The effect of palm pollen extract on sexual disorders in postmenopausal women A three-blind randomized clinical trial

doi:10.21203/rs.3.rs-1313240/v1

Background

The high prevalence of sexual problems among postmenopausal women needs more attention. Palm pollen extract seemed to help improve menopausal sexual dysfunction with estrogenic and antioxidant compounds. Therefore, this study was performed to investigate the effect of palm pollen on sexual disorders in postmenopausal women.

Methods

In this three-blind clinical trial, 110 postmenopausal women from Rafsanjan comprehensive health service centers were purposefully selected and randomly assigned to two groups.The intervention group received 300 mg capsule of palm extract and the control group received placebo for 4 weeks. Sexual disorders were assessed with a 6-item FSFI questionnaire before the intervention, at the end of the intervention, and 4 weeks after the intervention. Data were analyzed using SPSS software version 21 and analysis of variance, Chi-square and Mann-Whitney tests.

Results

The mean scores of sexual dysfunction before the intervention in the intervention and control groups were 15.36 ± 5.01 and 14.13 67 4.67, respectively (p = 0.684), at the end of the intervention 15.18 50 4.50 and 14.22 3 3.91 (p = 0.431) and 4 weeks after the intervention is 15.7 4 4.77 and 14.44 3 3.78 (p = 0.908).

Conclusions

According to the results, daily consumption of 300 mg of palm pollen extract does not significantly improve the sexual function of postmenopausal women. Due to the proof of phytoestrogenic and antioxidant effects of palm pollen in various studies, further studies with higher doses or increasing the duration of use are recommended.

Trial registration:

This three-blind clinical trial study was approved with the ethical code IR.RUMS.REC.1399.097 on 25/07/2020 and the clinical trial code IRCT20160308026971N10 on 06/12/2020.

Menopausal women

palm pollen

sexual disorders

Statistics show an increasing number of postmenopausal women worldwide and the population of these women in the world by 2030, will reach one billion and two hundred thousand people with an annual increase of 47 million new cases per year(1).. According to statistics provided by the Ministry of Health, it is estimated that by the end of 1400, about 5 million menopausal women will live in Iran(2).. Most women can expect to spend about 40% of their lives after menopause(3). Not only sound education but his alertness and dedication too are most required. In the last century, the main challenge is quality life(4). Sexual intercourse meets the biological and social needs of human beings and increases the quality of life(5).. The quality of sexual life is interrelated and intervened with the level of general quality of life, so that the low quality of sexual life can be a picture of the state of health and general quality of life(6).. The status of menopausal hypostrogenism has a severe negative effect on the health of the genitourinary system(7) Therefore, many women experience sexual dysfunction during this period(8).. The prevalence of sexual dysfunction among all women is estimated at 25 to 63% and Approximately 50 − 40% of all women report at least one symptom of a sexual disorder (8). This prevalence during menopause is even higher and reaches 68 to 86.5%(9). In a study in Iran, 70% of postmenopausal women expressed at least one of the sexual problems in terms of desire (46.3%), hydration (25%), orgasm (27%), and satisfaction (21.3%). 17.8% of women had experienced dyspareunia often or always(10). Ignoring the importance of sexual problems in marital relationships has caused a lot of damage to marital relations(11) And it can create jealousy, hatred for your spouse, resentment, competition, a sense of revenge, a sense of inquiry, depression and lack of self-confidence(11). Many aggressions, controversies, and couples' monitoring and control over each other's activities can be linked to sexual problems(12, 13). Hormone therapy has been the primary treatment for menopausal symptoms. However, due to the health risks associated with hormone therapy, many women can not or prefer not to use hormone therapy(14–16). Approximately 51% of women use complementary and alternative medicine and more than 60% find it effective for menopausal symptoms(14).. One of the plants that uses the fruit and its different parts is the date palm pollen(17). Research has shown that date palm pollen contains facilitating factors that increase arousal and sexual desire. This strengthening effect of date palm pollen may be due to the presence of alkaloids, saponins and flavonoids. Date palm pollen also increases plasma levels of testosterone and estradiol. This pollen contains cholesterol, retin and carotenoids, which trigger the activity of gonadotropins in rats(18).. Compounds such as zinc also increase testosterone production through the biosynthesis of 17-beta-hydroxysteroid dehydrogenase and It thus increases the metabolism of steroids And strong estrogenic effects of date palm pollen phytosterols (beta-sitosterol) have been demonstrated in female rats(1). In the study of Mushfeq et al. (2016), palm pollen was effective on several ovarian parameters including ovarian diameter, number of primary and secondary follicles as a result of increased estrogen and progesterone in female mice(19).. Administration of palm pollen extract to mice with thyroid disorders in the study of El-Kashla et al. (2015) increased sperm count and motility, serum levels of LH, T and E2 by increasing the activity of 3β-HSD and 17β-HSD as well as testicular antioxidant status(20). 35-day consumption of palm pollen capsules in Sadeghi et al. (2019) study improved sexual desire and arousal in postmenopausal women(21).. In the study of Yousefzadeh et al. (2017), palm pollen was effective in improving orgasm in postmenopausal women but had no effect on sexual satisfaction(1).. A review of these studies showed the effect of palm pollen on the reproductive system and due to the high prevalence of sexual disorders after menopause, the adverse effects of these disorders on quality of life and women's willingness to use alternative therapies and complementary medicine and a very limited number of studies. Regarding the effect of palm pollen on sexual function of postmenopausal women, the present study aimed to investigate the effect of date palm extract on sexual disorders in postmenopausal women.

