scholarly journals Preventive effect of greater occipital nerve block on patients with episodic migraine: A randomized double‐blind placebo‐controlled clinical trial

Cephalalgia ◽  
2021 ◽  
pp. 033310242110581
Author(s):  
Nazila Malekian ◽  
Pouya B Bastani ◽  
Shahram Oveisgharan ◽  
Ghaemeh Nabaei ◽  
Siamak Abdi
Keyword(s):  
Side Effects ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Episodic Migraine ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Greater Occipital Nerve Block ◽  
Greater Occipital Nerve ◽  
Registration Number

Objective Since the data regarding the efficacy of greater occipital in episodic migraines are rare, we aimed to examine the efficacy of greater occipital block in the prophylaxis of episodic migraines without aura and compare different injectable drug regimens. Methods In a randomized, double-blind placebo-controlled trial, adult patients suffering from episodic migraines without aura were randomized to one of the following: triamcinolone, lidocaine, triamcinolone plus lidocaine, and saline. Patients were assessed at baseline, one week, two weeks, and four weeks after the injection for severity and duration of headaches and side effects. Results Fifty-five patients completed the study. Repeated measures ANOVA indicated that the severity and duration decreased significantly after the greater occipital block (P < 0.001, P = 0.001 respectively) in all four groups. However, there was no difference between groups at any study time points (P > 0.05). In paired sample T-test, only groups 2 and 3 with lidocaine as a part of the injection showed a significant decrease in frequency compared to the baseline (P = 0.002, P = 0.019). Three patients reported side effects with a possible association with triamcinolone. Conclusion Greater occipital block with a local anesthetic significantly decreases the number of attacks in episodic migraine, whereas no injection was superior to the placebo in regards to the duration and severity of the headaches. Trial Registration Information: Iranian Registry of Clinical Trials (IRCT). Registration number: IRCT2017070334879N1. https://www.irct.ir/trial/26537 .

scholarly journals Effect of antenatal dietary myo-inositol supplementation on the incidence of gestational diabetes mellitus and fetal outcome: protocol for a double-blind randomised controlled trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e055314
Author(s):  
Ibrahim Ibrahim ◽  
Hala Abdullahi ◽  
Yassin Fagier ◽  
Osman Ortashi ◽  
Annalisa Terrangera ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Controlled Trial ◽  
Tolerance Test ◽  
Dietary Advice ◽  
Controlled Clinical Trial ◽  
Oral Glucose ◽  
Double Blind ◽  
Registration Number

IntroductionGestational diabetes mellitus (GDM) affects 23.6% of Qatari women and is associated with maternal and perinatal morbidity and long-term risk of developing type 2 diabetes. A number of challenges exist with current interventions, including non-compliance with dietary advice, the reluctance of mothers to ingest metformin tablets or use insulin injections. These challenges highlight the importance of pursuing evidence-based prevention strategies. Myo-inositol is readily available as an US Food and Drug Administration-approved food supplement with emerging but limited evidence suggesting it may be beneficial in reducing the incidence of GDM. Further studies, such as this one, from different ethnic contexts and with differing risk factors, are urgently needed to assess myo-inositol effects on maternal and neonatal outcomes.Methods and analysisThis study is a prospective, randomised, double-blinded, placebo controlled clinical trial to either myo-inositol supplementation or placebo.We plan to enrol 640 pregnant women attending antenatal care at Sidra Medicine, Doha, Qatar, 320 in each arm. All participants will complete at least 12 weeks of supplementation prior to undertaking the Oral Glucose Tolerance Test at 24–28 weeks. The daily use of the trial supplementation will continue until the end of pregnancy. All outcome measures will be collected from the electronic medical records.Ethics and disseminationEthical approval for the study was obtained on 12 April 2021 from Sidra Medicine (IRB number 1538656). Results of the primary trial outcome and secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberProspectively registered on 26 May 2021. Registration number ISRCTN16448440 (ISRCTN registry).

10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebo-controlled trial

2020 ◽  
pp. bmjsrh-2020-200670
Author(s):  
Nalinee Panichyawat ◽  
Theethat Mongkornthong ◽  
Thanyarat Wongwananuruk ◽  
Korakot Sirimai
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Reproductive Age ◽  
Double Blind ◽  
Lidocaine Group ◽  
Double Blind Placebo ◽  
Registration Number ◽  
Group A ◽  
Lidocaine Spray

