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Acne scarring results from a common inflammatory condition present in many people. These scars can have an impact on quality of life by influencing self-esteem and social acceptance. Current acne scarring treatments, such as chemical peels and laser treatments, often have limited success due to their time-consuming nature and the variability of acne scar types. The subcision technique has shown promise for the treatment of rolling acne scars. There are few studies to date that examine the effects of multiple subcision treatments on rolling acne scars. We evaluated whether the use of multiple subcision treatments improved the appearance of rolling acne scars compared to no treatment. Five patients with rolling acne scars on both sides of their face who met inclusion and exclusion criteria were enrolled in the study. One side of the face was randomized to receive treatment, while the contralateral side of the face received no treatment. Subjects underwent five sequential subcision treatments, spaced 4 weeks apart, with two follow-up visits at weeks 20 and 36 from the 1st treatment. Photographs were taken before and after the initial treatment visit and at each subsequent visit. Acne scar appearance was evaluated by the subject, a blinded live rater, and two double-blinded dermatologist raters. Evaluations of treatment outcomes involved overall acne scar appearance on a 5-point scale, acne scar improvement on a percentage scale, a modified quantitative global scarring grading system, and potential treatment side effects. There was a greater decrease in global scarring scores in the multiple subcision side compared to the control side. There was a greater difference in the average acne scar appearance scores between the Week 36 follow-up visit and baseline for the multiple subcision side compared to that of the control side. 50% of patients reported being more satisfied with the treatment side compared to the control side in regard to overall improvement. The study results suggest that multiple subcision treatments may improve the appearance of rolling acne scars compared to no treatment. [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]

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]

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]

Objective: To investigate the immediate effects of electro-acupuncture (EA) on endometrial blood flow among recurrent implantation failure (RIF) patients. Methods: Eighty RIF patients, enrolled from March 2022 to December 2022, were randomly allocated into either the EA group (40 cases) or the waiting-list (WL) group (40 cases) by using a random number table. The EA group underwent acupuncture at points of Shenting (GV 24), Baihui (GV 4), Benshen (GB 13), bilateral Zigong (EX-CA 1), Huangshu (KI 16), Sanyinjiao (SP 6) and Xuehai (SP10), and electric acupuncture apparatus was connected to EX-CA 1, KI 16, SP 6, and SP 10 with disperse-dense waves at 4/20 Hz frequencies for 30 min after transvaginal ultrasound, while the WL group received no intervention. The primary outcome measured was the endometrial volume blood flow. The secondary outcomes included the bilateral uterine artery index, endometrial volume, endometrial blood flow type, vascular distribution index (VIMV) for endometrial and ovary, clinical pregnancy rate, and embryo implantation rate. Results: In the EA group, there was a notable decrease in the bilateral pulsatility index and a significant improvement in the endometrial blood flow type post-EA (P<0.05). Both the endometrial blood flow type and VIMV for the endometrium and right ovary were markedly higher in the EA group compared to the WL group post-treatment (P<0.05). Conversely, no significant disparities were observed in vascular index, flow index, vascular blood flow index, uterine arterial blood flow indices, endometrial volume, clinical pregnancy rate and embryo implantation rate between the two groups after treatment (P>0.05). Besides, no adverse events related to EA were observed. Conclusions: EA can promptly ameliorate VIMV for the endometrial and right ovary, and endometrial blood flow type. Future randomized controlled trials are warranted to investigate the long-term effects of EA on blood flow of RIF patients and its implications for pregnancy outcomes. (Trial registration No. ChiCTR2200057377) [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction (TW) in treating patients with diabetic peripheral neuropathy (DPN). Methods: It is a multicenter double-blinded randomized controlled trial. Participants with DPN were recruited between November 18, 2016 and May 30, 2018 from 8 hospitals in China. All patients received basic treatments for glycemic management. Patients received foot baths with TW herbal granules either 66.9 g (intervention group) or 6.69 g (control group) for 30 min once a day for 2 weeks and followed by a 2-week rest, as a therapeutic course. If the Toronto Clinical Scoring System total score (TCSS-TS) ⩾6 points, the patients received a total of 3 therapeutic courses (for 12 weeks) and were followed up for 12 weeks. The primary outcome was change in TCSS-TS score at 12 and 24 weeks. Secondary outcomes included changes in bilateral motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the median and common peroneal nerve. Safety was also assessed. Results: Totally 632 patients were enrolled, and 317 and 315 were randomized to the intervention and control groups, respectively. After the 12-week intervention, patients in both groups showed significant declines in TCSSTS scores, and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment (P<0.05). The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group (P<0.05). The number of adverse events did not differ significantly between groups (P>0.05), and no serious adverse event was related with treatment. Conclusion: Treatment of TW foot baths was safe and significantly benefitted patients with DPN. A low dose of TW appeared to be more effective than a high dose. (Registry No. ChiCTR-IOR-16009331). [ABSTRACT FROM AUTHOR]

Background: The effects of acupuncture have varied in different randomized controlled trials (RCTs), and there are many factors that influence treatment effect of acupuncture in different outcomes, with conflicting results. Objective: To identify factors and their impact on the treatment effect of acupuncture in different outcomes. Methods: Acupuncture RCTs were searched from 7 databases including Medline (PubMed), Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc between January 1st, 2015 and December 31st, 2019. Eligible studies must compare acupuncture to no acupuncture, sham acupuncture, or waiting lists, and report at least 1 patient-important outcome. A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables, even those excluded from the multivariable model due to collinearities. We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences (SMDs), categorising them as small (<0.2), moderate (0.2–0.4), or large (>0.4) effects. Results: The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables. High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude, the difference of adjusted SMDs 0.46, 95% confidence interval (CI) 0.07 to 0.84; P=0.02]. The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables. Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture (0.30, 95% CI 0.06 to 0.53; P=0.01). The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables. Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects, compared to non-penetrating acupuncture and fixed regimen, respectively (0.40, 95% CI 0 to 0.80; P=0.05; 0.29, 95% CI 0.06 to 0.53; P=0.01). Conclusions: High-frequency acupuncture sessions appear to be a more effective approach to managing painful symptoms. Penetrating acupuncture demonstrated greater effect in relieving non-painful symptoms. Both penetrating acupuncture type and flexible acupuncture regimen were linked to significant treatment effects in function outcomes. Future studies should consider the factors that are significantly associated with the effects of acupuncture in patient-important outcomes. [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]

Orphans and vulnerable children (OVC) in sub-Saharan Africa are at high risk for HIV infection and transmission. HIV prevention and treatment efforts with OVC are hindered by mental health and substance use problems. This randomized controlled trial compared a mental health intervention, Trauma Focused Cognitive Behavioral Therapy (TF-CBT), to an enhanced version of an existing HIV Psychosocial Counseling (PC+) program among 610 adolescents who met PEPFAR criteria for OVC and had HIV risk behaviors in Lusaka, Zambia. Outcomes included HIV risk behaviors (e.g., risky sexual behaviors), mental health (internalizing symptoms, externalizing behaviors, PTSD) and substance use. At 12-month follow-up, there were significant within group reductions in both groups for all outcomes, with the only significant between group difference being for substance use, in which OVC who received TF-CBT had significantly greater reductions than OVC who received PC+. In a subgroup analysis of OVC with high levels of PTSD symptoms, TF-CBT was superior to PC + in reducing internalizing symptoms, functional impairment, and substance use. Findings support TF-CBT for reducing substance use among OVC. Subgroup analysis results suggest that a robust intervention such as TF-CBT is warranted for OVC with significant mental and behavioral health comorbidities. The similar performance of TF-CBT and PC + in the overall sample for risky sexual behavior and mild mental health problems indicates that enhancing existing psychosocial programs, such as PC, with standard implementation factors like having a defined training and supervision schedule (as was done to create PC+) may improve the efficacy of HIV risk reduction efforts. Clinical Trials Number: NCT02054780 [ABSTRACT FROM AUTHOR]

Depression in early childhood increases risk of psychopathology and impairment across the lifespan. Parent–Child Interaction Therapy-Emotion Development (PCIT-ED) effectively treats depression and improves functioning in preschoolers. Parental depression has been associated with inconsistent parenting, depression onset and maintenance in offspring, and decreased treatment efficacy for youth. Given the intensity of parent involvement in PCIT-ED, this secondary data analysis aimed to evaluate parental depression severity (i.e., Beck Depression Inventory-II Total Score; BDI-II) as a moderator and predictor of child, parenting, and engagement outcomes, within the context of a randomized trial. Children (N = 229; ages 3–6.11) with early childhood depression and a consenting caregiver were randomly assigned to receive PCIT-ED or Waitlist (WL). Moderation results supported the superiority of PCIT-ED over WL on child and parenting outcomes, independent of parent-reported BDI-II at baseline (p ≥ 0.684 and p ≥ 0.476, respectively). BDI-II did not significantly predict child (p ≥ 0.836), parenting (p ≥ 0.114) or engagement (p ≥ 0.114) outcomes. Finally, BDI-II did not surpass chance in predicting whether children would maintain a depression diagnosis after PCIT-ED (AUC = 0.530) or prematurely terminate treatment (AUC = 0.545). Our results suggest that PCIT-ED is not contraindicated by minimal-to-moderate symptoms of depression in parents. Taken together with previous reports, PCIT-ED may indeed be a particularly beneficial treatment choice for this population. Further research in samples with more severe parental depression is needed. ClinicalTrials.gov identifier: NCT02076425. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness and safety of Zhenqi Buxue Oral Liquid (ZQ), progesterone capsules, and their combination in treating oligomenorrhea and hypomenorrhea with qi-blood and Kidney (Shen) essence deficiency. Methods: This was a prospective, randomized, multi-center controlled trial between June 2022 to December 2022. Ninety-six oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency were randomly assigned to receive ZQ (ZQ group, 29 cases), progesterone capsules (PG group, 32 cases), or the combined Chinese and Western medicine (COM group, 31 cases) at a ratio of 1:1:1. Patients in the ZQ or PG group took daily 10 mL twice a day of ZQ or 200 mg once a day of progesterone capsules for 10 consecutive days on day 15 of the menstrual cycle respectively, and patients in the COM group received the same ZQ combined with progesterone capsules. The treatment course lasted for 3 months and follow-up was performed at 1 and 3 months after the end of treatment. Primary endpoint was the menstrual Traditional Chinese Medicine Syndrome Scale (TCMSS) scores. Secondary endpoints included pictorial blood loss assessment chart (PBAC) scores, clinical efficacy rate, 36-item Short Form Health Survey (SF-36) scores, sex hormones and thickness of endometrium. Adverse events (AEs) were recorded. Results: TCMSS scores after 1- and 3-month treatment in all groups were significantly lower than those at baseline (P<0.05). Only TCMSS scores after 3-month treatment in the ZQ and COM groups continuously decreased compared with those after 1-month treatment in the same group (P<0.01). TCMSS scores after 3-month treatment in the ZQ and COM groups were significantly lower than those in the PG group (P<0.05, P<0.01). Compared with baseline, PBAC scores in the ZQ and COM groups after 3 months of treatment were also significantly higher (both P<0.01). The total effective rates of TCM syndrome of 3-month treatment were significantly improved in all groups compared with that after 1 month of treatment (P<0.05). The total effective rate of the COM group was the highest in the 3rd month of treatment and significantly higher than that of PG group alone (P<0.05). Compared with baseline, only the SF-36 scores of COM group were significantly improved after 3 months of treatment (P<0.05). No serious adverse reactions were observed after treatment. Conclusions: The combination of ZQ and PG, or ZQ only had better effects on reducing TCMSS scores compared with PG, and COM showed the higher total effective rate compared with monotherapy. Besides, COM could effectively improve menstrual blood loss and quality of life. ZQ combined with PG may be an effective and safe option for oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency. [ABSTRACT FROM AUTHOR]

