Acupuncture and Herbal Medicine in Women's Health: Infertility in Women - Research Proposal Example

Acupuncture and Herbal Medicine in Womens Health: Infertility in Women Introduction & Background: Disruption of the integrity of the reproductive system affects normal reproduction. Infertility in women is an issue that is aggravated in the developed world due to the postponement of childbearing. Modern medicine uses techniques of in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), and assisted reproductive technologies (ART) to manage infertility in women. Herbal medicine and acupuncture attempt to normalize the reproductive system as a means to mange infertility in women. Literature Review: Women are drawn to herbal medicine and acupuncture in the belief that it is natural, and often do not inform their physician of its use. The influence of herbal medicine in reproduction is believed through its ability to increase the thickness of the endometrial lining. The beneficial effects of acupuncture are believed to be derived from mediation through endogenous opioid peptides in the central nervous system, with particular reference to beta-endorphin. Evidence from studies suggest that herbal medicine and acupuncture offer beneficial effects in the management of infertility. Acupuncture used in conjunction with IVF and ART provides better pregnancy outcomes in the use of these techniques to manage pregnancy. However, the lack of appropriate controls and methodological issues of these studies makes it difficult to arrive at firm conclusions on the benefits that herbal medicine and acupuncture provide in the management of infertility in women. Objective: The objective of the study is to answer the question is there enough reliable evidence to support the use of acupuncture in the management of infertility in women? The study has proposed leaving herbal medicine out of the ambit of the study to increase the focus on evaluating the benefits of acupuncture in infertility in women. Research Methodology: The study proposes use of qualitative methods as it is suitable to provide answers when data exists, and a systematic review of literature as the data collection means since it is suitable to evaluate research already done on the subject, with particular emphasis on the methods of the studies. The local library and the medical databases of PubMed, Medline, and CINAHL will be used to locate the appropriate studies. Studies published prior to the year 2000 will be excluded, and studies published on or after the year 2000 will be included. Timeline & Budget: The study is expected to take seven months and cost $56,000. Ethical Considerations: The statutory administrative sanctions will be received prior to the start of the study. Permission for use of articles, where necessary, will be received prior to the use of these articles, and due acknowledgement made for articles used in the study. Table of Contents 1. Introduction and Background : 4 2. Literature Review : 5 3. Objective of the Study : 9 4. Research Methodology : 10 5. Time Schedule : 11 6. Budget : 12 8. Ethical Issues : 12 1. Introduction and Background Garcia and Nelson 2006, provides the commonly accepted definition of infertility as “the lack of pregnancy (regardless of cause) after 1 year of unprotected intercourse”. Nearly fifteen percent of couples in the reproductive age find infertility affecting their ability to produce offspring. Over the last five decades the impact of infertility has more or less remained the same. In the developed countries like the United States of America, changed family priorities have led to postponing of child bearing to later stages of life, which has had its influence on infertility (Garcia & Nelson, 2006). Normal reproduction involves the interaction between the female and male reproductive tracts, which places an emphasis on their integrity. In other words fertility is dependent on the availability of normal pre-ovulatory oocyte; availability of sufficient spermatozoa; normal movement of the gametes to the ampullary portion of the fallopian tubes for fertilization; and the transport of the cleaving embryo into the endometrial cavity and implantation. Disruption in the integrity of any of these can cause infertility. Advances in science and technology have provided new means of addressing infertility in women, through the use of in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), and assisted reproductive technologies (ART) (Garcia & Nelson, 2006). Herbal medicine and acupuncture have been in practice to assist fertility, with particular emphasis on China in the Far East. In contrast to the hormonal and technological means that modern medicine uses to aid fertility, herbal medicine and acupuncture is grounded in normalizing and enhancing fertility functions as a means to assist fertility in women. The increasing postponement of child bearing in women, as practiced in the developed world, has an impact on the normal fertility functions in women and it is in this context that herbal medicine and acupuncture offer a possibility to address this age related infertility in women and other reasons for infertility in women. Such a perception arises from the believed ability of acupuncture and herbal medicine to address issues of substandard semen perimeter, inefficient follicular recruitment; inefficient vaginal lubrication; luteal phase defects; and slow or hastened ovulation seen in infertility (Goldberg, Trivieri & Anderson, 2002). 