This three-blind clinical trial study was conducted with the code of ethics IR.RUMS.REC.1399.097 and the clinical trial code IRCT20160308026971N10, after obtaining other necessary permits on postmenopausal women under the auspices of Rafsanjan Comprehensive Health Service Centers. The sample size was determined based on the same study (22) and statistical calculations, 104 people (52 people in each group), and with a 5% probability of loss, 110 people (55 people in each group). Inclusion criteria: age between 65 − 50 years, at least 12 months or more after the last menstrual period, no disease: breast and uterine cancers, abnormal vaginal bleeding, depression or known mental disorders, liver disease, Renal and thyroid, no medication: Progesterone estrogen, gonadotropin-releasing hormone agonists and antagonists, regular use of other herbal medicines, and Exclusion criteria include allergic reactions to palm pollen, occurrence of any accident during the study, forgetting to take the drug for two or more days in a row, starting other herbal remedies for any cause, and abnormal vaginal bleeding during It was a study.

Sampling was done easily according to the entry and outlet criteria with written consent. The subjects were assigned to the intervention and control groups randomly using lottery. An equal number of sheets with codes 1 and 2 were placed in packages where the codes could not be seen, and participants were asked to remove one of the sheets from the container. Palm pollen capsules with codes 1 and 2 were delivered from Shahid Bahonar University of Kerman without specifying the drug or placebo. Each person was given one capsule daily for 4 weeks according to the assigned code. To prevent forgetfulness, it was recommended to take the drug at a certain time each day, and by forming a group in WhatsApp, daily consumption was reminded and possible questions were answered. The daily registration form was also given to individuals to specify each use in it and bring it to the center after the intervention and at the time of completing the sexual dysfunction questionnaire. Codes 1 and 2 were identified by the capsule manufacturer after analyzing the data. Thus, postmenopausal women participating in the project, researchers, data collection partners, and data analysts were unaware of the type of drug and studied the three-blind study.

The construction of this capsule was performed in the chemistry laboratory of Shahid Bahonar University of Kerman. First, pollen powder was placed in distilled water for 24 hours at laboratory temperature and the extraction and extraction steps were performed for 24–48 hours using a Soxhlet apparatus. Then, in order to dry the extract, the resulting solution was placed at a temperature of 50 degrees and then the resulting powder was poured into 300 mg capsules and ready to use. Completely similar capsules containing 300 mg of starch were also prepared as placebo.

Sexual function was assessed with a standard questionnaire of 6 questions FSFI (Female Sexual Performance Index) before the intervention, the end of the intervention and 4 weeks after the end of the intervention. This questionnaire has 6 questions and its purpose is to assess women's sexual performance. The questionnaire is scored as a 6-point Likert scale. A score below 10 indicates poor sexual function, a score between 11 and 20 indicates moderate sexual function, and a score above 21 indicates desirable sexual function. Optimal validity and reliability of this questionnaire have been shown in foreign studies(19, 22, 23). Validity and reliability of the Persian version of this questionnaire shows that Cronbach's alpha coefficient in each domain and the whole scale is 0.70 and higher(23). The collected data were analyzed using SPSS software version 21.

In this study, 200 postmenopausal women were examined to enter the study, 110 people entered the study and 89 people completed the study. Exclusion reasons included travel, travel, and minor problems with medication (Figure 1).

The mean age of women participating in the intervention group was40/4 ± 16/56 and in the control group was 77/4± 58/55. The mean menopausal age of women in the intervention group was

62/5± 13/48 and in the control group was 48/4 ± 6/94 . Demographic findings of the study indicate that both groups were homogeneous in terms of age, body mass index, age of first menstruation, age of last menstruation, occupation, level of education, number of pregnancies, drug use and exercise before intervention. (Table No. 1).

