Acupuncture and Auricular Acupressure in Relieving Menopausal Hot Flashes of Bilaterally Ovariectomized Chinese Women: A Randomized Controlled Trial

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ecam Advance Access published February 2, 2009 ecam 2009;Page 1 of 8 doi: /ecam/nep001 Original Article Acupuncture and Auricular Acupressure in Relieving Menopausal Hot Flashes of Bilaterally Ovariectomized
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ecam Advance Access published February 2, 2009 ecam 2009;Page 1 of 8 doi: /ecam/nep001 Original Article Acupuncture and Auricular Acupressure in Relieving Menopausal Hot Flashes of Bilaterally Ovariectomized Chinese Women: A Randomized Controlled Trial Jue Zhou 1, *, Fan Qu 2, *, Xisheng Sang 3, Xiaotong Wang 4 and Rui Nan 5 1 Sino-Britain Joint Laboratory, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, Zhejiang , 2 Women s Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang , 3 Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, , 4 The First Affiliated Hospital, Liaoning University of Chinese Medicine, Shenyang, Liaoning, , P. R. China and 5 Colorado School of Traditional Chinese Medicine, 1441, York Street, Denver, CO 80206, USA 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 (n ¼ 21) and a hormone replacement therapy (HRT) group (Tibolone, n ¼ 25). 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 serum levels of follicle stimulating hormone (FSH), LH and E 2 were detected before and after the treatment. After the treatment and the follow-up, both the severity and frequency of hot flashes in the two groups were relieved significantly when compared with pre-treatment (P50.05). There was no significant difference in the severity of hot flashes between them after treatment (P40.05), while after the follow-up, the severity of hot flashes in the HRT group was alleviated more. After the treatment and the follow-up, the frequency of menopausal hot flashes in the HRT group was reduced more (P50.05). After treatment, the levels of FSH decreased significantly and the levels of E 2 increased significantly in both groups (P50.05), and they changed more in the HRT group (P50.05). 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. Keywords: acupuncture auricular acupressure hormone replacement therapy (HRT) hot flashes menopausal Introduction Hot flashes occur in the vast majority of post-menopausal women (1). An extensive questionnaire study of 506 women found that 87% had daily hot flashes (2). *These authors contribute equally to this work. For reprints and all correspondence: Fan Qu, No. 604 Room in B Building, School of Medicine, Zhejiang University, 388 Yuhang Tang Road, Hangzhou, Zhejiang , P. R. China. Tel: þ ; Hot flashes are episodic and usually accompanied by nausea, dizziness, headache, palpitations, diaphoresis or night sweats (3). Having hot flashes may decrease a woman s quality of life by decreasing the quality of sleep and aggravating fatigue and depression (4,5). Menopausal hot flashes make most of women seek medical care during the menopausal transition (2). Menopausal hot flashes are related to a psychological or mental disorder in menopausal women and the hormonal changes in these women may be the underlying mechanism (6,7). ß 2009 The Author(s). This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/ licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 2of8 Acupuncture and auricular acupressure in relieving menopausal hot flashes For those bilaterally ovariectomized pre-menopausal women, the estradiol (E 2 ) contents in their serum were reduced by 80% (8). The abrupt decline in E 2 usually leads to more frequent and severe menopausal symptoms, especially hot flashes. Menopausal hot flashes are also related to enhanced norepinephrine (NE) activity in the hypothalamus, resulting in an abrupt, transient, downward resetting of the normal thermoregulatory response set point (9, 10). Most of the bilaterally ovariectomized Chinese women have difficulty in stopping hormone replacement therapy (HRT) due to the severe menopausal symptoms. Although HRT historically has been used as the standard treatment for hot flashes (11), many women choose not to initiate or adhere to HRT because of its potential health risks and side effects (12,13). In recent years, non-pharmacological alternative treatments are being requested by more bilaterally ovariectomized women to relieve their menopausal symptoms, especially menopausal hot flashes. A study has demonstrated that acupuncture could induce accumulation of vaginal exfoliative cells, increase the weight of adrenal, and raise the level of serum corticosterone in ovariectomized model rats (14). It is deduced that estrogen levels may be elevated using acupuncture to create compensatory hyperplasia of the adrenal cortex, thereby enhancing