Objective: To assess the effect and safety of Reyanning Mixture (RYN) in treating asymptomatic or mild severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in children and adolescents. Methods: This is a prospective, open-label, randomized controlled trial. Patients aged 1–17 years and diagnosed with asymptomatic or mild coronavirus disease-2019 (COVID-19) were assigned to an intervention group (RYN plus standard care) and a control group (standard care) according to a randomization list. The primary outcomes were SARS-CoV-2 negative conversion time. Secondary outcomes included negative conversion rate on days 3 and 7, hospital length of stay, symptom relief rate, new-onset symptoms of asymptomatic infected patients, and progressive disease rate. The cycle threshold (Ct) values of ORF1ab or N genes were also tested. Results: A total of 214 patients in the intervention group and 217 in the control group were analyzed. The SARS-CoV-2 negative conversion time was significantly shortened in the intervention group [5 days (interquartile range (IQR): 5–6) vs. 7 days (IQR: 6–7), P<0.01]. By days 3 and 7, the negative conversion rates were significantly higher in the intervention group (day 3: 32.7% vs. 21.2%, P=0.007; day 7: 75.2% vs. 60.8%, P=0.001). Ct values significantly increase on day 2 [ORF1ab gene: 35.62 (IQR: 29.17–45.00) vs. 34.22 (IQR: 28.41–39.41), P=0.03; N gene: 34.97 (IQR: 28.50–45.00) vs. 33.51 (IQR: 27.70–38.25), P=0.024] and day 3 [ORF1ab gene: 38.00 (IQR: 32.72–45.00) vs. 35.81 (IQR: 29.96–45.00), P=0.003; N gene: 37.16 (IQR: 32.01–45.00) vs. 35.26 (IQR: 29.09–45.00), P=0.01]. No significant difference was found in hospital length of stay between the two groups (P>0.05). Symptoms of cough were significantly improved (82.2% vs. 70.0%, P=0.02) and wheezing was significantly reduced (0.7% vs. 12.9%, P<0.01) in the intervention group compared with the control group. During the trial, no disease progression or serious adverse events were reported. Conclusion: Adding RYN to standard care may be a safe and effective treatment for children with asymptomatic and mild SARS-CoV-2 infection. (Registration No. ChiCTR2200060292) [ABSTRACT FROM AUTHOR]

Background: Frailty is associated with poor outcomes among older adults with hypertension and complicates its pharmacological management. Here, we assessed whether 12-weeks of instructor-guided, group Tai Chi (TC) practice improved frailty relative to Healthy Aging Practice-centered Education (HAP-E) classes in older adults with hypertension. Methods: Secondary analysis of a randomized controlled trial in San Diego County, USA, of 167 community-dwelling individuals aged ≥ 60 yrs (70% female; 72.1 ± 7.5 yrs), defined as non-frail (66%) or frail (34%) based on 53-item deficit accumulation frailty index (FI). Linear mixed-effects models were used to assess pre-to-post intervention differences in FI and logistic regression to explore differential odds of clinically meaningful FI change. Results: One hundred thirty-one participants completed post-intervention assessments. Frailty decreased pre-to-post intervention in the TC (ΔFI = − 0.016, d = − 0.39, − 0.75 to − 0.03), but not the HAP-E arm (ΔFI = − 0.009, d = − 0.13, − 0.52–0.27), despite no significant group differences between the TC and HAP-E arms (d = − 0.11, − 0.46–0.23). Furthermore, greater odds of improved FI were observed for frail participants in the TC (OR = 3.84, 1.14–14.9), but not the HAP-E (OR = 1.34, 0.39–4.56) arm. Subgroup analysis indicated treatment effects in TC were attributed to frail participants (frail: ΔFI = − 0.035, d = − 0.68, -1.26 to − 0.08; non-frail: ΔFI = − 0.005, d = − 0.19, − 0.59–0.22), which was not the case in the HAP-E arm (frail: ΔFI = − 0.017, d = − 0.23, − 0.81–0.35; non-frail: ΔFI = − 0.003, d = − 0.07, − 0.47–0.33). Frail participants were no more likely to drop-out of the study than non-frail (71% vs. 69% retained). Conclusions: Twelve weeks of twice-weekly guided TC practice was well-tolerated, associated with decreases in frailty, and increased odds of clinically meaningful FI improvement at post-intervention. [ABSTRACT FROM AUTHOR]

Objective: To evaluate whether electroacupuncture (EA) would improve gastrointestinal function and clinical prognosis in patients with severe traumatic brain injury (TBI) complicocted by acute gastrointestinal injury (AGI). Methods: This multicenter, single-blind trial included patients with TBI and AGI admitted to 5 Chinese hospitals from September 2018 to December 2019. A total of 500 patients were randomized to the control or acupuncture groups using a random number table, 250 cases in each group. Patients in the control group received conventional treatment, including mannitol, nutritional support, epilepsy and infection prevention, and maintenance of water, electrolytes, and acid-base balance. While patients in the acupuncture group received EA intervention at bilateral Zusanli (ST 36), Shangjuxu (ST 37), Xiajuxu (ST 39), Tianshu (ST 25), and Zhongwan (RN 12) acupoints in addition to the conventional treatment, 30 min per time, twice daily, for 7 d. The primary endpoint was 28-d mortality. The secondary endpoints were serum levels of D-lactic acid (D-lac), diamine oxidase (DAO), lipopolysaccharide (LPS), motilin (MTL) and gastrin (GAS), intra-abdominal pressure (IAP), bowel sounds, abdominal circumference, AGI grade, scores of gastrointestinal failure (GIF), Glasgow Coma Scale (GCS), Acute Physiology and Chronic Health Evaluation (APACHE II), Sequential Organ Failure Assessment (SOFA), and Multiple Organ Dysfunction Syndrome (MODS), mechanical ventilation time, intense care unit (ICU) stay, and the incidence of hospital-acquired pneumonia. Results: The 28-d mortality in the acupuncture group was lower than that in the control group (22.80% vs. 33.20%, P<0.05). Compared with the control group, the acupuncture group at 7 d showed lower GIF, APACHE II, SOFA, MODS scores, D-lac, DAO, LPS, IAP, and abdominal circumference and higher GCS score, MTL, GAS, and bowel sound frequency (all P<0.05). In addition, the above indices showed simillar changes at 7 d compared with days 1 and 3 (all P<0.05) in the EA group. Conclusion: Early EA can improve gastrointestinal function and clinical prognosis in patients with severe TBI complicated by AGI. (Registration No. ChiCTR2000032276) [ABSTRACT FROM AUTHOR]

Objective: This study examined whether a 4-week group-based mindfulness intervention would be superior in reducing psychological distress in colorectal cancer (CRC) patients compared to a psychoeducation and cognitive behavioural skills learning support active control group. Methods: Patients with CRC were randomized via Computerised Permuted Block Randomisation to mindfulness or active control groups (2-h weekly sessions over 4 weeks). Outcomes were measured pre-intervention, and 8 weeks and 6 months post-baseline. The primary outcome was psychological distress measured by the Hospital Anxiety and Depression Scale. Secondary outcomes were generic quality of life (QoL), disease specific QoL, mindfulness, and intervention credibility and acceptability. Results: Sixty-eight participants were randomized to mindfulness (n=35) or active control group (n=33). Uptake of potentially eligible patients consenting was low (28.0%) and the dropout rate was 33.8%. Depression scores were reduced in both groups at week 8 (P=0.020). Control participants had greater improvement in generic mental QoL scores at week 8 than mindfulness (P=0.023). In disease specific QoL, there was reduction in impotence symptom in the mindfulness group (P=0.022) and reduction in faecal incontinence in the control group (P=0.019). The embarrassment symptom had a significantly lower increase in the mindfulness group at week 8 compared to the control group (P=0.009). Both groups rated the treatments as credible and acceptable. Conclusions: Mindfulness was not superior to the active control group in terms of alleviating psychological distress but both treatments were associated with some improvements in depression. There was low uptake of both interventions. (Trial registration number: ACTRN12616001033437) [ABSTRACT FROM AUTHOR]

