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Dear editor

Randomized controlled trials (RCTs) are gold standard for evaluating intervention efficacy. Yet, for complex physical interventions like acupuncture, establishing an adequate placebo control remains challenging.¹ Common placebo procedures include shallow needling (SN), non-penetrating needle device (NPND), non-acupoint needling, and needling at acupoints not traditionally indicated for the target condition, either alone or in combination.² A critical question is which placebo technique is optimal.

Wang et al recently addressed this using a Bayesian Network Meta-Analysis (NMA) in primary insomnia (PI). They concluded that NPND is preferable to SN as a placebo control in acupuncture RCTs for PI, citing comparable effects on reducing PSQI scores and altering objective sleep parameters, but a lower overall ranking for NPND on the SUCRA curve, suggesting weaker therapeutic activity.³

While we acknowledge the rigor of this study, we respectfully offer a different perspective to stimulate further discussion.

Evidence for NPND Inertness Remains Restricted

An ideal control should be physiologically inert, exerting no therapeutic effect while ensuring participant blinding.¹ Validating NPND necessitates rigorous demonstration of inertness. Wang et al reported no significant difference between NPND and non-acupuncture controls in improving subjective sleep—but this relied on only two trials: one with a no-treatment control (n = 16)⁴ and another permitting any insomnia treatment except acupuncture and herbal medicine—potentially including CBTi or hypnotics (n = 49).⁵ This limited evidence introduces substantial uncertainty. Furthermore, if NPND produces outcomes comparable to conventional treatments, it might possess intrinsic efficacy rather than being inert. Future studies should compare within-group outcomes before and after NPND intervention to confirm inertness.

Beyond Efficacy: Practical Considerations in Placebo Selection

Wang et al’s conclusion—that NPND is preferable to SN based exclusively on therapeutic outcomes in sleep—oversimplifies the methodological complexity of acupuncture RCTs. Practical factors must also be considered.

First, insomnia treatment often involves head acupoints (eg, GV20, EX-HN1),⁶ typically needled transversely (≤15° relative to the skin surface). NPND like Streitberger or Park devices relies on adhesive bases and perpendicular application, making them unsuitable for simulating transverse needling. Moreover, in participants with abundant scalp hair, device adhesion is often compromised, potentially necessitating shaving—a requirement that further undermines feasibility in clinical trials.

Second, blinding efficacy with NPND may be inadequate in participants familiar with acupuncture. Pilot data from our previous RCT on perimenopausal insomnia revealed that participants could readily distinguish NPND from real needles based on tactile sensation and perceived penetration. Consequently, we substituted NPND with SN at non-insomnia-relevant acupoints. The sham group achieved a Bang’s Blinding Index of −0.14 (within −0.20 to 0.20), indicating successful blinding.⁷

The Unique Advantages of SN as a Control Should Not Be Overlooked

Beyond enhancing blinding credibility through a more authentic needling sensation, SN offers additional advantages over NPND, including: (1) Superior cost-effectiveness and accessibility, as it utilizes standard acupuncture needles instead of costly specialized devices; (2) Enhanced clinical relevance and external validity, by reframing the research question around a clinically meaningful dose-response relationship (ie, therapeutic deep needling versus minimal shallow needling), the findings of which directly inform real-world practice; (3) Greater ethical acceptability, owing to the mild physiological stimulus provided even at non-indication points, thereby alleviating concerns associated with administering a completely inert intervention.

While NPND remains appropriate in certain contexts—such as acupuncture-naïve populations in Western settings, or trials restricted to perpendicularly needled acupoints (eg, HT7, PC6)—SN may be preferable in East Asian participants familiar with acupuncture, in RCTs involving scalp acupoints, or when budget constraints are considerable.

Conclusion

In RCTs of acupuncture for insomnia, placebo selection should not only consider inertness but also other factors such as blinding effect, applicability across different needling techniques, costs, cultural context, and ethics. Rather than pursuing a single “ideal” placebo, we recommend making context-specific choices tailored to the study population, clinical setting, and research objectives. Adopting such a nuanced and flexible approach can enhance the internal validity of RCTs while ensuring the clinical relevance of the findings.

Abbreviations

CBTi, Cognitive Behavioral Therapy for Insomnia; NMA, Network Meta-Analysis; NPND, Non-Penetrating Needle Device; PI, Primary Insomnia; PSQI, Pittsburgh Sleep Quality Index; RCT(s), Randomized Controlled Trial(s); SN, Shallow Needling; SUCRA, Surface Under the Cumulative Ranking; TCM, Traditional Chinese Medicine.

