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Clinical Studies

infertility clinical studies

There have been numerous clinical studies researching the benefits of acupuncture and Chinese herbal medicine. Here are just a few of them. Select the trials you wish to read about.

Acupuncture and IVF treatment for infertility

Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis. A recent meta-analysis reported in the prestigious British Medical Journal of 7 clinical trials involving 1366 women who underwent IVF treatment for infertility has found that acupuncture, administered within a day of embryo transfer, led to significantly increased rates of pregnancy and live births when compared to either sham (pretend) acupuncture or no acupuncture at all. Women who received acupuncture were around 65% more likely to become pregnant and 91% more likely to have a live birth. The authors of the study conclude: “Current preliminary evidence suggests that acupuncture given with embryo transfer improves rates of pregnancy and live birth among women undergoing in vitro fertilization”. This is a significant endorsement for the use of acupuncture as part of the standard care programme during IVF treatment. www.bmj.com/cgi/content/full/bmj.39471.430451.BEv1

Research into Chinese herbal medicine and ovarian dysfunction

(1) The effectiveness of a Chinese formula called ‘Tian gui fang’ in comparison with metformin was tested on patients with polycystic ovarian syndrome [PCOS]. The patients were divided into two groups and either Tian gui fang or metformin was administered for three months. After treatment, 4 out of the 8 patients on metformin had restoration of menstrual cyclicity, and two of them had a double phase BBT. The testosterone levels had decreased. No other measures changed. In the group that received the Chinese medicine, 6 patients out of 8 had a restored cycle as well as a double phase BBT. Testosterone and the body mass index (BMI) decreased significantly. The authors conclude that both therapies can induce ovulation but that Chinese herbal medicine has a higher efficacy in restoring ovulation and normal BBT measures.

Hou J, Yu J, Wei M. ‘[Study on treatment of hyperandrogenism and hyperinsulinism in polycystic ovary syndrome with chinese herbal formula ‘tian gui fang]’. Zhongguo Zhong Xi Jie he Za Zhi. 2000; 20 (8):589.

(2) The effectiveness of a Chinese herbal formulary was tested on patients with high LH levels due to polycystic ovary syndrome. Eight weeks of treatment with Chinese herbal medicine significantly reduced plasma LH. Ushiroyama T, Ikeda A, Sakai M, Hosotani T, Suzuki Y, Tsubokura S, Ueki M. ‘Effects of unkei-to, an herbal medicine, on endocrine function and ovulation in women with high basal levels of luteinizing hormone secretion.’ J Reprod Med. 2001 May; 46(5):451-6.

(3) In Japan, a Chinese herbal formulary was tested on patients with polycystic ovarian disease [PCOD] to find an effective treatment without side effects that could be used instead of clomiphene citrate or gonadotropin therapy. After a course of treatment, the FSH/ LH ratio had significantly decreased, and the ovulatory rate was 70.6%. Serum testosterone did not change during treatment. The authors conclude that the Chinese formula may be useful for the treatment of anovulation in PCOS patients. Sakai A, Kondo Z, Kamei K, Izumi S, Sumi K. ‘Induction of ovulation by Sairei-to for polycystic ovary syndrome patients.’ Endocr J. 1999 Feb; 46(1):217-20.

(4) A case study from Taiwan discusses the effective treatment of premature ovarian failure using Chinese herbal medicine. Clomiphene citrate therapy over 8 months had not changed the FSH and LH levels from the post menopausal range. A course of 4 months treatment with Chinese herbal medicine based on Zuo gui wan induced an ovulation, and the patient fell pregnant. The authors conclude that Chinese herbal medicine can restore ovarian function effectively and promptly and offers another option for treating infertility in patients with premature ovarian failure. Chao SL, Huang LW, Yen HR. ‘Pregnancy in premature ovarianfailure after therapy using Chinese herbal medicine. A case study.’Chang Gung Medical Journal 2003 Jun; 26(6): 449-52.

(5) At Shanghai medical university, the effectiveness of Chinese medical herbs from the category of yin supplementing weretested on 35 patients with polycystic anovulation. The patients were treated for three months, and a variety of tests were carried out before and after the course of treatment. Testosterone levels lowered significantly. In 59.7% of patients and a regular cycle was restablished. 41.2% of women became pregnant. The authors conclude that Kidney Yin nourishing herbs could provide a good microcircumstance for ovarian follicular growth, which results in ovulation and pregnancy. Zhou LR, Yu J. [Clinical observation on treatment of hyperinsulinemia and hyperandrogenism anovulatory patient with replenishing kidney-yin drugs] Zhongguo Zhong Xi Yi Jie He Za Zhi. 1996Sep; 16(9): 515-8.

