Introduction
Research is a methodical, thorough investigation of a problem to generate new knowledge or validate the existing one. Several types of research exist, and each research depends on the kind of knowledge being sought, or the problem being investigated. This essay critically analyzes healthcare research that was conducted to generate new knowledge on the effect of local estriol cream on virginal health parameters.
Describing the type of Research
This type of research is an experimental or a clinical one. This is because experimental or clinical research is objective and systematic. This study involves a controlled investigation that is focused on the effect of virginal estriol cream on Escherichia coli colonization. The experimental or clinical research study is carried out when researchers want to establish cause-and-effect relationships (Martin et.al., 1999).
Research Problem & Questions
The global healthcare community is facing great obstacles in its fight against the growth of the HIV/AIDS pandemic. Lack of an effective and acceptable means of blocking the sexual transmission of HIV in women is a major obstacle the community is facing (Martin et.al., 1999). Women are the most vulnerable group to sexual HIV infections because most men are reluctant to use condoms as they believe that they reduce sensation and pleasure during intercourse. This has made the international health community focus on research to develop female-controlled means of protection. For instance, studies on viginal microbicides and viginal infections protection are promising. The research question under investigation in this study is whether the epithelial thickness of the viginal can protect women against sexual HIV acquisition. The researchers wanted to know whether a thick viginal epithelium will block HIV from accessing its target cells (Raz &Stamm, 2004).
The hypothesis of the Research
- Thickened, matured viginal epithelium would protect against sexual acquisition of HIV.
- Estriol treatment will make the viginal epithelium thicken, mature, and have a high percentage of glycogen-positive cells. It will also enhance plenty of tight junctions and desmosomes between cells (Cummins et. al., 2003).
Purpose of the Research
This research investigates the effects of local estrogen treatment on viginal epithelial thickness and maturity in pre-menopausal women. The major aim is to determine the effect of topically applied estrogen on the virginal epithelium. On the other hand, the minor objective is to investigate the reaction of local estrogen on lactobacillus colonization and viginal PH.
Research Design
This study was designed to be a multi-center, randomized, double-blind, placebo-controlled phase 1 trial. The researchers planned to treat a total of 98 reproductive-age women with estriol cream and placebo for two months. Of the total women population, 49 were treated with local estriol and the rest with placebo. The research study was conducted at the University of Illinois-Chicago and Los Angeles county Harbor-UCLA medical center, CA. Lab work and histology were conducted at Tulane University and Magee-Women’s research institute.
How the Research was Conducted/Methods/ and Sample Size
The research was conducted on pre-menopausal women aged between 18-40 years. The study sample comprised of eligible women who agreed voluntarily to participate in the study. The participants attended the clinic five times during the whole study process. The first visit was scheduled for screening and enrollment, whereas the other four visits, were scheduled for the collection of experimental data, and recording of the observations on the effects of local estriol cream on the viginal epithelium. Each participant’s clinical visit lasted for 30 minutes, and the appointments were scheduled according to each woman’s menstrual cycle.
The participants were given diaries to record their activities, application of the cream, and any side effects they would experience throughout the study. Throughout the research study, virginal swabs were extracted from fornix for culture and gram stain at luteal and follicular phases of the menstrual cycle before product use (cream) and during product use. During the first visit, two biopsies tissues were obtained from approximately 10 o’clock position on the lateral vaginal wall, whereas on the second visit, they were taken from the approximately 4-o’clock position.
Randomization was done on the participants during the second visit such that two groups were created. One group was for treatment and the other for control depending on random numbers each participant was assigned in groups of 10. Some women were given a cream containing estriol while others were given a cream without medication (placebo). The participants were to insert 4mL of the cream into their vigina using the applicator thrice a week. The type of cream each participant received was kept anonymous such that both the participants and the analysts were blinded. During the third visit, biopsies were taken from the approximately 2-o’clock position, and lastly, during the fourth visit, biopsies were taken from an approximately 8-o’clock position on the viginal wall. Results were shipped overnight to a central lab for microbiological analysis.
How the Rights of the Participants were Protected
All the participants were given informed consent before the research study began. Only those women who agreed voluntarily to participate in the research were considered eligible. During the study, the participants’ confidentiality was maintained. Any private information concerning viginal illness or side effects from the cream was maintained private and confidential. Study forms were identified by ID numbers to hide the identity of the participants. Moreover, they were protected by the investigators against any Serious Adverse Events (SAEs). Each study site was presented with SAE forms for protection purposes. During report filling the investigators referred to the participants using their unique codes and not their actual names. The participants’ interview information and answers to the questionnaire were only used for research.
What was learned from the Research?
It was learned that the rate of E. coli colonization among women with regular menstrual cycles and without exogenous hormones was similar in both follicular and luteal phases of the menstrual period before treatment. However, after treatment, it was discovered that estriol cream caused the increase of E. coli colonization associated. On the other hand, the use of viginal creams/ virginal products use did not change lactobacillus colonization. Lastly, it was learned that estriol cream increased the thickness of the virginal epithelium by a smaller margin (Smith et. al., 2004).
Results of the Study
Rates of E. coli Colonization
The above results justify that the increase in E. coli colonization was as a result of estrogen cream. Before treatment, placebo and estriol groups showed no difference in the rates of E. coli colonization between menstrual cycle phases (Ildgruben, Sjoberg, & Hammarstrom, 2003).
Rates of lactobacillus colonization
Those results show that lactobacillus colonization remained the same during pre-treatment and post-treatment. This implies that estriol cream did not have any effect on virginal lactobacillus. However, it increased epithelial thickness in both luteal and follicle phases of the cycle. Thickness increased by 11% above the luteal baseline. This was slightly lower than the projected 25% increase. The layers of transitional cells in the viginal walls increased for estriol-treated women as compared to placebo-treated ones.
References
Cummins, J., Villanueva, J., Evans-Strickfaden, T., Sesay, M., Abner, S.R., Bush, T.J., Green, T.A., Lennox, J.L., Wright, T., Folks, T.M., Hart, C.E., & Dezzutti, C.S. (2003). Detection of Infectious Human Immunodeficiency Virus type 1 in Female Genital Secretions by a short-term Culture Method. J Clin Microbiol, 41(9): 4081-4088.
Ildgruben, K., Sjoberg, M., & Hammarstrom, L. (2003). Influence of Hormonal Contraceptives on the Immune Cells and Thickness of Human Vaginal Epithelium. Obstet Gynecol, 102(3): 571-82.
Martin, H.L., Richardson, B.A., Nyange, P.M., Lavreys, L., Hillier, S.L., Chohan, B., Mandaliya, K., Ndinya-Achola, J.O., Bwayo, J., & Kreiss, J. (1999). Vaginal Lactobacilli, Microbial Flora, and Risk of Human Immunodeficiency Virus type 1 and Sexually Transmitted Disease Acquisition. J Infect Dis, 180(6): 1863-1868.
Raz, R., & Stamm, W. (2004). A controlled Trial of Intravaginal Estriol in Post-menopausal Women with Recurrent Urinary Tract Infections. N Engl J Med, 329(11): 753-756.
Smith, S.M., Mefford, M., Sodora, D., Klase, Z., Singh, M., Alexander, N., Hess, D., & Marx, P.A. (2004). Topical Estrogen Protects against SIV Vaginal Transmission without evidence of Systemic Effect. AIDS, 18(12): 1637-1643.