Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy : A Randomized, Controlled, 2 × 2 Factorial Trial.

BACKGROUND: An effective and safe treatment for nausea and vomiting of pregnancy (NVP) is lacking. OBJECTIVE: To assess the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in women with moderate to severe NVP. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. (ClinicalTrials.gov: NCT04401384). SETTING: 13 tertiary hospitals in mainland China from 21 June 2020 to 2 February 2022. PARTICIPANTS: 352 women in early pregnancy with moderate to severe NVP. INTERVENTION: Participants received daily active or sham acupuncture for 30 minutes and doxylamine-pyridoxine or placebo for 14 days. MEASUREMENTS: The primary outcome was the reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at the end of the intervention at day 15 relative to baseline. Secondary outcomes included quality of life, adverse events, and maternal and perinatal complications. RESULTS: No significant interaction was detected between the interventions (P = 0.69). Participants receiving acupuncture (mean difference [MD], -0.7 [95% CI, -1.3 to -0.1]), doxylamine-pyridoxine (MD, -1.0 [CI, -1.6 to -0.4]), and the combination of both (MD, -1.6 [CI, -2.2 to -0.9]) had a larger reduction in PUQE score over the treatment course than their respective control groups (sham acupuncture, placebo, and sham acupuncture plus placebo). Compared with placebo, a higher risk for births with children who were small for gestational age was observed with doxylamine-pyridoxine (odds ratio, 3.8 [CI, 1.0 to 14.1]). LIMITATION: The placebo effects of the interventions and natural regression of the disease were not evaluated. CONCLUSION: Both acupuncture and doxylamine-pyridoxine alone are efficacious for moderate and severe NVP. However, the clinical importance of this effect is uncertain because of its modest magnitude. The combination of acupuncture and doxylamine-pyridoxine may yield a potentially larger benefit than each treatment alone. PRIMARY FUNDING SOURCE: The National Key R&D Program of China and the Project of Heilongjiang Province "TouYan" Innovation Team.

Enhanced Thermoelectric Performance of CoSb3 Thin Films by Ag and Ti Co-Doping.

The Skutterudites CoSb3 material has been the focus of research for the conversion applications of waste heat to electricity due to its ability to accommodate a large variety of ions in the cages that have been proven effective in improving the thermoelectric performance. Although the co-doped CoSb3 bulk materials have attracted increasing attention and have been widely studied, co-doped CoSb3 thin films have been rarely reported. In this work, Ag and Ti were co-doped into CoSb3 thin films via a facile in situ growth method, and the influence of doping content in the thermoelectric properties was investigated. The results show that all the Ag and Ti co-doped CoSb3 thin films contain a pure well-crystallized CoSb3 phase. Compared to the un-doped thin film, the co-doped samples show simultaneous increase in the Seebeck coefficient and the electrical conductivity, leading to a distinctly enhanced power factor. The high power factor value can reach ~0.31 mWm-1K-2 at 623 K after appropriate co-doping, which is two times the value of the un-doped thin film we have been obtained. All the results show that the co-doping is efficient in optimizing the performance of the CoSb3 thin films; the key point is to control the doping element content so as to obtain high thermoelectric properties.

Association between preconception serum lipid concentrations and treatment outcomes in women with PCOS who underwent ovulation induction.

