebo arm. Patients receiving Anaferon had significantly shorter time to resolution of all ARVI symptoms than patients receiving placebo: 4.1 ± 1.6 days vs 4.5 ± 1.5 days (p = 0.032). The disease was on average 1 day shorter in patients from the experimental group compared to controls: 3.6 ± 1.5 days vs 4.6 ± 1.5 days (p = 0.007). The proportion of patients who had resolution of symptoms of clinically diagnosed and/or PCR-confirmed ARVI was significantly higher in the Anaferon arm compared to Placebo arm (p = 0.0012). Among patients with PCR-verified ARVI, treatment with Anaferon resulted in twice as frequent recovery as in the control group on day 4 (53.7% vs 26.3%) and day 7 (70.7% vs 36.8%). In the Anaferon arm, we observed shorter disease duration and higher proportion of patients recovered compared to the Placebo arm; however, patients in both groups had a similar need for antipyretic drugs on days 1–3 of treatment, as well as for antibiotic therapy. The incidence of AEs in the Anaferon and Placebo groups did not vary significantly. No AEs with a reliable association with Anaferon were registered. Conclusion. Our findings suggest high efficacy and safety of Anaferon in patients with ARVI. The best results were obtained in patients with PCR-verified diagnosis, which can be attributed to the involvement of the interferon system in the action of the drug. The results of this RCT confirm the data obtained in previous studies and long-term clinical experience of using Anaferon. Key words: acute respiratory viral infections, ARVI, treatment, effective therapy, placebo-controlled study, Anaferon, randomized clinical trial, comprehensive therapy, efficacy, safety

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Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study

Dementia and Geriatric Cognitive Disorders Extra ◽

10.1159/000458521 ◽

2017 ◽

Vol 7 (1) ◽

pp. 136-142 ◽

Cited By ~ 2

Author(s):

Hossein Pakdaman ◽

Ali Amini Harandi ◽

Mehdi Abbasi ◽

Hosein Delavar Kasmaei ◽

Farzad Ashrafi ◽

...

Keyword(s):

Cognitive Impairment ◽

Placebo Group ◽

Mild Cognitive Impairment ◽

Cognitive Function ◽

Disease Assessment ◽

Controlled Study ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Global Cognitive Function

Background and Aim: Mild cognitive impairment (MCI) is characterized by declined cognitive function greater than that expected for a person’s age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients. Methods: Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs) and abnormal laboratory results. Results: Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD) in cognition scores over 6 months in the MLC601 group were –2.26 (±3.42) for the MMSE and 3.82 (±6.16) for the ADAS-cog; in the placebo group, they were –2.66 (±3.43) for the MMSE and 4.41 (±6.66) for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group (p < 0.001). Only 5 patients (14.7%) reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal. Conclusion: MLC601 has shown promising efficacy and acceptable AEs in MCI patients.

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Efficacy and safety of Kami-guibi-tang for mild cognitive impairment: a pilot, randomized, double-blind, placebo-controlled trial

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-021-03428-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Hee-Yeon Shin ◽

Ha-Ri Kim ◽

Geon-Ho Jahng ◽

Chul Jin ◽

Seungwon Kwon ◽

...

Keyword(s):