This was a randomized controlled trial, conducted to determine the effectiveness of CBT for depression delivered by trained therapists with an adapted Bengali CBT (BaCBT) manual, as compared to a control group. A total of 148 patients with a diagnosis of depression and attending psychiatry departments of three hospitals in Dhaka, Bangladesh, were assessed for eligibility, and 107 were randomly allocated to either treatment (n = 54) or a waitlist (n = 53). Assessments of outcome were completed at 3 time points (pre-test, post-test, and 1-month follow-up). The results revealed significant reductions in depression severity, anxiety, perceived stress, and suicidal ideation in the group that received the intervention, but modest to no significant changes in the control group. This is the first report of the results of an adapted CBT program for depression from Bangladesh. Although several limitations of the study are noted, and further studies are needed to generalize these current results, they indicate that CBT is an efficacious treatment option for depression in varied cultures. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of Chinese plaster containing rhubarb and mirabilite on surgical site infection (SSI) in patients with cesarean delivery (CD) by performing a randomized controlled trial. Methods: This randomized controlled trial included 560 patients with CD due to fetal head descent enrolled at a tertiary teaching center between December 31, 2018 and October 31, 2021. Eligible patients were randomly assigned to a Chinese medicine (CM) group (280 cases) or a placebo group (280 cases) by a random number table, and were treated with CM plaster (made by rhubarb and mirabilite) or a placebo plaster, respectively. Both courses of treatment lasted from the day 1 of CD, followed day 2 until discharge. The primary outcome was the total number of patients with superficial, deep and organ/space SSI. The secondary outcome was duration of postoperative hospital stay, antibiotic intake, and unplanned readmission or reoperation due to SSI. All reported efficacy and safety outcomes were confirmed by a central adjudication committee that was unaware of the study-group assignments. Results: During the recovery process after CD, the rates of localized swelling, redness and heat were significantly lower in the CM group than in the placebo group [7.55% (20/265) vs. 17.21% (47/274), P<0.01]. The durution of postoperative antibiotic intake was shorter in the CM group than in the placebo group (P<0.01). The duration of postoperative hospital stay was significantly shorter in the CM group than in the placebo group (5.49 ± 2.68 days vs. 8.96 ± 2.35 days, P<0.01). The rate of postoperative C-reactive protein elevation (≽100 mg/L) was lower in the CM group than in the placebo group [27.6% (73/265) vs. 43.8% (120/274), P<0.01]. However, there was no difference in purulent drainage rate from incision and superficial opening of incision between the two groups. No intestinal reactions and skin allergies were found in the CM group. Conclusions: CM plaster containing rhubarb and mirabilite had an effect on SSI. It is safe for mothers and imposes lower economic and mental burdens on patients undergoing CD. (Registration No. ChiCTR2100054626) [ABSTRACT FROM AUTHOR]

Purpose: To evaluate whether the 24-weeks postoperative fracture union rate for the investigational TFNA intramedullary nail was non-inferior compared to the control product PFNA-II. Methods: The study was a prospective, randomized, single-blind, noninferiority dual-arm study drawing from 9 trauma centers across China, between November 2018 and September 2020, with follow-up measurements at 24 weeks after internal fixation. The full analysis data set (FAS [Intent-to-Treat]) was analyzed and is summarized here. The primary outcome was fracture union rate, a composite score combining clinical and radiographic assessment. Secondary endpoints comprised (a) clinical outcomes including (1) SF-12, (2) Harris Hip, and (3) EQ-5D Scores, (b) radiographic incidence of complications such as loosening or cut-out requiring revision, (c) revision rates, (d) reoperation rates, and (e) adverse events, including 24-weeks revision and reoperation rates. Results: Both TFNA and PFNA-II group fracture healing rates were 100% at 24 weeks; TFNA was therefore shown to be non-inferior to PFNA-II. With baseline data matched in all parameters except age in both the TFNA and PFNA-II groups, comparisons of union rates, SF-12, Harris Hip, and EQ-5D Scores yielded p values > 0.05 indicating no significant difference between the two groups, further supporting the noninferiority of TFNA. In both groups, revision and re-operation rates were 0, and the incidences of serious adverse events were 19.4% and 17.4%, respectively. Conclusion: In terms of fracture union rate at 24 weeks, the DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) was not inferior to the marketed Proximal Femoral Nail Antirotation (PFNA-II) device produced by the same manufacturer. Secondary and safety outcomes showed no significant differences between the two groups. Registration: Registration was completed at ClinicalTrials.gov NCT03635320. [ABSTRACT FROM AUTHOR]

Objectives: Sarcopenia is recognized as a major public health concern because of its association with several adverse health events. Beta-hydroxy-beta-methylbutyrate (HMB) supplementation reportedly delays the loss of muscle mass and function; however, the effect of HMB on sarcopenia remains inconclusive. We aimed to evaluate the impact of HMB intervention on muscle strength, physical performance, body compositions, and inflammatory factors in older adults with sarcopenia. Design: Randomized, double-blind, placebo-controlled trial. Setting and Participants: This study included subjects aged ≥60 years with sarcopenia which were assigned to the HMB group (HMBG, n=18) and the placebo group (PG, n=16). Intervention: The HMBG and PG were supplied with HMB and placebo products twice daily for 12 weeks, and both received resistance exercise training twice a week in 12 weeks. Measurements: Hand grip strength was selected as the primary outcome; gait speed, five-time chair stand test, body composition and inflammatory indicators were selected as the secondary outcomes. The differences in changes from baseline between the two groups were analyzed using the analysis of covariance(ANCOVA). Results: After the 12-week intervention, the HMBG demonstrated significantly greater improvements in handgrip strength (4.61(95%CI:2.93,6.28) kg, P<0.001), gait speed (0.11(95%CI:0.02,0.20)m/s, P=0.014), five-time chair stand test (−3.65 (95%CI:−5.72, −1.58)s, P=0.001), muscle quality (2.47(95%CI:1.15,3.80),kg·kg−1 P=0.001) and tumor necrosis factorlike weak inducer of apoptosis (−15.23(95%CI:−29.80,−0.66)pmol/mL, P=0.041) compared with the PG; no significant differences in skeletal muscle mass, skeletal muscle index, and other body composition parameters were found between the two groups. Conclusion: In older adults with sarcopenia, HMB significantly enhance the effect of resistance exercise training on muscle strength, physical performance, muscle quality, and reduced inflammatory factors. Therefore, HMB supplementation could be an effective treatment for sarcorpenia. The trial protocol was registered at http://www.chictr.org.cn/showproj.aspx?proj=47571 as ChiCTR2000028778. [ABSTRACT FROM AUTHOR]

The exact aetiology of pityriasis lichenoides chronica (PLC) remains unknown. While phototherapy is the most investigated therapeutic modality, azithromycin has been used scarcely. The aim of this study is to evaluate the therapeutic efficacy of azithromycin in the treatment of PLC compared to NB-UVB and evaluating the presence of streptococcal infection as a possible etiological factor in PLC patients. The study was designed as a randomised controlled trial. Twenty-four patients with PLC were randomly allocated into either azithromycin (n = 13, standard dose every 10 days) or NB-UVB (n = 11, thrice weekly) groups. End of study (EOS) was either complete clearance of lesions or a maximum of 8 weeks. Therapeutic efficacy was defined as percent reduction in lesions and was calculated for the rash as a whole, erythematous papules alone, and hypopigmented lesions alone and graded into complete, very-good, good, poor or no response. Anti-streptolysin O titre (ASOT), anti-deoxyribonuclease B titre (anti-DNaseB) and throat culture were evaluated at day 0. No significant difference existed between both groups as regards therapeutic efficacy. At EOS, NB-UVB achieved significantly more percent reduction in the extent of hypopigmented lesions and consequently in the rash as a whole (p = 0.001, p = 0.034, respectively). The extent of the rash as a whole was significantly less in the NB-UVB at EOS (p = 0.029, respectively). The effect of NB-UVB on hypopigmented lesions appeared early at week 4 of treatment. Only two patients, one from each group, relapsed during the 3 month follow-up. Evidence of recent streptococcal infection was present in 79% of the cases, mainly in the form of elevated ASOT (94.7%). It was significantly more encountered in young children (< 13 years) (p = 0.03) and was associated with more extent of erythematous papules and consequently with more extent of the rash as a whole (p = 0.05 and p = 0.01, respectively). It did not affect outcome of therapy at EOS. Azithromycin did not show more favorable response in patients with recent streptococcal infection. Therapeutic efficacy of azithromycin is comparable to NB-UVB in treatment of PLC; however, NB-UVB is superior in management of hypopigmented lesions. It is highly suggested that PLC could be a post streptococcal immune mediated disorder. Registration number: ClinicalTrials.gov, NCT03831269. [ABSTRACT FROM AUTHOR]

Introduction: Bimekizumab treatment resulted in improved clinical outcomes in patients with moderate-to-severe plaque psoriasis in BE VIVID, a 52-week, phase 3, randomized, ustekinumab and placebo-controlled study. We present data from the BE VIVID Japan patient subpopulation. Methods: Globally, patients were randomized to receive bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16, then bimekizumab 320 mg Q4W). Efficacy endpoints included week 16 Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) 0/1, and other outcomes [PASI 100, PASI 75, IGA 0, Dermatology Life Quality Index (DLQI) 0/1, absolute PASI, scalp IGA, Psoriasis Symptoms and Impacts Measure (P-SIM) responses]. Safety analyses were conducted. Results: There were 108 Japanese randomized patients (bimekizumab: 62; ustekinumab: 29; placebo: 17). At week 16, bimekizumab-treated patients had a higher clinical response versus ustekinumab and placebo (PASI 90: 85.5% versus 51.7% and 5.9%; IGA 0/1: 82.3% versus 48.3% and 0.0%). Over 52 weeks, improved clinical response was maintained with bimekizumab, including patients switching from placebo at week 16. Overall, the safety profile in Japanese patients was consistent with that observed in the global population. Conclusion: Bimekizumab resulted in improved clinical response versus ustekinumab and placebo, and was well-tolerated in Japanese patients. Trial registration: NCT03370133. [ABSTRACT FROM AUTHOR]

Third wave cognitive behavioural therapy has drawn attention to the value of interventions focusing on improved psychological functioning and wellbeing, rather than recovery or absence of disorder alone. The current study compared behavioural therapy combined with either self-compassion training or cognitive therapy (experimental treatment with standard treatment) in a randomized controlled trial for an initial presentation of a depressive disorder or post-traumatic stress disorder at a publicly funded outpatient unit. A battery of reliable and valid scales to assess the severity of the presenting problem and level of self-compassion were administered at both commencement and end of a 12-week treatment intervention. Basic sociodemographic variables were also recorded. Effective randomization was achieved for all variables except self-compassion, for which the standard treatment group reported higher levels than the experimental group. The greater efficacy of the experimental protocol was indicated by significant time by group interactions in severity measures over time in the experimental group relative to the standard group. This study contributes to a relatively fledgling literature on the therapeutic efficacy of self-compassion, providing both researchers and clinicians with valuable insight into the circumstances in which training in self-compassion may be of potential benefit when incorporated into standard practice. The trial was registered with the Australian New Zealand Clinical Trials Registry (TRN 12617000885392, June 16, 2017). [ABSTRACT FROM AUTHOR]

