The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial

Abstract Background: Around 90% of postmenopausal women are suffering from vaginal atrophy. This study aimed to evaluate the effect of oxytocin vaginal gel on vaginal atrophy among postmenopausal women. Methods: This was a randomized controlled trial that was conducted on 96 postmenopausal women who suffered from vaginal atrophy. The inclusion criteria were: literate women, age 40-60, at least one year passed from their last menstrual period or the level of FSH>40IU, monogamous women with the sexual relationship. Women in the intervention group, requested to use one applicator of 400 IU oxytocin gel per night and women in the placebo group used placebo each night. The subjective symptoms of vaginal atrophy, vaginal PH, maturation index were measured before and after the intervention. Results: The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7±7.18 vs. 3.69±2.76, p=0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention. The improvement of the maturation index was more dominant in the oxytocin group (increased from 7.76±4.68 to 52.48±7.54) in comparison to the placebo group (increased from 8.58±4.35 to 13.25±5.06). The PH of the vagina decreased significantly in the oxytocin group in comparison to the placebo group (p=0.0001). After eight weeks, 88.6% and 7.1% of women in the oxytocin and placebo groups did not show the severe symptoms of vaginal atrophy (p=0.001) Conclusion: The results of this study showed that eight weeks intervention with oxytocin vaginal gel (400 IU) could significantly improve the vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina. Using this medication in women who have a contraindication for hormone therapy is recommended.

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The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial

10.21203/rs.2.13815/v1 ◽

2019 ◽

Author(s):

Ilnaz Zohrabi ◽

Parvin Abedi ◽

Somayeh Ansari ◽

Elham Maraghi ◽

Nader Shakiba Maram

Keyword(s):

Randomized Controlled Trial ◽

Placebo Group ◽

Postmenopausal Women ◽

Controlled Trial ◽

Intervention Group ◽

Subjective Symptoms ◽

Vaginal Atrophy ◽

Randomized Controlled ◽

Vaginal Gel ◽

Maturation Index

Abstract Background: Around 90% of postmenopausal women are suffering from vaginal atrophy. This study aimed to evaluate the effect of oxytocin vaginal gel on vaginal atrophy among postmenopausal women. Methods: This was a randomized controlled trial that was conducted on 96 postmenopausal women who suffered from vaginal atrophy. The inclusion criteria were: literate women, age 40-60, at least one year passed from their last menstrual period or the level of FSH>40IU, monogamous women with the sexual relationship. Women in the intervention group, requested to use one applicator of 400 IU oxytocin gel per night and women in the placebo group used placebo each night. The subjective symptoms of vaginal atrophy, vaginal PH, maturation index were measured before and after the intervention. Results: The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7±7.18 vs. 3.69±2.76, p=0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention. The improvement of the maturation index was more dominant in the oxytocin group (increased from 7.76±4.68 to 52.48±7.54) in comparison to the placebo group (increased from 8.58±4.35 to 13.25±5.06). The PH of the vagina decreased significantly in the oxytocin group in comparison to the placebo group (p=0.0001). After eight weeks, 88.6% and 7.1% of women in the oxytocin and placebo groups did not show the severe symptoms of vaginal atrophy (p=0.001) Conclusion: The results of this study showed that eight week intervention with oxytocin vaginal gel (400 IU) could significantly improve the vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina. Using this medication in women who have a contraindication for hormone therapy is recommended.

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The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial

10.21203/rs.2.13815/v3 ◽

2020 ◽

Author(s):

Ilnaz Zohrabi ◽

Parvin Abedi ◽

Somayeh Ansari ◽

Elham Maraghi ◽

Nader Shakiba Maram ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Placebo Group ◽

