Immunogenicity of Fractional-Dose Vaccine during a Yellow Fever Outbreak - Final Report.

BACKGROUND: In 2016, the response to a yellow fever outbreak in Angola and the Democratic Republic of Congo led to a global shortage of yellow fever vaccine. As a result, a fractional dose of the 17DD yellow fever vaccine (containing one fifth [0.1 ml] of the standard dose) was offered to 7.6 million children 2 years of age or older and nonpregnant adults in a preemptive campaign in Kinshasa. The goal of this study was to assess the immune response to the fractional dose in a large-scale campaign. METHODS: We recruited participants in four age strata at six vaccination sites. We assessed neutralizing antibody titers against yellow fever virus in blood samples obtained before vaccination and at 1 month and 1 year after vaccination, using a plaque reduction neutralization test with a 50% cutoff (PRNT50). Participants with a PRNT50 titer of 10 or higher were considered to be seropositive. Those with a baseline titer of less than 10 who became seropositive at follow-up were classified as having undergone seroconversion. Participants who were seropositive at baseline and who had an increase in the titer by a factor of 4 or more at follow-up were classified as having an immune response. RESULTS: Among 716 participants who completed the 1-month follow-up, 705 (98%; 95% confidence interval [CI], 97 to 99) were seropositive after vaccination. Among 493 participants who were seronegative at baseline, 482 (98%; 95% CI, 96 to 99) underwent seroconversion. Among 223 participants who were seropositive at baseline, 148 (66%; 95% CI, 60 to 72) had an immune response. Lower baseline titers were associated with a higher probability of having an immune response (P<0.001). Among 684 participants who completed the 1-year follow-up, 666 (97%; 95% CI, 96 to 98) were seropositive for yellow fever antibody. The distribution of titers among the participants who were seronegative for yellow fever antibody at baseline varied significantly among age groups at 1 month and at 1 year (P<0.001 for both comparisons). CONCLUSIONS: A fractional dose of the 17DD yellow fever vaccine was effective at inducing seroconversion in participants who were seronegative at baseline. Titers remained above the threshold for seropositivity at 1 year after vaccination in nearly all participants who were seropositive at 1 month after vaccination. These findings support the use of fractional-dose vaccination for outbreak control. (Funded by the U.S. Agency for International Development and the Centers for Disease Control and Prevention.).

Yellow Fever Outbreak - Kongo Central Province, Democratic Republic of the Congo, August 2016.

On April 23, 2016, the Democratic Republic of the Congo's (DRC's) Ministry of Health declared a yellow fever outbreak. As of May 24, 2016, approximately 90% of suspected yellow fever cases (n = 459) and deaths (45) were reported in a single province, Kongo Central Province, that borders Angola, where a large yellow fever outbreak had begun in December 2015. Two yellow fever mass vaccination campaigns were conducted in Kongo Central Province during May 25-June 7, 2016 and August 17-28, 2016. In June 2016, the DRC Ministry of Health requested assistance from CDC to control the outbreak. As of August 18, 2016, a total of 410 suspected yellow fever cases and 42 deaths were reported in Kongo Central Province. Thirty seven of the 393 specimens tested in the laboratory were confirmed as positive for yellow fever virus (local outbreak threshold is one laboratory-confirmed case of yellow fever). Although not well-documented for this outbreak, malaria, viral hepatitis, and typhoid fever are common differential diagnoses among suspected yellow fever cases in this region. Other possible diagnoses include Zika, West Nile, or dengue viruses; however, no laboratory-confirmed cases of these viruses were reported. Thirty five of the 37 cases of yellow fever were imported from Angola. Two-thirds of confirmed cases occurred in persons who crossed the DRC-Angola border at one market city on the DRC side, where ≤40,000 travelers cross the border each week on market day. Strategies to improve coordination between health surveillance and cross-border trade activities at land borders and to enhance laboratory and case-based surveillance and health border screening capacity are needed to prevent and control future yellow fever outbreaks.

Application of a broadly tunable SG-DBR QCL for multi-species trace gas spectroscopy.

