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Aims Conditional average treatment effects are often reported in intervention studies, in which assumptions are made regarding how effects are similar across a heterogeneous sample. Nonetheless, differing factors, such as genetics, age, and sex, can impact an intervention's effect on outcomes. The study aimed to estimate the individualized effects of a digital alcohol intervention among individuals looking online to reduce their drinking. Methods We used data from a randomized controlled trial (RCT), including 2129 adults from the Swedish general population. The RCT concerned a text message-based alcohol intervention that sought to engender change through increasing knowledge on how to change and instilling confidence in changing behaviour. Outcomes were total weekly alcohol consumption and monthly heavy episodic drinking. Individualized treatment effects were modelled using baseline characteristics (age, gender, alcohol consumption, and psychosocial variables) and engagement with the intervention content. Results We found evidence that the effects of the digital alcohol intervention were heterogeneous concerning participants' age, baseline alcohol consumption, confidence, and importance. For heavy episodic drinking, there was evidence that effects were heterogeneous concerning age, sex, and baseline alcohol consumption. Overall, women, older individuals, and heavier drinkers benefitted more from the intervention in terms of effect size. In addition, participants who engaged more with the goal-setting and screening content reported better outcomes. Conclusions The results highlight how different individuals respond differently to a digital alcohol intervention. This allows insight into who benefits the most and least from the intervention and highlights the potential merit of designing interventions adapted to different individuals' needs. [ABSTRACT FROM AUTHOR]

Background: Obsessive-compulsive disorder (OCD) is a prevalent and burdensome mental health condition, often resistant to conventional treatments. Agomelatine (Valdoxan), a compound acting on serotonin and melatonin systems, has shown promise in treating those with treatment-resistant OCD based on anecdotal reports and case studies. Methods: A randomized, double-blind controlled trial was conducted with 60 patients diagnosed with treatment-resistant OCD. Participants were randomized into an intervention group (receiving agomelatine 50 mg/day) and a control group (receiving placebo). OCD symptoms were assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) over a 12-week period. Results: There were no significant differences in age, gender, or baseline Y-BOCS scores between intervention and control groups. Agomelatine did not demonstrate a significant improvement in OCD symptoms compared to placebo. Adverse events were comparable between groups, and liver enzyme levels remained within the normal range. Conclusion: This study, while not confirming superior efficacy compared to placebo, underscores the need for continued investigation into agomelatine's potential for treating specific subgroups of OCD patients, underscoring the need for more comprehensive and well-controlled trials in the future. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and safety of Sanjie Analgesic Capsule (SAC) in Chinese patients with endometriosis-associated pain. Methods: This was a multicenter, randomized, double-blind, placebo-controlled trial conducted at 15 centers between November 2013 and July 2017 in China. Eligible 323 patients with endometriosis were randomized at a 3:1 ratio to the SAC group (241 cases) and placebo group (82 cases) by stratified block randomization. Patients in the SAC or placebo groups were given SAC or placebo 1.6 g 3 times per day, orally, respectively since the first day of menstruation for 3 consecutive menstrual cycles. The primary endpoint was clinical response to dysmenorrhea evaluated using a 10-point Visual Analogue Scale at 3 and 6 months. The secondary endpoint was the pain score evaluated by VAS (chronic pelvic pain, defecation pain, and dyspareunia) at 3 and 6 months, and the pain recurrence rate at 6 months. Adverse events (AEs) were recorded during the study. Results: A total of 241 women were included in the SAC group, and 82 were in the placebo group. Among these women, 217 (90.0%) and 71 (86.6%) completed the intervention, respectively. At 3 months, overall response rate (ORR) was significantly higher in women administered SAC (80.1%) compared with those who received a placebo (30.5%, P<0.01). Six months after treatment, the ORR for dysmenorrhea was 62.7% in the SAC group and 31.7% in the placebo group (P<0.01). Chronic pelvic pain and defecation pain were significantly improved by SAC compared with placebo (both P<0.05). The incidence rates of total AEs events in the SAC and placebo groups were 6.6% and 9.8%, respectively, and no significant difference was shown between the two groups (P=0.339). Conclusion: SAC is well-tolerated and may improve dysmenorrhea in women with endometriosis-associated pain. (Trial registration: ClinicalTrials.gov, No. NCT02031523) [ABSTRACT FROM AUTHOR]

Trial design: This is a randomized, controlled, superiority, double-blinded, parallel-group, two-arms trial with an allocation ratio of 1:1. This study aimed to assess whether the cavity design could affect the clinical performance of the CAD/CAM generated indirect resin composite restoration in endodontically treated teeth (ETT) evaluated using the Modified USPHS criteria after a two-year follow up. Methods: A total of 30 participants who underwent endodontic treatment for MOD cavities in permanent molars were divided randomly into two parallel groups (n = 30 restorations) according to the performed cavity design to group 1 in which there was no cuspal reduction (inlay) and group 2 in which cuspal reduction was performed (overlay). All pulp chambers were filled with bulk fill flowable composite, and the cavities were prepared following the criteria of the cavities for indirect restorations and restored using nano-hybrid composite resin blocks (Brilliant, Coltene, Switzerland). The restorations were evaluated using the modified USPHS criteria at baseline, six months, one-year and two years follow-up visits. For qualitative data, frequencies (n) and percentages (%) were used to display the data, while mean and standard deviation (SD) were used for quantitative data. The normality of the data was evaluated using the Shapiro-Wilk and Kolmogorov-Smirnov tests. For every test, P ≤ 0.05 was used as the significance threshold. Results: Twenty-six individuals completed the follow-up period after receiving the assigned intervention.The inter-group comparison showed that, at the 6- months and 12- months observation points, the overlay design had significantly better marginal adaptation, less incidence of discoloration or tooth/restoration fracture, and similar marginal integrity and caries incidence to the inlay design. After 24- months, the overlay design still had better marginal adaptation, less incidence of discoloration or tooth/restoration fracture and less caries incidence in comparison to the inlay design, while there was no difference in the marginal integrity between either design. Conclusions and clinical relevance: Cuspal reduction in endodontically treated teeth showed better clinical performance than the cusp preservation thus, the former is more reliable. [ABSTRACT FROM AUTHOR]

Background: Heart failure (HF) is a debilitating disease with worsening symptoms and family caregiving burden. HF affects more than 8 million Americans. West Virginia has the highest HF death rate in the U.S. and limited healthcare services. This study tested whether the family HF palliative and end-of-life care intervention (FamPALcare) improved patient and caregiver outcomes at 3- and 6-month study endpoints. Methods: This study used a randomized controlled trial design. Patients with HF and their caregivers were randomly assigned together to the intervention (n = 21) or control (n = 18) group. The intervention included five telephone coaching sessions on the HF home, palliative, and end-of-life care. The outcome data collected at baseline and at 3 and 6 months were from the patients' (a) HF-related health status and depression/anxiety scale scores; and from caregivers' (b) caregiving burden and depression/anxiety scale scores; and (c) anonymous ratings on the 11-item FamPALcare helpfulness scale, completed by the intervention participants. Results: The mean age of the patients was 65.66 (SD = 13.72) years, and 67% were White males. The mean age of the caregivers was 62.05 (SD = 13.14) years, and 77% were White females. Compared to the controls, patients in the intervention group had significantly greater scores for HF-related health status (p <.05) and lower depression/anxiety scores at 6 months, the study endpoint. The family caregivers in the intervention group had significantly lower scores on caregiving burden (p <.05) and depression/anxiety (p <.01) at 3 months. The mean helpfulness rating was M = 4.46 out of 5 (SD = 0.49). Conclusions: The FamPALcare intervention was found to be effective at improving patient HF-related health status and reducing caregiver burden and improving both patient and caregiver depression and anxiety scores. The FamPALcare HF intervention was found feasible and consistently delivered (fidelity). The FamPALcare intervention's cost-effectiveness and helpfulness ratings information will be used to plan for subsequent clinical trials. Trial registration: ClinicalTrials.gov NCT04153890, Registered on 4 November 2019, https://clinicaltrials.gov/ct2/show/NCT04153890. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the efficacy and safety of individualized homeopathic medicines (IHMs) in treating hemorrhoids compared with placebo. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The trial was conducted at the surgery outpatient department of the State National Homoeopathic Medical College and Hospital, Lucknow, Uttar Pradesh, India. Subjects: Patients were 140 women and men, aged between 18 and 65 years, with a diagnosis of primary hemorrhoids grades I–III for at least 3 months. Excluded were the patients with grade IV hemorrhoids, anal fissure, and fistula, hypertrophic anal papillae, inflammatory bowel disease, coagulation disorders, rectal malignancies, obstructed portal circulation, patients requiring immediate surgical intervention, and vulnerable samples. Interventions: Patients were randomized to Group 1 (n = 70; IHMs plus concomitant care; verum) and Group 2 (n = 70; placebos plus concomitant care; control). Outcome measures: Primary—the anorectal symptom severity and quality-of-life (ARSSQoL) questionnaire, and secondary—the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire and EQ visual analogue scale (VAS); all of them were measured at baseline, and every month, up to 3 months. Results: Out of the 140 randomized patients, 122 were protocol compliant. Intention-to-treat sample (n = 140) was analyzed. The level of significance was set at p < 0.05 two tailed. Statistically significant between-group differences were elicited in the ARSSQoL total (Mann–Whitney U [MWU]: 1227.0, p < 0.001) and EQ-5D-5L VAS (MWU: 1228.0, p = 0.001) favoring homeopathy against placebos. Sulfur was the most frequently prescribed medicine. No harm or serious adverse events were reported from either of the groups. Conclusions: IHMs demonstrated superior results over placebo in the short-term treatment of hemorrhoids of grades I–III. The findings are promising, but need to be substantiated by further phase 3 trials. Clinical Trial Registration Number: CTRI/2020/03/024342. [ABSTRACT FROM AUTHOR]