Objective: To examine whether the combination of Naoxintong Capsule with standard care could further reduce the recurrence of ischemic stroke without increasing the risk of severe bleeding. Methods: A total of 23 Chinese medical centers participated in this trial. Adult patients with a history of ischemic stroke were randomly assigned in a 1:1 ratio using a block design to receive either Naoxintong Capsule (1.2 g orally, twice a day) or placebo in addition to standard care. The primary endpoint was recurrence of ischemic stroke within 2 years. Secondary outcomes included myocardial infarction, death due to recurrent ischemic stroke, and all-cause mortality. The safety of drugs was monitored. Results were analyzed using the intention-to-treat principle. Results: A total of 2,200 patients were enrolled from March 2015 to March 2016, of whom 143 and 158 in the Naoxintong and placebo groups were lost to follow-up, respectively. Compared with the placebo group, the recurrence rate of ischemic stroke within 2 years was significantly lower in the Naoxintong group [6.5% vs. 9.5%, hazard ratio (HR): 0.665, 95% confidence interval (CI): 0.492-0.899, P=0.008]. The two groups showed no significant differences in the secondary outcomes and safety, including rates of severe hemorrhage, cerebral hemorrhage and subarachnoid hemorrhage (P>0.05). Conclusion: The combination of Naoxintong Capsule with standard care reduced the 2-year stroke recurrence rate in patients with ischemic stroke without increasing the risk of severe hemorrhage in high-risk patients. (Trial registration No. NCT02334969) [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effects of auricular acupoint bloodletting (AB) and auricular acupressure (AA) on sleep quality and the levels of melatonin (MT), glutamic acid (Glu), and γ -aminobutyric acid (GABA) in college students with primary insomnia, and to explore the possible mechanism. Methods: Totally 74 college students at Hebei University of Chinese Medicine with primary insomnia were selected from October 2019 to October 2020. All patients were assigned to AB+AA group (37 cases, received combination of AB and AA) and AA group (37 cases, received only AA on the same acupoints) by a random number table. Each group was treated twice a week for 4 weeks. The Pittsburgh Sleep Quality Index (PSQI) score, Chinese medicine (CM) syndrome score, total effective rate, serum concentrations of MT, Glu, and GABA, and Glu/GABA ratio were compared between the two groups after treatment and at follow-up. The safety of therapy was also evaluated. Results: After 4-week treatment, the total scores of PSQI, each PSQI component score, and the CM syndrome scores in both groups all decreased (P<0.05); the serum MT concentrations in both groups all increased (P<0.05). The concentrations of Glu and GABA in the AB+AA group were significantly higher than those in the AA group after treatment (P<0.05). However, there was no significant difference in the ratio of Glu/GABA in both groups before and after treatment (P>0.05). At follow-up, the CM syndrome score in the AB+AA group was significantly lower than that in the AA group (P<0.05). There was no significant difference between the two groups in total effective rates and adverse events (P>0.05). Conclusions: Both AB+AA and AA can relieve insomnia symptoms, but a stronger long-term effect were observed for AB+AA. AB+AA can promote the secretion of MT, increase the levels of Glu and GABA more effective than AA, and regulate their imbalance, and thus it may be benificial for treating insomnia. [ABSTRACT FROM AUTHOR]

We assessed an intervention aimed at improving adherence to antiretroviral therapy (ART) among pregnant and postpartum women living with HIV (PPWLH). We randomized 133 pregnant women initiating ART in Uganda to receive text reminders generated by real time-enabled electronic monitors and data-informed counseling through 3 months postpartum (PPM3) or standard care. Intention-to-treat analyses found low adherence levels and no intervention impact. Proportions achieving ≥95% adherence in PPM3 were 16.4% vs. 9.1% (t = -1.14, p = 0.26) in intervention vs. comparison groups, respectively; 30.9% vs. 29.1% achieved ≥80% adherence. Additional analyses found significant adherence declines after delivery, and no effect on disease progression (CD4-cell count, viral load), though treatment interruptions were significantly fewer in intervention participants. Per-protocol analyses encompassing participants who used adherence monitors as designed experienced better outcomes, suggesting potential benefit for some PPWLH. The study was registered on ClinicalTrials.Gov (NCT02396394). [ABSTRACT FROM AUTHOR]

Lactational breast abscess results from inadequate or partially treated mastitis. Recently, needle aspiration or catheter suction drainage is being adopted in place of incision and drainage. We planned to evaluate the effectiveness of needle aspiration versus vacuum suction drainage in resolution of puerperal breast abscess. One-hundred-twelve mothers with lactational breast abscess were randomized to either ultrasound-guided needle aspiration or vacuum suction drainage. These patients were followed up on alternate days and assessed for complete resolution of breast abscess, pain in the breast on Visual Analog Scale (VAS) of 0–10, day of return to normal breast feeding, number of aspirations needed, recurrence of abscess and total cost of care. In the suction drain group, 98% of mothers enjoyed complete resolution within 10 days as compared to 87% of mothers treated with needle aspiration. Mean VAS at first follow-up was 2.89 in aspiration group and 2.62 in suction group. The VAS reduced to 0.74 in aspiration group and 0.53 in suction drainage group, at the last follow-up. The mean day of recovery was 7 days for aspiration and 5.73 days for suction. Most patients required 3 aspirations. The mean drainage time was 4.5 days. Vacuum suction drainage is the more effective method for achieving resolution of lactational breast abscess and offers greater patient satisfaction compared to needle aspiration. [ABSTRACT FROM AUTHOR]

Several studies have demonstrated the benefits of thalidomide as a treatment for patients with ankylosing spondylitis (AS); however, published literature reported controversial results. We conducted a meta-analysis to systematically evaluate the efficacy of thalidomide in AS patients. PubMed, Embase, Cochrane Library, Web of Science, Wanfang Data, and China National Knowledge Infrastructure (CNKI) were searched for relevant studies. The Q test and I2 statistic were used to examine between-study heterogeneity. Fixed- or random-effects models were selected based on study heterogeneity. The risk difference (RD), absolute risk reduction (ARR), and weighted mean difference (WMD) with 95% confidence intervals (CI) were pooled for dichotomous or continuous data, as appropriate. Sensitivity analyses, funnel plots, and the Begg's tests were also performed. Overall, 19 trials with 1471 patients were included. The effectiveness of thalidomide alone and combined with other drugs was significantly higher than the control group, and the pooled RDs were 0.15 (95% CI: 0.10–0.20, I2 = 0%) and 0.20 (95% CI: 0.14–0.25, I2 = 13.4%), respectively. Thalidomide treatment yielded significant improvements in secondary outcomes for patients with AS. The adverse reaction rate for thalidomide alone was low than that for the control group (ARR = 0.08, 95% CI: 0.01–0.15, I2 = 0.0%), while there was no significant difference in the safety between the group in which thalidomide was combined with other drugs and the control (ARR = 0.03, 95% CI: − 0.04–0.10, I2 = 41.1%). The findings suggest that thalidomide improves the effectiveness of AS treatment, which should be considered by physicians. However, owing to the inclusion of several low-quality and Chinese studies, additional rigorous randomized controlled trials (RCTs) are needed in the future to confirm the results of this meta‑analysis. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety of Tibetan medicine Ruyi Zhenbao Pills (RZPs) in the treatment of patients with motor and sensory dysfunction after stroke. Methods: A total of 120 convalescent stroke patients hospitalized in the Rehabilitation Department of Guangdong Provincial Hospital of Chinese Medicine from June 2017 to December 2019 were enrolled in this trial. Patients were assigned to control (60 cases) and research (60 cases) groups by computer random assignment. All patients received internal treatment and modern rehabilitation training. On this basis, the research group was given oral RZPs for 4 weeks, while the control group was given oral placebo. The primary outcome was motor function of the affected side evaluated by simplified Fugl-Meyer Motion Assessment Scale (FMA-M). The secondary outcomes included sensory function, activity of daily living (ADL), quality of life, balance function, and pain, which were assessed by Fugl-Meyer Sensory Assessment Scale (FMA-S), Modified Barthel Index (MBI), Special Scale of the Quality of Life (SS-QOL), Berg Balance Scale (BBS), and Visual Analogue Scale (VAS), respectively. All of the assessments were performed before treatment, and 4 and 8 weeks after treatment. Vital signs, liver and kidney functions, routine blood test, blood coagulation profile, and routine urinalysis of patients were monitored. Results: After 4-week treatment, the FMA-M, BBS and FMA-S scores in the research group significantly increased compared with the control group (P<0.05). At 8-week follow-up, the BBS and MBI scores in the research group were higher than the control group (P<0.05). There was no statistical difference between the 2 groups in the SS-QOL and VAS scores at 4 and 8 weeks (P>0.05). Moreover, after treatment, there was no significant difference in vital signs, liver and kidney functions, blood coagulation function, blood routine and urinalysis between the 2 groups (P>0.05). Conclusion: RZPs improved limb motor, balance, and sensory functions of stroke patients during recovery period with good safety. (Trial registration No. NCT04029701) [ABSTRACT FROM AUTHOR]

Objective: To observe the efficacy and safety of Guihuang Formula (GHF) in treating patients with type III prostatitis and Chinese medicine syndrome of dampness-heat and blood stasis. Methods: Sixty-six patients diagnosed with type III prostatitis with dampness-heat and blood stasis syndrome were randomly divided into the treatment group (GHF) and the control group (tamsulosin) using a random number table, with 33 cases each group. The treatment group received GHF twice a day, and the control group received tamsulosin 0.2 mg once daily before bedtime. Patients in both groups received treatment for 6 weeks and was followed up for 2 weeks. The outcomes included the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score, Chinese Medicine Symptoms Score (CMSS), expressed prostatic secretions (EPS) and adverse events (AEs). Results: After treatment, the NIH-CPSI total score and domain scores of pain discomfort, urination and quality of life decreased significantly from the baseline in both groups (P<0.05). The CMSS score decreased in both groups (P<0.05). The WBC count decreased and lecithin body count increased in both groups (P<0.05). GHF showed a more obvious advantage in reducing the pain discomfort and quality of life domain scores of NIH-CPSI, reducing the CMSS score, increasing the improvement rate of the WBC and lecithin body counts, compared with the control group (P<0.05). There were no significant differences in decreasing urination domain score of NIH-CPSI between two groups (P>0.05). In addition, no serious AEs were observed. Conclusion: GHF is effective in treating type III prostatitis patients with dampness-heat and blood stasis syndrome without serious AEs. (Registration No. ChiCTR1900026966) [ABSTRACT FROM AUTHOR]

