Double-blind Randomized Clinical Trial Research Articles

A double-blind randomized clinical trial on the suggestive effect of anxiety management questionnaires in dental emergencies.

Dental anxiety is widespread among both children and adults. To diagnose dental anxiety, standardized anxiety questionnaires are recommended. Based on the suggestive nature of the questionnaires, the study aimed to find out whether asking respondents about personal coping strategies before dental treatment influences their anxiety. This prospective, double-blind, randomized controlled clinical trial included a total of 158 patients of a university dental clinic on emergency service. The intervention group (n = 82) received the Coping with Anxiety Questionnaire (CAQ) and the control group (n = 76) the Hierarchical Anxiety Questionnaire (HAF). State anxiety scores were assessed by using the State-Trait Anxiety Inventory (STAI) before and after the completion of each questionnaire. Anxiety decreased in the intervention group (CAQ) (p < 0.001) and increased in the control group (HAF) (p < 0.001). Within the limitations of the current study, a diagnostic tool of a standardized questionnaire for the assessment to assess personal coping strategies decreased state anxiety in comparison to a questionnaire assessing anxiety. https://www.drks.de, German Trials Register (DRKS00032450).

Patient perspectives and experiences with psilocybin treatment for treatment-resistant depression: a qualitative study

Psilocybin is the most researched classic psychedelic for Treatment-Resistant Depression (TRD). While optimizing set and setting are considered essential for efficacy and safety, patient perspectives on these aspects have rarely been investigated. To address this knowledge gap, the current paper explored the experiences of 11 TRD patients (8 women, 3 men) participating in a double-blind randomized clinical trial with a single session of oral (1, 10 or 25 mg) psilocybin treatment. After qualitative analysis, three major themes were identified: (1) challenges with trust-building and expectation management; (2) navigating the experience; and (3) the need for a more comprehensive treatment. Subthemes of the first theme include a general distrust in mental healthcare, trust in study therapists, limited time for preparation, and managing expectations. The second theme included the following subthemes: trusting to surrender, profound and overwhelming experiences, and music as a guide. The third theme addressed a desire for multiple psilocybin sessions, and challenges with sensemaking. Patients’ perspectives provided important insights into potential optimization of psilocybin treatment of TRD, including individualized preparation, investment in trust-building, offering additional psilocybin sessions, providing access to sustained (psycho)therapy with trusted therapists, and personalizing treatment approaches, which may also enhance real-world adaption of these treatments.

Phytocannabinoids and gingival inflammation: Preclinical findings and a placebo-controlled double-blind randomized clinical trial with cannabidiol.

The aim of this study was to: (1) evaluate the anti-inflammatory effects of cannabidiol (CBD) on primary cultures of human gingival fibroblasts (HGFs) and (2) to clinically monitor the effect of CBD in subjects with periodontitis. The use of phytocannabinoids is a new approach in the treatment of widely prevalent periodontal disease. Cannabinoid receptors were analyzed by western blot and interleukin production detected using enzyme immunoassay. Activation of the Nrf2 pathway was studied via monitoring the mRNA level of heme oxygenase-1. Antimicrobial effects were determined by standard microdilution and 16S rRNA screening. In the clinical part, a placebo-control double-blind randomized study was conducted (56 days) in three groups (n = 90) using dental gel without CBD (group A) and with 1% (w/w) CBD (group B) and corresponding toothpaste (group A - no CBD, group B - with CBD) for home use to maintain oral health. Group C used dental gel containing 1% chlorhexidine digluconate (active comparator) and toothpaste without CBD. Human gingival fibroblasts were confirmed to express the cannabinoid receptor CB2. Lipopolysaccharide-induced cells exhibited increased production of pro-inflammatory IL-6 and IL-8, with deceasing levels upon exposure to CBD. CBD also exhibited antimicrobial activities against Porphyromonas gingivalis, with an MIC of 1.5 μg/mL. Activation of the Nrf2 pathway was also demonstrated. In the clinical part, statistically significant improvement was found for the gingival, gingival bleeding, and modified gingival indices between placebo group A and CBD group B after 56 days. Cannabidiol reduced inflammation and the growth of selected periodontal pathogenic bacteria. The clinical trial demonstrated a statistically significant improvement after CBD application. No adverse effects of CBD were reported by patients or observed upon clinical examination during the study. The results are a promising basis for a more comprehensive investigation of the application of non-psychotropic cannabinoids in dentistry.

