The evaluation of nightshade elimination diet (NED) on inflammatory and rheumatologic markers of rheumatoid arthritis patients: study protocol for a randomized controlled trial.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic disease with a global prevalence rate of 1%. Patients with RA often associate specific foods like tomatoes and eggplants with adverse symptoms. These plants contain solanine, which could potentially contribute to bone and joint damage. Despite patient reports, there is a lack of randomized controlled trials (RCTs) investigating the effects of nightshades on patients with RA. This study aims to assess the effect of nightshade elimination diet (NED) on inflammatory and rheumatologic marker levels in rheumatoid arthritis patients for the first time. METHODS: A single-blinded controlled trial will be conducted to evaluate the effect of an NED on 40 participants over 8 weeks (2 months). Participants will be equally divided into intervention and placebo groups. Both groups will receive general anti-inflammatory dietary recommendations, with the intervention group undergoing an NED during the study. Clinical symptoms will be assessed using questionnaires, and blood samples will be collected to measure relevant indicators. DISCUSSION: This RCT signifies a groundbreaking exploration into NED effects on RA markers, potentially initiating crucial discussions in the field. Its outcomes could serve as a cornerstone for larger and more robust trials, offering pivotal insights to nutritionists and physicians for the nuanced management of patients with RA. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20230220057465N1 ( https://irct.behdasht.gov.ir/trial/68959 ). Registered on 8 April 2023.

Effects of Wisdom-Enhancement Narrative-Therapy and Empathy-Focused interventions on loneliness over 4 weeks among older adults: A Randomized Controlled Trial.

OBJECTIVE: In this three-armed RCT, we tested the effects of a telephone-delivered wisdom enhancement narrative therapy-based intervention (Tele-NT) and a telephone-delivered empathy-focused intervention (Tele-EP) in reducing loneliness against an active control group that received regular call (ACG) at the 4-week follow-up assessment. DESIGN, SETTING, INTERVENTION, AND PARTICIPANTS: To evaluate the effects of the interventions on loneliness, we randomized 287 older adults based in Hong Kong, ages 65 to 90, into Tele-NT (N = 97), Tele-EP (N = 95), or ACG (N = 95). MEASUREMENT: The primary outcome was loneliness, calculated using the De Jong Gierveld Scale and the UCLA Loneliness Scale. Secondary outcomes were sleep quality, depressive symptoms, social network engagement, and perceived social support. Assessments were done before training and 4 weeks after the intervention period. RESULTS: Results from linear mixed models showed significant positive effects of Tele-NT on loneliness measured by the De Jong Gierveld Loneliness Scale compared to ACG. Compared to the ACG, the Tele-NT group significantly reduced loneliness at the 4-week follow-up (mean difference = -0.51, p = 0.019, Cohen's d = 0.60). However, the difference between Tele-EP and the ACG at the 4-week follow-up was not significant (MD = -0.34, p = 0.179, Cohen's d = 0.49). Tele-NT and Tele-EP did not show significant effects on the secondary outcomes, compared to the ACG. CONCLUSIONS: In this randomized clinical trial, we found that a 4-week wisdom enhancement narrative therapy program significantly reduced feelings of loneliness. This effective telephone-based, lay-therapist-delivered program is scalable for broader implementation.

Efficacy of electro-acupuncture on pregnancy outcomes for women undergoing in vitro fertilization: study protocol for a pilot randomized controlled trial.

Introduction: In vitro fertilization (IVF) is a technology that assists couples experiencing infertility to conceive children. However, unsuccessful attempts can lead to significant physical and financial strain. Some individuals opt for electro-acupuncture (EA) during IVF, even though there is limited evidence regarding the efficacy of this practice. Thus, this pilot study aims to explore the effectiveness and safety of EA during IVF on pregnancy outcomes. Methods and analysis: This clinical trial is a parallel, randomized, sham-controlled study. It aims to include a total of 118 infertile women who intend to undergo IVF. The participants will be randomly divided into three groups in a 1:1:1 ratio: the EA + IVF group, the placebo electro-acupuncture (pEA) +IVF group, and the IVF control group. All of the patients will be required to use ovarian stimulation drugs, while those in the EA + IVF and pEA + IVF groups will receive acupuncture treatment at three sessions per week (every other day) until trigger day with a minimum five session. The primary outcome of this trial will focus on the clinical pregnancy rate (CPR). CPR is defined as the rate of achieving clinical pregnancy from the first fresh/frozen embryo transfer cycle with an ultrasound-confirmed gestational sac in the uterine cavity. The secondary outcomes will assess embryology data, biochemical pregnancy rate, early miscarriage rate, Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Pittsburgh Sleep Quality Index (PSQI), Fertile Quality of Life (FertiQoL), patient retention rate, treatment adherence, and safety outcomes. Ethics and dissemination: Ethics approval was obtained from the Ethics Committee of Sichuan Jinxin Xi'nan Women and Children Hospital (number 2021-007). The results will be disseminated through peer-reviewed publications. The participants gave informed consent to participate in the study before taking part in it. Clinical trial registration: https://www.chictr.org.cn, identifier ChiCTR2300074455.

