Efficacy of a standardised acupuncture approach for women with bothersome menopausal symptoms: a pragmatic randomised study in primary care (the ACOM study)

The ACOM study was a randomized controlled clinical trial conducted in nine primary care clinics in Denmark, investigating the efficacy of a standardized acupuncture protocol for women with moderate to severe menopausal symptoms. The research involved 70 women aged 40 to 65 years with significant hot flashes, with 36 allocated to the intervention group and 34 to the control group. The protocol used Western medical acupuncture with standardized points (CV-3, CV-4, LR-8, SP-6, and SP-9), administered by general practitioners with certified training in acupuncture. Treatment consisted of five weekly sessions of 15 minutes each, with needles retained for 10 minutes and manual stimulation to elicit the 'de-qi' sensation.

Outcomes were assessed using the MenoScores questionnaire, a validated instrument specific to menopausal symptoms. The primary outcome was reduction in hot flashes, while secondary outcomes included other domains such as night sweats, sleep problems, emotional symptoms, and physical symptoms. Results demonstrated significant efficacy of acupuncture compared with the control group. Hot flashes were reduced by 1.6 points on the scale (95% CI -2.3 to -0.8; p < 0.0001), with improvement already evident after just 3 weeks of treatment.

Other symptoms also showed statistically significant reductions: daytime and nighttime sweats (-1.2 points), general perspiration (-0.9 points), specific sleep problems related to menopause (-1.8 points), emotional symptoms (-3.4 points), physical symptoms (-1.7 points), and skin and hair changes (-1.5 points). Treatment adherence was exceptional, with only 4 participants withdrawing from the study and 34 of 36 women in the intervention group completing all five sessions. Questionnaire response rates were 100% at all assessment time points. Eighty percent of participants reported perceiving an overall beneficial effect from treatment.

Regarding safety, no serious adverse events were reported. Only four participants reported mild adverse effects: fatigue and headache, temporary increase in hot flashes related to stress, increased urinary frequency, and local tingling. One participant withdrew because she found needling uncomfortable. The clinical implications are important, especially considering that many women cannot or prefer not to use hormone therapy due to associated risks.

Acupuncture proved to be a pragmatic alternative, with a standardized protocol that can be easily implemented in primary care. The study stands out for its high methodologic quality, including adequate randomization, allocation concealment, blinding of outcome assessors and statistician, and use of a validated measurement instrument. The brief and standardized protocol enhances the applicability of the findings in real-world clinical practice, offering a new therapeutic option for women with moderate to severe menopausal symptoms.