The Effect of Botulinum Toxin (Masport) Injection Following Internal Urethrotomy of Bulbar Urethral Stricture: A Pilot Study.

The application of Botulinum toxin (Masport) in urology has a long history. We aimed to assess the effect of local Masport on improvement in patients with urethral stricture by reducing the recurrence of urethral stricture. This pilot study conducted was a double-blind randomized clinical trial with code IRCT20191222045852N1 on patients suffering from urethral stricture. Finally, 28 patients were allocated to intervention and control groups. Twelve patients received intralesional injection with Masport in addition to internal urethrotomy, while 16 patients underwent internal urethrotomy with normal saline. The Cox regression hazard model was used to evaluate the effect of treatment status on recurrence time adjusted for the age, length, and location of the stenosis, cause of the stenosis, and history of previous operations. The effect of treatment type was significant at the .05 level. The past medical history and cause of urethral stricture had a significant impact on relapse-free survival. Also, the improvement in the mean score of the EuroQol Visual Analogue Scale (EQ-VAS), International Prostate Symptom Score (IPSS), and Q-max in the group with Masport was significantly different from the group with normal saline. The internal urethrotomy with intralesional injection of Masport has a better survival prognosis than internal urethrotomy with normal saline group. Therefore, the authors suggest that, given this successful initial clinical trial, consideration be given to future studies involving the use of botox in the management of urethral strictures in conjunction with internal urethrotomy.

A preliminary report comparing the effect of Asafoetida with oral contraceptive on polycystic ovarian syndrome in a double-blind randomized trial.

Polycystic ovarian syndrome (PCOS) is the most common cause of infertility and endocrine disorders in women of childbearing age. In Persian medicine, Ferula assafoetida L. (Asafoetida) was recommended for treating PCOS. The present study was conducted to compare the effect of Asafoetida with oral contraceptive tablets on PCOS patients. Patients with PCOS (n=30) were enrolled in a double-blind randomized clinical trial. On Day 5 of the menstrual cycle, patients received two periods of 21-day treatment, with 7 days rest between the two treatments. On a daily basis, half of the patients (n=15) received Asafoetida (1 g), and the rest received low dose oral contraceptive (LD; one tablet). Menstrual status, anthropometric characteristics, hematology and biochemistry parameters, ovarian ultrasound examination and hirsutism were evaluated prior to the initiation of the experiment and 14 days after the end of treatment. The occurrence of menstrual cycles and pregnancy was assessed eight months after the end of treatment. The incidence of pregnancy was greater in patients who received Asafoetida compared to those who received LD (p=0.019). The time intervals between menstrual cycles became shorter in both groups (p<0.05). The occurrence of regular menstrual cycles remained longer in the Asafoetida compared to the LD group (p=0.001). Concentrations of triglycerides, cholesterol, HDL and LDL were significantly increased after treating with LD (p<0.05). In PCOS patients, the occurrence of regular menstrual cycles and the incidence of pregnancy were improved following treatment with Asafoetida. This medicament could be considered a safe treatment for patients with PCOS.

Evaluation of oral nano-curcumin efficacy on respiratory function and quality of life in patients with bronchial non-atopic asthma: A randomized controlled trial.

Asthma is a common disease and curcumin has modest effect in inflammatory disorders. This study investigated the efficacy of nano-curcumin on asthma. In this double-blinded randomized clinical trial, 60 patients with non-atopic bronchial asthma were randomly stratified in two groups of intervention (N=30) and control (N=30) groups. Apart from their standard treatment, the intervention group received 40 mg nano-curcumin (soft gel) three times daily while the control group received placebo. During the 60-day study, patients were assessed using spirometry to measure Forced expiratory volume in first second (FEV1). Asthma control test (ACT) was completed every 30 days and asthma quality of life questionnaire (AQLQ) was completed at the first and end of the study. Totally, 31 patients (51.7%) were male and the mean age was 51.45±12.58 years. FEV1 was improved but there was no significant difference between intervention and control groups. ACT and AQLQ domains scores significantly improved. However, it was not statistically different between control and intervention groups. Nano-curcumin at administered dosage had no additive effect on the standard treatment in asthmatic patients.