Data Sharing Statement

Data availability is not applicable as no new data was generated or analyzed in this communication.

Author Contributions

Fei-Yi Zhao – Conceptualization, Formal analysis, Investigation, Writing – original draft; Wen-Jing Zhang – Formal analysis, Supervision, Writing – review & editing; Qiang-Qiang Fu – Conceptualization, Formal analysis, Investigation, Writing – review & editing. All authors gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Funding

No funding was received.

Disclosure

The authors declare no competing interests.

References

1. Zhang CS, Tan HY, Zhang GS, Zhang AL, Xue CC, Xie YM. Placebo devices as effective control methods in acupuncture clinical trials: a systematic review. PLoS One. 2015;10(11):e0140825. doi:10.1371/journal.pone.0140825

2. Appleyard I, Lundeberg T, Robinson N. Should systematic reviews assess the risk of bias from sham–placebo acupuncture control procedures? Eur J Int Med. 2014;6(2):234–243. doi:10.1016/j.eujim.2014.03.004

3. Wang Y, Wu M, Zhang J, et al. Is Sham acupuncture equally effective for primary insomnia? A Bayesian network meta-analysis. Nat Sci Sleep. 2025;17:1997–2012. doi:10.2147/NSS.S541797

4. Xu SF, Sun YN, Wang S, Wu JY, Yin P. Clinical observation of electroacupuncture at Baihui (GV20) and Shenting (GV24) for the treatment of primary insomnia. Sichuan J Tradit Chin Med. 2014;32(5):154–156.

5. Lee B, Kim BK, Kim HJ, et al. Efficacy and safety of electroacupuncture for insomnia disorder: a multicenter, randomized, assessor-blinded, controlled trial. Nat Sci Sleep. 2020;12:1145–1159. doi:10.2147/NSS.S281231

6. Zhao FY, Spencer SJ, Kennedy GA, et al. Acupuncture for primary insomnia: effectiveness, safety, mechanisms and recommendations for clinical practice. Sleep Med Rev. 2024;74:101892. doi:10.1016/j.smrv.2023.101892

7. Zhao FY, Zheng Z, Fu QQ, et al. Acupuncture for comorbid depression and insomnia in perimenopause: a feasibility patient-assessor-blinded, randomized, and sham-controlled clinical trial. Front Public Health. 2023;11:1120567. doi:10.3389/fpubh.2023.1120567

The upmarket bakery chain Gail’s is planning 40 more outlets after sales rose by a fifth last year as it opened 36 new bakeries and sales to supermarkets increased.

The cafe and retailer, which currently has 185 sites, said sales rose to £278m in the year to the end of February but that pre-tax losses widened to £7.8m, from £7.4m a year before, as costs rose and it spent millions on opening new outlets.

Gail’s directors said staff and energy costs had risen, hitting profit margins, while it spent £51m on store reopening costs.

Sales at its retail arm rose almost 23%, more than double the pace of its wholesale division, which supplies clients including Waitrose, Ocado and Amazon from bakeries in London, Manchester and Bath.

A Gail’s spokesperson told the Propel trade journal: “We are pleased to have delivered strong year-on-year growth. This performance is underpinned by the increasing demand for high-quality, nutrient dense food, and by the support of the communities we serve. We will continue to build on this momentum by growing with purpose and remaining committed to improving access to good food.”

Speaking at a conference organised by Propel this month, Tom Molnar, who co-founded Gail’s 20 years ago, said the business was “still early in our growth”.

He said: “We do have a lot of bakeries now, but it took 20 years to get there. It wasn’t easy, and it wasn’t very fast. Twice, we had to stop growing altogether, because we didn’t think that we could be better; we were worried about getting consumed by speed. We’re still early in our growth. You take McDonald’s, Greggs or any other successful food business here in the UK – they operate from thousands of sites, and we’re still below 200.”

Gail’s owners, led by the private equity group Bain Capital, last year reportedly hired the financial advisory company Goldman Sachs to help find new investors in an effort to drive expansion. The chain was said to be worth as much as £500m.

The bakery was founded by Yael (Gail) Mejia in the early 1990s serving restaurants and other venues in London. In 2003, Molnar and a few others joined Mejia and the group opened the first bakery cafe in Hampstead in 2005.

The rapidly expanding chain has become an unlikely political bellwether – used by the Liberal Democrats to help identify areas where voters might be ready to switch from the Conservatives.

Its expansion has also spurred local protests, including a heated one in Walthamstow, east London, where a petition to stop a Gail’s opening was signed by hundreds of residents. A new branch in Brighton was spray-painted with the world “boring” and a large image of a penis, according the local newspaper the Argus.