scholarly journals Maternal–Infant Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Affect Child Blood Pressure at 4–6 Y in Ghana: Follow-up of a Randomized Trial

2019 ◽  
Vol 149 (3) ◽  
pp. 522-531 ◽  
Author(s):  
Sika M Kumordzie ◽  
Seth Adu-Afarwuah ◽  
Rebecca R Young ◽  
Brietta M Oaks ◽  
Solace M Tamakloe ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Birth Weight ◽  
Controlled Trial ◽  
Intervention Group ◽  
Path Model ◽  
Secondary Outcome ◽  
Double Blind ◽  
Blood Institute ◽  
Nutrient Supplements ◽  
Pregnancy And Postpartum

ABSTRACT Background In the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD-Ghana trial, prenatal small-quantity lipid-based nutrient supplements (LNSs) had a positive effect on birth weight. Birth weight may be inversely related to blood pressure (BP) later in life. Objectives We examined the effect of the intervention on BP at 4–6 y of age, and maternal and child factors related to BP. Methods The iLiNS-DYAD-Ghana study was a partially double-blind, randomized controlled trial which assigned women (n = 1320) ≤20 weeks of gestation to daily supplementation with: 1) iron and folic acid during pregnancy and 200 mg Ca for 6 mo postpartum , 2) multiple micronutrients during pregnancy and postpartum, or 3) LNSs during pregnancy and postpartum plus LNSs for infants from 6 to 18 mo of age. At 4–6 y of age (n = 858, 70% of live births), we compared BP, a secondary outcome, between non-LNS and LNS groups and examined whether BP was related to several factors including maternal BP, child weight-for-age z score (WAZ), and physical activity. Results Non-LNS and LNS groups did not differ in systolic (99.2 ± 0.4 compared with 98.5 ± 0.6 mm Hg; P = 0.317) or diastolic (60.1 ± 0.3 compared with 60.0 ± 0.4 mm Hg; P = 0.805) BP, or prevalence of high BP (systolic or diastolic BP ≥90th percentile of the US National Heart, Lung, and Blood Institute reference: 31% compared with 28%; P = 0.251). BP at 4–6 y of age was positively related to birth weight; this relation was largely mediated through concurrent WAZ in a path model. Concurrent WAZ and maternal BP were the factors most strongly related to child BP. Conclusions Despite greater birth weight in the LNS group, there was no intervention group difference in BP at 4–6 y. In this preschool population at high risk of adult hypertension based on BP at 4–6 y, high maternal BP and child WAZ were key factors related to BP. This trial was registered at clinicaltrials.gov as NCT00970866.

scholarly journals Efficacy of Hawthorn fruit extract on blood pressure and quality of sleep in patients with hypertension along with sleep disorders: A randomized double-blind controlled trial

2021 ◽  
Vol 7 (4) ◽  
Keyword(s):  
Blood Pressure ◽  
Sleep Disorder ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Groups ◽  
Quality Of Sleep ◽  
Fruit Extract ◽  
Double Blind ◽  
Significant Difference

Objective: This study aimed to investigate the effect of Crataegus monogyna (C.monogyna) on controlling the blood pressure in patients with hypertension along with sleep disorder. Methods: This was a parallel double-blind, placebo-controlled trial study from May, 2018 to December, 2019. Total of 60 patients with hypertension and sleep disorder were randomly assigned to C.monogyna and placebo groups. The groups received C.monogyna and placebo capsules twice-daily for 8 weeks. The primary outcomes were the changes of systolic and diastolic blood pressure and Pittsburgh questionnaire’s scores from baseline measurements. The secondary outcomes were changes in serum biochemical markers from baseline. Results: Before treatment, there was no significant difference between study groups in terms of demographic data and outcomes (P>0.05) except body mass index (P=0.02). After treatments, the intervention group had a significant improvement in systolic and diastolic blood pressure compared to placebo ((118.14±6.76 vs 129.76±8.28, 95% CI: 7.54 – 15.69, P<0.001 and 77.14±5.32 vs 83.57±6.73, 95% CI: 3.17 – 9.68, P<0.001, respectively) analysis revealed no significant difference observed between study groups in terms of baseline characteristics and pre-and posttreatment laboratory tests. Also, none of the groups had superiority in terms of the Pittsburgh questionnaire’s scores (P=0.44); however, the intragroup analysis revealed significant improvements in the intervention group (P= 0.001). Conclusion: C.monogyna fruit extract as a supplementary medication has beneficial effects on controlling blood pressure and quality of sleep in patients with hypertension along with sleep disorders.

scholarly journals Individualized Homeopathic Medicines in Chronic Rhinosinusitis: Randomized, Double-Blind, Placebo-Controlled Trial

