Double-blind Randomized Clinical Trial Research Articles

Comparison of liposomal gel with and without addition of chamomile for prevention of radiation dermatitis in head and neck cancer patients: A randomized controlled trial

Background and purposeHead and neck cancer patients frequently develop radiation dermatitis (RD) during radiotherapy. We compared liposomal gel with and without chamomile extract for the prevention and management of RD in head and neck cancer patients undergoing radiotherapy. Materials and methodsSixty participants undergoing radiotherapy for the first time for head and neck cancer were recruited in a double-blind randomized clinical trial. Primary outcomes were the occurrence of dry desquamation and the cumulative dose of ionizing radiation at the first occurrence of dry desquamation. Secondary outcomes were the occurrence of erythema, moist desquamation, global RD, and participant self-reported symptoms. ResultsDry desquamation occurred in 76.9 % (95 % CI: 57.9, 89.0) of participants in the chamomile liposomal gel group and in 88.9 % (95 % CI: 71.9, 96.1) in the liposomal gel group (p = 0.43). The median cumulative dose of ionizing radiation when dry desquamation occurred was 48.0 Gy in the chamomile liposomal gel group and 40.0 Gy in the liposomal gel group. Fewer symptoms were reported in the chamomile liposomal gel group. ConclusionNo statistically significant differences in outcomes were found between the two groups, though the chamomile liposomal gel group presented with lower grades of RD than the liposomal gel group. In addition, when compared to the literature on other topical interventions to manage RD, our results show that chamomile liposomal gel has potential for better management and prevention of RD in this population, which should be further tested. This study provides crucial information to design future studies.Clinical Trials Registration (REBEC): RBR-92cts3.

Fingertip injuries: Does administration of antibiotics give benefits? A double-blind randomized controlled trial.

Adequate debridement and defect closure is an important treatment in fingertip injuries in addition to administration of antibiotic. However, administration of anitibiotics remains controversial whether it necessary for fingertip injuries that have been treated with adequate debridement and defect closure. The goal of study is to assess the differences of infection rate between subgroups with administration of antibiotics and without antibiotic in FTI treated by debridement and simple defect closure. The study design was a double-blind randomized clinical trial. Data collection was carried out at Cipto Mangunkusumo General Hospital, Jakarta and Tangerang Regency Hospital, Banten, in July 2022-February 2023. The target population of this study were adult patients with Fingertip injuries that treated by debridement and simple defect closures with antibiotics administration and without antibiotic. Infection was assessed at day-7, 14, and 21 follow-up. There were 31 FTI subjects with 41 fingers affected. The number of male subjects was 27 people and female subjects 4 people. The most affected finger was the little finger (12 fingers, 30.8%), with most type of Allen classification was type IV (18 fingers, 43.90%), most procedure performed was primary suture (24 fingers, 58.54%). 15 subjects randomized to antibiotic group and 16 subjects to no-antibiotic group. There was 1 subject of antibiotic group and 1 subject of no-antibiotic group has infection. There are no significant differences between two groups. There were no significant differences of infection rate between antibiotics administration and without antibiotic in FTI cases that treated by debridement and simple defect closures.

Effect of esketamine on haemodynamic fluctuations in patients undergoing hysteroscopic surgery: A prospective, double-blind randomized clinical trial.

We explored whether esketamine anesthesia during hysteroscopic surgery can reduce intraoperative hemodynamic fluctuations and improve patient benefit. A total of 170 patients undergoing hysteroscopic surgery were enrolled, and 151 patients were finally included in the analysis, among which 19 used vasoactive drugs during surgery. Patients were randomly assigned to either the esketamine anesthesia group (E group) or the sufentanil anesthesia group (S group). The primary outcomes were blood pressure and heart rate during the surgery. Secondary outcomes included resistance to laryngeal mask insertion, demand for propofol and remifentanil, nausea and vomiting, Richmond Agitation and Sedation Scale (RASS), dizziness and pain intensity after resuscitation, vasoactive medication treatment, hospitalization time and expenses. E group had a more stable heart rate, systolic blood pressure, diastolic blood pressure and mean blood pressure than the S group (p < 0.001). Patients in E group had a higher demand for propofol (p < 0.001) but better RASS scores (p < 0.001) after resuscitation. The incidence of intraoperative vasoactive medication use was higher in the S group (18.4% vs. 6.7%, p = 0.029). There were no statistically significant differences in terms of resistance to laryngeal mask insertion, remifentanil demand, time required for resuscitation, postoperative pain, dizziness, nausea or vomiting. Compared with sufentanil, esketamine-induced anesthesia during hysteroscopic surgery can reduce intraoperative hemodynamic fluctuations and the incidence of intraoperative vasoactive medication. Although esketamine-induced anesthesia may increase the demand for propofol during surgery, it does not affect the anesthesia recovery time and the quality of patient recovery is better.