A diffusion decision model analysis of the cognitive effects of neurofeedback for ADHD.

To examine cognitive effects of neurofeedback (NF) for attention-deficit hyperactivity disorder (ADHD) as a secondary outcome of a randomized clinical trial. In a double-blind randomized clinical trial (NCT02251743), 133 7-10-year olds with ADHD received either 38 sessions of NF (n = 78) or control treatment (n = 55) and performed an integrated visual and auditory continuous performance test at baseline, mid- and end-treatment. We used the diffusion decision model to decompose integrated visual and auditory continuous performance test performance at each assessment into cognitive components: efficiency of integrating stimulus information (v), context sensitivity (cv), response cautiousness (a), response bias (z/a), and nondecision time for perceptual encoding and response execution (Ter). Based on prior findings, we tested whether the components known to be deficient improved with NF and explored whether other cognitive components improved using linear mixed modeling. Before NF, children with ADHD showed main deficits in integrating stimulus information (v), which led to less accurate and slower responses than healthy controls (p = .008). The NF group showed significantly more improvement in integrating auditory stimulus information (v) than control treatment (significant group-by-time-by-modality effect: p = .044). NF seems to improve v, deficient in ADHD. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Cognitive-Motor Training Improves Reading-Related Executive Functions: A Randomized Clinical Trial Study in Dyslexia.

Children with developmental dyslexia (DD) often struggle with executive function difficulties which can continue into adulthood if not addressed. This double-blinded randomized clinical trial study evaluated the short-term effects of the Verbal Working Memory-Balance (VWM-B) program on reading-related executive functions, reading skills, and reading comprehension in Persian children with DD. The active control group [12 children with DD with a mean age of 9 years (SD = 0.90)] received training using the single-task VWM program, while the experiment group [15 children with DD with a mean age of 8 years (SD = 0.74)] received training with the dual-task VWM-B program. Both groups received fifteen training sessions, and assessments were conducted before and after the intervention. The groups were homogenized for possible confounders of age, gender, IQ level, and attention level. The study employed separate mixed ANOVA analyses to estimate the impact of training programs on various measured functions. Significant improvements were observed in the outcome measures of backward digit span, text comprehension, verbal fluency, Stroop color-word test and interference, and the reading subtests. Additionally, significant correlations were found between reading skills and backward digit span, text comprehension, verbal fluency, and Stroop variables. In conclusion, the dual-task VWM-B program was found to be more effective than the single-task VWM program in improving selective attention, cognitive inhibition, verbal working memory capacity, information processing speed, naming ability, and lexical access speed. These enhanced executive functions were associated with improved reading skills in children with DD.

Effectiveness of promethazine on preoperative and intraoperative sequelae in cleft palate surgeries.

Anxiety and nosocomial infection are the most common reported problems in children undergoing cleft surgeries. Research shows that there is an enigma in the use of antihistamine therapy in children for the management of upper respiratory tract infection. 'Promethazine' is a first-generation H1 receptor antagonist, and antihistamine also has strong sedative effects. Our study aims at evaluating the Effectiveness of Promethazine (Phenergan) in preoperative and intra operative sequelae in cleft surgeries. This is a single-centre, parallel, randomized, double-blinded randomized control clinical trial, which was conducted among 128 children between 2 and 4 years of age undergoing cleft palate surgery under general anaesthesia. After randomization, the case group was subjected to promethazine syrup 1 mg/kg body weight twice a day, orally for 3 days. The primary outcomes were preoperative anxiety levels which were recorded by children fear scale. The secondary outcomes include preoperative sleep quality and cough rate of children which are recorded by using sleep and cough objective scale respectively. The intraoperative heart rate is monitored with an ECG connected to a monitor. Promethazine causes a reduction in the anxiety level by 70%, 64% reduction in cold and cough, improvement in sleep score by 70% and the heart rate was found to be stable throughout the surgery when compared to the control group. As the benefits of promethazine in cleft palate surgery rule over its adverse effects, promethazine is considered safe to be used as premedication for children undergoing cleft palate surgeries.

