Menopause, Sleep Initiation and Maintenance Disorders
Conditions
Keywords
aromatherapy, traditional Chinese medicine, menopause, sleep quality, Pittsburgh Sleep Quality Index, nursing
Brief summary
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.
Detailed description
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).
Interventions
OTHERTraditional Chinese medicine aromatic sachet
Aromatic sachet containing Albizia flower 12 g, lavender 12 g, Acorus (Acorus tatarinowii) 5 g, rose (Rosa rugosa) 12 g, white chrysanthemum 12 g, Atractylodes (Atractylodes lancea) 12 g, Angelica sinensis 12 g, mugwort 12 g, chuanxiong 7 g and cinnamon bark (Cinnamomi Cortex) 7 g, 103 g total, ground to powder and sealed in a non-woven inner bag (12 x 16 cm) inside a non-woven outer bag (13 x 18 cm). Used nightly within 30 cm of the pillow for nine weeks and replaced every three weeks.
OTHERPlacebo aromatic sachet
Odour-plausible placebo sachet containing Agastache rugosa, Angelica dahurica, Pueraria montana var. lobata, Plantago asiatica and pumice, matched to the active sachet in appearance, weight and packaging. Used nightly beside the pillow for nine weeks and replaced every three weeks.
Sponsors
Macao Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants were not informed whether they received the active or placebo sachet. The research team was aware of group assignment, outcomes were self-reported, and blinding effectiveness was not assessed.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index (PSQI) global score | Baseline, week 3, week 6, week 9 | The Pittsburgh Sleep Quality Index is a 19-item self-report instrument yielding seven component scores summed to a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving a reduction of at least 3 points in PSQI global score | Baseline to week 9 | Proportion of participants whose PSQI global score decreased by at least 3 points from baseline, a commonly used marker of clinically meaningful improvement. |
| Sleep Quality Improvement Index (SQII) | Baseline to week 9 | SQII was calculated by the Nimodipine method as (baseline PSQI - post-intervention PSQI) / baseline PSQI x 100%. Higher values indicate greater improvement in sleep quality. |
| Change in Greene Climacteric Scale (GCS) total score | Baseline, week 3, week 6, week 9 | The Greene Climacteric Scale is a 21-item self-report instrument. Each item is scored 0 to 3, giving a total score from 0 to 63. Higher scores indicate greater menopausal symptom burden. |
| Change in Greene Climacteric Scale (GCS) symptom cluster scores | Baseline, week 3, week 6, week 9 | Cluster scores derived from the Greene Climacteric Scale: anxiety (items 1-6, range 0-18), depressive (items 7-11, range 0-15), somatic (items 12-18, range 0-21), vasomotor (items 19-20, range 0-6) and sexual function (item 21, range 0-3). Higher scores indicate greater symptom burden. |
| Proportion of participants with a PSQI global score of 5 or below | Baseline to week 9 | Proportion of participants achieving a PSQI global score of 5 or below, the conventional threshold for good sleep quality. |
Countries
Macau
Contacts
PRINCIPAL_INVESTIGATORCindy Sin U LEONG, DHSc, RN
Macao Polytechnic University
Outcome results
None listed