A phase 2b double-blind placebo-controlled randomized clinical trial of SB-061, an aggrecan mimetic, in patients with symptomatic knee osteoarthritis

ObjectivesTo evaluate the efficacy and safety of intra-articular injections of a novel aggrecan mimetic, SB-061, in subjects with knee OA. MethodsThis was a randomized, placebo-controlled, double-blind phase II study comparing intra-articular injections of SB-061 with placebo (isotonic saline) for 52 weeks, administered at baseline, Wk 16, and Wk 32. Eligible subjects had a KL grade of 2 or 3 on X-ray of the target knee and a WOMAC pain score ≥20 out of 50 at screening and baseline visits. Subjects having any other knee condition were excluded. Use of analgesics was prohibited, except for rescue medication. The primary endpoint was change from baseline (CFB) in WOMAC pain at Week 8. Secondary endpoints were CFB in WOMAC function and total, ICOAP, PGA, and 20-meter walk test. Exploratory endpoints included structural CFB in MRI entities. Results288 subjects were randomized to SB-061 (n=145) or placebo (n=143), and 252 (87.5%) completed injections. The groups were comparable at baseline. The primary endpoint was not met, as no significant difference in the CFB of the WOMAC pain score at Week 8 between groups was observed, nor at any other time point during the study. Similarly, neither of the secondary or exploratory endpoints indicated any significant difference between groups. The frequency and type of adverse events was similar between groups. SB-061 was well-tolerated. ConclusionIntra-articular injections of SB-061 administered at baseline, Wk 16, and Wk 32, over one year in subjects with knee OA was safe but did not show any statistically significant effect on knee pain nor on other symptomatic or structural entities compared to placebo. Trial registration number EudraCT No2019-004515-31

Intraoperative Administration of Diphenhydramine Attenuates Postoperative Catheter Related Bladder Discomfort in Patient Following Percutaneous Nephrolithotomy

Background: We intend to evaluate the effect of intraoperative diphenhydramine administration on incidence and severity of catheter related bladder discomfort (CRBD) and pain after percutaneous nephrolithotomy. Methods: In a double blind randomized clinical trial, adult male patients undergoing percutaneous nephrolithotomy were enrolled. They were randomized into two groups by a computerized digital random allocation method. Before anesthesia induction, group D (Diphenhydramine group) (n = 48) received 5 ml normal saline containing 0.5 mg/kg of diphenhydramine intravenously. In group C (Control group) (n = 48), 5 ml of normal saline was injected in the same manner. Induction and maintenance of anesthesia were identical in both groups. The incidence and severity of CRBD and postoperative pain were assessed at recovery room. Results: The incidence of CRBD was significantly lower in group D than in group C (14% vs. 63%, P=0.001). The severity of CRBD was milder in group D in comparison to group C (P&lt;0.05). Postoperative pain score was significantly lower in group D (P&lt;0.05). Conclusion: Intraoperative administration of diphenhydramine is an effective practice for the prevention of CRBD after percutaneous nephrolithotomy in male patients and can reduce postoperative pain as well.

Comparative effectiveness of preemptive administration of ibuprofen and ibuprofen-arginine on the anesthetic success of inferior alveolar nerve block in teeth with symptomatic irreversible pulpitis - A double-blind randomized clinical trial.