Background and aims: Offering financial incentives is effective for smoking cessation during pregnancy. We tested the effectiveness of financial incentives for maintaining postpartum cessation, comparing 12‐month and 3‐month incentives with each other and with usual care (UC). Design, setting and participants: This study was a pragmatic, multi‐centre, three‐arm randomized controlled trial involving four English, National Health Service, stop smoking services. A total of 462 postpartum women (aged ≥ 16 years) took part, who stopped smoking during pregnancy with financial incentives, validated as abstinent from smoking at end of pregnancy or early postpartum. Interventions: Interventions comprised (i) UC; (ii) UC plus up to £60 of financial voucher incentives offered to participants and £60 offered to an optional significant‐other supporter, over 3 months postpartum, contingent upon validated abstinence ('3‐month incentives'); or (iii) UC plus '3‐month incentives' plus £180 of vouchers offered to participants over 9 months postpartum, contingent upon abstinence ('12‐month incentives'). Measurements: Primary outcome: biochemically validated abstinence at 1 year postpartum. To adjust for testing all comparisons between groups with equal precision, P < 0.017 was necessary for significance. Secondary outcomes: self‐reported and validated abstinence at 3 months postpartum; self‐reported abstinence at 1 year postpartum. Findings Primary outcome ascertainment: abstinence was 39.6% (63/159) 12 months incentives, 21.4% (33/154) 3 months incentives and 28.2% (42/149) UC. Adjusted odds ratios [95% confidence interval (CI)] = 12‐month versus 3‐month incentives OR = 2.41 (95% CI = 1.46−3.96), P = 0.001; 12 months versus UC 1.67 (1.04−2.70), P = 0.035; 3 months versus UC 0.69 (0.41−1.17), P = 0.174. Bayes factors indicated that for 12‐month versus 3‐month incentives and 12 months versus UC there was good evidence for the alternative hypothesis, and for 3 months versus UC there was good evidence for the null hypothesis. Conclusions: This randomized controlled trial provides weak evidence that up to £300 of voucher incentives over 12 months is effective for maintaining smoking abstinence postpartum compared with usual care. There was good evidence that 12‐month incentives are superior to those over only 3 months, for which there was no evidence of effectiveness relative to usual care. [ABSTRACT FROM AUTHOR]

Resilience training has beneficial effects on the ability of undergraduate students to withstand adversity and stress. However, there are inconsistencies in the content and delivery approaches for resilience training. Given the increasing shifts towards computer‐assisted instruction, there is a need to develop and evaluate innovative approaches for resilience training. This study aimed to examine the efficacy of two versions of the Resilience Skills Enhancement (RISE) programme. A randomized controlled trial was used to evaluate the effects of blended learning (BL) and a self‐guided RISE programme on the resilience, social support, and learning outcomes of undergraduate students. One hundred and fourteen students were recruited and randomly allocated to receive either BL or the self‐guided RISE programme. The within‐group analyses indicated significant improvements in resilience scores for the BL (F = 37.74, p < 0.001) and self‐guided groups (F = 10.16, p < 0.001) with moderate (d = 0.62, 95% CI: 0.25, 1.00) to large effect sizes (d = 1.11, 95% CI: 0.71, 1.50) respectively. There were also significant differences across the three time points for social support scores for the BL (F = 4.50, p < 0.05) and self‐guided groups (F = 4.59, p < 0.05). Students in the BL group had considerable improvements in self‐efficacy of learning and performance (F = 5.42, p < 0.01) and meta‐cognitive self‐regulation scores (F = 5.91, p < 0.01). In the between‐group analyses, both BL and self‐guided RISE were comparable for resilience, social support, and learning scores (p > 0.05). The study provided preliminary evidence that both modes, BL and self‐guided RISE programme lead to positive effects on the resilience, social support, and learning scores of students. [ABSTRACT FROM AUTHOR]

Purpose: This study investigated the effects of an eye care protocol (ECP) on patients in the intensive care unit (ICU). Methods: This study utilized a randomized controlled design. Participants were patients who met the inclusion criteria and were admitted to the ICU (36 in the experimental group and 38 in the control group). The experimental group received an ECP, while the control group received standard eye care, starting the day after admission, for a duration of 10 days. The ECP classifies the degree of eyelid obstruction into three stages based on the degree of exposure to the lower eyelid conjunctiva and cornea. The protocol included cleansing with normal saline gauze, administering eye drops, applying silicone and polyurethane films, and recommending consultation with an ophthalmologist if necessary. The effectiveness of ECP was assessed by analyzing tear volume, hyperemia, chemosis, and eye discharge. Data analysis was conducted using SPSS 27.0, employing the Mann-Whitney U-test and generalized estimating equations. Results: On day 5, the experimental group demonstrated a significant increase in tear volume in both eyes compared with the control group. However, no statistically significant differences were observed in the incidence of hyperemia, chemosis, and eye discharge on days 5 and 10 of the intervention. Conclusion: The application of the ECP in this study increased tear volume in ICU patients, thereby reducing discomfort caused by dry eyes. It has the potential to prevent complications such as damage to the surface of the eyeball resulting from decreased tear volume. [ABSTRACT FROM AUTHOR]

Purpose: The manifestation of behavioral and psychological symptoms of dementia (BPSD) poses a considerable care burden and precipitates adverse health outcomes. Despite the increasing development of digital interventions, their application in the dementia population, specifically regarding their effectiveness in addressing BPSD, remains limited. Therefore, in this study, we aimed to describe a study protocol for evaluating the effectiveness of a mobile app-based individualized non-pharmacological intervention to improve BPSD in community-dwelling older adults. Methods: Employing a randomized control group pretest-posttest design, 36 dyads comprising people living with dementia (PLWD) and their family caregivers will be assigned to either an experimental or control group. The experimental group will engage in a 4-week regimen using a mobile app-based individualized non-pharmacological intervention, which includes recording and predicting BPSD. The control group will use the BPSD record system without accessing the individualized interventions. Both groups will continue with their usual care practices throughout the study period. Results: We hypothesize that the implementation of the mobile app-based individualized non-pharmacological intervention will alleviate BPSD. After the intervention, results will be analyzed to evaluate the effectiveness of the mobile app-based individualized non-pharmacological intervention on BPSD. Conclusion: The research team may encounter several challenges owing to the novelty of digitalized interventions. Nevertheless, the results of this study will provide robust evidence regarding the efficacy of mobile app-based individualized non-pharmacological interventions for community-dwelling older PLWD. [ABSTRACT FROM AUTHOR]

This study compares the clinical performances of two lithium disilicate (Initial LiSi press vs. Initial LiSi Block, GC Corp.) and a 3D printed resin (Temp Print, GC Corp.) partial crown using modified United States Public Health Service (USPHS) evaluation criteria and survival rates after one year of clinical service. Eighty-nine partial adhesive restorations on posterior teeth were realized using different materials: Group 1 used Initial LiSi press, Group 2 used Initial LiSi Block, and Group 3 used Temp Print. An analog workflow was used to realize the restoration of Group 1, while a fully digital workflow was used for Groups 2 and 3. The modified USPHS parameters, together with periodontal parameters, were collected at baseline and at the one-year recall. Contingency tables to assess for significant differences of success over time in each group were used. All modified USPHS parameters showed Alpha or Bravo; no Charlie was recorded. No statistically significant difference emerged between the three groups in any of the assessed variables (p > 0.05). All modified USPHS scores were compatible with the outcome of clinical success, no restoration was replaced or repaired, and the survival rate was 100% at the one-year recall. No difference was found between the traditional and digital workflows used to fabricate the restorations. [ABSTRACT FROM AUTHOR]

