Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA protocol

This randomized controlled study, conducted at BC Women's Hospital in Vancouver between 2005 and 2008, investigated whether auricular acupuncture using the NADA (National Acupuncture Detoxification Association) protocol could reduce neonatal abstinence syndrome in infants of mothers with substance use disorder. Maternal drug use during pregnancy affects 6-10% of pregnancies in North America, resulting in serious consequences for newborns, including increased perinatal mortality and lasting physical, neurobehavioral, and psychosocial problems. Methadone is often used to wean from illicit drugs but is also associated with adverse fetal and neonatal effects. The NADA protocol consists of inserting five acupuncture needles at specific points in both ears (Sympathetic, Shen men, Liver, Kidney, and Lung), developed specifically for the treatment of substance use disorder.

The mechanism of action of acupuncture in substance use disorder is related to the stimulation of endorphin release, neurotransmitters involved in pain inhibition that are 10-100 times more potent than morphine. The study randomized 89 pregnant women with substance use disorder admitted to the hospital's substance use disorder unit: 50 to daily acupuncture plus standard care and 39 to standard care with methadone alone. The primary outcome was the number of days neonates required morphine treatment for neonatal abstinence syndrome. Secondary outcomes included gestational age at birth, Apgar scores, days to regain birth weight, neonatal ICU admission rates, and transfer to substitute care.

The intention-to-treat analysis showed no significant benefits of acupuncture: the mean duration of morphine treatment was 2.7 days in the acupuncture group versus 2.8 days in the control group. However, a major limitation of the study was the low adherence to the acupuncture protocol, with only 28% of participants considered adherent (defined as having received nine or more treatments). In a secondary "as-treated" analysis, comparing adherent women with non-adherent women and controls, the newborns of the adherent group showed reductions of 2.1 and 1.5 days in treatment time for neonatal abstinence syndrome compared with the non-adherent and control groups, respectively, although these differences did not reach statistical significance. Interestingly, the adherent women were receiving higher doses of methadone at admission and were able to reduce their doses to a greater extent than the other groups, suggesting that those with greater need may have perceived benefits from the treatment.

The study faced several important methodological limitations. The inability to blind participants and acupuncturists due to the nature of the intervention may have introduced bias. The high non-adherence rate significantly reduced the statistical power to detect differences. The hospital environment offered multiple complementary therapies, which may have diluted the specific effect of acupuncture.

In addition, the sample size calculations were based on longer periods of morphine treatment than those observed in the study. The clinical implications suggest that auricular acupuncture may be a safe, low-tech intervention during pregnancy, potentially helping to reduce the methadone dose. Although the results are not conclusive, the trend toward reduction in the duration of neonatal abstinence syndrome among infants of treatment-adherent mothers warrants further investigation. The study highlights the importance of considering strategies to improve adherence in future research, possibly including "run-in" periods to measure adherence prior to randomization.

The findings contribute to the growing body of evidence on complementary therapies in substance use disorder during pregnancy, but emphasize the need for larger studies with better adherence to definitively establish the efficacy of auricular acupuncture in this specific clinical context.