RESEARCH QUESTION: What is the association between preconception serum lipid concentrations and reproductive outcomes after ovulation induction in women with polycystic ovary syndrome (PCOS)? DESIGN: A secondary analysis of a randomized controlled trial with 1000 PCOS women undergoing ovulation induction with clomiphene with or without acupuncture. Preconception serum total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB) were measured. Outcomes were ovulation, conception, pregnancy, live birth and miscarriage. Logistic regression was used to calculate odds ratios (OR) with 95% confidence intervals (CI). RESULTS: In total, 780 women ovulated; 320 women achieved conception, 218 had a clinical pregnancy, 205 had a live birth and 115 had a miscarriage. Serum lipid concentrations per one unit increment were independently associated with reproductive outcomes after controlling for confounders. Increasing LDL-C (OR 0.79, 95% CI 0.63-0.99) was independently associated with a lower chance of ovulation. Increasing total cholesterol (OR 0.76, 95% CI 0.62-0.92), LDL-C (OR 0.73, 95% CI 0.57-0.93), triglycerides (OR 0.74, 95% CI 0.58-0.95) and ApoB (OR 0.34, 95% CI 0.16-0.74) were independently associated with a lower chance of clinical pregnancy. Increased total cholesterol (OR 0.78, 95% CI 0.64-0.96), LDL-C (OR 0.77, 95% CI 0.60-0.99), triglycerides (OR 0.76, 95% CI 0.59-0.96) and ApoB (OR 0.39, 95% CI 0.18-0.86) were independently associated with a lower chance of live birth. Furthermore, increased total cholesterol (OR 1.43, 95% CI 1.06-1.93), LDL-C (OR 1.51, 95% CI 1.04-2.19) and ApoB (OR 3.82, 95% CI 1.17-12.41) were independently associated with a higher chance of miscarriage. CONCLUSIONS: Increased serum lipids were negatively associated with the reproductive outcomes of PCOS women undergoing ovulation induction with clomiphene with or without acupuncture.

Crystal Growth Promotion and Defect Passivation by Hydrothermal and Selenized Deposition for Substrate-Structured Antimony Selenosulfide Solar Cells.

Antimony sulfide-selenide (Sb2(S,Se)3) is a promising light-harvesting material for stable and high-efficiency thin-film photovoltaics (PV) because of its excellent light-harvesting capability, abundant elemental storage, and excellent stability. This study aimed to expand the application of Sb2(S,Se)3 solar cells with a substrate structure as a flexible or tandem device. The use of a hydrothermal method accompanied by a postselenization process for the deposition of Sb2(S,Se)3 film based on the solar cell substrate structure was first demonstrated. The mechanism of postselenization treatment on crystal growth promotion of the Sb2(S,Se)3 film and the defect passivation of the Sb2(S,Se)3 solar cell were revealed through different characterization methods. The crystallinity and the carrier transport property of the Sb2(S,Se)3 film improved, and both the interface defect density of the Sb2(S,Se)3/CdS interface and the bulk defect density of the Sb2(S,Se)3 absorber decreased. Through these above-mentioned processes, the transport and collection of electronics can be improved, and the defect recombination loss can be reduced. By using postselenization treatment to optimize the absorber layer, Sb2(S,Se)3 solar cells with the configuration SLG/Mo/Sb2(S,Se)3/CdS/ITO/Ag achieved an efficiency of 4.05%. This work can provide valuable information for the further development and improvement of Sb2(S,Se)3 solar cells.

Enhanced Recovery After Surgery protocol for elderly gastric cancer patients: A prospective study for safety and efficacy.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) has been used to improve surgical outcomes in recent years. However, its safety and efficacy in elderly patients with gastric cancer remain unclear. The aim of this study was to reveal the safety and efficacy of the ERAS protocol in elderly patients with gastric cancer. METHODS: Elderly gastric cancer patients (age≥70 years) who underwent gastrectomy were divided into the ERAS group and the conventional group. Postoperative complications, postoperative hospital stay, hospitalization expenses, and readmission rates were compared between the two groups. RESULTS: From December 2019 to January 2021, 100 eligible patients were enrolled in our study. All baseline data were balanced between the ERAS group and the conventional group. There was no significant difference in terms of complications (18% vs. 16%, P = 0.14) between the two groups. The most common complication was pneumonia. Four patients were observed in the conventional group and three patients in the ERAS group. The postoperative hospital stay was shorter in the ERAS group (8.2 vs. 10.4, P = 0.001). CONCLUSIONS: The ERAS protocol could be safely used in elderly gastric cancer patients undergoing gastrectomy and shorten postoperative hospital stay.

Organic Chloride Salt Interfacial Modified Crystallization for Efficient Antimony Selenosulfide Solar Cells.

