The association between paralytic side and health-related quality of life in facial palsy: a cross-sectional study of the Korea National Health and Nutrition Examination Survey (2008-2012).

BACKGROUND: Facial palsy is known to have correlations with low level of quality of life. However, little is known about the association between preference based health-related quality of life (HRQoL) and paralytic side of facial palsy. METHODS: This study used Korea National Health and Nutrition Examination Survey (KNHANES, 2008-2012) data, only when the facial palsy examination had been included in the survey contents. Hierarchical regression analyses were used to obtain optimal regression coefficients in the association between paralytic side of the facial palsy and HRQoL measured by EuroQoL-5 Dimension (EQ-5D). We also analyzed the association between the deteriorated domains of EQ-5D and facial palsy in both subgroups by using multiple logistic regression models. RESULTS: We included the data of 28,106 participants aged ≥19 years who were examined as facial palsy according to House-Brackmann score and completed EQ-5D questionnaire in KNHANES 2008-2012. The mean EQ-5D score was significantly low and percentages of deteriorated numbers in its domains were significantly high in facial palsy group. CONCLUSIONS: These results show that, after adjusting for confounding variables, left facial palsy is associated with impaired HRQoL compared with right-sided palsy. Among the domains of EQ-5D, only 'self-care' domain was directly affected by the disease in left facial palsy patients. These findings could be used in developing model and conducting analyses of economic evaluation about facial palsy interventions.

The efficacy and safety of a proposed herbal moisturising cream for dry skin and itch relief: a randomised, double-blind, placebo-controlled trial--study protocol.

BACKGROUND: Moisturisers prevent and treat dry skin. They can also protect sensitive skin, improve skin tone and texture, and mask imperfections. Herbal medicines or their extracts have been available as topical formulations and cosmetics. Arctium lappa L. (Asteraceae) has been used to treat inflammatory disorders and various skin problems. It could be a candidate herbal medicine for treating dry skin condition.This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract, which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics. METHODS/DESIGNS: This study is a randomised, double-blind, placebo-controlled study with two parallel groups (proposed herbal moisturising cream vs. placebo cream). We will recruit 66 healthy male and female participants, aged 20 to 65 years, who have been diagnosed with dry skin conditions. Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks. Each participant will be examined for signs and symptoms before and after using the cream. Skin hydration, sebum (oily secretion) levels and transepidermal water loss (TEWL; constitutive loss of water from the skin surface) will be assessed. Participants will also be asked to fill out a health-related quality of life questionnaire. Safety will be assessed using blood tests, urine analysis, a pregnancy test, and the assessment of vital signs. DISCUSSION: This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea. It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief. Moreover, we will also employ health-related quality of life questionnaires to assess changes in the quality of life. The results of this study will be used to present the evidence needed to request advertising/display allowances, in compliance with the recently amended Cosmetics Act for advertisement in Korea. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46216631.

Hwangryunhaedoktang in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, two-centre trial--study protocol.

BACKGROUND: Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence and rising costs. It has a clear impact on a patient's quality of life. Many patients are worried about the use of usual care techniques, such as corticosteroids and antihistamine due to the widespread fear of adverse effects. Complementary and alternative medical approaches have been employed to relieve symptoms of Atopic Dermatitis. Hwangryunhaedoktang is among the most strongly preferred and widely used herbal medicines for Atopic Dermatitis in Korea, as it causes very few serious adverse effects.We aim to establish basic clinical efficacy and safety data for Hwangryunhaedoktang, which is approved as an herbal medication by the Korean Food and Drug Administration, in adult patients with Atopic Dermatitis. METHODS/DESIGNS: This study is a randomised, double blind, placebo-controlled, two-centre trial with two parallel arms (Hwangryunhaedoktang and a placebo). The diagnosis of Atopic Dermatitis will be made according to the criteria of Hanifin and Rajka by two different Oriental medicine doctors. We will include participants experiencing typical conditions of intermittent or continuous Atopic Eczema for six or more months. Participants will receive Hwangryunhaedoktang or a placebo-drug for eight weeks. The total duration of each arm is eleven weeks. Each participant will be examined for signs and symptoms of Atopic Dermatitis before and after taking medication. A follow-up to evaluate the maintenance of safety will be performed two weeks after the final administration of medication. DISCUSSION: This trial will utilize high quality trial methodologies in accordance with consolidated standards of reporting trials guidelines. It will provide evidence for the clinical efficacy and safety evaluation of Hwangryunhaedoktang in adult patients with Atopic Dermatitis. Moreover, we will also employ health-related quality of life questionnaires to assess the changes in quality of life.

Bojungikgitang and banhabaekchulchonmatang in adult patients with tinnitus, a randomized, double-blind, three-arm, placebo-controlled trial--study protocol.