Cognitive Impairment ◽

Placebo Group ◽

Mild Cognitive Impairment ◽

Adverse Events ◽

Vital Signs ◽

Efficacy And Safety ◽

Mri Findings ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference

Abstract Background Mild cognitive impairment (MCI) is considered an intermediate phase between normal aging and dementia. As the majority of cases of amnestic MCI (aMCI) progress to Alzheimer’s disease (AD), it is considered the prodromal stage of AD, and a treatment target for prevention of further cognitive decline. However, no medications have been shown to have symptomatic or preventive benefits in MCI. Kami-guibi-tang (KGT) is a traditional herbal formula used in Korean medicine to treat amnesia, which is reported to increase acetylcholine levels via activation of choline acetyltransferase. The objective of this study was to evaluate the efficacy and safety of KGT in patients with aMCI. Methods This study was designed as a single-center, randomized, double-blind, placebo-controlled pilot study. Participants diagnosed with aMCI were randomized to receive either KGT or placebo granules for 24 weeks. The efficacy measure was a change in the Seoul Neuropsychological Screening Battery (SNSB) score. The safety measures included the occurrence of adverse events and abnormalities in vital signs and blood chemistry, electrocardiogram (ECG), and brain magnetic resonance imaging (MRI) findings. Results A total of 16 patients in the KGT group and 14 patients in the placebo group were investigated in the study. The mean score of Clinical Dementia Rating-Sum of Boxes (CDR-SB) significantly improved from 1.53 (0.64) points to 1.13 (0.62) points in the KGT group (p = 0.010), whereas it worsened from 1.61 (0.88) points to 1.75 (0.94) points in the placebo group. There was a significant difference in the CDR-SB scores between the two groups after the intervention (p = 0.045). The total SNSB-D scores and the scores in the memory domain after the treatment were significantly higher than the baseline values in the KGT group, but not in the placebo group. The frequency of adverse events was not significantly different between the two groups, and there were no abnormalities in vital signs or blood test, ECG, and brain MRI findings after the intervention. Conclusions KGT may provide a safe and effective treatment option for patients with aMCI. Further studies with a larger sample size are needed to validate the findings. Trial registration Korean Clinical Trial Registry, ID: KCT0002407; Registered on March 30, 2017, http://cris.nih.go.kr/

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Zhizhu Kuanzhong Capsule in Treating Patients With Functional Dyspepsia Postprandial Distress Syndrome: Study Protocol For a Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Clinical Trial

10.21203/rs.3.rs-757640/v1 ◽

2021 ◽

Author(s):

Mengli Xiao ◽

Linda LD Zhong ◽

Wai Ching Lam ◽

Yingpan Zhao ◽

Kok-Ann Gwee ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Functional Dyspepsia ◽

Distress Syndrome ◽

Functional Gastrointestinal Disorders ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Postprandial Distress Syndrome ◽

Parallel Group

Abstract Background: Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders. Based on the various symptoms present in patients with functional dyspepsia-postprandial distress syndrome (FD-PDS), routine agents such as acid suppressants, prokinetic drugs, and centrally acting drugs, offer limited treatment choice with potential side effects. As preliminary clinical trial showed that the marketed product Zhizhu Kuanzhong Capsule (ZZKZ) can improve symptoms in FD-PDS patients, our study aims to provide further evidence on the clinical efficacy and safety of ZZKZ in the treatment of patients with FD-PDS. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial, we recruit patients with FD-PDS from 18 hospitals in China and Australia. The trial enrolls patients with FD-PDS based on the Rome IV diagnostic criteria. A total of 480 eligible patients are randomized 1:1 into either ZZKZ or placebo group with 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint is measured by self-rated Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early satiation, recorded once a day and 7 days a week. The primary analysis aims to compare the response rate for FD-PDS VAS score between the groups before and after 8 weeks of treatment with an alpha level of 0.05 (2-sided).Discussion: This trial aims to strengthen the evidence for the efficacy and safety of ZZKZ, a marketed product, in treating FD-PDS. Compared to previous clinical trial targeted FD-PDS, this trial has 8-week double-blind treatment period to investigate the effect of long-term mediation through comparison with the placebo group.Trial registration: This study is registered with ClinicalTrials.gov on 28 January 2019, number NCT03825692.

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A Randomized, Double-Blind, Placebo-Controlled, Multicentre Trial of the Effects of a Shrimp Protein Hydrolysate on Blood Pressure

International Journal of Hypertension ◽

10.1155/2019/2345042 ◽

2019 ◽

Vol 2019 ◽

pp. 1-13

Author(s):

Kathy Musa-Veloso ◽

Lina Paulionis ◽

Tetyana Pelipyagina ◽

Mal Evans

Keyword(s):

