|Year : 2020 | Volume
| Issue : 3 | Page : 110-114
Evaluation of the effect of perforan (Hypericum perforatum) on premenstrual syndrome severity of physical and behavioural symptoms in patients with premenstrual syndrome: A clinical randomised trial
Nasim Khademi1, Haniyeh Abbassinya2, Farahnaz Heshmat3, Mahdis Naafe4, Abolfazl Mohammadbeigi5
1 Department of Midwifery, Nursing and Midwifery Sciences Development Research Center, Islamic Azad University, Najafabad Branch, Najafabad, Iran
2 Department of midwifery, School of Nursing and Midwifery, Tehran University of Medical Science, Tehran, Iran
3 Department of midwifery, Heshmatie Hospital, Isfahan University of Medical Science, Isfahan, Iran
4 Department of midwifery, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran
5 Department of Epidemiology and Biostatistics, Neuroscience Research Center, Qom University of Medical Sciences, Qom, Iran
|Date of Submission||13-Jun-2020|
|Date of Decision||12-Jul-2020|
|Date of Acceptance||18-Aug-2020|
|Date of Web Publication||22-Sep-2020|
School of Nursing and Midwifery, Tehran University of Medical Science, Tehran
Source of Support: None, Conflict of Interest: None
Background: Premenstrual syndrome (PMS) is an extensive group of emotional, behavioural and physical symptoms that occur before menstruation. It has a negative impact on activities of daily living, social activities, sexual functioning and quality of life. This study aimed to evaluate the effect of perforan (Hypericum perforatum) on the severity of physical and behavioural symptoms associated with PMS. Materials and Methods: In a triple-blind clinical trial, 93 students with PMS were randomly divided into two groups, including perforan and control (placebo) groups, and followed for three subsequent cycles. They took capsules daily in the first cycle for 1 month, and in the second and third cycles, they took capsules from 8 days pre-menstruation to 2 days post-menstruation and recorded the severity of physical and behavioural symptoms using a PMS questionnaire. Statistical analyses were performed using SPSS version 20. Repeated measures ANOVA, Chi-squared tests and independent t-tests were used to compare the mean scores of the two groups. Results: The data showed that there were no significant differences between the two groups before the intervention (P > 0.05). Nevertheless, the severity of physical and behavioural symptoms of PMS was significantly lower in the perforan group than the control group. This was the case 1, 2 and 3 months after consumption of perforan (P < 0.001). Moreover, a significant difference between the two groups in the decrease of PMS scores was observed by repeated measurement tests (P < 0.001). Conclusion: Perforan significantly reduces the severity of physical and behavioural symptoms of PMS. Therefore, perforan could be effective in the treatment of physical and behavioural symptoms of patients with PMS. Nevertheless, future studies are necessary to confirm these results.
Keywords: Hypericum perforatum, perforan, premenstrual syndrome, symptoms
|How to cite this article:|
Khademi N, Abbassinya H, Heshmat F, Naafe M, Mohammadbeigi A. Evaluation of the effect of perforan (Hypericum perforatum) on premenstrual syndrome severity of physical and behavioural symptoms in patients with premenstrual syndrome: A clinical randomised trial. Adv Hum Biol 2020;10:110-4
|How to cite this URL:|
Khademi N, Abbassinya H, Heshmat F, Naafe M, Mohammadbeigi A. Evaluation of the effect of perforan (Hypericum perforatum) on premenstrual syndrome severity of physical and behavioural symptoms in patients with premenstrual syndrome: A clinical randomised trial. Adv Hum Biol [serial online] 2020 [cited 2021 Apr 17];10:110-4. Available from: https://www.aihbonline.com/text.asp?2020/10/3/110/295825
| Introduction|| |
Premenstrual syndrome (PMS) is characterised by the repeated occurrence of disruptive physical and emotional symptoms before menses. It has a negative impact on activities of daily living, interpersonal relationships, social activities, leisure activities, sexual functioning, occupation and quality of life., Although the mean prevalence of PMS is 47.8%, 99.5% of Iranian students have reported at least one premenstrual symptom., Surveys have suggested that more than 80% of women report PMS when strict diagnostic criteria are applied; the prevalence of severe PMS is estimated at around 2%–6% in women of reproductive age., According to research in Iran on the prevalence of PMS among university students, the most commonly reported symptoms were mood symptoms (72.6%) and somatic symptoms (62.7%). It was reported that the prevalence of PMS is 80.4% among high school students, 68.9% among university students and 54.9% in the general population.
