The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group.Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7(259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone ().Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (), successful ECV, whereas 38 women, who received NLP, had a 44.7% () successful ECV (). The control group had similar patient characteristics compared to the intervention groups (). In the control group () 27.3% () had a statistically significant lower successful ECV procedure than NLP () and hypnosis and NLP ().Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

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An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial

British Journal Of Nutrition ◽

10.1017/s000711451100479x ◽

2011 ◽

Vol 107 (11) ◽

pp. 1616-1622 ◽

Cited By ~ 25

Author(s):

Jean-Christophe Rozé ◽

Sébastien Barbarot ◽

Marie-José Butel ◽

Nathalie Kapel ◽

Anne-Judith Waligora-Dupriet ◽

...

Keyword(s):

Atopic Dermatitis ◽

Infant Formula ◽

Controlled Trial ◽

Randomised Trial ◽

Secretory Iga ◽

Control Group ◽

Double Blind ◽

Randomised Controlled ◽

Similar Growth ◽

Experimental Group

The aim of the present study was to evaluate the safety, tolerance and preventive effect on atopic dermatitis of an experimental α-lactalbumin-enriched and symbiotic-supplemented infant formula. A total of ninety-seven non-breastfed term neonates were enrolled into a double-blind, multicentre, randomised controlled trial in which they received experimental (n 48) or standard formula (n 49) for 6 months. The primary outcome was weight at 6 months of age. Secondary outcomes were gastrointestinal tolerance and manifestation of atopic dermatitis. Faecal secretory IgA (SIgA) concentration and microbiota composition of forty-three infants were analysed at 1 and 6 months. Growth was similar in both groups. At 1 month, compared to those in the control group, infants in the experimental group exhibited less crying or agitation, and more quiet behaviour (P = 0·03). At 6 months, atopic dermatitis was less frequently observed in the experimental group (P < 0·05). Decrease of faecal SIgA concentration between 1 and 6 months was mainly observed in the control group. This decrease was significantly associated with atopic dermatitis (P < 0·014) and negatively correlated to the level of colonisation by bifidobacteria (P < 0·005). In conclusion, compared to the control formula, the experimental formula guaranteed a similar growth, was better tolerated at 1 month and had a protective effect against the development of atopic dermatitis.

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ROLE OF FIBRIN GLUE FOR BETTER SUCCESS RATE IN MYRINGOPLASTY

Pakistan Armed Forces Medical Journal ◽

10.51253/pafmj.v71isuppl-3.4298 ◽

2021 ◽

Vol 71 (Suppl-3) ◽

pp. S603-06

Author(s):

Sohail Aslam ◽

Adnan Asghar ◽

Syed Muhammad Asad Shabbir Bukhari ◽

Sunarays Akhtar ◽

Hamza Mumtaz ◽

...

Keyword(s):

Success Rate ◽

Controlled Trial ◽

Sampling Technique ◽

Conventional Technique ◽

Control Group ◽

P Value ◽

Temporalis Fascia ◽

Double Blind ◽

Platelet Rich Fibrin ◽

Fascia Graft

Objective: To see graft uptake success rate in platelet rich fibrin aided underlay myringoplasties using temporalis fascia graft compared to conventional underlay myringoplasties. Study Design: Double blind randomized controlled trial study. Place and Duration of Study: ENT department, Pakistan Naval Ship Shifa Hospital, from Jan to Jun 2019. Methodology: Sixty cases with dry central tympanic membrane perforations were recruited. The patients suffering from sensori-neural hearing loss and co-morbidities like diabetes were excluded. The sampling technique was probability simple random. Patients were divided into two groups by lottery method. Statistical analysis was performed by using SPSS. The chi square test was applied to calculate p-value. Results: Out of total 60 patients 38 were males and 22 were females. Study group’s (Fibrin) mean age was 31.77 ± 12.43 years and Control group’s mean age was 27.53 ± 11.41 years. All the patients in platelet rich fibrin group had successful graft uptake at 2 months follow-up. In control group with conventional technique 23 out of 30 patients had successful graft uptake and rest 7 patients had different issues leading to graft rejection. Conclusion: In under lay myringoplasty procedure, application of platelet rich fibrin on temporalis fascia graft edge and perforation edges has significantly improved the successful uptake rate of graft.

