madman
Super Moderator
Aloe Vera; A new treatment for atrophic vaginitis, A Randomized Double-blinded Controlled Trial
Abstract
Aim of the study
Vaginal atrophy is of the most common problems during menopause with significant psychosocial and medical consequences. Estrogen as an approved therapy for vaginal atrophy can be associated with adverse effects and several contraindications in menopause patients. The aim is to compare the effect of Aloe Vera vaginal cream with commercially available estrogen vaginal cream for the management of vaginal atrophy in menopause females.
Materials and Methods
This is a double-blinded randomized controlled trial on 60menopause female with complaints of vaginal atrophy symptoms. Subjects were randomly allocated in two groups of 30 patients, named as estrogen and Aloe Vera groups. Vaginal health index (VHI), maturity value (MV), vaginal cytologic smear, transvaginal sonography (TVS), and severity of symptoms related to vaginal atrophy were assessed before and after 6-weeks of vaginal cream administration.
Results
Comparison of MV before and after treatment revealed that superficial cells were significantly increased after administration of both vaginal cream (6.67 VS 54.33 in Aloe Vera group; 4.33 VS 59.67 in estrogen group). In addition, VHI (13.83 vs 20.13 in Aloe Vera group; 13.97 vs 19.93 in estrogen group) and symptoms of vaginal atrophy (3.63 vs 1.10 in Aloe Vera group; 3.90 vs 0.66 in estrogen groups) were also significantly improved after treatment in both groups. There was no significant difference between groups after treatment except for fluid volume with superiority in the Aloe Vera group (P-value= 0.004).
Conclusion
Aloe Vera vaginal cream can be as effective as estrogen vaginal cream in the management of vaginal atrophy in menopause females.
Introduction
According to the North American Menopause Society, 40% of post-menopausal women may present symptoms of vaginal atrophy which include dryness, vulvar pruritus, discharge, burning, and dyspareunia (Griesser et al., 2012; Pickar, 2013). Moreover, susceptibility to genitourinary (GU) infection increases in such patients which may be related to a decrease in lactic acid as a result of an alteration of bacterial flora of GU and, thus, amplification in PH levels(Palacios, 2009). The high prevalence of genitourinary atrophy, who seek medication therapy and its effects on quality of life ensures the necessity of introducing better management strategies for such complications of GU aging process (Palacios, 2009). Estrogen depletion receptors which can be found in the vulva, the vagina, and the pelvic floor muscles, are considered as the main cause of genitourinary symptoms of menopause females. However, these receptors do not disappear completely and the remnant ones are sensitive to exogenous estrogen consumption (Chen et al., 1999; Gebhart et al., 2001). Estrogen-containing compounds can enhance estrogen receptor amount even, in some cases to its pre-menopausal counts. This can ultimately lead to epithelial proliferation, vascularization, and vaginal secretion (Cavallini et al., 2008). Thus, estrogen compounds take more attention as a treatment for postmenopausal vaginal atrophy in addition to the aging population (Castelo-Branco et al., 2005).
However, estrogen might be associated with some complications in postmenopausal women, leading to reduced compliance in routine use of estrogen cream (JUDD et al., 1983). Furthermore, long-term estrogen therapy can increase the chance of breast cancer and endometrial thickness(Cummings, 1991). It can also aggravate or induce hypertension in post-menopausal women (Mashchak and Lobo, 1985). Hence, an estrogen alternative is needed for the management of patients who might suffer from complications of estrogen creams. Although many compounds have been studied for this purpose, the recommendation of a compound with similar or higher efficacy compared to estrogen is still controversial.