Background: This study investigated the optimal concentration of ropivacaine epidural anesthesia for clinical use in percutaneous transforaminal endoscopic discectomy (PTED) by comparing the effects of different concentrations. Methods: Seventy patients scheduled for their first PTED procedure were enrolled in this randomized controlled trial. Patients were randomized to receive ropivacaine at varying concentrations (0.3% or 0.4%). Primary outcome measures included the numeric rating scale (NRS) and hip extension level (HEL). Secondary outcome measures included intraoperative fentanyl dosage and postoperative complications. Results: One patient withdrew due to severe postoperative complications. The remaining 69 patients were allocated to the 0.3% (n = 34) and 0.4% (n = 35) groups, respectively. Baseline characteristics showed no significant differences between the two groups (P > 0.05). The NRS score was significantly lower in the 0.4% group than in the 0.3% group (P < 0.01), whereas the HEL score was significantly higher (P < 0.001). The average fentanyl dose in the 0.4% group was significantly lower than that in the 0.3% group (P < 0.01). Postoperative complications occurred in five and two patients in the 0.3% and 0.4% groups, respectively. Conclusion: Although 0.4% ropivacaine (20 mL) impacts muscle strength, it does not impede PTED surgery. Given its effective analgesic properties and few postoperative complications, 0.4% ropivacaine can be considered a preferred dose for PTED. Trial registration: This study was registered with the Chinese Clinical Trials Registry (Registration number: ChiCTR2200060364; Registration Date: 29/5/2022) and on chictr.org.cn (https://www.chictr.org.cn/showproj.html?proj=171002). [ABSTRACT FROM AUTHOR]

Background and aims: Pre‐clinical studies suggest that the simultaneous blockade of the α1b and 5HT2A receptors may be effective in reducing alcohol consumption. This study aimed to assess the efficacy and safety of prazosin (α1b blocker) and cyproheptadine (5HT2A blocker) combination in decreasing total alcohol consumption (TAC) in alcohol use disorder (AUD). Design, setting and participants: This was a double‐blind, parallel group, placebo‐controlled, Phase 2, randomized clinical trial conducted in 32 addiction treatment centres in France. A total of 108 men and 46 women with severe AUD took part. Intervention: Participants were randomly assigned to one of the following 3‐month treatments: (1) low‐dose group (LDG) receiving 8 mg cyproheptadine and 5 mg prazosin extended‐release (ER) formulation daily; (2) high‐dose group (HDG) receiving 12 mg cyproheptadine and 10 mg prazosin ER daily; and (3) placebo group (PG) receiving placebo of cyproheptadine and prazosin ER. A total of 154 patients were randomized: 54 in the PG, 54 in the LDG and 46 in the HDG. Measurements The primary outcome was TAC change from baseline to month 3. Findings: A significant main treatment effect in the change in TAC was found in the intent‐to‐treat population (P = 0.039). The HDG and LDG showed a benefit in the change in TAC from baseline to month 3 compared with PG: −23.6 g/day, P = 0.016, Cohen's d = −0.44; −18.4 g/day, P = 0.048 (Bonferroni correction P < 0.025), Cohen's d = −0.36. In a subgroup of very high‐risk drinking‐level participants (> 100 g/day of pure alcohol for men and > 60 g/day for women), the difference between the HDG and the PG in the primary outcome was −29.8 g/day (P = 0.031, Cohen's d = −0.51). The high and low doses were well‐tolerated with a similar safety profile. Conclusions: A randomized controlled trial of treatment of severe alcohol use disorder with a cyproheptadine−prazosin combination for 3 months reduced drinking by more than 23 g per day compared with placebo. A higher dose combination was associated with a larger magnitude of drinking reduction than a lower dose combination while showing similar safety profile. [ABSTRACT FROM AUTHOR]

Background: One anastomosis gastric bypass (OAGB) has been proposed as an effective alternative to the current standard procedure in Switzerland, Roux-en-Y gastric bypass (RYGB). Prospective data comparing both procedures are scarce. Therefore, we performed a non-inferiority randomized controlled trial assessing the effectiveness and safety of these 2 operative techniques. Method: Eighty patients were randomized 1:1. OAGB consisted of a very long gastric pouch with a 200 cm biliopancreatic limb, RYGB of a 150 cm ante-colic alimentary and a 60 cm biliopancreatic limb, respectively. Primary endpoint was the percent excess weight loss (%EWL) at 12 months after surgery. Results: Mean %EWL at 12 months was 87.9% (SD24.4) in the RYGB group and 104.1% (SD24.6) in the OAGB group (p = 0.006). There was no mortality. The rate of marginal ulcers was higher in patients with OAGB compared to those with RYGB (p = 0.011), while the total number of late complications did not statistically differ between the two groups. Except for the remission of GERD, which was higher in the RYGB group compared to OAGB, there was no difference between the groups regarding the remission of comorbidities. OAGB showed improved glucose control compared to the RYGB after 1 year (p = 0.001). Furthermore, glucagon-like peptide-1 increase was significantly higher in OAGB at 6 weeks (p = 0.041) and 1 year after surgery (p = 0.029). Quality of life improved after both surgeries, without differences between the groups. Conclusions: %EWL 1 year after surgery was higher in OAGB than in RYGB. A better glycemic control with a higher increase in GLP-1 was observed after OAGB compared to RYGB. Trial registration: This trial is registered on ClinicalTrials.gov under the identifier NCT02601092. [ABSTRACT FROM AUTHOR]

The study aimed to compare the effectiveness of a traditional cardiac rehabilitation (CR) program with an enhanced program incorporating the model of therapeutic engagement (MTE) and extended remote support for patients undergoing coronary artery bypass graft (CABG) patients. In a randomized controlled trial, 88 CABG patients were assigned to experimental and control groups. The experimental group received integrated MTE cardiac rehabilitation, and assessments were conducted at three time points: pre-CR, one month later, and three months post-CR. The study measured medication adherence (MARS-5) and sense of coherence (SoC-13) scales. The study found no significant differences in demographic factors between the experimental and control groups. However, significant differences were observed in MARS and individuals' SoC scores over time in the experimental group, with notable improvements (p < 0.001). The control group showed significant changes only up to one month. Group effects were evident, with consistent increases in the experimental group's outcomes at each assessment point. Integrating the MTE into CR programs offers benefits in terms of medication adherence and individuals' sense of coherence, which warrants further investigation and clinical implementation. Cardiac rehabilitation (CR) is recognized as one of the most effective interventions for secondary prevention, but its accessibility is limited in middle-income countries (MICs). This study represents one of the first theoretically-informed CR trials in a MIC that incorporates the model of therapeutic engagement (MTE) combined with extended remote support services into CR program. The MTE model, as a theoretical framework, was highly suitable for CR settings and demonstrated favorable outcomes. This approach has the potential to greatly benefit cardiac patients, particularly those who may initially show hesitance or reluctance towards engaging in CR. [ABSTRACT FROM AUTHOR]

Aim: To systematically identify, synthesize and critically summarize the available scientific evidence from randomized controlled trials (RCTs) regarding whether short (≤6 mm) perform as well as long (≥10 mm) implants regarding implant survival, marginal bone loss, and biologic and prosthetic complications in different clinical scenarios. Materials and Methods: Cochrane Collaboration's risk of bias tool and the GRADE approach were applied. Results were synthesized using random‐effects meta‐analyses assessed by trial sequential analyses. Results: Forty reports on 19 RCTs comprising 2214 (1097 short; 1117 long) implants were included. Moderate/high certainty/quality evidence demonstrated similar 5‐year survival rates for ≤6‐mm and ≥10‐mm implants in non‐augmented bone and full‐mouth rehabilitation in either jaw, and for 6‐mm implants in the maxilla instead of sinus lift. Nevertheless, the evidence for 5‐year survival rates remains inconclusive or insufficient for the remaining combinations of implant lengths and clinical scenarios. They include 4‐mm and 5‐mm implants as alternatives to sinus lift as well as placing all implant lengths ≤6 mm instead of vertical ridge augmentation with long implants. Marginal bone level and short‐ and long‐term biologic or prosthetic complications were similar. Conclusions: Based on moderate/high certainty/quality evidence from 5‐year RCTs, implants ≤6 mm may be viable alternatives to ≥10‐mm implants in either jaw in native bone and full‐arch rehabilitation, and 6‐mm implants may be used as an alternative to sinus lift. Trial registration: PROSPERO ID: CRD42021254365. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness of an individualized nutritional education program in promoting adequate nutrient intake in pregnant women. Methods: A stratified randomized controlled trial was conducted. Participants were stratified by factors affecting the primary outcome and randomly assigned to the intervention or control groups. Intervention group participants received an individualized 30‐min booklet‐based education program in their 2nd and 3rd trimesters; the control group received usual care. The primary outcome was protein intake after the intervention, which was compared between the intervention and control groups. Secondary outcomes included comparing the amount of increase of protein before and after the intervention. Nutrient intake was measured using a self‐administered short dietary history questionnaire, and analyses of covariance and t tests were performed. Results: Of the 130 participants, 66 were assigned to the intervention group and 64 to the control group. There was no difference in protein intake between the two groups after the intervention (p =.051, 95% CI [−0.021, 12.4]). Comparing the increase in protein intake before and after intervention, the intervention group was 7.4 g/day higher than that of the control group (p =.040; F = 4.31; effect size = 0.36). Conclusions: The primary outcome, a comparison of protein intake between the groups after the program, revealed no significant differences. However, on comparing the amount of protein increase before and after the intervention, the intervention group's increase was significantly higher than that of the control group. Results indicate the potential for individualized face‐to‐face interventions for pregnant women in Japan. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and safety of Bufei Jiedu (BFJD) ranules as adjuvant therapy for patients with multidrug-resistant pulmonary tuberculosis (MDR-PTB). Methods: A large-scale, multi-center, double-blinded, and randomized controlled trial was conducted in 18 sentinel hospitals in China from December 2012 to December 2016. A total of 312 MDR-PTB patients were randomly assigned to BFJD Granules or placebo groups (1:1) using a stratified randomization method, which both received the long-course chemotherapy regimen for 18 months (6 Am-Lfx-P-Z-Pto, 12 Lfx-P-Z-Pto). Meanwhile, patients in both groups also received BFJD Granules or placebo twice a day for a total of 18 months, respectively. The primary outcome was cure rate. The secondary outcomes included time to sputum-culture conversion, changes in lung cavities and quality of life (QoL) of patients. Adverse reactions were monitored during and after the trial. Results: A total of 216 cases completed the trial, 111 in the BFJD Granules group and 105 in the placebo group. BFJD Granules, as an adjuvant treatment, increased the cure rate by 13.6% at the end of treatment, compared with the placebo (58.4% vs. 44.8%, P=0.02), and accelerated the median time to sputum-culture conversion (5 months vs. 11 months). The cavity closure rate of the BFJD Granules group (50.6%, 43/85) was higher than that of the placebo group (32.1%, 26/81; P=0.02) in patients who completed the treatment. At the end of the intensive treatment, according to the 36-item Short Form, the BFJD Granules significantly improved physical functioning, general health, and vitality of patients relative to the placebo group (all P<0.01). Overall, the death rates in the two groups were not significantly different; 5.1% (8/156) in the BFJD Granules group and 2.6% (4/156) in the placebo group. Conclusions: Supplementing BFJD Granules with the long-course chemotherapy regimen significantly increased the cure rate and cavity closure rates, and rapidly improved QoL of patients with MDR-PTB (Registration No. ChiCTR-TRC-12002850) [ABSTRACT FROM AUTHOR]