2. Literature Review The advanced age is an important causative factor in infertility in women. In women attempting pregnancy at the age of forty or more the fertility rates dip to fifty percent, with an increased risk for miscarriages. The common causes attributed to infertility in women in the face of advancing age are poor egg quality and quantity; poor endocrine readings of high follicle stimulating hormone and low estrogen levels, reduced frequency of monthly ovulations’ reduced secretions of cervical mucus, and diminished perfusion of blood perfusion to the ovaries and uterus. Elevated levels of chromosomal abnormalities in the embryos, as a result of poor egg quality, is a common cause attributed for the higher levels of miscarriage in women of advanced age (Heese, 2006). Use of Chinese herbal medicine and acupuncture offers an effective means to improve ovarian and uterine functions and other fertility markers, thus increasing the probability of infertile women conceiving and delivering a child. The issue of the reduced quality of the egg in older women cannot be directly addressed by herbal medicine and acupuncture, but is capable of improving the environment an egg matures in and through that has an influence on the maturity and the quality of the egg. The increased chances of successful conception and pregnancy attributed to herbal medicine and acupuncture stem from the increase in the thickness of the endometrial lining as a result of their use. Findings from studies and clinical experience suggest that the beneficial effects of herbal medicine and acupuncture in infertility is due to improved ovarian and uterine blood perfusion, regulation of the endocrine hormones, and the normalization of the follicular as well as the luteal phases of the menstrual cycle (Heese, 2006). Women are attracted towards herbal medicines as they have the perception that herbal medicines are natural, and therefore are bereft of the side effects associated with allopathic drugs and interventions (Dennehy, 2006). In the United States of America this is particularly true of ethnics groups like the Asians or Hispanics, with whom there is a cultural history associated with the use of herbal medicines. The use of herbal medicines in these ethnic groups is not easy to quantify or evaluate, as there is a tendency among these women not to disclose the use of herbal medicine to their physicians (Howell et al, 2006). The understanding and use of acupuncture to assist in fertility has its origins in ancient Chinese medical theory, yet studies evaluating the role of acupuncture in fertility add credence to these medical theories. Such studies suggest that the beneficial affects of acupuncture the result of mediation through endogenous opioid peptides in the central nervous system, with particular reference to beta-endorphin. These neuropeptides have an action on GnRH, whereby there is an influence on gonadotropin secretion, which leads to the hypothesis that acupuncture influences the menstrual cycle through these neuropeptides. The central effect of acupuncture is in sympathoinhibitory effects, which results in the concept that acupuncture can influence uterine blood flow (Chang, Chung & Rosenwaks, 2002). Increasing evidence of the benefits of acupuncture in female infertility has resulted in its popularity and an increase in the use of acupuncture in female infertility over the last decade. This increased use of acupuncture is as an adjuvant to the conventional medical interventions of assisted reproductive technologies (ART). Such adjuvant use of acupuncture results from the increased uterine and ovarian blood flow, analgesic effects during the performance of ART, and the normalizing action on endocrine and metabolic disturbances including instances of polycystic ovary syndrome (PCOS). Use of acupuncture as an adjuvant to ART is practices prior to and after the embryo transfer. Results from randomized control studies demonstrate that acupuncture significantly increases the pregnancy rates, when compared to the control groups, who did not receive any acupuncture. Definitive conclusions from these studies are difficult to derive, due to the different study protocols. However, a