Feasibility of using a mid-Infrared tunable sampled-grating distributed Bragg reflectors quantum cascade laser for high resolution multicomponent trace gas spectroscopy is demonstrated. By controlling the driving currents to the front and back sections of the laser, we were able to tune a pulsed 4.55 µm laser over a frequency range a of 30 cm(-1) with high resolution, accuracy and repeatability. The laser was applied to absorption spectroscopy of ambient and reduced pressure (150 Torr) air in a 205 meters multi-pass Herriott cell, and by using standard LSQ fitting to a spectral database of these trace gases (HITRAN), the concentrations of nitrous oxide, carbon monoxide, and water vapor were retrieved.

New nano-complexes targeting protein 3S7S in breast cancer and protein 4OO6 in liver cancer investigated in cell line.

Cancer, a lethal ailment, possesses a multitude of therapeutic alternatives to combat its presence, metal complexes have emerged as significant classes of medicinal compounds, exhibiting considerable biological efficacy, especially as anticancer agents. The utilization of cis-platin in the treatment of various cancer types, including breast cancer, has served as inspiration to devise novel nanostructured metal complexes for breast cancer therapy. Notably, homo- and hetero-octahedral bimetallic complexes of an innovative multifunctional ether ligand (comprising Mn(II), Ni(II), Cu(II), Zn(II), Hg(II), and Ag(I) ions) have been synthesized. To ascertain their structural characteristics, elemental and spectral analyses, encompassing IR, UV-Vis, 1H-NMR, mass and electron spin resonance (ESR) spectra, magnetic moments, molar conductance, thermal analysis, and electron microscopy, were employed. The molar conductance of these complexes in DMF demonstrated a non-electrolytic nature. Nanostructured forms of the complexes were identified through electron microscopic data. At ambient temperature, the ESR spectra of the solid complexes exhibited anisotropic and isotropic variants, indicative of covalent bonding. The ligand and several of its metal complexes were subjected to cytotoxicity testing against breast cancer protein 3S7S and liver cancer protein 4OO6, with the Ag(I) complex (7) evincing the most potent effect, followed by the Cu(II) with ligand (complex (2)), Cis-platin, the ligand itself, and the Cu(II)/Zn(II) complex (8). Molecular docking data unveiled the inhibitory order of several complexes.

Immunohistochemistry of Leukemia Inhibitory Factor and Integrin αVß3 in Mouse Endometrium Following Kisspeptin-54 Ovulation Trigger.

Kisspeptin (KP) is a group of hypothalamic neuropeptides encoded by KISS-1 gene. KP-54, a 54-amino-acid peptide, helps regulate the hypothalamic-pituitary-ovarian axis and plays a potential role in implantation. C57BL/6 J female mice were superovulated via intraperitoneal injection of 5 International Units (IU) pregnant mare serum gonadotrophin (day 1). Forty-eight hours later, mice (5/group) were injected with phosphate-buffered saline (PBS) (group A), 5 IU human chorionic gonadotrophin (hCG) (group B), or 3 nmol KP-54 (group C). On day 7, mice were euthanized and uteri excised to create paraformaldehyde-fixed paraffin-embedded sections that were immunostained for the implantation markers: leukemia inhibitory factor (LIF) and integrin αVß3 (ITG αVß3). Slides were scored for intensity of staining in endometrial glandular epithelium (GE) and stromal cells (SCs) via histoscore (H-score). Data were analyzed using the Kruskal-Wallis test followed by the Mann-Whitney U test for pairwise comparisons. LIF expression was significantly higher in GE and SCs of mice triggered with KP-54 compared to placebo (P = .009 for both), but only higher than hCG trigger group in SCs (P = .009). Meanwhile, ITG αVß3 expression was significantly higher in SCs of mice triggered with KP-54 compared to placebo (P = .028). In conclusion, using KP-54 as an ovulation trigger resulted in higher expression of the implantation markers LIF and ITG αVß3 in mice endometrium compared to hCG or placebo. This suggests a potential role for KP-54 trigger in improving embryo implantation in clinical IVF. However, further studies are needed to correlate these results with clinical implantation rates and pregnancy outcomes.

Receptor activator of nuclear factor kappa B ligand serum and synovial fluid level. A comparative study between rheumatoid arthritis and osteoarthritis.