Cancer-related fatigue (CRF) is unrelenting. As neither rest nor sleep ameliorates cognitive, emotional, and physical symptoms, quality of life is diminished. This study examines resistance training (RT) effectiveness on CRF in cancer survivors. The secondary aims were to identify the dose-response relationship of RT frequency, intensity, and volume on CRF in different cancer survivor populations. Systematic searches via numerous databases for RCTs were performed in June 2022. Patient-reported outcome measures (PROM), were analysed, pre-to-post intervention, using a random-effects model. The Physiotherapy Evidence Database (PEDro) scale informed methodological quality assessment. Eight studies were included (cancer survivors: breast (BCS) = 5; endometrial (ECS) = 1; prostate (PCS) = 2). Overall, RT interventions ≥ 6 weeks elicited large significant reductions in CRF for FACIT-F (SMD = 0.932, p = <0.001) and moderate significant reductions in CRF for PFS-R (SMD = −0.622, p = 0.004). Main findings indicate that RT ameliorates CRF, especially in BCS; however, individualised approaches should be advocated. Supervised training elicited the greatest positive outcomes, thus should be a pivotal part of the cancer rehabilitation pathway. Future studies should be adequately powered, undertake discrete analyses of different cancer types, and investigate chronic RT effects. Cancer-related fatigue (CRF) is debilitating and distressing, leading to reduced quality of life and function in cancer survivors. Considerable heterogeneity exists in disease histology and clinical patient presentation. Individualised resistance training (RT) is an effective, safe, and accessible intervention to mitigat:e fatigue levels, thus aid function, most notably in breast cancer survivors [ABSTRACT FROM AUTHOR]

To verify the effectiveness of experimental occupational therapy plus intensive standard rehabilitation compared to intensive standard rehabilitation alone on the reintegration to social activities of complex patients three months after hospital discharge. Patients with a score ≥ 9 on the Rehabilitation Complexity Scale at admission to an intensive rehabilitation ward were randomized to the control or experimental group. Both groups received intensive multidisciplinary rehabilitation aimed at recovering independence in the basic activities of daily life (ADL). The experimental group also received experimental occupational therapy services to address goals identified through the administration of the Canadian Occupational Performance Measure (COPM). Experimental occupational therapy began during the in-hospital phase and continued in the home-based setting. It consisted of teaching strategies, recommending aids, and providing personalized information regarding available community support. Ninety-two individuals with a mean age of 65 years (female 44.6%) were enrolled. The experimental group significantly improved participation measured by the Reintegration to Normal Living Index (mean changes 8.61, 95% CI: 1–16.23, p = 0.027). The performance and satisfaction scores of the COPM, both during hospitalization and after discharge, and independence in ADL also improved. No differences in mood disturbances were found. Early post-discharge occupational therapy integrated with multidisciplinary rehabilitation improves the social participation of complex patients. Future research should investigate the concrete feasibility of implementing this complex intervention cost-effectively and in different contexts. ClinicalTrials.gov Identifier NCT03668938 (first posted date 13/09/2018) Early post-discharge rehabilitation assists patients' transition from hospital to home by improving the management of problems they encounter. In complex patients, occupational therapy initiated during hospitalization and extended to the early post-discharge phase improves social participation, independence in basic and instrumental daily activities, and performance and satisfaction when carrying out relevant occupational activities. The strong partnership between the Occupational Therapist and the patient improves compliance to treatment, enhancing the chances of success of rehabilitation interventions. [ABSTRACT FROM AUTHOR]

Conventional treatments for allergic rhinitis (AR) exhibit insufficiency and long-term use-related side effects. Considering the reported anti-inflammatory and immunoregulatory effects of Bojungikgi-tang (BJIGT), we aimed to assess its efficacy on persistent AR (PAR). Patients with PAR were randomly assigned in a 1:1:1 ratio into high-dose BJIGT, standard-dose BJIGT, and placebo groups, followed by 1-week run-in and 4-week treatment periods. The primary outcome included the mean change in Total Nasal Symptom Score (TNSS), with secondary outcomes encompassing the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, biomarkers, overall assessment, TNSS by AR pattern identification, and the Sasang constitution. The mean TNSS change was more improved in the BJIGT group than in the placebo group; however, no statistically significant differences were observed. Additional interaction effect analysis revealed a statistically significant improvement in the high-dose BJIGT group compared with the placebo group from weeks 1–2 to weeks 3–4. Regarding secondary outcomes, the BJIGT group exhibited similar or improved results compared with the placebo group, showing no statistically significant differences. No serious adverse effects or clinically significant changes in safety assessments were observed. Given that this study validated clinical improvement and safety, it serves as potential groundwork for pertinent future studies. [ABSTRACT FROM AUTHOR]

Background: High consumption of sugar-sweetened beverages (SSB) is a global health concern. Additionally, sugar-sweetened beverage (SSB) consumption is disproportionately high among adolescents and adults in rural Appalachia. The primary study objective is to determine the intervention effects of Kids SIPsmartER on students' SSB consumption. Secondary objectives focus on caregivers' SSB consumption and secondary student and caregiver outcomes [e.g, body mass index (BMI), quality of life (QOL)]. Methods: This Type 1 hybrid, cluster randomized controlled trial includes 12 Appalachian middle schools (6 randomized to Kids SIPsmartER and 6 to control). Kids SIPsmartER is a 6-month, 12 lesson, multi-level, school-based, behavior and health literacy program aimed at reducing SSB among 7th grade middle school students. The program also incorporates a two-way text message strategy for caregivers. In this primary prevention intervention, all 7th grade students and their caregivers from participating schools were eligible to participate, regardless of baseline SSB consumption. Validated instruments were used to assess SSB behaviors and QOL. Height and weight were objectively measured in students and self-reported by caregivers. Analyses included modified two-part models with time fixed effects that controlled for relevant demographics and included school cluster robust standard errors. Results: Of the 526 students and 220 caregivers, mean (SD) ages were 12.7 (0.5) and 40.6 (6.7) years, respectively. Students were 55% female. Caregivers were mostly female (95%) and White (93%); 25% had a high school education or less and 33% had an annual household income less than $50,000. Regardless of SSB intake at baseline and relative to control participants, SSB significantly decreased among students [-7.2 ounces/day (95% CI = -10.7, -3.7); p < 0.001, effect size (ES) = 0.35] and caregivers [-6.3 ounces/day (95% CI = -11.3, -1.3); p = 0.014, ES = 0.33]. Among students (42%) and caregivers (28%) who consumed > 24 SSB ounces/day at baseline (i.e., high consumers), the ES increased to 0.45 and 0.95, respectively. There were no significant effects for student or caregiver QOL indicators or objectively measured student BMI; however, caregiver self-reported BMI significantly decreased in the intervention versus control schools (p = 0.001). Conclusions: Kids SIPsmartER was effective at reducing SSB consumption among students and their caregivers in the rural, medically underserved Appalachian region. Importantly, SSB effects were even stronger among students and caregivers who were high consumers at baseline. Trial registration: Clincialtrials.gov: NCT03740113. Registered 14 November 2018– Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03740113. [ABSTRACT FROM AUTHOR]

