The effect of a homeopathic complex on psychophysiological onset insomnia in males: a randomized pilot study.
ABSTRACT Context • Psychophysiological onset insomnia (PI) is defined as sleeplessness exceeding 30 min due to learned, sleep-preventing behaviors and hyperarousal at bedtime. This common condition significantly impacts sufferers' health, occupational performance, and interpersonal relationships. Conventional treatment with hypnotics has many shortcomings. Homeopathic medication may present an alternative treatment for this condition. Objective The study intended to determine the effect of a homeopathic complex on PI. Design The research team designed a randomized, double-blind, placebo-controlled, 4-wk pilot study, using matched pairs. Setting The study took place at the Homeopathy Health Clinic at the University of Johannesburg in Johannesburg, South Africa. Participants Forty-six males aged between 18 and 40 y with chronic PI were recruited; 28 completed the study- placebo group (n = 14) and experimental group (n = 14). Interventions The homeopathic complex was made in 20% alcohol. The placebo consisted of the unmedicated vehicle only. Outcome Measures The study used the Pre-sleep Arousal Scale (PSAS) and the Sleep Diary (SD), which assessed sleep-onset latency. Results The experimental group showed a statistically significant improvement in presleep arousal as well as sleep onset latency over the 4 wks of the study. The Wilcoxon signed-rank test revealed that the improvement occurred gradually. Intergroup analysis showed through both the PSAS and the SD that the experimental group had outperformed the placebo group by day 28 of the study. Conclusion Findings suggest that daily use of the homeopathic complex does have an effect over a 4-wk period on physiological and cognitive arousal at bedtime as well as on sleep onset latency in PI sufferers. Further research on the use of this complex for PI is warranted before any definitive conclusions can be drawn.