scholarly journals A possible preventive effect of low-dose fish oil on early delivery and pre-eclampsia: Indications from a 50-year-old controlled trial

1990 ◽  
Vol 64 (3) ◽  
pp. 599-609 ◽  
Author(s):  
Sjúrður F. Olsen ◽  
Niels J. Secher
Keyword(s):  
Confidence Interval ◽  
Fish Oil ◽  
Low Dose ◽  
Controlled Trial ◽  
Control Group ◽  
Controlled Trials ◽  
Preventive Effect ◽  
High Quality ◽  
Average Birth Weight ◽  
In Pregnancy

A preventive effect of dietary marinen−3 fatty acids on early delivery and toxaemia has recently been hypothesized. In only one published controlled trial fish oil has been given to pregnant women, namely in that conducted during 1938–9 in London by the People's League of Health with a dietary supplement containing vitamins, minerals, and halibut liver oil. Although it was of high quality and its findings are hitherto unexplained, neglect and misinterpretation of the trial seem to occur commonly in reviews. Of the 5644 women who were enrolled the 622 withdrawals were independent of treatment. Alternate allocation to treatment was used, producing two groups that were well balanced as to age and parity. The supplement was given from about week 20. The control group did not receive any supplement. Reductions of 20.4% (95% confidence interval 9–30%,P= 0.00083) and 31.5% (95% confidence interval 11–47%,P= 0.0047) were seen in odds of delivering before 40 weeks of gestation and pre-eclampsia respectively. No significant effects were seen on perinatal mortality, average birth weight, deliveries after 40 weeks, hypertension in the absence of oedema and proteinuria, duration of labour, sepsis or breast-feeding occurrence. Later controlled trials with vitamins or minerals given in the same amounts as in this trial have largely failed to show convincing effects as seen here. A controlled trial assessing the isolated effects of fish oil in pregnancy is warranted.

scholarly journals Fish oil in recent onset rheumatoid arthritis: a randomised, double-blind controlled trial within algorithm-based drug use

2013 ◽  
Vol 74 (1) ◽  
pp. 89-95 ◽  
Author(s):  
Susanna M Proudman ◽  
Michael J James ◽  
Llewellyn D Spargo ◽  
Robert G Metcalf ◽  
Thomas R Sullivan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Fish Oil ◽  
Low Dose ◽  
Controlled Trial ◽  
Smoking History ◽  
Treat To Target ◽  
Control Group ◽  
High Dose ◽  
Dmard Therapy ◽  
Early Ra

BackgroundThe effects of fish oil (FO) in rheumatoid arthritis (RA) have not been examined in the context of contemporary treatment of early RA. This study examined the effects of high versus low dose FO in early RA employing a ‘treat-to-target’ protocol of combination disease-modifying anti-rheumatic drugs (DMARDs).MethodsPatients with RA <12 months’ duration and who were DMARD-naïve were enrolled and randomised 2:1 to FO at a high dose or low dose (for masking). These groups, designated FO and control, were given 5.5 or 0.4 g/day, respectively, of the omega-3 fats, eicosapentaenoic acid + docosahexaenoic acid. All patients received methotrexate (MTX), sulphasalazine and hydroxychloroquine, and DMARD doses were adjusted according to an algorithm taking disease activity and toxicity into account. DAS28-erythrocyte sedimentation rate, modified Health Assessment Questionnaire (mHAQ) and remission were assessed three monthly. The primary outcome measure was failure of triple DMARD therapy.ResultsIn the FO group, failure of triple DMARD therapy was lower (HR=0.28 (95% CI 0.12 to 0.63; p=0.002) unadjusted and 0.24 (95% CI 0.10 to 0.54; p=0.0006) following adjustment for smoking history, shared epitope and baseline anti–cyclic citrullinated peptide. The rate of first American College of Rheumatology (ACR) remission was significantly greater in the FO compared with the control group (HRs=2.17 (95% CI 1.07 to 4.42; p=0.03) unadjusted and 2.09 (95% CI 1.02 to 4.30; p=0.04) adjusted). There were no differences between groups in MTX dose, DAS28 or mHAQ scores, or adverse events.ConclusionsFO was associated with benefits additional to those achieved by combination ‘treat-to-target’ DMARDs with similar MTX use. These included reduced triple DMARD failure and a higher rate of ACR remission.