To assess the levels of receptor activator of NF-κB ligand (RANKL) in serum and synovial fluid (SF) of patients with rheumatoid arthritis (RA) and osteoarthritis (OA) and to correlate its levels with disease activity and severity. Serum and SF levels of RANKL were measured in 24 patients with RA (Group I) and 20 patients with OA (Group II); patients were selected according to the ACR criteria, and serum RANKL was measured in 13 healthy controls. All patients were subjected to full rheumatological assessment. In RA group, serum level of RANKL was significantly higher than control group (P = 0.01), but not correlated with disease activity and severity parameters apart from number of tender joints (P = 0.03). SF level of RANKL was significantly correlated with disease duration (P = 0.02), number of tender (P = 0.002) and swollen joints (P = 003), ESR (P = 0.01), CRP (P = 0.000), DAS-28 (P = 0.004), and SENS (P = 0.03). In patients with OA, serum level of RANKL was significantly higher than the control group (P < 0.001), and it was statistically insignificant with clinical, laboratory, or radiological data, while SF level of RANKL was statistically significantly higher in patients with Heberden and Bouchard nodes (P = 0.007), Kellgren-Lawrence score (P = 0.002), and with the erosive changes of hands (P = 0.006). The mean serum RANKL in RA group was insignificant with that of total OA group. SF level of RANKL was significantly higher in RA than erosive OA patients and in erosive than non-erosive OA with (P = 0.001, in each one). The SF level of RANKL is an important marker of both disease activity and severity in RA patients; while in OA patients, it is an important marker of disease severity especially in erosive than non-erosive types. Serum level of RANKL may be of low benefit in disease activity and severity of both rheumatoid arthritis and osteoarthritis.

Ultrasonographic diagnosis of articular chondrocalcinosis.

To investigate the role of high-frequency ultrasonography in the diagnosis of calcium pyrophosphate dihydrate (CPPD) calcifications, in the most commonly affected joints in CPPD disease. Sixty patients with knee effusion were included in the study. All patients underwent musculoskeletal ultrasonography (on the shoulder, elbow, wrist, and knee joints), radiological examination of the sites examined by US, and synovial fluid analysis (using polarized light microscopy). Out of 60 patients with knee effusion, ultrasonographic calcifications (knees, shoulders, and wrists) were present in 38 patients (63.3%) and out of those patients; 32 had calcification characteristic of CPPD crystals deposition (hyperechoic deposits) in the knee and wrist joints. Pattern II (punctate pattern) was the most common pattern of calcification. It was present in all patients who had wrist calcification (18 patients) and in the knee in either alone (21 patients) or in association with pattern I (hyperechoic band) and/or pattern III (hyperechoic nodular or oval deposits) (9 patients). The sensitivity of ultrasonography for the detection of calcification was 84.2% while that of plain radiography was 13.2%, the specificity of both ultrasonography and plain radiography for the detection of calcification was 100%, and ultrasonography is valuable for diagnosing articular chondrocalcinosis via the detection of calcifications within the joint cartilage and fibrocartilage. Both sensitivity and specificity are high for detecting CPPD deposits.

Synthesis, characterization, thermal properties, antimicrobial evaluation, ADMET study, and molecular docking simulation of new mono Cu (II) and Zn (II) complexes with 2-oxoindole derivatives.

One of the interesting research fields is developing and assessing novel metal-containing medications. A new isatin-3-thiosemicarbazone derivative 4 was synthesized by two different methods based on hydrazone derivatives 2 and 3. Additionally, the chelation of thiosemicarbazone with copper (II) and zinc (II) forms a monobasic tridentate (ONS) complex with two five-member rings and a tetrahedral geometry structure. The structure of synthesized complexes was characterized using elemental analysis, FT-IR, mass spectra, and 1H/13C NMR. Thermogravimetric analysis revealed the upgrading of the thermal stability of metal complexes compared to their thiosemicarbazone ligand. The stoichiometric ratio of the coordination confirmed the formation of 1:1 (M: L) stoichiometry. In vitro antimicrobial activity was screened against two gram-positive, two gram-negative, and one fungal strain. Both ligand 4 and Zn complex 6 displayed high antimicrobial activity compared with copper complex 5 based on the zone of inhibition. Further, MIC and MBC were determined for both zinc and ligand. The zinc complex 6 displayed excellent antimicrobial activity with (MIC = 3.9-27.77 µg/mL) against bacterial strains and (MIC = 7.81 µg/mL) against C. albicans, as well as exhibited MBC values ranging between (MBC = 6.51-45.58 µg/mL) and (MFC = 13.58 µg/mL), respectively, and demonstrated bactericidal and fungicidal behavior. The in-silico ADMET study for ligand and two complexes were determined and showed non-AMES toxicity, non-carcinogenic, and obey the rule of five. A comparative docking study provided more insight into the binding mechanisms and suggested that antimicrobial activity may be due to inhibition of different targets.