This study examined the impact of premedication with ibuprofen and ibuprofen-arginine and the influence of preoperative pain and anxiety on inferior alveolar nerve block (IANB) efficacy in cases of symptomatic irreversible pulpitis. The study involved 150 SIP patients who were randomly assigned to receive ibuprofen (600mg), ibuprofen-arginine (1,155mg), or a placebo 30min before IANB. Preoperative anxiety and pain levels were assessed using the Modified Dental Anxiety Scale and the Heft-Parker visual scale. IANB efficacy was determined by the absence of or mild pain during the procedure. Statistical analysis included chi-square, z-tests, Analysis of Variance, and Student's t tests. The ibuprofen and ibuprofen-arginine groups exhibited significantly higher IANB success rates (62% and 78%, respectively) compared to the placebo group (34%). However, no significant difference was observed between the ibuprofen and ibuprofen-arginine groups. Patients with successful IANB in the ibuprofen and ibuprofen-arginine groups displayed lower median anxiety scores (8) than those with failed blocks (15) and lower mean preoperative pain scores (118.3). In cases of symptomatic irreversible pulpitis the preemptive medication with ibuprofen-arginine effectively increased the efficacy of the inferior alveolar nerve block The inferior alveolar nerve block efficacy was influenced by preoperative anxiety levels and the intensity of pain. This research underscores the potential benefits of oral premedication with ibuprofen and ibuprofen-arginine in improving anesthesia outcomes in cases of symptomatic irreversible pulpitis.

Expediting the reversal of inferior alveolar nerve block anesthesia in children with photobiomodulation therapy.

In pediatric dentistry, complications arising from extended soft tissue anesthesia can negatively impact patient comfort and trust in dental care. This study evaluates the clinical efficacy of diode laser-based photobiomodulation therapy (PBMT) in expediting the resolution of anesthesia in children aged 6-9 receiving inferior alveolar nerve block (IANB) injections. In this split-mouth double-blind randomized clinical trial, 36 pediatric subjects aged 6-9, requiring pulpotomy procedures on both sides of the mandible, received IANBs (single cartridge of 2% lidocaine/1:100,000 epinephrine). PBMT and sham laser were alternately applied to each side of the mandible, in two separate sessions, with the envelope method determining treatment allocation and intervention side on the first treatment day. During the laser session, laser (808nm, 250 mW, 23s continuous, 0.5cm², 11.5J/cm², direct contact) irradiated two points at the injection site, five intra-oral and five extra-oral points along the infra-alveolar nerve's pathway. Soft tissue anesthesia reversal was quantified through tactile assessment. Soft tissue trauma was also assessed by the researcher and reported by parents 24h post-dental visit. All data were analyzed using IBM SPSS Statistics v25.0 via Paired T-test, two-way repeated measures ANOVA, and McNemar's test. The laser group exhibited a mean lip anesthesia duration of 122.78 ± 2.26min, while the sham laser group experienced 134.44 ± 21.8min, indicating an 11.66-minute reduction in anesthesia duration for the laser group. (P < 0.001) Soft tissue trauma occurred in two sham laser group patients and one laser group patient, with no significant difference. (P = 1) The findings indicate that employing laser with defined parameters can reduce the length of IANB-induced anesthesia.

Occurrence of neurosensory disturbance after the use of articaine and lidocaine in the inferior alveolar nerve block: a double-blind randomised clinical trial

This double-blind, randomised clinical trial aimed to find out whether there is a difference in the prevalence of neurosensory disturbance (NSD) between patients who received 2% lidocaine and those who received 4% articaine during inferior alveolar nerve blocks (IANBs). Patients who underwent third molar extraction were randomised into two groups. IANB was performed using 2% lidocaine in Group 1 and 4% articaine in Group 2. The occurrence of NSD was documented. Patients were visited within 48 hours and one week after the tooth was removed. The type of anaesthetic drug (4% articaine versus 2% lidocaine) was the study’s predictive factor. A total of 2400 patients were studied in two groups (1200 in each group). The mean (range) age of the patients was 28.40 (18–44) years. Five patients (0.41%) in the lidocaine group and seven (0.58%) in the articaine group had NSD after injection (p = 0.77). The prevalence of NSD after IANB was no higher in the articaine group than in the lidocaine group.

Effects of Serious Games in Older Adults With Mild Cognitive Impairment.