Protocol of a multisite randomized controlled trial of Bright IDEAS-Young Adults: Problem-solving skills training to reduce distress among young adults with Cancer.

BACKGROUND: Young adults with cancer diagnosed between the ages of 18 to 39 are recognized as a vulnerable group with unique emotional, social, and practical needs that put them at risk of poor psychosocial outcomes and impaired health-related quality of life (HRQOL). This study describes the protocol of a randomized controlled trial to evaluate the efficacy of Bright IDEAS-Young Adults (Bright IDEAS-YA), a problem-solving skills training intervention, on psychosocial outcomes of young adults newly diagnosed with cancer. METHODS: Bright IDEAS-YA is a two-arm, parallel, randomized controlled trial. Young adults are eligible if they are 18-39 years of age, within four months of a first cancer diagnosis, and receiving systemic therapy with life expectancy of at least six months. Participants are randomized 1:1 to Bright IDEAS-YA or enhanced usual care. Survey measures are completed at enrollment and 3, 6, 12, and 24 months. The primary endpoint will be the estimated change from baseline to 6 months in symptoms of depression, anxiety, and psychosocial HRQOL. The other time points are secondary endpoints. Mediators and moderators will be examined. CONCLUSIONS: This randomized trial will determine the efficacy of Bright IDEAS-YA on psychosocial outcomes for young adults newly diagnosed with cancer. Analyses will also examine mechanisms of action and potentially identify subgroups for whom the intervention is particularly useful. TRIAL REGISTRATION: clinicaltrials.gov #NCT04585269.

Surgical treatment of refractory low back pain using implanted BurstDR spinal cord stimulation (SCS) in a cohort of patients without options for corrective surgery: Findings and results from the DISTINCT study, a prospective randomized multi-center-controlled trial.

Background: Low back pain (LBP) is a highly prevalent, disabling condition affecting millions of people. Patients with an identifiable anatomic pain generator and resulting neuropathic lower extremity symptoms often undergo spine surgery, but many patients lack identifiable and/or surgically corrective pathology. Nonoperative treatment options often fail to provide sustained relief. Spinal cord stimulation (SCS) is sometimes used to treat these patients, but the lack of level 1 evidence limits its widespread use and insurance coverage. The DISTINCT RCT study evaluates the efficacy of passive recharge burst SCS compared to conventional medical treatment (CMM) in alleviating chronic, refractory axial low back pain. Methods: This prospective, multicenter, randomized, study with an optional 6-month crossover involved patients who were not candidates for lumbar spine surgery. The primary and secondary endpoints evaluated improvements in low back pain intensity (NRS), back pain-related disability (ODI), pain catastrophizing (PCS), and healthcare utilization. Patients were randomized to SCS therapy or CMM at 30 US study sites. Results: The SCS arm reported an 85.3% NRS responder rate (≥ 50% reduction) compared to 6.2% (5/81) in the CMM arm. After the 6M primary endpoint, SCS patients elected to remain on assigned therapy and 66.2% (49/74) of CMM patients chose to trial SCS (crossover). At the 12M follow-up, SCS and crossover patients reported 78.6% and 71.4% NRS responder rates. Secondary outcomes indicated significant improvements in ODI, PCS, and reduced healthcare utilization. Six serious adverse events were reported and resolved without sequelae. Conclusion: DISTINCT chronic low back pain patients with no indication for corrective surgery experienced a significant and sustained response to burst SCS therapy for up to 12 months. CMM patients who crossed over to the SCS arm reported profound improvements after 6 months. This data advocates for a timely consideration of SCS therapy in patients unresponsive to conservative therapy.

A double-blind randomized controlled trial of N-acetylcysteine (NAC) for the treatment of acute exacerbation of chronic obstructive pulmonary disease.

