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A Randomized Three-Arm Double-Blind Placebo-Controlled Study of Homeopathic Treatment of Children and Youth with Attention-Deficit/Hyperactivity Disorder.

David Brulé, Beth Landau-Halpern, Violeta Nastase, Marcia Zemans, Nicholas Mitsakakis, Heather Boon · Journal of integrative and complementary medicine · 2024

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The short version

This randomized trial of 146 treated children and adolescents with attention-deficit/hyperactivity disorder (ADHD) explored whether homeopathy helps manage the condition, and which part of the treatment might be responsible. ADHD is a neurodevelopmental condition marked by inattention, hyperactivity and impulsivity, and roughly 30% of diagnosed children do not respond to standard medication or behavioral treatment. Homeopathy uses highly diluted natural substances prescribed one patient at a time, and in practice it combines a long consultation with a chosen remedy. Earlier open-label results could not tell those two components apart, so this study separated them. Children aged 6 to 16 in Toronto, Canada were randomly assigned to one of three groups. One group (47 children) received homeopathic consultations plus an individualized remedy, a second (48 children) received the same consultations plus a look-alike placebo granule, and a third (51 children) continued usual care only. Consultations lasted up to two hours at intake and recurred about monthly for 28 weeks. Parents rated symptoms with the Conners 3 Global Index-Parent T-score, where lower scores mean fewer symptoms. Symptom scores fell by about 6.2 points in the remedy group and 6.4 points in the placebo group, compared with 2.2 points in usual care (complete-case analysis, 126 children). After adjustment, the remedy-plus-consultation group differed from usual care (p=0.037), while the placebo-plus-consultation group fell just short of the corrected significance threshold (p=0.026 against a cutoff of 0.025). The two consultation groups did not differ from each other (p=0.93). A clinically meaningful improvement (a drop of at least 7.36 Conners T-score points) occurred in 35.9%, 44.2% and 13.6% of the three groups respectively (p=0.006). Parents in both consultation groups also reported better coping (p=0.012 and p=0.003). Side effects were all mild (Grade 1), mainly increased hyperactivity, emotional outbursts and tics, and did not differ between groups. Because the remedy and placebo groups improved similarly, the authors attribute the benefit to the consultation rather than the remedy itself. Participants knew whether they were receiving consultations, parents scored the main outcome, and recruitment fell short of the planned 177 because the COVID-19 pandemic halted trials, so expectation effects and limited statistical power remain possible. The authors recommend further research into the mechanism and into whether other forms of consultation or psychological support produce comparable results.

Key findings

  • This randomized trial (participants were assigned to groups by chance) enrolled 151 children and adolescents aged 6 to 16 with ADHD in Toronto, and 146 received an intervention.
  • Parent-rated ADHD symptom scores (Conners 3 Global Index-Parent T-score) fell by about 6 points with homeopathic consultation plus remedy and with consultation plus placebo, versus about 2 points with usual care.
  • The remedy added nothing beyond the placebo (difference -0.17 points, p=0.93), so the authors conclude the benefit is not due to the remedy itself.
  • Parents in both consultation groups also reported better coping with the child's symptoms (p=0.012 and p=0.003), and all side effects were mild (Grade 1).
  • Participants could not be blinded to the consultation, parents scored the main outcome, and the trial recruited fewer children than planned because of the COVID-19 pandemic, so expectation effects and limited statistical power remain possible.

Common questions

What healing modality was studied?

Classical individualized homeopathy: 90-120 minute homeopathic consultations about every four weeks (up to eight over 28 weeks) with a single individualized Boiron remedy (potencies 6CH to 10M), compared with consultation plus identical placebo and with usual care.

What condition was addressed?

Attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 16 years.

What were the main findings?

Conners 3 Global Index-Parent T-scores fell 6.23 points (remedy+consultation) and 6.37 points (placebo+consultation) versus 2.18 points with usual care. Remedy+consultation differed from usual care (p=0.037); placebo+consultation fell just short of the corrected threshold (p=0.026 vs 0.025); remedy and placebo arms did not differ (p=0.93). Parent-rated coping efficacy improved in both consultation arms.

How strong is the evidence?

Moderate to limited. It is a double-blind, three-arm randomized trial, but 126 of 146 treated children were in the primary analysis, recruitment fell short of the planned 177, participants could not be blinded to the consultation, parents rated the primary outcome, and the intention-to-treat estimates were not significant for the remedy arm (p=0.062).

What are the clinical implications?

The authors conclude that the improvement followed the homeopathic consultation rather than the remedy, since remedy and placebo arms did not differ, and call for research into mechanism and into whether other consultation or psychological interventions have similar effects.

This summary and its findings were generated by AI from the published paper and may contain imperfections. It describes a study and is not medical advice — talk to a qualified clinician about your own health (terms). The original study is always the source of truth — read it above.