Acupuncture and Combined Acupuncture and Auricular Acupuncture for Insomnia: A Randomized, Waitlist-Controlled Trial

Insomnia is one of the most common sleep problems faced by the world's population, affecting approximately 10 to 20% of people with symptoms that cause significant distress and impairment in daily activities. Although effective pharmacological and psychological treatments are available, many patients face important limitations with these conventional approaches. Sleep medications can cause dependence, tolerance, and undesirable side effects, especially with prolonged use. Behavioral psychological therapies, while effective, require active patient participation and can be time-consuming, which limits their use.

Given these limitations, many people seek alternatives in complementary medicine, especially acupuncture and auricular acupuncture (applied to the ear). Acupuncture has gained increasing popularity, with studies showing it may have beneficial effects on sleep and be more effective than placebo treatments.

The primary objective of this study was to investigate whether the combination of traditional acupuncture with auricular acupuncture would be more effective in treating insomnia than traditional acupuncture alone. The researchers conducted a randomized controlled trial involving 224 Chinese adult participants (mean age 53.4 years, 75.4% women) who suffered from insomnia disorder according to international diagnostic criteria. Participants were carefully selected after in-person screening and polysomnography to exclude other sleep disorders. They were randomly assigned to three groups: one receiving traditional acupuncture only, another receiving acupuncture combined with auricular acupuncture, and a third waitlist control group.

Treatment consisted of nine sessions over three weeks, three times per week. Traditional acupuncture used specific points on the head, hands, and legs with electrical stimulation, while auricular acupuncture included the application of borneol crystals to specific points on the ear that patients pressed daily.

The results revealed important but perhaps unexpected findings for the researchers. There was no significant difference between the combined treatment and traditional acupuncture alone on sleep efficiency, which was the primary outcome measure assessed through patient-kept sleep diaries. Both treatments, however, were superior to the control group on several important measures. Participants who received any form of acupuncture showed significant improvements in insomnia severity, anxiety and depression symptoms, fatigue, and overall functioning compared with those who remained on the waiting list.

The effect size of traditional acupuncture for sleep-diary variables was moderate (0.45), while the combined treatment showed a smaller effect (0.25). Interestingly, effects on insomnia-assessment questionnaires were larger than on objective sleep measures, and the benefits were maintained for at least 13 weeks after the end of treatment.

From a clinical standpoint, these results provide valuable information for both patients and health care professionals. Acupuncture proved to be a safe and well-tolerated option for the treatment of insomnia, with only 2.6% of participants discontinuing treatment due to adverse effects. Most adverse events were mild, including small hematomas at the needle site, mild pain, and transient headache. For patients who do not respond adequately to conventional treatments or prefer to avoid medications, acupuncture may represent a valid alternative.

The fact that no additional efficacy was observed with auricular acupuncture suggests that traditional acupuncture alone may be sufficient, simplifying treatment and potentially reducing costs. The benefits maintained for several weeks after the end of treatment are particularly encouraging, suggesting that acupuncture may have lasting effects beyond the active treatment period.

It is important to acknowledge some important limitations of this study that should be considered when interpreting the results. The three-week treatment period was relatively short, and the 13-week follow-up may not reflect long-term benefits. Participants were not blinded to the type of treatment received, which could influence their perceptions of improvement. In addition, a standardized acupuncture protocol was used rather than individualized treatment, which is more common in real clinical practice.

The study also did not include direct comparison with conventional treatments such as medications or cognitive behavioral therapy. Despite these limitations, this represents one of the largest controlled studies of acupuncture for insomnia, providing important evidence on its safety and moderate efficacy. The findings suggest that, although acupuncture may not be as effective as some conventional treatments, it offers a valid and safe therapeutic option, especially for patients seeking nonpharmacological alternatives for the management of insomnia.