Iron Supplementation in Twin Pregnancy — The Benefit of Doubling the Iron Dose in Iron Deficient Pregnant Women: A Randomized Controlled Trial

Objective: To assess the efficacy of doubling the daily dose of iron supplement in iron-deficient women with twin pregnancies. Study design: Using a prospective randomized controlled trial, iron-deficient women with twin gestations were randomized to receive a single or a double dose of daily iron from 16 weeks of gestation until 6 weeks postpartum. The primary outcome was hemoglobin at 32 weeks. Secondary outcomes included ferritin at 32 weeks, hemoglobin during pregnancy and postpartum, birth weights, preterm birth rate, gastrointestinal side effects, intravenous iron administration, and compliance with treatment. Results: Eighty-five and 87 women were randomized to receive one capsule (group A) or two capsules (group B) of 34 mg of ferrous sulfate, respectively. Mean hemoglobin (9.6 g/dL and 9.7 g/dL) and ferritin (8.6 ng/ml and 8.5 ng/ml) were similar in both groups A and B, respectively, at allocation. Hemoglobin in group B was significantly higher from 32 weeks onward, until 6 weeks postpartum. There were no significant differences in any of the secondary outcomes examined. Conclusions: In twin pregnancies complicated by iron deficiency anemia, doubling the dose of iron increases hemoglobin and ferritin without worsening gastrointestinal side effects.

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Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽

10.1177/17085381211010022 ◽

2021 ◽

pp. 170853812110100

Author(s):

Mohamed Shukri Abdelgawad ◽

Amr M El-Shafei ◽

Hesham A Sharaf El-Din ◽

Ehab M Saad ◽

Tamer A Khafagy ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Radiofrequency Ablation ◽

Controlled Trial ◽

Compression Therapy ◽

Randomized Controlled ◽

Venous Ulcers ◽

Group A ◽

Group B ◽

To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

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Saccharomyces boulardii Combined With Quadruple Therapy for Helicobacter pylori Eradication Decreased the Duration and Severity of Diarrhea: A Multi-Center Prospective Randomized Controlled Trial

Frontiers in Medicine ◽

10.3389/fmed.2021.776955 ◽

2021 ◽

Vol 8 ◽

Author(s):

Yuchong Zhao ◽

Yilei Yang ◽

Aruna ◽

Jun Xiao ◽

Jun Song ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Side Effects ◽

Controlled Trial ◽

Saccharomyces Boulardii ◽

Quadruple Therapy ◽

Severe Diarrhea ◽

Randomized Controlled ◽

Group A ◽

H Pylori ◽

Group B

Background: Whether probiotics helped the Helicobacter pylori (H. pylori) eradication was still highly controversial. The non-bacterial Saccharomyces boulardii (S. boulardii) has demonstrated its efficacy in the treatment of antibiotic-associated and infectious diarrhea. We aimed to evaluate the effects of S. boulardii combined with quadruple therapy for H. pylori eradication and associated side effects.Methods: Three hundred and sixty H. pylori-infected patients were recruited in this multicenter, randomized controlled trial. The patients who underwent H. pylori eradication treatment were randomized in a ratio of 1:1 into two separate groups that received standard quadruple therapy (Group A) and quadruple therapy plus S. boulardii sachets (Group B) for 14 days. The everyday medication and side-effect records were collected for compliance and adverse effect analysis. All patients accepted 13C/14C-urea breath tests 4 weeks after the therapy completion.Results:Saccharomyces boulardii and quadruple therapy-combined intervention significantly reduced the incidences of overall side effects (27.8 vs. 38.5%, p = 0.034) and diarrhea (11.2 vs. 21.2%, p = 0.012) in Group B compared with quadruple therapy alone in Group A, especially reduced the diarrhea duration (5.0 days vs. 7.7 days, p = 0.032) and incidence of severe diarrhea (4.7 vs. 10.1%, p = 0.040). Intention-to-treat (ITT) analysis and per-protocol (PP) analysis both indicated no statistical differences of eradication rate between Groups A and B (ITT: 82.7 vs. 85.8%, p = 0.426; PP: 89.7 vs. 94.2%, p = 0.146). The joint use of S. boulardii and quadruple therapy markedly improved the overall pre-eradication alimentary symptoms (hazard ratio (HR): 2.507, 95% CI: 1.449–4.338) recovery.Conclusion:Saccharomyces boulardii ameliorated H. pylori eradication-induced antibiotic-associated side effects especially reduced the incidence of severe diarrhea and the duration of diarrhea. However, there was no significant effect of S. boulardii on the rate of H. pylori eradication.Trial Registration: The protocol had retrospectively registered at ClinicalTrails.gov, Unique identifier: NCT03688828, date of registration: September 27, 2018; https://clinicaltrials.gov/show/NCT03688828

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A Randomized Controlled Trial of Misoprostol and Sulprostone to End Pregnancy after Fetal Death