The rising prevalence of mild cognitive impairment (MCI) has spurred interest in innovative cognitive rehabilitation approaches, including serious games. This review summarizes randomized clinical trials (RCTs) exploring the impact of serious games on MCI patients. We conducted a comprehensive data search using key terms such as "gamification," "digital therapy," "cognition," "mild cognitive impairment," and "Alzheimer's disease." We exclusively considered published RCTs, excluding animal studies and basic research. We identified eight RCTs. Four RCTs examined the effects of serious games using cognitive training for MCI patients. Notably, one study found that non-specific training (Nintendo Wii) significantly enhanced cognitive function and quality of life compared to cognition-specific computer training (CoTras). Among the remaining three RCTs, one specifically demonstrated that personalized serious game-based cognitive training yielded superior cognitive outcomes and reduced depressive symptoms. One RCT focused on serious games incorporating physical exercise, highlighting the effectiveness of kinetic-based exergaming in enhancing overall cognition. Three RCT focused on combined cognitive training and physical exercise. A double-blind RCT revealed that progressive resistance training or standalone physical exercise outperformed the combined approach in improving executive function and global cognition. Two additional RCTs reported positive outcomes, including improvements in cognitive function and electroencephalogram patterns associated with game-based interventions. Serious games, whether focusing on cognitive training, physical exercise, or a combination of both, have potential to improve cognitive and functional outcomes in individuals with MCI. Further research and standardization of protocols are needed to better understand the full potential of serious games in MCI.

Effects of speculum lubrication on cervical smears for cervical cancer screening: A double blind randomized clinical trial.

Speculum lubrication may help to reduce the pain experienced during Pap-smear collection and hence increase uptake of cervical cancer screening and repeat testing, but there are fears of its interference with cytological results. To determine and compare the adequacy of cervical cytology smears and the mean pain scores of women undergoing cervical cancer screening with or without speculum lubrication. This was a randomised controlled study of 132 women having cervical cancer screening at a tertiary hospital in Nigeria. Sixty-six participants were randomly assigned to the 'Gel' and 'No Gel' groups, respectively. Pap smears were collected from each participant with a lubricated speculum ('Gel group') or a non-lubricated speculum ('No Gel group'). The primary outcome measures were the proportion of women with unsatisfactory cervical cytology smears and the mean numeric rating scale pain scores, while the secondary outcome measures were the proportion of women who were willing to come for repeat testing and the cytological diagnosis of Pap-smear results. The baseline socio-demographic variables were similar in both groups. There was no significant difference in the proportion of unsatisfactory cervical smear results between the two groups (13.6% vs. 21.2%, p = 0.359). However, the mean pain scores were significantly lower in the gel group than in the no gel group (45.04 vs. 87.96; p<0.001). An equal proportion of the participants in each group (90.9% vs. 90.9%; p > 0.999) were willing to come for repeat cervical smears in the future. Speculum lubrication did not affect the adequacy of cervical smears but significantly reduced the pain experienced during pap smear collection. Also, it did not significantly affect the willingness to come for repeat cervical smears in the future. The trial was registered with the Pan-African Clinical Trial Registry with a unique identification and registration number: PACTR2020077533364675.

Clinical performance of posterior restorations using a universal adhesive over moist and dry dentin: A 36-month double-blind split-mouth randomized clinical trial

ObjectivesTo evaluate the influence of dentin moisture on the clinical behavior of a universal adhesive on posterior teeth after 36 months of follow-up. MethodsForty-five patients participated in this study. Following a split-mouth design, three operators placed 90 Class I/Class II restorations over moist dentin (MD) or dry (DD) (n = 45) with resin composite (Filtek Bulk Fill) and a universal adhesive used in the etch-and-rinse mode (Single Bond Universal). Each restoration was evaluated according to the FDI and USPHS criteria (postoperative sensitivity, fracture and retention, marginal staining, marginal adaptation, and recurrence of caries) at baseline and after 6-, 12-, and 36 months. For statistical analysis, Kruskal Wallis analysis of variance rank (α = 0.05) and Kaplan-Meier survival analysis were used. ResultsNo significant difference between groups was observed in each FDI criterion after 36 months of clinical evaluation (p > 0.05). The retention rates (confidence interval 95 %) were 97.37 % (86.5 - 99.5) for both MD and DD without significant difference between them (p > 0.05). Eight restorations (MD = 4; DD = 4) showed minimal marginal staining defects (p > 0.05). Two restorations were lost (MD = 1; DD = 1). Fifteen restorations (MD = 8; DD = 7) presented minor marginal discrepancies according to the FDI criteria (p > 0.05). ConclusionThe clinical performance of the universal adhesive when applied in etch-and-rinse mode was not influenced by dentin moisture in posterior bulk-fill composite restorations. Clinical significanceThe level of dentin moisture appears not to influence the clinical efficacy of a universal adhesive when applied using the etch-and-rinse technique in posterior composite resin restorations.