BackgroundVarious medications have been investigated for their efficacy in pain reduction during intrauterine device (IUD) insertion, but there is currently no standard recommendation. This study aimed to investigate the efficacy of 10% lidocaine spray in reducing pain during copper-containing intrauterine device (Cu-IUD) insertion.MethodsThis study was a randomised, double-blind, placebo-controlled trial. Reproductive-age women were randomised at a 1:1 ratio into 10% lidocaine spray or placebo spray group. A 10 cm visual analogue scale (VAS) was used to evaluate pain during several steps of the IUD insertion procedure, and after the procedure.ResultsOne hundred and twenty-four women were included and 62 women were randomised in each group. Baseline characteristics between groups were similar. The 10% lidocaine spray group demonstrated significantly lower median VAS immediately after IUD insertion than the placebo group (2.95 (IQR=1.00–5.63) vs 5.00 (IQR=3.35–7.00), respectively; p=0.002). Similarly, women receiving 10% lidocaine spray reported significantly lower median VAS than those receiving placebo during tenaculum use and uterine sounding. The maximum median VAS occurred immediately after Cu-IUD insertion. The proportion of women who reported VAS≥4 during uterine sounding and after IUD placement was significantly lower in the 10% lidocaine group than in the placebo group (p<0.05). Median change in VAS from baseline to IUD placement was significantly different between 10% lidocaine spray group and placebo group (1.85 (IQR=0.08–4.03) vs 3.6 (IQR=2.40–5.80), respectively; p=0.004).Conclusion10% lidocaine spray was found to be an effective local anaesthetic method for reducing pain during insertion of Cu-IUD.Trial registration numberClinicaltrials.gov NCT03870711

scholarly journals The Effect of Antioxidant Supplementation in Patients with Tinnitus and Normal Hearing or Hearing Loss: A Randomized, Double-Blind, Placebo Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 3037 ◽  
Author(s):  
Anna I. Petridou ◽  
Eleftheria T. Zagora ◽  
Petros Petridis ◽  
George S. Korres ◽  
Maria Gazouli ◽  
...  
Keyword(s):  
Oxidized Ldl ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Antioxidant Compounds ◽  
Antioxidant Supplementation ◽  
Post Intervention ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Total Antioxidant ◽  
Post Measure

Tinnitus is the perception of sound in the absence of any external stimulus. Oxidative stress is possibly involved in its pathogenesis and a variety of antioxidant compounds have been studied as potential treatment approaches. The objective of the present study was to assess the effects of antioxidant supplementation in tinnitus patients. This is a randomized, double-blind, placebo-controlled clinical trial. Patients (N = 70) were randomly allocated to antioxidant supplementation (N = 35) or to placebo (N = 35) for a total of 3 months. Demographic, anthropometric, clinical, and nutritional data were collected. Serum total antioxidant capacity (TAC), oxidized LDL (oxLDL), and superoxide dismutase (SOD), tinnitus loudness, frequency, and minimum masking level (MML), and scores in Tinnitus Handicap Inventory questionnaire (THI), Tinnitus Functional Index (TFI), and Visual Analogue Scale (VAS) were evaluated at baseline and follow-up. Tinnitus loudness and MML significantly decreased from baseline to post measure (p < 0.001) only in the antioxidant group, the overall change being significantly different between the two groups post-intervention (p < 0.001). THI and VAS decreased only in the antioxidant group. Differences in changes in serum TAC, SOD, and oxLDL post-intervention were insignificant. In conclusion, antioxidant therapy seems to reduce the subjective discomfort and tinnitus intensity in tinnitus patients.

scholarly journals Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placebo-controlled clinical trial in the Netherlands

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036735
Author(s):  
Lisa Smit ◽  
Zoran Trogrlić ◽  
John W Devlin ◽  
Robert-Jan Osse ◽  
Huibert H Ponssen ◽  
...  
Keyword(s):  
Intensive Care ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Neurological Injury ◽  
Study Endpoint ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Icu Discharge

IntroductionDelirium in critically ill adults is associated with prolonged hospital stay, increased mortality and greater cognitive and functional decline. Current practice guideline recommendations advocate the use of non-pharmacological strategies to reduce delirium. The routine use of scheduled haloperidol to treat delirium is not recommended given a lack of evidence regarding its ability to resolve delirium nor improve relevant short-term and longer-term outcomes. This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.Methods and analysisEuRIDICE is a prospective, multi-centre, randomised, double-blind, placebo-controlled trial. Study population consists of adult intensive care unit (ICU) patients without acute neurological injury who have delirium based on a positive Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU) assessment. Intervention is intravenous haloperidol 2.5 mg (or matching placebo) every 8 hours, titrated daily based on ICDSC or CAM-ICU positivity to a maximum of 5 mg every 8 hours, until delirium resolution or ICU discharge. Main study endpoint is delirium and coma-free days (DCFD) up to 14 days after randomisation. Secondary endpoints include (1) 28-day and 1-year mortality, (2) cognitive and functional performance at 3 and 12 months, (3) patient and family delirium and ICU experience, (4) psychological sequelae during and after ICU stay, (4) safety concerns associated with haloperidol use and (5) cost-effectiveness. Differences in DCFDs between haloperidol and placebo group will be analysed using Poisson regression analysis. Study recruitment started in February 2018 and continues.Ethics and disseminationThe study has been approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam (MEC2017-511) and by the Institutional Review Boards of the participating sites. Its results will be disseminated via peer-reviewed publication and conference presentations.Trial registrationNCT03628391

