Is Sham Acupuncture Really a Placebo?

A New Study and a Chinese Medicine Perspective

A new landmark study published in the Journal of Pain (Schlaeger et al., October 2025) is the most rigorous investigation of acupuncture for vulvodynia to date — and its findings raise a question that goes to the heart of how we understand both acupuncture and this condition.

What the research found

The double-blind randomised controlled trial tested 89 women with vulvodynia using specially designed needles that prevented both patients and practitioners from knowing whether real or sham acupuncture was being administered. Both groups received 10 sessions over 5 weeks.

The immediate results were almost identical: 58% of the real acupuncture group responded to treatment, compared to 57% in the sham group — no significant difference between them.

But the follow-up told a different story. Among those who responded, women in the sham group were 2.72 times more likely to return to their baseline pain level during the 12 weeks after treatment ended. Real acupuncture produced significantly longer-lasting relief.

The authors themselves concluded that the effects of acupuncture on vulvodynia may have been underestimated — because the sham produced a surprisingly strong response.

This raises an important question: was the sham truly a placebo?

A brief history: needling is not the only way

My colleague Hila Yaffe raises an important historical point in our lecture "All You Need to Know About Hui Yin Ren-1."* Historical records from educated scholars as early as the 16th century describe needling as something rarely used. Until not so long ago, acupuncture needling carried a real risk of infection — there was no awareness of sterility, and infection was a life-threatening danger before the discovery of antibiotics. Hila suggests this is one reason needling was far less common than it is today.

Needling however was never the only way to stimulate acupuncture points. The non-invasive methods of point activation — warming with moxa, plasters, massage (acupressure), and movement practices to open the channels — were not modern alternatives or substitutes. They were established tools for much of history, existing alongside needling from the very beginning. Points were routinely activated without a needle ever being inserted.

This matters. In the modern era, as needling became safer and more widespread, these other methods were increasingly set aside — and with them, a broader understanding of how points work. Each method of activating a point has a different effect on how that point functions. Needling is one way in. It is not the only way.

The skin-touch sham needles used in Schlaeger's study — which press lightly against the skin without penetrating — may therefore not have been as inert as the study design required. In the light of this history, skin contact alone has always been understood as potentially therapeutic.

De qi and heightened sensitivity

De qi (得气, dé qì — "arrival of qi") is the therapeutic sensation that acupuncturists look for during needling: a dull ache, warmth, heaviness, or radiating feeling that indicates the point has been activated. Or, as I tell my patients: any weird feeling that does not feel like a needle prick.

In my 22 years treating women, I have consistently observed that women with chronic pain reach de qi faster and more intensely than the general population. Their sensitivity is heightened throughout the system — not just locally. A skin-touch stimulus that would produce no response in most patients may well have activated a genuine physiological response in this population — and this alone could explain the unexpectedly strong sham response.

This kind of sensitivity also shapes how I work. I sometimes use very short needles, or small seeds held in place with a bandage to apply pressure instead of penetrating. The point is activated. The therapeutic effect is real.

When a point is too sensitive, I would not want to aggravate it with painful needling — because pain itself blocks Qi. As the classical principle states: 不通則痛，通則不痛 (bù tōng zé tòng, tōng zé bù tòng), "where there is no free flow, there is pain; where there is free flow, there is no pain." Causing pain at the very point I am trying to open may deepen the blockage I came to resolve.

The real challenge: Western research demands and their limitations

This is not a criticism of Schlaeger's research — quite the opposite. The 2025 study represents an enormous achievement: the first double-blind, practitioner-patient blinded RCT of acupuncture for vulvodynia, funded by the National Institutes of Health and involving researchers from Harvard Medical School's Program in Placebo Studies. It is rigorous, careful, and important.

The challenge lies not with the sham design, but with what Western evidence-based medicine requires in order to take a treatment seriously: a standardised protocol, a control group, sufficient participants, blinding. These are reasonable scientific demands. But they create an inherent tension with how Chinese medicine actually works — and that tension affects the results.

