A new acupuncture trial with a positive result – alas, it seems too good to be true

Electroacupuncture (EA) is often advocated for depression and sleep disorders but its efficacy remains uncertain. The aim of this study was, therefore, to “assess the efficacy and safety of EA as an alternative therapy in improving sleep quality and mental state for patients with insomnia and depression.”

A 32-week patient- and assessor-blinded, randomized, sham-controlled clinical trial (8-week intervention plus 24-week follow-up) was conducted from September 1, 2016, to July 30, 2019, at 3 tertiary hospitals in Shanghai, China. Patients were randomized to receive

1. EA treatment and standard care,
2. sham acupuncture (SA) treatment and standard care,
3. standard care only as control.

Patients in the EA or SA groups received a 30-minute treatment 3 times per week (usually every other day except Sunday) for 8 consecutive weeks. All treatments were performed by licensed acupuncturists with at least 5 years of clinical experience. A total of 6 acupuncturists (2 at each center; including X.Y. and S.Z.) performed EA and SA, and they received standardized training on the intervention method before the trial. The regular acupuncture method was applied at the Baihui (GV20), Shenting (GV24), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), and SanYinjiao (SP6) acupuncture points, with 0.25 × 25-mm and 0.30 × 40-mm real needles (Wuxi Jiajian Medical Device Co, Ltd), or 0.30 × 30-mm sham needles (Streitberger sham device [Asia-med GmbH]).

For patients in the EA group, rotating or lifting-thrusting manipulation was applied for deqi sensation after needle insertion. The 2 electrodes of the electrostimulator (CMNS6-1 [Wuxi Jiajian Medical Device Co, Ltd]) were connected to the needles at GV20 and GV29, delivering a continuous wave based on the patient’s tolerance. Patients in the SA group felt a pricking sensation when the blunt needle tip touched the skin, but without needle insertion. All indicators of the nearby electrostimulator were set to 0, with the light switched on. Standard care (also known as treatment as usual or routine care) was used in the control group. Patients receiving standard care were recommended by the researchers to get regular exercise, eat a healthy diet, and manage their stress level during the trial. They were asked to keep the regular administration of antidepressants, sedatives, or hypnotics as well. Psychiatrists in the Shanghai Mental Health Center (including X.L.) guided all patients’ standard care treatment and provided professional advice when a patient’s condition changed.

The primary outcome was change in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8. Secondary outcomes included PSQI at 12, 20, and 32 weeks of follow-up; sleep parameters recorded in actigraphy; Insomnia Severity Index; 17-item Hamilton Depression Rating Scale score; and Self-rating Anxiety Scale score.

Among the 270 patients (194 women [71.9%] and 76 men [28.1%]; mean [SD] age, 50.3 [14.2] years) included in the intention-to-treat analysis, 247 (91.5%) completed all outcome measurements at week 32, and 23 (8.5%) dropped out of the trial. The mean difference in PSQI from baseline to week 8 within the EA group was -6.2 (95% CI, -6.9 to -5.6). At week 8, the difference in PSQI score was -3.6 (95% CI, -4.4 to -2.8; P < .001) between the EA and SA groups and -5.1 (95% CI, -6.0 to -4.2; P < .001) between the EA and control groups. The efficacy of EA in treating insomnia was sustained during the 24-week postintervention follow-up. Significant improvement in the 17-item Hamilton Depression Rating Scale (-10.7 [95% CI, -11.8 to -9.7]), Insomnia Severity Index (-7.6 [95% CI, -8.5 to -6.7]), and Self-rating Anxiety Scale (-2.9 [95% CI, -4.1 to -1.7]) scores and the total sleep time recorded in the actigraphy (29.1 [95% CI, 21.5-36.7] minutes) was observed in the EA group during the 8-week intervention period (P < .001 for all). No between-group differences were found in the frequency of sleep awakenings. No serious adverse events were reported.

The result of the blinding assessment showed that 56 patients (62.2%) in the SA group guessed wrongly about their group assignment (Bang blinding index, −0.4 [95% CI, −0.6 to −0.3]), whereas 15 (16.7%) in the EA group also guessed wrongly (Bang blinding index, 0.5 [95% CI, 0.4-0.7]). This indicated a relatively higher degree of blinding in the SA group.

The authors concluded that, in this randomized clinical trial of EA treatment for insomnia in patients with depression, quality of sleep improved significantly in the EA group compared with the SA or control group at week 8 and was sustained at week 32.

This trial seems rigorous, it has a sizable sample size, uses a credible placebo procedure, and is reported in sufficient detail. Why then am I skeptical?

• Perhaps because we have often discussed how untrustworthy acupuncture studies from China are?
• Perhaps because I fail to see a plausible mechanism of action?
• Perhaps because the acupuncturists could not be blinded and thus might have influenced the outcome?
• Perhaps because the effects of sham acupuncture seem unreasonably small?
• Perhaps because I cannot be sure whether the acupuncture or the electrical current is supposed to have caused the effects?
• Perhaps because the authors of the study are from institutions such as the Shanghai Municipal Hospital of Traditional Chinese Medicine, the Department of Acupuncture and Moxibustion, Huadong Hospital, Fudan University, Shanghai,
• Perhaps because the results seem too good to be true?

If you have other and better reasons, I’d be most interested to hear them.