Background: Chronic obstructive pulmonary disease (COPD) is a common respiratory disease with acute exacerbation (AECOPD) being a common sequalae which negatively impact health status, rates of hospitalization and readmission, and disease progression. N-acetylcysteine (NAC) has been studied in COPD in both stable state and acute exacerbations, which has been shown to have small beneficial effects in stable COPD, as well as AECOPD. Yet, there has been lack of study with well-designed protocol to assess the role of NAC in more objective outcomes in AECOPD. Methods: This is a double-blind randomized controlled trial. Patients will be randomized in 1:1 ratio to receive oral NAC at 600 mg twice daily or placebo twice daily with standard of care. Partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2) and the ratio of partial pressure arterial oxygen and fraction of inspired oxygen (PaO2/FiO2) will be measured on days 1 and 7. The following will be measure at baseline and on day 4 and 7: Forced expiratory volume in one second (FEV1), 24-hour sputum volume, oxygen saturation (SaO2), end-tidal CO2, Leicester Cough Questionnaire (LCQ) score, COPD Assessment Test (CAT) score, grading of wheeze and grade of dyspnoea; blood inflammatory markers (leucocyte count, neutrophil count, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and high sensitivity CRP (hs-CRP)). Patients will be randomized to oral NAC at 600 mg twice daily or placebo for 7 days. The main outcome measures include: The difference in PaO2 on day 7. Secondary outcome: Change in following parameters on day 4/7 from baseline: FEV1, sputum volume, CAT score, LCQ score, SaO2, grade of wheeze; mMRC Dyspnoea Scale, end-tidal CO2, blood inflammatory marker, change in PaO2/FiO2 ratio from baseline to day 7, PaCO2 on day 7, 28 and 90 days' mortality, time to wean off supplemental oxygen, length of stay.Primary and secondary outcomes will be compared among the two treatment groups with two-sample t-test. Discussion: We hypothesize that NAC use in COPD exacerbation can provide benefits in clinical and laboratory parameters. Trial Registration: Name of the registry : ClinicalTrials.gov Trial registration number : NCT05706402. URL of the trial registry record for this trial : https://classic.clinicaltrials.gov/ct2/show/NCT05706402 Date of registration : Registered on 11th January 2023 Funding of the trial : The Health and Medical Research Fund (HMRF). Name and contact information for the trial sponsor : Wang Chung Kwok, Clinical Assistant Professor, Honorary Associate Consultant, Queen Mary Hospital, The University of Hong Kong, Hong Kong. Role of sponsor : The funder is not involved in the planning of the study, gathering, analysing, and interpreting the data, or in preparing the manuscript.

Effectiveness of sports intervention: A meta-analysis of the effects of different interventions on adolescent internet addiction.

BACKGROUND: To evaluate the effects of different interventions on adolescent internet addiction, a meta-analysis and network meta-analysis were performed to determine the possible intervention effects of these interventions. METHODS: Computer searches of the China National Knowledge Network, Wanfang, VIP, EMBASE, PubMed, Web of Science, EBSCO, and Cochrane Library databases were performed. The relevant randomized controlled trials were designed to assess the effects of interventions on adolescent internet addiction. The retrieval period ranged from the establishment of the database to January 31, 2024. Literature screening, data extraction, and bias risk assessment were carried out independently by two researchers. CMA 3.3, Stata 17.0 software and Review Manager 5.3 were used for the data analysis. RESULTS: A total of 89 studies with 6876 samples were included. A traditional meta-analysis of 51 single interventions and controlled studies revealed that sports intervention, cognitive behavior therapy, family therapy, mindfulness intervention, attention bias training and group counseling significantly improved adolescent Internet addiction [standardized mean difference (SMD) = -1.75, 95 % CI (-2.07, -1.44), p < 0.01; I2 = 94 %] compared to no-treatment groups. A network meta-analysis showed that combined intervention (Sucra = 93.5) had the highest probability of being the best intervention for adolescent Internet addiction, and acupuncture interventions showed the most promise as a single intervention modality; however, due to the limited number of studies, we believe that sports intervention could be the most appropriate single intervention. DISCUSSION: The evidence provided by existing studies shows that compared with other single interventions, combined interventions have the greatest effect on adolescent IA, and sports may be the best single intervention. However, because of the limitations of sample size and quality of individual studies, the strength of the evidence still needs to be further verified by additional standardized and high-quality studies.

Efficacy and safety of probiotics in IBD: An overview of systematic reviews and updated meta-analysis of randomized controlled trials.

BACKGROUND AND OBJECTIVE: Probiotics show promise in inflammatory bowel disease (IBD), yet knowledge gaps persist. We performed an overview of systematic reviews and an updated metanalysis of randomized controlled trials (RCT) assessing the effect of probiotics on Crohn's disease (CD) and ulcerative colitis (UC). METHODS: MEDLINE, Web of Science, and the Cochrane Central Register of Controlled Trials were searched up to September 2023. Primary outcomes were clinical remission and recurrence; secondary outcomes included endoscopic response and remission, and adverse events. We calculated odds ratios (OR) using a random-effects model in R. The quality of systematic reviews was assessed using the AMSTAR-2; the trials' risk of bias was evaluated using the Cochrane Collaboration tool. Evidence certainty was rated using the GRADE framework. RESULTS: Out of 2613 results, 67 studies (22 systematic reviews and 45 RCTs) met the eligibility criteria. In the updated meta-analysis, the OR for clinical remission in UC and CD was 2.00 (95% CI 1.28-3.11) and 1.61 (95% CI 0.21-12.50), respectively. The subgroup analysis suggested that combining 5-ASA and probiotics may be beneficial for inducing remission in mild-to-moderate UC (OR 2.35, 95% CI 1.29-4.28). Probiotics decreased the odds of recurrence in relapsing pouchitis (OR 0.03, 95% CI 0.00-0.25) and trended toward reducing clinical recurrence in inactive UC (OR 0.65, 95% CI 0.42-1.01). No protective effect against recurrence was identified for CD. Multi-strain formulations appear superior in achieving remission and preventing recurrence in UC. The use of probiotics was not associated with better endoscopic outcomes. Adverse events were similar to control. However, the overall certainty of evidence was low. CONCLUSION: Probiotics, particularly multi-strain formulations, appear efficacious for the induction of clinical remission and the prevention of relapse in UC patients as well as for relapsing pouchitis. Notwithstanding, no significant effect was identified for CD. The favorable safety profile of probiotics was also highlighted.

