Acupuncture and herbs improve outcomes for premature ovarian failure patients. Chongqing Banan People’s Hospital researchers conclude that the addition of Traditional Chinese Medicine (TCM) to hormone replacement therapy (HRT) protocols significantly improves outcomes. The hospital researchers confirm that a combination of acupuncture, moxibustion, herbal medicine, and HRT significantly alleviates premature ovarian failure symptoms, regulates hormone levels, and increases endometrial thickness. Based on the data, the researchers conclude that the combination of TCM therapies with HRT produces greater outcomes than HRT monotherapy.

The researchers based their conclusions on TCM efficacy index scores, changes in endometrial thickness, Kupperman Index scores (KI), and changes in levels of serum follicle stimulating hormone (FSH) , luteinizing hormone (LH), and estradiol (E2). A study group receiving TCM and HRT had a total effective rate of 91.7%, compared with 72.9% in the HRT monotherapy group. [1]

Ninety-six women were recruited to the study and were randomly assigned to receive either combined acupuncture, moxibustion, herbs, and HRT or HRT alone. The TCM group was comprised of 48 women, ages 26–38 (mean age 31). The mean age of menarche was 13 years and the mean duration of premature ovarian failure was 2.07 years. The HRT group was comprised of 48 women, ages 24–39 (mean age 31). The mean age of menarche was 14 years and the mean duration of premature ovarian failure was 2.24 years. There were no statistically significant differences between the two groups prior to treatments.

For inclusion in the study, the participants were required to be between the ages of 20–40 years, have experienced amenorrhea for at least four months, and show ovarian atrophy with no dominant follicle. Other inclusion criteria were FSH>40IU/L, LH>30IU/L, E2<73.4pmol/L, and endometrial thickness <6mm.

TCM diagnostic criteria included amenorrhea before the age of 40 years, prolonged or scanty menses, sore lumbar region and knees, vaginal dryness, palpitations, shortness of breath, five palms heat, irritability, dizziness, tinnitus, insomnia, poor memory, fatigue, a pale-dull tongue, and a sinking-fine pulse. At least three of the aforementioned criteria were required.

Women were excluded from the study that had received hormonal treatments or immune inhibitors within the previous three months, undergone ovarian surgery, had been exposed to environmental toxins, or had liver, kidney, cardiovascular, or other systemic diseases. Also excluded were patients with tumors, psychiatric disorders, multiple organ dysplasia, or drug allergies.

 

Hormone Replacement Therapy
The women assigned to both groups were treated with identical drug therapy to artificially stimulate menstruation. They were prescribed estradiol valerate (1mg) to be taken daily for 21 days, and progesterone (100mg) to be taken daily on days 12–21 of estradiol treatment. This drug protocol was designed to induce menstruation either on day five of treatment, or five days after withdrawal from medications. This cycle was repeated for three consecutive months.

 

TCM
Women assigned to the TCM group were treated with the aforementioned HRT protocol, plus acupuncture, moxibustion, and herbs. The selected acupoints were divided into two groups. The first group included:

  • Baihui (GV20)
  • Shenting (GV24)
  • Benshen (GB13)
  • Guanyuan (CV4)
  • Dahe (KD12)
  • Tianshu (ST25)
  • Zhongwan (CV12)
  • Zusanli (ST36)
  • Sanyinjiao (SP6)
  • Taixi (KD3)
  • Taichong (LV3)
  • Luanchao (Ovary) – located three finger widths superior and four finger widths lateral to the midpoint of the pubic symphysis

Acupuncture was administered every Monday and Friday. The women rested in a supine position and single-use 0.25 × 25mm needles were inserted transversely at Baihui, Shenting, and Benshen to a depth of 5–15mm. At the remaining acupoints, 0.25 × 40mm needles were inserted perpendicularly to a depth of 5–30mm. After the arrival of deqi, needles were retained for 25 minutes. Following acupuncture treatment, moxibustion was administered by suspending a moxa tube above Guanyuan, Zigong (MCA18), and Qihai (CV6). The height and temperature were adjusted to an appropriate level, and the points were warmed for 20 minutes. The second group of acupoints included:

  • Shenshu (BL23)
  • Ciliao (BL32)
  • Shiqizhuixia (MBW25)