Background: Adherence to treatment recommendations is challenging in hemodialysis (HD) patients, yet it has been found to be extremely crucial in obtaining positive clinical and health outcomes. Aim: To evaluate the influence of implementing an educational process provided by the clinical pharmacist on HD patients' adherence to treatment recommendations and clinical outcomes. Method: A randomized controlled trial was conducted in which patients from three HD units in Jordan were randomly allocated to either an intervention (n = 60) or a control group (n = 60). During a three-month period, the intervention group received a monthly educational approach from a clinical pharmacist with recommendations for improving medication, nutrition, and fluid adherence, whereas the control received standard medical care. The primary outcome was patient adherence to HD-related recommendations. Quality of life (QOL), disease awareness, hospitalization, and changes in biochemicals were secondary outcomes. Results: The final analysis included 114 patients (n = 57/group). In the intervention group, there was a significant improvement in total adherence score versus control (1170.6 ± 44.1 vs. 665.8 ± 220.7, p < 0.001), and adherence to various aspects including episodes/duration of shortening HD, dietary guidelines, fluid restriction, and prescription medications. The clinical pharmacist intervention enhanced patients' QOL and improved awareness and perspective of the disease. Following the intervention, laboratory values for urea, creatinine, phosphorus, and hemoglobin were considerably improved. Additionally, the intervention group had fewer hospitalizations than the control group (0.54 ± 0.07 vs. 0.78 ± 0.26, p < 0.001). Conclusion: Providing clinical pharmacy education to HD patients improved adherence behavior and clinical outcomes. This illustrates the importance of clinical pharmacists as interdisciplinary team members in dialysis care. Trial registration This trial has been registered in ISRCTN Register (ISRCTN75517095). https://clinicaltrials.gov/ct2/show/ISRCTN75517095 [ABSTRACT FROM AUTHOR]

Introduction: Acute syndesmosis tears can be treated by static screw or dynamic fixation. Various studies have compared these techniques regarding postoperative outcome. However, to our knowledge, no study has used 3D-instrumented gait analysis (IGA). We hypothesized that a dynamic fixation would perform non-inferior to screw fixation in terms of biomechanical and clinical outcomes.Patients were prospectively randomized to both groups. All patients received the same follow-up rehabilitation and consultations (6 and 12 weeks; 6 and 12 months) postoperatively. Standardized questionnaires were used to objectify pain and ankle function. At 6 months follow-up, IGA was conducted additionally to objectify the biomechanical outcome.Twenty-five patients in the dynamic fixation (DF) group using TightRope® and twenty-five in the screw fixation group (SF) completed gait analysis. The DF group showed significantly higher mean values for maximum moment in the affected ankle joint (DF: 1.40 ± 0.21 Nm, SF: 1.23 ± 0.30 Nm; p = 0.023) and the unaffected ankle joint (DF: 1.52 ± 0.20 Nm, SF: 1.37 ± 0.27 Nm; p = 0.035). The difference between the affected and unaffected ankle joint was significantly higher in the SF group for active plantarflexion (DF: 1.52 ± 0.20°, SF: 1.37 ± 0.27°; p = 0.035). Both dynamic and screw fixation groups exhibited significantly reduced plantarflexion during the push-off and early swing phase, with moments and powers in the ankle joint also significantly impaired.Our study demonstrated that dynamic fixation has better or similar biomechanical and clinical outcomes compared to screw fixation. Future research should focus on biomechanical differences during gait as well as clinical outcomes in case of earlier weight-bearing after dynamic fixation.DRKS00013562 Date of Registration: 07/12/2017.Materials and methods: Acute syndesmosis tears can be treated by static screw or dynamic fixation. Various studies have compared these techniques regarding postoperative outcome. However, to our knowledge, no study has used 3D-instrumented gait analysis (IGA). We hypothesized that a dynamic fixation would perform non-inferior to screw fixation in terms of biomechanical and clinical outcomes.Patients were prospectively randomized to both groups. All patients received the same follow-up rehabilitation and consultations (6 and 12 weeks; 6 and 12 months) postoperatively. Standardized questionnaires were used to objectify pain and ankle function. At 6 months follow-up, IGA was conducted additionally to objectify the biomechanical outcome.Twenty-five patients in the dynamic fixation (DF) group using TightRope® and twenty-five in the screw fixation group (SF) completed gait analysis. The DF group showed significantly higher mean values for maximum moment in the affected ankle joint (DF: 1.40 ± 0.21 Nm, SF: 1.23 ± 0.30 Nm; p = 0.023) and the unaffected ankle joint (DF: 1.52 ± 0.20 Nm, SF: 1.37 ± 0.27 Nm; p = 0.035). The difference between the affected and unaffected ankle joint was significantly higher in the SF group for active plantarflexion (DF: 1.52 ± 0.20°, SF: 1.37 ± 0.27°; p = 0.035). Both dynamic and screw fixation groups exhibited significantly reduced plantarflexion during the push-off and early swing phase, with moments and powers in the ankle joint also significantly impaired.Our study demonstrated that dynamic fixation has better or similar biomechanical and clinical outcomes compared to screw fixation. Future research should focus on biomechanical differences during gait as well as clinical outcomes in case of earlier weight-bearing after dynamic fixation.DRKS00013562 Date of Registration: 07/12/2017.Results: Acute syndesmosis tears can be treated by static screw or dynamic fixation. Various studies have compared these techniques regarding postoperative outcome. However, to our knowledge, no study has used 3D-instrumented gait analysis (IGA). We hypothesized that a dynamic fixation would perform non-inferior to screw fixation in terms of biomechanical and clinical outcomes.Patients were prospectively randomized to both groups. All patients received the same follow-up rehabilitation and consultations (6 and 12 weeks; 6 and 12 months) postoperatively. Standardized questionnaires were used to objectify pain and ankle function. At 6 months follow-up, IGA was conducted additionally to objectify the biomechanical outcome.Twenty-five patients in the dynamic fixation (DF) group using TightRope® and twenty-five in the screw fixation group (SF) completed gait analysis. The DF group showed significantly higher mean values for maximum moment in the affected ankle joint (DF: 1.40 ± 0.21 Nm, SF: 1.23 ± 0.30 Nm; p = 0.023) and the unaffected ankle joint (DF: 1.52 ± 0.20 Nm, SF: 1.37 ± 0.27 Nm; p = 0.035). The difference between the affected and unaffected ankle joint was significantly higher in the SF group for active plantarflexion (DF: 1.52 ± 0.20°, SF: 1.37 ± 0.27°; p = 0.035). Both dynamic and screw fixation groups exhibited significantly reduced plantarflexion during the push-off and early swing phase, with moments and powers in the ankle joint also significantly impaired.Our study demonstrated that dynamic fixation has better or similar biomechanical and clinical outcomes compared to screw fixation. Future research should focus on biomechanical differences during gait as well as clinical outcomes in case of earlier weight-bearing after dynamic fixation.DRKS00013562 Date of Registration: 07/12/2017.Conclusions: Acute syndesmosis tears can be treated by static screw or dynamic fixation. Various studies have compared these techniques regarding postoperative outcome. However, to our knowledge, no study has used 3D-instrumented gait analysis (IGA). We hypothesized that a dynamic fixation would perform non-inferior to screw fixation in terms of biomechanical and clinical outcomes.Patients were prospectively randomized to both groups. All patients received the same follow-up rehabilitation and consultations (6 and 12 weeks; 6 and 12 months) postoperatively. Standardized questionnaires were used to objectify pain and ankle function. At 6 months follow-up, IGA was conducted additionally to objectify the biomechanical outcome.Twenty-five patients in the dynamic fixation (DF) group using TightRope® and twenty-five in the screw fixation group (SF) completed gait analysis. The DF group showed significantly higher mean values for maximum moment in the affected ankle joint (DF: 1.40 ± 0.21 Nm, SF: 1.23 ± 0.30 Nm; p = 0.023) and the unaffected ankle joint (DF: 1.52 ± 0.20 Nm, SF: 1.37 ± 0.27 Nm; p = 0.035). The difference between the affected and unaffected ankle joint was significantly higher in the SF group for active plantarflexion (DF: 1.52 ± 0.20°, SF: 1.37 ± 0.27°; p = 0.035). Both dynamic and screw fixation groups exhibited significantly reduced plantarflexion during the push-off and early swing phase, with moments and powers in the ankle joint also significantly impaired.Our study demonstrated that dynamic fixation has better or similar biomechanical and clinical outcomes compared to screw fixation. Future research should focus on biomechanical differences during gait as well as clinical outcomes in case of earlier weight-bearing after dynamic fixation.DRKS00013562 Date of Registration: 07/12/2017.Trial registration number (TRN): Acute syndesmosis tears can be treated by static screw or dynamic fixation. Various studies have compared these techniques regarding postoperative outcome. However, to our knowledge, no study has used 3D-instrumented gait analysis (IGA). We hypothesized that a dynamic fixation would perform non-inferior to screw fixation in terms of biomechanical and clinical outcomes.Patients were prospectively randomized to both groups. All patients received the same follow-up rehabilitation and consultations (6 and 12 weeks; 6 and 12 months) postoperatively. Standardized questionnaires were used to objectify pain and ankle function. At 6 months follow-up, IGA was conducted additionally to objectify the biomechanical outcome.Twenty-five patients in the dynamic fixation (DF) group using TightRope® and twenty-five in the screw fixation group (SF) completed gait analysis. The DF group showed significantly higher mean values for maximum moment in the affected ankle joint (DF: 1.40 ± 0.21 Nm, SF: 1.23 ± 0.30 Nm; p = 0.023) and the unaffected ankle joint (DF: 1.52 ± 0.20 Nm, SF: 1.37 ± 0.27 Nm; p = 0.035). The difference between the affected and unaffected ankle joint was significantly higher in the SF group for active plantarflexion (DF: 1.52 ± 0.20°, SF: 1.37 ± 0.27°; p = 0.035). Both dynamic and screw fixation groups exhibited significantly reduced plantarflexion during the push-off and early swing phase, with moments and powers in the ankle joint also significantly impaired.Our study demonstrated that dynamic fixation has better or similar biomechanical and clinical outcomes compared to screw fixation. Future research should focus on biomechanical differences during gait as well as clinical outcomes in case of earlier weight-bearing after dynamic fixation.DRKS00013562 Date of Registration: 07/12/2017. [ABSTRACT FROM AUTHOR]

