scholarly journals A randomized controlled trial on lactoferrin versus ferrous sulphate for the treatment of mild to moderate iron deficiency anaemia in pregnancy

2020 ◽  
Vol 9 (2) ◽  
pp. 562
Author(s):  
Swati Gawai ◽  
Michelle Fonseca ◽  
Deepali Kapote
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Ferrous Sulphate ◽  
Controlled Study ◽  
Promising Alternative ◽  
Randomized Controlled ◽  
Gastrointestinal Side Effects ◽  
Group A ◽  
Anaemia In Pregnancy

Background: One of the important factors associated with maternal and foetal complications during pregnancy is Anaemia. Various oral preparations of iron are available, and each has different bioavailability, efficacy and adverse effects. Lactoferrin is a naturally existing iron-binding multifunctional glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. Lactoferrin has considerably less gastrointestinal side effects than ferrous sulfate and is very useful as well as promising alternative to ferrous sulphate.Methods: Prospective randomized controlled study. Total 100 females with 24 to 36 weeks of pregnancy with haemoglobin between 8 to 10 grams were included out of which 50 patients were given ferrous sulphate 200 mg BD and 50 patients were given lactoferrin 250 mg BD daily for 8 weeks. Various haematological parameters and the adverse effects of both the drugs were studied at registration, 4 weeks and 8 weeks and compared.Results: Thus, after this study authors can say that the rise in haemoglobin with lactoferrin was 1.58 g/dl while with ferrous sulphate it was 1.67 g/dl at 8 weeks. Adverse effects were much lesser in Group A taking lactoferrin compared to Group B.Conclusions: Thus, lactoferrin has the advantage over ferrous sulphate in having   less side effects and increasing the compliance and thus the efficacy of the drug compared to ferrous sulphate.

scholarly journals EVALUATION OF EFFECTIVENESS OF AROGYA KASHAYAM-20 IN COVID-19 CASES - A RANDOMIZED CONTROLLED STUDY

2021 ◽  
Author(s):  
Umesh Shukla ◽  
Nitin Ujjaliya
Keyword(s):  
Controlled Trial ◽  
Care Center ◽  
Large Population ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Rt Pcr ◽  
Randomized Controlled ◽  
Group A ◽  
Negative Conversion

Introduction: The characteristic clinical features of Covid-19 disease range between asymptomatic to mild-moderate symptoms. Studies suggest that a large population (80%) presents its asymptomatic or milder form. Remaining 20 percent, owing to severity of the diseases, need hospital-based care. Many treatment protocols and strategies have been promoted and recommended by authorities including WHO, but nothing has actually been finalized till date. The present study was planned to evaluate the effectiveness of an Ayurvedic formulation viz. Arogya Kashayam-20 in the hospitalized cases of Covid-19.Aim: To evaluate the effectiveness of Arogya Kashayam-20 in the cases of COVID-19 particularly the negative conversion of RTPCR in 10 days duration.Material and Methods: This was a randomized controlled trial conducted at COVID-19 Care Center, Pt. Khushilal Sharma Government Ayurveda College & Institute, Bhopal, Madhya Pradesh with a sample size of 112 participants, aged between 16 to 60 years of either sex. Participants were divided in two groups viz. group A and B. Both the groups received Hydroxychloroquine (HCQ), vitamin C and Zinc as per the prevailing ICMR guidelines and group 'A' received additionally Arogya Kashayam-20 for 10 days. Outcome measure of the study was to see the negative conversion RT-PCR test after intervention period of 10 days. CTRI Registration: CTRI/2020/06/026221. Results: Among the 60 cases registered in study group (group A), 51 cases (85.00%) were reported with negative RTPCR on 10th day. Out of 52 cases registered in control group (group B); 39 cases (75.00%) were tested negative RTPCR on 10th day. In both the groups all the cases were discharged asymptomatically on 10th day as per the prevailing ICMR guidelines. No ADR/AE observed during the intervention period.Conclusion: The study observes that the add on intervention group has a better outcome in terms of RT-PCR negative reports after 10 days comparing to the control group.