Table 1. Comparison of individual characteristics of postmenopausal women studied in two groups consuming palm pollen extract and placebo

group Specifications Individual		Control Standard deviation ± mean Or Number (percent)	Intervention Standard deviation ± mean Or Number (percent)	P value = The significance level
Age (years)		77/4± 58/55	40/4 ± 16/56	507/0 ^*
Age of first menstruation		80/1±87/12	97/1±78/ 12	802/0 ^*
Age of last menstruation		94/4±6/48	62/5± 13/48	971/0 ^*
BMI	Slim = below 18.5	0 (0/0)	1 (8/1)	477 /0 ^**
	Normal = 18.5-24.9	11 (0/20)	9 (4/16)
	Overweight = 25-29.9	20 (4/36)	30(5/54)
	Grade 1 obesity = 30-34.9	20(4/36)	11 (0/20)
	Grade 2 obesity = 35-39.9	3 (5/5)	2 (6/3)
	Severe obesity = Greater than equal to 40	1 (8/1)	2 (6/3)
education	illiterate	20 (4/36)	25 (5/45)	653/0 ^**
	Cycle	24 (6/43)	20 (4/36)
	Diploma	9 (4/16)	7 (7/12)
	University	2 (6/3)	3 (5/5)
Job	housewife	49 (1/89)	48 (3/87)	768/0 ^**
Job	Employed	6 (9/10)	7 (7/12)	768/0 ^**
physical activity	Yes	29 (7/52)	26(3/47)	567/0 ^**
physical activity	No	26 (3/47)	29 (7/52)	567/0 ^**
Number of deliveries	Nolly Gravid	4 (3/7)	4 (3/7)	1 ^**
	Nolly Par	1 (8/1)	0 (0/0)
	Multi-par	50 (9/90)	51 (7/92)
Use of chemical drugs	Yes	31 (4/56)	37 (3/67)	239/0 ^**
Use of chemical drugs	No	24 (6/43)	18 (7/32)	239/0 ^**

* Independent t-test ** Chi-square test

Chi-square test showed the frequency of sexual dysfunction in the two groups before the intervention did not show a statistically significant difference (p = 0.684). At the end of the intervention and 4 weeks after the intervention, there was no statistically significant difference between the two groups in terms of sexual dysfunction (Table 2).

Table 2: Distribution of absolute and relative frequency of sexual function according to FSFI score of postmenopausal women before the intervention, at the end of the intervention and 4 weeks after the intervention in the two groups consuming palm pollen extract and placebo

Variable	group	Control (Percentage) number	Intervention (Percentage) number	*P Value
Overall score of sexual disorders before intervention	Weak	(5/34 % ) 19	(9/30 %) 17	684/0
	Moderate	(5/65 %) 36	(1/69 %) 38
	optimal	( 0 %) 0	( 0 %) 0
Overall score of sexual dysfunction after the intervention	Weak	(2/22 % ) 10	(9/15 %) 7	431/0
	Moderate	(3/73 %) 33	(2/72 %) 32
	optimal	(4/4 %) 2	(4/11 %) 5
Overall score of sexual disorders 4 weeks after the intervention	Weak	(8/17 % ) 8	(2/18 %) 8	908/0
	Moderate	(6/75 %) 34	(7/72 %) 32
	optimal	(7/6 %) 3	(1/9 %) 4

*Chi-square

Based on the results of Repeated Mesure test, there is no statistically significant difference between the intervention and control groups by examining the effect of group, time, and interaction of time group (Table 3).

Table No. 3: Comparison of mean and standard deviation of total score of sexual disorders in postmenopausal women studied in two groups consuming palm extract and placebo before the intervention, at the end of the intervention and 4 weeks after the intervention

Variable

Intervention

Standard deviation ± mean

Control

Standard deviation ± mean

*P Value

**P Value

***P Value

Overall score of sexual disorders before intervention

01/5± 36/15

67/4± 13/14

241/0

991/0

790/0

Overall score of sexual dysfunction after the intervention

50/4± 18/15

91/3± 22/14

Overall score of sexual disorders 4 weeks after the intervention

77/4± 07/15

78/3± 44/14

Repeated Mesure test: * Group effect ** Time effect *** Time group interaction

In the present study, which aimed to investigate the effect of palm pollen extract on sexual disorders in postmenopausal women, after the intervention and one month after the intervention, the difference in the overall score of sexual disorders between the two groups was not significant. Due to the fact that very limited studies were found on the effect of palm pollen on female sexual function, the results were discussed and interpreted with the most relevant and closest articles to the research topic.