Mastectomy serves as the main surgical treatment for both invasive and in situ breast carcinoma and large phyllodes tumors. It is associated with skin necrosis, seroma, and surgical site infection in up to 30% of patients. In the present trial, we compared the complications in patients undergoing skin flap elevation by one of the 4 techniques: thick skin flap raised by scalpel(group1), thin skin flap raised with scalpel (group 2), thick skin flap raised with diathermy (group 3), and thin skin flap raised with diathermy (group 4). A randomized trial with superiority hypothesis and 2 × 2 factorial design was conducted at All India Institute of Medical Sciences New Delhi. Mastectomy skin flap necrosis (MSN) was recorded as the main outcome of interest. MSN was noted in 2.5% in group1, 10% in group 2, 7.5% in group 3, and 30% in group 4. MSN was observed in 5% cases with thick flap compared to 20% cases with a thin skin flap (p = 0.007). Raising the flap with scalpel was associated with MSN in 6.25% compared to 18.75% in the diathermy group (p = 0.029). We conclude that raising a thick flap with scalpel is associated with lowest risk of skin flap necrosis. Trial Registration: Clinical Trial Registry- India CTRI/2014/09/004978 [ABSTRACT FROM AUTHOR]

Background: Trauma is prevalent amongst early psychosis patients and associated with adverse outcomes. Past trials of trauma-focused therapy have focused on chronic patients with psychosis/schizophrenia and comorbid Post-Traumatic Stress Disorder (PTSD). We aimed to determine the feasibility of a large-scale randomized controlled trial (RCT) of an Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) intervention for early psychosis service users. Methods: A single-blind RCT comparing 16 sessions of EMDRp + TAU v. TAU only was conducted. Participants completed baseline, 6-month and 12-month post-randomization assessments. EMDRp and trial assessments were delivered both in-person and remotely due to COVID-19 restrictions. Feasibility outcomes were recruitment and retention, therapy attendance/engagement, adherence to EMDRp treatment protocol, and the 'promise of efficacy' of EMDRp on relevant clinical outcomes. Results: Sixty participants (100% of the recruitment target) received TAU or EMDR + TAU. 83% completed at least one follow-up assessment, with 74% at 6-month and 70% at 12-month. 74% of EMDRp + TAU participants received at least eight therapy sessions and 97% rated therapy sessions demonstrated good treatment fidelity. At 6-month, there were signals of promise of efficacy of EMDRp + TAU v. TAU for total psychotic symptoms (PANSS), subjective recovery from psychosis, PTSD symptoms, depression, anxiety, and general health status. Signals of efficacy at 12-month were less pronounced but remained robust for PTSD symptoms and general health status. Conclusions: The trial feasibility criteria were fully met, and EMDRp was associated with promising signals of efficacy on a range of valuable clinical outcomes. A larger-scale, multi-center trial of EMDRp is feasible and warranted. [ABSTRACT FROM AUTHOR]

Chinese immigrant survivors of men's violence experience both significant mental health impacts from abuse and barriers to formal services. Therefore, we examined the preliminary efficacy of an innovative mobile-based empowerment-based intervention (self-compassion, health, and empowerment; SHE) that specifically focuses on abused Chinese immigrant women in the US. This pilot study used a two-arm randomized controlled design with repeated measures. A convenience sample (N = 50) of Chinese immigrant women who experienced past year intimate partner violence (IPV) were recruited online and randomly assigned to the intervention or control group (25 per group). We assessed IPV exposure, safety behaviors, depressive symptoms, anxiety symptoms, post-traumatic stress disorder (PTSD) symptoms, and self-compassion at baseline, post-intervention, and 8-week follow-up. Of 95 eligible participants, 50 (52.6%) agreed to participate and completed baseline data collection; intervention completion rate was 64%. We found a significant group and time interaction for self-judgment (a self-compassion component), with a significant reduction seen in the intervention group compared to the control group. Despite no other significant group differences observed over time, the intervention group showed consistent trends toward improvements in most outcome measures, including specific types of IPV (i.e., negotiation, psychological aggression, and sexual coercion), depressive and PTSD symptoms, self-compassion, and certain components of self-compassion (i.e., isolation and over-identification) when compared to the control group. Our findings suggest that the SHE intervention shows promise in improving the mental health well-being of Chinese immigrant survivors. However, a fully powered randomized controlled trial is warranted to determine its efficacy. Our intervention has the potential to be translated in the Chinese immigrant populations with the necessary organizational support. [ABSTRACT FROM AUTHOR]

We report midline impacts of a community-randomized cash transfer intervention to 1857 vulnerable mothers in 140 rural cocoa-farming communities of Côte d'Ivoire. Compared to mothers in the comparison group who participated in village savings and loan associations (VSLAs), treatment mothers participated in VSLAs and received 8 € each week for up to one year with no conditions attached (the midway point of a two-year program). We find small- to moderate-sized treatment effects on four of six indicators of economic well-being (d = 0.23–0.75), as well as small reductions in maternal stress (d = −0.27). We find no statistically detectable impacts on educational engagement, educational aspirations, or educational expectations for children. Results suggest that cash transfer programs in rural West African communities can improve economic well-being and reduce maternal stress. Implications for children and families and for future cash transfer evaluations are discussed. [ABSTRACT FROM AUTHOR]

Mobile health applications (mHealth apps) may lead to health benefits. In recent years, the use of apps in multiple sclerosis (MS) has increased. Apps to train and improve dexterity in MS are scarce. This study investigated the effectiveness of a tablet app-based home-based training to improve dexterity in individuals with MS. In a randomized controlled trial, two standardized 4-week home-based interventions focussing on different aspects of dexterity and upper limb function were compared. Assessments were done at baseline, post-intervention and 12-week follow-up. The primary endpoint was the Arm Function in Multiple Sclerosis Questionnaire, a dexterity-related measure of patient-reported activities of daily living. Secondary endpoints were dexterous function, grip strength and health-related quality of life. Forty-eight individuals were randomly assigned to a tablet app-based program (n = 26) or a control strengthening exercise program (n = 22). No significant differences were found for the primary endpoint (p = 0.35). Some significant differences in favour of the app-group were found in fine coordinated finger movements and strength. No significant differences were found at the 12-week follow-up for all endpoints. Adherence in both groups was above 90%. App-based training was not superior compared to a control strengthening exercise program concerning the arm- and hand function from the participant's perspective. However, app-based training was found to be effective in improving specific dimensions (finger movements and strength), and can easily be applied at home. Therefore, individuals living with MS with impaired dexterity should consider app-based training. Clinicaltrials.gov NCT03369470. This study provides initial evidence for the effectiveness of a home-based app-based program for improving dexterous function in individuals living with multiple sclerosis through the implementation of a tablet app-based dexterity training. App-based training was not superior compared to a control strengthening exercise program concerning the arm- and hand function from the participant's perspective. Patients attending the app-based dexterity program showed some statistically significant improvements in fine coordinated finger movements and strength. [ABSTRACT FROM AUTHOR]

BACKGROUND: Since the outbreak of the COVID-19 pandemic, university students have been exposed to a heightened vulnerability towards developing psychological issues, such as psychological distress and shyness. Internet-based interventions offer a convenient avenue for scalability, thus prompting the development of a smartphone-based hypnotic intervention aimed at addressing shyness among university students. OBJECTIVE: We devised an innovative smartphone-based hypnotic intervention called mHypnosis to examine its impact on shyness among undergraduate students. Furthermore, we aimed to investigate whether the apprehension of negative evaluations before treatment could serve as a predictor for the effectiveness of the intervention on shyness. METHODS: Eighty students with high shyness scores were randomly assigned to the experimental group and the control group. Another 40 participants with low shyness score were selected as the baseline group. The Shyness Scale (SS), Fear of Negative evaluation scale (FNE), Self-Acceptance Questionnaire (SAQ), and Self-Esteem Scale (SES) were used to evaluate the effect of hypnotic intervention. RESULTS: Before the intervention, the scores of the experimental and control groups on the SS, FNE, SAQ, and SES were higher than those in the baseline group (p < 0.05). There was no significant difference in scores between the experimental and control group (p > 0.05). After the intervention, the scores of the SS, FNE, SAQ, and SES were significantly lower in the experimental group than those in the control group (p < 0.05). The pretest score of FNE could predict the shyness score after hypnotic intervention (B = 0.35, p < 0.05). CONCLUSION: Smartphone-based hypnotic intervention had a significant effect on ameliorating shyness during the COVID-19 pandemic; fear of negative evaluation can be a target for treating shyness. [ABSTRACT FROM AUTHOR]