Immunoreactivity of Kisspeptin and Kisspeptin Receptor in Eutopic and Ectopic Endometrial Tissue of Women With and Without Endometriosis.

Endometriosis is characterized by the presence of ectopic endometrial tissues. Mechanisms of tissue dissemination in endometriosis may be similar to those involved in tumor metastasis. We hypothesize that dysregulation of kisspeptin (KISS1), a metastasis suppressor in endometrial carcinoma, may contribute to the pathogenesis of endometriosis. In this study, we characterized the immunoreactivity of kisspeptin and its receptor, KISS1R, in eutopic and ectopic endometrial tissue of women with and without endometriosis, in proliferative and secretory menstrual cycle phases. Immunohistochemistry was performed using KISS1 and KISS1R antibodies on samples from women with (n = 35) and without (n = 14) endometriosis. Samples from women with endometriosis included eutopic endometrium (n = 20) samples, superficial endometriotic implants (SUP, n = 10) deep infiltrating endometriotic implants (DIE, n = 15), and ovarian endometriomas (OMA, n = 15). Immunoreactivity was quantified using histoscores. KISS1 and KISS1R immunoreactivity was significantly lower in eutopic endometrial stroma of women with versus without endometriosis, regardless of the menstrual cycle phase (P = 0.001 and P = 0.015 respectively). In endometriotic implants, KISS1 levels were significantly lower in both glandular and stromal components of DIE (P < 0.01) and OMA (P < 0.01) compared to SUP. KISS1R immunoreactivity was lower in the glandular component of OMA (P = 0.035) compared to SUP. KISS1 and KISS1R levels are lower in eutopic endometrial stroma from women with versus without endometriosis, consistent with a role for decreased KISS1 expression in the pathogenesis of endometriosis. As deeply invasive lesions showed lower KISS1 levels than superficial lesions, downregulation of KISS1 levels may contribute to implant invasiveness.

The role of the economic environment in kidney transplant outcomes.

The relationship between global economic indicators and kidney allograft and patient survival is unknown. To investigate possible relationships between the two, we analyzed kidney transplant recipients receiving transplants between January of 1995 and December of 2002 (n = 105,181) in the USA using Cox regression models. We found that: The Dow Jones Industrial Average had a negative association with outcome at one year post-transplant (HR 1.03 and 1.06, p < 0.001 for graft and recipient survival, respectively) but changed to a protective effect in the late period (HR 0.77, p < 0.001, and HR 0.83, p < 0.001 for graft and recipient survival, respectively, five yr after transplantation). Unemployment rate had a protective effect at the time of transplantation (HR 0.97, p < 0.005) and at one year after transplantation (HR 0.95, p < 0.005) but changed to the opposite in the late period at the fifth post-transplant year (HR 1.35, p < 0.001, and HR 1.20, p < 0.001, for graft and recipient survival respectively). The Consumer Price Index measured at different post-transplant time points seems to have had a protective effect on the graft (HR 0.77, p < 0.001 at five yr) and recipient (HR 0.83, p < 0.001 at five yr) survival. Beyond three yr after transplantation, when some of the recipients lose Medicare benefits, economic downturns might have a negative association with the kidney graft and recipient survival.

Synthesis, characterization and fungicidal activity of binary and ternary metal(II) complexes derived from 4,4'-((4-nitro-1,2-phenylene) bis(azanylylidene))bis(3-(hydroxyimino)pentan-2-one).