scholarly journals Effect of Hope-oriented group counseling on mental health of infertile women with failed IVF cycles: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Roya Rahimi ◽  
Shirin Hasanpour ◽  
Mojgan. Mirghafourvand ◽  
Khalil Esmaeilpour
Keyword(s):  
Mental Health ◽  
Confidence Interval ◽  
Group Counseling ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
The Mean ◽  
And Control

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women’s mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles. Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 min sessions (once a week). The control group only received routine care to undergo another IVF cycle. The Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale were filled out by interviewing the participants before the intervention and one week and one month after the intervention. After intervention 26 participants in each group were included in the analysis. Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (adjusted mean difference = − 1.7, 95% confidence interval: − 3.2 to − 0.3, P = 0.018) and depression (adjusted mean difference = − 1.3, 95% confidence interval: − 4.7 to − 1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (adjusted mean difference = − 1.1, 95% confidence interval: − 2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (adjusted mean difference = 6.9, 95% confidence interval: 5.1 to 8.8, P < 0.001). Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles. Trial registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019.

scholarly journals Design and analysis of a clinical trial using previous trials as historical control

2019 ◽  
Vol 16 (5) ◽  
pp. 531-538 ◽  
Author(s):  
David Alan Schoenfeld ◽  
Dianne M Finkelstein ◽  
Eric Macklin ◽  
Neta Zach ◽  
David L Ennist ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Amyotrophic Lateral Sclerosis ◽  
Sample Size ◽  
Standard Error ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Control Group ◽  
Controlled Trials ◽  
Number Of Patients ◽  
Lateral Sclerosis

Background/AimsFor single arm trials, a treatment is evaluated by comparing an outcome estimate to historically reported outcome estimates. Such a historically controlled trial is often analyzed as if the estimates from previous trials were known without variation and there is no trial-to-trial variation in their estimands. We develop a test of treatment efficacy and sample size calculation for historically controlled trials that considers these sources of variation.MethodsWe fit a Bayesian hierarchical model, providing a sample from the posterior predictive distribution of the outcome estimand of a new trial, which, along with the standard error of the estimate, can be used to calculate the probability that the estimate exceeds a threshold. We then calculate criteria for statistical significance as a function of the standard error of the new trial and calculate sample size as a function of difference to be detected. We apply these methods to clinical trials for amyotrophic lateral sclerosis using data from the placebo groups of 16 trials.ResultsWe find that when attempting to detect the small to moderate effect sizes usually assumed in amyotrophic lateral sclerosis clinical trials, historically controlled trials would require a greater total number of patients than concurrently controlled trials, and only when an effect size is extraordinarily large is a historically controlled trial a reasonable alternative. We also show that utilizing patient level data for the prognostic covariates can reduce the sample size required for a historically controlled trial.ConclusionThis article quantifies when historically controlled trials would not provide any sample size advantage, despite dispensing with a control group.

scholarly journals Effect of Low-Dose (Single-Dose) Magnesium Sulfate on Postoperative Analgesia in Hysterectomy Patients Receiving Balanced General Anesthesia

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Arman Taheri ◽  
Katayoun Haryalchi ◽  
Mandana Mansour Ghanaie ◽  
Neda Habibi Arejan
Keyword(s):  
Single Dose ◽  
Postoperative Pain ◽  
General Anesthesia ◽  
Magnesium Sulfate ◽  
Pain Score ◽  
Normal Saline ◽  
Low Dose ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group

