Acupuncture for post-tonsillectomy pain: evidence from a recent randomized clinical trial

The French Society of Otorhinolaryngology (SFORL) published a guideline on the nonpharmacological treatment of post-tonsillectomy pain in 2014 (1). The guideline states that acupuncture for post-tonsillectomy pain remains controversial (level of evidence: 2); additionally, the guideline notes that moderate side effects are found in 11.8% of pediatric acupuncture cases (level of evidence: 2) (1,2).

A prospective, double-blinded, randomized controlled trial of acupuncture for post-tonsillectomy pain was published in 2017 (3). The authors concluded that acupuncture is clinically effective in reducing post-tonsillectomy swallowing pain and may be performed in addition to the administration of standard medications without any relevant side effects (3). There are conflicts between the two reports (1,3); therefore, further trials on acupuncture use in post-tonsillectomy pain are warranted.

In 2009, Sertel et al. (4) reported on a patient-assessor-blinded randomized, controlled trial of patients with post-tonsillectomy aged ≥16 years. The trial randomized the subjects (n=123) into three groups [nonsteroidal anti-inflammatory drug (NSAID) plus verum acupuncture, n=41; NSAID plus control acupuncture (non-specific control points on the body), n=41; and NSAID only, n=41]. Verum acupuncture demonstrated pain reduction without side effects (4).

A 2-armed, randomized controlled trial (2015) of conventional postoperative analgesia plus acupuncture (n=30) versus only conventional postoperative analgesia (n=30) (5) and a retrospective review of pediatric acupuncture for postoperative pain in tonsillectomy (2013) (6) both reported positive effects on pain reduction when acupuncture was added to conventional analgesia. A double-blind, placebo-controlled, randomized trial published in 2015 (7) allocated pediatric tonsillectomy patients undergoing standard surgery into a real acupuncture group (n=30) and a Streitberger sham acupuncture group (n=29) to investigate whether pain was reduced by acupuncture treatment. The researchers concluded that intraoperative acupuncture demonstrated analgesic effects and was well tolerated (7). Although these studies (4-7) generally showed positive results for pain reduction with acupuncture use and safety of the technique, there are conflicts within the total body of evidence (1). Why is there a gap between the 2014 evidence and other results?

A recent randomized controlled trial (3) presented moderate risk of bias when assessed by the Cochran risk of bias tool (Table 1). In addition, the effect size (ES) and power of the trial had less of an impact on the evidence regarding acupuncture analgesia for post-tonsillectomy pain. Recalculation of results of ES and power (G*Power Version 3.1.9.2 statistical software; Franz Faul, Universität Kiel, Germany) between the verum acupuncture group (n=16) and the sham acupuncture group (n=15) yielded T_0/20 [ES: 0.35; estimated sample size: 260 (130+130), σ=0.05, β=0.2, 1:1 group allocation ratio, compared means between two independent groups; post hoc recalculated power: 0.16]; T_0/60 [ES: 0.46; estimated sample size: 148 (74+74); post hoc power: 0.24]; T_0/120 [ES: 0.27; estimated sample size: 430 (215+215); post hoc recalculated power: 0.11]; and T_0/180 [ES: 0.25; estimated sample size: 518 (259+259); post hoc recalculated power: 0.10]. Therefore, the trial seemed to be underpowered with insufficient sample size. Clearly, a powered trial with low risk of bias would impact the evidence regarding analgesic effects of acupuncture for post-tonsillectomy patients or postoperative pain management (8,9).

Table 1 Cochrane risk of bias of the randomized clinical trial
Full table

Debates regarding sham acupuncture are ongoing (10). Dingemann et al. (3) adopted control acupuncture for practitioner-patient-blinding to acupuncture at nonspecific acupuncture points in the midaxillary line. A validation questionnaire could have been administered to blinded subjects to determine whether blinding was successful (11). Another issue in acupuncture studies is use of the Standards for Reporting Interventions in Controlled Trails of Acupuncture (STRICTA) reporting guideline to improve transparent reporting of acupuncture trials (12). The Dingemann et al. study (3) showed scant reporting on items regarding acupuncture rationale, details of needling, other components of treatment, and practitioner background (Table S1).

A last issue in acupuncture trials is safety reporting. Dingemann et al. (3) noted no significant side effects, but more detailed reporting is required. In contrast, the SFORL guideline reported moderate side effects in 11.8% of pediatric acupuncture patients (2). Future trials should focus on risk of bias, ES, power, use of sham acupuncture controls, use of STRICTA reporting guidelines, and safety.

Table S1 Checklist for items in STRICTA 2010 of the randomized clinical trial
Full table

Acknowledgments

Funding: None.

Footnote

Provenance and Peer Review: This article was commissioned and reviewed by the Editor-in-Chief, Zhen Xiao, MD, MPA (Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China).

Conflicts of Interest: The author has completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/lcm.2018.09.02). The author has no conflicts of interest to declare.

Ethical Statement: The author is accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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