Effect of an herbal supplement on quality of life in participants with insomnia: A randomized placebo controlled cross-over pilot trial

Clinical Snapshot

Key Findings

• P Value: Not reported for primary comparisons

• Effect Size: Not reported with statistical precision

• Primary Outcome: No significant improvement in quality of life or sleep measures with herbal supplement versus placebo

• Nnt Or Sensitivity: Not applicable - no beneficial effect demonstrated

• Confidence Interval: Not provided

Clinical Application

Supplement appears safe but ineffective; 7-day treatment period may be too short for meaningful assessment Results do not support TGA therapeutic claims for this herbal combination; consistent with RACGP guidelines recommending evidence-based insomnia treatments over unproven supplements Limited applicability due to small sample size and specific demographic (adults 50+ with insomnia)

Abstract

BACKGROUND: Insomnia is a common sleep disorder linked to poor quality of life. Patients with insomnia frequently rely on herbal supplements to improve sleep and quality of life; however, most supplements do not undergo rigorous testing to determine their effectiveness. The primary objective of the pilot trial was to test the effectiveness of the herbal supplement on sleep and quality of life. METHODS: In a double-blind, randomized, placebo-controlled, crossover pilot trial, participants were assigned study drinks consisting of the herbal supplement containing extracts from chicory and green tea or placebo for 7 days. This was followed by a crossover to the other arm after 2 weeks of a washout period. Participants were healthy individuals of the age of 50 years or more with insomnia. Study measures included subjective assessments of sleep, daytime sleepiness, fatigue, and quality of life via questionnaires. Habitual sleep patterns and sleep architecture were objectively evaluated by a 7-day accelerometry and polysomnography. RESULTS: Ten participants (9 women; age 59 ± 6 y; BMI 30 ± 10 kg/m2) with insomnia severity index of 21 ± 4 and wake after sleep onset (WASO) of 75 ± 33 min were enrolled in the study. The impact of placebo and supplement was different for measures related to daytime sleepiness and physical fatigue but not quality of life. No within and between treatment differences were observed for any objective measures of habitual sleep patterns or sleep architecture. Within group analysis showed improvement in subjective sleep quality, daytime sleepiness, and general fatigue after 7-day consumption of the placebo drink, but not after consumption of herbal supplement. There were no adverse events related to study participation. CONCLUSION: Compared to placebo drink, daily consumption of the herbal supplement for 7 days did not improve any aspect of quality of life or sleep in our pilot study participants with insomnia. Well controlled clinical trials are needed to confirm the claims related to supplements.

References

1. 1.Singh, P., Griffith, I., Tanksley, M., Beyl, R. A., & Greenway, F. (2026). Effect of an herbal supplement on quality of life in participants with insomnia: A randomized placebo controlled cross-over pilot trial. *PLoS One*. https://doi.org/10.1371/journal.pone.0350039