The effect of the scent of Sage officinalis on sexual function and satisfaction in postmenopausal women: a randomized controlled trial BMC Women’s Health

The effect of the scent of Sage officinalis on sexual function and satisfaction in postmenopausal women: a randomized controlled trial  BMC Women’s Health

Study design and participants

This double-blind, randomized clinical trial (RCT) was conducted using two parallel groups on eligible postmenopausal women referring to health centers in Kermanshah, Iran, from April to September 2019. Figure 1 shows the CONSORT flowchart of the study. Inclusion criteria were: age 45–60 years, menopause for at least 12 months, ability to read and write, FSFI score ≥ 28, married and living with a spouse, no mental or physical illness, no smoking, no alcohol consumption, no Having a history of allergic rhinitis or known respiratory problems such as asthma, no exposure to stressful events (e.g. divorce, death of immediate family members, etc.) during the six months prior to the study, and having a health record at a health care center. Exclusion criteria were unwillingness to continue participation and failure to complete the intervention for any reason.

Chart 1

Flowchart of study participants

Calculate sample size

The sample size for each group was calculated based on the results of a previous similar study (22). The following formula was used to calculate the sample size.

$$N=\frac {({{Z}_{1-\frac{\alpha }{2}}+{Z}_{1-\beta })}^{2} \times ({s}_ {1}^{2}+{s}_{2}^{2})}{{({\mu }_{1}- {\mu }_{2})}^{2}}$$

where α = 0.01, β = 0.1, μ1 = 1.4, μ2 = 4.4, S1 = 4.2, and S2 = 0.4, and n = 31. We added 5% for dropout and the total number of women in each group was calculated to be 32.

Sampling and random assignment method

After obtaining approval from the Ethics Committee of Kermanshah University of Medical Sciences, four health centers in Kermanshah were designated for data collection. Eligible postmenopausal women were randomly assigned to the Salvia officinalis (n = 32) and control (n = 32) groups and completed baseline testing questionnaires. The women were taught how to use aromatherapy. Each week, a researcher made phone calls to participants to ensure proper use of the oil and check for any adverse effects. After the six-week intervention, post-tests were conducted including the same questionnaires as in the baseline test to determine the effects of the intervention. In total, data were collected from two time points.

The block randomization method was used in this research. The allocation sequence was determined by computer using a random number table with a block size of 6 and an allocation ratio of 1:1. Salvia officinalis and almond oils were stored in identical containers and labeled by the pharmacist. To blind the allocation, each woman was assigned a unique code and all codes were kept in an opaque envelope until intervention. Neither the statistician (who conducted the data analysis) nor the researcher (who participated in the sampling) was aware of the group allocation.

Odor interference

Women in the intervention and control groups were asked to apply two drops of 10% sage extract or almond oil extract, respectively, to the skin of the forearm (left or right) twice daily (10 a.m. and 10 p.m.) and inhale the scent. For 5 consecutive days a week, and continued for 6 weeks. Following Malkooti et al., we asked participants to sit in a comfortable position, place their forearm 30 cm from their nose, and inhale the odor for five minutes with normal breathing (22). The essential oil of Salvia officinalis 10% was purchased from a pharmaceutical research center in Tehran (Iran) and was approved by the Faculty of Pharmacy, Kermanshah University of Medical Sciences. Odorless almond oil diluted with propylene glycol was purchased from the herbal market in Kermanshah (Iran) and was approved by the Faculty of Pharmacy of Kermanshah University of Medical Sciences. Based on previous studies, almond oil was used in the control group (27, 28). The essential oil concentration was 10%, i.e. 10 mg of sage essential oil in 100 ml of odorless almond oil diluted with propylene glycol. Propylene glycol maintains the stability of the essential oil. The amount of essential oil needed for the 6-week intervention was stored in a dropper by a pharmacist and administered to participants at the beginning of the study.

Data collection tools

Demographic and social information form

This form was used to record information such as age, menopause, educational attainment, occupation, monthly income, body mass index, and number of children.

Female Sexual Function Index (FSFI)

This questionnaire included 19 questions scored on a scale of 0 to 5 or 1 to 5, where 0 indicated no sexual activity in the past month (Table 1) (29). Results for each of the six domains were standardized by adding the individual domain search results and multiplying them by the domain factor. For example, 0.6 for desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain. The FSFI total score is the sum of the scores of six separate domains (30). The total score range was between 2 and 36, with a higher score indicating better sexual functioning. Below 28 is considered a sexual dysfunction (31). Rosen et al. The validity and reliability of the FSFI has been confirmed, with the average reliability of the entire scale being 0.88 and domains ranging from 0.79 to 0.8620 ( 29 ). In Iran, this was confirmed by Mohammadi et al. (2007) on 53 women with a sensitivity of 83% and specificity of 82% (31).

Table 1: Female Sexual Function Index scoring system. A domain score of zero indicates that no sexual activity was reported during the past month

Lindaberg Sexual Satisfaction Questionnaire: This questionnaire included 17 questions scored as follows: always: 5, often: 4, sometimes: 3, rarely: 2, and never: 1. The maximum and minimum scores are 85 and 17, respectively. Scores between 17 and 51 represent poor satisfaction, 67 to 52 indicate moderate satisfaction, and 85 to 65 indicate good satisfaction. This questionnaire was prepared by Lindaberg in 1997, and its validity and reliability were confirmed in Iran by Salehi Federdi. The reliability of the interview form and average sexual satisfaction was confirmed by interrater reliability by obtaining correlation coefficients r < 0.7 and r = 0.78, respectively, and a Cronbach's alpha coefficient of 0.87 was obtained ( 32 , 33 ).

statistical analysis

All data were analyzed using SPSS version 23. The level of statistical significance was set at P < 0.05. Mean and standard deviation were used to describe quantitative variables while percentage and frequency were used to describe qualitative variables. Normal distribution of numerical variables was verified using the Kolmogorov-Smirnov test. The independent t-test or Mann-Whitney test was used to examine the difference between two groups. Paired t test or non-parametric equivalent (Wilcoxon test) was used to evaluate within-group differences. Sociodemographic characteristics of the studied women were compared using the independent t test, Mann-Whitney test, and Fisher's exact test.

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