Aloe barbadensis miller, known as Aloe Vera can increase the collagen content of the wound. The botanical name of Aloe vera is Aloe barbadensis miller and belongs to Asphodelaceae (Liliaceae) family. It grows mainly in the dry regions, originated from North Africa. The plant has triangular, fleshy leaves with serrated edges, yellow tubular flowers, and fruits that contain numerous seeds. Aloe Vera contains 75 potentially active constituents: vitamins, enzymes, minerals, sugars, lignin, saponins, salicylic acids, and amino acids (Atherton, 1997). Increased synthesis of hyaluronic acid and dermatan sulfate in the granulation tissue of a healing wound has been also reported (Chithra et al., 1998). Aloe Vera also shows antimicrobial activity by rupturing bacterial cell walls (Athiban et al., 2012; Ndhlala et al., 2009). Aloe Vera also has an antioxidant effect through free radical- and superoxide radical-scavenging activities (Anilakumar et al., 2010) and anti-inflammatory activities via inhibition of the cyclooxygenase pathway and reduce prostaglandin E2 production from arachidonic acid (Hutter et al., 1996). It also serves as a moisturizing and anti-aging agent (West and Zhu, 2003). On the other hand, some studies showed that Aloe Vera has also some estrogenic-like activity (Pourfarid et al., 2012). Considering the well-known dominant wound healing and anti-inflammatory effect combined with less likely or weak estrogenic effect (especially in form of low dose topical gel), it can be hypothesized that this compound can be effective in vaginal atrophy therapy with no or less complication as compared to pure estrogenic compounds. According to these healing and anti-inflammatory properties, we decided to investigate the efficacy of an Aloe Vera cream as compared to estrogen vaginal cream, on vaginal atrophy symptoms in menopausal women.
2.3 Aloe Vera cream preparation
Liquid white paraffin, stearyl alcohol, cetyl alcohol, and white soft paraffin were mixed and heated to the boiling point as the oil phase. Aloe Vera powder (Barijessence, Phytopharmaceutical Company, Iran) mixed with deionized water was added to a mixture of propylene glycol, sodium lauryl sulfate, and methylparaben. The mixture was heated in the aqueous phase. These two separate phases were mixed continuously while being cooled (Eshghi et al., 2010; Khorasani et al., 2009). Thus, after cooling, the uniform cream that was produced was placed in an aluminum package similar to a conjugated estrogen tube, weighing 50 g. The cream contained Aloe Vera gel powder 2%. Our experimental research and formulations were carried out in sterile conditions under the supervision of the pharmaceutic group at the School of Pharmacy, Shiraz. The final creams were tested for any probable contamination.
Commercial vaginal Estrogen cream: conjugated estrogen 0.625 vaginal cream Manufactured by ALDO-UNION, S.A. (Barcelona Spain).
This study showed that Aloe Vera can be safely used as a treatment option in vaginal atrophy in menopause patients. However, further studies with higher statistical power are still required to investigate the effect of this compound in patients who cannot tolerate estrogen.
Abstract
Aim of the study
Vaginal atrophy is of the most common problems during menopause with significant psychosocial and medical consequences. Estrogen as an approved therapy for vaginal atrophy can be associated with adverse effects and several contraindications in menopause patients. The aim is to compare the effect of Aloe Vera vaginal cream with commercially available estrogen vaginal cream for the management of vaginal atrophy in menopause females.
Materials and Methods
This is a double-blinded randomized controlled trial on 60menopause female with complaints of vaginal atrophy symptoms. Subjects were randomly allocated in two groups of 30 patients, named as estrogen and Aloe Vera groups. Vaginal health index (VHI), maturity value (MV), vaginal cytologic smear, transvaginal sonography (TVS), and severity of symptoms related to vaginal atrophy were assessed before and after 6-weeks of vaginal cream administration.
Results
Comparison of MV before and after treatment revealed that superficial cells were significantly increased after administration of both vaginal cream (6.67 VS 54.33 in Aloe Vera group; 4.33 VS 59.67 in estrogen group). In addition, VHI (13.83 vs 20.13 in Aloe Vera group; 13.97 vs 19.93 in estrogen group) and symptoms of vaginal atrophy (3.63 vs 1.10 in Aloe Vera group; 3.90 vs 0.66 in estrogen groups) were also significantly improved after treatment in both groups. There was no significant difference between groups after treatment except for fluid volume with superiority in the Aloe Vera group (P-value= 0.004).
Conclusion
Aloe Vera vaginal cream can be as effective as estrogen vaginal cream in the management of vaginal atrophy in menopause females.