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Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽

10.1177/0333102421989232 ◽

2021 ◽

Vol 41 (3) ◽

pp. 294-304 ◽

Cited By ~ 2

Author(s):

Messoud Ashina ◽

Uwe Reuter ◽

Timothy Smith ◽

Judith Krikke-Workel ◽

Suzanne R Klise ◽

...

Keyword(s):

Controlled Trial ◽

Study Drug ◽

Statistical Testing ◽

Control Group ◽

Double Blind ◽

Treatment Groups ◽

Primary Endpoints ◽

Registration Number ◽

Secondary Endpoints ◽

Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

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Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽

10.3390/nu13041280 ◽

2021 ◽

Vol 13 (4) ◽

pp. 1280

Author(s):

Jan Mieszkowski ◽

Andżelika Borkowska ◽

Błażej Stankiewicz ◽

Andrzej Kochanowicz ◽

Bartłomiej Niespodziński ◽

...

Keyword(s):

Vitamin D ◽

Inflammatory Marker ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Oncostatin M ◽

Control Group ◽

High Dose ◽

Double Blind ◽

Single High Dose ◽

High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

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Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-021-03206-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Merlin Willcox ◽

Catherine Simpson ◽

Sam Wilding ◽

Beth Stuart ◽

Dia Soilemezi ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Randomised Trial ◽

Acute Bronchitis ◽

Antibiotic Prescribing ◽

Root Extract ◽

Double Blind ◽

Double Blind Placebo ◽

Link Type ◽

Pelargonium Sidoides

Abstract Background Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or “Kaloba®”, is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. Study design Feasibility double-blind randomised placebo-controlled clinical trial. Methods We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2–4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. Results Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18–21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. Conclusions It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. Trial registration HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884.

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Consumption of a Double-Fortified Salt Affects Perceptual, Attentional, and Mnemonic Functioning in Women in a Randomized Controlled Trial in India

Journal of Nutrition ◽

10.3945/jn.117.251587 ◽

2017 ◽

Vol 147 (12) ◽

pp. 2297-2308 ◽

Cited By ~ 6

Author(s):

Michael J Wenger ◽

Laura E Murray-Kolb ◽

Julie EH Nevins ◽

Sudha Venkatramanan ◽

Gregory A Reinhart ◽

...

Keyword(s):

Iron Deficiency ◽

Iron Status ◽

Controlled Trial ◽

Reproductive Age ◽

Deficiency Anemia ◽

Control Group ◽

Attention And Memory ◽

Double Blind ◽

Iron Deficient ◽

Mnemonic Function

Abstract Background: Iron deficiency and iron deficiency anemia have been shown to have negative effects on aspects of perception, attention, and memory. Objective: The purpose of this investigation was to assess the extent to which increases in dietary iron consumption are related to improvements in behavioral measures of perceptual, attentional, and mnemonic function. Methods: Women were selected from a randomized, double-blind, controlled food-fortification trial involving ad libitum consumption of either a double-fortified salt (DFS) containing 47 mg potassium iodate/kg and 3.3 mg microencapsulated ferrous fumarate/g (1.1 mg elemental Fe/g) or a control iodized salt. Participants' blood iron status (primary outcomes) and cognitive functioning (secondary outcomes) were assessed at baseline and after 10 mo at endline. The study was performed on a tea plantation in the Darjeeling district of India. Participants (n = 126; 66% iron deficient and 49% anemic at baseline) were otherwise healthy women of reproductive age, 18–55 y. Results: Significant improvements were documented for iron status and for perceptual, attentional, and mnemonic function in the DFS group (percentage of variance accounted for: 16.5%) compared with the control group. In addition, the amount of change in perceptual and cognitive performance was significantly (P < 0.05) related to the amount of change in blood iron markers (mean percentage of variance accounted for: 16.0%) and baseline concentrations of blood iron markers (mean percentage of variance accounted for: 25.0%). Overall, there was evidence that the strongest effects of change in iron status were obtained for perceptual and low-level attentional function. Conclusion: DFS produced measurable and significant improvements in the perceptual, attentional, and mnemonic performance of Indian female tea pickers of reproductive age. This trial was registered at clinicaltrials.gov as NCT01032005.