(6) Hachimijiogan, a Chinese herbal formulary (Liu wei di huang wan + rou gui, yin yang huo, huang qi), was shown in one study to benefit female infertility due to pituitary dysfunction. Two infertile women (one with and one without a pituitary adenoma) who were resistant to medical treatment, were given Hachimijiogan which subsequently reduced the serum prolactin level, and resulted in a normal ovulatory cycle and pregnancy, without side effects. Usuki S; Kubota S; Usuki Y. Treatment with hachimijiogan, anon-ergot Chinese herbal medicine, in two hyperprolactinemic infertile women’. Acta Obstet Gynecol Scand 1989, 68 (5) p475-8.

(7) In another study looking at pituitary dysfunction causing infertility, 27 women were given the same formulae as discussed above.6 of the women had amenorrhea. In 15 patients, the prolactin levels dropped to a healthy range, and remained low 6 months after the course of treatment. Four patients with amenorrhea ovulated. Eleven patients conceived and delivered a healthy baby. In three women, the prolactin level did not lower. The authors conclude that a modification of Liuwei di huang wan can be a safe and effective treatment for hyperprolactinemic women.

Usuki S, Usuki Y. ‘Hachimijiogan treatment is effective in themanagement of infertile women with hyperprolactaemia orbromocriptine-resistant hyperprolactaemia.’ American Journal of Chinese Medicine 1989; 17 (3-4):225-41.

Research into endometriosis and Chinese herbal medicine

(1) A study from Beijing compared three treatment methods to find the most effective treatment for endometrial ovarian cysts. 152 patients with endometrial ovarian cysts were split into three groups: an integrated laparoscopy and Chinese herbal medicine (combination group), a Chinese herbal medicine group, and a Danazol group. The clinical efficacy, side-effects and reproductive hormones were compared. The shrinking rate and disappearance rate of the cysts were highest in the combination group as was the pregnancy rate. Few side effects were noticed in the combination and Chinese herbal medicine group. The authors conclude that combining laparoscopy with Chinese herbal medicine is an effective treatment for endometrial ovarian cysts with minimal side effects and a maximal preservation of the reproductive function. Wu Y, Hua L, Jin Y [Clinical study on endometrial ovarian cyst treated by integrated laparoscopy and Chinese herbal medicine] Zhongguo Zhong Xi Yi Jie He Za Zhi. 2000 Mar; 20 (3):183-6.

(2) A study was carried out in Shanghai to explore the mechanism of treating endometriosis by tonifying Kidney and removing blood stasis with Neiyixiao Recipe (NYXR). METHODS: One hundred and three patients with endometriosis were divided randomly into the NYXR group (58 cases, treated with NYXR) and the control group (45 cases, treated with danazol) and were reviewed for the improvement of clinical symptoms, serum level of FSH, LH, PRL, E2, P and T, humoral and cellular immunity (C3, C4, CD3, CD4, CD8), and plasma prostaglandin after treatment. RESULTS: There was no significant difference in effect between the NYXR group and the control group in relief of dysmenorrhea and degradation of elevated plasma prostaglandin (chi 2 = 0.71, P > 0.05). But there was significant difference between the two groups in curing infertility (chi 2 = 14.77, P < 0.01), and the effect of NYXR in regulating endocrine and immunity was significantly better than that of danazol. The authors conclude that by tonifying Kidney and removing blood stasis, Chinese herbal medicine is an effective method for the treatment of endometriosis, simultaneously maintaining and improving fertility. Liu J, Li X, Hu X. [Clinical observations on treatment of endometriosis by tonifying kidney and removing blood stasis] Zhongguo Zhong Xi Yi Jie He Za Zhi. 1998 Mar;18 (3):145-7.

(3) A study in Shanghai tested the therapeutic mechanism of endometriosis by the treatment of Yiqi Huoxue Huayu Tongfu Principle (YQHXHYTFP, tonifying Qi and promoting blood circulation to remove stasis and purgation therapy) with Neiyi 1+ pill. METHODS: Forty-five cases with endometriosis were divided randomly into TCM group (30 cases, treated with Neiyi 1+ pill) and the control group (15 cases, treated with tamoxifen). The activity of natural killer cell of peripheral blood, T lymphocyte subsets, secreting interleukin-II and the EmAb were determined. RESULTS: Endometriosis is associated with immunologic disturbance. After treatment, the activity of NK cells and the count of T-suppressor cells were significantly increased (P < 0.01), the count of T-helper cells, the secretion of interleukin-II and TH/TS ratio were significantly reduced (P < 0.01). Over 50% of the cases whose EmAb was positive eventually turned to negative. The effective rate of this therapy was 90%. There was no significant difference between TCM group and the control group. CONCLUSION: Chinese herbal medicine could modulate the immunologic disturbance in women with endometriosis, and could clearly improve clinical symptoms and signs. Li J, Zheng J, Wang D. [Clinical observation on treatment of endometriosis by tonifying qi and promoting blood circulation to remove stasis and purgation principle] Zhongguo Zhong Xi Yi Jie He Za Zhi. 1999 Sep; 19 (9):533-5.

