Chinese Herbal Sachet Therapy for Sleep Quality in Menopausal Women

Overview

Many women sleep poorly during the menopausal transition. Some prefer not to take hormone therapy or sleeping tablets, and ask their nurses about other options. This study tested a traditional Chinese medicine aromatic sachet containing ten herbs, chosen by a panel of experts. Women placed the sachet beside their pillow each night for nine weeks and removed it each morning. One hundred and twenty-two women aged 45 to 59 who reported poor sleep and were recruited in Macao took part. Half received the herbal sachet and half received a placebo sachet, which was identical in appearance, weight and packaging and carried a herbal scent, but did not contain the herbs being tested. Participants were not told which sachet they had been given. Sleep quality was measured using the Pittsburgh Sleep Quality Index at the start of the study and again after 3, 6 and 9 weeks.

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).