Antimony selenosulfide, Sb2(SSe)3, is recognized as an excellent photoactive material owing to its light harvesting capability. There is still room for improvement of the film quality for device performance improvement. Herein, an organic chloride salt [diethylamine hydrochloride, DEA(Cl)] has been introduced for fabricating Sb2(SSe)3 solar cells for the first time. A champion device with a power conversion efficiency (PCE) of 9.17% has been achieved with a relatively improved fill factor and open-circuit voltage (VOC). It has been revealed that DEA(Cl) successfully interacts with Sb2(SSe)3, which can facilitate the crystallization process to give rise to the closely packed bigger grain sizes with reduced surface cracks; it successfully suppressed the oxidized Sb species (Sb2O3) in the Sb2(SSe)3 film to give rise to phase purity, thus leading to superior surface morphology and electrical characteristics of DEA(Cl)-modified Sb2(SSe)3 absorber films. Chloride modification is thus efficiently helpful in suppressing interfacial defects, improving junction quality, and optimizing energy-level alignment. This facile interfacial modification demonstrates the remarkable potential for efficient Sb2(SSe)3 solar cells.

p66Shc-mediated oxidative stress is involved in gestational diabetes mellitus.

BACKGROUND: Gestational diabetes mellitus (GDM) is associated with a heightened level of oxidative stress, which is characterized by the overproduction of reactive oxygen species (ROS) from mitochondria. Previous studies showed that mitochondrial dysfunction is regulated by dynamin-related protein 1 (Drp1) and p66Shc in GDM. AIM: The aim was to investigate the expression of Drp1 and p66Shc and their possible mechanisms in the pathogenesis of GDM. METHODS: A total of 30 pregnant women, 15 with GDM and 15 without GDM, were enrolled. Peripheral blood mononuclear cells and placental tissue were collected. The human JEG3 trophoblast cell line was cultivated in 5.5 mmol/L or 30 mmol/L glucose and transfected with wild-type (wt)-p66Shc and p66Shc siRNA. P66Shc and Drp1 mRNA levels were detected by quantitative real-time polymerase chain reaction. The expression of p66Shc and Drp1 was assayed by immunohistochemistry and western blotting. ROS was assayed by dihydroethidium staining. RESULTS: The p66Shc mRNA level was increased in the serum (P < 0.01) and placentas (P < 0.01) of women with GDM, and the expression of Drp1 mRNA and protein were also increased in placentas (P < 0.05). In JEG3 cells treated with 30 mmol/L glucose, the mRNA and protein expression of p66Shc and Drp1 were increased at 24 h (both P < 0.05), 48 h (both P < 0.01) and 72 h (both P < 0.001). ROS expression was also increased. High levels of Drp1 and ROS expression were detected in JEG3 cells transfected with wt-p66Shc (P < 0.01), and low levels were detected in JEG3 cells transfected with p66Shc siRNA (P < 0.05). CONCLUSION: The upregulated expression of Drp1 and p66shc may contribute to the occurrence and development of GDM. Regulation of the mitochondrial fusion-fission balance could be a novel strategy for GDM treatment.

Associations of Serum Magnesium With Insulin Resistance and Testosterone in Women With Polycystic Ovary Syndrome.

Objective: This article aimed to investigate whether serum magnesium is associated with insulin resistance index and testosterone level in women with polycystic ovary syndrome (PCOS). Materials and Methods: Overall 1000 women with PCOS were enrolled in a randomized controlled trial and a cross-sectional analysis of the association of serum magnesium with glucose metabolism markers and testosterone was performed. Serum magnesium, glucose metabolism markers and testosterone were measured. Insulin resistance was evaluated by homeostatic model assessment of insulin resistance (HOMA-IR) and quantitative insulin-sensitivity check index (QUICKI). Multivariable linear regression and logistic regression models were used to estimate the association between serum magnesium, insulin resistance and testosterone. Results: In comparative analyses, women with higher quartile of serum magnesium had significantly lower fasting glucose, HOMA-IR and testosterone. Multiple linear regression showed serum magnesium was independently negatively associated with insulin, glucose, HOMA-IR, testosterone and positively associated with QUICKI (P for trend <0.05) after adjusting confounding covariates. Logistic regression showed serum magnesium in quartile 1 and 2 were independently associated with insulin resistance status (Quartile 1: OR: 2.15, 95%CI: 1.35-3.40, P = 0.001; Quartile 2: OR: 1.90, 95%CI: 1.20-3.02, P = 0.006), while quartile 1 was marginally associated with hyperandrogenemia status (Quartile 1: OR: 1.45, 95%CI: 0.99-2.11, P = 0.055) after adjusting confounding covariates. Conclusion: The current findings suggest that lower serum magnesium was associated with aggravated insulin resistance and higher testosterone levels among women with PCOS.