Changes in the Sprint, Vertical Jump and Quadriceps Strength after a Capacitive Resistive Electric Transfer Therapy Intervention-A Randomized Clinical Trial.

Generating large mechanical power during actions such as sprinting or jumping is a crucial factor in many sports. These types of actions require a good warm-up activation. Capacitive-Resistive Electric Transfer (CRET) is a non-invasive therapy based on the application of radio frequency electric currents within the range of 300 kHz-1.2 MHz to accelerate tissue metabolic activity. This study aimed to evaluate the effectiveness of adding CRET to an active warm-up protocol in young adult athletes. For the double-blind randomized clinical trial, 60 healthy athletes were recruited and divided into an Experimental group (EG) and a Sham group (SG). EG received a CRET protocol in addition to an active warm-up. SG carried out the same warm-up but with a placebo CRET. The main outcome measures were isometric extension force, countermovement-jump (CMJ), 30 m-sprint test, and surface electromyography (sEMG). There is no statistically significant interaction (group-time) for any of the variables studied. Significant main effects for time were found in isometric extension force (p = 0.008); 30 m sprint (p = 0.017); rectus femoris sEMG during CMJ (p = 0.002); vastus lateralis sEMG during CMJ (p = 0.012); vastus medialis during CMJ (p = 0.010) and rectus femoris sEMG during the 30 m sprint test (p = 0.012). Non-significant differences between means are observed in the isometric extension force (48.91 EG; 10.87 SG) and 30 m sprint (-0.13 EG; -0.04 SG) variables. To conclude, a non-significant tendency was observed in sprint and quadriceps strength following CRET therapy, compared to the individuals' pre-treatment state. Future research should use more treatment sessions to observe this tendency.

Can Pharmacological Conditioning as an Add-On Treatment Optimize Standard Pharmacological Treatment in Patients with Recent-Onset Rheumatoid Arthritis? A Proof-of-Principle Randomized Clinical Trial.

Medication regimens using conditioning via variable reinforcement have shown similar or improved therapeutic effects as full pharmacological treatment, but evidence in patient populations is scarce. This proof-of-principle double-blind randomized clinical trial examined whether treatment effects in recent-onset rheumatoid arthritis (RA) can be optimized through pharmacological conditioning. After four months of standardized treatment (n = 46), patients in clinical remission (n = 19) were randomized to the Control group (C), continuing standardized treatment (n = 8), or the Pharmacological Conditioning (PC) group, receiving variable treatment according to conditioning principles (n = 11). After eight months, treatment was tapered and discontinued linearly (C) or variably (PC). Standard treatment led to large improvements in disease activity and HRQoL in both groups. The groups did not differ in the percentage of drug-free clinical remission obtained after conditioning or continued standard treatment. The PC group did show a larger decrease in self-reported disease activity (Cohen's d = 0.9) and a smaller increase in TNF-α levels (Cohen's d = 0.7) than the C group. During all phases, more differences between groups were found for the patients who followed protocol than for the intention-to-treat sample. Although the results are not conclusive, pharmacological conditioning may have some advantages in terms of disease progression and stability, especially during the conditioning phase, compared with standard clinical treatment. The effects may be particularly beneficial for patients who show a good initial response to increased medication dosages.

Effect of oral silymarin on liver function in pediatric acute lymphoblastic leukemia in the maintenance phase: a double-blind randomized clinical trial.