Blood Pressure ◽

Placebo Group ◽

Systolic Blood Pressure ◽

Diastolic Blood Pressure ◽

Protein Hydrolysate ◽

Office Blood Pressure ◽

Double Blind ◽

Double Blind Placebo ◽

Intention To Treat ◽

Significant Difference

In this randomized, double-blind, placebo-controlled, multicentre, parallel, 8-week study, the efficacy of a daily dose of 1200 mg of protein hydrolysate from Coldwater Shrimp (Pandalus borealis) on ambulatory and office blood pressure was investigated in 144 free-living adults with mild to moderate hypertension. The primary outcomes of the study were daytime ambulatory systolic blood pressure and office blood pressure. During the 8-week intervention period and in the intention-to-treat analysis (n=144), there were significant reductions in the group consuming the shrimp-derived protein hydrolysate relative to the placebo group in daytime ambulatory systolic blood pressure at 4 weeks (p=0.014) and at 8 weeks (p=0.002), and in office systolic blood pressure at 2 weeks (p=0.031) and 4 weeks (p=0.010), with a trend toward significance at 8 weeks (p=0.087). By 8 weeks, significant and favourable improvements in the group consuming the shrimp-derived protein hydrolysate relative to the placebo group were also observed for several secondary outcomes, including 24-hour ambulatory systolic and diastolic blood pressure, daytime ambulatory diastolic blood pressure, and daytime and 24-hour ambulatory mean arterial pressure. Also by Week 8, there was a statistically significant difference between groups in the distribution of subjects across National Institutes of Health-defined blood pressure categories (i.e., Normotensive, Prehypertensive, Stage 1 hypertension, and Stage 2 hypertension), with a more favourable distribution in the shrimp-derived protein hydrolysate group than in the placebo group (p=0.006). Based on exploratory analyses conducted only in participants in the shrimp-derived protein hydrolysate group, angiotensin II levels were significantly reduced relative to baseline. This study is registered at ClinicalTrials.gov NCT01974570.

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Efficacy and safety of oral Guanxinshutong capsules in patients with stable angina pectoris in China: a prospective, multicenter, double-blind, placebo-controlled, randomized clinical trial

BMC Complementary and Alternative Medicine ◽

10.1186/s12906-019-2778-z ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 2

Author(s):

Yang Li ◽

Lei Zhang ◽

Shuzheng Lv ◽

Xiaozeng Wang ◽

Jian Zhang ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Angina Pectoris ◽

Randomized Clinical Trial ◽

Stable Angina ◽

Efficacy And Safety ◽

Stable Angina Pectoris ◽

Double Blind ◽

Double Blind Placebo ◽

St Segment

Abstract Background To assess the efficacy and safety of oral Guanxinshutong (GXST) capsules in Chinese patients with stable angina pectoris (SAP) in a prospective, multicenter, double-Blind, placebo-controlled, randomized clinical trial (clinicaltrials.gov Identifier: NCT02280850). Methods Eligible patients were randomized 1:1 to the GXST or placebo group. Current standard antianginal treatment except for nitrate drugs was continued in both groups, who received an additional 4-week treatment of GXST capsule or placebo. Primary endpoint was the change from baseline in angina attack frequency after the 4-week treatment. Secondary endpoints included the reduction of nitroglycerin dose, score of Seatntle Agina Questionnaire, exercise tolerance test defined as time to onset of chest pain and ST-segment depression at least 1 mm greater than the resting one. Results A total of 300 SAP patients from 12 centers in China were enrolled between January 2013 and October 2015, and they were randomly divided into the GXST group and the placebo group (150 patients in each group). Of whom, 287 patients completed the study (143 patients in the GXST group, 144 patients in the placebo group). The baseline characteristics of the two groups were comparable. After 4-week treatment with GXST capsules, the number of angina attacks and the consumption of short-acting nitrates were significantly reduced. In addition, the quality of life of patients were also substantially improved in the GXST group. No significant differences in the time of onset of angina and 1-mm ST segment depression were noted between the two groups. 7 patients (4.1%) in the GXST group and 3 patients (2.1%) in the placebo group reported at least one adverse event, respectively. Conclusions GXST capsules are beneficial for the treatment of SAP patients.

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