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The effects of maternal and infant vitamin A supplementation on vitamin A status: a randomised trial in Kenya

British Journal Of Nutrition ◽

10.1017/s0007114507705019 ◽

2007 ◽

Vol 98 (2) ◽

pp. 422-430 ◽

Cited By ~ 25

Author(s):

R. A. Ayah ◽

D. L. Mwaniki ◽

P. Magnussen ◽

A. E. Tedstone ◽

T. Marshall ◽

...

Keyword(s):

Vitamin A ◽

Controlled Trial ◽

Randomised Trial ◽

Maternal Serum ◽

High Dose ◽

Serum Retinol ◽

Double Blind ◽

Vitamin A Supplementation ◽

Factors Affecting ◽

Vitamin A Status

Postpartum vitamin A supplementation of mothers and infants is recommended, but the efficacy has been questioned. In this double-blind, placebo-controlled trial, Kenyan mother–infant pairs were randomised to maternal vitamin A (400 000 IU) or placebo < 24 h postpartum, and infant vitamin A (100 000 IU) or placebo at 14 weeks. Milk retinol was determined at weeks 4, 14 and 26, and maternal and infant serum retinol at weeks 14 and 26. Infant retinol stores were assessed at week 26, using a modified relative dose response (MRDR) test. Among 564 women, serum retinol at 36 weeks gestation was 0·81 (sd 0·21) μmol/l, and 33·3 % were < 0·7 μmol/l. Maternal serum retinol was not different between groups, but milk retinol was higher in the vitamin A group: (0·67 v. 0·60 μmol/l; 0·52 v. 0·44 μmol/l; 0·50 v. 0·44 μmol/l at 4, 14 and 26 weeks, respectively). When expressed per gram fat, milk retinol was higher in the vitamin A group only at 4 weeks. Infant serum retinol was not different between groups. However, although most infants had deficient vitamin A stores (MRDR>0·06 %) at 26 weeks, vitamin A to infants, but not mothers, resulted in a lower proportion of infants with deficient vitamin A stores (69 v. 78 %). High-dose postpartum vitamin A supplementation failed to increase serum retinol and infant stores, despite modest effects on milk retinol. Infant supplementation, however, increased stores. There is a need for a better understanding of factors affecting absorption and metabolism of vitamin A.

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Controlled Study of the Use of Local Steroid Injection in the Treatment of Trigger Finger and Thumb

Journal of Hand Surgery (European Volume) ◽

10.1016/0266-7681(92)90014-s ◽

1992 ◽

Vol 17 (1) ◽

pp. 69-70 ◽

Cited By ~ 79

Author(s):

M. A. LAMBERT ◽

R. J. MORTON ◽

J. P. SLOAN

Keyword(s):

Local Anaesthetic ◽

Steroid Injection ◽

Controlled Trial ◽

Trigger Finger ◽

Controlled Study ◽

Control Group ◽

Methylprednisolone Acetate ◽

Double Blind ◽

Local Steroid Injection ◽

Control Injection

A controlled double-blind prospective study of injection of methylprednisolone acetate plus local anaesthetic against a control injection of a local anaesthetic in the treatment of trigger finger and thumb has shown a 60% success rate for the steroid injection against 16% for the control group (p < 0.05). This is the first controlled trial of local steroid therapy in this condition.

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Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA)

BMJ Open ◽

10.1136/bmjopen-2020-037842 ◽

2020 ◽

Vol 10 (10) ◽

pp. e037842

Author(s):

Wei Chen ◽

Naya Huang ◽

Haiping Mao ◽

Xiao Yang ◽

Qian Zhou ◽

...

Keyword(s):

Peritoneal Dialysis ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Dropout Rate ◽

Cardiovascular Outcomes ◽

Control Group ◽

Type I ◽

Dialysis Patients ◽

Double Blind ◽

Randomised Controlled

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.

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Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

European Respiratory Journal ◽

10.1183/13993003.00752-2021 ◽

2021 ◽

pp. 2100752

Author(s):

Pradeesh Sivapalan ◽

Charlotte Suppli Ulrik ◽

Therese Sophie Lapperre ◽

Rasmus Dahlin Bojesen ◽

Josefin Eklöf ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Safety Outcome ◽

Hospitalised Patients ◽

Double Blinded ◽

Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

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