PMS causes criminal behaviour, suicide attempts, work absences, hospital admissions and an increase in accidents. It influences women's feelings about themselves and others, and it co-occurs with a range of other problems, for example, anxiety, nutrition disorders and obesity.,, Women with PMS complain of cyclical mastalgia (breast pain) that it leads to disturbances in sexual function and physical and social activities.,, It was seen that in the luteal phase of women, menstrual migraine, headaches, depression, irritability, anxiety and nausea were increased., Although the aetiology of PMS is unknown, the causative factors include hormonal imbalances, abnormalities in thyroid hormones, low serotonin levels, nutritional deficiencies and increased levels of inflammatory prostaglandins, cortisol, prolactin, β-endorphins and electrolytes.,
Many treatments for PMS have been tested over the years. These include non-pharmacological (dietary modification, dietary supplements and regular physical activity) and pharmacological treatments, which have varying outcomes., As PMS is a persistent condition, we must pay attention to the side effects of medications., Recent research demonstrates that herbal medicines are more acceptable to patients because they have fewer side effects., The extract of Hypericum perforatum (perforan) has been shown to be effective through experimental investigations and clinical trials., Since herbs can be safer and less expensive than chemical drugs, they are accepted more easily, and since women have the right to choose treatments that are affordable and have fewer side effects, we evaluate in this study the effect of perforan on the physical symptoms of PMS.
| Materials and Methods|| |
This study is a two-blind clinical trial that was conducted to evaluate the effect of perforan on the physical symptoms of PMS. The study was conducted on students living in Isfahan university residence halls and included all unmarried students who were dormitory residents during the study period.
Data were collected using a questionnaire including two sections: demographic characteristics and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) that includes eight physical symptoms and five behavioural symptoms of PMS: breast tenderness or swelling, headaches, back pain, abdominal pain, weight gain, swelling of the extremities, gastrointestinal disorders, feeling exhausted, lack of energy, sleep disorders, difficulty concentrating and appetite disorders.
The inclusion criteria were predefined as follows: regular menstrual cycles (arriving every 24–35 days) and being single. Exclusion criteria included unwillingness to remain in the study, drug allergies or side effects, physical and psychiatric symptoms resulting from endocrine disorders, severe PMS, taking any drugs or herbal medicines, having physical illnesses such as endocrine disorders, taking medication for PMS, consumption of alcohol, having relatives death history in the last 3 months and having had surgery in the last 3 months.
The sample size was calculated based on a study power of 80%, an alpha error of 5% and minimal difference between the two groups. In the first stage of the study, only 250 students from the 500 who were invited to participate returned the DSM-IV form. Following exclusion of participants with incomplete forms (n = 120), 130 students had completed the DSM-IV form at baseline. In the second stage of the study, participants were issued with a form for completion over a period of 2 months. This form was a daily schedule listing 13 symptoms that could be experienced on days 1–35 of the menstrual cycle. The individuals were advised not to use any drugs (including vitamins) during this time and were also advised to avoid caffeine and salt during the premenstrual period. The form was filled out in this way: absence of symptoms, 0 points; mild symptoms with no interference with daily activities, 1 point; moderate symptoms that may interfere with daily activities, 2 points; and severe symptoms that interfere with daily tasks such as attending class or using painkilling drugs, 3 points. A student had PMS if they had at least five symptoms in the period from a week before her menstruation until 3 days after. To analyse the severity of physical and behavioural symptoms of PMS, the total scores of 13 symptoms from 1 week pre-menstruation until 3 days after were added together. Then, the cases were classified as follows: lack of physical and behavioural symptoms of PMS (score = 0), mild physical and behavioural symptoms of PMS (1–130), moderate physical and behavioural symptoms of PMS (131–260) and severe physical and behavioural symptoms of PMS (>260). In enrolment phase, from 130 individuals who completed the daily symptoms and having inclusion criteria, 30 individuals excluded due to severe PMS or lack physical symptoms (n = 30) and finally 100 individuals entered to study. In the third stage of the study, the individuals were randomly assigned to two groups of 50 students, one taking perforan 280 mg/day and the other a placebo. The participants took these medicines over three menstrual cycles. During the first cycle, drugs were taken on each day of the cycle. During the second and third cycles, drugs were taken daily in the period starting 8 days before menstruation and finishing 2 days afterwards. The participants recorded any symptoms experienced during the total study period on a daily basis using the daily symptoms form. Seven students were excluded due to fear of dependence in the perforan group (n = 2) and gastrointestinal complications in the placebo group (n = 5) during the study period [Figure 1]. Written informed consent was taken from all eligible participants. Participation in the study was voluntary. The study protocol was approved by the Ethics Committee of Tehran University of Medical Sciences and registered with the Iranian Registry Clinical Trial Center.