Effects of Helichrysum Psudoplicatum supplementation on pruritus intensity, fatigue, quality of life and anorexia in hemodialysis patients: a randomized, double-blind placebo-controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Maryam Mohajeranirad ◽  
Naser Saeidi ◽  
Mohammad Kamali Nejad ◽  
Amir Almasi-Hashiani ◽  
Mehdi Salehi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Dialysis Patients ◽  
Time Duration ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Objectives Anorexia, fatigue and pruritus are common complications of hemodialysis (HD) patients. Today, the use of medicinal plants is more than synthetic drugs due to their safety. Therefore, we designed a randomized controlled clinical trial to evaluate the effects of Helichrysum psudoplicatum (H. psudoplicatum) supplementation on biochemical parameters, pruritus intensity, fatigue, quality of life and anorexia in HD patients. Methods This randomized, double-blind, placebo-controlled trial was performed on 50 subjects with, aged 55–65 years old. HD patients were randomly divided into two groups. Intervention group received 250 mg/day of H. psudoplicatum supplement capsule for 6 weeks (n=25), and the placebo group was given placebo capsule for the same time duration and dosage (n=25). The serum concentrations of urea, creatinine, albumin and hemoglobin were measured enzymatically methods. Anorexia, pruritus intensity, quality of life the dialysis patients with pruritus and fatigue score was measured using a Simplified Nutritional Appetite Questionnaire (SNAQ), Numerical rating scale (NRS), Fatigue severity scale (FSS) and ItchyQoL questionnaire, respectively. Shapiro–Wilk and independent-samples t-test or Mann–Whitney test were used for the analysis of the data. Results The results showed that the H. psudoplicatum supplementation significantly improved the pruritus intensity, quality of life the dialysis patients with pruritus and fatigue in HD patients, for 6 weeks (p<0.001). However, it did not significantly effect on the anorexia, albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05). Conclusions According to the results of this study, H. psudoplicatum supplementation can be effective as an adjunct therapy to improve pruritus intensity, quality of life, fatigue and relative improvement of anorexia in HD patients.

Efficacy of individualized homeopathic medicines in primary dysmenorrhea: a double-blind, randomized, placebo-controlled, clinical trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Shubhamoy Ghosh ◽  
Rai Khushboo Ravindra ◽  
Amila Modak ◽  
Shukdeb Maiti ◽  
Arunava Nath ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Rating Scales ◽  
Controlled Trial ◽  
Attrition Rate ◽  
Effect Sizes ◽  
Secondary Outcome ◽  
Systematic Research ◽  
Controlled Clinical Trial ◽  
Serious Adverse Events ◽  
Double Blind

Abstract Objectives Homeopathic treatment is claimed to be beneficial for primary dysmenorrhoea (PD); still, systematic research evidences remain compromised. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IH) against placebo in the treatment of PD. Methods A double-blind, randomized, placebo-controlled trial was conducted at the gynecology outpatient department of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IH (n=64) or identical-looking placebo (n=64). Primary and secondary outcome measures were 0–10 numeric rating scales (NRS) measuring intensity of pain of dysmenorrhea and verbal multidimensional scoring system (VMSS) respectively; all measured at baseline, and every month, up to 3 months. Group differences and effect sizes (Cohen’s d) were calculated on intention-to-treat (ITT) sample. Results Groups were comparable at baseline (all p>0.05). Attrition rate was 10.9% (IH: 7, placebo: 7). Differences between groups in both pain NRS and VMSS favoured IH over placebo at all time points (all p<0.001, unpaired t-tests and two-ways repeated measures analysis of variance) with medium to large effect sizes. Natrum muriaticum and Pulsatilla nigricans (n=20 each; 15.6%) were the most frequently prescribed medicines. No harms, serious adverse events and intercurrent illnesses were recorded in either of the groups. Conclusions Homeopathic medicines acted significantly better than placebo in the treatment of PD. Independent replication is warranted. Trial registration: CTRI/2018/10/016013.

scholarly journals Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
A. A. Harandi ◽  
R. Abolfazli ◽  
A. Hatemian ◽  
K. Ghragozlee ◽  
M. Ghaffar-Pour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Treatment Group ◽  
Repeated Measures ◽  
Motor Recovery ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Stroke Treatment ◽  
Double Blind Placebo

Objective. To investigate the safety and efficacy of MLC601 (NeuroAid) as a traditional Chinese medicine on motor recovery after ischemic stroke.Methods. This study was a double-blind, placebo-controlled clinical trial on 150 patients with a recent (less than 1 month) ischemic stroke. All patients were given either MLC601 (100 patients) or placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard stroke treatment for 3 months.Results. Sex, age, elapsed time from stroke onset, and risk factors in the treatment group were not significantly different from placebo group at baseline (P>.05). Repeated measures analysis showed that Fugl-Meyer assessment was significantly higher in the treatment group during 12 weeks after stroke (P<.001). Good tolerability to treatment was shown, and adverse events were mild and transient.Conclusion. MLC601 showed better motor recovery than placebo and was safe on top of standard ischemic stroke medications especially in the severe and moderate cases.

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