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Volume 9, Issue 4 (2-2020)                   cmja 2020, 9(4): 3852-3867 | Back to browse issues page

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Shabani F, Zareian M A. Evaluation of the Synergism of Medicinal Effects of Chamomile and Ginger on Pain and Symptoms of Primary Dysmenorrhea: A Randomized Controlled Trial. cmja. 2020; 9 (4) :3852-3867
URL: http://cmja.arakmu.ac.ir/article-1-706-en.html
1- Department of Midwifery, School of Medicine, Arak University of Medical Sciences, Arak, Iran.
2- Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. , dr.m.a.zareian@gmail.com
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Extended Abstract
1. Introduction

Dysmenorrhea is one of the most common menstrual disorders that reduce the Quality of Life and disruption in women’s social and occupational activities [3]. The prevalence of dysmenorrhea in Iran is about 71% [4]. The first line of treatment for dysmenorrhea are Non-Steroidal Anti-inflammatory Drugs (NSAIDs), but in addition to NSAIDs, several oral and non-oral therapies have been suggested for primary dysmenorrhea but there is still insufficient evidence to support their efficacy [5]. 
Studies on the effects of chamomile, ginger, and honey on dysmenorrhea have been carried out separately [15, 21, 28], but no study was done on the simultaneous administration of these three cases and their possible synergism. The purpose of this study was to evaluate the effect of chamomile-ginger decoction along with honey on the severity of primary dysmenorrhea and its associated symptoms in comparison with chamomile-decoction, honey-ginger decoction, and mefenamic acid capsule in Arak University students.
2. Materials and Methods
This study is a randomized controlled clinical trial on 400 female students of Arak University. Samples were randomly divided into four groups of 100 individuals. After obtaining informed consent, each received: 1000 mg of ginger root powder plus honey (one tablespoon), 500 mg of chamomile with honey, (1000 mg of ginger and 500 mg of chamomile), and mefenamic acid (250 mg).
 The drugs were administered in two successive cycles, from two days before menstruation until the first three days and three times daily. Severity of pain was measured using a Visual Analogue Scale (VAS), symptoms based on the Andersch-Millsom Verbal Scale, and bleeding rates were measured using the Pictorial Blood Loss Assessment Chart (PBACs). All of these were measured in the first three days of the menstrual cycle before the intervention, the first month, and the second month after the intervention. Participants were provided with the same brand of hygiene pads, all necessary charts, as well as medicines for free.
 Statistical analysis was performed by SPSS V. 19 using Kruskal-Wallis, Chi-square, Fisher, Friedman, and ANOVA tests with repeated measure at 0.05 significance level.
3. Results
During the study, 23 patients were excluded because of not completing the questionnaire, marrying, unwillingness to continue, and discontinuing medication. Overall, the reported side effects of the drugs were skin allergy (n=17), gastrointestinal side effects (n=18), and hot flash (n=9). Most of the complications were related to the ginger group; there was no statistically significant difference between the groups in terms of complications.
The mean age of the samples was 21.002±1.91 years and they were between 18-30 years old. Demographic indices and menstrual characteristics were not significantly different between groups, except for the mean age in the chamomile group and menstrual cycle length in the ginger group (Table 1). The severity of pain, number of days of pain, low back pain, amount of analgesia, total symptom score, and bleeding rate were significantly decreased in all 4 groups (P=0.001). No significant differences were observed except for the difference in total symptom score and bleeding rate between groups.
The combination of ginger-chamomile did better in reducing overall symptom score than other interventions (P=0.02). Mefenamic acid also had a better effect on reducing bleeding than other interventions (P=0.008). Ginger group had the highest effect on fatigue reduction (P=0.02).
4. Discussion 
So far, no study has investigated the effect of ginger-chamomile and honey on dysmenorrhea. In the case of distilled extracts, we should expect some chemical interactions to occur between the compounds. The decoction may alter the amount of active ingredient extraction or produce new compounds, which may exhibit new medication [42]. Combination of medicines is usually aimed at increasing efficacy and reducing complications, but not every combination results in synergism [41]. 
Considering the total pain experienced by dysmenorrhea patients, i.e., low back pain and headache, all four interventions had similar effects in controlling pain severity, reducing pain-killing consumption, and reducing back pain but did not have significant effect on ginger- chamomile group headaches; chamomile did better than mefenamic acid, as confirmed by previous studies [32]. The combination of chamomile and ginger does not seem to be superior to chamomile in controlling the pain experience of a patient with dysmenorrhea. 
In the present study, although chamomile did better in controlling pain, but ginger-chamomile did better in controlling mood symptoms and ginger did better in controlling fatigue. Given that one of the mechanisms involved in the onset of mood symptoms is the relative decrease in serotonin in the menstrual cycle [36], the role of ginger in controlling these symptoms can be justified because ginger also contains compounds that are agonists of a group of serotonin receptors [37]. Taken together, the results suggest that combining ginger and chamomile does not cause synergy or reduce drug side effects, and this combination is not significantly superior to ginger or chamomile with honey for the treatment of dysmenorrhea.

Ethical Considerations
Compliance with ethical guidelines
This project was registered (Code of Ethics: ARAKMU.REC.1395.164) by the Ethics Committee of Arak University of Medical Sciences and Code N52016100825031 at the Clinical Trials Registration Center.
All the expenses of this project have been provided by the research deputy of Arak University of Medical Sciences.
Authors' contributions
Presenter: Fatemeh Shabani; Final report: Mohammad Ali Zareian.
Conflicts of interest
The authors declared no conflict of interest.
The researchers are grateful to the Vice Chancellor for Research Center of Complementary Medicine, the Research Council of the Faculty of Nursing and Midwifery, the Ethics Committee, the officials and staff of Arak University of Medical Sciences, and other affiliated universities.
Type of Study: Applicable | Subject: Medicinal Plants

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