The trial, registered prospectively on ClinicalTrials.gov as NCT05408377, enrolled 108 adult women with cyclic mastalgia across three outpatient centers in China. Participants were randomized in a one-to-one ratio to receive either manual acupuncture or sham acupuncture, and both groups followed an identical schedule: 18 sessions delivered over 12 weeks. That design choice matters. By matching the two groups for visit frequency, practitioner attention and the ritual of treatment, the investigators attempted to isolate the specific effect of needling at defined acupuncture points from the considerable placebo and context effects that are known to accompany any hands-on therapy. Of the 108 women who entered the study, 94—87.0 percent—completed the full protocol, a retention rate that lends weight to the results.

The primary endpoint was the change from baseline to week 12 in the Visual Analogue Scale for Breast Pain, or VAS-BP, a standard instrument in which patients rate their pain intensity on a continuous scale. In the intention-to-treat analysis, which included all 108 randomized participants regardless of whether they completed every session, the manual acupuncture group showed a between-group difference of minus 2.0 points at week 12, with a 95 percent confidence interval of minus 2.5 to minus 1.4. In plain terms, women receiving real acupuncture reported substantially less breast pain than women receiving the sham procedure, and the statistical uncertainty around that estimate did not come close to crossing zero. What makes the study unusual is what happened next: at week 36, twenty-four weeks after treatment had ended, the between-group difference was minus 2.2 points, with a confidence interval of minus 2.8 to minus 1.6. The benefit had not faded; it had, if anything, deepened slightly.

Pain intensity is only part of the story for cyclic mastalgia, and the trial’s secondary outcomes addressed the condition’s broader footprint. The number of days of breast pain fell more in the acupuncture group, with a between-group difference of minus 2.0 days at week 12 and minus 3.0 days at week 36. Quality of life, measured with the World Health Organization’s WHOQOL-BREF questionnaire, improved significantly more in the acupuncture group, with a total score advantage of 13.5 points and a physical health domain advantage of 1.0 points. Perhaps most striking for clinicians is the response rate: at week 12, 72.2 percent of women in the manual acupuncture group—39 of 54—were classified as responders, compared with just 22.2 percent—12 of 54—in the sham group. A threefold difference in responder rates between an active treatment and a matched sham control is a large effect by the standards of pain research.

The statistical machinery behind these conclusions was designed to handle the realities of longitudinal clinical data. The investigators used generalized estimating equations, a framework well suited to repeated measurements collected at multiple time points, and they analyzed the data under both intention-to-treat and per-protocol assumptions. Reporting both analyses is important because intention-to-treat preserves the benefits of randomization even when participants drop out, while per-protocol analysis asks what happened among those who actually received the full intervention. The consistency of the results across these frameworks, and the narrow confidence intervals around the primary estimates, suggest the findings are not an artifact of how missing data were handled.

Safety is always a central question for needle-based therapies, and here the trial’s record was reassuring. Three mild adverse events were reported in the manual acupuncture group, and none were reported in the sham group. Mild adverse events in acupuncture trials typically include minor bruising or transient soreness at needle sites, and the low event rate in this study is consistent with the generally favorable safety profile documented for the technique when performed by trained practitioners. For a condition in which standard drug options can carry hormonal side effects, a low-risk non-pharmacological alternative is an attractive proposition, provided the efficacy evidence is credible.

Why might needling at specific points influence cyclic breast pain at all? The trial’s authors are affiliated with acupuncture and moxibustion departments, including the Beijing Key Laboratory of Acupuncture Neuromodulation, and the study sits within a growing research program that seeks mechanistic explanations in neuroscience rather than traditional metaphysics. Pain of hormonal origin involves fluctuating levels of estrogen, progesterone and prolactin acting on breast tissue, and the trial recorded these hormones—estradiol, progesterone and prolactin—among its study variables. Acupuncture is known from other lines of research to engage endogenous opioid and descending pain-modulatory pathways, and neuromodulation at spinal and supraspinal levels can alter how painful signals from the chest wall are processed. Whether such mechanisms fully explain a benefit that persists for six months after treatment ends remains an open question, and the study was not designed to answer it definitively.

The sham-controlled design deserves particular attention, because it is where acupuncture trials most often stumble. Sham acupuncture in such trials typically mimics the sensory experience of treatment—insertion at non-acupoint locations or the use of blunt, retractable needles—so that patients cannot easily tell which arm they are in. The large gap between the two groups in this study, with responder rates of 72.2 percent versus 22.2 percent, suggests the sham procedure did capture much of the ritual of care without reproducing the therapeutic effect. That said, blinding in acupuncture is never perfect: patients may guess their assignment from the presence or absence of deqi sensations, and practitioners cannot be blinded. The authors’ use of a sham rather than a waitlist control strengthens the causal interpretation considerably, but readers should keep these structural limitations in mind.

There are also limits of scope to weigh. The trial was conducted entirely in China, in settings where acupuncture is an established part of routine care, and it is not yet clear whether the same effect sizes would appear in health systems where patient expectations differ. The sample of 108 participants, while adequate for the primary endpoint, is modest, and the study focused specifically on cyclic mastalgia—the cyclical, hormone-linked form of breast pain—rather than non-cyclic pain, which has different underlying mechanisms and may respond differently. The published version notes that the article was shared early as an accepted manuscript subject to further editorial processing, so some details may be refined in the final version of record. None of these caveats, however, undermines the core result of a durable, statistically robust separation between real and sham treatment.

For the millions of women who experience cyclical breast pain severe enough to seek care, the practical message is cautiously encouraging. The trial suggests that a 12-week course of manual acupuncture—18 sessions in all—can deliver relief that outlasts the treatment itself by at least half a year, alongside measurable gains in quality of life, with only mild side effects. It also offers a methodological template: a prospectively registered, sham-controlled, multicenter design with long-term follow-up is exactly the standard that complementary medicine trials need to meet if their results are to change clinical guidelines. Whether acupuncture earns a place alongside analgesics and hormonal agents in the mastalgia treatment algorithm will depend on replication in other populations and on cost-effectiveness analyses, but this study moves the needle—literally and figuratively—toward taking the therapy seriously for a condition medicine has long under-served.

Subject of Research: Long-term efficacy of manual acupuncture versus sham acupuncture for cyclic mastalgia in a multicenter randomized clinical trial

Article Title: The long-term effects of acupuncture for cyclic mastalgia: a multicenter randomized clinical trial

Article References: Yu, C., Shen, B., Li, X., Fang, Y., Xu, L., Han, P., Wang, X., Gao, Y., Zhang, Y., & Guo, J. (2026). The long-term effects of acupuncture for cyclic mastalgia: a multicenter randomized clinical trial. BMC Complementary Medicine and Therapies. https://doi.org/10.1186/s12906-026-05622-w

Image Credits: AI Generated

DOI: 10.1186/s12906-026-05622-w

Keywords: acupuncture, cyclic mastalgia, breast pain, sham-controlled trial, randomized clinical trial, pain management, quality of life, VAS-BP, WHOQOL-BREF, complementary medicine, neuromodulation, women's health