Finally, the forms were collected, and the severity of symptoms was measured and analysed separately for each group. We used descriptive statistics to describe the demographic characteristics of the sample and used the repeated measures ANOVA test for quantitative variables, the Chi-squared test for relationships between categorical variables and the independent t-test to compare the mean scores of each group in each cycle. The normally distributed population was tested using the Kolmogorov–Smirnov test. Scheffe's post hoc test in repeated measures ANOVA test was used for two-by-two comparisons. All data analysis was performed using SPSS version 20 (SPSS Inc., Chicago, IL, USA).
| Results|| |
Confounding factors that were controlled through randomisation included age, age at menarche, length of menstrual cycle, duration of menstrual bleeding and body mass index. The two groups demonstrated similarities in all of these parameters [Table 1].
|Table 1: Comparison of demographic and obstetrical characteristics among two groups using independent t-tests|
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The mean scores for physical and behavioural symptoms of PMS were similar in the two groups before the intervention, but there was a substantial difference between these groups in mean scores for physical and behavioural symptoms of PMS, 1, 2 and 3 months after the intervention. Scheffe's test showed that this difference was due to the difference between the placebo and drug groups [Table 2].
|Table 2: Comparison of the mean scores for physical and behavioural premenstrual syndrome of two groups using independent t-tests|
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A significant and similarly decreased mean PMS severity score was observed during treatment cycles in the treatment group, but it did not change in the placebo group [Figure 2]. Repeated measurement tests showed a significant difference between the two groups (P < 0.001).
|Figure 2: The trend of premenstrual syndrome severity mean scores comparing two study groups.|
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The mean scores for the severity of physical and behavioural symptoms were similar in the two groups before the intervention, but there was a significant difference between these groups in mean scores for the severity of these symptoms, 1, 2 and 3 months after the intervention. Scheffe's test showed that the difference was caused by the difference between the placebo and the drug groups [Table 3]. Moreover, the success rates in the treatment groups were not similar. Perforan significantly reduced the physical and behavioural symptoms of PMS [Table 4].
|Table 3: Comparison of the mean scores for severity of physical and behavioural symptoms of two groups using independent t-tests|
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|Table 4: Comparison of the mean scores for physical and behavioural premenstrual syndrome of two treatment groups using independent t-test|
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| Discussion|| |
H. perforatum has been used to treat many diseases for 2000 years, especially depression.,, Perforan prevents amino oxidase activity and reuptake of norepinephrine, serotonin and dopamine. Perforan is an effective treatment for mild depression, fatigue, nervous depression, menopausal symptoms and PMS., Our study shows that perforan significantly alleviates the physical and behavioural symptoms of PMS. Some studies have reported that factors such as age, age at menarche, length of menstrual cycle, duration of menstrual bleeding and body mass index are involved in the occurrence of PMS; we controlled for all of these parameters through randomisation.
H. perforatum is statistically superior to placebo in its ability to improve the physical and behavioural symptoms of PMS. Another study demonstrated that using H. perforatum, the physical symptoms were significantly reduced in both the groups. In accordance with the results reported by Ghazanfarpour et al., Ryoo et al., Pakgohar et al. and Hicks et al., we observed that perforan significantly reduces PMS.
As mentioned above, treatment with perforan differs in effectiveness from treatment with placebo. According to this study, perforan significantly reduces the physical and behavioural symptoms of PMS. However, the cause of PMS is unknown, and some people with this syndrome do not respond to conventional treatments, so a new method is suggested in these cases. Herbal medicines have been recognised as effective treatments because they are affordable and have fewer side effects.
The present study has limitations. Although the researcher tried to call the students once a week during the study period and ensure that drugs were used correctly, the participants may have not taken the drugs (poor compliance). This was out of our control. Despite this limitation, there are certainly important aspects of the design of this study that may have enhanced the accuracy of the study. For example, the triple-blind design reduced bias to the maximum extent possible. Similarly, having a control group enabled us to find if the treatments were effective.
| Conclusion|| |
According to our results, perforan significantly reduces the physical and behavioural symptoms of PMS. Moreover, based on repeated measurement tests, a significant decrease was observed in the perforan treatment group regarding the PMS severity score. Therefore, it seems that perforan could be effective in reducing the physical and behavioural symptoms of PMS in patients. Nevertheless, future studies should be performed to confirm these results.
We express our deep gratitude towards all dear colleagues and individuals taking part in this study for their sincere cooperation. We are also thankful to the Deputy of Research and Technology of Tehran University of Medical Sciences for providing facilities and opportunities to conduct this study. This study was approved by the Ethical Committee of the university. The registered article number in IRCT is 201107262751N3.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]