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

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

Risk of infectious, hematological, and gastrointestinal side effects in patients treatedwith ibrutinib: A systematic review and meta-analysis of randomized controlled trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18265-e18265
Author(s):  
Myo Zaw ◽  
Kyaw Zin Thein ◽  
Aung Tun ◽  
Lukman Tijani ◽  
Elizabeth Guevara
Keyword(s):  
Systematic Review ◽  
Side Effects ◽  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Chemokine Receptors ◽  
Meta Analysis ◽  
Controlled Trials ◽  
High Grade ◽  
Randomized Controlled ◽  
Gastrointestinal Side Effects

e18265 Background: Bruton’s tyrosine kinase (BTK) is essential for signaling of B-cell and chemokine receptors. Ibrutinib targets BTK and has become frontier in many hematologic malignancies. We undertook systematic review and pooled analysis of randomized controlled trials (RCTs) to determine infectious, hematological and gastrointestinal risks associated with ibrutinib. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts through December 31, 2016. The RCTs that mention infectious, hematological and gastrointestinal side effects as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% confidence interval (CI). Results: Four RCTs with a total of 1505 patients were eligible for the analysis. Studies compared Ibrutinib (I) vs ofatumumab, I vs chlorambucil, I+ bendamustine (B)+ rituximab (R) vs placebo + B+ R and I vs temsirolimus were included in the analysis. The relative risks (RR) of all-grade side effects were as follows: infection, 1.34 (95% CI: 1.04 – 1.74; p = 0.02); pneumonia, 1.16 (95% CI: 0.82–1.66; p = 0.38); anemia, 0.77 (95% CI: 0.64 – 0.93; p = 0.007); neutropenia, 0.99 (95% CI: 0.87 – 1.14; p = 0.98); thrombocytopenia, 0.86 (95% CI: 0.71 – 1.04; p = 0.12); diarrhea, 1.74 (95% CI: 1.48 – 2.05; p < 0.0001); nausea, 0.94 (95% CI: 0.80 – 1.10; p = 0.45); and vomiting, 0.98 (95% CI 0.74 – 1.30; p = 0.93). The RR of high-grade adverse effects were as follows: febrile neutropenia, 1.32 (95% CI: 0.84 – 2.08; p = 0.21); infection, 1.20 (95% CI: 0.73 – 1.98; p = 0.45); pneumonia, 1.22 (95% CI: 0.76–1.95; p = 0.39); anemia, 0.48 (95% CI: 0.33 – 0.71; p < 0.0001); neutropenia, 0.99 (95% CI: 0.86 – 1.15; p = 0.94); thrombocytopenia, 0.61 (95% CI: 0.47 – 0.81; p = 0.001); diarrhea, 1.72 (95% CI: 0.88 – 3.34;p = 0.10); nausea, 2.56 (95% CI: 0.59 – 10.99; p = 0.20); and vomiting, 0.42 (95% CI 0.11 – 1.63; p = 0.21). Conclusions: Ibrutinib increased the risk of all-grade diarrhea and infection whereas the risks of all-grade anemia, high-grade anemia and thrombocytopenia were significantly lower in the study arm, favoring ibrutinib.

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

2009 ◽  
Vol 2009 ◽  
pp. 1-8 ◽  
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.

scholarly journals The side-effects of different doses of iron sulfate on women of reproductive age: a randomized double-blind, placebo-controlled study

2011 ◽  
Vol 11 (3) ◽  
pp. 275-281 ◽  
Author(s):  
Katia Maria de Melo Machado ◽  
Luiz Oscar Cardoso Ferreira ◽  
Ariani Impieri de Souza ◽  
Alcides da Silva Diniz
Keyword(s):  
Side Effects ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Iron Sulfate ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Main Complaint ◽  
Gastrointestinal Side Effects ◽  
Different Doses

OBJECTIVES: to identify side effects of the use of different doses of iron sulfate (IS). METHODS: an eight-week randomized, double blind, placebo-controlled trial was carried out involving 727 women aged 20-49 years between October 2005 and October 2006. The women were randomly allocated into eight groups with daily or twice-weekly doses administered during or in between meals. The information was obtained by weekly telephone contact. Analysis involved comparison of the proportion of complaints from the different groups. RESULTS: of 726 women initially selected, 74.2% completed eight weeks of follow up. In the regimens containing IS 95.2% of women reported gastrointestinal complaints. More complaints were reported for daily doses than for ones (p <0.001). Those taken between meals were associated with more nausea than those taken during meals (p<0.001). Of the 95 women who withdrew from the experiment, 88.4% belonged to the IS group and diarrhea was the main complaint (29.8%). CONCLUSIONS: the use of iron sulfate was associated with gastrointestinal side effects, especially when taken daily and diarrhea was the main complaint associated with IS.