Background and objectives: Chronic headaches are a frequent cause of pain and disability. The purpose of this randomized trial was to examine whether transcranial direct current stimulation (tDCS) applied to the primary motor cortex, reduces pain and increases daily function in individuals suffering from primary chronic headache. Materials and methods: A prospective, randomized, controlled trial, where participants and assessors were blinded, investigated the effect of active tDCS vs. sham tDCS in chronic headache sufferers. Forty subjects between 18 and 70 years of age, with a diagnosis of primary chronic headache were randomized to either active tDCS or sham tDCS treatment groups. All patients received eight treatments over four consecutive weeks. Anodal stimulation (2 mA) directed at the primary motor cortex (M1), was applied for 30 min in the active tDCS group. Participants in the sham tDCS group received 30 s of M1 stimulation at the start and end of the 30-minute procedure; for the remaining 29 min, they did not receive any stimulation. Outcome measures based on data collected at baseline, after eight treatments and three months later included changes in daily function, pain levels, and medication. Results: Significant improvements in both daily function and pain levels were observed in participants treated with active tDCS, compared to sham tDCS. Effects lasted up to 12 weeks post-treatment. Medication use remained unchanged in both groups throughout the trial with no serious adverse effects reported. Conclusion: These results suggest that tDCS has the potential to improve daily function and reduce pain in patients suffering from chronic headaches. Larger randomized, controlled trials are needed to confirm these findings. Trial registration: The study was approved by the local ethics committee (2018/ 2514) and by the Norwegian Centre for Research Data (54483). [ABSTRACT FROM AUTHOR]

Objective: In this single‐blinded randomized controlled trial, we compared the "Test in‐Train Out" structured home‐based exercise program (TiTo‐SHB) with the traditional "go home and walk" exercise intervention in people with peripheral artery disease (PAD). Methods: Peripheral artery disease patients at Leriche‐Fontaine's stage II were randomized to receive TiTo‐SHB or walking advice (C‐WA). The TiTo‐SHB group performed two daily 8‐min sessions of pain‐free interval walking at progressive low‐to‐moderate speed maintained with a metronome. The C‐WA group was recommended to walk for 30 min at least three times per week and to endure claudication pain. Outcomes collected at baseline and at the end of the program (6 months) included: 6‐min and pain‐free walking distance (6MWD, PFWD), ankle‐brachial index (ABI), 5‐time sit‐to‐stand test (5STS), and health‐related quality of life (HRQoL) by the VascuQoL‐6 questionnaire. Results: A total of 68 patients were randomized (males n = 50; aged 73 ± 9; TiTo‐SHB n = 34). At the end of the program, patients in the TiTo‐SHB group compared with the C‐WA group had significantly improved 6MWD (Δ + 60 ± 32 m vs. Δ − 5 ± 37 m; p < 0.001) and PFWD (Δ + 140 ± 92 m vs. Δ − 7 ± 87 m; p < 0.001). A significant between‐group difference in favor of the TiTo‐SHB group was also recorded for all the secondary outcomes, including 5STS (Δ − 2.6 ± 1.8 s vs. Δ + 0.8 ± 2.6 s; p < 0.001), ABI of the more impaired limb (Δ + 0.10 ± 0.11 vs. Δ + 0.02 ± 0.08; p = 0.003), and VascuQoL‐6 score (Δ +2 ± 2 vs. −1 ± 4; p < 0.001). Conclusion: In PAD patients with claudication, the pain‐free in‐home TiTo‐SHB program was more effective in improving exercise capacity and HRQoL than the traditional walking advice recommendation. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to examine changes in compulsive exercise among adults with eating disorders (ED) admitted for inpatient treatment in a randomized controlled trial comparing cognitive behavioral therapy (CBT) and compassion‐focused therapy (CFT) and whether such changes were influenced by treatment condition, childhood trauma, or level of compulsive exercise. Method: A total of 130 adults admitted to inpatient treatment for EDs mean (SD) age 30.9 (9.7) years, mean illness duration 14.2 (8.9) years, were randomized to receive CBT or CFT and analyzed using multilevel modeling. Assessments included Eating Disorders Examination – Interview, Compulsive Exercise Test and Childhood Trauma Questionnaire. Results: Mean total CET score at baseline was 14.7 (4.0) with no difference between the treatment groups. A total of 63 (48.5%) had CET score ≥ 15, indicating clinical levels. There was an overall time effect on reduction in CET total and all CET subscale scores except Lack of enjoyment, and CFT provided greater reduction compared to CBT on the CET subscale Mood improvements. Patients with clinical CET score levels showed greater reduction on CET total and the subscales Avoidance, Weight, and Rigidity across time compared to persons with non‐clinical CET score. Childhood trauma did not predict changes in CET total or subscale scores. Discussion: Both CBT and CFT improve overall compulsive exercise. The greater effect of CFT than CBT on exercise as a maladaptive mood regulator calls for further research on how affective oriented psychotherapies can not only reduce compulsive exercise but also promote functional exercise among persons with EDs. Public Significance Statement: Understanding and addressing compulsive exercise in adults with eating disorders is crucial. This study comparing cognitive‐behavioral therapy and compassion‐focused therapy shows both improve compulsive exercise. Importantly, compassion‐focused therapy has a greater impact as an emotion‐focused regulator. This emphasizes the need for further exploration into how emotion‐focused therapies can reduce compulsive exercise and promote healthier, functional physical activity for individuals with eating disorders. [ABSTRACT FROM AUTHOR]

Background: Cannabidiol (CBD) has been shown recently to positively affect patient pain and satisfaction immediately after arthroscopic rotator cuff repair (ARCR). However, it is unclear whether the addition of CBD to a perioperative regimen could affect postoperative outcomes. Purpose: To evaluate patient-reported outcomes among patients who underwent ARCR and received buccally absorbed CBD or an identical placebo for early postoperative pain management at 1-year follow-up. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Eligible patients had previously participated in a multicenter, placebo-controlled, randomized, double-blinded trial that evaluated the analgesic effects of CBD in the immediate postoperative period after ARCR. The experimental group received 25 mg of CBD 3 times/day if <80 kg and 50 mg of CBD 3 times/day if >80 kg for 14 days, with the control group receiving an identical placebo. The following outcomes were assessed at minimum 1-year follow-up: visual analog scale (VAS) for pain, American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE), and patient satisfaction. The rates of achievement of the Patient Acceptable Symptom State (PASS) were compared based on ASES at latest follow-up. Continuous and categorical variables were compared with the Mann-Whitney U test and Fisher exact test, respectively. Results: Follow-up was obtained from 83 of 99 patients (83.8%) who completed the original trial. There were no significant differences between the CBD and control groups with respect to age, sex, body mass index, rate of concomitant procedures, or number of anchors used intraoperatively. At 1-year follow-up, there were no significant differences between the CBD and control groups in VAS pain (0.8 vs 1.2, P =.38), ASES (93.0 vs 91.1, P =.71), SANE (87.6 vs 90.1, P =.24), or satisfaction (97.4 vs 95.4, P =.41). A majority of patients achieved the PASS (81.0% [CBD] vs 77.5% [control]; P =.79). Conclusion: Perioperative use of CBD for pain control among patients undergoing ARCR did not result in any significant deficits in pain, satisfaction, or patient-reported outcomes at 1-year postoperatively compared with a placebo control group. These findings suggest that CBD can be considered in a postoperative multimodal pain management regimen without detrimental effects on outcome. Registration: NCT04672252 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Background: Although previous studies have showed that epidural morphine can be used as a complement to local anesthetics for analgesia after postcesarean delivery under spinal anesthesia, there is little known about the analgesic dosage of epidural morphine and hydromorphone for hemorrhoidectomy. Therefore, we conducted this study to examine the potency ratio of hydromorphone to epidural morphine as well as effective analgesic dose for 50% patients (ED50) undergoing elective hemorrhoidectomy. Methods: 80 patients under elective hemorrhoidectomy with combined spinal and epidural anesthesia(CSEA) in department of anesthesia, Dongguan Tungwah hospital. To assess the ED50, patients were treated with epidural morphine or epidural hydromorphone randomly using a biased coin method-determined dose with a sequential allocation procedure. Following surgery, standardized multimodal analgesia was administered to all patients. A pain response score of ≤ 3 (on a scale of 0–10) was determined to be the effective dose after 24 h following CSEA. The ED50 in both groups were determined using the probit regression and isotonic regression method. We also measured pain intensity by patient interview using a 10 point verbal numeric rating scale prospectively at 6, 12 and 24 h after CSEA, and adverse effects were also noted. Results: The ED50 was 0.350 mg (95% CI, 0.259–0.376 mg) in hydromorphone group and 1.129 mg (95% CI, 0.903–1.187 mg) in morphine group, respectively, estimated by isotonic regression method. Regression analysis with the probit, the ED50 of epidural hydromorphone was 0.366 mg (95% CI, 0.276–0.388 mg) and epidural morphine was 1.138 mg (95% CI, 0.910–1.201 mg). Exploratory findings showed that there was no difference between the most frequent dosages of epidural hydromorphone or epidural morphine in the occurrence of nausea, vomiting and pruritus. When administered with epidural opioids at ED50 doses or higher, 97.5% (39/40) of epidural morphine patients and 97.5% (39/40) epidural hydromorphone of patients were satisfied with their analgesia. Conclusion: Effective hemorrhoidectomy analgesia requires a 3:1 ratio of epidural morphine to epidural hydromorphone. Both drugs provide excellent patient satisfaction. [ABSTRACT FROM AUTHOR]