Background: Women veterans experience higher levels of stress-related symptoms than their civilian counterparts. Psychological stress is associated with greater inflammation and may increase risk for cardiovascular disease (CVD). Mindfulness-based stress reduction (MBSR) has been found to improve psychological well-being in other populations but no randomized controlled trials (RCT) have been conducted examining the impact of MBSR on well-being and inflammation in women veterans at risk for CVD.Objective: Determine the effectiveness of MBSR in improving psychological well-being, cortisol, and inflammation associated with CVD in women veterans.Design: The design is a RCT comparing MBSR to an active control condition (ACC) consisting of a health education program.Participants: Women veterans (N=164) with risk factors for CVD from the Chicagoland area participated in the study.Intervention: An 8-week MBSR program with weekly 2.5-h classes was compared to an ACC consisting of an 8-week health promotion education program with weekly 2.5-h classes.Main Measures: The outcomes were psychological well-being [perceived stress, depressive symptoms, loneliness, and post-traumatic stress disorder (PTSD)] symptoms and stress-related markers, including diurnal salivary cortisol and cytokines interleukin-6 (IL-6) and interferon gamma (IFN-γ). Data were collected at baseline, 4 weeks (mid-point of intervention), 8 weeks (completion of intervention), and 6 months after completion of MBSR or ACC.Key Results: Compared to the ACC, women who participated in MBSR reported less perceived stress, loneliness, and symptoms of PTSD. Although there were no significant differences between groups or changes over time in IL-6 or IFN-γ, participants in the MBSR program demonstrated a more rapid decline in diurnal salivary cortisol as compared to those in the ACC.Conclusions: MBSR was found to improve psychological well-being and decrease diurnal salivary cortisol in women veterans at risk for CVD. Health care providers may consider MBSR for women veterans as a means by which to improve their psychological well-being. [ABSTRACT FROM AUTHOR]

Background: Erenumab, a fully human monoclonal antibody that targets the calcitonin gene-related peptide receptor, has demonstrated efficacy and safety in the prevention of episodic and chronic migraine. There exists an unmet need to establish the safety of erenumab in older individuals, in view of existing multiple comorbidities, polypharmacy, and age-related physiological changes. This pooled analysis of five large migraine-prevention studies examined the safety of erenumab stratified across age groups, particularly in older populations. Methods: Pooled and age-stratified analysis of safety data from the 12-week double-blind treatment phase (DBTP) of five randomized, placebo-controlled Phase 2 and 3 studies of erenumab in participants with episodic or chronic migraine across the age groups < 40 years, 40–49 years, 50–59 years, and ≥ 60 years was completed. The safety of erenumab across age groups was determined by assessing safety endpoints including treatment-emergent adverse events (AEs), serious AEs, and events leading to study drug discontinuation. Results: Overall, 3345 participants across five studies were randomized to receive either placebo (n = 1359), erenumab 70 mg (n = 1132) or erenumab 140 mg (n = 854); 3176 (94.9%) completed the DBTP, and 169 (5.1%) discontinued, mainly due to participant decision (110; 3.3%). Overall, 1349 (40.6%), 1122 (33.8%), and 850 (25.6%) participants received at least one dose of placebo, erenumab 70 mg, and erenumab 140 mg, respectively. Incidence of treatment-emergent AEs was similar across all age groups for both doses of erenumab (70 mg or 140 mg) and placebo (< 40 years, 44.0% vs 44.4%; 40–49 years, 42.5% vs 49.2%; 50–59 years, 46.5% vs 41.6%; ≥ 60 years, 43.8% vs 59.4%). Incidence of treatment-emergent serious AEs overall, and stratified by age groups for both doses and placebo was low (< 40 years, 0.9% vs 1.2%; 40–49 years, 1.7% vs 1.9%; and 50–59 years, 1.6% vs 1.1%), with no serious AEs reported in participants aged ≥ 60 years. No deaths were reported. Conclusions: Erenumab (70 mg or 140 mg) exhibited a similar safety profile compared with placebo across age groups in individuals with episodic or chronic migraine, with no increased emergence of events due to age. Erenumab was well tolerated in older participants with multiple comorbidities, polypharmacy, and age-related physiological changes. Trial registration number: ClinicalTrials.gov Identifiers: NCT02066415, NCT02456740, NCT02483585, NCT03096834, NCT03333109. [ABSTRACT FROM AUTHOR]

In a randomized controlled trial, we tested the efficacy of Baby Triple P in a community sample of first-time parent couples. The intervention was developed to promote better mental health, a positive couple relationship, positive parenting, and a better parent-infant relationship. One hundred and fifty six couples were randomly allocated to intervention (n = 78) or care as usual (n = 78) conditions. The intervention was delivered in four antenatal face-to-face group sessions followed by four early postnatal individual telephone sessions. Couples completed self-report assessments at baseline, immediately postintervention and at 12 and 24 months. The study had one primary (the Depression, Anxiety and Stress Scale) and 11 secondary outcomes. Over half of the intervention and care as usual participants remained in the study for the full 24 months. Intention to treat analysis of the full sample yielded positive results in some mental health domains for mothers and fathers, but this was not evident when follow up sensitivity analysis was conducted on a subsample of the data. There was limited support for the intervention in relation to secondary outcomes such as the couple relationship, social support and parenting. However, the parent couples were positive about the intervention and described it as providing the support that they wanted. This trial provides some evidence in support of Baby Triple P as an early intervention for new parent couples. High levels of satisfaction with the intervention are promising, especially in relation to the engagement of fathers. Trial Registration: ISRCTN31955576 Highlights: This randomized controlled trial provides some evidence that the mental health of new parents is amenable to intervention. This randomized controlled trial provides some evidence in support of Baby Triple P as an early intervention. Evidence from this study demonstrates that engagement and retention of fathers is possible and fathers value involvement. Initial engagement is a critical point in the delivery of early interventions; couples who are engaged are more likely to complete the intervention. [ABSTRACT FROM AUTHOR]

Purpose: Anterior cervical discectomy and fusion (ACDF) surgery is commonly performed to treat cervical degenerative disc disease (CDDD). The lost of range of motion (ROM) is also found after ACDF, which contributes to degenerate in adjacent segment disease (ASD). Artificial cervical disc replacement (ACDR), an alternative to ACDF, is developed to preserve the ROM and reduce ASD. This article aims to compare the outcomes between ACDR and ACDF in the short-, mid-, and long-term.Methods: Databases including Cochrane, Embase, PubMed, and Web of Science were searched. Only RCTs were included in this meta-analysis, and the search strategy followed the requirements of the Cochrane Handbook. The strength of evidence was assessed using GRADE. Two reviewers independently assessed the methodological quality of each included study and extracted the relevant data.Results: Thirty prospective RCTs were included. Prolonged operative duration, better overall success, neurological success, and NDI success rates were found in ACDR group in all follow-up periods, with lower dysphagia/dysphonia during short-term follow-up. Moreover, a lower ASD was found in ACDR group during long-term follow-up and overall analysis, with lower reoperation rates in all follow-up periods. Comparable length of hospital stay and blood loss were found in both groups. Moreover, ASD was similar in short- and mid-term follow-ups, while dysphagia/dysphonia incidence was similar in mid- and long-term follow-ups. The incidence of implant events was comparable in all follow-up periods (p > 0.05).Conclusions: ACDR is as effective as ACDF and superior for some success rates. Disc replacement can reduce the risk of dysphagia/dysphonia, ASD, and re-operation. [ABSTRACT FROM AUTHOR]

Purpose: The present study aimed to investigate fish oil plus vitamin D3 (FO + D) supplementation on biomarkers of non-alcoholic fatty liver disease (NAFLD). Methods: In a 3-month randomized controlled trial, 111 subjects with NAFLD, aged 56.0 ± 15.9 y, were randomized into FO + D group (n = 37), fish oil group (FO, n = 37) or corn oil group (CO, n = 37). The subjects consumed the following capsules (3 g/day), which provided 2.34 g/day of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) + 1680 IU vitamin D3 (FO + D group), or 2.34 g/day of EPA + DHA (FO group), or 1.70 g/d linoleic acid (CO group). Results: Using multivariable-adjusted general linear model, there were significant net reductions in serum alanine aminotransferase (ALT), and triacylglycerol (TAG) and TNF-α levels in the FO + D and FO groups, compared with the control group (P < 0.05). The supplemental FO + D also showed significant reductions in insulin (− 1.58 ± 2.00 mU/L vs. − 0.63 ± 1.55 mU/L, P = 0.050) and IL-1β (− 6.92 ± 7.29 ng/L vs. 1.06 ± 5.83 ng/L, P < 0.001) in comparison with control group. Although there were no significant differences between FO + D and FO groups regarding biochemical parameters, supplemental FO + D showed decreases in ALT (from 26.2 ± 13.5 U/L to 21.4 ± 9.6 U/L, P = 0.007), aspartate aminotransferase (AST, from 22.5 ± 7.0 U/L to 20.2 ± 4.0 U/L, P = 0.029), HOMA-IR (from 3.69 ± 1.22 to 3.38 ± 1.10, P = 0.047), and TNF-α (from 0.43 ± 0.38 ng/L to 0.25 ± 0.42 ng/L, P < 0.001) levels following the intervention. Conclusion: The present study demonstrated that groups supplemented with FO + D and FO had similar beneficial effects on biomarkers of hepatocellular damage and plasma TAG levels in subjects with NAFLD, while in the FO + D group, there were some suggestive additional benefits compared with FO group on insulin levels and inflammation. Trial registration: ChiCTR1900024866. [ABSTRACT FROM AUTHOR]