Efficacy of empirical Ciprofloxacin or Cefixime plus Metronidazole therapy for the treatment of liver abscess: a randomized control clinical trial

Liver abscess is a potentially life-threatening medical emergency. Prompt empirical antimicrobial with or without percutaneous aspiration or drainage is therapeutic. The rational for using empirical intravenous broad-spectrum antimicrobials upfront instead of oral Fluoroquinolone or Cephalosporin is contentious. In this double blind randomized control clinical trial 69 participants received Ciprofloxacin (500 mg q 12 hourly) and 71 participants received Cefixime (200 mg q 12 hourly) orally for 2 weeks. Both the group received oral Metronidazole (800 mg q 8 hourly) for 2 weeks and percutaneous drainage or aspiration of the abscess was done as per indication and followed-up for 8 weeks. Out of 140 participants, 89.3% (N = 125) achieved clinical cure, 59 (85.5%) in Ciprofloxacin group and 66 (93%) in Cefixime group (p = 0.154). Mean duration of antimicrobial therapy was 16.2 ± 4.3 days, 15.1 ± 4.5 days in Ciprofloxacin group and 16.0 ± 4.2 days in Cefixime group (p = 0.223). Total 15 (10.7%) participants had treatment failure, 10 (14.5%) in Ciprofloxacin group and 5 (7.0%) in Cefixime group (p = 0.154). The most common reason for treatment failure was need of prolong (> 4 weeks) antimicrobial therapy due to persistent hepatic collection requiring drainage, which was significantly (p = 0.036) higher in Ciprofloxacin (14.5%, N = 10) group, compared to the Cefixime (4.2%, N = 3) group. In conclusion, both, the Ciprofloxacin or Cefixime plus Metronidazole for duration of 2–3 weeks were efficacious as empirical oral antimicrobial regimen along with prompt percutaneous drainage or aspiration for the treatment of uncomplicated liver abscess with similar efficacy. Oral Cefixime was better than Ciprofloxacin in term of lesser chance of treatment failure due to persistent collection which is required to be investigated further in larger clinical trial.Trial registration: clinicaltrials.gov PRS ID: NCT03969758, 31/05/2019.

Subgingival 0.75% boric acid vs 1% povidone-iodine adjunctive to subgingival instrumentation in stage II and III periodontitis-A double-blind randomized clinical trial.

To compare the effects of subgingival irrigation with 0.75% boric acid (BA) and 1% povidone-iodine (PVP-I) as an adjunct to scaling and root planing (SRP) on clinical and microbiologic parameters in the management of patients with periodontitis after a 12-month follow-up. Sixty systemically healthy individuals diagnosed with periodontitis were included in this double-blind randomised clinical trial. The patients were randomly allocated to treatment groups: (1) SRP plus 0.75% BA and (2) SRP plus 1% PVP-I. Whole-mouth periodontals were clinically examined, and the counts of bacteria including Aggregatibacter actinomycetemcomitans (Aa), Fusobacterium nucleatum (Fn), Porphyromonas gingivalis (Pg), Treponema denticola (Td), Tannerella forsythia (Tf), Solobacterium moorei (Sm) and Streptococcus salivarius (Ss) were tested by real-time polymerase chain reaction (PCR). All periodontal parameters and the counts of Aa, Fn, Pg, Td, Tf, Sm and Ss in both groups showed statistically significant reductions at T3, T6 and T12 compared to T0. Whole-mouth or moderate or severe PD and CAL improvements were significantly found in the 0.75% BA group compared to the 1% PVP-I group at T3, T6 and T12. The reduction in Aa or Fn and the reduction in Ss were significantly higher in the 0.75% BA group at T6 and T12 than in the 1% PVP-I group. This study shows that subgingival irrigation with 0.75% BA may be an alternative to 1% PVP-I because it promotes greater PD reductions and CAL gain, particularly up to 12 months after treatment.

