Acupuncture and chinese herbal treatment for women undergoing intrauterine insemination

ARTICLE IN PRESS
Available online at www.sciencedirect.com Acupuncture and Chinese herbal treatment for women undergoing Keren Sela , Ofer Lehavi , Amnon Buchan , Karin Kedar-Shalem , a Unit of Complementary Medicine, Tel Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizmann St., Tel Aviv 64239, Israel b Fertility Research Institute, Tel Aviv Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel Received 19 September 2010; received in revised form 10 April 2011; accepted 11 April 2011 Abstract
Aim: To assess the effect of traditional Chinese medicine (TCM, acupuncture and medicinal herbs) as a therapeutic adjuvant to ovulation inductionwith intrauterine insemination (IUI) procedures and evaluate its contribution to pregnancy and “take-home baby” rates.
Materials and methods: A comparative retrospective study was carried out in a university – affiliated municipal hospital. All women undergoingartificial insemination by donor spermatozoa (AID) and concomitantly treated with TCM were invited to participate. The enrolled women underwentweekly TCM in parallel with medical therapy. The treatment lasted between 2 and 36 cycles (equivalent to a time period ranging from one monthto one year). The control group was comprised of women who underwent AID without TCM and whose data were retrospectively retrieved fromhospital files. Pregnancy was assessed by human chorionic gonadotropin findings in blood 12–14 days after IUI. The birth rate was calculatedduring follow-up.
Results: A total of 29 women aged 30–45 years were enrolled in the study. The historical control group included 94 women aged 28–46 years.
Women who combined TCM with the procedures for undergoing IUI had significantly higher pregnancy (OR = 4.403, 95% CI 1.51–12.835,p = 0.007) and birth rates (OR = 3.905, 95% CI 1.321–11.549, p = 0.014) than the control group.
Conclusions: TCM appears to be beneficial as an adjunctive treatment in IUI procedures. Randomized controlled trials are needed to further assessthe role of acupuncture and herbs in this setting.
2011 Elsevier GmbH. All rights reserved.
Keywords: Traditional Chinese medicine; Infertility; IUI; Integrative medicine Introduction
120,000 treatment cycles were performed in clinics in the UnitedStates alone The term “infertility” is generally defined as the failure of a Two critical factors in establishing the prognosis, time course couple to conceive after 12 months of regular unprotected inter- for evaluation and treatment are the age of the female partner course. Around 10–15% of couples have difficulty conceiving at and the duration of infertility. In general, there is a decrease in some point in their reproductive lives and seek specialist fertil- fertility with age. Studies show a decrease in monthly fecun- ity treatment n 2000, about 200,000 babies were conceived dity beyond age 30 with a more significant decline after age 35 through in vitro fertilization (IVF) worldwide, and in 2003, over The causes of this age-related decrease in conception haveto do with chromosomal abnormalities, spontaneous abortions,aging of oocytes and luteal phase defects that are characteris-tic findings among older women. In terms of the duration of ∗ Corresponding author at: Laboratory of Herbal Medicine and Cancer infertility, women who have not conceived after 2–3 years have Research, Research, Complementary and Integrative Medicine Unit, Israel.
a poor prognosis, although the advances in assisted reproduc- Tel.: +972 3 6947506; fax: +972 3 6974789.
tion therapies (ART) have greatly enhanced the likelihood for E-mail address: (S. Lev-ari).
1876-3820/$ – see front matter 2011 Elsevier GmbH. All rights reserved.
Please cite this article in press as: Sela K, et al. Acupuncture and Chinese herbal treatment for women undergoing intrauterine insemination.
Eur J Integr Med (2011), doi: ARTICLE IN PRESS
K. Sela et al. / European Journal of Integrative Medicine xxx (2011) xxx–xxx Originating 2500 years ago in China, acupuncture is one of and Ligusticum Chuanxiong Both acupuncture and Chi- the most widespread forms of complementary and alternative nese herbal medicine have been widely used for thousands of medicine (CAM) in the USA and Europe The general years in Eastern societies and are gaining rapid popularity in the theory of acupuncture is based on the premise that disruptions of natural balanced energy flow (Qi) are responsible for diseasepathogenesis. The use of acupuncture is aimed at correcting Aim of the study
these imbalances and restoring health by the stimulation ofanatomical points on the skin with thin metallic needles that are To date, no studies have been done to assess effect of acupunc- usually manipulated by the practitioner’s hands or by electrical ture in combination with Chinese herbs on patients undergoing stimulation. The National Institutes of Health (NIH) Consensus Panel on Acupuncture (1997) concluded that acupuncture may The present study employs a retrospective study, the first in be useful as an adjunct treatment or an acceptable alternative in our knowledge, to investigate the effect of both acupuncture and a comprehensive management program for avoiding the use or Chinese herbs as an adjunct to women undergoing AID.
reducing the dose of conventional medication ge clinicaltrials have shown that acupuncture is an effective treatment fora variety of conditions Materials and methods
The topic of infertility and traditional Chinese medicine (TCM) has sparked much curiosity over the past few years.