Introduction: Liver dysfunction is one of the most common disorders in patients with acute lymphoblastic leukemia (ALL). In recent studies, silymarin has been observed to have hepatic protective effects. Therefore, in this study, the effect of oral silymarin on the hepatic functions of patients with ALL was investigated. Methods: In the present double-blind clinical trial study, 121 patients with ALL over 5years of age were divided into two groups after obtaining informed consent. The subjects were randomly divided into a silymarin-treatment group and a placebo group. In the silymarin-treatment group, patients received 70mg oral capsules of silymarin twice daily or syrup of silymarin three times a day (each 5ml of syrup contains 50mg of silymarin). Patients were examined once a month for 9months to receive capsules and measure the levels of alanine aminotransferase (ALT), aspartate transferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), bilirubin, albumin, and cholesterol. Results: Comparison of changes before and after treatment in the two groups showed that receiving oral silymarin resulted in a slight significant decrease in the levels of ALT, AST, GGT, and bilirubin (p < 0.05), but had no effect on ALP, albumin, and cholesterol (p > 0.05). Discussion: The results of the present study showed that in pediatric patients with ALL, silymarin intake improves liver function. The very strong antioxidant effect of silymarin may explain its protective effect on the liver. Clinical Trial Registration: IRCT20150119020715N10.

Adjuvant administration of probiotic effects on sexual function in depressant women undergoing SSRIs treatment: a double-blinded randomized controlled trial

BackgroundAccording to the Institute of Health Metrics and Evaluation’s Global Health Data Exchange (2023) it is estimated that 5% of all adults will experience depressive disorder. Amongst the general loss of pleasure and interest in everyday activities that are symptoms of low mood, reduced sexual desire and sexual dysfunction can be particularly overlooked. Human sexuality is complex, but finding solutions based on scientific evidence to limit the symptoms of depressive disorder and the iatrogenic impact of antidepressant treatment to improve this outcome is an important step in promoting psychological health and general wellbeing.ObjectiveThe present study aimed is to provide scientific evidence to assess the effect of oral probiotic on sexual function in women with depressive disorder treated with Selective Serotonin Reuptake Inhibitors (SSRIs) in an Iranian population.DesignThis study was a double-blind randomized clinical trial. Eligible women were assigned to lactofem plus SSRIs (n = 58) or SSRIs alone (n = 54). In group A, SSRI antidepressants were prescribed together with Lactofem, and in group B, SSRI antidepressants were prescribed alone. Lactofem including Lactobacillus acidophilus 2 × 109 cfu/g, Bifidobacterium bifidus 2 × 109 cfu/g, Lactobacillus rutri 2 × 109 cfu/g, Lactobacillus fermentum 2 × 109 cfu/g; capsule weight of 500 mg bio-capsule administered orally and daily. The duration of intervention in two groups was two months. All questionnaires were completed by the patients before and after the intervention. The Female Sexual Function Index (FSFI), Hamilton Depression Rating Scale and Larson's Sexual Satisfaction Questionnaire were used to evaluate sexual function, severity of depressive disorder and sexual satisfaction, respectively.ResultsBased on the results of the present study, there was a statistically significant difference in sexual satisfaction and severity of depressive disorder between the groups before and after the intervention (P < 0.05). Also, our findings showed that after eight weeks, the Lactofem plus SSRIs group showed significant improvement in FSFI domains and total scores compared to SSRIs alone group (P < 0.05).ConclusionsThe results of the present study show that taking probiotics for eight weeks may improve the severity of depressive disorder, sexual function and sexual satisfaction in depressed women treated with SSRIs.Trial registrationClinicalTrials.govidentifier: IRCT20160524028038N14 (19/12/2022)

Immunogenicity and reactogenicity following MMR vaccination in 5–7-month-old infants: a double-blind placebo-controlled randomized clinical trial in 6540 Danish infants