Bisoprolol in Patients With Chronic Obstructive Pulmonary Disease at High Risk of Exacerbation

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Observational studies report that β-blocker use may be associated with reduced risk of COPD exacerbations. However, a recent trial reported that metoprolol did not reduce COPD exacerbations and increased COPD exacerbations requiring hospital admission. To test whether bisoprolol decreased COPD exacerbations in people with COPD at high risk of exacerbations. The Bisoprolol in COPD Study (BICS) was a double-blind placebo-controlled randomized clinical trial conducted in 76 UK sites (45 primary care clinics and 31 secondary clinics). Patients with COPD who had at least moderate airflow obstruction on spirometry (ratio of forced expiratory volume in the first second of expiration [FEV1] to forced vital capacity <0.7; FEV1 <80% predicted) and at least 2 COPD exacerbations treated with oral corticosteroids, antibiotics, or both in the prior 12 months were enrolled from October 17, 2018, to May 31, 2022. Follow-up concluded on April 18, 2023. Patients were randomly assigned to bisoprolol (n = 261) or placebo (n = 258). Bisoprolol was started at 1.25 mg orally daily and was titrated as tolerated during 4 sessions to a maximum dose of 5 mg/d, using a standardized protocol. The primary clinical outcome was the number of patient-reported COPD exacerbations treated with oral corticosteroids, antibiotics, or both during the 1-year treatment period. Safety outcomes included serious adverse events and adverse reactions. Although the trial planned to enroll 1574 patients, recruitment was suspended from March 16, 2020, to July 31, 2021, due to the COVID-19 pandemic. Two patients in each group were excluded postrandomization. Among the 515 patients (mean [SD] age, 68 [7.9] years; 274 men [53%]; mean FEV1, 50.1%), primary outcome data were available for 514 patients (99.8%) and 371 (72.0%) continued taking the study drug. The primary outcome of patient-reported COPD exacerbations treated with oral corticosteroids, antibiotics, or both was 526 in the bisoprolol group, with a mean exacerbation rate of 2.03/y, vs 513 exacerbations in the placebo group, with a mean exacerbation rate of 2.01/y. The adjusted incidence rate ratio was 0.97 (95% CI, 0.84-1.13; P = .72). Serious adverse events occurred in 37 of 255 patients in the bisoprolol group (14.5%) vs 36 of 251 in the placebo group (14.3%; relative risk, 1.01; 95% CI, 0.62-1.66; P = .96). Among people with COPD at high risk of exacerbation, treatment with bisoprolol did not reduce the number of self-reported COPD exacerbations requiring treatment with oral corticosteroids, antibiotics, or both. isrctn.org Identifier: ISRCTN10497306.

Evaluation of the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol oral solution (150 mg/mL) versus placebo in mild to moderate anxiety subjects: A double blind multicenter randomized clinical trial

BackgroundAnxiety disorders, an increasingly prevalent global mental health illness, affected approximately 301 million individuals worldwide in 2019. There is an unmet need for the treatment of anxiety disorders, as current therapies are associated with limited response rates, residual symptoms, and adverse effects. ObjectivesTo evaluate the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol (CBD) oral solution versus placebo for the treatment of mild to moderate anxiety disorders. MethodsThis phase 3 prospective, randomized, double blind, parallel group, placebo-controlled, 15-week cohort study took place at multiple sites across India. Eligible participants were randomly assigned to one of the two treatment arms (CBD or placebo) in a 1:1 ratio. Results178 participants were randomized to receive CBD (n=89) or placebo (n=89). The study met both primary (GAD-7 and HAM-A scores) and secondary outcomes (CGI-I, CGI-S, PHQ-9 and PSQI scores). The GAD-7 score difference between the end of treatment and baseline for the CBD versus the placebo was −7.02 (S.E: 0.25, 95% CI −7.52; −6.52), p<0.0001. Similarly, the HAM-A score difference at the end of treatment compared to baseline for the CBD versus the placebo was −11.9 (S.E: 0.33, 95% CI −12.6; −11.3), p<0.0001. ConclusionsNanodispersible CBD was therapeutically safe with no serious adverse events, well tolerated, and effective for the treatment of mild to moderate anxiety disorders, as well as associated depression and sleep quality disturbances. These results pave way for probable prospective use of nanodispersible CBD formulation for various psychiatry disorders alone or in conjunction with other drugs.

The effects of grape seed extract supplementation on cardiovascular risk factors, liver enzymes and hepatic steatosis in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled study.