The results of this study showed that daily consumption of 300 mg of palm pollen extract did not significantly reduce the score of sexual dysfunction in postmenopausal women. In a clinical trial conducted by Yousefzadeh et al. (2017) on 60 postmenopausal women, it was shown that consumption of 300 mg capsule of palm pollen improves orgasm in postmenopausal women but has no effect on sexual satisfaction(1).. A closer look at the study of Yousefzadeh et al. Revealed that the palm pollen used in the groves of Hormozgan province and the palm pollen used in our study were from the groves of Larestan region in the south of Fars province. TahvilZade study (2016) showed amino acids including aspartic, threonine, glutamine, proline, glycine, alanine, valine, methionine, isoleucine, leucine, tyrosine, phenylalanine, histidine, lysine, arginine and serine in different dates with different percentages Can be found(24). Therefore, due to the great diversity of palms in Iran and also the difference in the type of palm and the type of date in different geographical areas, the composition or percentage of pollen composition of different palms can be different And this issue may have caused the difference between the results of Yousefzadeh's study and the present study. In Yousefzadeh's study, the capsules contained palm pollen and in our study contained its extract. In Yousefzadeh's study, the 19-item Sexual Disorders Questionnaire (FSFI) was used, and in our study, the FSFI 6-item summary questionnaire was used. Cases can also affect the results.

Mushfeq et al. (2015) showed that consumption of 200–400 mg of palm pollen per kg of body weight leads to a significant increase in serum levels of estrogen and progesterone in female mice(25).. A study in Iraq also showed that doses greater than 50 mg / kg of palm pollen ethanolic extract increased antioxidants and gonadotropin hormones in female rats(26).. Also in a study conducted by Sadeghi et al. (2018) on dyspareunia and vaginal slippage in postmenopausal women, a daily dose of 350 mg of palm pollen for 35 days reduced dyspareunia in postmenopausal women and increased vaginal slipperiness(27).. The difference between the results of these studies and the present study can be related to the difference in drug dose, duration of use, drug administration in kilograms of body weight, drug content used and differences in questionnaires. According to the findings of this study, before the intervention, 32.7% of all postmenopausal women had poor sexual function and 67.3% had moderate sexual function And none of the women had good sexual function. At the end of the intervention, poor sexual function was 15.5% and moderate sexual function was 59.1% and good sexual function was observed in 6.4% of women. In the study conducted in this study, although the differences between the control and intervention groups were not significant, but after the intervention, with the consumption of palm pollen, poor sexual function decreased from 30/9 to 15/9, moderate sexual function from 69/1 to 72/2 increase and optimal sexual function increased from zero to 11/4. These results can be clinically significant.

Due to the fact that in this study over time, improvement in sexual function of women consuming palm pollen extract occurred But the difference between this decrease and the control group was not significant, perhaps longer drug use could have caused a significant difference between the two groups.

Also in similar studies, palm pollen was manually poured into medicine capsules and the impurities in the pollen were not removed. However, the present study is the first study performed in the chemistry laboratory, pollen purification and extraction steps, and then used as a drug capsule. Therefore, in this method, it may be necessary to use a different dose than similar studies.

Abbas FA et al. (2011) confirmed the presence of chemical compounds such as estradiol, estriol, estrone, cholesterol, flavonoids and antioxidant properties of date palm pollen in their research(28).. The effects of dietary phytoestrogens depend on the amount of exposure (type of phytoestrogen, matrix, concentration and bioavailability), ethnicity, hormone levels (related to age, sex and physiological conditions) and the health status of the consumer. In premenopausal and postmenopausal women, the reported effects of phytoestrogens on hormones are contradictory, although beneficial effects in improving glycemic control and cardiovascular risk markers in postmenopausal women have been described(29). According to the findings of the Abbas FA study, differences in the results of studies related to palm pollen extract can also be influenced by demographic differences and other mentioned cases. Palm pollen contains various vitamins and antioxidants such as vitamins A, E and C, as well as a good source of minerals such as Zn, Se, Fe, Mo, Cu, Mn, Co, Ni and B. The predominant fatty acids in palm pollen grains are palmitic (C16: 0), linoleic (C18: 2) and myristic (C14: 0) (30). Therefore, in addition to phytoestrogenic properties, palm pollen can be studied as a dietary supplement and antioxidant in many cases, including menopausal problems and sexual dysfunction, according to the mentioned influential variables.

Daily consumption of 300 mg of palm pollen extract does not significantly improve the sexual function of postmenopausal women. Due to the phytoestrogenic and antioxidant compounds of palm pollen, the need for further study with different doses and periods of consumption and palms of different regions is suggested.

Trial registration: This three-blind clinical trial study was approved with the ethical code IR.RUMS.REC.1399.097 on 25/07/2020 and the clinical trial code IRCT20160308026971N10 on 06/12/2020.

Acknowledgments

This article is an excerpt from the research project approved by Rafsanjan University of Medical Sciences and hereby appreciates the financial support of this university, the University Vice Chancellor for Health, all postmenopausal women participating in the project and midwives who assisted in collecting research information. Come on.

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No competing interests reported.

The effect of palm pollen extract on sexual disorders in postmenopausal women A three-blind randomized clinical trial

Status:

Version 1

Abstract

Background

Methods

Results

Conclusions

Trial registration:

Figures

Introduction

Materials And Methods

Findings

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Version 1