Ternary copper(II) and binary copper(II), nickel(II) and cobalt(II) complexes derived from 4,4'-((4-nitro-1,2-phenylene)bis(azanylylidene))bis(3-(hydroxyimino)pentan-2-one) (H2L) were synthesized and characterized by elemental and thermal analyses, IR, UV-Vis. and (1)H NMR spectroscopy, conductivity and magnetic moments measurements. The analytical and spectral data showed that, the ligand acts as dibasic tetradentate or dibasic hexadentate bonding to the metal ion via the two-imine nitrogen, two nitrogen and/or oximato oxygen atoms of deprotonated oxime groups forming five and/or six rings including the metal ions. The complexes adopt either tetragonal distorted octahedral or square planar geometry around metal ions. The ESR spectra of the solid copper(II) complexes are characteristic to d(9) configuration and having an axial symmetry type of a d(x2-y2) ground state. The g values confirmed the geometry is elongated tetragonal octahedral geometry with considerably ionic or covalent environment. The antifungal biological activity of the prepared compounds was studied using well diffusion method. The obtained results showed that, the ligand is biologically inactive while its metal complexes were more potent fungicides than the ligand and standard antifungal drug (Amphotericin B).

Early detection of spondyloarthropathy in patients with psoriasis by using the ultrasonography and magnetic resonance image.

OBJECTIVE: To assess the validity of ultrasound (US) in the early detection of arthritis and enthesitis, with assessment of the validity of magnetic resonance imaging (MRI) in the early detection of sacroiliitis and spondylitis in patients with psoriasis and to compare the findings of clinical examination and conventional radiography. MATERIAL AND METHODS: The study included 50 patients with psoriasis and 20 healthy controls. All patients and controls underwent US and power Doppler analyses for the joints of both hands and feet and the entheseal sites. MRI of the lumbosacral spine and sacroiliac joints was performed. RESULTS: Abnormal US findings of arthritis were present in 18% patients, whereas only 6% patients had X-ray abnormalities, the enthesopathy represent 74%, at a higher percentage than clinical and radiological assessment (46, 26% respectively). MRI and radiological study demonstrated evidence of inflammation in the spine in 44% and 16% patients, respectively, and evidence of sacroiliitis in 10% and 6% patients, respectively. CONCLUSION: Use of newer imaging modalities allows early diagnosis and early initiation of therapy.

Inferior hypogastric plexus blockade versus acupuncture for the management of idiopathic chronic pelvic pain: A randomized clinical trial.

BACKGROUND: To compare the clinical efficacies of inferior hypogastric plexus blockade and acupuncture in the management of idiopathic chronic pelvic pain (CPP). METHODS: The study included 117 patients with CPP. Group 1 included 62 patients who underwent inferior hypogastric plexus blockade and group 2 included 55 patients who underwent acupuncture. Pain level was assessed using a visual analogue scale (VAS) immediately and at 2, 6, and 12 weeks after treatment. RESULTS: The preprocedure VAS score was 7.6 ± 0.15 in group 1 and 7.7 ± 0.24 in group 2 (p > 0.05). Pelvic pain decreased significantly in both groups after treatment, with pretreatment and posttreatment scores of 7.6 ± 0.15 and 2.2 ± 0.88, respectively, in group 1 (p < 0.0001) and 7.7 ± 0.24 and 4.7 ± 0.11, respectively, in group 2 (p < 0.0001). However, the decrease in pain scores throughout the clinical follow-up was significantly more in group 1 than in group 2 (p< 0.0001). Complete disappearance of symptoms was achieved in 72.6% of patients in group 1 compared to 54.5% of patients in group 2 (p = 0.3737). Patients who did not benefit from the treatment were significantly more in group 2 than in group 1 (25.5% vs. 6.5%, p = 0.0294). No complications were reported in both groups. CONCLUSION: The study results showed that inferior hypogastric blockade had a 72.6% success rate and showed a significantly higher effect on reducing pain intensity in a short period of time in the management of CPP, compared to acupuncture.

Suppression of transplant immunity in experimental trichinellosis.