Despite the high antioxidant potential of grape seed extract (GSE), very limited studies have investigated its effect on non-alcoholic fatty liver disease (NAFLD). Therefore, this study was conducted with the aim of investigating the effect of GSE on metabolic factors, blood pressure and steatosis severity in patients with NAFLD. In this double-blind randomized clinical trial study, 50 NAFLD patients were divided into two groups of 25 participants who were treated with 520mg/day of GSE or the placebo group for 2 months. The parameters of glycemic, lipid profile, blood pressure and steatohepatitis were measured before and after the intervention. The GSE group had an average age of 43.52 ± 8.12 years with 15 women and 10 men, while the placebo group had an average age of 44.88 ± 10.14 years with 11 women and 14 men. After 2 months of intervention with GSE, it was observed that insulin, HOMA-IR, TC, TG, LDL-c, ALT, AST, AST/ALT, SBP, DBP and MAP decreased and QUICKi and HDL-c increased significantly (p-value for all < 0.05). Also, before and after adjustment based on baseline, the average changes indicated that the levels of insulin, HOMA-IR, TC, TG, LDL-c, SBP, DBP, MAP in the GSE group decreased more than in the control group (p for all < 0.05). Furthermore, the changes in HDL-c were significantly higher in the GSE group (p < 0.05). The between-groups analysis showed a significant decrease in the HOMA-β and AST before and after adjustment based on baseline levels (p < 0.05). Moreover, the changes in QUICKi after adjustment based on baseline levels were higher in the GSE group than in the control group. Also, between-groups analysis showed that the severity of hepatic steatosis was reduced in the intervention group compared to the placebo group (P = 0.002). It seems that GSE can be considered one of the appropriate strategies for controlling insulin resistance, hyperlipidemia, hypertension and hepatic steatosis in NAFLD patients. The clinical trial was registered in the Iranian Clinical Trial Registration Center (IRCT20190731044392N1). https://irct.behdasht.gov.ir/trial/61413 . (The registration date: 30/03/2022).

The effects of virtual reality training on postural sway and physical function performance on older women with chronic low back pain: A double-blind randomized clinical trial.

Chronic low back pain (CLBP) is known as an important debilitating health condition among older women. This study aimed to evaluate the effects of eight-week virtual reality training (VRT) exercises on postural sway and physical function performance (PFP) among older women suffering from CLBP. Twenty-seven older women presenting with CLBP were randomized into experimental and control groups. The experimental group was instructed to perform 30-minute VRT exercises three times a week for eight weeks. Plantar pressure variables [sway velocity (SV) and anterior-posterior (AP) and medial-lateral (ML) fluctuations of the center of pressure (CoP)], 30-second chair stand test (30CST), and timed up and go (TUG) test were recorded. The VRT group exhibited significant decreases in SV (p= 0.002), AP (p= 0.008), and ML (p= 0.02) fluctuations. Also, the performance of the VRT group in the 30CST and TUG tests significantly improved after the exercises (P< 0.001). According to the results, VRT and the program used in this study should be used to enhance balance and PFP in older women with CLBP who mostly prefer activities that are accessible and feasible in low-risk environments.

Pregnancy outcomes in pregnant women taking oral probiotic undergoing cerclage compared to placebo: two blinded randomized controlled trial

AimThe purpose of this study is to evaluate the oral probiotic effect on pregnancy outcomes in pregnant women undergoing cerclage compared to placebo.MethodsThis study was a double-blind randomized clinical trial undertaken in Yasuj, Iran. 114 eligible participants who have undergone cerclage were randomly divided to either receive probiotic adjuvant or 17α-OHP (250 mg, IM) with placebo from the 16th -37th week of pregnancy by “block” randomization method. Our primary outcomes were preterm labor (PTB) (late and early) and secondary outcomes were other obstetrical and neonatal outcomes included preterm pre-labor rupture of membranes (PPROM), pre-labor rupture of membranes (PROM), mode of delivery, and neonatal outcomes including anthropometric characterize and Apgar score (one and fifth-minute).ResultsResults show that there are no statistically significant differences between the two groups in terms of PTB in < 34th (15.51% vs. 17.86%; P = 0.73) and 34-37th weeks of pregnancy (8.7% vs. 16.1%; P = 0.22), and mode of delivery (P = 0.09). PPROM (8.7% vs. 28.5%; P = 0.006) PROM (10.3% vs. 25%; P = 0.04) was significantly lower in patients receiving probiotic adjuvant compared to the control group. After delivery, the findings of the present study showed that there were no significant differences in newborn’s weight (3082.46 ± 521.8vs. 2983.89 ± 623.89), head circumstance (36.86 ± 1.53vs. 36.574 ± 1.52), height (45.4 ± 5.34 vs. 47.33 ± 4.92) and Apgar score in one (0.89 ± 0.03 vs. 0.88 ± 0.05) and five minutes (0.99 ± 0.03vs. 0.99 ± 0.03) after birth.ConclusionOur result has shown that the consumption of Lactofem probiotic from the 16th week until 37th of pregnancy can lead to a reduction of complications such as PPROM and PROM.

Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID-19 encephalopathy: A randomized controlled trial.

COVID-19 can lead to encephalopathy and loss of consciousness. This double-blinded randomized clinical trial conducted in Tehran, Iran, aimed to assess the potential effectiveness of modafinil in patients with COVID-19-related encephalopathy. Nineteen non-intubated COVID-19 patients with encephalopathy were randomized into two groups: a treatment group receiving crushed modafinil tablets and a placebo group receiving starch powder. Modafinil was administered at a dose of 100 mg every 2 h, reaching a peak dosage of 400 mg. The level of consciousness was assessed using the Glasgow Coma Score (GCS) at multiple time points on the day of medication administration. The trial was registered under IRCT20170903036041N3 on 23/5/2021. The average age in the modafinil and placebo groups was 75.33 and 70 years, respectively. No significant differences were observed between the two groups in terms of chronic conditions, clinical symptoms, or laboratory data. GCS scores were similar between the groups at baseline (p-value = 0.699). After four doses of modafinil, GCS scores were slightly higher in the treatment group, but this difference was not statistically significant (p-value = 0.581). GCS scores after each round of drug administration didn't significantly differ between the treatment and placebo groups (p-value = 0.908). Modafinil exhibited a slight improvement in the level of consciousness among COVID-19 patients with encephalopathy, although this improvement did not reach statistical significance when compared to the control group. Further research with larger sample sizes and longer treatment durations is recommended to explore modafinil's potential benefits in managing altered consciousness in COVID-19 patients.

Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes

The prevalence of e-cigarette use among US adults, especially young adults, is rising. Many would like to quit vaping nicotine but are unable to do so. Cytisinicline, a plant-based alkaloid, targets nicotinic acetylcholine receptors, reduces nicotine dependence, and helps adults to stop smoking cigarettes. Cytisinicline may also help e-cigarette users to quit vaping. To determine the efficacy and safety of cytisinicline vs placebo to produce abstinence from e-cigarette use in adults seeking to quit vaping nicotine. This double-blind placebo-controlled randomized clinical trial compared 12 weeks of treatment with cytisinicline vs placebo, with follow-up to 16 weeks. It was conducted from July 2022 to February 2023 across 5 US clinical trial sites. A total of 160 adults who vaped nicotine daily, sought to quit, and did not currently smoke cigarettes were enrolled, and 131 (81.9%) completed the trial. Participants were randomized (2:1) to cytisinicline, 3 mg, taken 3 times daily (n = 107) or placebo (n = 53) for 12 weeks. All participants received weekly behavioral support. Biochemically verified continuous e-cigarette abstinence during the last 4 weeks of treatment (weeks 9-12; primary outcome) and through 4 weeks posttreatment (weeks 9-16; secondary outcome). Missing outcomes were counted as nonabstinence. Of 160 randomized participants (mean [SD] age, 33.6 [11.1] years; 83 [51.9%] female), 115 (71.9%) formerly smoked (≥100 lifetime cigarettes). Continuous e-cigarette abstinence in cytisinicline and placebo groups occurred in 34 of 107 participants (31.8%) vs 8 of 53 participants (15.1%) (odds ratio, 2.64; 95% CI, 1.06-7.10; P = .04) at end of treatment (weeks 9-12) and in 25 of 107 participants (23.4%) vs 7 of 53 participants (13.2%) during weeks 9 to 16 (odds ratio, 2.00; 95% CI, 0.82-5.32; P = .15). There was no evidence, based on nonsignificant interactions, that cytisinicline efficacy differed in subgroups defined by demographic characteristics, vaping pattern, e-cigarette dependence, or smoking history. Cytisinicline was well tolerated, with 4 participants (3.8%) discontinuing cytisinicline due to an adverse event. In this randomized clinical trial, cytisinicline for 12 weeks, with behavioral support, demonstrated efficacy for cessation of e-cigarette use at end of treatment and was well tolerated by adults, offering a potential pharmacotherapy option for treating nicotine e-cigarette use in adults who seek to quit vaping. These results need confirmation in a larger trial with longer follow-up. ClinicalTrials.gov Identifier: NCT05431387.