The objective of this study is to explore the effects of acupuncture and auricular acupressure in relieving menopausal hot flashes of bilaterally ovariectomized Chinese women. Between May 2006 and March 2008, 46 bilaterally ovariectomized Chinese women were randomized into an acupuncture and auricular acupressure group (
Hot flashes occur in the vast majority of post-menopausal women [
For those bilaterally ovariectomized pre-menopausal women, the estradiol (E2) contents in their serum were reduced by 80% [
Between May 2006 and March 2008, 46 bilaterally ovariectomized Chinese women were recruited through advertisement to complete 12 weeks of intervention with either acupuncture and auricular acupressure or Livial (Tibolone).
Inclusion criteria were as follows: the subject had received a bilateral ovariectomy in the previous 2 years and suffered from menopausal hot flashes; the patient did not manifest any perimenopausal symptoms before the bilateral ovariectomy and had not taken any drugs containing hormones or affecting the cardiovascular system during the previous 6 months; the level of thyroid-stimulating hormone (TSH) was normal and the E2 concentration was
Exclusion criteria were as follows: the subject was under other medical treatment during the research period, had metabolic, renal, anaphylactic or endocrine disease, or suffered from primary hypertension, primary hypotension, chronic anemia, tuberculosis, a mental disorder or a chronic affection; the body mass index (BMI) of the subject was more than 24 or she was a cigarette smoker. Patients were excluded from the study if they fit any of the above criteria.
The women were informed of the short- and long-term benefits of HRT and were informed about the aim and methodology of the study. Ethical approval and permission to conduct the study were obtained from the local ethical committee and the administration of the study was based on international ethical guidelines. Voluntary participation was requested and informed consent was obtained.
Subjects were randomized to either the acupuncture and auricular acupressure group or the HRT group with the use of a randomization chart constructed in Microsoft Excel that randomized numbers into two groups. Having been divided, the acupuncture and auricular acupressure group had 21 cases and HRT group had 25. In the statistical analysis, 43 of the women were included. Three subjects were considered missing cases during the study (Figure
The baseline characteristics of the participants.
Item | Acupuncture and auricular acupressure group ( | HRT group ( |
---|---|---|
Age (years) | 41.6 | 42.8 |
Time since ovariectomy (years) | 1.3 | 1.2 |
Married/living as married | 14 (73.7%) | 18 (75.0%) |
Divorced/separated | 4 (21.1%) | 5 (20.8%) |
Never married | 1 (5.3%) | 1 (4.2%) |
Women with children | 14 (73.7%) | 14 (58.3%) |
Urban | 12 (63.2%) | 21 (87.5%) |
Suburban | 3 (15.8%) | 2 (8.3%) |
Small town | 2 (10.5%) | 0 |
Rural | 2 (10.5%) | 1 (4.2%) |
Full-time employment | 8 (42.1%) | 18 (75.0%) |
Part-time employment | 5 (26.3%) | 2 (8.3%) |
Registered unemployed | 3 (15.8%) | 2 (8.3%) |
Retired | 3 (15.8%) | 2 (8.3%) |
Bilateral tubal-ovarian cyst | 2 (10.5%) | 8 (33.3%) |
Bilateral tubal-ovarian abscess | 3 (15.8%) | 2 (8.3%) |
Malignant tumor of uterus and/or ovary | 3 (15.8%) | 2 (8.3%) |
Benign tumor of uterus and/or ovary | 2 (10.5%) | 3 (12.5%) |
Removing the need for contraception | 1 (5.3%) | 2 (8.3%) |
Prophylactic ovariectomy | 2 (10.5%) | 1 (4.2%) |
Bilateral severe ovarian endometriosis | 3 (15.8%) | 2 (8.3%) |
Cessation of menstruation | 2 (10.5%) | 2 (8.3%) |
Other | 1 (5.3%) | 2 (8.3%) |
Duration of the menopausal hot flashes (year) | 1.1 | 1.3 |
Study design.
