Acupuncture Side Effects

Effects of acupuncture on hot flushes in Perimenopausal and Postmenopausal women

Effects of acupuncture on hot flushes in Perimenopausal and Postmenopausal women:

Hot flushes are the most frequent climacteric symptom and a major cause of suffering among menopausal women. Menopause is said to have occurred once a period of 12 months of amenorrhea has elapsed, which reflects a near complete but natural diminution of ovarian hormone secretion (Soules 2001). Perimenopause is the time period prior to menopause and ends 12 months after the final menstrual period (Soules 2001). This menopausal transition reflects a period of changing ovarian function which may precede the final menstrual period by between two and 8 years (Greendale 1999).

Postmenopause is defined as all the years beyond the last menstrual period (Soules 2001). The menopause can occur naturally as the result of aging or from surgical removal of ovaries, radiation, or chemotherapy. Most women experience natural menopause between 40 and 58 years of age (NIH 2005).From Perimenopause to late Postmenopause, some women experience various signs and symptoms such as vasomotor symptoms, headaches, vaginal dryness, urinary incontinence, sleep disturbances, sexual dysfunction, fatigue, mood disturbance, depression and cognitive difficulties (Greendale 1999; Grady 2006). Hot flushes (or hot flashes) are the most common symptoms related to menopause and Perimenopause. Hot flush is characterized by a sensation of intense heat associated with objective signs of coetaneous vasodilatation and a subsequent drop in core temperature (Stearns 2002). This sensation can also be accompanied by sweating, flushing, palpitations, anxiety, irritability and night sweats (Stearns 2002). A recent systematic review indicated that vasomotor symptoms were highly prevalent across menopausal stages in most societies (Freeman 2007).

The prevalence of hot flushes varies between 13% and 79% (median rate of 41%) among perimenopausal women and between 8% and 80% (median rate of 41.5%) in postmenopausal women. The condition negatively influences many aspects of women’s lives. To date, conventional hormone replacement therapy (HRT) is considered the most effective treatment for hot flushes. However, HRT is associated with a host of negative side effects. Complementary and alternative medical (CAM) approaches have been employed to relieve symptoms and to avoid these side effects. Acupuncture is one of the most strongly preferred CAM treatments for many diseases, causing few serious adverse effects, and is frequently used in Korea. We aim to evaluate the effectiveness of Traditional Korean Acupuncture (TKA) in conjunction with usual care, compared to usual care alone, on hot flushes in Perimenopausal and postmenopausal women in Korea. This study consists of a multi-center randomized controlled trial with 2 parallel arms. Participants included in the study will meet the following criteria: 1) a documented daily average hot flush score greater than or equal to10 for one week prior to the screening visit 2) not taking HRT and other pharmaceutical therapies which might affect hot flushes or other vasomotor symptoms. While maintaining usual care, the treatment group will receive acupuncture 3 times a week, for a total of 12 sessions over 4 weeks.

The control group will receive usual care alone during the same period. Post-treatment follow-up will be performed one month after completing 12 sessions of acupuncture. This trial will provide evidence for the effectiveness of acupuncture as a treatment for hot flushes. The primary endpoint in both groups is a change in hot flush score from baseline to week 4 and/or week 8. As the secondary endpoint, we will employ the Menopause Rating Scale (MRS), a health-related quality of life questionnaire. Further analysis will examine the frequency, severity and difference in symptoms for daytime vs. nighttime hot flushes, sub-domain analysis of MRS, and participants’ expectations of acupuncture treatment.