The Development and Pilot Testing of a Minority Stress Psychoeducation Tool for Transgender and Nonbinary People.

Purpose: In this study, we aimed to develop and test the acceptability of a minority stress psychoeducation tool for transgender and nonbinary (TNB) people. Methods: Patients in one treatment group who were enrolled in a larger randomized controlled trial received this study's minority stress psychoeducation pre-treatment. Data on the acceptability of the tool and minority stress experiences were collected post-treatment. Results: All (100%) patients reported that the psychoeducation tool was helpful and qualitative data suggested patients experienced an increased ability to externalize minority stress experiences. Conclusion: Results support the acceptability of this minority stress psychoeducation tool for TNB patients. Clinical trial number: NCT03369054.

Assessing the effectiveness and feasibility of the Experienced Carers Helping Others program in relatives of adolescents with eating disorders using an online application format with individual sessions.

Eating disorders (ED) usually involve hospital admission and a high relapse rate, with the return home being a critical moment for patients and their families. After their return home, they often have trouble incorporating the guidelines they have learned into their daily context. ECHOMANTRA intervention program aims to facilitate this transition by offering psychological strategies that involve both patients and their families and carers. Specifically, the ECHO program is aimed at the relatives of these patients. The present study aimed to analyze the efficacy of adding the ECHO program to the usual treatment (TAU) of relatives through a novel format based on individual intervention and with an online format and to examine the acceptability and feasibility of this new format. The study design was multi-center, randomized, controlled, with a longitudinal design and comparing two parallel groups. A total of 108 family members participated. Results indicated that relatives from both groups, TAU and ECHO + TAU, showed improvements in expressed emotion, accommodation, impact of the ED, emotional well-being, and caregiver skills. However, effect sizes in the ECHO + TAU group were slightly larger than the TAU group. In addition, the changes were greater in depression and caregiver skills when the ECHO component was added. Most caregivers (81.48%) completed the ECHO and indicated a high level of satisfaction with the program. These results suggest the efficacy and the feasibility of adding the ECHO intervention program to the usual treatment in an individual online format.

[Effects of thunder-fire moxibustion on balance function and musculoskeletal metabolism in female patients of primary osteoporosis with low muscle mass].

OBJECTIVE: To observe the effects of thunder-fire moxibustion on the balance function and musculoskeletal metabolism in female patients of primary osteoporosis (POP) with low muscle mass. METHODS: Sixty female patients of POP with low muscle mass were randomly divided into an observation group (30 cases, 5 cases dropped out) and a control group (30 cases, 2 cases dropped out). The patients in the control group were treated with oral administration of Caltrate D (1.5 g calcium carbonate + 125 IU vitamin D3), one tablet per day for 12 weeks. In addition to the control treatment, the patients in the observation group were treated with thunder-fire moxibustion at Mingmen (GV 4), Yaoyangguan (GV 3), bilateral Ganshu (BL 18), Shenshu (BL 23), and Dachangshu (BL 25), 30 min per acupoint, once every other day, three times a week, for 12 weeks. Balance function indexes (95% confidence ellipse area of the center of pressure [COP], total displacement, average speed), lumbar pain visual analogue scale (VAS), serum muscle metabolism factors (myostatin [MSTN], peroxisome proliferator-activated receptor γ coactivator-1α [PGC-1α]) and bone metabolism factors (aminoterminal propeptide typeⅠ procollagen [PINP], C-terminal telopeptide of typeⅠcollagen [CTX-Ⅰ]) were compared before and after treatment in both groups. RESULTS: Compared before treatment, the 95% confidence ellipse area of COP, total displacement, and average speed in the observation group were decreased after treatment (P<0.01), and the above indexes in the observation group were lower than those in the control group (P<0.05). Compared before treatment, the VAS scores in both groups were decreased after treatment (P<0.01), the score in the observation group was lower than that in the control group (P<0.01). Compared before treatment, the serum levels of MSTN, PINP and CTX-Ⅰ in the observation group were reduced after treatment (P<0.01), while the serum level of PGC-1α was increased (P<0.01). The control group showed a decrease in serum level of MSTN (P<0.05). The observation group had lower serum levels of MSTN and PINP (P<0.05) and higher serum level of PGC-1α (P<0.01) compared to the control group. CONCLUSION: The thunder-fire moxibustion can effectively relieve lumbar pain, improve balance function, and regulate musculoskeletal metabolism in female patients of POP with low muscle mass.

