Effect of Chinese Herbal Sachet Therapy on Improving Sleep Quality of Midlife Women in Macao: A Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change in Pittsburgh Sleep Quality Index (PSQI) global score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TCM aromatic sachet
Ten-herb traditional Chinese medicine aromatic sachet, 103 g total, in a non-woven inner bag (12 x 16 cm) inside a non-woven outer bag (13 x 18 cm). Participants removed the sachet from a sealed plastic bag 15 minutes before bedtime, placed it within 30 cm of the pillow throughout the sleep period, and resealed it in the plastic bag on waking. The sachet was replaced every three weeks, for a total of nine weeks.
干预措施: Traditional Chinese medicine aromatic sachet (Other)
Placebo sachet
Placebo sachet identical to the active sachet in inner and outer bag, packaging, total weight, usage instructions and three-weekly replacement schedule, for a total of nine weeks. It contained Agastache rugosa, Angelica dahurica, Pueraria montana var. lobata, Plantago asiatica and pumice, selected to give a plausible but non-identical herbal odour.
干预措施: Placebo aromatic sachet (Other)
结局指标
主要结局
Change in Pittsburgh Sleep Quality Index (PSQI) global score
时间窗: 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.
次要结局
- Proportion of participants with a PSQI global score of 5 or below(Baseline to week 9)
- Proportion of participants achieving a reduction of at least 3 points in PSQI global score(Baseline to week 9)
- Sleep Quality Improvement Index (SQII)(Baseline to week 9)
- Change in Greene Climacteric Scale (GCS) total score(Baseline, week 3, week 6, week 9)
- Change in Greene Climacteric Scale (GCS) symptom cluster scores(Baseline, week 3, week 6, week 9)
研究者
Cindy Sin U Leong
Associate Professor
Macao Polytechnic University