Introduction
According to the North American Menopause Society, 40% of post-menopausal women may present symptoms of vaginal atrophy which include dryness, vulvar pruritus, discharge, burning, and dyspareunia (Griesser et al., 2012; Pickar, 2013). Moreover, susceptibility to genitourinary (GU) infection increases in such patients which may be related to a decrease in lactic acid as a result of an alteration of bacterial flora of GU and, thus, amplification in PH levels(Palacios, 2009). The high prevalence of genitourinary atrophy, who seek medication therapy and its effects on quality of life ensures the necessity of introducing better management strategies for such complications of GU aging process (Palacios, 2009). Estrogen depletion receptors which can be found in the vulva, the vagina, and the pelvic floor muscles, are considered as the main cause of genitourinary symptoms of menopause females. However, these receptors do not disappear completely and the remnant ones are sensitive to exogenous estrogen consumption (Chen et al., 1999; Gebhart et al., 2001). Estrogen-containing compounds can enhance estrogen receptor amount even, in some cases to its pre-menopausal counts. This can ultimately lead to epithelial proliferation, vascularization, and vaginal secretion (Cavallini et al., 2008). Thus, estrogen compounds take more attention as a treatment for postmenopausal vaginal atrophy in addition to the aging population (Castelo-Branco et al., 2005).
However, estrogen might be associated with some complications in postmenopausal women, leading to reduced compliance in routine use of estrogen cream (JUDD et al., 1983). Furthermore, long-term estrogen therapy can increase the chance of breast cancer and endometrial thickness(Cummings, 1991). It can also aggravate or induce hypertension in post-menopausal women (Mashchak and Lobo, 1985). Hence, an estrogen alternative is needed for the management of patients who might suffer from complications of estrogen creams. Although many compounds have been studied for this purpose, the recommendation of a compound with similar or higher efficacy compared to estrogen is still controversial.
Aloe barbadensis miller, known as Aloe Vera can increase the collagen content of the wound. The botanical name of Aloe vera is Aloe barbadensis miller and belongs to Asphodelaceae (Liliaceae) family. It grows mainly in the dry regions, originated from North Africa. The plant has triangular, fleshy leaves with serrated edges, yellow tubular flowers, and fruits that contain numerous seeds. Aloe Vera contains 75 potentially active constituents: vitamins, enzymes, minerals, sugars, lignin, saponins, salicylic acids, and amino acids (Atherton, 1997). Increased synthesis of hyaluronic acid and dermatan sulfate in the granulation tissue of a healing wound has been also reported (Chithra et al., 1998). Aloe Vera also shows antimicrobial activity by rupturing bacterial cell walls (Athiban et al., 2012; Ndhlala et al., 2009). Aloe Vera also has an antioxidant effect through free radical- and superoxide radical-scavenging activities (Anilakumar et al., 2010) and anti-inflammatory activities via inhibition of the cyclooxygenase pathway and reduce prostaglandin E2 production from arachidonic acid (Hutter et al., 1996). It also serves as a moisturizing and anti-aging agent (West and Zhu, 2003). On the other hand, some studies showed that Aloe Vera has also some estrogenic-like activity (Pourfarid et al., 2012). Considering the well-known dominant wound healing and anti-inflammatory effect combined with less likely or weak estrogenic effect (especially in form of low dose topical gel), it can be hypothesized that this compound can be effective in vaginal atrophy therapy with no or less complication as compared to pure estrogenic compounds. According to these healing and anti-inflammatory properties, we decided to investigate the efficacy of an Aloe Vera cream as compared to estrogen vaginal cream, on vaginal atrophy symptoms in menopausal women.
2.3 Aloe Vera cream preparation
Liquid white paraffin, stearyl alcohol, cetyl alcohol, and white soft paraffin were mixed and heated to the boiling point as the oil phase. Aloe Vera powder (Barijessence, Phytopharmaceutical Company, Iran) mixed with deionized water was added to a mixture of propylene glycol, sodium lauryl sulfate, and methylparaben. The mixture was heated in the aqueous phase. These two separate phases were mixed continuously while being cooled (Eshghi et al., 2010; Khorasani et al., 2009). Thus, after cooling, the uniform cream that was produced was placed in an aluminum package similar to a conjugated estrogen tube, weighing 50 g. The cream contained Aloe Vera gel powder 2%. Our experimental research and formulations were carried out in sterile conditions under the supervision of the pharmaceutic group at the School of Pharmacy, Shiraz. The final creams were tested for any probable contamination.
Commercial vaginal Estrogen cream: conjugated estrogen 0.625 vaginal cream Manufactured by ALDO-UNION, S.A. (Barcelona Spain).
ConclusionThis study showed that Aloe Vera can be safely used as a treatment option in vaginal atrophy in menopause patients. However, further studies with higher statistical power are still required to investigate the effect of this compound in patients who cannot tolerate estrogen.