Measles is a highly contagious viral disease. Vaccinated mothers transfer fewer antibodies during pregnancy, resulting in shortened infant immunity. Earlier primary vaccination might avert the gap in protection. Healthy 5-7-month-old Danish infants were assigned in a 1:1 ratio to M-M-RVaxPro or placebo (solvent) in a double-blind, randomized trial between April 15, 2019 and November 1, 2021 (ClinicalTrials.govNCT03780179, EudraCT 2016-001901-18). Eligibility criteria were birth weight >1000g and gestational age ≥32 weeks.Immunogenicity was measured by plaque reduction neutralization test (PRNT) and IgG ELISA before intervention, four weeks after intervention and routine MMR. Reactogenicity data were collected for six weeks and measured by hazard ratios (HR). 647 and 6540 infants participated in the immunogenicity and reactogenicity study, respectively; 87% and 99% completed follow-up. After early MMR, seroprotection rates (SPRs) were 47% (13%) in measles PRNT; 28% (2%), 57% (8%) in mumps and rubella IgG (placebo). For measles PRNT, geometric mean ratio was 4.3 (95% CI: 3.4-5.3) between randomization groups after intervention and 1.5 (95% CI: 1.3-1.9) after routine MMR.Reactogenicity was independent of randomization (HR, 1.0; 95% CI: 0.9-1.1). Severe adverse events occurred in 25 infants (HR, 1.8; 95% CI: 0.8-4.0); none deemed vaccine related. Early MMR elicited low SPRs but did not negatively impact short-term responses to a subsequent MMR. MMR at 5-7 months was safe and not associated with higher rates of reactogenicity than placebo. Innovation Fund Denmark.

Selenium supplementation and placebo are equally effective in improving quality of life in patients with hypothyroidism.

We investigated whether selenium supplementation improves quality-of-life (QoL) in patients with autoimmune thyroiditis (ID:NCT02013479). We included 412 patients ≥18 years with serum thyroid peroxidase antibody (TPOAb) level ≥100 IU/mL in a multicentre double-blinded randomised clinical trial. The patients were allocated 1:1 to daily supplementation with either 200 μg selenium as selenium-enriched yeast or matching placebo tablets for 12 months, as add-on to levothyroxine (LT4) treatment. QoL, assessed by the Thyroid-related Patient-Reported-Outcome questionnaire (ThyPRO-39), was measured at baseline, after six weeks, three, six, 12, and 18 months. In total, 332 patients (81%) completed the intervention period, of whom 82% were women. Although QoL improved during the trial, no difference in any of the ThyPRO-39 scales was found between the selenium group and the placebo group after 12 months of intervention. In addition, employing linear mixed model regression no difference between the two groups was observed in the ThyPRO-39 composite score (28.8 [95%CI:24.5-33.6] and 28.0 [24.5-33.1], respectively; P=0.602). Stratifying the patients according to duration of the disease at inclusion, ThyPRO-39 composite score, TPOAb level, or selenium status at baseline did not significantly change the results. TPOAb levels after 12 months of intervention were lower in the selenium group than in the placebo group (1995 [95%CI:1512-2512] vs. 2344 kIU/L [1862-2951]; P=0.016) but did not influence LT4 dosage or free triiodothyronine/free thyroxin ratio. In hypothyroid patients on LT4 therapy due to autoimmune thyroiditis, daily supplementation with 200 μg selenium or placebo for 12 months improved QoL to the same extent.

Evaluation of the efficacy of N-acetylcysteine and bromhexine compared with standard care in preventing hospitalization of outpatients with COVID-19: a double blind randomized clinical trial

Introduction and aimSince its emergence in December 2019, the coronavirus disease caused by the severe acute respiratory syndrome coronavirus 2 has become a global emergency, spreading rapidly worldwide. In response to the early referral of these patients to outpatient health centers, we decided to seek more effective treatments in the early stages of their referral. This study aims to prevent both the progression and deterioration of the physical conditions of COVID-19 patients, reduce the rate of referrals, and mitigate the risks of hospitalization and death. Material and methodsConducted at Dibaj Therapeutic Center, Hamadan City, Iran, a double-blind randomized controlled trial encompassed 225 COVID-19 patients from April to September 2022. Ethical approval was obtained from Hamadan University of Medical Sciences (Approval No.: IR.UMSHA.REC.1400.957), with the protocol registered in the Iranian Registry of Clinical Trials (Registration No. : IRCT20220302054167N1). In this study, we included patients who tested positive for COVID-19- PCR and were symptomatic, excluding those who were pregnant or had received a COVID-19 vaccine. Patients with oxygen saturation above 92% were allocated to three groups: Group A received N-acetylcysteine, Group B received Bromhexine, and Group C received standard care. Follow-ups on oxygen levels, symptoms, and hospitalization needs were conducted on days 7 and 14, with hospitalized patients monitored for one month post-hospitalization. ResultsThe study found that both N-acetylcysteine and Bromhexine can effectively reduce hospitalization rates and mortality and shorten the duration of hospitalization. The third visit of patients who received N-acetylcysteine showed an increase of 1.33% in oxygen saturation compared to their first visit, and in patients who received Bromhexine, this increase was 1.19%. The mortality rate was 9.33% in the control group and zero in both groups of patients who received medication. ConclusionIn conclusion, the results of this study indicate that NAC and bromhexine may be effective in the treatment of patients with positive COVID-19, with a lower hospitalization rate, shorter hospitalization, faster recovery time, and reduced mortality compared to the control group.

