Chinese Herbal Sachet Therapy for Sleep Quality in Menopausal Women

This participant-blinded, randomized, placebo-controlled trial evaluated a Delphi-developed ten-herb traditional Chinese medicine aromatic sachet for self-reported sleep quality in community-dwelling menopausal women aged 45 to 59 years with a baseline Pittsburgh Sleep Quality Index (PSQI) global score of 5 or above. The formula was developed before recruitment through a three-round Delphi consensus with ten experts. Participants recruited through the study institution, two Macao community organisations and online channels were randomised 1:1 by computer-generated numbers to the active sachet or an odour-plausible placebo sachet identical in appearance, weight and packaging; participants were not told their allocation, while the research team was aware of it. Sachets were placed within 30 cm of the pillow nightly and replaced every three weeks for nine weeks; nightly adherence was logged through a WeChat check-in mini-program. The PSQI was completed at baseline and weeks 3, 6 and 9. The primary analysis used generalized estimating equations (normal distribution, identity link, exchangeable working correlation, robust standard errors) with group, time and group-by-time interaction, plus Mann-Whitney U comparisons at each timepoint; secondary outcomes were responder proportions (PSQI 5 or below; reduction of 3 or more points) and the Sleep Quality Improvement Index. Analyses were performed on the 112 participants who completed all four assessments (completer analysis). The trial was registered retrospectively after data collection was complete; the ethics approval (13 October 2023) and the pre-specified protocol predate enrolment (first participant December 2023).

Inclusion criteria

• Aged 45 to 59 years
• Self-reported sleep disturbance during the menopausal transition
• Baseline Pittsburgh Sleep Quality Index (PSQI) global score of 5 or above
• Greene Climacteric Scale (GCS) total score of 12 or more at screening
• Normal olfactory function
• Fluent in reading and writing Chinese
• Able to use a smartphone application for daily adherence logging
• Provided written informed consent

Exclusion criteria

• Severe systemic illness such as cancer or renal or hepatic failure
• Drug-induced insomnia
• History of severe drug allergy
• Acute respiratory illness
• Drug or alcohol dependence
• Secondary insomnia due to pain
• Pregnancy or lactation
• Current use of non-pharmacological sleep interventions such as acupuncture
• Current or newly initiated hormone replacement therapy
• Unstable hypnotic medication use during the study period