Obstetrics and Gynecology International ◽

10.1155/2009/496320 ◽

2009 ◽

Vol 2009 ◽

pp. 1-8 ◽

Cited By ~ 6

Author(s):

Kristin Van Mensel ◽

Filip Claerhout ◽

Patrick Debois ◽

Marc J. N. C. Keirse ◽

Myriam Hanssens

Keyword(s):

Randomized Controlled Trial ◽

Side Effects ◽

Pain Perception ◽

Fetal Death ◽

Controlled Trial ◽

Freedom Of Movement ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Gastrointestinal Side Effects ◽

Vaginal Misoprostol

Objective. To compare effectiveness, side effects, and patients' perception of vaginal misoprostolversusintravenous sulprostone for ending pregnancy after fetal death between 14 and 42 weeks gestation.Method. Multicenter randomized controlled trial, using block randomization, central allocation, and prior power analysis.Outcome measures. Induction-delivery interval, gastrointestinal side effects, use of analgesia, pain perception, pyrexia, placental retention, hemorrhage, and women's opinions.Results. Of 176 women aimed for, 143 were randomized over 7 years, of whom 4 were excluded. There was no difference in delivery within 24 and 36 hours: 91.4% and 97.1% with misoprostol ()versus85.5% and 92.8% with sulprostone (). There was no difference in either gastrointestinal side effects, as reported by the women and their caregivers, use of analgesia, women's pain perception, blood loss or placental retention. Hyperthermia 38°C was more common with misoprostol (24.3%) than with sulprostone (11.6%; difference: +12.7%; 95% CI: +1.2% to +25.3%) and related to the total dose used. Acceptability of both induction methods was similar except for freedom of movement, which was substantially in favor of misoprostol (lack of freedom reported with misoprostol in 34.3%versus63.8% with sulprostone; difference: −29.5%; 95% CI: −13.6% to −45.4%).Conclusions. Misoprostol and sulprostone are similarly effective with little difference in side effects except for hyperthermia, related to the dose of misoprostol used, and women's reported lack of mobility with intravenous sulprostone. Effectiveness of both methods increased with gestational age.

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Efficacy of Tamsulosin plus Tadalafil versus Tamsulosin as Medical Expulsive Therapy for Lower Ureteric Stones: A Randomized Controlled Trial

Advances in Urology ◽

10.1155/2020/4347598 ◽

2020 ◽

Vol 2020 ◽

pp. 1-5

Author(s):

Diwas Gnyawali ◽

Manish Man Pradhan ◽

Prem Raj Sigdel ◽

Purushottam Parajuli ◽

Sampanna Chudal ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Side Effects ◽

Emergency Room ◽

Controlled Trial ◽

University Teaching ◽

Emergency Room Visits ◽

Medical Expulsive Therapy ◽

Randomized Controlled ◽

Group A ◽

Group B

Introduction. Urolithiasis is one of the common disorder with which about 1/5th is found in the ureter, of which 2/3rd is seen in the lower ureter. Medical expulsive therapy is one of the routine modalities of treatment which uses various drugs acting on the ureter smooth muscle by different mechanism. We aim to compare the efficacy of combination vs. single drug. Methods. This randomized controlled trial was done in 176 consecutive patients over a period of six months (March 2019 to August 2019) in Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching. Participants were divided into two groups (Group A, tamsulosin plus tadalafil, and Group B, tamsulosin) from computer-generated random numbers. Therapy was continued for a maximum of 3 weeks. Stone expulsion rate, time to stone expulsion, analgesic use, number of colic and emergency room visits for pain, early intervention, and adverse effects of drugs were recorded. Results. Among 176 patients who were enrolled in study, 7 were lost to follow-up, and 5 people required immediate intervention. There was a significant higher stone passage rate in group A than group B (64 vs. 50; P=0.025) and shorter expulsion time (1.66 vs. 2.32 weeks P=0.001) and less number of emergency room visits and colic episodes. No significant side effects were noted during study. Conclusion. Tamsulosin plus Tadalafil is more effective than tamsulosin with early passage of stone and decreased number of colic episodes and emergency visits without significant side effects for lower ureteric calculi of 5 mm to 10 mm.