Decreased Sex Hormone-Binding Globulin Indicated Worse Biometric, Lipid, Liver, and Renal Function Parameters in Women with Polycystic Ovary Syndrome.

OBJECTIVE: To investigate the relationships between sex hormone-binding globulin (SHBG) and comprehensive metabolic parameters including biometric, glycemic, lipid, liver, and renal functions of women with polycystic ovary syndrome (PCOS). Study Design and Methods. A total of 1000 women diagnosed as PCOS by modified Rotterdam criteria were enrolled in a randomized controlled trial. SHBG and comprehensive metabolic parameters were measured at the baseline visit. Metabolic parameters included biometric parameters, glucose and lipid panels, and liver and renal function parameters. An independent t-test and linear regression were performed to investigate the associations between SHBG and metabolic parameters. Logistic regression was used to detect the relationship between SHBG and the presence of metabolic syndrome. RESULTS: In comparative analyses, PCOS women with lower SHBG levels had higher body mass index, waist circumference, insulin, homeostatic model assessment-insulin resistance (HOMA-IR) index, systolic and diastolic blood pressure, triglycerides, apolipoprotein B (APOB), low-density lipoprotein (LDL), aspartate transferase (AST), alanine transferase (ALT), and blood urea nitrogen (BUN), but lower high-density lipoprotein (HDL) and apolipoprotein A1 (APOA1). In linear regression, SHBG was inversely associated with waist circumference, systolic blood pressure, triglyceride, LDL, APOB, ALT, AST, and BUN but positively associated with HDL and APOA1 after adjusting the BMI. In logistic regression, SHBG is a protective predictor for metabolic syndrome (odds ratio = 0.96; 95% confidence interval: 0.95-0.97). The area under the receiver-operator characteristic curve is 0.732 with a 95% confidence interval of 0.695-0.770. SHBG <26.75 mmol/L is the cutoff point with the best Youden index, which has a sensitivity of 0.656 and specificity of 0.698. CONCLUSIONS: Lower SHBG was associated with worsening biometric, lipid, liver, and renal functions but not glycemic parameters among women with PCOS. SHBG can be used as a tool to screen metabolic syndrome. This trial is registered with NCT01573858 and ChiCTR-TRC-12002081.

Lateral ventricular volume and calcarine sulcus depth: a fetal MRI analysis of mild ventriculomegaly: A STROBE compliant article.

The aim of this study was to quantify changes in the lateral ventricular volume, the depth of the calcarine sulcus (CS), and apparent diffusion coefficient (ADC) values of occipital lobe in fetuses with isolated mild ventriculomegaly (IMVM) using MRI.Seventy-one fetuses with IMVM at 25 to 38 weeks gestational age (GA) and 58 fetuses with normal lateral ventricles at 25 to 38 weeks GA were enrolled. Volumes of the lateral ventricles were measured by 3D magnetic resonance hydrography. Depths of the CS and ADC values were also evaluated. All differences were tested by t test. Bivariate correlations were performed using Pearson method.Fetuses with IMVM had significantly larger lateral ventricular volumes and smaller CS depths than controls (volumes: 9.37 ±â€Š2.20 mL vs 5.04 ±â€Š1.33 mL, respectively, P < .001; depths: 8.27 ±â€Š2.55 mm vs 10.30 ±â€Š3.14 mm, respectively, P < .001). In IMVM cases, the CS depths were smaller on the side with the larger ventricle (8.10 ±â€Š2.54 mm vs 9.59 ±â€Š2.81 mm, P < .001). No differences were observed in occipital lobe ADC values between the2 groups (IMVM = 1.80 ±â€Š0.24 µm/ms; controls = 1.78 ±â€Š0.28 µm/ms, P > .05).Fetuses with IMVM had larger lateral ventricular volumes, shallower CS depths, but normal occipital lobe ADC values.