[Clinical observation on acupuncture at infusion points of "four seas" on refractory peripheral facial paralysis].

OBJECTIVE: To observe the clinical effect of acupuncture at the infusion points of "four seas" for refractory peripheral facial paralysis on the basis of conventional acupuncture. METHODS: A total of 52 patients with refractory peripheral facial paralysis were randomized into an observation group (26 cases, 2 cases dropped out) and a control group (26 cases, 1 case dropped out). On the basis of conventional acupuncture (Yintang [GV 24+] and Yangbai [GB 14], Dicang [ST 4] at affected side, etc.), acupuncture at the infusion points of "four seas", i.e. Baihui (GV 20), Dazhui (GV 14) and bilateral Shangjuxu (ST 37), Xiajuxu (ST 39), Zusanli (ST 36), was delivered in the observation group. On the basis of conventional acupuncture, shallow acupuncture was applied at corresponding non-meridian and non-acupoint points of the infusion points of "four seas" in the control group. The needles were maintained for 30 min, the treatment was given once every other day, 3 times a week for 4 weeks in the two groups. Before and after treatment, the House-Brackmann (H-B) facial nerve grading and the dynamic view score of the facial nerve function scoring system were observed, and the clinical efficacy was evaluated after treatment in the two groups. RESULTS: After treatment, the H-B facial nerve grading was improved compared with that before treatment in the two groups (P<0.05), and the grading in the observation group was superior to that in the control group (P<0.05); the dynamic view scores of the facial nerve function scoring system were increased compared with those before treatment in the two groups (P<0.05), and the score in the observation group was higher than that in the control group (P<0.05). The total effective rate was 91.7% (22/24) in the observation group, and that in the control group was 84.0% (21/25), there was no significant difference in the total effective rate between the two groups (P>0.05). The cure rate was 62.5% (15/24) in the observation group, which was higher than 20.0% (5/25) in the control group (P<0.05). CONCLUSION: On the basis of conventional acupuncture, acupuncture at infusion points of "four seas" can effectively treat refractory peripheral facial paralysis, improve the facial nerve function and increase the cure rate.

[Guasha-fangsha therapy combined with electroacupuncture in treatment of greater occipital neuralgia: a randomized controlled trial].

OBJECTIVE: To observe the clinical effect of guasha-fangsha (scrapping and bleeding) therapy combined with electroacupuncture (EA) on greater occipital neuralgia. METHODS: Ninety patients with greater occipital neuralgia were randomly divided into an observation group (45 cases) and a control group (45 cases, 2 cases dropped out). In the control group, EA was delivered at Fengfu (GV 16) and bilateral Tianzhu (BL 10), Fengchi (GB 20), Wangu (GB 12), Yuzhen (BL 9) and Houxi (SI 3), with disperse-dense wave, at 2 Hz/100 Hz in frequency and 2 mA to 6 mA in intensity, for 30 min in each intervention, once every other days, 3 times a week. In the observation group, on the basis of the intervention as the control group, guasha-fangsha therapy was used along the distribution of the bladder meridian of foot-taiyang on the occipital region and that of the gallbladder meridian of foot-shaoyang on the lateral side of the head, once weekly. The duration of treatment was 3 weeks in the two groups. In the two groups, before treatment, after 1, 2 and 3 weeks of treatment and in follow-up visit after 3 weeks of treatment completion, the score of visual analogue scale (VAS) was observed; before and after treatment, as well as in follow-up visit after 3 weeks of treatment completion, the scores of self-rating anxiety scale (SAS), self-rating depression scale (SDS) and 36-item short-form health survey (SF-36) were observed; after treatment and in follow-up visit after 3 weeks of treatment completion, the clinical efficacy was evaluated. RESULTS: After one week of treatment, the VAS score in the observation group decreased when compared with that before treatment (P<0.05), while the scores in 2 and 3 weeks of treatment and in follow-up visit after 3 weeks of treatment completion were lower than those before treatment in the two groups (P<0.05) separately. At each time point after treatment, the VAS scores in the observation group were lower than those in the control group (P<0.05). After treatment and during the follow-up visit, the scores of SAS and SDS decreased when compared with those before treatment in the two groups (P<0.05), and the scores in the observation group were lower than those in the control group (P<0.05); the scores of each item in SF-36 were elevated in comparison with those before treatment in the two groups (P<0.05), and the scores in the observation group were higher than those in the control group (P<0.05). After treatment, the total effective rate of the observation group was 91.1% (41/45), higher than that (76.7%, 33/43) of the control group (P<0.05). In follow-up visit, the total effective rate of the observation group was 91.1% (41/45), which was higher than 72.1% (31/43) of the control group (P<0.05). CONCLUSION: Guasha-fangsha therapy combined with electroacupuncture can effectively relieve greater occipital neuralgia, alleviate pain severity, ameliorate anxiety and depression and improve the quality of life in the patients.

