Characteristics and Outcomes of Female Infertility Treatment Programs Using Traditional Medicine in Korea: A Multisite Analysis

Introduction

In complementary and alternative medicine, infertility has long been recognized as a treatable disease, and attempts have been made to treat this condition using acupuncture, moxibustion, and traditional Korean medicine (TKM). ¹ Recently, a number of published studies have shown that acupuncture and Korean herbal medicine are effective for treating infertility in women. ^2,3

The total fertility rate worldwide, at an average of 2.50 people from 2010 to 2015, has declined by 1.9 people compared with the average of 4.44 people from 1970 to 1975. ⁴ In Korea, the total birth rate in 2014 was 1.205, and this rate has now fallen short of 1.30, which is the reference line for the lowest fertility, for more than 10 consecutive years. ⁵ Moreover, the natural increase in the population, which is obtained by subtracting the number of deaths from the number of births, was only 167,200, which is the lowest reported value since the national birth survey was started. Although most European countries have shifted from high fertility societies to low fertility societies over an extended period, that is, greater than one century, the change in Korea's birth rate is rapid and unprecedented. ⁵

However, that global levels of primary and secondary infertility hardly changed between 1990 and 2010, ⁶ in Korea, the number of individuals who have been diagnosed as infertile increased by an average of 7.7% annually from 2005 to 2011. Given that this value was 190,000 persons in 2011, support programs are considered an essential element for the promotion of childbirth. ⁷

To respond to infertility, the Korean government has investigated the cause for this low fertility, and it continues to provide overall measures to address the problem. One such representative government program is termed the “National Support Program for Infertile Couples” under which the government provides support for the cost of fertility procedures, including in vitro fertilization (IVF) and artificial insemination. ⁸

However, it is important to note that assisted reproductive technologies, including IVF and artificial insemination, are a series of medical and laboratory processes that artificially induce ovulation, collect eggs, incubate them in laboratory and perform various manipulations for insemination. As such, there can be side effects and sequelae due to the drugs and procedures used in these processes. ⁹

Given the potential risks associated with assisted reproductive technologies, local governments have conducted TKM infertility support programs. However, in the absence of national TKM infertility support program guideline, there were many differences in subject, duration, method, support system, and budget according to the situation of each local government. In all programs, the subject was selected as a female with a diagnosis of infertility, but in some cases, there was a limit depending on age, receiving biomedical fertility treatment, and contraceptive use, etc. There were also programs with only treatment periods and with additional follow-up periods. Especially, the program, which was conducted in cooperation with the local public health center or the local university, was managed systematically and the detailed data remained. However, in the case where the local Korean medicine doctor performed alone, the quality of the business was relatively low and the data were often poor. Although historical evidence is abundant, medical evidence for the role of TKM in infertility remains insufficient. In the following study, the authors analyzed the results of the TKM infertility support projects performed in Korea between 2006 and 2016.

Method

Results

Discussion

Thirteen TKM infertility treatment programs ^{10 –18} were included in this study. In total, 205 of 887 participants receiving follow-up reported successful pregnancies (23.1%).The clinical pregnancy rates of the Daegu 2009 program, Daegu 2010 program, ¹² and Iksan 2015 program ¹⁶ were greater than 30%, whereas the rates for the Daegu 2013 program, Daegu 2014 program, ¹⁸ and Incheon 2011 program ¹⁷ were less than 20%. According to the Iksan 2014 report, ¹⁵ an older age of participants and longer duration of infertility were noted as reasons for decreased pregnancy rates. Therefore, the variety of enrolled participants might have affected the differences in pregnancy rates between programs.

Moreover, the high pregnancy rates for the Daegu 2010 program could not be regarded as typical results because the rates were attributed to high dropout rates (47.4%). ¹²

In a study conducted in 2009, in which 15,450 subjects were given financial support for procedures performed under the government's support program for infertile couples, 93.9% of females and 72.8% of male subjects visited TKM hospitals for a diagnosis of infertility and treatment. In addition, 77.9% of subjects before their infertility diagnosis and 71.6% after their diagnosis used TKM services to overcome infertility, indicating that demand for TKM service is high. ¹⁹