Background: Central obesity is considered as a significant health threat to individuals. Scientific research has demonstrated that intra-abdominal fat accumulation is associated with higher metabolic and cardiovascular disease risks independent of Body Mass Index (BMI). This study aimed to evaluate the efficacy and safety of electro-acupuncture in treating central obesity compared with sham acupuncture. Method: This was a patient-assessor blinded, randomized, sham-controlled clinical trial. One hundred sixty eight participants aged between 18 and 65 years old with BMI ≥ 25 kg/m2 and waist circumference (WC) of men ≥ 90 cm / women ≥ 80 cm were enrolled and allocated to the acupuncture or sham acupuncture group equally. For the acupuncture group, disposable acupuncture needles were inserted into eight body acupoints, including Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) with electrical stimulation. For the control group, Streitberger's non-invasive acupuncture needles were utilized at the same acupoints with identical stimulation modalities. The treatment duration was 8 weeks with 2 sessions per week and the follow-up period was 8 weeks. The primary outcome was the change in WC before and after the treatment. The secondary outcomes were the changes in hip circumference, waist-to-hip circumference ratio, BMI, and body fat percentage during the treatment and follow-up period. Results: The acupuncture group displayed a significant change in WC compared to the sham group both treatment and follow-up period (MD = -1.1 cm, 95% CI = -2.8 to 4.1). Significant change in body fat percentage was recorded for both groups after treatment but no significance was observed during the follow-up period (MD = -0.1%, 95% CI = -1.9 to 2.2). The changes in hip circumference were also significant both treatment and follow-up period for the acupuncture group (MD = -2.0 cm, 95% CI = -3.7 to -1.7). Compared with sham acupuncture, the body weight (MD = -1 kg, 95% CI = -3.3 to 5.3), BMI (MD = -0.5, 95% CI = -0.7 to 1.9) also decreased significantly within and between groups. The incidence of adverse events was similar in the two groups. Conclusion: This study provided evidence that electro-acupuncture could be effective in treating central obesity by reducing WC, hip circumference, body weight, BMI, and waist-to-hip circumference ratio. Trial registration: ClinicalTrials.gov Identifier: NCT03815253, Registered 24 Jan 2019. [ABSTRACT FROM AUTHOR]

Background: The training methods utilized in football play a crucial role in improving player performance. Complex training, which combines strength and conditioning exercises with sport-specific movements, has shown promise in enhancing athletic performance. However, previous studies investigating the effectiveness of complex training for football players have been limited by small sample sizes, warranting further investigation. Purpose: The purpose of this study was to rigorously examine the effectiveness of complex training for intermediate football players. Materials and Methods: A randomized controlled trial design was implemented, enlisting a total of 120 intermediate-level football players who were randomly assigned to either a complex training group (n=60) and a conventional group (n=60). The complex training group engaged in a 6 week complex training program, while the conventional group adhered to a conventional training. Pre and post-test were conducted to evaluate performance measures. Results: The findings demonstrated statistically significant improvements in the complex training group compared to the conventional group across all performance measures. The complex training group exhibited substantial enhancements in agility (pre: M=8.21, SD=1.05; post: M=9.43, SD=1.08; p<0.001), speed (pre: M=5.76, SD=0.68; post: M=6.12, SD=0.59; p<0.05), power (pre: M=225.68, SD=34.27; post: M=258.94, SD=30.91; p<0.01), and kicking accuracy (pre: M=73.41%, SD=5.86; post: M=81.52%, SD=6.21; p<0.001), indicating superior performance in the experimental group. Conclusion: This study provides robust evidence supporting the effectiveness of complex training in enhancing various aspects of performance among intermediate football players, enabling them to improve agility, speed, power, and kicking accuracy. [ABSTRACT FROM AUTHOR]

Background: Under the guidance of a preliminary Live with Love Conceptual Framework, a Caring for Couples Coping with Colorectal Cancer (4Cs: CRC) programme was designed specifically for colorectal cancer couples. The objectives of this study included examining the efficacy of the programme for couples adapting to colorectal cancer and comparing the effects of different intervention delivery modes (online, face‐to‐face and blended) on couple outcomes. Methods: A four‐arm randomized controlled trial was conducted among Chinese colorectal cancer couples. Couples were randomly assigned to an online intervention, a face‐to‐face intervention, a blended intervention or a control group. Self‐efficacy, dyadic coping, communication and dyadic outcomes (physical and mental health, negative and positive emotions and marital satisfaction) were evaluated at baseline and 6 weeks later. Analysis of variance (ANOVA) and repeated measures ANOVA were employed to assess between‐group differences and within‐group effects in the four groups, respectively. Results: A total of 179 couples completed the 6‐week study and post‐study assessments. The intervention showed generally medium‐to‐large effects across multiple measured outcomes, including self‐efficacy, dyadic coping, communication, mental health, negative emotions and positive emotions for both patients and spouse caregivers. Additionally, interventions delivered through different modes produced equally significant effects on couple outcomes. Conclusions: The integrated intervention programme is effective in improving cancer adaptation in colorectal cancer couples. Long‐term follow‐up and a mix of quantitative and qualitative assessments are crucial for further evaluation of the programme. Trial registration: Retroactive registration is under review. [ABSTRACT FROM AUTHOR]

The authors investigate the effects of centering meditation on state hope among college and graduate students through a randomized controlled trial. Participants (n = 150; 65% white, 84% female) were randomized to either a centering meditation group or a waitlist control group. Time‐series analyses indicated that centering meditation significantly improved hope, suggesting long‐term dynamic adjustment, compared to a control group. Specifically, the autoregressive integrated moving average (ARIMA) procedures indicated that the treatment group exhibited a statistically significant upward trend in hope, ARIMA (1, 1, 0). As expected, the control group's levels of hope were stationary, ARIMA (1, 0, 1). The study highlights the potential benefits of centering meditation as an evidence‐based counseling intervention for improving hope in the college population. [ABSTRACT FROM AUTHOR]

Objective: Borderline personality disorder (BPD) is a serious public health problem. Dialectical Behavior Therapy (DBT) is a program that has provided encouraging results for its treatment. However, scientific evidence about its efficacy is scarce. Therefore, we aimed to describe the scientific production on the components of the DBT program and its therapeutic efficacy in the treatment of people with BPD. Method: A systematic review with relevant keywords was conducted based on studies available in Scopus, Web of Science, and PubMed until June 2023, including studies in English, research on therapeutic intervention, studies with a randomized controlled trial (RCT) design that included people with the diagnosis of BPD. Results: We found 18 RCTs, most of which supported the effectiveness of DBT for BPD. There were a total of 1,755 participants in these studies, most of whom were women. These studies looked for treating self-injurious behaviors, suicidal thoughts or ideations, number of visits to emergency services, and frequency of hospital admissions. Most studies revealed that both short-term DBT and standard DBT improved suicidality in BPD patients with small or moderate effect sizes, lasting up to 24 months after the treatment period. Furthermore, these studies showed that DBT can significantly improve general psychopathology and depressive symptoms in patients with BPD. Improvement of compliance, impulsivity, mood instability, as well as reduction in hospitalization rate are other findings observed in the trials following DBT. Conclusion: Although DBT shows efficacy in the treatment of BPD, heterogeneity in the methodologies employed is highlighted. Therefore, it is necessary to design studies from a homogeneous theoretical and methodological framework. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of manual acupuncture on endometrial blood flow parameters by three-dimensional (3D) power Doppler ultrasound in women undergoing in vitro fertilization embryo transfer (IVF-ET). Methods: Seventy patients undergoing IVF-ET were equally randomized into traditional or sham acupuncture treatment group for totally 4 days (from the day of oocyte aspiration to the day of embryo transfer) of treatment by random envelope method at the Reproductive Medicine Center and Outpatient Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology from January 2013 to December 2015. Patients in the traditional acupuncture group accepted traditional acupuncture methods with manual acupuncture, and Zhongji (CV3), Qihai (CV 6), Sanyinjiao (SP6), Taichong (LR 3), Tianshu (ST 25), Guilai (ST 29) and Zusanli (ST 36) were chosen. Patients at the sham acupuncture group accepted shallow acupuncture methods at 4 non-meridian points at each shoulder and upper arm. Outcome measures included endometrial ultrasonic indices such as vascularization index (VI), flow index (FI) and vascularization flow index (VFI), endometrial thickness and volume, subendometrial VI (sVI), subendometrial FI (sFI), subendometrial VFI (sVFI), implantation rate, clinical pregnancy rate, abortion rate, live birth rate and number of live births. Results: Finally, 34 patients in the traditional acupuncture group and 35 in the sham acupuncture group completed this trial. VI, FI and VFI of the traditional acupuncture group were significantly higher than those in the sham acupuncture group (P<0.05). No significant differences were found in endometrial thickness, endometrial volume, sVI, sFI, sVFI, implantation rate, clinical pregnancy rate, abortion rate, live birth rate and number of live births (P>0.05). Conclusions: Manual acupuncture performed after oocyte aspiration and before transplantation improved the endometrial blood flow parameters VI, RI and VFI in women who underwent IVF-ET, instead of sVI, sFI and sVFI. Therefore, acupuncture might be beneficial in women undergoing IVF-ET by increasing endometrial blood flow and endometrial receptivity. (Registration No. ChiCTR2100053354) [ABSTRACT FROM AUTHOR]