the transferring of androgen into estrogen in peripheral tissues (14). In as early as 1995, the acupuncture s efficacy in relieving menopausal symptoms has been demonstrated (15). Alternative and complementary therapies, including acupuncture, have been used increasingly in recent years to relieve menopausal symptoms (16 23), although one of them suggested that the used medical acupuncture was not any more effective for reducing menopausal hot flashes than was the chosen sham acupuncture (16). As hot flashes are the most common menopausal symptoms in bilaterally ovariectomized women, it is important to find effective, nonpharmacological treatments to relieve their menopausal hot flashes. This study was designed to explore the effects of acupuncture and auricular acupressure in relieving menopausal hot flashes of bilaterally ovariectomized Chinese women. Subjects and Methods Subjects 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 E 2 concentration was 550 pg/ml; a gynecologic examination and laboratory tests showed that the patient did not suffer from other organic diseases of the reproductive system after the bilateral ovariectomy; written consent was obtained from the subject stating that the subject would complete the study. To have been considered for the study, patients must have met all criteria. 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 (Fig. 1). There was no significant difference in baseline characteristics between the two groups (Table 1). 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. ecam of8 Acupuncture & auricular acupressure group (n=21) Simultaneously received acupuncture and auricular acupressure treatment for twelve consecutive weeks Missing cases excluded from analysis (n=2) lost to follow-up (n=1) no explanation (n=1) Analysed (n=19) Figure 1. Study design. Group and Administration Assessed for eligibility (n=46) Randomized (n=46) Excluded (n=0) HRT group (n=25) Received oral Livial (Tibolone) one tablet a day (2.5mg/tab) for twelve consecutive weeks Missing cases excluded from analysis (n=1) no explanation (n=1) Analysed (n=24) Acupuncture and Auricular Acupressure Group Each patient randomized into the acupuncture and auricular acupressure group received both acupuncture and auricular acupressure treatments. Acupuncture. 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 40 mm sterilized, disposable needles (provided by Suzhou Hua Tuo Medical Instruments Co. Ltd, Suzhou, China) were inserted using the double hand-needle insertion technique. The depth of insertion was adjusted based on the patient s body size and the permissible depth of insertion of the specific acupoint. A technique using lifting, thrusting and twirling in a small range was performed until the appearance of De-qi, an obtained needle sensation, when there emerge a soreness, numbness and a feeling of distension around the point after the needle is inserted to a certain depth, and tenseness around the needle felt by the operator. Then, an even reinforcing-reducing technique was applied. The needle was retained for 40 min each Table 1. The baseline characteristics of the participants Item Acupuncture and auricular acupressure group (n ¼ 19) HRT group (n ¼ 24) Demographic characteristics Age (years) Time since ovariectomy (years) 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%) Area of residence 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%) Current employment status 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%) Cause of ovariectomy Bilateral tubal-ovarian cyst 2 (10.5%) 8 (33.3%) Bilateral tubal-ovarian abscess 3 (15.8%) 2 (8.3%) Malignant tumor of 3 (15.8%) 2 (8.3%) uterus and/or ovary Benign tumor of uterus 2 (10.5%) 3 (12.5%) and/or ovary Removing the need 1 (5.3%) 2 (8.3%) for contraception Prophylactic ovariectomy 2 (10.5%) 1 (4.2%) Bilateral severe ovarian 3 (15.8%) 2 (8.3%) endometriosis Cessation of menstruation 2 (10.5%) 2 (8.3%) Other 1 (5.3%) 2 (8.3%) Duration of the menopausal hot flashes (year) time and manipulated twice during that time using a twirling technique in a small range. The manipulation lasted 30 s for each acupoint. The acupuncture treatment consisted of two sessions each week for 12 consecutive weeks. Auricular Acupressure. 