Homeopathy ◽  
2020 ◽  
Author(s):  
Pankhuri Misra ◽  
Chintamani Nayak ◽  
Abhijit Chattopadhyay ◽  
Tarun Kumar Palit ◽  
Bharti Gupta ◽  
...  
Keyword(s):  
Chronic Rhinosinusitis ◽  
Rating Scales ◽  
Controlled Trial ◽  
Intervention Group ◽  
Attrition Rate ◽  
Effect Sizes ◽  
Medium Effect ◽  
Secondary Outcome ◽  
Group Differences ◽  
Double Blind

Abstract Background Chronic rhinosinusitis (CRS) is a common disorder, with up to an estimated 134 million Indian sufferers, and having significant impact on quality of life (QOL) and health costs. Despite the evidence favoring homeopathy in CRS being inadequate, it is highly popular. This trial attempts to study the efficacy of individualized homeopathy (IH) medicines in comparison with placebo in patients with CRS. Methods A double-blind, randomized (1:1), placebo-controlled, preliminary trial (n = 62) was conducted at the National Institute of Homoeopathy, West Bengal, India. Primary outcome measure was the sino-nasal outcome test-20 (SNOT-20) questionnaire; secondary outcomes were the EQ-5D-5L questionnaire and EQ-5D-5L visual analog scale scores, and five numeric rating scales (0–10) assessing intensity of sneezing, rhinorrhea, post-nasal drip, facial pain/pressure, and disturbance in sense of smell, all measured at baseline and after the 2nd and 4th months of intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample. Results Groups were comparable at baseline. Attrition rate was 6.5% (IH: 1, Placebo: 3). Although improvements in both primary and secondary outcome measures were higher in the IH group than placebo, with small to medium effect sizes, the group differences were statistically non-significant (all p > 0.05, unpaired t-tests). Calcarea carbonica, Lycopodium clavatum, Sulphur, Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines. No harmful or unintended effects, homeopathic aggravations or any serious adverse events were reported from either group. Conclusion There was a small but non-significant direction of effect favoring homeopathy, which ultimately renders the trial as inconclusive. Rigorous trials and independent replications are recommended to arrive at a confirmatory conclusion. [Trial registration: CTRI/2018/03/012557; UTN: U1111–1210–7201].

scholarly journals Effects of prayer on the vital signs of patients with chronic kidney disease: randomized controlled trial

2017 ◽  
Vol 51 (0) ◽  
Author(s):  
Thaila Oliveira Zatiti Brasileiro ◽  
Andressa Anunciação de Oliveira Prado ◽  
Bianca Bacelar de Assis ◽  
Denismar Alves Nogueira ◽  
Rogério Silva Lima ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Chronic Kidney Disease ◽  
Heart Rate ◽  
Kidney Disease ◽  
Respiratory Rate ◽  
Controlled Trial ◽  
Group Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind

Abstract OBJECTIVE To assess the effect of prayer on blood pressure, heart rate and respiratory rate in patients with chronic kidney disease and learn their perception of the intervention. METHOD A randomized controlledtrial, double blind with a sample of volunteers, randomized into an intervention group (n=42) and a control group (n=37). Questionnaires addressing socio-demographic, clinical and spiritual characteristics and the Duke University Religious Index were applied. Blood pressure, heart rate and respiratory rate were measured. The prayer was conducted at three different moments on alternating weeks. The qualitative data were organized and analyzed through Thematic Analysis. RESULTS The sample consisted of 95 randomized volunteers. In the intra-group analysis, a statistically significant reduction (P<0001) of blood pressure, heart rate and respiratory rate was observed in all evaluations of the people who were prayed for. The qualitative analysis resulted in the themes Prayer in a "Place of Suffering" and Positive Evaluation and in the sub-themes Relief from Suffering, Hope for Improvement, and Coping with Hemodialysis. CONCLUSIONPrayer reduced blood pressure, heart rate and respiratory rate in patients who suffer from chronic kidney disease, and the volunteers’ evaluation of the intervention was positive.BrazilianClinicalTrials Registry: RBR-2zv39y.

scholarly journals Effect of tart cherry juice on risk of gout attacks: protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e035108
Author(s):  
Kirstie Louise Lamb ◽  
Anthony Lynn ◽  
Jean Russell ◽  
Margo E Barker
Keyword(s):  
Research Ethics ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Serum Urate ◽  
Secondary Outcome ◽  
Primary Study ◽  
Tart Cherry ◽  
Double Blind ◽  
Cherry Juice