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Phenobarbitone versus levetiracetam in neonatal seizures

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20203051 ◽

2020 ◽

Vol 7 (8) ◽

pp. 1701

Author(s):

Ravindra Kumar Jain ◽

Hemant Kumar

Keyword(s):

Adverse Effect ◽

Randomized Controlled Trial ◽

Side Effects ◽

Controlled Trial ◽

Good Alternative ◽

Preterm Neonates ◽

Neonatal Seizures ◽

Medical College ◽

Randomized Controlled ◽

To Receive

Background: There is increasing evidence that neonatal seizures have an adverse effect on neurodevelopmental progression and it may predispose to cognitive, behavioral or epileptic complications later in life. The objective of this study was to compare the efficacy of phenobarbitone and levetiracetam for the treatment of neonatal seizures in term and late preterm neonates. The study was aimed to know the efficacy of phenobarbitone (PB) in comparison with levetiracetam (LEV) in controlling neonatal seizures.Methods: This was a randomized controlled trial where data of the babies with seizures weighing more than 2 kg who were admitted in NICU of Muzaffarnagar Medical College was collected and analysed for intervention to either phenobarbitone or levetiracetam.Results: Clinically apparent seizures were controlled in only 65.38% neonates assigned to receive levetiracetam as compared to 76.92% neonates assigned to receive phenobarbitone.Conclusions: LEV although lesser effective than PB with very fewer side effects is found to be a good alternative in controlling neonatal seizures.

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Baclofen versus clonidine in the treatment of opiates withdrawal, side-effects aspect: a double-blind randomized controlled trial

Journal of Clinical Pharmacy and Therapeutics ◽

10.1046/j.1365-2710.2001.00325.x ◽

2001 ◽

Vol 26 (1) ◽

pp. 67-71 ◽

Cited By ~ 20

Author(s):

S. A. Ahmadi-Abhari ◽

S. Akhondzadeh ◽

S. M. Assadi ◽

O. L. Shabestari ◽

Z. M. Farzanehgan ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Side Effects ◽

Controlled Trial ◽

Double Blind ◽

Randomized Controlled

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Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04354-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Aaron Gazendam ◽

◽

Seper Ekhtiari ◽

Nolan S. Horner ◽

Nicole Simunovic ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Pain Control ◽

Shoulder Arthroscopy ◽

Controlled Trial ◽

Arthroscopic Surgery ◽

Standard Of Care ◽

Opioid Prescription ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Arthroscopic Knee

Abstract Background Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250).

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Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05077-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Rui Luo ◽

Fangfang Zheng ◽

Haobo Zhang ◽

Weiquan Zhu ◽

Penghui He ◽

...

Keyword(s):

Colorectal Cancer ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Natural Orifice ◽

Specimen Extraction ◽

Natural Orifice Specimen Extraction ◽

Robotic Assisted ◽

Randomized Controlled ◽

Robotic Assisted Surgery ◽

Secondary Outcomes

Abstract Background Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes. Method/design Accordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system. Discussion This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes. Trial registration ClinicalTrials.govNCT04230772. Registered on January 15, 2020.

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Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial

Trials ◽

10.1186/s13063-021-05060-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Edward C. Deehan ◽

Eloisa Colin-Ramirez ◽

Lucila Triador ◽

Karen L. Madsen ◽

Carla M. Prado ◽

...

Keyword(s):

Insulin Resistance ◽

Randomized Controlled Trial ◽

Combination Therapy ◽

Gut Microbiome ◽

Controlled Trial ◽

Fecal Microbiota ◽

Metabolic Effects ◽

Microbiota Composition ◽

Randomized Controlled ◽

Secondary Outcomes

Abstract Background Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the gut microbiome. Pre-clinical animal models have established that the addition of fiber to metformin monotherapy improves glucose tolerance. However, possible synergistic effects of combination therapy (metformin plus fiber) have not been investigated in humans. Moreover, the underlying mechanisms of synergy have yet to be elucidated. The aim of this study is to compare in adolescents with obesity the metabolic effects of metformin and fermentable fibers in combination with those of metformin or fiber alone. We will also determine if therapeutic responses correlate with compositional and functional features of the gut microbiome. Methods This is a parallel three-armed, double-blinded, randomized controlled trial. Adolescents (aged 12–18 years) with obesity, insulin resistance (IR), and a family history of type 2 diabetes mellitus (T2DM) will receive either metformin (850 mg p.o. twice/day), fermentable fibers (35 g/day), or a combination of metformin plus fiber for 12 months. Participants will be seen at baseline, 3, 6, and 12 months, with a phone follow-up at 1 and 9 months. Primary and secondary outcomes will be assessed at baseline, 6, and 12 months. The primary outcome is change in IR estimated by homeostatic model assessment of IR; key secondary outcomes include changes in the Matsuda index, oral disposition index, body mass index z-score, and fat mass to fat-free mass ratio. To gain mechanistic insight, endpoints that reflect host-microbiota interactions will also be assessed: obesity-related immune, metabolic, and satiety markers; humoral metabolites; and fecal microbiota composition, short-chain fatty acids, and bile acids. Discussion This study will compare the potential metabolic benefits of fiber with those of metformin in adolescents with obesity, determine if metformin and fiber act synergistically to improve IR, and elucidate whether the metabolic benefits of metformin and fiber associate with changes in fecal microbiota composition and the output of health-related metabolites. This study will provide insight into the potential role of the gut microbiome as a target for enhancing the therapeutic efficacy of emerging treatments for T2DM prevention. Trial registration ClinicalTrials.gov NCT04578652. Registered on 8 October 2020.

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