Study Protocol Systematic Review Medicine ®

OPEN

Aromatherapy for managing menopausal

symptoms
A protocol for systematic review and meta-analysis
Jiae Choi, MBAa,e, Hye Won Lee, PhDb, Ju Ah Lee, KMD, PhDc, Hyun-Ja Lim, RN, PhDd,
∗
Myeong Soo Lee, PhDa,

Abstract
Background: Aromatherapy is often used as a complementary therapy for women’s health. This systematic review aims to
evaluate the therapeutic effects of aromatherapy as a management for menopausal symptoms.
Methods: Eleven electronic databases will be searched from inception to February 2018. Randomized controlled trials that
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evaluated any type of aromatherapy against any type of control in individuals with menopausal symptoms will be eligible. The
methodological quality will be assessed using the Cochrane risk of bias tool. Two authors will independently assess each study for
eligibility and risk of bias and to extract data.
Results: This study will provide a high quality synthesis of current evidence of aromatherapy for menopausal symptoms measured
with Menopause Rating Scale, the Kupperman Index, the Greene Climacteric Scale, or other validated questionnaires.
Conclusions: The conclusion of our systematic review will provide evidence to judge whether aromatherapy is an effective
intervention for patient with menopausal women.
Ethics and dissemination: Ethical approval will not be required, given that this protocol is for a systematic review. The
systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print.
Systematic review registration: PROSPERO CRD42017079191.
Abbreviations: CI = confidence interval, MD = mean difference, RCT = randomized controlled trial, RR = relative risk.
Keywords: aromatherapy, essential oil, menopausal symptoms, randomized controlled trials, systematic review

1. Introduction
Jiae Choi and Hye Won Lee have equally contributed to this work.
The protocol of a review was drafted by all authors. The search strategy was Menopause induces several uncomfortable symptoms, including
established by JC, JAL and MSL. Copies of studies will be obtained by JC and hot flashes, depression, vaginal dryness, low libido, osteoporosis,
HWL. Selection of the studies to include will be performed by JC, HWL, and fatigue, sleep disturbances, palpitations, emotional imbalance,
MSL. MSL will act as an arbiter in the study selection stage. Extraction of data
etc.[1] The symptoms of menopause can be effectively treated with
from studies will be conducted by JAL and HWL. Entering data into RevMan
5.3.0 Version will be conducted by H-JL and HWL. Interpretation of results will hormone replacement therapy (HRT), including estrogens
be performed by all authors. The final review will be drafted and revised by all combined with progestagens or estrogens alone.[2] However,
authors. The review will be updated by JC, JAL, HWL, H-JL and MSL. The first many women are concerned about the much-publicized risks of
2 authors (JC and HWL) equally contributed for developing this systematic this therapy and, therefore, look for alternatives.[3–6] The use of
review.
phytoestrogens such as aromatherapy may relieve menopausal
This study is supported by the Korea Institute of Oriental Medicine (K18292 and
symptoms and improve lipid profiles in postmenopausal
K18122). The authors alone are responsible for the writing and content of paper.
The funder will not do any role for this study. women.[7]
The authors have no conflicts of interest to disclose.
Aromatherapy uses essential oils extracted from herbs, flowers,
a and other plants to improve physical, emotional, and spiritual
Clinical Research Division, Korea Institute of Oriental Medicine, b KM
Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon, well-being and to treat various diseases through inhaling,
c
Department of Korean Internal Medicine, College of Korean Medicine, Gacheon massage, or bath treatment.[7] Many clinical studies on
University, Incheon, d Deportment of Nursing, Chodang University, Muan, aromatherapy have shown that it is beneficial for reducing stress
e
Present address: Healthy Life Management Team, Korea Health Promotion and pain, enhances alertness and feelings of relaxation, and
Institute, Seoul, Republic of Korea.
∗ reduces anxiety by stimulating endorphin production.[7–11]
Correspondence: Myeong Soo Lee, Clinical Research Division, Korea Institute
A recent systematic review included 5 trials (2 randomized
of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon 34054,
Republic of Korea (e-mail: drmslee@gmail.com). clinical trials [RCTs] and 3 controlled clinical trials) on the effects
Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc.
of aromatherapy on menopausal symptoms.[12] Its findings
This is an open access article distributed under the Creative Commons suggested that aromatherapy is effective for managing meno-
Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and pausal symptoms. However, the review lacked a comprehensive
reproduction in any medium, provided the original work is properly cited. literature search and was outdated. Hence, the aim of the current
Medicine (2018) 97:6(e9792) systematic review is to summarize and critically evaluate the
Received: 13 January 2018 / Accepted: 15 January 2018 evidence for or against the effectiveness of aromatherapy as
http://dx.doi.org/10.1097/MD.0000000000009792 management of menopausal symptoms.

