Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 3, Issue 1, 2016

Objective: To study and critically analyze the published evidence on use of metformin for different indications during pregnancy through a systematic review and to provide background for its use through a narrative review. Data sources and Selection of the studies: PubMed, CENTRAL, Embase, SCIENCE DIRECT were searched up to March 2015. Medical subject handling terms (MeSH) and free text term key words like metformin, gestational diabetes, metformin in polycystic ovary syndrome (PCOS), metformin in prevention of gestational diabetes (GDM), metformin in pregnant diabetics were used in combination with Randomised clinical trial (RCT), metaanalyses and observational studies. Results: Metformin was used for mainly 4 indications during pregnancy; for glycemic control in gestational and pregestational diabetes, to prevent GDM and to prevent complications in pregnant patients with PCOS. It was found that metformin alone or in combination with insulin is effective to achieve glycemic control and is safe to use in pregnancy. In addition, it is cheap and easy to use with higher patient compliance. It can prevent miscarriage in patients with PCOS but is not effective in preventing GDM in high risk pregnancies. Conclusion: In pre-gestational diabetes, use of metformin is encouraging but lacks enough evidence for efficacy as monotherapy. In GDM, it is safe and effective but the requirement for additional insulin is variable and unpredictable till now. There is an increasing need for more RCTs to study the clinico-demographic profile of patients in whom metformin is most likely to be effective as monotherapy. In patients with PCOS, metformin is effective in preventing early pregnancy loss and improving live birth rate. It was found that use of metformin is not effective in preventing GDM in pregnancy.

Background: In developing countries such as Zambia, couples seldom make decisions with regard to fertility solely in consultation with each other. At all stages of family formation couples are strongly persuaded by cultural and social norms. In additions couples are influenced by opinions and information provided by close friends and relatives in couple’s social net works. Social net works play an important role in enabling husbands seeks information with respect to planning births. One drawback of studies on expected fertility in developing countries is that they have not adequately addressed the impact of reproductive decision making on expected fertility. Consequently, though husbands strongly influence fertility decision making, fertility studies do not pay adequate attention to the role played by husbands in fertility decisions making. The objective of this study is to examine the development of a planning process with respect to timing and spacing of children. Methods: The sample for this study consists of husbands from one hundred sixty three households randomly selected from low income communities located in Kitwe, Zambia. Two questionnaires, one for the husband and the other for the wife, were designed to gather data. Husbands and wives were interviewed simultaneously in order to limit opportunities for spouses to influence each other. We examine men’s fertility decision making by analyzing data on six questions: Can a couple ever have too many children?; Have you ever talked or received advice from any one about the best length of time to have between pregnancies?; Have you ever talked to or received advice from anyone on methods how to space your children or prevent pregnancy?; Have you and your husband/wife ever talked about the number of sons and daughters you would like to have before stopping?; Have you and your wife ever discussed the best length of time to have between pregnancies and finally, is it costly to have children today? Results: Husbands who engaged in birth planning were more likely than the rest to believe that too many children are undesirable. In Zambia, a rational approach to the control of fertility among birth planers is realized in social settings rather than in isolation. The transition from natural fertility to controlled fertility is associated with modernization and accepting modern values. Knowledge of birth control is also essential and is often associated with increases in education. However, social networks also play an important role in reducing expected family size by facilitating a rational and planned approach to family building in Zambia. Conclusion: Husbands were not averse to sharing information with group members in close social networks to arrive at decisions with respect to planning births. Recognition of the social milieu in which contraceptive use takes place is necessary for the promotion of modern contraception. Husband’s social networks significantly influence his fertility decisionmaking. Subsequently, from a policy point of view it appears crucial to facilitate the maintenance of the social networks involved in making contraceptive use decisions to promote prolonged use of modern contraception. The implications for family planning programs are discussed.

Background: Tooth wear or tooth surface loss is a common finding that has been recently increasingly associated with the pediatric population. Many factors can contribute to this condition. Aim of the Study: To determine the prevalence of tooth wear and identify possible risk factors in the primary dentition of Abu Dhabi, UAE, school children. Methods: This cross-sectional study examined 506 children aged 2.6-6.8 years. Dental tooth wear was coded as none, mild, moderate or severe. A questionnaire was completed by the children’s legal guardians to investigate the presence of associated risk factors. Results: Out of the 506 examined subjects, 97.6% showed tooth wear. Among the 9213 teeth examined 41.6%, 42.1%, 16.2%, 0.15% showed no tooth wear, mild, moderate and severe tooth wear respectively. Upper incisor and canine segments demonstrated the highest prevalence and severity of tooth wear whereas lower and upper molar segments had the lowest. Within the upper arch, upper canines showed the highest prevalence and severity of tooth wear whereas upper second molars exhibited the lowest. Within the lower dentition, lower incisors had the highest prevalence and lower canines had the highest severity of tooth wear. The lowest prevalence and severity of tooth wear within the lower arch was associated with the lower second molars. Variables such as age, mother’s employment, mouth breathing, anterior deep bite, canine classification, type of toothbrush and gender were significantly related to the prevalence and severity of tooth wear, moreover, 52% of tooth wear was explained by the above mentioned variables adjusted over type of tooth brush. Conclusion: The study demonstrated a prevalence of 97.6% of tooth wear in primary teeth. The study also demonstrated a difference in the prevalence and severity of tooth wear within the primary teeth and within the upper and lower dentition. The study suggests possible risk factors related to tooth wear such as: age, mother’s employment, mouth breathing, and anterior deep bite.