Background and Aim. Aparallel, randomized, double blinded, placebo-controlled trial study was designed to assess the efficacy of single low dose of intravenous magnesium sulfate on post-total abdominal hysterectomy (TAH) pain relief under balanced general anesthesia.Subject and Methods. Forty women undergoing TAH surgery were assigned to two magnesium sulfate (N=20) and normal saline (N=20) groups randomly. The magnesium group received magnesium sulfate 50 mg·kg−1in 100 mL of normal saline solution i.v as single-dose, just 15 minutes before induction of anesthesia whereas patients in control group received 100 mL of 0.9% sodium chloride solution at the same time. The same balanced general anesthesia was induced for two groups. Pethidine consumption was recorded over 24 hours precisely as postoperative analgesic. Pain score was evaluated with Numeric Rating Scale (NRS) at 0, 6, 12, and 24 hours after the surgeries.Results. Postoperative pain score was lower in magnesium group at 6, 12, and 24 hours after the operations significantly (P<0.05).Pethidinerequirement was significantly lower in magnesium group throughout 24 hours after the surgeries (P=0.0001).Conclusion. Single dose of magnesium sulfate during balanced general anesthesia could be considered as effective and safe method to reduce postoperative pain and opioid consumption after TAH.

scholarly journals Do low-dose corticosteroids improve survival or shock reversal from septic shock in adults? Meta-analysis with trial sequential analysis

2018 ◽  
Vol 46 (7) ◽  
pp. 2513-2524 ◽  
Author(s):  
Rui Xu ◽  
Qian Wang ◽  
Yan Huang ◽  
Ling Wu ◽  
Qi Liu ◽  
...  
Keyword(s):  
Septic Shock ◽  
Relative Risk ◽  
Confidence Interval ◽  
Sequential Analysis ◽  
Low Dose ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Trial Sequential Analysis ◽  
Control Group ◽  
Shock Reversal

Objective This meta-analysis with trial sequential analysis (TSA) was performed to determine whether low-dose corticosteroids (LDCs) can improve survival or shock reversal from septic shock in adults. Methods A literature search was performed using several databases (Medline, Cochrane Library, Embase, and Chinese Biological Medical Database) until 23 October 2017. The systematic review was registered in PROSPERO. Results Nine randomized controlled trials (RCTs) (n = 1182) were included. LDC intervention improved 7-day shock reversal compared with the control group (relative risk, 1.36; TSA-adjusted 95% confidence interval, 1.20–1.54). LDCs had no statistically significant effects on gastrointestinal bleeding or superinfection. LDCs did not reduce 28-day mortality from septic shock (relative risk, 0.96; TSA-adjusted 95% confidence interval, 0.74–1.24). The TSA indicated that RCTs of about 3000 patients would be needed to draw definitive conclusions; similar results were obtained in a subgroup analysis of nonresponders. Conclusions LDCs improve 7-day shock reversal. However, whether LDCs improve 28-day survival from septic shock in adults remains unclear. The results of well-designed larger RCTs are needed.

scholarly journals Does pregabalin effectively and safely relieve postoperative pain in patients undergoing pulmonary resections?

2019 ◽  
Vol 29 (4) ◽  
pp. 555-560 ◽  
Author(s):  
Shuangjiang Li ◽  
Wenbiao Zhang ◽  
Shan Cheng ◽  
Yongjiang Li
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Perioperative Period ◽  
Control Group ◽  
Controlled Trials ◽  
Clinical Question ◽  
Randomized Controlled ◽  
Study Type

Summary A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was whether pregabalin could effectively and safely reduce postoperative pain in patients undergoing pulmonary resections. Altogether 23 papers were found using the reported search, of which 6 randomized controlled trials represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Five of 6 randomized controlled trials demonstrated that the application of oral pregabalin during the perioperative period could effectively reduce postoperative pain after pulmonary resections without compromising patients’ safety. One randomized controlled trial reported no difference in the postoperative pain levels between the pregabalin group and the control group. The rates of adverse effects were generally found to be decreased in patients who received pregabalin compared to the patients who received routine analgesia, although 2 studies reported significantly higher incidences of mild drowsiness and dizziness among the pregabalin-treated patients. Currently available evidence supports that the perioperative administration of pregabalin can effectively and safely relieve postoperative pain for patients undergoing pulmonary resections.