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Choi et al. Medicine (2018) 97:6 Medicine

2. Methods 2.4. Data collection and analysis

2.4.1. Study selection. The data screening and selection process
2.1. Registration will be performed independently by 2 authors (JC and HWL) and
The protocol of this systematic review has been registered on will be verified by the third author (JAL). When disagreements on
PROSPERO 2017 CRD42017079191) (Available from: the selection are not resolved through discussions, the arbiter
http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID= (MSL) will decide. No language restrictions will be imposed.
CRD42017079191). This systematic review protocol was Hard copies of all the articles will be obtained and read in full.
reported using the Preferred Reporting Items for Systematic Details of the selection process are shown in the PRISMA flow
Reviews and Meta-Analyses (PRISMA-P) statement guidelines.[13] diagram.
2.4.2. Data extraction and management. All the articles will be
2.2. Search methods for identifying the studies read by 3 independent reviewers, who will extract the data from
2.2.1. Electronic sources. The following electronic databases the articles according to predefined criteria. The extracted data
will be searched for studies published from their dates of will include specific details about the authors, years of
inception to February 2018: AMED (EBSCO), CINAHL publication, study designs, sample sizes, interventions (regimens),
(EBSCO), EMBASE (EBSCO), MEDLINE (PubMed), and the controls (regimens), main outcome measures, adverse effects, and
Cochrane Central Register of Controlled Trials (CENTRAL), as authors’ conclusions. The extracted data will be tabulated for
well as Korea Med, Oriental Medicine Advanced Search further analysis.
Integrated System (OASIS), DBPIA, the Korean Medical
Database (KM base), the Research Information Service System 2.4.3. Risk of biased assessment. We will independently
(RISS), and the Korean Studies Information Services System assess bias in the included studies according to the criteria from
(KISS). In addition, the reference lists of potentially eligible the Cochrane Handbook version 5.1.0, which includes random
articles will be searched manually to identify additional relevant sequence generation, allocation concealment, blinding of partic-
reports. In addition, the reference lists of all identified articles will ipants and personnel, blinding of outcome assessment, incom-
be further searched for potentially relevant papers. Hard copies plete outcome data, selective reporting, and other sources of
of all the articles will be obtained and read in full. The search bias.[14] The quality of each trial will be categorized into a low,
strategy will be used with modifications of this for each database. unclear, or high risk of bias. We will resolve any differences in
opinion through discussion or consultation with the third author.
2.2.2. Search strategies. The searches will be conducted The overall quality of this systematic review and meta-analysis
using the medical subject headings (MeSHs) “aromatherapy will be summarized and evaluated with GRADEpro software
OR essential oil” AND “menopause OR climacteric OR (http://www.gradepro.org).
menopausal.”
2.4.4. Measures of the treatment effect. The differences
between the intervention and control groups will be assessed.
2.3. Eligibility criteria For the continuous data, we will use the mean difference (MD)
2.3.1. Types of studies. All the prospective RCTs identifying
with 95% confidence intervals (CIs) to measure the treatment
the therapeutic effects of aromatherapy compared with no
effect. We will convert other forms of data into MDs. In the case
treatment, placebo or conventional medication will be included.
of outcome variables with different scales, we will use the
2.3.2. Types of participants. We will include menopausal standard MD with 95% CIs. For dichotomous data, we will
women: women who are going through the menopausal present the treatment effect as a relative risk (RR) with 95% CIs
transition or women who are postmenopausal. to assess the effect size of each included study. We will convert
other binary data into an RR value.
2.3.3. Types of interventions. The review will include all trials All of the statistical analyses will be conducted using Cochrane
of any duration that investigated the effects of any type of Collaboration’s software program, Review Manager (RevMan),
aromatherapy, including aromatherapy administered via mas- Version 5.3.5 for Windows (Copenhagen, the Nordic Cochrane
sage or the inhaled or oral routes, regardless of how the therapy Centre, the Cochrane Collaboration 2014). For studies
was dosed, prepared, or processed. We will compare all types of with insufficient information, we will contact the corresponding
control interventions, including placebo treatments, conventional authors to acquire and verify the data when possible.
medicines, standard care methods, and no treatments. Studies Chi-squared and I-squared tests will be used to evaluate
comparing 2 types of aromatherapy will be excluded from the the heterogeneity of the included studies. Unless excessive
review. statistical heterogeneity is present, we will then pool the data
across studies for a meta-analysis using a random-effects or
2.3.4. Outcome measures2.3.4.1. Primary outcomes. Meno- fixed-effects model.
pausal symptoms (hot flashes, night sweats, vaginal dryness, etc.)
measured with Menopause Rating Scale, the Kupperman Index, 2.4.5. Unit of analysis issues. For cross-over trials, data from
the Greene Climacteric Scale, or other validated questionnaires the first treatment period will be used. For trials in which more
Female sexual function measured with the validated ques- than 1 control group was assessed, the primary analysis will
tionnaires including the Female Sexual Function Index, the Brief combine the data from each control group. Subgroup analyses of
Index of Sexual Functioning for Women, Sexual Functioning the control groups will also be performed. Each patient will be
Questionnaire, etc. counted only once in the analysis.