Volume growth trend and correlation of atrial diameter with lateral ventricular volume in normal fetus and fetus with ventriculomegaly: A STROBE compliant article.

To explore the growth trend of fetal lateral ventricular volume, for understanding the relationship between atrial diameter (AD) and volume in normal fetus and fetus with ventriculomegaly.Overall, 97 sequential fetal head magnetic resonance imaging scans were performed; these pertained to 50 fetuses with normal lateral ventricles [normal group; gestational age (GA): 24-38 weeks] and 47 fetuses with ventriculomegaly (VM) (VM group; GA: 24-37 weeks). The left, right, and total lateral ventricular volume were measured using 3-dimensional magnetic resonance hydrography (MRH). Correlation coefficient (r) was calculated to assess the relationships of measurements. Lineal regression analysis was used to assess correlation of AD and GA with volume. Between-group differences in terms of AD and volume were assessed using t test.Significant linear growth was observed in the total lateral ventricular volume compared with GA in the normal group with a relative growth rate of 2.87% per week (P <.001). Significant linear relationship between AD and volume was observed, and a significant equation was acquired in the normal group and VM groups, respectively, using the simple linear regression model: left volume = 0.438 * normal left diameter (NLD) + 1.359; right volume = 0.493 * normal right diameter (NRD) + 1.012; left volume = 0.959 * left diameter in VM (VLD) - 2.074; right volume = 0.799 * right diameter in VM (VRD) - 0.443. A significant equation was obtained in the normal group and the VM group, using the multiple linear regression model: Total volume (mL) = 0.396 * NLD + 0.410 * NRD + 3.101; and total volume = 0.989 * VLD + 0.834 * VRD - 3.141, respectively. In terms of AD and volume, the left lateral ventricle was significantly larger than the right side in both groups. The volume of lateral ventricle in AD ≥10 mm group was larger than that in the AD <10 mm group. The total volume in the VM group was significantly larger than that in the normal group.The total lateral ventricular volume increased with GA. AD can be used to evaluate the fetal ventricular volume.

[Comparison of Prenatal Diagnostic Value between Fast Imaging Employing Steady State Acquisition and Single Shot Fast Spin Echo Sequence in Diagnosis of Placental Invasion].

Objective To compare the prenatal diagnostic value and image quality of magnetic resonance imaging(MRI)with fast imaging employing steady state acquisition(FIESTA)or single shot fast spin echo(SSFSE)sequence,in order to provide references for sequence selection of prenatal diagnosis.Methods The MRI data of 121 patients with suspected placental invasion were retrospectively analyzed. The ability of FIESTA in displaying MRI signs associated with placental invasion and its image quality were assessed and compared with SSFSE. Based on the records of cesarean section and pathological finding,the sensitivity,specificity,positive predictive values,and negative predictive values of these two sequences were calculated.Results The image quality was significantly higher in FIESTA than in SSFSE(χ 2=29.74,P=0.000). FIESTA had significantly higher ability to display focal interruptions in the myometrial wall than SSFSE(χ 2=6.750,P=0.006);in addition,the ability to display abnormal vessel in the placenta(χ 2=8.471,P=0.020),placental heterogeneity(χ 2=13.885,P=0.000),hypointense intraplacental bands(χ 2=4.267,P=0.035)were also significantly higher in SSFSE than in FIESTA,while the efficiency for displaying uterine bulging(χ 2=0.250,P=0.625),uterine recess(χ 2=0.167,P=0.687),uterine penetration and parametrium implantation(χ 2=0.800,P=0.375),and protrusion of the placenta into the cervix(χ 2=0.081,P=0.776)were not significantly different between these two sequences. Both sequences had a specificity of 100% in displaying uterine penetration and parametrium implantation,uterine recess,and protrusion of the placenta into the cervix. Conclusions FIESTA has better ability in displaying the contour and demarcation of placenta and uterine,whereas SSFSE is more efficient in displaying the changes of intraplacental signals. FIESTA can be used to observe the relationship between the placenta and the surrounding structures and whether the surrounding tissue is implanted,and the changes of placental signals can be observed in SSFSE. The combination of these two sequences can improve the prenatal diagnosis of placenta invasion.