Postmenopausal Women ◽

Controlled Trial ◽

Intervention Group ◽

Subjective Symptoms ◽

Vaginal Atrophy ◽

Randomized Controlled ◽

Vaginal Gel ◽

Maturation Index

Abstract Background: Around 90% of postmenopausal women are suffering from vaginal atrophy. This study aimed to evaluate the effect of oxytocin vaginal gel on vaginal atrophy among postmenopausal women. Methods: This was a randomized controlled trial that was conducted on 96 postmenopausal women who suffered from vaginal atrophy. The inclusion criteria were: literate women, age 40-60, at least one year passed from their last menstrual period or the level of FSH>40IU, monogamous women with the sexual relationship. Women in the intervention group, requested to use one applicator of 400 IU oxytocin gel per night and women in the placebo group used placebo each night. The subjective symptoms of vaginal atrophy, vaginal PH, maturation index were measured before and after the intervention. Results: The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7±7.18 vs. 3.69±2.76, p=0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention. The improvement of the maturation index was more dominant in the oxytocin group (increased from 7.76±4.68 to 52.48±7.54) in comparison to the placebo group (increased from 8.58±4.35 to 13.25±5.06). The PH of the vagina decreased significantly in the oxytocin group in comparison to the placebo group (p=0.0001). After eight weeks, 88.6% and 7.1% of women in the oxytocin and placebo groups did not show the severe symptoms of vaginal atrophy (p=0.001) Conclusion: The results of this study showed that eight- week intervention with oxytocin vaginal gel (400 IU) could significantly improve the vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina. Using this medication in women who have a contraindication for hormone therapy is recommended. Keywords: oxytocin; vaginal atrophy; postmenopausal women Trial registration number: IRCT20160602028220N2

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The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial

BMC Women s Health ◽

10.1186/s12905-020-00935-5 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Ilnaz Zohrabi ◽

Parvin Abedi ◽

Somayeh Ansari ◽

Elham Maraghi ◽

Nader Shakiba Maram ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Controlled Trial ◽

Vaginal Atrophy ◽

Randomized Controlled ◽

Vaginal Gel

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The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0245 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Asieh Mehdipour ◽

Parvin Abedi ◽

Somayeh Ansari ◽

Maryam Dastoorpoor

Keyword(s):

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Moderate Depression ◽

Before And After ◽

The Mean ◽

And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

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The impact of oxytocin vaginal gel on sexual function in postmenopausal women: a randomized controlled trial

Maturitas ◽

10.1016/j.maturitas.2021.08.017 ◽

2021 ◽

Vol 152 ◽

pp. 70-71

Author(s):

Parvin Abedi ◽

Ilnaz Zohrabi ◽

Somayeh Ansari ◽

Elham Maraghi ◽

Nader Shakiba Maram ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Sexual Function ◽

Postmenopausal Women ◽

Controlled Trial ◽

Randomized Controlled ◽

Vaginal Gel ◽

The Impact

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Role of topical oxytocin in improving vaginal atrophy in postmenopausal women: a randomized, controlled trial

Climacteric ◽

10.1080/13697137.2017.1421924 ◽

2018 ◽

Vol 21 (2) ◽

pp. 174-178 ◽

Cited By ~ 5

Author(s):

H. A. Torky ◽

A. Taha ◽

H. Marie ◽

E. El-Desouky ◽

O. Raslan ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Controlled Trial ◽

Vaginal Atrophy ◽

Randomized Controlled

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Efficacy and safety of He-He-Shu-Yang Particles plus Anluohuaxian Pills for early liver fibrosis in Chronic Hepatitis B patients: study protocol for a multicenter, randomized controlled trial

10.21203/rs.3.rs-67829/v1 ◽

2021 ◽

Author(s):

Meijie Shi ◽

Huanming Xiao ◽

Junmin Jiang ◽

Pengtao Zhao ◽

Shuduo Wu ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Chronic Hepatitis ◽

Placebo Group ◽

Chinese Medicine ◽

Liver Fibrosis ◽

Controlled Trial ◽

Intervention Group ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

Abstract Background: In recent years, more and more studies revealed that liver fibrosis progression could happen at early stage in chronic hepatitis B (CHB) patients. However, there is no anti-fibrotic agent available at present in modern medicine.He-He-Shu-YangParticles (HHSYP) and Anluohuaxian Pills (AHP)are two commonly used Traditional Chinese Medicine (TCM) agents for liver fibrosis, but there is no data of them for early liver fibrosis(F1 or F2) in multicenter, randomized controlled trial. Therefore, the aim of this study is to evaluate efficacy and safety ofHHSYP plus AHP for early liver fibrosis in CHB patients. Methods/design: For the 72-week randomized controlled study, 480 CHB patients with early liver fibrosis are randomly assigned at a 2:1 ratio to two groups: the intervention group and the placebo group. The intervention group was treated with HHSYP plus AHP. The placebo group was treated with placebo of HHSYP and AHP. The primary end point is the histological change after 72-week treatment.Discussion: Although previous studies have confirmed the anti-fibrosis efficacy of HHSYP and AHP in CHB patients, the efficacy and safety of their combination treatment for early liver fibrosis is still not clear.Therefore, this will be the first multicenter randomized trial to prove the efficacy and safety of combination TCM treatment of HHSYP and AHP for early liver fibrosis, which will use histological changes as the primary end point. This will provide reliable data for the TCM combination treatment of early liver fibrosis and might give a new direction for further international studies on liver fibrosis.Ethics and dissemination: This study protocol was approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (BF2018-175-01) and all other participating centers (Project number2018ZX10725506-003).The study findings will be published in peer-reviewed journals and presented at the national and international conferences. Trial registration: Chinese Clinical Trial Registration: ChiCTR1900025897, Registered:13 September 2019, http://www.chictr.org.cn/edit.aspx?pid=40222&htm=4