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the gold-standard treatment for insomnia, which is common among breast cancer survivors (BCS). This pilot randomized controlled trial tested the first CBT-I intervention for Spanish-speaking BCS delivered using eHealth. Participants (N = 30) were Spanish-speaking BCS with insomnia symptoms recruited in Puerto Rico and randomized to a 6-week eHealth CBT-I group intervention or a waitlist control. Primary outcomes were acceptability (recruitment, treatment satisfaction) and feasibility (retention, attendance). Secondary outcomes were group differences in sleep outcomes post-treatment (i.e., insomnia symptoms, sleep disturbance, sleep efficiency). Recruitment (95%) and retention (97%) were excellent. All CBT-I participants (100%) attended ≥ 3 of 6 sessions. Satisfaction with CBT-I was acceptable. Post-intervention, there were medium to large group differences for average insomnia symptoms (d = 1.02), sleep disturbance (d = 1.25), and sleep efficiency (d = 0.77) favoring CBT-I. There were small/medium to medium/large group differences for the proportion of participants with clinically significant insomnia symptoms (d = 0.52), sleep disturbance (d = 0.67), and low sleep efficiency (d = 0.33) favoring CBT-I. Spanish-language eHealth CBT-I for BCS was acceptable and feasible and showed preliminary efficacy. ClinicalTrials.gov TRN: NCT04101526 (Posted September 24, 2019). [ABSTRACT FROM AUTHOR]

Robust clinical evidence has not been available for melatonin, a drug commonly administered for treating sleep problems of children with autism spectrum disorder (ASD). In a phase 3 randomized, placebo-controlled clinical trial, we administered 1-mg melatonin (n = 65), 4-mg melatonin (n = 65), or placebo (n = 66) to196 children with ASD once daily before bedtime under adequate sleep hygiene interventions. The primary outcome was sleep onset latency (SOL) assessed with the electronic sleep diary. SOL shortened significantly in the 1- and 4-mg melatonin groups compared to the placebo group (− 22.0, − 28.0, and − 5.0 min, respectively; p < 0.0001 each). This therapeutic regimen of melatonin is a reasonable clinical approach to cope with ASD-emergent difficulties in children with ASD. [ABSTRACT FROM AUTHOR]

Endovascular coiling has revolutionized intracranial aneurysm treatment; however, recurrence continues to represent a major limitation. The hydrogel coil was developed to increase packing density and improve neck healing and therefore decrease recurrence rates. In this paper, we review treatment outcomes of first- (1HCs) and second-generation (2HCs) hydrogel coils and compare them to those of bare platinum coils (BPC). A query of multiple databases was performed. Articles with at least 10 aneurysms treated with either 1HC or 2HC were selected for analysis. Collected data included aneurysm size, rupture status, initial occlusion, initial residual neck/aneurysm, packing density, mortality, morbidity, recurrence, and retreatment rates. The primary endpoint was recurrence at final follow-up. Secondary endpoints included residual neck and dome rates as well as procedure-related complications and functional dependence at final follow-up. Studies that compared 1HC to BPC showed significant lower recurrence (24% vs. 30.8%, p = 0.02) and higher packing density (58.5% vs. 24.1%, p < 0.001) in 1HC but no significant difference in initial occlusion rate (p = 0.08). Studies that compared 2HC to BPC showed lower recurrence (6.3% vs. 14.3%, p = 0.007) and retreatment rates (3.4% vs. 7.7%, p = 0.010) as well as higher packing density (36.4% vs. 29.2%, p = 0.002) in 2HC, with similar initial occlusion rate (p = 0.86). The rate of complications was not statistically different between HC (25.5%) and BPC (22.6%, p = 0.06). Based on our review, the 1HC and 2HC achieved higher packing density and lower recurrence rates compared to BPC. The safety profile was similar between both groups. [ABSTRACT FROM AUTHOR]

Treatment fidelity is a crucial consideration within randomized controlled trials (RCTs). The present study relies on data from a feasibility RCT conducted with 62 treatment-seeking suicidal college students. Issues of experimental fidelity were germane in this investigation because the same clinicians provided both the experimental (the Collaborative Assessment and Management of Suicidality—CAMS) and the control (treatment as usual—TAU) care. The first aim of the current study was to determine adherence to the CAMS model within the experimental (CAMS) and control (TAU) treatment conditions. A second exploratory aim was included to examine how treatment fidelity impacted treatment outcomes (i.e., depression, suicidal ideation, hopelessness, and potential treatment moderators). The CAMS Rating Scale (CRS.3-R) was used to determine treatment adherence to the CAMS model and to ensure between-group fidelity within the trial. The CRS.3-R was completed throughout the course of care based on reviews of a selected number of video recordings of both CAMS and TAU sessions to measure treatment fidelity. Mean CRS.3-R scores revealed differences across treatment conditions such that clinicians were successfully able to provide each treatment separately without contamination. Further, higher CRS.3-R scores in CAMS sessions resulted in decreased hopelessness over the treatment period. Higher CRS.3-R scores in TAU sessions resulted in an increased likelihood of suicidal ideation and less reduction in hopelessness over the treatment period. Overall, clinicians can serve as their own controls in a RCT and levels of adherence to the CAMS model have different effects on suicidal ideation and hopelessness. [ABSTRACT FROM AUTHOR]

Objective: To assess the effectiveness of Jiuwei Zhuhuang Powder (JWZH), a Tibetan patent medicine in treating upper respiratory tract infection (URTI) associated cough in children. Methods: The study was a multicenter, randomized, open-label, controlled trial. A total of 142 children aged 2 to 14 years old, with URTI-associated cough within 48 h of onset, were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence. Children were treated with JWZH (1 to 1.5 g, twice to thrice daily) in the treatment group or conventional treatment (Pediatric Paracetamol, Artificial Cow-bezoar and Chlorphenamine Maleate Granules, 0.25 to 1 g, thrice daily) in the control group for 5 days. The primary endpoints were the time to cough resolution and 4-day cough resolution rate. The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period. Results: A total of 138 children were included in the intention-to-treat analysis, with 71 cases in the treatment group and 67 cases in the control group. Compared with the conventional treatment, the children receiving JWZH had a shorter time to cough resolution [hazard ratio, 2.10; 95% confidence interval (CI), 1.29–3.40; P=0.003]. The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment (2 days vs. 3 days; P<0.001). The 4-day cough resolution rate in the JWZH group was higher than that of the control group (94.4% vs. 74.6%; risk difference: 19.8%, 95% CI: 8.1%–31.5%; relative risk: 1.265, 95% CI: 1.088–1.470; P=0.001). There were no statistically significant differences in the improvement of other symptoms caused by URTI (P>0.05). Adverse events was reported in 5.6% (4/71) and 4.5% (3/67) in participants of JWZH and PPACCM groups (P>0.05), respectively, which were all mild and resolved without treatment. Conclusion: JWZH seemed to be a safe and effective therapy for URTI-associated cough in children. (Trial registration No. ChiCTR2000039421) [ABSTRACT FROM AUTHOR]

Objective: To explore the therapeutic effect of Bushen Yiqi Huoxue Decoction BYHD) in patients with diminished ovarian reserve (DOR). Methods: A total of 180 patients with DOR diagnosed from December 2013 to December 2014 were equally assigned into progynova and duphaston (E+D) group, Zuogui Pill group and BYHD group with 60 cases in each by computerized randomization. Patients received E+D, Zuogui Pill or BYHD for 12 months, respectively. Follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), anti-Müllerian hormone (AMH), antral follicle count (AFC), ovarian volume, endometrial thickness, and the resistance indices (RIs) of ovarian arteries and uterine arteries were observed before and after treatment. Results: Nine women (4 from the E+D group, 3 from the Zuogui Pill group, and 2 from the BYHD group) withdrew from the study. After 6 months, Zuogui Pill and BYHD significantly decreased FSH and LH and increased endometrial thickness and AMH (all P<0.01). BYHD also resulted in E2 elevation (P<0.05), ovary enlargement (P<0.05), AFC increase (P<0.01), and RI of ovarian arteries decrease (P<0.05). After 12 months, further improvements were observed in the Zuogui Pill and BYHD groups (all P<0.01), but BYHD showed better outcomes, with lower FSH, larger ovaries and a thicker endometrium compared with the Zuogui Pill group (all P<0.01). However, E+D only significantly increased endometrial thickness (P<0.01) and no significant improvements were observed in the RI of uterine arteries in the three groups. Conclusions: BYHD had a favorable therapeutic effect in patients with DOR by rebalancing hormone levels, promoting ovulation, and repairing the thin endometrium. The combination of tonifying Shen (Kidney), benefiting qi and activating blood circulation may be a promising therapeutic strategy for DOR. [ABSTRACT FROM AUTHOR]

Behavioral activation (BA) is a beneficial and relatively cost-effective treatment option for depression. This study utilized a pragmatic randomized controlled research design to investigate whether BA, as compared with treatment as usual (TAU), led to superior treatment effects, when delivered in community mental health settings by retrained community mental health professionals. Patients with depressive disorders (n = 64) were randomly assigned to a 10-session BA (n = 31) or TAU (n = 33) group. The depressive symptoms and behavioral engagement were assessed at the baseline, post-treatment, and a six-month follow-up. Results showed that, as compared to the TAU group, the BA group had: (1) a reduction in depression severity, as evidenced by large effect sizes and greater response rates, and (2) an increase in behavioral engagement. However, the post-treatment gains were not maintained at the six-month follow-up. The implications and limitations of the study are also discussed (KCT0004098, June 27, 2019, retrospectively registered). [ABSTRACT FROM AUTHOR]