The authors found that the pregnancy rate was lower than 32.4% ($2,280 per session, 2012) for each external procedure and greater than 13.5% ($486 per session, 2012) for artificial fertilization in Korea. ²⁰ It is notable that the primary objective was natural conception, which was achieved by some couples, although the sexual relationships between husband and wife, a key factor to pregnancy, cannot be controlled in the clinic. Similarly, this finding is notable because most of the patients were not followed since completion of the programs and only included pregnant patients during programs. It is assumed that the actual frequency of intercourse between couples would be lower than estimated, based on the results showing that an infertile woman experiences a decline in sexual function and a reduced frequency of sexual intercourse during marital life ²¹ and that the male spouse in an infertile couple also reports to suffer from reduced sexual function. ²² There is also a large possibility that TKM treatment was not considered as a primary treatment for infertility-related anamnesis. ¹⁹ Together, these factors are assumed to have an effect on the pregnancy rate.

Upon assessing the 13 programs with regard to the interventional details, the Korean herbal formulas used were primarily Jogyeongjongok-tang (Tiaojing Zhongyu Tang) and Onkyung-tang (Wenjing Tang). Jogyeongjongok-tang (Tiaojing Zhongyu Tang) is reported to promote ovarian growth, ovulation, and maturity of the ovarian follicle, leading to fertilization and increased embryo generation. ^{12 –16} Onkyung-tang (Wenjing Tang) exhibits positive effects by relaxing the muscles of the uterus, balancing hormone secretion and controlling proliferation of endometrium tissues. ^23,24 Common acupoints, such as ST36, SP6, LR3, LI4, and SP10, and ear acupuncture used in the included programs have been utilized successfully in past reproductive therapy studies. ^3,25,26 Brain, Hormone, and Uterine are among the auricular points most frequently used in treatments of the urogenital system, endocrine system, and gynecology-related disease. ²⁵ Previous surveys on TKM for infertile Korean patients ²⁷ have reported the similar use of herbal medicines, acupuncture, and moxibustion. Thus, it is assumed that the most clinically popular prescriptions were considered for the programs included in the analysis. In addition, the treatment periods, which ranged from 3 to 4 months in most cases, were also estimated according to clinical recommendations. ²⁸

In East Asia, various treatments have long been available to help women become pregnant and give birth. ²⁹ Today, many Korean women still follow traditional body restoring methods over the course of pregnancy and when giving birth. Individual Korean medical clinics have long engaged in treatments for infertile women. However, due to the lack of guidelines, such as the Clinical Practice Guideline, previous treatments have differed from one another. In addition, clinical research was insufficient to demonstrate treatment effects. ¹³ Subsequently, the Korean government provided subsidies to local governments for infertility treatments using TKM, and the publication of reports from these complied data have increased the credibility of these methods.

Given that ART can increase the possibility of premature birth compared with natural conception, ³⁰ cause instability and stress due to invasive procedures and emotional strain, ²⁰ and may not sustain an increase in the conception rate, ³¹ TKM treatments are essential components of infertility treatment programs.

TKM should serve as the primary treatment method before any ART based on research results showing that diverse TKM treatments, including acupuncture, can have positive effects on the conception rate and birth rate among infertile women, especially when external fertilization is executed. ^32,33 Reported improvements in overall symptoms, such as menstrual pain, premenstrual syndrome, and vaginal discharge, also support the significance of TKM as a primary treatment method.

In Korea, 60% of couples who inquire about infertility are subsequently diagnosed with this condition and may spend three to six million won during the treatment period on supplements and alternative medicine. More aggressive and social approaches are desirable considering the positive recognition of TKM among infertile couples and the increased preference and satisfaction with this method. ¹⁹

However, specific limitations of this analysis should be noted. First, each program included different treatments, durations, years with no control group, and the number of participants varied in size from 18 to 261. Some programs have runs for multiple years, while some have not, and treatments provided in the programs were quiet varied: acupoints, acupuncture treatment frequency and method, herbal medicine variety and dose, and utilization of moxa. Also, some programs have collected more detailed data than others. Thus, clinical studies on infertility treatment should be conducted to develop the best standard of care.

In addition, the effects and economics of an objective treatment should be analyzed to help infertile couples obtain reasonable treatments. Also, 23.1% pregnancy rate of TKM receiving patients include natural pregnancy rate during each program so that it has limitation to reflect the only TKM program's effect. Only 98 of 205 patients reported method of pregnancy among natural, IVF, and intrauterine device (IUD).