Acupuncture and clomiphene for Chinese women with polycystic ovary syndrome (PCOSAct): statistical analysis approach with the revision and explanation.

BACKGROUND: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women. Clomiphene is regarded as the first-line medical treatment for ovulation induction in PCOS patients and acupuncture is often used as an alternative and complementary treatment for fertility issues such as those associated with PCOS. The efficacy of acupuncture alone or combined with clomiphene still lacks strong supporting evidence. Factorial 2 × 2 designs can be used for the evaluations of two treatments within a single study, to test the main effects of acupuncture and clomiphene and their interactions. METHODS: PCOSAct was designed to test the effect of clomiphene and acupuncture by three two-group comparisons in the original protocol. However, the trial was designed as a standard factorial trial and the factorial analysis approach for analyzing the data that were actually obtained during the trial was found to be more appropriate and more powerful than the three two-group comparisons described in the original protocol, so the statistical analysis approach and different datasets of PCOSAct in the primary publication were accordingly changed. DISCUSSION: Although the statistical analysis approach used in the primary publication deviated from the statistical analysis planned in the study protocol, focusing on the main effects of the two interventions and their interactions was a more standard approach to a factorial trial and proved to be more suitable and consistent with the characteristics of the trial data. Statistically, the revision is more powerful and precise and should be more useful to the journal and the readers. TRIAL REGISTRATION: Chinese clinical trial registry, ChiCTR-TRC-12002081 . Registered on 20 March 2012. Clinicaltrials.gov, NCT01573858 . Registered on 4 April 2012.

High-performance p-type inorganic-organic hybrid thermoelectric thin films.

The performance of organic-inorganic hybrid thermoelectric thin films can be dramatically enhanced by optimizing energy filtering and carrier transport states at the organic-inorganic interfaces. In this work, p-type "Sb2Te3/CH3NH3I/Sb2Te3" multilayer thin films were firstly fabricated with varied contents of CH3NH3I, and then an annealing process was used in order to form homogeneous organic-inorganic hybrid thin films. The results revealed that the introduced organic component can promote thin film growth and develop a dense nanostructure with improved crystallinity, thus resulting in a significantly increased Seebeck coefficient and a reduced thermal conductivity as a result of the optimized electronic transport characteristics and enhanced effects of phonon scattering. As is expected, the thermoelectric performance of the hybrid-nanocomposite films is enhanced, achieving the maximum ZT value of 1.55 at a temperature of 413 K, which is several times higher than that of the as-fabricated film, thereby suggesting that the proposed strategy can be applied as an efficient method for the preparation of high-performance thermoelectric thin films.

Study on the growth of Al-doped ZnO thin films with (112̄0) and (0002) preferential orientations and their thermoelectric characteristics.

In this work, using a conventional magnetron sputtering system, Al-doped ZnO (AZO) films with (112̄0) and (0002) preferential orientations were grown on r-sapphire and a-sapphire substrates, respectively. The effect of substrate and deposition temperature on the growth of AZO films and their preferential orientations were investigated. The crystallographic characteristics of AZO films were characterized by X-ray diffraction (XRD). The surface morphology of AZO films was studied by scanning electron microscopy (SEM) and atomic force microscopy (AFM). It is found that the lattice mismatch between AZO and substrate determines the growth of AZO films and their preferential orientations. The thermoelectric properties are strongly dependent on the crystal grain shape and the grain boundaries induced by the preferred orientation. The highly connected and elongated grains lead to high thermoelectric properties. The in-plane anisotropy performances of thermoelectric characteristics were found in the (112̄0) preferential oriented ZnO films. The in-plane power factor of the (112̄0) preferential oriented ZnO films in the [0001] direction was more than 1.5 × 10-3 W m-1 K-2 at 573 K, which is larger than that of the (0002) preferential oriented ZnO films.

Lateral ventricular volume measurement by 3D MR hydrography in fetal ventriculomegaly and normal lateral ventricles.