[Pricking-cupping combined with auricular thumbtack needle for postherpetic neuralgia of qi stagnation and blood stasis on chest and waist: a randomized controlled trial].

OBJECTIVE: To observe the clinical effect of pricking-cupping combined with auricular thumbtack needle for postherpetic neuralgia (PHN) of qi stagnation and blood stasis on chest and waist. METHODS: A total of 98 patients with PHN of qi stagnation and blood stasis on chest and waist were randomized into an observation group (49 cases, 1 case was eliminated, 1 case dropped out) and a control group (49 cases, 1 case dropped out). In the observation group, treatment of pricking-cupping combined with auricular thumbtack needle was delivered, pricking and cupping were applied at Jiaji points (EX-B 2) at the related spinal segments corresponding to the pain sites and regional ashi points, once every other day, auricular thumbtack needle was applied at Xin (CO15), Shenmen (TF4), Neifenmi (CO18), Pizhixia (AT4), etc., once every 3 days. In the control group, pregabalin capsule was taken orally, 75 mg a time, twice a day. The treatment of 4 weeks was required in the two groups. Before and after treatment, the scores of TCM symptom, visual analogue scale (VAS), Pittsburgh sleep quality index (PSQI), self-rating depression scale (SDS) and self-rating anxiety scale (SAS) were observed, the serum levels of immunoglobulin G (IgG), interleukin-6 (IL-6), C-reactive protein (CRP) were detected, and the clinical efficacy and safety were evaluated in the two groups. RESULTS: After treatment, the item scores and total scores of TCM symptom, as well as the scores of VAS, PSQI, SDS and SAS were decreased compared with those before treatment (P<0.05); the item scores of pruritus degree, tactile sensitivity, skin numbness and total score of TCM symptom, as well as the scores of VAS, PSQI, SDS and SAS in the observation group were lower than those in the control group (P<0.05). After treatment, the serum levels of IgG were increased (P<0.05), while the serum levels of IL-6 and CRP were decreased (P<0.05) compared with those before treatment in the two groups; in the observation group, the serum level of IgG was higher (P<0.05), while the serum levels of IL-6 and CRP were lower (P<0.05) than those in the control group. The total effective rate was 95.7% (45/47) in the observation group, which was superior to 77.1% (37/48) in the control group (P<0.05). The incidence rate of adverse reaction was 6.4% (3/47) in the observation group, which was lower than 12.5% (6/48) in the control group (P<0.05). CONCLUSION: Pricking-cupping combined with auricular thumbtack needle can effectively relieve the clinical symptoms in patients with PHN of qi stagnation and blood stasis on chest and waist, reduce the pigmentation of herpes and improve itch or burning, numb sensations in the skin lesions, improve the sleep quality and relieve anxiety and depression.

[Fu's subcutaneous needling combined with monkshood cake-separated moxibustion for primary dysmenorrhea with cold congealing and blood stasis: a randomized controlled trial].

OBJECTIVE: To observe the clinical efficacy of Fu's subcutaneous needling combined with monkshood cake-separated moxibustion for primary dysmenorrhea with cold congealing and blood stasis. METHODS: Sixty patients with primary dysmenorrhea of cold congealing and blood stasis were randomly divided into an observation group (30 cases, 1 case dropped out) and a control group (30 cases, 2 cases dropped out). The control group received monkshood cake-separated moxibustion at Shenque (CV 8) and bilateral Zigong (EX-CA 1), while the observation group received Fu's subcutaneous needling based on the control group. The muscles were palpated and the affected muscles were determined. Needles were inserted 5-10 cm away from the affected muscles and reperfusion activity was performed simultaneously. All the treatment started on the first day of menstrual cycle pain, once a day, for 3 days, totaling for 3 menstrual cycles. The visual analogue scale (VAS) score, Cox menstrual symptom scale (CMSS) score, and traditional Chinese medicine (TCM) syndrome score in the two groups were observed before treatment, after 2 treatment courses and after 3 treatment courses. The serum prostaglandin F2α(PGF2α) levels before and after 3 treatment courses were measured, and the clinical efficacy of the two groups was evaluated. RESULTS: After 2 and 3 treatment courses, the VAS scores, CMSS scores, and TCM syndrome scores in the two groups were lower than those before treatment (P<0.05), and the scores in the observation group were lower than those in the control group (P<0.05). After 3 treatment courses, the PGF2α level in the observation group was decreased (P<0.05), and were lower than that in the control group (P<0.05). The total effective rate was 96.6% (28/29) in the observation group, which was higher than 64.3% (18/28) in the control group (P<0.05). CONCLUSION: Fu's subcutaneous needling combined with monkshood cake-separated moxibustion could effectively reduce the pain intensity, improve clinical symptoms of dysmenorrhea, and lower PGF2α level in patients with primary dysmenorrhea of cold congealing and blood stasis.

Individual Placement and Support and Participatory Workplace Intervention on the Work Participation of People with Disabilities: A Randomised Controlled Trial.