Objective: To compare the clinical effects of interactive dynamic scalp acupuncture (IDSA), simple combination therapy (SCT), and traditional scalp acupuncture (TSA) on cognitive function, depression and anxiety in patients with post-stroke cognitive impairment. Methods: A total of 660 patients with post-stroke cognitive impairment who were admitted to 3 hospitals in Shenzhen City between May 2017 and May 2020 were recruited and randomly assigned to the IDSA (218 cases), SCT (222 cases) and TSA groups (220 cases) according to a random number table. All the patients received conventional drug therapy for cerebral stroke and exercise rehabilitation training. Scalp acupuncture and computer-based cognitive training (CBCT) were performed simultaneously in the IDSA group, but separately in the morning and in the afternoon in the SCT group. The patients in the TSA group underwent scalp acupuncture only. The course of treatment was 8 weeks. Before treatment (M0), 1 (M1) and 2 months (M2) after treatment, as well as follow-up at 1 (M3) and 2 months (M4), the cognitive function of patients was assessed using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment Scale (MoCA) Scales; depression, anxiety, sleep quality, and self-care ability of patients were assessed using Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), Pittsburgh Sleep Quality Index (PSQI), and Modified Barthel Index (MBI), respectively. During this trial, all adverse events (AEs) were accurately recorded. Results: There were no significant differences in the MMSE, MoCA, HAMD, HAMA, PSQI, and MBI scores among the 3 groups at M0 (all P>0.05). In the IDSA group, the MMSE, MoCA and MBI scores from M2 to M4 were significantly higher than those in the SCT and TSA groups, while the HAMD, HAMA and PSQI scores were significantly reduced (all P<0.01). The changes of all above scores (M2-M0, M4-M0) were significantly superior to those in the SCT and TSA groups (all P<0.01, except M4-M0 of HAMD). At M2, the severity of MMSE, HAMD, HAMA, PSQI and MBI in the IDSA group was significantly lower than that in the SCT and TSA groups (all P<0.01). There was no serious AE during this trial. Conclusions: IDSA can not only significantly improve cognitive function, but also reduce depression, anxiety, which finally improves the patient's self-care ability. The effect of IDSA was significantly better than SCT and TSA. (Trial registration No. ChiCTR1900027206) [ABSTRACT FROM AUTHOR]

This randomized controlled trial tested the efficacy of a multi-session, evidence-based, lay counselor-delivered transdiagnostic therapy, the Common Elements Treatment Approach (CETA), in reducing unhealthy alcohol use and comorbidities among persons living with HIV (PLWH) in Zambia. Adult PLWH with (a) unhealthy alcohol use plus mental health or substance use comorbidities, or (b) severe unhealthy alcohol use were randomized to receive a single-session alcohol brief intervention (BI) alone or BI plus referral to CETA. Outcomes were measured at baseline and a 6-month follow-up and included Alcohol Use Disorders Identification Test (AUDIT) score (primary), depression and trauma symptoms, and other substance use (secondary). We enrolled 160 participants; 78 were randomized to BI alone and 82 to BI plus CETA. Due to COVID-19, the trial ended early before 36 participants completed. Statistically and clinically significant reductions in mean AUDIT score from baseline to 6-month follow-up were observed in both groups, however, participants assigned to BI plus CETA had significantly greater reductions compared to BI alone (− 3.2, 95% CI − 6.2 to − 0.1; Cohen's d: 0.48). The CETA effect size for AUDIT score increased in line with increasing mental health/substance use comorbidity (0 comorbidities d = 0.25; 1–2 comorbidities d = 0.36; 3+ comorbidities d = 1.6). Significant CETA treatment effects were observed for depression, trauma, and several other substances. BI plus referral to CETA was feasible and superior to BI alone for unhealthy alcohol use among adults with HIV, particularly among those with comorbidities. Findings support future effectiveness testing of CETA for HIV outcomes among PLWH with unhealthy alcohol use. Clinical Trials Number: NCT03966885 [ABSTRACT FROM AUTHOR]

Introduction: Currently, the best and simplest way that used to select the distal femoral valgus cut (DFVC) angle in total knee arthroplasty (TKA) is standing long leg radiograph. However, this kind of film is still not available in all hospitals. The purpose of this study is to compare the accuracy of different empirical DFVC angles in the restoration of the neutral mechanical alignment of the femoral component after TKA. Method: 125 patients who diagnosed primary osteoarthritic knee and underwent unilateral TKA were randomly assigned into three groups: A, B, and C, according to the use of an intramedullary guide with the DFVC angle of 4°, 5°, and 6°, respectively. At three months after surgery, anteroposterior hip-to-ankle computed tomography (CT) scanograms were evaluated. Mechanical axis angle (MAA), mechanical lateral distal femoral angle (LDFA), femoral bowing, femoral neck-shaft angle (FNSA), and outliers of femoral component position were measured and compared among three groups. Independent influencing factors for the outliers > ±3° were determined using binary logistic regression analysis. Results: Group B was older than group A. There were no significant differences of postoperative MAA, LDFA, femoral bowing, and FNSA among three groups. Outliers > ±3° of femoral component position in each group were 14.6%, 19.0%, and 16.7%, respectively (p = 0.865). When considering the outliers > ±2°, group C (35.7%) had a trend to have fewer outliers than groups A and B (41.5 and 42.9%). However, this finding was not reached the statistical significance (p = 0.778). Femoral bowing was only significantly influencing factors that related to the outliers > ±3° (p = 0.003). Conclusion: This study demonstrates that there are no significant differences in coronal femoral component alignment among using the DFVC angle of 4°, 5°, and 6°. The use of the DFVC angle of 6° had a trend to reduce the outliers. Nevertheless, femoral bowing is the crucial influencing factor for selecting the degree of DFVC angle. [ABSTRACT FROM AUTHOR]

Pivotal Response Treatment (PRT) is promising for children with Autism Spectrum Disorder (ASD), but more methodologically robust designed studies are needed. In this randomized controlled trial, forty-four children with ASD, aged 9–15 years, were randomly allocated to PRT (n = 22) or treatment-as-usual (TAU; n = 22). Measurements were obtained after 12- and 20-weeks treatment, and 2-month follow-up. PRT resulted in significant greater improvements on parent-rated social-communicative skills after 12 weeks treatment (p =.004, partial η2 = 0.22), compared to TAU. Furthermore, larger gains in PRT compared to TAU were observed on blindly rated global functioning, and parent-rated adaptive socialization skills and attention problems. Implications for clinical practice and suggestions for future research are discussed. [ABSTRACT FROM AUTHOR]

Objective: To observe the clinical effect of penetrating moxibustion on migraine without aura (MO) patients. Methods: Totally 60 MO patients from the Acupuncture Clinic of the Third Affiliated Hospital of Henan University of Chinese Medicine were collected from November 2015 to February 2017. All patients were assigned to a treatment group and a control group using a random number table, 30 cases in each group. The treatment group was treated with penetrating moxibustion, and the control group was treated with mild moxibustion, thrice a week for 4 consecutive weeks. The total effective rate, Visual Analogue Scale (VAS) scores, headache intensity, and Migraine Specific Quality of Life Questionnaire (MSQ) scores of patients after treatment were compared between the two groups. The moxibustion sensation and reaction after moxibustion were observed, and the adverse reactions were evaluated. All patients were followed up at 4 and 16 weeks after treatment. Results: The total effective rate of the treatment group was significantly higher than that of the control group (93.33% vs. 80.00%, P<0.05). The improvement of VAS scores, headache intensity, and the role restrictive and role preventive scores in MSQ in the treatment group was better than those in the control group (P<0.05). The person-time of moxibustion sensations of itching, numbness and cold as well as flushing and sweating after moxibustion in the treatment group was all significantly higher than that in the control group (P<0.01). There was no significant difference in safety evaluation between the two groups (P>0.05). Conclusions: Penetrating moxibustion can significantly relieve pain and improve quality of life of MO patients. After penetrating moxibustion, flushing and sweating of patients were obvious, and the curative effect was superior to the mild moxibustion. [ABSTRACT FROM AUTHOR]

Purpose: A randomized controlled trial was conducted to investigate whether cognitive behavioral therapy (CBT) can improve postoperative pain, knee function, and negative emotion in patients aged 70 years and older who underwent total knee arthroplasty (TKA). Methods: This study used randomized, parallel group, controlled trial to divide the included 90 patients into CBT group and usual care group. The primary outcome measure of the study was the Visual Analogue Scale (VAS) at activity. The secondary outcome measures included the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Knee Range of Motion (ROM), Oxford Knee Score (OKS), Hospital for Special Surgery Knee Rating Scale (HSS), analgesics dose, and postoperative complications. Results: 83 patients who met the criteria were randomized into CBT group and usual care group. In the SAS, score of the CBT group decreased by 4.3 points at 7th day and 8.2 at 14th day after surgery with respect to preoperative SAS score, the usual care group increased by 1.5 at 7th day and decreased 1.1 at 14th day, and tended to be similar at 3rd month after surgery. There were no significant differences at 7th and 14th day in SDS, however, score of the CBT group was 5.8 and the usual care group was 1.9 at 3rd month after surgery. No statistically significant differences in VAS at activity, ROM, OKS, HSS, analgesics frequency, and postoperative complications between two groups. Conclusions: CBT was superior to usual care group in relieving anxiety at 7th day and 14th day, and depression at 3rd month, however, CBT cannot relieve postoperative pain and improve joint function after TKA in patients aged 70 years and older. [ABSTRACT FROM AUTHOR]

Objective: To investigate the combined anti-inflammatory effect of activating blood circulation and detoxifying Chinese medicines in unstable angina (UA) patients. Methods: This study was an open-labeled, randomized controlled trial conducted in 5 centers in Beijing. A total of 154 patients were randomized into two groups at a 1:1 ratio by random numbers. Based on the conventional treatment, patients in the activating blood circulation (ABC) group were treated with Guanxin Danshen Droping Pill (冠心丹参滴丸, 0.4 g, thrice daily), and patients in the activating blood circulation and detoxifying (ABCD) group were treated with Guanxin Danshen Droping Pill (0.4 g, thrice daily) and Andrographis tablet (0.2 g, thrice daily) for 4 weeks. The primary outcome was the serum level of high sensitive C reaction protein (hs-CRP), and the secondary outcome index included the serum levels of tumor necrosis factor α (TNF-α), interleukin 6 (IL-6), soluble CD40 ligand (sCD40L), thrombomodulin (TM), the score of angina pectoris, the score of blood stasis syndrome, and the score of Chinese medicine symptoms, observed at week 0 and week 4. Results: A total of 144 patients completed the trial (ABC group, n=70; ABCD group, n=74). There were no significant differences in the clinical baseline characteristics between the two groups. When compared with the ABC group, ABCD group showed better performance in reducing the level of inflammatory factors, especially hs-CRP (P<0.05), IL-6 (P<0.01) and TNF-α (P<0.01). In term of clinical symptoms, ABCD group played a better role in improving the scores of angina pectoris and blood stasis syndrome than ABC group (all P<0.05). Conclusions: The combination of Guanxin Danshen Dropping Pill and Andrographis tablet exert significant anti-inflammatory effect on UA patients, which is superior to single Guanxin Danshen Dropping Pill. (Registration No. ChiCTR-TRC-13004072) [ABSTRACT FROM AUTHOR]