Background: Child mortality rates remain stubbornly high in many parts of India. One reason for the high child mortality rates is related to breast feeding practices. Less than one third of the mothers breastfeed within half an hour of birth in urban areas and only one fifth do so in the rural areas. When mothers either delay or do not breastfeed at all, the likelihood of child mortality rate increases. While urban - rural differences in breastfeeding practices are known to exist, very few studies have examined the differences empirically. The objective of this study is to examine the urban-rural differences in the likelihood of breastfeeding soon after birth in India. Methods: We used data from the national population-based third wave of the National Family and Health Survey of India (NHFS-3) commissioned by the Ministry of Health and Family Welfare, an agency of the Government of India. Conducted in all states during 2005-2006, NHFS-3 is the most recent survey available of the representative households in India. Binary Logistic regression method is used to analyze the data. Results: Results of our study do not support the popular notion that there is strong cultural resistance against starting breast-feeding soon after childbirth. We discuss several opportunities for social workers to promote healthy breast-feeding practices in India. Conclusion: Our study suggests that rural -urban differences in terms of healthy breast feeding practices are not intrackable and that the rural and cultural beliefs systems with regard to breast feeding practices are likely to support healthy breastfeeding practices.

Background: Health status is important for the all age groups particularly for the elderly who mostly suffer from chronic illnesses, progressive disabilities and ailments. Socio-economic status, however, has been known as a significant determinant for health of both communities and individuals. Indeed further information about the effects of socio-economic factors on the health of the elderly would be helpful for decision makers and decent resource allocation. Methods: The current research is a cross-sectional one, which was carried-out in Tehran, Iran. We selected the participants randomly, and data were collected by questionnaire. We did internet and library searches in order to make and improve an appropriate questionnaire. In order to determine the content validity of questionnaire, we did the literature review as well as interviewed eight experts and professor of health care management. Questionnaires were distributed among 140 elderly who were older than 60 year and lived in nursing home and 280 elderly who had the same age criterion but lived with their families. SPSS software was used for data analysis. Results: 406 out of 420 questionnaires were filled by participants, which presents 96.6% responsibility. Our data show a statistical significant correlation between socioeconomic status and mental, physical and social health. Conclusion: According to the results, the elderly’s marital status, educational level, occupational type, and property ownership are affective on the all of physical, social and mental health status of the elderly.

Background: Microsponges is a class of polymeric microspheres that are porous and are aimed to deliver a pharmaceutically active constituent competently at the smallest dose and also, to alter release of the drug. Objective: The aim of the present work was to formulate a topical gel based drug delivery system of microsponges containing Celecoxib (CXB). Method: Quasi emulsion solvent diffusion method was used to prepare microsponges. The inner phase of formulation (drug dissolved in polymer solution) was added drop-wise into outer phase of Polyvinyl Alcohol (PVA) solution at room temperature. Microsponges were obtained after stirring for 3 hours. Drug loaded microsponges, dispersed in propylene glycol, were added to soaked carbopol and mixed thoroughly. Final pH was adjusted by triethanolamine. Final formulation was evaluated for particle size, % entrapment efficiency, % production yield, surface morphology, % drug release, drug content, rheological behaviour, in vitro skin permeation etc. Results: Microsponges of optimized batch were spherical, fine and free flowing. The optimized formulation showed % practical yield of 72.84 ± 1.34, % entrapment efficiency of 82.4 ± 1.48 and mean particle size of 26.4 μm. The optimized batch incorporated in gel showed pH of 6.1, 12.35 grams-cm/sec of spreadability, 99.06 % of drug content and 68.1 % drug release. Skin permeation studies concluded that the drug was released in a controlled manner for a period of 12 hours. The optimized batch was found to be appropriately stable. Conclusion: The CXB loaded in a microsponge based gel was found to have good appearance, other micromeritic properties and entrapment efficiency along with controlled in vitro release profile of drug.

Objective: The aim of the present study was to formulate fast disintegrating sublingual tablet of Timolol maleate (TM) for the potential emergency treatment of hypertension and also its potential to circumvent the first-pass metabolism and to improve its bioavailability. The demand of fast disintegrating sublingual tablet has been growing mainly for geriatric because of potential emergency treatment. Methods: The tablets were prepared by direct compression method by incorporation of two disintegrants Ac-di-sol and sodium starch glycolate (SSG). Importance behind the incorporation of super-disintegrant was to break the tablet in less time period which imparts release of drug. To study the effect of independent variables (Ac-di-sol and SSG) on disintegration time and in vitro drug release a 3² factorial design was utilized. Spectroscopic techniques like Ultraviolet (UV) and Fourier transform infrared spectroscopy (FTIR) were utilized for study physiochemical properties of drug. The formulations were evaluated for crushing strength, weight variation, thickness, friability, drug content, wetting time, In-vitro disintegration time, In-vitro dissolution study. Results: FTIR studies showed no evidence of interactions between drug and excipients. Formulation (F4) was compared with rest of the formulations for disintegration time, wetting time, % drug release, content uniformity which were found to be superior to others. The Disintegration time of all nine formulations was lies between 31 ± 1.732 s to 127 ± 8.718 s. Except the formulation (F1) and formulation (F9) all remaining formulations showed diffusional exponent (n) values of peppas model were lies between 0.624 - 0.9333 means that these formulations followed anomalous transport for release of drug which is a combination of diffusion and erosion. Conclusion: It was concluded that combination of super - disintegrants (Ac-di-sol: SSG in 3:4) showed significant (p < 0.001) disintegrating time, wetting time and water absorption ratio than the rest of the formulations. We successfully developed the sublingual tablet of TM with achieving desired objective.