The Dutch Committee for the Evaluation of Oncological Agents (cieBOM) assesses the clinical benefit of systemic anti-cancer treatments (SACTs). For SACTs tested in non-randomized trials (NRTs), cieBOM primarily utilizes response-related thresholds as assessment criteria. As sufficiency of NRT-based evidence for benefit assessments is questionable, this study investigated whether and how NRTs can be used to assess the clinical benefit of new SACTs initially appraised by cieBOM based on randomized controlled trials (RCTs). Using the RCTs underpinning cieBOM recommendations issued between 2015 and 2017, we searched for matching NRTs and applied the NRT-related assessment criteria by cieBOM to them. We then compared the assessment outcomes to the respective RCT-based cieBOM recommendations. Further, we investigated how the assessments would change when applying different response-related thresholds and adding a progression-free survival (PFS) threshold. For 13 of the 37 eligible recommendations, a matching NRT was found. Two treatments were assessed positively and six negatively; five treatments were non-assessable. Two positive recommendations matched a positive NRT-based assessment; one matching negative assessment was found, and one treatment could not be assessed based on either trial results. Adding a > 6 months PFS threshold decreased the number of non-assessable NRTs (five to two). Limited publications and inconsistent data reporting hampered the viability of NRTs for clinical benefit assessments of SACTs beyond the scope of rare indications. Further, response-related assessment criteria alone might not fully grasp the clinical benefit of novel SACTs. NRT-based assessments should be considered with caution due to uncertainty of the trial results. • CieBOM assesses the clinical value of NRT-tested SACTs on response-based criteria. • Scarce publications and lack of data impede NRT-based clinical value evaluations. • Comparing assessment outcomes shows differences between RCTs and NRTs as basis. • Adding a PFS threshold as a criterion reduces the number of non-assessable SACTs. • Generalization of value assessment criteria to non-rare indications is unfeasible. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate whether the use of 8.25% sodium hypochlorite (NaOCl), compared with the use of 2.5% NaOCl, leads to higher postoperative pain after endodontic treatment. A total of 154 patients were randomly assigned into 2 groups: 8.25% and 2.5% NaOCl. A single-visit endodontic treatment was performed using a standard protocol, varying only the NaOCl concentration. Postoperative pain was assessed using the numeric rating scale at multiple times over 30 days. Overall pain scores over time were explored via multilevel mixed-effects negative binomial regression. The need for pain medication was recorded and compared between groups via the Mann-Whitney U test. The use of 8.25% NaOCl increased postoperative pain scores over time by 3.48 times compared with the use of 2.5% NaOCl (incident rate ratio [IRR], 3.48; 95% CI, 1.57 to 7.67). Furthermore, the 8.25% NaOCl group exhibited higher pain incidence than the 2.5% NaOCl group during the 12-hour through 3-day period, with scores at these times ranging from 2.21 (IRR, 2.21; 95% CI, 1.35 to 3.62) through 10.74 (IRR, 10.74; 95% CI, 3.74 to 30.87) higher. No difference was detected in the number of analgesic capsules administered between groups. The use of 8.25% NaOCl resulted in higher postoperative pain than the use of 2.5% NaOCl, with pain scores increasing by 3.48 times when this solution was used. Furthermore, the 8.25% NaOCl group exhibited higher pain incidence than the 2.5% NaOCl group during the 12-hour through 3-day period. The use of 8.25% NaOCl during endodontic treatment can increase postoperative pain significantly. This clinical trial was registered at the Brazilian Registry of Clinical Trials database (RBR-6vq3hc4). [ABSTRACT FROM AUTHOR]

• A home-delivered non-pharmacological intervention contributed to reducing the immediate total and social loneliness of homebound older adults. • The decrease in perceived social loneliness mediated the improvement of depressive symptom levels. • Social loneliness may be a relevant target of intervention to improve depressive symptomatology. The present study aimed to explore whether the Homebound Elderly People Psychotherapeutic Intervention (HEPPI), a home-delivered ten-week cognitive-emotional intervention, was effective in reducing self-reported loneliness among homebound older adults presenting mild cognitive impairment and psychological symptomatology. Effects of HEPPI in total, social, and emotional loneliness, compared with a treatment-as-usual group, were investigated at post-intervention and 3-month follow-up. In addition, the potential role of social and emotional loneliness as mediators of the HEPPI impact on episodic memory and symptoms of depression and anxiety was examined. This study built upon the data of a previously conducted randomized controlled trial. Participants were randomly assigned to the HEPPI group (n = 98) or the treatment-as-usual group (n = 101) and completed baseline, post-intervention, and 3-month follow-up assessments, including measures of loneliness (UCLA - Loneliness scale), episodic memory (Wechsler Memory Scale-III), depressive symptoms (Geriatric Depression Scale-30), and anxiety symptoms (Geriatric Anxiety Inventory). Data were analyzed on an intention-to-treat basis employing linear mixed models and mediation analyses for repeated measures. ClinicalTrials.gov identifier: NCT05499767. Compared with usual care controls, the HEPPI participants reported a significant immediate decrease in total and social loneliness, but these effects were not maintained at a 3-month follow-up. The reduction in immediate perceived social loneliness significantly mediated the improvement of depressive symptoms. The current findings suggest that HEPPI potentially reduced total and social loneliness of the homebound older population immediately post-intervention, and such decrease in social loneliness may be a relevant mechanism for improving their short-term depressive symptomatology. [ABSTRACT FROM AUTHOR]

Parenting of preterm infants presents unique challenges, particularly during their transition from hospital to home. Early discharge programs can assist parents during this critical period. However, the feasibility of delivering a family-focused online discharge program remains understudied. This study was conducted to investigate the impact of a family-focused online parenting support intervention on parents' sense of competence, depression, caregiving, social support, family functioning, and the weight and length of preterm infants. We conducted a single-blind, two-arm randomized controlled trial with a repeated-measures design. Participants were recruited from a specialized tertiary hospital in China between May and December 2022. Forty-five families were randomly assigned to the intervention group and 44 to the control group. The intervention included three components: (1) two one-hour group sessions and three 30-minute individual sessions of online parenting support; (2) two follow-up telephone calls (15–30 min each) post-discharge; and (3) access to online parenting resources. Primary outcomes included parenting sense of competence, parental care ability, and preterm infants' weight and length. Secondary outcomes included depression, social support, and family functioning. Measurements were taken at baseline, preterm infant discharge, one month post-discharge, and three months post-discharge. A generalized estimating equation model was employed based on the intention-to-treat principle for outcome comparison. Parents in the intervention group showed significant improvements in parenting sense of competence (P < 0.001), parental care ability (P < 0.001), depression (P < 0.001), and social support (P = 0.002). However, no statistically significant differences were observed in preterm infants' weight and length, or in family functioning (P > 0.05). Although the intervention did not affect preterm infants' outcomes, the positive enhancements in parenting sense of competence, care ability, depression, and social support indicate that online family-focused parenting support can effectively prepare parents for hospital discharge and the early transition period. [ABSTRACT FROM AUTHOR]

Sleep disturbance is commonly reported among individuals meeting criteria for cannabis use disorder (CUD), and people who use cannabis frequently report sleep disturbance as a contributor to failed quit attempts. The purpose of this study was to measure sleep in individuals enrolled in treatment for CUD, and to determine whether use of hypnotic medication during treatment increased abstinence rates. The study enrolled 127 adults seeking treatment for CUD in a 12-week clinical trial and randomized to receive extended-release zolpidem (zolpidem-XR) or placebo. All participants received computerized behavioral therapy and abstinence-based contingency management. The study conducted in-home ambulatory polysomnography (PSG) assessments at baseline and during treatment to objectively measure sleep. Self-report measures of recent sleep, Insomnia Severity Index (ISI), and drug use (Timeline Follow-Back) were collected at each study visit, and the study confirmed self-reported abstinence via quantitative urine drug testing. Participants randomized to placebo, but not zolpidem-XR exhibited significant sleep disturbance during week 1 of treatment. Sleep disturbance emerged in the zolpidem-XR group after study medication was stopped at the end of treatment. Though participants assigned to the zolpidem-XR condition had qualitatively greater rates of abstinence compared with placebo (27 % versus 15 % negative at end of treatment), the difference was not statistically significant. Treatment retention was poor (about 50 % drop out in both groups) and medication adherence was a challenge without the use of contingent incentives. Results from this randomized controlled trial suggest that zolpidem-XR can attenuate abstinence-induced sleep disturbance early in treatment for CUD, but that sleep problems are likely to emerge after the medication is stopped. Further research should identify alternative pharmacotherapies and behavioral treatments for CUD and elucidate the role of sleep disturbance in the development and maintenance of CUD. • Sleep disturbance is commonly reported among individuals with cannabis use disorder. • This RCT evaluated extended-release zolpidem for cannabis-related sleep disturbance. • Zolpidem-XR attenuated sleep disturbance but sleep problems re-emerged at EoT. • Zolpidem-XR resulted in non-significant improvement in cannabis abstinence relative to placebo. [ABSTRACT FROM AUTHOR]