(4) A study in Kunmin aimed to find a medicine that treats endometriosis effectively with less side-effects. METHODS: A Chinese herbal prescription [Dan’e mixture] (DEM, consists of Radix Salviae Miltiorrhizae and Rhizoma Zedoariae) was used to treat 189 cases of endometriosis and the change of symptom and sign, the B ultrasonograph, the anti-endometrium antibody and endometriosis quantitative diagnostic index were observed. Another 160 cases were treated with Danazol as control. RESULTS: One hundred and eighty-nine cases were treated for 9 months. According to National Standards, 39 cases (20.6%) were cured, 67 cases (35.4%) were markedly effective, 67 cases (35.4%) were effective, and 16 cases (8.4%) were ineffective. Compared with 160 cases treated with Danazol for 9 months, the total effective rates were 95% and 91.5% respectively, the difference between them was insignificant. Animal experiments showed similar results to the clinical ones. CONCLUSION: The authors conclude that the Chinese herbal prescription is as effective as Danazol for the treatment of endometriosis, without observed side effects. It is particularly helpful for diagnosis, treatment and prevention of endometriosis in the early stage. Cai L, Shu Y, Xie H. [Clinical and experimental study on the treatment of endometriosis with dan’e mixture] Zhongguo Zhong Xi Yi Jie He Za Zhi. 1999 Mar;19 (3):159-61.

Research into Acupuncture and abnormality of sperm.

(1) Idiopathic infertility A study carried out in Brazil observed the effect of acupuncture and moxibustion on sperm abnormalities. 19 patients with idiopathic infertility were divided into a study and into a control group. The study group was treated twice a week for 10 weeks (25 min acupuncture, 20 min moxa). Sperm analysis was carried out before and after the treatment course. The patients in the study group showed a significant increase in the percentage of normal-form sperm. The authors conclude that acupuncture and moxa treatments seem to favourably modify normal-form sperm counting.’ Gurfinkel E, Cedenho AP, Yamamura Y, Srougi M.Effects of acupuncture and moxa treatment in patients with semen abnormalities. Asian J Androl. 2003 Dec; 5(4):345-8.

(2) Low sperm count (Oligospermia) A study carried out in Tel Aviv observed the effect of acupuncture on males with very low sperm count. 15 of the males were azoospermic patients, two were pseudoazoospermic and three had severe oligoteratoasthenozoospermia (OTA). After a course of acupuncture, the OTA had only a slight increase in sperm count. 67% of azoospermic patients showed a definite increase in sperm count, seven of them significantly. Males with genital tract inflammation exhibited the most remarkable improvement in sperm density. Two pregnancies were achieved in conjunction with IVF-ICSI. The authors conclude that acupuncture might be a useful treatment for males with very poor sperm count, especially those with a history of genital tract inflammation. Siterman S, Eltes F, Wolfson V, Lederman H, Bartoov B. Does acupuncture treatment affect sperm density in males with very low sperm count? A pilot study. Andrologia. 2000 Jan; 32(1):31-9.

(3) Spem motility In a study from Israel, 16 patients with subfertility related to sperm impairment were treated with acupuncture twice a week for 5 weeks and compared to a control group. The sperm motility and intactness of the axonema were greatly increased in the study group. Siterman S, Eltes F, Wolfson V, Zabludovsky N, Bartoov B.Effect of acupuncture on sperm parameters of males suffering from subfertility related to low sperm quality. Arch Androl. 1997 Sep-Oct; 39(2):155-61.

(4) Spem morphology A study in treating subfertility by acupuncture was carried out in Germany on 28 men. Each patient received a total of 10 treatments for a period of three weeks. The spermiograms and hormone levels were checked before and after acupuncture. Total count, concentration and motility were evaluated and in all cases the researchers observed a statistically significant improvement of sperm quality. The authors conclude that acupuncture therapy at the time of ovulation might increase the chances of a pregnancy. Fischl F, Riegler R, Bieglmayer C, Nasr F, Neumark J. [Modification of semen quality by acupuncture in subfertile males] Geburtshilfe Frauenheilkd. 1984 Aug;44 (8):510-2.