BACKGROUND: In fetuses with prenatal ventriculomegaly (VM), ventricular volume on MRI has been shown to correlate with poor postnatal outcomes and in utero death. 3D magnetic resonance hydrography (MRH) has been widely used for MR cholangiopancreatography. PURPOSE: To investigate the reliability of 3D MRH for lateral ventricular volume measurement in fetuses with VM and normal lateral ventricles, using manual multisection planimetry (MSP) as a reference standard. STUDY TYPE: Prospective study. POPULATION: Thirty-five fetuses with VM at 24-37 gestational weeks (GA) and 35 fetuses with normal lateral ventricles at 24-38 GA. FIELD STRENGTH/SEQUENCE: 1.5T MRI with 3D MRH and T2 -weighted single-shot fast-spin echo sequence. ASSESSMENT: Left, right, and total lateral ventricle volumes in fetuses were acquired from 3D MRH and manual MSP. All image analysis was performed by a radiologist twice and another radiologist once, blindly. STATISTICAL TESTS: Analysis of linear regression analysis, Pearson's correlation coefficient, Bland-Altman plots, intraclass correlation coefficient (ICC), and independent samples t-test were used for statistical analyses. RESULTS: There were highly significant relationships between all 3D MRH and manual MSP measurements of lateral ventricular volumes (rVM = 0.92-0.98; rN = 0.95-0.98; all P < 0.0001; VM: VM group, N: normal group), although left, right, and total lateral ventricular volumes measured by 3D MRH tended to be slightly larger than MSP (biasVM 0.1 ± 0.95, 0.26 ± 0.63, and 0.3 ± 0.68 mL, respectively; biasN 0.1 ± 0.95, 0.26 ± 0.63, and 0.3 ± 0.68 mL, respectively). Interrater agreement and intrarater repeatability were also excellent for 3D MRH (ICCVM = 0.994-0.99, ICCN = 0.989-0.992; ICCVM = 0.975-0.987, ICCN = 0.958-0.971, respectively). 3D MRH showed significantly reduced measurement time (VM: 3.55 ± 0.42 vs. 11.81 ± 0.13 min; N: 3.08 ± 0.39 vs. 12.12 ± 0.11 min; all P < 0.0001). DATA CONCLUSION: Lateral ventricular volume measurement by 3D MRH was comparable to manual MSP. LEVEL OF EVIDENCE: 1 Technical Efficacy Stage 1 J. Magn. Reson. Imaging 2017.

Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial.

Importance: Acupuncture is used to induce ovulation in some women with polycystic ovary syndrome, without supporting clinical evidence. Objective: To assess whether active acupuncture, either alone or combined with clomiphene, increases the likelihood of live births among women with polycystic ovary syndrome. Design, Setting, and Participants: A double-blind (clomiphene vs placebo), single-blind (active vs control acupuncture) factorial trial was conducted at 21 sites (27 hospitals) in mainland China between July 6, 2012, and November 18, 2014, with 10 months of pregnancy follow-up until October 7, 2015. Chinese women with polycystic ovary syndrome were randomized in a 1:1:1:1 ratio to 4 groups. Interventions: Active or control acupuncture administered twice a week for 30 minutes per treatment and clomiphene or placebo administered for 5 days per cycle, for up to 4 cycles. The active acupuncture group received deep needle insertion with combined manual and low-frequency electrical stimulation; the control acupuncture group received superficial needle insertion, no manual stimulation, and mock electricity. Main Outcomes and Measures: The primary outcome was live birth. Secondary outcomes included adverse events. Results: Among the 1000 randomized women (mean [SD] age, 27.9 [3.3] years; mean [SD] body mass index, 24.2 [4.3]), 250 were randomized to each group; a total of 926 women (92.6%) completed the trial. Live births occurred in 69 of 235 women (29.4%) in the active acupuncture plus clomiphene group, 66 of 236 (28.0%) in the control acupuncture plus clomiphene group, 31 of 223 (13.9%) in the active acupuncture plus placebo group, and 39 of 232 (16.8%) in the control acupuncture plus placebo group. There was no significant interaction between active acupuncture and clomiphene (P = .39), so main effects were evaluated. The live birth rate was significantly higher in the women treated with clomiphene than with placebo (135 of 471 [28.7%] vs 70 of 455 [15.4%], respectively; difference, 13.3%; 95% CI, 8.0% to 18.5%) and not significantly different between women treated with active vs control acupuncture (100 of 458 [21.8%] vs 105 of 468 [22.4%], respectively; difference, -0.6%; 95% CI, -5.9% to 4.7%). Diarrhea and bruising were more common in patients receiving active acupuncture than control acupuncture (diarrhea: 25 of 500 [5.0%] vs 8 of 500 [1.6%], respectively; difference, 3.4%; 95% CI, 1.2% to 5.6%; bruising: 37 of 500 [7.4%] vs 9 of 500 [1.8%], respectively; difference, 5.6%; 95% CI, 3.0% to 8.2%). Conclusions and Relevance: Among Chinese women with polycystic ovary syndrome, the use of acupuncture with or without clomiphene, compared with control acupuncture and placebo, did not increase live births. This finding does not support acupuncture as an infertility treatment in such women. Trial Registration: clinicaltrials.gov Identifier: NCT01573858.