There is also a deeper paradox here. Vulvodynia is itself a condition that Western medicine has not yet fully explained or standardised. Its diagnosis is one of exclusion — defined by what it is not, rather than what it is. Western medicine does not yet agree on its cause, its subtypes, or its optimal treatment pathway. And yet Chinese medicine is being asked to submit to a standardised protocol for a condition that the very system demanding that standardisation has not yet standardised itself.

A standardised 13-point protocol applied uniformly to a Western diagnosis is a necessary compromise for controlled research — but it is a compromise. Chinese medicine is individual by nature. The same condition — vulvodynia — presents as different patterns in different women: heat, cold, stagnation, deficiency, or a combination. The classical principle states: 同病異治，異病同治 (tóng bìng yì zhì, yì bìng tóng zhì) — the same disease may require different treatments; different diseases may respond to the same treatment. In clinical practice, where treatment is adapted to the individual patient's pattern, results can be better. The study likely underestimates what acupuncture achieves when practised as it is designed to be practised.

Putting it in context: five studies, one clear direction

Schlaeger's 2025 study is the most rigorous — but it is part of a growing body of evidence. Five clinical studies have now examined acupuncture for vulvodynia:

• Powell & Wojnarowska (1999) — the first published case series, Journal of the Royal Society of Medicine

• Danielsson et al. (2001) — pilot study in vulvar vestibulitis, Acta Obstetricia et Gynecologica Scandinavica

• Curran et al. (2010) — the ACTIV study, Journal of Sexual Medicine

• Schlaeger et al. (2015) — the first randomised wait-list controlled pilot study, Journal of Sexual Medicine

• Hullender Rubin et al. (2019) — acupuncture augmentation of lidocaine for provoked vulvodynia, Journal of Lower Genital Tract Disease

  
  

Schlaeger's 2015 pilot is worth highlighting specifically. Comparing real acupuncture to a waiting list — no treatment at all — it showed clear, significant benefits: significantly reduced vulvar pain, reduced dyspareunia, and improved overall sexual function in the acupuncture group. The contrast between those clear between-group differences and the near-identical immediate results in the 2025 sham-controlled study is itself suggestive: the sham was producing a real effect.

What this means

The 2025 study confirms what practitioners and patients have observed: real acupuncture produces lasting results for vulvodynia. The durability of that effect — not just immediate pain reduction, but sustained improvement over months — is what matters most for women living with this condition.

The strong sham response does not diminish that finding. If anything, it raises fascinating questions about sensitivity, point activation, and the nature of the therapeutic response in this particular population — questions that deserve further investigation.

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Footnote *:

"All You Need to Know About Hui Yin Ren-1" is a pro-bono lecture on the ethical, respectful, and safe use of intimate acupuncture points — presented internationally by Waveny Holland, Hila Yaffe and Orit Zilberman. The lecture has been delivered for AACMA, ETCMA, TCM Academy, and Reidman College. All live deliveries have been offered free of charge. For institutions interested in hosting this lecture, please get in touch here .

References — complete list:

• Schlaeger JM et al. Long-lasting effect of penetrating acupuncture among responders: Double-blind RCT of acupuncture for vulvodynia. Journal of Pain. 2025 Oct 25;38:105584. doi: 10.1016/j.jpain.2025.105584

• Schlaeger JM et al. Acupuncture for the treatment of vulvodynia: a randomized wait-list controlled pilot study. Journal of Sexual Medicine. 2015;12(4):1019-1027. doi: 10.1111/jsm.12830

• Hullender Rubin L et al. Acupuncture augmentation of lidocaine for provoked, localised vulvodynia. Journal of Lower Genital Tract Disease. 2019;23.

• Curran S et al. The ACTIV study: acupuncture treatment in provoked vestibulodynia. Journal of Sexual Medicine. 2010;7(2):981-995.

• Danielsson I et al. Acupuncture for the treatment of vulvar vestibulitis: a pilot study. Acta Obstetricia et Gynecologica Scandinavica. 2001;80(5):437-441.

• Powell J, Wojnarowska F. Acupuncture for vulvodynia. Journal of the Royal Society of Medicine. 1999;92(11):579-581.