IntroductionGout is a painful form of inflammatory arthritis associated with several comorbidities, particularly cardiovascular disease. Cherries, which are rich in anti-inflammatory and antioxidative bioactive compounds, are proposed to be efficacious in preventing and treating gout, but recommendations to patients are conflicting. Cherry consumption has been demonstrated to lower serum urate levels and inflammation in several small studies. One observational case cross-over study reported that cherry consumption was associated with reduced risk of recurrent gout attacks. This preliminary evidence requires substantiation. The proposed randomised clinical trial aims to test the effect of consumption of tart cherry juice on risk of gout attacks.Methods and analysisThis 12-month, parallel, double-blind, randomised, placebo-controlled trial will recruit 120 individuals (aged 18–80 years) with a clinical diagnosis of gout who have self-reported a gout flare in the previous year. Participants will be randomly assigned to an intervention group, which will receive Montmorency tart cherry juice daily for a 12-month period, or a corresponding placebo group, which will receive a cherry-flavoured placebo drink. The primary study outcome is change in frequency of self-reported gout attacks. Secondary outcome measures include attack intensity, serum urate concentration, fractional excretion of uric acid, biomarkers of inflammation, blood lipids and other markers of cardiovascular risk. Other secondary outcome measures will be changes in physical activity and functional status. Statistical analysis will be conducted on an intention-to-treat basis.Ethics and disseminationThis study has been granted ethical approval by the National Research Ethics Service, Yorkshire and The Humber—Leeds West Research Ethics Committee (ref: 18/SW/0262). Results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03621215.

scholarly journals Feasibility of Low-Sodium, High-Potassium Processed Foods and Their Effect on Blood Pressure in Free-Living Japanese Men: A Randomized, Double-Blind Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3497
Author(s):  
Yoko Umeki ◽  
Hitomi Hayabuchi ◽  
Hisashi Adachi ◽  
Masanori Ohta
Keyword(s):  
Blood Pressure ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Processed Foods ◽  
Free Living ◽  
Double Blind ◽  
High Potassium ◽  
Japanese Men ◽  
Low Sodium

We aimed to verify the effect of new low-sodium high-potassium seasonings and processed foods containing poly-γ-glutamic acid on blood pressure in free-living settings. To this end, we conducted a randomized, double-blind controlled trial on 187 Japanese men, aged 35–67 years, who did not use antihypertensives. Participants were randomly allocated to an intervention (n = 93) or a control group (n = 94). They were given a boxed lunch and miso soup (average Na and K content for the intervention group: 1175 and 1476 mg; for the control group: 2243 and 703 mg, respectively). Blood pressure was measured three times every morning for 1 week immediately before and during the final week of the trial. On the day before and the final day of the intervention period, 24 h urine samples were collected. After intervention, the intervention group showed a significantly stronger decrease in the urinary sodium-to-potassium ratio than the control group (p < 0.001). The mean difference in systolic blood pressure change after adjustment for baseline values between the two groups was −2.1 (95% CI: −3.6, −0.6) mmHg. Compliance between the groups was similar, suggesting successful blinding. In conclusion, the use of new seasonings and processed foods aimed at lowering blood pressure in free-living settings may be feasible and effective.

scholarly journals OP0010 EFFECTIVENESS OF THE MAKING IT WORK™ PROGRAM AT IMPROVING PRESENTEEISM AND WORK CESSATION IN WORKERS WITH INFLAMMATORY ARTHRITIS – RESULTS OF A RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 7.1-8
Author(s):  
A. Luquini ◽  
Y. Zheng ◽  
H. Xie ◽  
C. Backman ◽  
P. Rogers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Work Disability ◽  
Inflammatory Arthritis ◽  
Missing Values ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Mixed Effect ◽  
Randomized Controlled ◽  
Baseline Characteristics