The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial.

BACKGROUND: Although Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP). METHODS: The trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting. We specified detailed methods for data management and statistical analyses. Statistics in corresponding tables, listings, and graphs were outlined. DISCUSSION: The SAP provided more detailed information than trial protocol on data management and statistical analysis methods. Any post hoc analyses could be identified via referring to this SAP, and the possible selection bias and performance bias will be reduced in the trial. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov, NCT01138930 , registered on 7 June 2010.

[Body acupuncture combined with auricular acupressure for menstrual headache: a randomized controlled clinical trial].

OBJECTIVE: To observe the therapeutic effect of body acupuncture combined with auricular acupressure for treatment of menstrual headache of hyperactivity of "liver fire". METHODS: A total of 85 menstrual headache patients with hyperactivity of "liver-fire" were randomly divided into control group (n = 42) and treatment group (n = 43). Patients of the control group were treated by oral administration of Flunarizine Hydrochloride Capsules (Sibelium, 5 mg/time, twice daily) for 5 days beginning at the headache attack in the first menstrual cycle, and for two weeks (except weekends) in the second and third menstrual cycles. Patients of the treatment group were treated by manual acupuncture stimulation of body acupoints Baihui (GV 20), Fengchi (GB 20), Sanyinjiao (SP 6), Taichong (LR 3), Xiaxi (GB 43), Taiyang (EX-HN 5), Hanyan (GB 4), Xuanlu (GB 5) and Shuaigu (GB 8) beginning from the headache attack, and otopoint-pellet pressure of otopoints unilateral Endocrine, Ovaries, Shenmen, Cortex, Liver, Spleen and Kidney (beginning 5 days before menstrual onset) and bilateral Shenmen, Nie, Liver, Gallbladder, Subcortex and Jiaogan during headache attack. Clinical symptom scores were assessed according to the "Guiding Principles for Clinical Research on New Chinese Herbal Drugs" issued by the Chinese Ministry of Health. RESULTS: After the treatment, of the 42 and 43 cases in the control and treatment groups, 9 (21.43%) and 20 (46.51%) were cured, 12 (28.57%) and 14 (32.56%) had a marked improvement, 13 (30.95%) and 7 (16.28%) were effective, 8 (19.05%) and 2 (4.65%) invalid, with the effective rates being 80.95% and 95.35% , respectively. The curative effect of the treatment group was significantly better than that of the control group (P<0.05). The symptom score and VAS score after the treatment and 3 months post-treatment in the treatment group were significantly lower than those of the control group (P<0.01). The headache scores and VAS scores were significantly reduced following the treatment and 3 months after the treatment in both control and treatment groups (P<0.01). After the treatment for 2-3 therapeutic courses, the headache attack duration during menstruation was markedly and gradually shortened in both groups (P<0.01), and therapeutic effect of the treatment group was significantly better than that of the control group (P<0.01). CONCLUSION: Body acupuncture combined with auricular acupressure treatment can effectively relieve menstrual headache in menstrual women with hyperactivity of "liver fire".