scholarly journals Acupuncture Efficacy on Ischemic Stroke Recovery

Stroke ◽  
2015 ◽  
Vol 46 (5) ◽  
pp. 1301-1306 ◽  
Author(s):  
Shihong Zhang ◽  
Bo Wu ◽  
Ming Liu ◽  
Ning Li ◽  
Xianrong Zeng ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Standard Care ◽  
Controlled Trial ◽  
Health Gain ◽  
Institutional Care ◽  
Stroke Recovery ◽  
Control Group ◽  
Clinical Trial Registration

Background and Purpose— Acupuncture is a frequently used complementary treatment for ischemic stroke in China but the evidence available from previous randomized trials is inconclusive. The objective of this study was to assess the efficacy and safety of acupuncture in a more robustly designed larger scale trial. Methods— This is a multicenter, single-blinded, randomized controlled trial. Eight hundred sixty-two hospitalized patients with limb paralysis between 3 to 10 days after ischemic stroke onset were allocated acupuncture plus standard care or standard care alone. The acupuncture was applied 5 times per week for 3 to 4 weeks. The primary outcomes were defined as follows: (1) death/disability according to Barthel index and (2) death/institutional care at 6 months. Results— There was a tendency of fewer patients being dead or dependent in acupuncture group (80/385, 20.7%) than in control group (102/396, 25.8%) at 6 months (odds ratio, 0.75; 95% confidence interval, 0.54–1.05). The benefit was noted in subgroup receiving ≥10 sessions of acupuncture (odds ratio, 0.68; 95% confidence interval, 0.47–0.98). There was no statistical difference in death or institutional care between the 2 groups (odds ratio, 1.06; 95% confidence interval, 0.63–1.79). Severe adverse events occurred in 7.6% and 8.3% of patients in the 2 groups, respectively. Conclusions— Acupuncture seemed to be safe in the subacute phase of ischemic stroke. If the potential benefits observed are confirmed in future larger study, the health gain from wider use of the treatment could be substantial. Clinical Trial Registration— URL: http://www.chictr.org/en/ . Unique identifier: ChiCTR-TRC-11001353.

Adjunctive metformin for antipsychotic-related hyperprolactinemia: A meta-analysis of randomized controlled trials

2017 ◽  
Vol 31 (5) ◽  
pp. 625-631 ◽  
Author(s):  
Wei Zheng ◽  
Xin-Hu Yang ◽  
Dong-Bin Cai ◽  
Gabor S Ungvari ◽  
Chee H Ng ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Serum Prolactin ◽  
Control Group ◽  
Controlled Trials ◽  
Large Sample Size ◽  
Weighted Mean ◽  
Randomized Controlled ◽  
Metformin Group

Hyperprolactinemia is a common and severe antipsychotic-induced adverse drug reaction. This meta-analysis of randomized controlled trials systematically examined the efficacy and safety of adjunctive metformin for antipsychotic-related hyperprolactinemia in schizophrenia patients. Two independent investigators searched, extracted, and synthesized data. Weighted mean differences and risk ratios with their 95% confidence intervals were calculated using random effect model. Four randomized controlled trials ( n=509) comparing adjunctive metformin ( n=253) with the control groups ( n=256), lasting 22.7 weeks of treatment, were included in the meta-analysis. The metformin group had significantly lower serum prolactin level at endpoint (four randomized controlled trials, n=501; weighted mean difference: −6.87 ug/L (95% confidence interval: −13.24 to −0.51), p=0.03; I2=80%) with “moderate quality” based on the grading of recommendations assessment, development, and evaluation system. In patients with menstrual disturbances, the rate of menstruation resumption was 66.7% in the metformin group and 4.8% in the control group. Adverse drug reactions and all-cause discontinuation (three randomized controlled trials, n=339, risk ratio: 0.76 (95% confidence interval: 0.29, 1.97), p=0.57; I2= 0%) were similar between the two groups. Adjunctive metformin appears to be effective and safe for reducing antipsychotic-induced hyperprolactinemia and prolactin-related symptoms in schizophrenia patients. Higher quality randomized controlled trials with a large sample size are warranted to confirm these findings.

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