Acupuncture was administered at these points every Wednesday. The women rested in a prone position and single-use 0.25 × 40mm needles were inserted perpendicularly at Shenshu and Shiqizhuixia to a depth of 5 –30mm. Following this, 0.30 × 75mm needles were inserted at Ciliao to a depth of 50–60mm, penetrating through the sacral foramen towards the lower abdomen. After the arrival of deqi, needles were retained for 25 minutes. Moxibustion was administered at Shenshu, Pishu (BL20), and Ciliao. Twelve acupuncture treatments made up one course, and a total of three courses were administered. Women in the TCM group were also prescribed the following herbal formula:

  • Huang Qi 10g
  • Shu Di Huang 10g
  • Tu Si Zi 20g
  • Lu Jiao Shuang 20g
  • Yan Du Zhong 10g
  • Gou Qi Zi 10g
  • Yin Yang Huo 10g
  • Ba Ji Tian 10g
  • Jiu Huang Jing 10g
  • Tai Zi Shen 10gLiu Ji Nu 10g
  • Yi Mu Cao 15g
  • Mu Dan Pi 10g
  • Xiang Fu 6g
  • Fu Pen Zi 10g
  • Gan Cao 10g

For stomach and spleen deficiency, Chao Bai Zhu (10g) was added. For aversion to cold, Rou Gui (6g) was added. For liver depression, Yue Ji Hua (10g) was added. For insomnia with excessive dreaming, Yuan Zhi (10g) was added. For yin deficiency with deficiency heat, Nu Zhen Zi (10g) was added. The herbs were decocted and taken morning and evening for 21 consecutive days. After five days, the treatment was recommenced. A total of three courses were administered.

 

Outcomes and Discussion
Outcome measures included Kupperman Index scores (KI), rating a total of 12 items including physical and psychological symptoms on a scale of 0–3, with a higher score indicating more severe symptoms. Serum FSH, LH, E2, and endometrial thickness were also taken into account. In the HRT group, KI scores fell from a mean 16.86 to 10.65 following treatment. In the TCM group, KI scores fell from a mean 17.08 to 7.92.

In the HRT group, mean FSH and LH decreased from 72.71IU/L to 45.20IU/L and 56.34IU/L to 37.67IU/L respectively, and E2 increased from 48.76pmol/L to 88.28pmol/L. In the TCM group, mean FSH and LH decreased from 69.32IU/L to 36.96IU/L and 53.14IU/L to 28.76IU/L respectively, and E2 increased from 46.93pmol/L to 115.20pmol/L. The objective findings indicate that the TCM protocol provides significant outcome improvements.

In the HRT monotherapy group, endometrial thickness increased from a mean 5.24mm to 5.73mm following treatment. In the TCM group, endometrial thickness increased from a mean 5.43mm to 7.11mm. Outcome measures were significantly better for women in the TCM group across all parameters.

TCM efficacy index scores were calculated for both groups based on improvements in clinical symptoms and hormone levels. Women that experienced restored menstruation and improved hormone levels three months after the cessation of treatments were classified as cured, with an efficacy index of ≥90%. Women that experienced restored menstruation and improved hormone levels for one month after the cessation of treatment, the therapy was classified as highly effective, with an efficacy index of ≥70%. Women whose clinical symptoms were alleviated and had improved hormone levels but did not menstruate following cessation of treatment, the therapy was classified as effective, with an efficacy index of ≥30%. Women showing no improvement in symptoms or hormone levels and that did not menstruate following cessation of treatment, the therapy was classified as ineffective, with an efficacy index of <30%.

The cured, highly effective, and effective rates were added together to give the total effective rate. The total effective rate in the HRT group was 72.9%. The total effective rate in the TCM plus HRT group was significantly higher at 91.7%.

The safety of both therapies was taken into account. A total of three adverse effects were experienced in the HRT group, compared with one in the TCM group. There were no serious adverse effects, liver or kidney dysfunction in either group. The outcomes of this study suggest that combined HRT and TCM therapy is safe and effective in the treatment of premature ovarian failure, and performs significantly better than HRT monotherapy.

Reference
1. Wang Yu, Yu Hongmei (2018) “Therapeutic Observation of Acupuncture-moxibustion plus Chinese and Western Medications for Premature Ovarian Failure” Shanghai Journal of Acupuncture and Moxibustion. Vol.37 (9) pp.1042-1046.

 

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