Each patient was given a standard daily log and was required to record the frequency and severity of hot flashes and side effects of the treatment felt daily, from 1 week before the treatment started to the fourth week after the treatment ended. The patients were required to record the items before going to bed in the evening. The standard daily log was made in a structured way by the hospitals and all the possible side effects of the treatment had been listed on it, which had been validated beforehand.
Each participant received a physical examination, a routine blood examination, a routine uronoscopy, a liver function test and a renal function test, respectively, 1 day before the treatment started and 1 day after the treatment ended.
Each patient randomized into the acupuncture and auricular acupressure group received both acupuncture and auricular acupressure treatments.
The selected acupoints: Sanyinjiao (SP6), Fengchi (GB20), Hegu (LI4), Quchi (LI11), Guanyuan (CV4), Dazhui (GV14), Fuliu (KI7) and Zigong (EX-CA1).
The patient was in a comfortable, supine position.
After the skin was routinely disinfected and the acupoints
were carefully localized, filiform 0.35 mm
The selected auricular acupoints: sympathetic (AH6a), shenmen (TF4), adrenal gland (TG2p), subcortex (AT4), endocrine (CO18), kidney (CO10), heart (CO15) and liver (CO12).
After the above acupoints were sterilized with 75% alcohol, pieces of plaster with magnetic beads of proper size and good quality were stuck to the acupoints, which were then pressed slightly until the patient had an aching pain, numbness, distention and a warm sensation. The patients were asked to press the acupoints by themselves six times a day for a 3 minutes duration each time. It was explained that the strength of the pressing should make the local auricle congestive, flushed, hot and achy. The auricular acupressure was alternatively conducted on the two ears every 2 days. The plaster with magnetic beads was exchanged for a fresh set once a week.
The acupuncture process adhered to the Standards for
Reporting Interventions in Controlled Trials of Acupuncture
(STRICTA) criteria [
The patients were prescribed with oral Livial (Tibolone, made by Nanjing Oujianong Pharmaceutical Company Limited, Nanjing, China), in the dosage of one tablet a day (2.5 mg/tablet) for 12 consecutive weeks.
One day before the treatment and at the end of the treatment, the levels of follicle stimulating hormone (FSH) and luteinizing hormone (LH) were measured with enzyme-linked immunosorbent assay (ELISA) and the levels of E2 were measured with double antibiotic ELISA. All the reagents were provided by Lianxing Biological Technology Company, Tianjin, China.
The severity of hot flashes was defined as follows: mild—a fleeting, warm sensation without sweating or disruption of normal activities; moderate—a warm sensation associated with sweating, and disruption of normal activities; severe—a hot sensation associated with sweating and the discontinuation of normal activities [
The score of the hot flash severity for a particular day is calculated by adding 1 × the number of mild hot flashes
The frequency of hot flashes is the total number of the mild, moderate and severe hot flashes occurred during 24 hours.
Results were analyzed by an independent university statistician using Statistical Package for Social Sciences (SPSS 13.0 for Windows), a computer software. Non-parametric Mann-Whitney tests were used to analyze the inter-group and intra-group differences of the severity and frequency of menopausal hot flashes. Analysis of variance (ANOVA) was used to compare the inter-group and intra-group differences of the serum levels of FSH, LH and E2. A 5% significance level (
There were no significant difference between the two groups’ baseline characteristics (
There was no significant difference between the two groups’ severity of hot flashes before treatment. After the 12 weeks of treatment, both groups’ severity of hot flashes decreased significantly (
The severity and frequency of hot flashes and the serum levels of FSH, LH and E2.