BACKGROUND: Tinnitus is the perception of hearing a sound for which there is no external acoustic source. It is often associated with sudden, temporary hearing loss and has a clear impact on a patient's quality of life. Despite numerous trials, there are no treatments that can be considered well established in terms of providing replicable long-term tinnitus reduction. Complementary and alternative medical approaches have been employed to relieve symptoms of tinnitus. Bojungikgitang and banhabaekchulchonmatang are among the most strongly preferred and widely used herbal medicines for tinnitus in Korea, as they cause very few serious adverse effects.We aim to establish basic clinical efficacy and safety data for bojungikgitang and banhabaekchulchonmatang, which are approved as herbal medications by the Korea Food and Drug Administration in adult patients with tinnitus. METHODS/DESIGN: This study was a randomised, double-blind, placebo-controlled trial with three parallel arms (bojungikgitang, banhabaekchulchonmatang, and a placebo). Participants included in the study met the following criteria: typical conditions of intermittent or continuous tinnitus, for more than three months, with involuntary perceptions of the concept of a sound in the absence of an external source. Participants received bojungikgitang, banhabaekchulchonmatang, or a placebo-drug for eight weeks. The total duration of each arm was eleven weeks. Each participant was examined for signs and symptoms of tinnitus before and after taking medication. Post-treatment follow-up was performed two weeks after the final administration of medication. DISCUSSION: This trial provided evidence for the efficacy and safety of bojungikgitang and banhabaekchulchonmatang in adult patients with tinnitus. The primary outcome measure was the Tinnitus Handicap Inventory, an assessment used to identify difficulties that may be experienced due to tinnitus. The secondary measures were included an Acoustic Examination and the Visual Analogue Scale. We employed the Euro-Qol 5-Dimension and the Health Utilities Index Mark 3, a health-related quality of life questionnaire. Safety was assessed by complete blood cell count, erythrocyte sedimentation rate, blood chemistry, urine analysis, PA chest film, brain computed tomography, otologic examination, and vital signs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN23691284.

The role of prophylactic cerclage in preventing preterm delivery after electrosurgical conization.

OBJECTIVE: To evaluate pregnancy outcomes after electrosurgical conization. METHODS: We retrospectively analyzed the outcomes of 56 singleton pregnancies after electrosurgical conization of the uterine cervix. Of the 56 cases, 25 women underwent prophylactic cerclage with McDonald procedure (cerclage group), and 31 were managed expectantly (expectant group). Pregnancy outcomes including rate of preterm delivery were compared, and the effect of potential risk factors such as depth of cone, interval between conization and pregnancy, and cervical length on the risk of preterm delivery was assessed. RESULTS: The rate of preterm delivery was significantly higher in women with a history of electrosurgical conization than those without (32.1% vs. 15.2%, p<0.001). However, preterm delivery rate was not different between the two groups (expectant group vs. cerclage group; <28 week, 6.5% vs. 8.0%, p=1.000; <34 week, 19.4% vs. 20.0%, p=1.000; <37 week, 29.0% vs. 36.0%, p=0.579). All obstetric and neonatal outcomes were similar in the two groups. Even when we confined the study subjects to 19 women (19/56, 33.9%) with cervical length less than 25 mm, the preterm delivery rate also was not significantly different between the expectant (n=7) and cerclage group (n=12). Finally, the potential risk factors for preterm delivery were not associated with risk of preterm delivery in patients with a history of electrosurgical conization. CONCLUSION: The rate of preterm delivery was significantly higher in women with a history of electrosurgical conization before pregnancy. However, prophylactic cervical cerclage did not prevent preterm delivery in these patients.

The effect of single or multiple courses of antenatal corticosteroid therapy on neonatal respiratory distress syndrome in singleton versus twin pregnancies.

BACKGROUND: Antenatal corticosteroid (ACS) treatment is widely used for the prevention of respiratory distress syndrome (RDS) in preterm infants. However, the efficacy and safety of ACS treatment remains controversial in twin pregnancies. AIMS: To investigate the effect of ACS therapy, single or multiple courses, on the incidence of neonatal RDS in singleton and twin pregnancies. METHODS: We retrospectively evaluated the pregnancy and neonatal outcomes of 450 singleton and 117 twin pregnancies delivered at 24-34 weeks of gestation due to preterm labour or preterm premature rupture of membranes. The subjects were categorised into four groups according to ACS exposure: 0, 1, 2 and > or = 3 courses. RESULTS: Overall, RDS occurred more frequently in twins compared to singletons (41.0% vs 25.3%, P < 0.001). In singleton pregnancy, the incidence of RDS was significantly lower in the ACS user groups than in the non-user group, with the lowest incidence in the multiple course groups. An increase in the number of courses of ACS was associated with a reduction in the incidence of RDS (odds ratio 0.349, 95% confidence interval 0.226, 0.537, P < 0.001) independent of confounding variables. In twin pregnancies, however, the incidence of RDS was not significantly different in comparisons among the four groups. CONCLUSION: Multiple courses of ACS were associated with a significantly decreased risk of RDS in singleton pregnancies. However, the current standard dose or interval for ACS administration in singleton pregnancy, as either a single or multiple courses, did not reduce RDS in twins.

Increased toll-like receptor 9 expression in cervical neoplasia.

Toll-like receptors (TLRs) recognize pathogen-associated molecular patterns (PAMPs) and enable innate immune responses. Although TLR9 has been previously considered to be expressed only in immune cells, there is now increasing evidence that TLR9 expression is present in nonimmune cells as well. In this study, we undertook to determine whether TLR9 expression was associated with disease progression in cervical neoplasia. TLR9 expression was evaluated by immunohistochemistry in 55 formalin-fixed paraffin-embedded cervical tissues; nine normal cervical specimens, 10 low-grade cervical intraepithelial neoplasias (CINs), 12 high-grade CINs, and 24 invasive squamous cell carcinomas (ISCCs). In addition, TLR9 expression was evaluated, at the RNA level, in fresh frozen cervical carcinoma tissues by real-time quantitative RT-PCR. Immunohistochemical staining showed that TLR9 expression was undetectable (55.6%) or weak (44.4%) in normal cervical squamous epithelial tissues, however, variable staining was observed in the basal layer of all normal endocervical glands. TLR9 expression, which was mainly observed as cytoplasmic staining, gradually increased in accordance with the histopathological grade in the following order: low-grade CIN