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 4of8 Acupuncture and auricular acupressure in relieving menopausal hot flashes 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 min 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 (24). HRT Group 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 E 2 were measured with double antibiotic ELISA. All the reagents were provided by Lianxing Biological Technology Company, Tianjin, China. Index and Method 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 (16,19,23,25,26). The score of the hot flash severity for a particular day is calculated by adding 1 the number of mild hot flashes þ 2 the number of moderate hot flashes þ 3 the number of severe hot flashes (16,19,23,25,26). The frequency of hot flashes is the total number of the mild, moderate and severe hot flashes occurred during 24 h. Data Analysis Results were analyzed by an independent university statistician using Statistical Package for Social Sciences (SPSS 13.0 for Windows), a computer software. Nonparametric 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 E 2. A 5% significance level (P50.05) and twotailed tests were used for all hypothesis tests. Ninetyfive percent confidence intervals (CI) for the median differences between the acupuncture and auricular acupressure group and the HRT group were determined. Results The Baseline Characteristics There were no significant difference between the two groups baseline characteristics (P40.05) (Table 1). The Severity of Hot Flashes 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 (P50.05) with no significant difference between the groups (P40.05). The 4-week follow-up showed that both groups were alleviated significantly when compared with pre-treatment (P50.05) and HRT had greater effects (P50.05) (Table 2). The Frequency of Hot Flashes 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 (P50.05) and HRT had greater effects (P50.05) (Table 2). The 4-week follow-up showed that the frequency of hot flashes in the two groups both decreased significantly when compared with pre-treatment (P40.05) and the patients in the HRT group were alleviated more (P50.05) (Table 2). The Serum Levels of FSH, LH and E 2 Before treatment, there was no significant difference in the serum levels of FSH, LH and E 2 between the acupuncture and auricular acupressure group and the HRT group. After treatment, the levels of FSH decreased significantly and the levels of E 2 increased significantly in both of the two groups and the levels of LH decreased significantly in the HRT group (P50.05) (Table 2). The serum levels of FSH, LH and E 2 in the HRT group changed more (P50.05) (Table 2). Adverse Result No side-effect was reported in either group during the period of the research or in the follow-up phase. Discussion Although menopause is associated with changes in the hypothalamic and pituitary hormones that regulate the menstrual cycle, menopause is not a central ecam of8 Table 2. The severity and frequency of hot flashes and the serum levels of FSH, LH and E 2 Item Acupuncture and auricular acupressure group (n ¼ 19) HRT group (n ¼ 24) Hot flash severity Pre-treatment (95% CI ) (95% CI ) Post-treatment * (95% CI ) * (95% CI ) Follow-up *,# (95% CI ) * (95% CI ) Hot flash frequency Pre-treatment (95% CI ) (95% CI ) Post-treatment *,# (95% CI ) * (95% CI ) Follow-up *,# (95% CI ) * (95% CI ) FSH (miu/ml) Pre-treatment (95% CI ) (95% CI ) Post-treatment *,# (95% CI ) * (95% CI ) LH (miu/ml) Pre-treatment (95% CI ) (95% CI ) Post-treatment # (95% CI ) * (95% CI ) E 2 (pg/ml) Pre-treatment (95% CI ) (95% CI ) Post-treatment *,# (95% CI ) * (95% CI ) FSH, follicle stimulating hormone; LH, luteinizing hormone; E 2, estradiol; CI, Confidence intervals. *P50.05, compared with pre-treatment in the same group. # P50.05, compared with the HRT group. event, but rather primary ovarian failure (27). As the hypothalamic-pituitary-ovarian axis remains intact during the menopausal transition, FSH levels rise in response to ovarian failure and the absence of negative feedback from the ovary (27). Atresia of the follicular apparatus, in particular the granulosa cells, results in the reduced production of estrogen and inhibin, which leads to the reduced inhibin levels and the elevated FSH levels, a cardinal sign of menopause (27). Correlations between endocrine levels and symptom severity ratings over time revealed that hot flash severity was significantly and positively related to FSH (28). Investigations of hormonal connections between hot flash severity and reproductive hormones in Study of Women s Health Across the Nation (SWAN), Melbourne Midlife Women s Health Project (MMWHP) and Penn Ovarian Aging Study cohorts found that decreased serum E 2 and increased serum FSH were associated with the increases in hot flash severity (29 31). In an analysis of SWAN data, which modeled the effects of FSH and E 2 (and other reproductive hormones) together, Randolph and colleagues noted that FSH was associated with hot flash prevalence and frequency (7). 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 (32 34). Acupuncture in specific acupoints has been found to significantly increase blood concentrations of E 2 in the ovariectomized rats (35), while reducing the elevated plasma LH due to ovariectomy (36); in addition, acupuncture also restored the number of gonad
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