PURPOSE: This study assessed the effectiveness of Individual Placement and Support (IPS), Participatory Workplace Intervention (PWI), and IPS + PWI on work participation and health of people with work disabilities. METHODS: A randomised controlled 2 × 2 factorial trial with 120 clients and an 18-month follow-up was performed. Differences between IPS and no-IPS and between PWI and no-PWI were assessed using log-rank tests and Cox proportional hazards models. RESULTS: In the IPS group, restricted mean survival time (RMST) for sustainable paid employment was 352 days, compared to 394 in the no-IPS group (HR = 1.47, 95% CI = 0.81-2.63). In the PWI group the RMST was 378 days, compared to 367 in the no-PWI group (HR = 0.89, 95% CI = 0.48-1.64). For the secondary outcome 'starting any paid employment, a trial placement, or education' RMST was significantly lower for the IPS group (222 days) than for the no-IPS group (335 days; HR = 1.85, 95% CI = 1.01-3.42). Mental health was significantly lower (worse) in the PWI group (difference -4.07, 95% CI = -7.93 to -0.22) than in the no-PWI group. For all other secondary outcomes, no statistically significant differences were found. CONCLUSION: No statistically significant differences were observed in the duration until starting sustainable employment between IPS and no-IPS, and between PWI and no-PWI. The duration until starting any paid employment, a trial placement, or education was shorter in the IPS group than in the no-IPS group, but further research should explore whether this also increases sustainable employment in the longer term.

Effectiveness of a program to lower unwanted media screens among 2-5-year-old children: a randomized controlled trial.

Background: Limited interventions exist on reducing unwanted screen time (ST) among children from low- and middle-income countries (LMICs), so we developed and assessed the effectiveness of the program to lower unwanted media screen time (PLUMS) among children aged 2-5 years in Chandigarh, Union Territory, North India. Methods: An open-label randomized control parallel group trial per CONSORT guidelines was conducted among randomly selected 340 families with children aged 2-5 (±3 months) years in Chandigarh, India. PLUMS was implemented at the family level with a focus on modifying the home media environment and targeted individual-level interventions using parent and child modules for 2 months. A post-intervention (immediately) and a follow-up assessment after 6 months was done. During the follow-up period, the interaction was done passively via WhatsApp groups. The control group received routine healthcare services. Validated and standardized tools, including a digital screen exposure questionnaire with a physical activity component, preschool child behavior checklist, and sleep disturbance scale for children, were used to collect data at baseline, post-intervention, and follow-up periods. The primary outcome was the mean difference in ST (minutes/day) among children in the intervention group versus the control group. Generalized estimating equation (GEE) analysis was performed to adjust for clustering. Results: An equal number of families (n = 170) were randomly assigned to the intervention and control arms. In the post-intervention assessment, 161 and 166 families continued while, at the follow-up assessment, 154 and 147 were in the intervention and control arm, respectively. The mean difference in ST on a typical day [27.7 min, 95% Confidence Interval (CI) 5.1, 50.3] at the post-intervention assessment significantly (p < 0.05) decreased in the intervention (102.6 ± 98.5 min) arm as compared with the control (130.3 ± 112.8 min) arm. A significant reduction in ST (ß = -35.81 min, CI -70.6, -1.04) from baseline (ß = 123.1 min) to follow-up phase (ß = 116 min) was observed in GEE analysis. The duration of physical activity increased both at post-intervention (ß = 48.4 min, CI = +6.6, +90.3) and follow-up (ß = 73.4 min, CI = 36.2, 110.5) assessments in the intervention arm. Conclusion: The PLUMS intervention significantly reduced the children's mean ST on a typical day and increased the physical activity immediately post-intervention and during the 6-month follow-up period. These results might guide the policymakers to include strategies in the national child health programs in the Southeast Asia Region to reduce unwanted ST.Clinical trial registration: https://clinicaltrials.gov/, identifier CTRI/2017/09/009761.

Effect of reduced follow-up care on patient satisfaction with care among patients with endometrial cancer: The ENSURE randomized controlled trial.

BACKGROUND: Evidence on the optimal follow-up schedule after endometrial cancer is lacking. The study aim was to compare satisfaction with care between women who received reduced follow-up care and women who received usual guideline-directed follow-up care for three years after surgery. METHODS: The ENSURE (ENdometrial cancer SURvivors' follow-up carE) trial was a non-inferiority randomized controlled multicenter trial in 42 hospitals in the Netherlands. The intervention arm received reduced follow-up care (4 visits/3 years), while the control group received usual follow-up care (8-11 visits/3 years). Primary outcome was overall satisfaction with care, PSQIII score, over three years follow-up, with a non-inferiority margin of 6. Mixed linear regression, intention-to-treat and per-protocol analyses (presented below) were used. RESULTS: Among 316 women included, overall satisfaction with care was not lower in the reduced follow-up (mean 82; SD = 15) compared with the usual follow-up group (mean 80; SD = 15) group (B = 1.80(-2.09;5.68)). At 6, 12 and 36 months, more women (93/94/90%) in the reduced follow-up group were satisfied with their follow-up schedule than in the usual follow-up group (79/79/82%; p < 0.001; p < 0.001; p = 0.050). CONCLUSIONS AND RELEVANCE: Women with low-risk, early-stage endometrial cancer who received reduced follow-up care were no less satisfied with their care than women receiving usual follow-up care. Compared with usual follow-up, women in the reduced follow-up group had fewer clinical visits and, at the same time, more often reported being satisfied with their follow-up schedule. Findings suggest that reduced follow-up care may be the new standard, but should be tailored to meet additional needs where indicated.