Skin allograft rejection in Balb/c and C57BL/6J mice following experimental infection with 300 larvae of Trichinella spiralis or Trichinella pseudospiralis was studied. Skin grafts from normal C57BL/6J mice were transplanted to infected Balb/c mice and vice versa at days 3, 10, 20 and 30 post-infection. The clinical criteria for graft rejection, scarring and graft falling, were followed. The results indicated that T. spiralis and T. pseudospiralis infections induced a significant delay in graft rejection when compared to the control groups. A maximum rejection time of 24 days was observed in T. spiralis infected C57BL/6J mice which received skin grafts from Balb/c mice on day 3 post-infection. The rejection in the uninfected control group was on day 7 post transplant. The mean rejection times for transplants on various days post-infection, with both species were very similar. Also, the rejection profiles in Balb/c mice were comparable to that observed in C57BL/6J mice, with a maximum delay of 26 days to rejection again obtained in mice transplanted on day 3 post-infection, for both species. When the skin grafts were performed 5 or 10 days prior to infection, the rejection occurred on day 7, as in the control group. The effect of T. spiralis and T. pseudospiralis soluble larval extracts (TSE or TPE) on graft rejection was also examined. Four intraperitoneal injections of 50 micrograms each of TSE or TPE every 48 h for 7 days did not induce any significant delay in graft rejection. In contrast, secretory antigens prepared from cultured larvae in vitro induced significant delays in graft rejection.(ABSTRACT TRUNCATED AT 250 WORDS)

Infectivity, reproductive capacity and distribution of Trichinella spiralis and T. pseudospiralis larvae in experimentally infected sheep.

Twelve Merino sheep were experimentally shown to be susceptible to infection with Trichinella spiralis or T. pseudospiralis by feeding on infected carcasses of mice or by oral intubation with recovered muscle larvae. The larvae recovered from the sheep showed variable tissue distribution. The diaphragm and tongue were most affected. The viability of the recovered larvae was confirmed by successful passage in mice. The reproductive capacity of T. spiralis in sheep was higher than that of T. pseudospiralis, and also higher than its reproductive capacity in C57BL/6J mice. The reproductive capacity of T. pseudospiralis in sheep at a lower dose was higher than that observed in mice. However at higher doses, it was significantly lower than that in mice. Therefore, it may be concluded that the sheep may be considered a suitable host for both species of Trichinella.

[The co-construction of change in community health service provision in Senegal]. / La co-construction des changements dans l'offre de sante communautaire au Senegal.

An experience of collaboration between researchers and the Ministry of Health of Senegal has encouraged the social uses of results from research on the health of communities. This article presents the contributions of partnership-based research to tackling health inequalities. Following a diagnostic shared with all the actors (practitioners and users) that allowed us to identify the reasons behind the under-utilization of well-equipped and renovated health establishments, three innovations were implemented: district surgery, complementary health insurance and flat-rate fees. In the four central regions of Senegal where this experiment was launched, the research that was carried out allowed for a better comprehension of the processes and challenges in 'co-constructing' knowledge between practitioners and researchers, in the context of relatively low access to healthcare. This article highlights the importance of this co-construction in encouraging concerted efforts to make relevant changes for improved, more equitable and more accessible local health services for communities.

Performance of the Abbott Real Time CT/NG assay in urines and cervico-vaginal samples from Senegal.

INTRODUCTION: Chlamydia trachomatis and Neisseria gonorrhoeae are the most common causes of sexually transmitted disease in Senegal and worldwide. Molecular techniques have become the standard for their detection, and due to the frequency of co-infections, these tests can detect both agents and can be used on urine samples, vaginal swabs, or endocervical samples. In developing countries, the use of these molecular techniques is very limited and there is a need for evaluations of these techniques to be done. METHODOLOGY: A total of 181 samples were tested with the Abbott RealTime CT/NG assay and compared with the Roche Cobas Amplicor CT/NG assay. Specimens were collected from the key population of men having sex with men (urine, n = 60), female sex workers (genital swabs, n = 60) and from women visiting the laboratory for a gynecological checkup (urine, n = 60 and endocervical samples, n = 61). RESULTS: The agreement between the two techniques was 98.90% with a Kappa coefficient of 0.98. A sensitivity of 93.3%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 93.3% were found for both Chlamydia trachomatis and Neisseria gonorrhoeae. CONCLUSION: These results showed that both methods are similar and suitable for the detection of CT/NG in all types of samples examined in this study.

Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study.