2.4.6. Dealing with missing data. Intention-to-treat analyses

2.3.4.2. Secondary outcomes.
that include all of the populations will be performed. For
 Adverse effects populations with missing outcome data, a carry-forward of the
 General well-being or quality of life last observed response will be used. If missing data are detected,

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we will request any missing or incomplete information from the [2] Baber RJ, Panay N, Fenton A, et al. 2016 IMS Recommendations on
women’s midlife health and menopause hormone therapy. Climacteric
original source investigators.
2016;19:109–50.
[3] Bair YA, Gold EB, Zhang G, et al. Use of complementary and alternative
2.4.7. Assessment of heterogeneity. If a meta-analysis is
medicine during the menopause transition: longitudinal results from the
possible, we will use the I2 statistic to quantify the inconsistencies Study of Women’s Health Across the Nation. Menopause 2008;15:32–43.
among the included studies. According to the guidance given in [4] Daley A, MacArthur C, McManus R, et al. Factors associated with the
the Cochrane Handbook for Systematic Reviews of Interven- use of complementary medicine and non-pharmacological interventions
tions, an I2 value of 50% will be the cut-off point for meaningful in symptomatic menopausal women. Climacteric 2006;9:336–46.
[5] Peng W, Adams J, Sibbritt DW, et al. Critical review of complementary and
heterogeneity. If heterogeneity in the meta-analyses is observed, alternative medicine use in menopause: focus on prevalence, motivation,
we will conduct a subgroup analysis to explore the possible decision-making, and communication. Menopause 2014;21:536–48.
causes.[15] Subgroup analyses based on different control [6] Posadzki P, Lee MS, Moon TW, et al. Prevalence of complementary and
interventions, types of control, types of condition, and types alternative medicine (CAM) use by menopausal women: a systematic
review of surveys. Maturitas 2013;75:34–43.
of study design will be conducted. A sensitivity analysis will
[7] Buckle J. Clinical Aromatherapy. Elsevier, St. Louis, MO:2015.
be performed to evaluate the robustness of the meta-analysis [8] Choi J, Lee JA, Alimoradi Z, et al. Aromatherapy for the relief of
results. symptoms in burn patients: a systematic review of randomized controlled
trials. Burns 2017.
2.4.8. Assessment of reporting biases. If a sufficient number [9] Hur MH, Lee MS, Kim C, et al. Aromatherapy for treatment of
of the included studies (at least 10 trials) are available, we will use hypertension: a systematic review. J Eval Clin Pract 2012;18:37–41.
funnel plots to detect reporting biases.[16] If the funnel plot [10] Hur MH, Song JA, Lee J, et al. Aromatherapy for stress reduction in
healthy adults: a systematic review and meta-analysis of randomized
asymmetry is not the same as the publication bias, we will attempt clinical trials. Maturitas 2014;79:362–9.
to distinguish the possible reasons for the asymmetry, such as [11] Lee MS, Choi J, Posadzki P, et al. Aromatherapy for health care: an
small-study effects, poor methodological quality, and true overview of systematic reviews. Maturitas 2012;71:257–60.
heterogeneity in the included studies. [12] Kim S, Song JA, Kim ME, et al. Effects of aromatherapy on menopausal
symptoms, perceived stress and depression in middle-aged women: a
systematic review. J Korean Acad Nurs 2016;46:619–29.
3. Discussion [13] Knobloch K, Yoon U, Vogt PM. Preferred reporting items for systematic
reviews and meta-analyses (PRISMA) statement and publication bias. J
This systematic review may provide a detailed summary of the Craniomaxillofac Surg 2011;39:91–2.
current evidence related to the effectiveness of aromatherapy, as [14] Higgins J, Altman D, Sterne J. Higgins J, Green S. Assessing risk of bias in
well as useful information on the acceptability and applicability included studies. Cochrane Handbook for Systematic Reviews of
Interventions Version 510 2011;The Cochrane Collaboration, Available
in the field of complementary and alternative medicine research from www.cochrane-handbook.org.
for both practitioners and patients. The findings of this review [15] Deeks JJ, Higgins JPT, Altman DG. Analysing data and undertaking
will be disseminated widely through peer-reviewed publications meta-analyses. In: Higgins J, Green S, eds. Cochrane Handbook for
and conference presentations. Systematic Reviews of Interventions Version 510. The Cochrane
Collaboration, 2011. Available from www.cochrane-handbook.org.
[16] Sterne JAC, Egger M, Moher D. Addressing reporting biases. In: Higgins
J, Green S, eds. Cochrane Handbook for Systematic Reviews of
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