The effect of a single session of psychological first aid in the emergency department on PTSD and depressive symptoms three months post-intervention: results of a randomised controlled trial.

Background: Despite its popularity, evidence of the effectiveness of Psychological First Aid (PFA) is scarce.Objective: To assess whether PFA, compared to psychoeducation (PsyEd), an attention placebo control, reduces PTSD and depressive symptoms three months post-intervention.Methods: In two emergency departments, 166 recent-trauma adult survivors were randomised to a single session of PFA (n = 78) (active listening, breathing retraining, categorisation of needs, assisted referral to social networks, and PsyEd) or stand-alone PsyEd (n = 88). PTSD and depressive symptoms were assessed at baseline (T0), one (T1), and three months post-intervention (T2) with the PTSD Checklist (PCL-C at T0 and PCL-S at T1/T2) and the Beck Depression Inventory-II (BDI-II). Self-reported side effects, post-trauma increased alcohol/substance consumption and interpersonal conflicts, and use of psychotropics, psychotherapy, sick leave, and complementary/alternative medicine were also explored.Results: 86 participants (51.81% of those randomised) dropped out at T2. A significant proportion of participants in the PsyEd group also received PFA components (i.e. contamination). From T0 to T2, we did not find a significant advantage of PFA in reducing PTSD (p = .148) or depressive symptoms (p = .201). However, we found a significant dose-response effect between the number of delivered components, session duration, and PTSD symptom reduction. No significant difference in self-reported adverse effects was found. At T2, a smaller proportion of participants assigned to PFA reported increased consumption of alcohol/substances (OR = 0.09, p = .003), interpersonal conflicts (OR = 0.27, p = .014), and having used psychotropics (OR = 0.23, p = .013) or sick leave (OR = 0.11, p = .047).Conclusions: Three months post-intervention, we did not find evidence that PFA outperforms PsyEd in reducing PTSD or depressive symptoms. Contamination may have affected our results. PFA, nonetheless, appears to be promising in modifying some post-trauma behaviours. Further research is needed.

Psychological First Aid (PFA) is widely recommended early after trauma.We assessed PFA's effectiveness for decreasing PTSD symptoms and other problems 3 months post-trauma.We didn't find definitive evidence of PFA's effectiveness. Still, it seems to be a safe intervention.

Electroacupuncture for slow flow/no-reflow phenomenon in patients with acute myocardial infarction undergoing percutaneous coronary intervention: protocol for a pilot randomized controlled trial.

Background: Slow flow/no-reflow (SF-NR) during percutaneous coronary intervention (PCI) is associated with poor prognosis of patients with acute myocardial infarction (AMI). Currently, effective treatment is not available for SF-NR. Electroacupuncture (EA) has shown significant efficacy as an adjuvant therapy for many cardiovascular diseases by improving microcirculation and reducing ischemia-reperfusion injury. However, its effects on SF-NR in the AMI patients during PCI are not clear. This pilot trial aims to determine the efficacy of intraoperative EA in alleviating SF-NR in AMI patients undergoing PCI. Methods: This prospective, single-center, randomized controlled, pilot trial will recruit 60 AMI patients scheduled for PCI at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, China. The patients will be randomized in a 1:1 ratio into the EA or the control groups. Patients in the control group will undergo standard PCI. Patients in the EA group will undergo intraoperative electroacupuncture while undergoing standard PCI. Incidence of SF-NR is the primary outcome for this study. This study will also assess secondary outcomes including cardiac biomarkers, inflammatory biomarkers, pain and anxiety scores, electrocardiography parameters, traditional Chinese medicine (TCM) symptom score, and major adverse cardiovascular and cerebrovascular events (MACCE). All the included patients will undergo laboratory tests including routine blood tests, levels of electrolytes, as well as liver and renal function tests. Patients will be followed up for 1 month after the procedure. Discussion: This pilot trial will provide evidence for the potential benefits of intraoperative EA in improving microvascular perfusion and preventing or alleviating SF-NR during PCI in patients with AMI. If proven effective, intraoperative EA will provide a new and effective strategy against SF-NR and provide evidence for subsequent multicenter trials. Clinical Trial Registration: ClinicalTrials.gov, identifier (ChiCTR2300072265). Registered on 8 June 2023.