BACKGROUND: Uterine fibroids (UFs, also known as leiomyoma) affect 70% of reproductive-age women. Imposing a major burden on health-related quality-of-life (HRQL) of premenopausal women, UF is a public health concern. There are no effective medicinal treatment options currently available for women with symptomatic UF. OBJECTIVES: To evaluate the efficacy and safety of green tea extract (epigallocatechin gallate [EGCG]) on UF burden and quality of life in women with symptomatic UF, in a double-blinded, placebo-controlled randomized clinical trial. METHODS: A total of 39 reproductive-age women (age 18-50 years, day 3 serum follicle-stimulating hormone <10 \U/mL) with symptomatic UF were recruited for this study. All subjects had at least one fibroid lesion 2 cm(3) or larger, as confirmed by transvaginal ultrasonography. The subjects were randomized to oral daily treatment with either 800 mg of green tea extract (45% EGCG) or placebo (800 mg of brown rice) for 4 months, and UF volumes were measured at the end, also by transvaginal ultrasonography. The fibroid-specific symptom severity and HRQL of these UF patients were scored at each monthly visit, using the symptom severity and quality-of-life questionnaires. Student's t-test was used to evaluate statistical significance of treatment effect between the two groups. RESULTS: Of the final 39 women recruited for the study, 33 were compliant and completed all five visits of the study. In the placebo group (n = 11), fibroid volume increased (24.3%) over the study period; however, patients randomized to green tea extract (n = 22, 800 mg/day) treatment showed significant reduction (32.6%, P = 0.0001) in total UF volume. In addition, EGCG treatment significantly reduced fibroid-specific symptom severity (32.4%, P = 0.0001) and induced significant improvement in HRQL (18.53%, P = 0.01) compared to the placebo group. Anemia also significantly improved by 0.7 g/dL (P = 0.02) in the EGCG treatment group, while average blood loss significantly decreased from 71 mL/month to 45 mL/month (P = 0.001). No adverse effects, endometrial hyperplasia, or other endometrial pathology were observed in either group. CONCLUSION: EGCG shows promise as a safe and effective therapeutic agent for women with symptomatic UFs. Such a simple, inexpensive, and orally administered therapy can improve women's health globally.

Serum vitamin D3 level inversely correlates with uterine fibroid volume in different ethnic groups: a cross-sectional observational study.

PURPOSE: Currently there is no effective medicinal treatment for uterine fibroids (UFs), a common health disorder that affects women of reproductive age. Identification of modifiable risk factors such as vitamin D (Vit D) deficiency could help develop novel strategies for the prevention and/or treatment of UFs. The purpose of this study was to identify whether low serum Vit D3 levels correlate with increased risk of UFs. METHODS: A total of 154 premenopausal women were recruited for this cross-sectional study. The control group comprised 50 subjects with a normal, fibroid-free uterine structure, confirmed by transvaginal ultrasonography. The 104 case subjects had at least one fibroid lesion that was 2 cm(3) in volume or larger, confirmed by transvaginal ultrasonography. For each case subject, total uterine volume and total volume of all existing fibroids were measured in three perpendicular planes, with volume determined according to the prolate ellipse formula (a × b × c × 0.523), where a is height, b is width, and c is depth. Serum Vit D [25(OH) D3] levels were measured by radioimmunoassay. The independent t-test was used to compare serum Vit D levels across groups. Correlations were assessed by Spearman's rank correlation test. RESULTS: Lower serum 25-(OH) Vit D levels were significantly associated with the occurrence of UFs (P = 0.01). A statistically significant inverse correlation was also observed between serum 25-(OH) Vit D levels and total UF volume (r = -0.31; P = 0.002) within the case cohort. Subjects with larger fibroid volumes had lower serum Vit D levels and vice versa. Data stratified for ethnicity showed a statistically significant inverse correlation between serum 25-(OH) Vit D levels and total fibroid volume in black subjects (r = -0.42; P = 0.001). An inverse correlation was also evident in white subjects (r = -0.86; P = 0.58) but this did not reach statistical significance. CONCLUSION: Lower serum Vit D levels are inversely correlated with UF burden in different ethnic groups. Vit D deficiency is a possible risk factor for the occurrence of UFs.