A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause

Abstract

Objective To conduct a pilot study for feasibility of planning a definitive clinical trial comparing traditional acupuncture (TA) to sham acupuncture (SA) and waiting control (WC) on menopause related vasomotor symptoms (VMS), quality of life (QOL), and the hypothalamic-pituitary-adrenal (HPA) axis in peri and post-menopausal women. Methods Thirty-three peri and post-menopausal women with at least 7 VMS daily were randomized to TA, SA or WC. The TA and SA groups were given three treatments per week for 12 weeks. Outcomes included the number and severity of VMS, MENQOL questionnaire, Beck Depression Inventory, Spielberg State-Trait Anxiety Instrument, Pittsburgh Quality Sleep Index, 24 hour urine cortisol and metabolites, and ACTH stimulation testing. Results Both TA and SA groups demonstrated improved VMS trends compared to WC (Δ −3.5±3.00 vs. −4.1±3.79 vs. −1.2±2.4, respectively, p=.20), and significantly improved MENQOL vasomotor scores (Δ − 1.5±2.02 vs. −1.8±1.52 vs. 0.3±0.64, respectively, p=.04). There were no psychosocial group differences. Exit 24-hour urinary measures were lower in the TA vs the SA or WC in total cortisol metabolites (4,658.9±1,670.9 vs 7,735.8±3,747.9 vs 5,166.0±2,234.5, p=0.03, respectively) and DHEA (41.4±27.46, 161.2±222.77, 252.4±385.40, respectively, p=0.05). The ACTH stimulation cortisol response data also trended in the hypothesized direction (p=0.17). Conclusion Both TA and SA reduce VMS frequency and severity and improve VMS-related quality of life compared to WC; however, TA alone may impact the HPA axis. This association is viewed as preliminary and hypothesis-generating and should be explored in a large clinical trial.

Effects of stellate ganglion block on vasomotor symptoms

“…These measures are commonly evaluated in menopause studies. 17–21 For a minimum of two weeks before the injection procedure and for six months thereafter, participants recorded the frequency and severity of daily VMS in a paper diary. Participants were instructed to rate each hot flash as “mild” (< 5 minutes, warm, red face, uncomfortable), “moderate” (< 15 minutes, warmth involving neck, ears, head, whole body, with perspiration, clammy skin, dry mouth, tense muscles, tachycardia, irritation, agitation, embarrassment), “severe” (< 20 minutes, warmth described as a raging furnace or burning up, weak, faint, headache, chest heaviness, extreme perspiration, prickling sensation over skin, heart irregularities, anxious, panic attacks) or “very severe” (< 45 minutes, boiling eruption, rolling perspiration, inability to breathe, faint/dizzy, leg/foot cramps, heart irregularities, difficulty functioning, distressed, nausea).…”

Ischemic heart disease in women: A focus on risk factors

“…In a younger middle-aged cohort of post-menopausal women 50–59 years, there was decreased coronary artery calcification in the estrogen arm vs. placebo 150 ; in the Kronos Early Estrogen Prevention (KEEPS) Study, although use of hormone therapy reduced vasomotor symptoms, there was no difference in coronary artery calcification or carotid intima-medial thickness after 4 years of follow up 151, 152 . In women with a history of IHD who have significant vasomotor menopausal symptoms, non-hormonal options are available for management of these symptoms which include selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors (SNRI), life style and nutrition adjustments, sleep hygiene, and acupuncture 153 . If an SNRI is initiated, blood pressure should be monitored as these agents can cause hypertension.…”

Spatiotemporal changes of optical signals in the somatosensory cortex of neuropathic rats after electroacupuncture stimulation

“…Today, neural disorder management by acupuncture stimulation are widely adopted [6, 7]. The advantages of acupuncture stimulation include minimized side effects of pharmaceutical or other treatment methods, lower aversion in patients, and affordable costs [8].…”