Background:Arthritis often leads to presenteeism (decreased at-work productivity), missed days from work and permanent work disability, leading to reduced quality of life and high costs to individuals and society. Yet, health services addressing the employment needs of people with arthritis are lacking.Objectives:We evaluated the effectiveness of the Making-it-WorkTM(MiW) program, an online self-management program developed to help people with inflammatory arthritis (IA) deal with employment issues.Methods:A multi-center RCT evaluated the effectiveness of MiW at improving presenteeism and preventing work cessation (WC) over two years. Participants were recruited from rheumatologist practices, consumer organizations and arthritis programs, in three Canadian provinces. Eligibility criteria: diagnosis of IA, employed, age 18-59, and concerned about ability to work. Participants were randomized 1:1 to MiW or usual care plus printed material on workplace tips. MiW consists of five online self-learning modules and group meetings, and individual vocational counselling and ergonomic consultations. Questionnaires were administered every 6 months. Outcomes were presenteeism [Rheumatoid Arthritis Work Instability Scale (RA-WIS)], time to WC ≥ 6 months, and time to WC ≥ 2 months (secondary outcome). Baseline characteristics (age, gender, ethnicity, occupation, education, disease duration and self-employment) were collected. Intention-to-treat (ITT) longitudinal analysis of RA-WIS using linear mixed effect regression models with 2-year comparison as primary endpoint and survival analysis for time to WC using Kaplan-Meier and Cox Proportional Hazard models were performed. Robustness analyses were conducted by using various missing values imputation methods like last observation carried forward, imputation using worse possible outcomes and model-based multiple imputations; using square root transformation of RA-WIS outcome; and adjusting for baseline covariates. SAS version 9.4 was used.Results:A total of 564 participants were recruited, with 478 (84.75%) completing 2-year follow-up. Baseline characteristics were similar between groups. Mean RA-WIS scores were significantly lower in the intervention group from 6 months onwards, with the greatest difference observed at 2 years (-1.78, 95%CI: -2.7, -0.9, p < .0001), yielding a standardized effect size of 32%. Satisfactory robustness was observed. Work cessation occurred less often in intervention than control groups, but only reached statistical significance for WC ≥ 2 months (WC ≥ 6 months: 31 versus 44 events, aHR 0.70, 95%CI: 0.44, 1.11, p = 0.13; WC ≥ 2 months: 39 versus 61 events, aHR: 0.65, 95%CI: 0.43, 0.98, p = 0.04).Conclusion:Results of the RCT reveal the program was effective at improving presenteeism and preventing short-term WC. Effectiveness at preventing long-term work disability will be assessed at 5 years. This program fills one of the most important and costly unmet needs for people with inflammatory arthritis.References:[1]Carruthers EC, Rogers P, Backman CL, et al. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol).BMC Med Inform Decis Mak. 2014;14:59. Published 2014 Jul 21. doi:10.1186/1472-6947-14-59Disclosure of Interests:Andre Luquini: None declared, Yufei Zheng: None declared, Hui Xie: None declared, Catherine Backman: None declared, Pamela Rogers: None declared, Alex Kwok: None declared, Astrid Knight: None declared, Monique Gignac: None declared, Dianne Mosher: None declared, Linda Li: None declared, John Esdaile: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Lacaille: None declared

scholarly journals Methotrimeprazine versus haloperidol in palliative care patients with cancer-related nausea: a randomised, double-blind controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029942 ◽  
Author(s):  
Janet Rea Hardy ◽  
Helen Skerman ◽  
Jennifer Philip ◽  
Phillip Good ◽  
David C Currow ◽  
...  
Keyword(s):  
Palliative Care ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Response Rates ◽  
Complete Response ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Double Blind ◽  
Intention To Treat ◽  
Point Reduction

ObjectivesMethotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.DesignDouble-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.Setting11 palliative care sites in Australia.ParticipantsParticipants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.InterventionsBased on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.Main outcome measuresA ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.ResultsResponse to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In theper protocolanalysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Completeper protocolresponse rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.ConclusionThis study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.Trial registration numberACTRN 12615000177550.

SYSTEMIC HYPERTENSION FOLLOWING OCULAR ADMINISTRATION OF 10% PHENYLEPHRINE IN THE NEONATE

PEDIATRICS ◽  
1973 ◽  
Vol 51 (6) ◽  
pp. 1032-1036 ◽  
Author(s):  
Virginia Borromeo-McGrail ◽  
Joseph Bordiuk ◽  
Hans Keitel
Keyword(s):  
Blood Pressure ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Systemic Blood Pressure ◽  
Systemic Effect ◽  
Systemic Hypertension ◽  
Double Blind Study ◽  
Eye Drops ◽  
Low Birth Weight Infants ◽  
Double Blind

The effect of ophthalmic instillation of 10% phenylephrine on systemic blood pressure in the neonate has not been previously evaluated, despite reports of adverse reactions. The effect of 10% and 2½% phenylephrine eye drops in healthy low birth weight neonates was compared in a double-blind study. Blood pressure showed a rise of 12 to 16 mm Hg in systole and 10 to 14 mm Hg in diastole following administration of 10% phenylephrine. Blood pressure remained stable in infants receiving 2½% phenylephrine. Consistent, although more variable, increases in blood pressure were noted in eight low birth weight infants given 10% phenylephrine eye drops in a nonblind study. Complete mydriasis was achieved with 2½% phenylephrine as well as with 10%. Neither concentration had an effect on pulse or respiratory rates. Cutaneous administration of either 10% or 2½% phenylephrine to abdominal skin produced local blanching but no systemic effect. To avoid potentially dangerous sequelae from iatrogenic hypertension, it is recommended that not more than one drop of 2½% phenylephrine in each eye be administered to neonates for mydriasis.

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