(5) A Chinese study was carried out on 54 males with impaired fertility. 1-3 months of acupuncture therapy was given, and sperm analysis carried out before and after treatment. 55.5% of patients impregnated their partners in that period of time, and 24% showed a significant improvement in sperm parameters. 20% of patients, previously diagnosed with azoospermia and immune disturbance, did not improve. The best improvement was seen in patients with abnormal sperm. Qian, Z [Clinical observation of 54 cases of male infertility treated by acupuncture and moxibustion] Journal of Chinese Medicine, 1996 Sep; 52.

(6) A Chinese study was carried out on 248 males who suffered from sperm abnormities, absence of ejaculation and impotence. Treatment of acupuncture was given every other day. 20 treatments comprised one course. 2 courses were given (approx 2 months). About half of the patients with abnormal sperm achieved good sperm count and motility. (20-60mill/ml with 20-60% motility and less than 20% deformity). 52 % of patients with abnormal sperm failed to respond, a large percentage of those (40%) who were diagnosed with azoospermia, failed to respond at all. Zhang J [The Acupuncture treatment of 248 cases of male infertility], Chinese Acupuncture and Moxibustion, Vol 7, 1987.

Chinese Herbal Medicine better than drugs for Dysmenorrhoea (Painful Periods).

The evidence supporting the use of Chinese herbal medicine (CHM) for primary dysmenorrhoea is promising, but better quality research on the subject is still required. These are the conclusions of a systematic review by Australian researchers, which included 39 RCTs involving a total of 3475 women. CHM was found to result in significant improvements in pain relief, overall symptoms and use of additional medication when compared with use of pharmaceutical drugs. CHM also resulted in better pain relief than either acupuncture or heat compression in the studies analysed. There were no indications that CHM caused any adverse events. (Chinese herbal medicine for primary dysmenorrhoea. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005288).

Research into Recurrent Miscarriage & Chinese Herbal Medicine

(1) The effect of Chinese herbal medicine in threatened miscarriage was observed in a study at Shanghai Gynaecology & Obstetrics Department of Shanghai Medical University. In 40 women with threatened abortion and a history of miscarriage, blood test showed threatened abortion (TA), compared to the blood test of normal pregnant women (The plasma beta-EP level in TA was significantly higher than that in normal pregnant women, P < 0.01. On the contrary, plasma GnRH, HCG and P4 were obviously lower in TA as compared with those of the normal cases, P < 0.01.) After treatment with Chinese herbal medicine that supported reproduction and blood circulation and protected the foetus, 36 of the 40 patients continued their pregnancy without symptoms of TA, and the above-mentioned four criteria measured at 10-12th week of gestation were similar to those of normal cases, P > 0.05. The authors concluded that Chinese herbal Medicine can regulate plasma beta-EP and placental endocrine function in threatened abortion in women with a history of recurrent miscarriage. Sun F, Yu J. [Effect of TCM on plasma beta-endorphin and placental endocrine in threatened abortion] Zhongguo Zhong Xi Yi Jie He Za Zhi. 1999 Feb; 19 (2):87-9.

(2) A study in Japan showed that recurrent miscarriages with an immunological component (rejection of the foetus as foreign) benefit positively to the treatment with Chinese herbal medicine. Twelve patients with recurrent abortion who had shown positive anti-phospholipid antibodies were treated through the administration of a Japanese modified traditional Chinese herbal medicine Sairei-To (Cai ling Tang). The patients had experienced a total of 27 spontaneous abortions in their previous pregnancies and had no other pregnancy history except for one patient. The patients were treated with 9.0 g of Sairei-To per day before their next pregnancy. The positive value of antiphospholipid antibodies returned to negative in 9 patients out of 12 patients through the treatment. Out of 12 patients, 10 patients continued their new pregnancy uneventfully, and they delivered an offspring (Success rate: 83.3%). Thus, the current treatment was considered to be an effective therapy for patients with recurrent abortion whose miscarriage is immune related (positive anti-phospholipid antibodies). Takakuwa K, Yasuda M, Hataya I, Sekizuka N, Tamura M, Arakawa M, Higashino M, Hasegawa I, Tanaka K. Treatment for patients with recurrent abortion with positive antiphospholipid antibodies using a traditional Chinese herbal medicine. J Med. 1996; 24(5):489-94.

group … maintained more substantial improvement” than patients in the other two groups, they report. (The Journal of the American Medical Association 1998;280:1585-1589. 2)

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About The Centre For Natural Fertility

Grahame Gargini MBAcC MRCHM is the clinical director of AcuHealth, a company dedicated to achieving results and getting people well using Traditional Chinese Medicine incorporating acupuncture Chinese herbs and nutrition.  He is also the founder and centre manager of The Natural Healthcare Centre.

The Centre for Natural Fertility is a specialist clinic run at The Natural Healthcare Centre by Grahame to ensure couples have the very best chance of conceiving naturally or to increase their chances of success from assisted reproductive techniques, (eg IVF).


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