Paulus et al. evaluated the effect of acupuncture on the pregnancyrate in ART (IVF) by comparing a group of patients who under- The Chinese Medicine Department is part of the Fertility went acupuncture treatment shortly before and after embryo Research Institute in the Tel Aviv Sourasky Medical Center transfer with a control group that did not have acupuncture (TASMC). It is an outpatient clinic that caters to both women Those authors’ conclusions were that acupuncture seemed to be and men undergoing fertility treatments. In order to form our a useful tool for improving pregnancy rates after IVF. More study group, we included all the patients who underwent IUI recent randomized controlled studies evaluated the effect of by donor spermatozoa between the years 2002 and 2007. From acupuncture on reproductive outcome in patients treated with 110 female patients treated in our clinic, 45 underwent artifi- IVF/intracytoplasmic sperm injection (ICSI) Again, cial insemination by donor spermatozoa (AID). Excluding those both studies showed that acupuncture on the day of embryo who underwent IVF (n = 16), the remaining 29 women who transfer significantly improved the reproductive outcome of underwent IUI treatments comprised our study group.
IVF/ICSI compared with no acupuncture. A recently publishedsystematic review and meta-analysis of randomized controlled trials suggested that acupuncture given concomitantly withembryo transfer improves the rates of pregnancy and of live A team of two accredited acupuncture practitioners selected births among women undergoing IVF A research team acupuncture points and herbal formulae based on the TCM from Hong Kong further validated this claim In addition, method of pattern discrimination. This method aims at har- acupuncture may be effective in restoring ovulation in patients monizing different organ systems based on symptoms (menses with polycystic ovarian syndrome contributing a posi- history, number of eggs in failed treatment protocols, basal body tive effect on subfertility. In contrast, several other studies failed temperature, endometrial thickness and more) and signs (anal- to show any beneficial role of acupuncture in this field ysis of tongue and radial pulse, abdomen and body palpation).
One such example showed that placebo acupuncture was more Once a pattern of disharmony has been determined, the treatment effective than real acupuncture, drugs or other procedures in seeks to balance the body by acupuncture and herbal treatment.
enhancing pregnancy rates during IVF treatments Tonification of the kidney system and of the spleen qi, tonifi- Three main mechanisms have been suggested to explain cation of the liver blood and heart blood, and harmonization the effect of acupuncture on subfertility: by regulating the of the liver are common treatment principles in many cases of hypothalamic–pituitary–ovarian axis thus affecting ovulation infertility. They roughly correspond to anovulation patterns, thin and the menstrual cycle by affecting blood flow to the endometrial lining and poor ovarian quality due to age.
uterus by affecting endorphin production and secre- The standard acupuncture intervention in our institution tion, thus inhibiting the central nervous system and reducing entails the insertion of disposable sterile 0.16-mm thick nee- dles manufactured by “Seirin” company, Japan, and imported by Herbal medicine is the other large branch of TCM. Simi- “Medicin Bom” Co., with Israeli Health Department approval.
larly to acupuncture, herbal treatment aims at restoring balance Acupuncture is performed after alcohol wipe of the skin at and health by administering medicinal properties from plants, the specific point. Needles are left in place and manipulated animals and minerals. The Chinese pharmacopoeia includes manually. Treatments generally last for 20–25 min and are thousands of such herbal products, and their use in the field administered weekly, with special attention given during the fol- of gynecology and obstetrics both in China and in the west is licular phase. Treatment was sometimes given post-ovulation as widespread Some examples of these substances are Peo- well, such as in cases of luteal phase defect or frequent miscar- Please cite this article in press as: Sela K, et al. Acupuncture and Chinese herbal treatment for women undergoing intrauterine insemination.
