Asian Medicine & Acupuncture Research, Department of Physical Medicine & Rehabilitation, University of North Carolina at Chapel Hill, NC, USA.
J Altern Complement Med. 2010 Feb;16(2):193-8. doi: 10.1089/acm.2008.0600.
We aim to determine the safety and effectiveness of a standard therapeutic package of Korean medicine for the treatment of unexplained infertility in a cross-section of women who sought treatment at an integrative hospital in Seoul, Korea.
Infertility affects more than 1.2 million women in the United States alone. Treatment options for infertility vary, yet the barriers of invasiveness, cost, and access inhibit treatment use for many women. Alternative medical approaches exist for this indication, and sustain certain popularity. Therefore, we systematically studied a standard therapeutic package of Korean medicine to treat unexplained infertility in women.
Female participants included in this observational study met inclusion criteria before receiving a set of treatments including herbal medicine, acupuncture, and moxibustion. A study physician screened each patient in accordance with inclusion criteria, provided study information, and after the patients consented, performed the baseline assessment. Assessments included age, the history of assisted reproductive technology, and duration of infertility. The key outcome measure included the number who achieved pregnancy and any neo-natal morbidity and mortality at follow-up stage for those who got pregnant. Any other adverse events including aggravation of existing symptoms, and the number of dropouts, were recorded. Treatments were supposed to be completed after 6 menstrual cycles between February 2005 and April 2006.
One hundred and four (104) women with unexplained infertility were included in this observational study. Participant mean age was 32 years (SD: 2.7), with a range between 26 and 41 years. The median duration of infertility after diagnosis was 33.5 weeks (interquartile range: 20.8-50.3). In total, 41 participants (39.4%) had undergone a mean number of 1.4 (SD: 2.2) assisted reproductive technology treatments prior to joining the study. The number of patients remaining in or achieving pregnancy throughout the 6-month study period was 23 (14 pregnancies), 22.1%. Six (6) participants (4.8%) reported minor adverse events including rash in the face (n = 1), diarrhea (n = 2), dizziness (n = 1), and heartburn (n = 2). Of the 14 pregnancies, there were 10 normal births, and 4 miscarriages; otherwise, no neonatal morbidity/mortality occurred. According to per protocol analysis, 14 pregnancies out of 23 total were achieved by those who remained for the entire six menstruation cycle treatments, yielding a pregnancy rate of 60.9%.
The standard therapeutic package for unexplained infertility in women studied here is safe for infants and the treated women, when administered by licensed professionals. While it remains challenging to have the target population complete a 6-month treatment course, during which most patients have to pay out of pocket, the extent of successfully achieved pregnancy in those who received full treatment provides meaningful outcomes, warranting further attention. A future study that includes subsidized treatment costs, encouraging the appropriate compliance rate, is warranted. 194.
我们旨在确定在韩国首尔一家综合医院接受治疗的女性中,一套标准的韩医学治疗方案治疗不明原因不孕的安全性和有效性。
在美国,仅不孕的女性就超过 120 万。不孕的治疗选择多种多样,但由于侵入性、成本和获取途径的障碍,许多女性无法接受治疗。对于这种病症存在替代医学方法,并具有一定的知名度。因此,我们系统地研究了一套标准的韩医学治疗方案,以治疗女性的不明原因不孕。
本观察性研究纳入的女性参与者在接受包括草药、针灸和艾灸在内的一系列治疗前符合纳入标准。一名研究医生根据纳入标准对每位患者进行筛查,提供研究信息,在患者同意后,进行基线评估。评估包括年龄、辅助生殖技术史和不孕持续时间。主要结局指标包括怀孕的人数以及那些怀孕的人在随访阶段的任何新生儿发病率和死亡率。记录任何其他不良事件,包括现有症状加重和脱落人数。治疗应在 2005 年 2 月至 2006 年 4 月期间的 6 个月经周期内完成。
本观察性研究共纳入 104 例不明原因不孕的女性。参与者的平均年龄为 32 岁(标准差:2.7),年龄范围为 26 至 41 岁。诊断后不孕的中位持续时间为 33.5 周(四分位距:20.8-50.3)。共有 41 名参与者(39.4%)在加入研究前平均接受了 1.4 次(标准差:2.2 次)辅助生殖技术治疗。在整个 6 个月的研究期间,仍在治疗或成功怀孕的患者人数为 23 人(14 例妊娠),占 14 例妊娠。6 名(6%)参与者报告了轻微的不良事件,包括面部皮疹(n=1)、腹泻(n=2)、头晕(n=1)和烧心(n=2)。14 例妊娠中,有 10 例为正常分娩,4 例为流产;否则,无新生儿发病率/死亡率。根据方案分析,23 名患者中,有 14 名在整个 6 个月经周期的治疗中完成了治疗,妊娠率为 60.9%。
当由持牌专业人员管理时,针对女性不明原因不孕的标准治疗方案对婴儿和接受治疗的女性是安全的。虽然让目标人群完成 6 个月的治疗疗程仍然具有挑战性,因为大多数患者都需要自费,但在接受完整治疗的患者中成功怀孕的程度提供了有意义的结果,值得进一步关注。需要进行一项包括补贴治疗费用、鼓励适当合规率的未来研究。194.