scholarly journals Mefenamic Acid for the Prevention of Bleeding and Spotting From Depot-medroxyprogesterone Acetate: A Randomized Controlled Trial

2021 ◽  
Vol 9 (4) ◽  
pp. 291-294
Author(s):  
Jen Sothornwit ◽  
Yuthapong Werawatakul ◽  
Orathai Saenbon
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Medroxyprogesterone Acetate ◽  
Mefenamic Acid ◽  
Controlled Trial ◽  
Acid Group ◽  
Self Report ◽  
Controlled Study ◽  
Depot Medroxyprogesterone Acetate ◽  
Randomized Controlled

Objectives: To evaluate the efficacy of mefenamic acid for the reduction of bleeding and spotting in post-partum women initiating the use of depot-medroxyprogesterone acetate (DMPA) for contraception. Materials and Methods: This double-blind, placebo-controlled study included postpartum breastfeeding women in Khon Kaen, Thailand. Mefenamic acid or placebo was administered over the first 12 weeks of DMPA use. Then, participants completed a self-report bleeding diary. Results: Forty women, initiating the use of DMPA for postpartum contraception, were randomized to mefenamic acid (n=20) or placebo (n=20) group. The study was discontinued after 27 months because of suboptimal enrollment. The mefenamic acid group was less likely to have prolonged bleeding compared to placebo although this was not statistically significant (37.5% vs. 50%, respectively, P = 0.491). DMPA discontinuation rates were high at 50% in both groups although no participants in the mefenamic acid group stopped using DMPA due to bleeding side effects. Conclusions: The high discontinuation rates in the postpartum use of DMPA are attributed to the occurrence of bleeding/spotting side effects. Although mefenamic acid prophylaxis appeared to be beneficial to some women, a larger randomized controlled trial is required to confirm the effectiveness of this approach.

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

2017 ◽  
Vol 20 (5) ◽  
pp. 419-424 ◽  
Author(s):  
Shiri Shinar ◽  
Avital Skornick-Rapaport ◽  
Sharon Maslovitz
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Iron Deficient ◽  
Gastrointestinal Side Effects ◽  
Secondary Outcomes ◽  
Group B ◽  
To Receive ◽  
Twin Pregnancies

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.

scholarly journals Comparison of Conventional and Newer Iron Preparations for the Treatment of Iron Deficiency Anaemia in Children

2020 ◽  
Vol 24 (2) ◽  
pp. 112-116
Author(s):  
Asmat Perveen ◽  
Naima Fazil Raja ◽  
Imran Mahmood Khan ◽  
Hijab Shaheen ◽  
Muhammad Imran ◽  
...  
Keyword(s):  
Side Effects ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Controlled Trial ◽  
Ferrous Sulphate ◽  
Study Groups ◽  
Deficiency Anemia ◽  
Systematic Sampling ◽  
Gastrointestinal Side Effects ◽  
Group 2

Introduction: Commonly used iron salt, ferrous sulphate for the treatment of iron deficiency anemia, has several gastrointestinal side effects. Nowadays new iron salts such as ferrous bisglycinate are marketed with claims of raising hemoglobin faster with fewer gastrointestinal side effects. Objective: To compare the efficacy of ferrous sulphate with ferrous bisglycinate for the treatment of iron deficiency anemia in children. Methods: This randomized controlled trial was carried out at Children Hospital, PIMS, Islamabad from July 2015 to June 2016. A total of 136 children were selected through systematic sampling and randomized into 2 groups using a computer-generated table of random numbers; ferrous sulphate as group 1 and ferrous bisglycinate as group 2. Clinical outcome was assessed on the basis of a mean increase in hemoglobin after 12 weeks of therapy in both groups. The data was entered and analyzed using SPSS version 20.   Results: The baseline characteristics i.e. mean age, mean hemoglobin levels were similar in both study groups. After 12 weeks of treatment, the mean increase in hemoglobin was 1.8  ±1.59 g/dl in ferrous sulphate group as compare to 2.5  ±1.31g/dl in ferrous bisglycinate group showing the higher level of rising with ferrous bisglycinate than ferrous sulphate, P =0.0033. Conclusion: Newer iron preparation, ferrous bisglycinate is a better treatment option than conventional preparation of ferrous sulphate for increasing hemoglobin in iron deficiency anemia in children.

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

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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