Eur J Integr Med (2011), ARTICLE IN PRESS
K. Sela et al. / European Journal of Integrative Medicine xxx (2011) xxx–xxx Comparison of baseline data on women who underwent concomitant artificial Multi-variant analysis for primary outcomes (A) pregnancy (B) birth rates insemination by donor spermatozoa (AID) and traditional Chinese medicine comparison between the intervention and control groups, while controlling for treatment (TCM, study Group) and women who underwent AID alone (controls).
independent variables taken at baseline. All outcome measures were analyzedseparately, with a p-value <0.05 indicating statistical significance.
Herbal formulae aimed at restoring balance and well-being are also tailored to specific needs. These formulae are frequently changed according to the menstrual cycle and medical interven- tions. Some examples of Chinese herbs that are used includePeonia Albae, Angelica Sinensis, Rehmannia and LigusticumChuanxiong. Herbal formulas are administered in powder or raw cycles. We used the t-test to assess for differences in independent (dried) form and imported by “Zen Herbs”, with Israeli Health variables at baseline between intervention and control groups.
The Fisher exact test was used to compare pregnancy and birthrates between the groups. We performed multiple regression to test for primary outcomes (pregnancy and birth rates) betweenthe intervention and control groups, while controlling for inde- Our primary outcome measure was a positive human chori- pendent variables (age, number of IUI cycles). All outcome onic gonadotropin (HCG) blood test carried out 12–14 days measures were analyzed separately, with a p-value <0.05 indicat- post-ovulation. We also measured the birth rates of the study ing statistical significance. Statistical analyses were performed and control groups during follow-up.
The study group consisted of 29 women who underwent Nineteen of the twenty-nine women in the study group con- AID concomitantly with TCM. Primary infertility accounted for ceived (65.5%), of whom twelve delivered and six miscarried.
58.6% of these cases. Their average age was 39.43 years (ranged Thirty-seven of the ninety-four women in the control group con- 30–45), and they had previously undergone an average of nine ceived (39.4%), of whom twenty-five delivered (26.6%) and AID cycles before seeking Chinese medical intervention. They continued the course of TCM for an average of five more cycles A multi-variant analysis for differences between the inter- vention and control groups, for primary dependent variables ofpregnancy and birth rates while controlling for possible con- founders (age, number of IUI treatments) has demonstrated thatacupuncture group resulted in higher rates of both pregnancies The control group for this study was retrieved from a large (OR = 4.403, 95% CI 1.51–12.835, p = 0.007) and birth rates pool of women who underwent AID in our Fertility Research (OR = 3.905, 95% CI 1.321–11.549, p = 0.014). Institute. We randomly retrieved patients’ files between 2002 marizes the comparison of pregnancy and birth rates of the 29 and 2007 and selected the women who were between 30 and 45 patients who underwent concomitant TCM and AID and those years of age at the beginning of AID treatments. Excluded were women diagnosed as having cancer or clotting irregularities as Six women (20.7%) in the acupuncture intervention group well as those who had undergone AID treatments for more than and twelve (12.8%) of the control comparison group had mis- two consecutive years. A total of 94 women fulfilled these crite- carriages. This had no statistical significance (p = 0.367).
ria. Their average age was 37.12 years and they had undergone There were no adverse effects caused by either the acupunc- an average of six AID treatments. Ten of these women (11%) had ture needles or herbal formulae in the TCM patients.
conceived in the past. All women in study and control groupshad a hormonal profile that supported ovulation.
Discussion
the baseline characteristics of patients in The results of this comparative study demonstrated that TCM may be effective in enhancing fertility of women undergoing AID. The study group showed a significantly higher (p = 0.019)cumulative pregnancy rate (65.5%) over an average 4.5-month The patients’ records were retrospectively reviewed for treatment period compared to the control group (39.4%). In com- demographic information, such as age and number of previous parison, a retrospective analysis of 6139 AID cycles conducted Please cite this article in press as: Sela K, et al. Acupuncture and Chinese herbal treatment for women undergoing intrauterine insemination.
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K. Sela et al. / European Journal of Integrative Medicine xxx (2011) xxx–xxx in our facility between 1980 and 1997 showed a cumulative Conflict of interest
pregnancy rate of 36%, 53%, and 75% for 3, 6 and 12 months,respectively t should be noted that the average age of the women who underwent combined TCM and AID was 39 years,which is two years older than the average age of the controlgroup. As shown in this age difference has statisticalrelevance and makes the results more meaningful, given that References
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