Item | Acupuncture and auricular acupressure group ( | HRT group ( |
---|---|---|
Hot flash severity | ||
Pre-treatment | 14.71 | 15.28 |
Post-treatment | 3.86 | 3.71 |
Follow-up | 4.45 | 3.25 |
Hot flash frequency | ||
Pre-treatment | 14.21 | 15.11 |
Post-treatment | 10.32 | 7.48 |
Follow-up | 7.69 | 5.58 |
FSH (mIU/mL) | ||
Pre-treatment | 51.5 | 53.0. |
Post-treatment | 40.4 | 22.7 ± 5.1* (95% CI 20.6–24.8) |
LH (mIU/mL) | ||
Pre-treatment | 33.7 | 32.9 |
Post-treatment | 31.9 ± 5.7# (95% CI 28.6–34.9) | 15.6 |
E2 (pg/mL) | ||
Pre-treatment | 37.1 | 39.4 |
Post-treatment | 45.4 | 71.5 |
FSH, follicle stimulating hormone; LH, luteinizing hormone; E2, estradiol; CI, Confidence intervals.
There was no significant difference between the two groups before treatment. After the 12 weeks of treatment, the frequency of the menopausal hot flashes in both groups were reduced significantly (
Before treatment, there was no significant difference in the serum levels of FSH, LH and E2 between the acupuncture and auricular acupressure group and the HRT group. After treatment, the levels of FSH decreased significantly and the levels of E2 increased significantly in both of the two groups and the levels of LH decreased significantly in the HRT group (
No side-effect was reported in either group during the period of the research or in the follow-up phase.
Although menopause is associated with changes in the hypothalamic and pituitary hormones that regulate the menstrual cycle, menopause is not a central event, but rather primary ovarian failure [
It is well known that acupuncture is associated with homeostatic regulation, and possess effects such as buffering hormonal disturbance, modulating ovulation, as well as improving psychological or behavioral abnormity [
The present study showed that acupuncture and auricular acupressure significantly relieve the severity and frequency of menopausal hot flashes. The levels of FSH decreased significantly and the level of E2 increased significantly in both of the two groups after treatment. As the increased levels of FSH and the lowered level of E2 are mainly associated with hot flashes during the menopausal transition [
The protocol of the acupuncture treatments comes from a combination of literatures and clinical experiences. There is no corresponding name to menopausal hot flashes in ancient books of traditional Chinese medicine (TCM). Based on Zang-fu organs in TCM, disorders of the kidney and liver are generally considered as the main pathogenesis. According to the principle of reinforcing the kidney and regulating the liver, the main acupoints selected were Sanyinjiao (SP6), Fengchi (GB20), Hegu (LI4), Quchi (LI11), Guanyuan (CV4), Dazhui (GV14), Fuliu (KI7) and Zigong (EX-CA1). Among them, Sanyinjiao (SP6), Fengchi (GB20), Hegu (LI4) and Quchi (LI11) have been selected as the main acupoints in most of the clinical researches on menopausal hot flashes [
According to the theory of TCM, all channels of the body and all 12 meridians are closely connected with the ear [
Acupuncture has been found to significantly reduce the severity of nocturnal hot flashes in post-menopausal women [
Although the double-blind randomized controlled trial (RCT) has been known as the gold standard in clinical researches, the biggest challenges and the difficulties to the researchers in the fields of clinical acupuncture and moxibustion are the design of an ideal placebo-control method and the credibility and ethics behind sham acupuncture [
Acupuncture and auricular acupressure can be used as alternative treatments to relieve menopausal hot flashes for those bilaterally ovariectomized women who are unable or unwilling to receive HRT.
Natural Medicine Research UK (to J.Z.); China Postdoctoral Science Foundation (no. 20080441265 to J.Z.); Zhejiang Traditional Chinese Medicine Foundation (no. 2008YA015 to J.Z.); Zhejiang Province Postdoctoral Science Foundation (to J.Z.); China Postdoctoral Science Foundation (no. 20070421188 to F.Q.); Outstanding Young Medical Scientist Foundation of Zhejiang Province (no. 2008QN022); Zhejiang Traditional Chinese Medicine Foundation (no. 2008YB010).
The authors wish to thank the patients included in the research. The authors would also like to express their deep thanks to Elizabeth Burrows from Global College of Long Island University, Brooklyn, NY, USA for her kind editing. J. Zhou and F. Qu contributed equally to this work.