firm conclusion that results from these studies is the safety of the use of acupuncture in female infertility, wherein even if there are any remaining doubts on its positive effects in female fertility and pregnancy, there are no adverse affects associated with its use (Sterner-Victorin & Humaidan, 2006). The use of acupuncture as an adjuvant therapy in hormonal and technological interventions in female infertility is not restricted to only when ART is performed. Review of literature on the use of acupuncture along with in vitro fertilization (IVF) suggests that there are four possible mechanisms, whereby acupuncture offers beneficial effects to improve the outcomes of IVF, when employed as an adjunct therapy to IVF. These four mechanisms are modulation of the neuro-endocrinological factors; enhancing blood perfusion to the uterus and ovaries; modulation of cytokines, and reduction in stress, anxiety, and depression. As such acupuncture is associated with improving successful outcomes of IVF, improving the quality of life of women undergoing IVF, and it is a safe adjunct therapy to IVF. However, these conclusions need to given a lot of thought, as there are design limitations associated with most of the studies reviewed, and the acupuncture interventions employed cannot be taken as following all the principles of acupuncture interventions as put forth by traditional Chinese medicine. There is the need for larger number of studies with better design of high-quality, randomized and control elements, like the use of placebo acupuncture controls, authentic acupuncture interventions, along with a spectrum of outcome measures that are associated with clinical outcomes for a better perception of the efficacy of acupuncture as an adjunct to IVF (Anderson et al, 2007). Wang et al, 2007, evaluating whether acupuncture done during the follicular phase and luteal phase and not on the day that embryo transfer is performed in comparison to controls, offers better outcomes for IVF-ET, found that pregnancy rates of women subjects undergoing IVF-ET and acupuncture had no significant increase over the controls. This led the authors to conclude that acupuncture performed during the follicular phase and the luteal phase does offer improvement in pregnancy outcomes following IVF-ET (Wang et al, 2007). A recurring theme in the literature review is the caution to be observed in the acceptance of the evidence on the utility of herbal medicine and acupuncture in female infertility. This theme is reflected in the words of Kovacs 2008, “although there are some promising results, firm conclusions cannot be drawn yet due to methodologic issues with most studies”. In essence methodologic issues along with the lack of appropriate controls make the findings of most studies on the beneficial effects of acupuncture and herbal medicine in female fertility lack reliability. This status calls for larger, well-designed studies, with appropriate controls necessary to establish the place of herbal medicine and acupuncture in the management of infertility in women (Kovacs, 2008). 3. Objective of the Study The objective of the study is to answer the question Is there enough reliable evidence to support the use of acupuncture in the management of infertility in women? In answering this question the study aims to 1. Evaluate the evidence available on the use acupuncture in the management of infertility. 2. Whether this evidence supports the use of acupuncture as a stand alone strategy in the management of infertility in women or whether it is better used as an adjunct to hormonal and technological in the management of infertility in women. 4. Research Methodology The research methodology chosen for this study is qualitative, with a systematic literature review as the means of obtaining the data for in arriving at the findings of the study. The choice of a qualitative approach for the study is based on the inductive nature of qualitative research that enables the generation of solutions based on the available information on a given subject (Bryman, 2004). The choice of a systematic literature review for obtaining the required data lies in the ability of a systematic literary review to expand the knowledge that has been created by exploratory research on a particular subject, with particular emphasis on research design and methodologies used (Ruane, 2005). This is of relevance in this study, with the literature review recommending caution in the acceptance of evidence of the studies explored, because of methodologic issues along with the lack of appropriate controls. Obtaining relevant articles for the literature review will come from an initial activity of scouring the local library for articles relevant to the aims of the study. Relevant articles thus found would be kept aside for inclusion in the study. This activity will be followed