The effectiveness, safety, and economic evaluation of Korean medicine for unexplained infertile women

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Abstract

Infertility is a condition in which a woman has not been pregnant despite having had normal intercourse for 1 year. The number of unexplained infertile females is increasing because of late marriage customs, as well as environmental and lifestyle habits. In Korea, infertile females have been treated with Korean medicine (KM). However, these effects have not been objectively confirmed through clinical trials. Therefore, this study was conducted to demonstrate the effectiveness of herbal medicine treatment in infertile patients and to demonstrate the economic feasibility through economical evaluation with assisted reproductive technology.

This study is designed as a multicenter, single-arm clinical trial. All participants included will be from 3 Korean Medicine hospitals in Korea and will voluntarily sign an informed consent agreement. All recruited patients will conduct related surveys and tests, and be provided with treatment according to their menstrual cycle. Patients will take herbal medicines for 4 menstruation cycles and receive acupuncture and moxibustion treatment at 3 times (menstrual cycle day 3, 8, 14) during 4 menstruation cycles. They will also undergo an approximately 4 menstrual cycle treatment period, and 3 menstrual cycle observation period. If pregnant during the study, participants will take the herbal medicine for implantation for about 15 days. In this study, the primary outcome will be the clinical pregnancy rate, whereas the secondary outcome will include the implantation rate, ongoing pregnancy rate, and live birth rate.

Ultimately, this study will provide clinical data regarding the effectiveness and safety of KM treatment for females with unexplained infertility and important evidence for establishing standard KM treatments for unexplained infertility. Moreover, we will identify the most cost-effective way to treat unexplained infertility.

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Most cited references 32

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Unexplained infertility: an update and review of practice.

Arpita Ray, Amit Shah, Anil Gudi … (2012)

Of the couples unable to conceive without any identifiable cause, 30% are defined as having unexplained infertility. Management depends on duration of infertility and age of female partner. This review describes and comments on the definition and evidence for the management of unexplained infertility. A literature search was conducted in EMBASE, Medline, Ovid and Cochrane Database of Systematic reviews using the terms 'infertility', 'unexplained infertility', 'idiopathic infertility', 'definition of infertility', 'treatment options', 'intrauterine insemination', 'ovulation induction', 'Fallopian tube sperm', 'GIFT' and 'IVF'. There is no uniform definition for unexplained infertility. This varies in the literature depending on the duration of infertility and the age of the female partner. The treatment of unexplained infertility is empirical and many different regimens have been used. Among these are expectant management, ovulation stimulation with clomiphene citrate, gonadotrophins and aromatase inhibitors, Fallopian tube sperm perfusion, tubal flushing, intrauterine insemination, gamete intra-Fallopian transfer and IVF. The standard protocol is to progress from low-technology to high-technology treatment options. On the best available evidence, an algorithm for management is suggested. There is a definite need for multicentre randomized controlled trials to identify the best treatment option in unexplained infertility using a standard definition. Copyright © 2012. Published by Elsevier Ltd.

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Adverse Events of Acupuncture: A Systematic Review of Case Reports

Shifen Xu, Lizhen Wang, Emily Cooper … (2013)

Acupuncture, moxibustion, and cupping, important in traditional Eastern medicine, are increasingly used in the West. Their widening acceptance demands continual safety assessment. This review, a sequel to one our team published 10 years ago, is an evaluation of the frequency and severity of adverse events (AEs) reported for acupuncture, moxibustion, and cupping between 2000 and 2011. Relevant English-language reports in six databases were identified and assessed by two reviewers. During this 12-year period, 117 reports of 308 AEs from 25 countries and regions were associated with acupuncture (294 cases), moxibustion (4 cases), or cupping (10 cases). Country of occurrence, patient's sex and age, and outcome were extracted. Infections, mycobacterial, staphylococcal, and others, were the main complication of acupuncture. In the previous review, we found the main source of infection to be hepatitis, caused by reusable needles. In this review, we found the majority of infections to be bacterial, caused by skin contact at acupoint sites; we found no cases of hepatitis. Although the route of infection had changed, infections were still the major complication of acupuncture. Clearly, guidelines such as Clean Needle Technique must be followed in order to minimize acupuncture AEs.

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Ovarian hyperstimulation syndrome: pathophysiology and prevention.

Rui A Ferriani, Wellington Martins, Natalia Rocha … (2010)

To review and discuss the pathophysiology and prevention strategies for ovarian hyperstimulation syndrome (OHSS), which is a condition that may occur in up to 20% of the high risk women submitted to assisted reproductive technology cycles. The English language literature on these topics were reviewed through PubMed and discussed with emphasis on recent data. The role of estradiol, luteinizing hormone, human chorionic gonadotropin (hCG), inflammatory mediators, the renin-angiotensin system and vascular endothelial growth factor is discussed in the pathophysiology of OHSS. In addition we consider the prevention strategies, including coasting, administration of albumin, renin-angiotensin system blockage, dopamine agonist administration, non-steroidal anti-inflammatory administration, GnRH antagonist protocols, reducing hCG dosage, replacement of hCG and in vitro maturation of oocytes (IVM). Among the many prevention strategies that have been discussed, the current evidence points to the replacement of hCG by GnRH agonists in antagonist cycles and the performance of IVM procedures as the safest approaches.

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Author and article information

Journal

Journal ID (nlm-ta): Medicine (Baltimore)

Journal ID (iso-abbrev): Medicine (Baltimore)

Journal ID (publisher-id): MEDI

Title: Medicine

Publisher: Wolters Kluwer Health

ISSN (Print): 0025-7974

ISSN (Electronic): 1536-5964

Publication date Collection: December 2017

Publication date (Electronic): 22 December 2017

Volume: 96

Issue: 51

Electronic Location Identifier: e9360

Affiliations

[a ]Graduate School of Korean Medicine, Dongguk University, Gyeongju

[b ]Conmaul Hospital of Korean Medicine, Seoul

[c ]Department of Korean Obstetrics and Gynecology, Dongguk University Ilsan Hospital of Korean Medicine, Goyang, Republic of Korea.

Author notes

[∗ ]Correspondence: Junyoung Jo, 5F Conmaul Hospital of Korean Medicine, 110, Seochojungang-ro, Seocho-gu, Seoul 06634, Republic of Korea (e-mail: studd@ 123456naver.com ); Dong-Il Kim, Department of Obstetrics and Gynecology, College of Korean Medicine, Dong Guk University, 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 10326, Republic of Korea (e-mail: obgykdi@ 123456hanmail.net ).

Article

Publisher ID: MD-D-17-06693 Accession ID: 09360

DOI: 10.1097/MD.0000000000009360

PMC ID: 5758226

PubMed ID: 29390524

SO-VID: 7fccb797-6295-4d4f-a154-e7c4abe13d5e

License:

This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0