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Effects of an equol-containing supplement on advanced glycation end products, visceral fat and climacteric symptoms in postmenopausal women: A randomized controlled trial

10.21203/rs.3.rs-265906/v3 ◽

2021 ◽

Author(s):

Remi Yoshikata ◽

Khin Zay Yar Myint ◽

Hiroaki Ohta ◽

Yoko Ishigaki

Keyword(s):

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Visceral Fat ◽

Controlled Trial ◽

Intervention Group ◽

Skin Aging ◽

Control Group ◽

Climacteric Symptoms ◽

Visceral Fat Area ◽

Randomized Controlled

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered a potentially effective agent for relieving climacteric symptoms, for the prevention of lifestyle-related diseases, and for aging care in postmenopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging and climacteric symptoms with respect to internally produced equol in postmenopausal women.Methods: A single-center, randomized controlled trial (registration number: UMIN000030975) on 57 postmenopausal Japanese women (mean age: 56±5.37 years) was conducted. Twenty-seven women received the equol supplement, while the remaining received control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese postmenopausal women.Results: Three months postintervention, the treatment group showed significant improvement in climacteric symptoms compared to the control group (81% vs. 53%, respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations, significant improvement in skin autofluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers.Conclusion: Women receiving equol supplementation showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously produced equol to improve skin aging and visceral fat in certain populations.

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Efficacy of Combined Herbal Capsule on Sexual Function in Postmenopausal Women: A Triple-Blinded Randomized Controlled Trial

International Journal of Women s Health and Reproduction Sciences ◽

10.15296/ijwhr.2019.63 ◽

2018 ◽

Vol 7 (3) ◽

pp. 385-392

Author(s):

Paria Eliasvandi ◽

Laleh Khodaie ◽

Sakineh Mohammad Alizadeh Charandabi ◽

Mojgan Mirghafourvand

Keyword(s):

Randomized Controlled Trial ◽

Placebo Group ◽

Sexual Function ◽

Postmenopausal Women ◽

Controlled Trial ◽

Study Groups ◽

Randomized Controlled ◽

Significant Difference ◽

The Mean ◽

And Control

Objectives: Considering the prevalence of sexual problems in postmenopausal women as well as complications of hormone therapy, the tendency to use complementary medicine has increased. The present study was conducted to evaluate the efficacy of combined herbal drug on the sexual function of postmenopausal women. Materials and Methods: The present triple-blinded randomized controlled trial was done on 64 Iranian women in 2017. The women were randomly allocated to 2 groups of intervention (combined herbal capsules users) and control (placebo users). Herbal capsules contained carnation, Anise, Anison, violets, Terminalia chebula, fresh green raisins, Senna leaves, Tangerine and Golqand. Participants in both groups took 2 capsules twice a day (before lunch and before dinner) for 4 weeks. The Female Sexual Function Index (FSFI) was filled out before the intervention and 4 weeks after the intervention. Results: No statistically significant difference was observed between the study groups in terms of socio-demographic properties, the total mean score of sexual function and its sub-domains before the intervention. Four weeks after the intervention, the total mean (SD) sexual function score was 26.99 (5.31) in the combined herbal capsule group and it was 18.35 (4.51) in the placebo group, so it was significantly higher in the combined herbal capsule group compared to the placebo group (adjusted mean difference=8.70; 95% CI=6.58-10.82). Moreover, there was a significant difference in the mean score of desire, arousal, lubrication, orgasm, satisfaction, and pain subscales between study groups after the intervention. Conclusions: The results of the study show that taking combined herbal capsules improved sexual function in postmenopausal women. However, further studies are necessary to decide on its use as an alternative medication for the improvement of sexual function.

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