Adding L-carnitine to antagonist ovarian stimulation doesn’t improve the outcomes of IVF/ ICSI cycle in patients with polycystic ovarian syndrome: a double-blind randomized clinical trial

ObjectiveTo investigate the effect of L-carnitine supplementation during the controlled ovarian stimulation (COS) cycle with antagonist protocol in patients with polycystic ovary syndrome (PCOS) diagnosis undergoing IVF/ICSI treatment.Methods and materialsThis was a double-blind clinical trial study including 110 patients with PCOS attended to Royan Institute between March 2020 and February 2023. At the beginning of the COS cycle, the eligible patients were allocated into two groups randomly according to the coding list of the drugs prepared by the statistical consultant. In the experimental group, patients received 3 tablets daily (L-carnitine 1000 mg) from the second day of menstruation of the previous cycle until the puncture day in the cases of freeze-all embryos (6 weeks) or until the day of the pregnancy test (8 weeks) in fresh embryo transfer cycle. In the control group, patients received 3 placebo tablets for the same period of time. Weight assessment and fasting blood sugar and insulin tests, as well as serum lipid profile were also measured at the baseline and ovum pick-up day. The results of the COS cycle as well as the implantation and pregnancy rates were compared between groups.ResultsFinally, 45 cases in L-carnitine group versus 47 cases in the placebo group were completed study per protocol. Data analysis showed that the two groups were homogeneous in terms of demographic characteristics and baseline laboratory tests and severity of PCOS. There is no statistically significant difference in terms of the oocyte recovery ratio and oocyte maturity rate, and the number and quality of embryos, as well as the rates of the fertilization, chemical and clinical pregnancy between groups. However, the means of weight (P < 0.001) and serum levels of fasting blood sugar (P = 0.021), fasting insulin (P = 0.004), triglyceride (P < 0.001) and cholesterol (P < 0.001), LDL (P < 0.001) have significantly decreased in women after consuming L-carnitine supplementation.ConclusionThe oral intake of L-carnitine during COS in PCOS women for 6 weeks had no effect on COS and pregnancy outcomes. However, taking this supplement for 6 weeks has been associated with weight loss and improved lipid profile and serum glucose.Trial registrationThe study was registered in the Clinicaltrials.gov site on December 17, 2020 (NCT04672720).

Effect of grape-based syrup on cancer-related fatigue in patients with breast cancer: a double-blind randomized clinical trial

Effect of grape-based syrup on cancer-related fatigue in patients with breast cancer: a double-blind randomized clinical trial

Midazolam reduction with pre-operative melatonin in abdominal hysterectomy: double-blind randomized clinical trial

Midazolam reduction with pre-operative melatonin in abdominal hysterectomy: double-blind randomized clinical trial

Statement of Retraction: Effect of multivitamin versus multivitamin-mineral supplementation on metabolic profiles and biomarkers of oxidative stress in pregnant women: a double-blind randomized clinical trial

Statement of Retraction: Effect of multivitamin versus multivitamin-mineral supplementation on metabolic profiles and biomarkers of oxidative stress in pregnant women: a double-blind randomized clinical trial