by the use of the Internet to access databases like Medline, PubMed, and CINAHL for additional journal articles relevant to the aims of the study. Search terms used will include “acupuncture in the management of infertility in women”, “role of acupuncture in the management of infertility in women”, “managing infertility in women”, “acupuncture as an adjunct to ART”, “acupuncture as an adjunct to IVF”, and acupuncture in embryo transfer”. The inclusion and exclusion criteria will be employed to the journal articles thus collected. The inclusion criteria will consist of articles published on or after the year 2000. Articles published before the year 2000 will be excluded for the study purposes. The study expects to find that acupuncture has a useful role to play in management of infertility in women. It also expects to find that this beneficial role of acupuncture is best suited as an adjunct to the hormonal and technological interventions of IVF and ART in the management of infertility in women. This study expects to confirm these findings and thereby contribute to enhancing the pregnancy outcomes in the use of IVF and ART in the management of infertility in women, thereby benefiting women who would like to have children in spite of the infertility problems that they face. 5. Time Schedule GANTT CHART Activity Aug 09 Sep 09 Oct 09 Nov 09 Dec 09 Jan 10 Feb 10 Administrative Sanctions ----- Literary Search ----- Literary Review ----- ----- ----- Writing the Report ----- ----- Submitting the Report ----- 6. Budget Costing Table Sl. No. Item Costing in $ 01 Salaries – Researchers (2x $2000 x 7) + Support Staff (1x $1000 x 7) 35,000 02 Hire Charges – Computer, Furniture, etc. 7,000 03 Communication 7,000 04 Transportation 3,500 05 Consumables 3,500 Total 56,000 7. Ethical Issues Administrative sanction will be applied for prior to the start of the study. The study proposal will be submitted to the University Study Review Board for sanction to conduct the study. Amendments to the study proposal will be made, in case the Review Board calls for such changes. In any case the study will commence only with approval of the Review Board. The articles used for the study is the intellectual property of the authors of the articles. In case the authors require that their permission be sought before use in any studies, the permission would be sought and the articles used only with the permission of the authors. In the case of articles where permission is not require, due acknowledgement will be given to the authors, every time the article is used within the text and also in the list of references at the end of the report of the study. Literary References Anderson, B. J., Haimovici, F. Ginsburg, E. S., Schust, D. J. & Wayne, P. M. 2007, ‘In vitro fertilization and acupuncture: clinical efficacy and mechanistic basis’, Alternative therapies in health and medicine, vol.13, no.3, pp.38-48. Bryman, A. 2004, ‘Social Research Methods’, Oxford University Press: Oxford. Chang, R., Chung, P. H. & Rosenwaks, Z. 2002, ‘Role of acupuncture in the treatment of female infertility’, Fertility and sterility, vol.78, no.6, pp.1149-1153. Dennehy, C. 2006, ‘The Use of Herbs and Dietary Supplements in Gynecology: An Evidence-Based Review’, Journal of Midwifery & Womens Health, vol.51, no.6, pp.402-409. Garcia, J. E. & Nelson, L. M. 2006, ‘Infertility’, emedicine from WebMD [Online] Available at: http://emedicine.medscape.com/article/274143-overview (Accessed April 11, 2009) Goldberg, B., Trivieri, L. & Anderson, J. W. 2002, ‘Alternative medicine’, Celestial Arts: San Francisco. Heese, I. 2006,’ The ‘egg factor’: Using Chinese herbal medicine to improve fertility in a 45-year old woman’, Journal of Chinese Medicine, no.82, pp. 36-41. Howell, L., Kochar, K., Saywell, R., Zollinger, T., Koehler, J., Mandzuk, C., Sutton, B. Sevilla-Martir, J. & Allen, D. 2006, ‘Use of herbal remedies by Hispanic patients: do they inform their physician?’ Journal of the American Board of Family Medicine, vol.19, no.6, pp.566-578. Kovacs, P. 2008, ‘Viewpoint: Use of Acupuncture in the Treatment of Subfertility’, Medscape Ob/Gyn & Womens Health [Online] Available at: http://www.medscape.com/viewarticle/581008 (Accessed April 11, 2009). Ruane, J. M. 2005, ‘Essentials of Research Methods: A Guide to Social Science Research’, Blackwell Publishing: Massachusetts. Sterner-Victorin, E. & Humaidan, P. 2006, ‘Use of acupuncture in female infertility and a summary of recent acupuncture studies related to embryo transfer’, Acupuncture in medicine, vol.24, no.4, pp.157-163. Wang, W., Check, J. H., Liss, J. R. & Choe, J. K. 2007, ‘A matched controlled study to evaluate the efficacy of acupuncture for improving pregnancy rates following in vitro fertilization-embryo transfer’, Clinical and experimental obstetrics & gynecology, vol.34, no.3, pp.137-138. Read More