I have selected several studies I have written and spoken about in 2017, that have influenced my clinical practice in gynecological and primary care for women. In case you missed this information from me or others, I hope these selections benefit you and your patients.
Another Reason to Avoid Douching
Douching is quite common among US women, especially African American women, despite previous research demonstrating negative health outcomes such as pelvic inflammatory disease and ectopic pregnancy. In the current prospective cohort study, researchers investigated whether douching or genital use of talcum powder was predictive of an increased risk for ovarian cancer. This was done in about 50,000 women who had a sister with breast cancer.
After an average follow-up of seven years, 154 women were diagnosed with ovarian cancer. Women who had reported douching at the baseline of the study had a significantly higher risk for ovarian cancer, with a hazard ratio of 1.8. The use of talc was not associated with the development of ovarian cancer.
Commentary: Vaginal douching disturbs the normal vaginal flora and may impair the local immune system defense mechanisms. In addition, environmental toxins such as phthalates are higher in women who douche. Any reason that a woman may think she needs to douche can be solved in other ways. If for infections, then there are vaginal and/or oral treatments, both conventional and natural; if for hygiene reasons, there are other methods including vaginal suppositories, enhanced personal washing, and perhaps getting more comfortable with what could be normal odors. A strong fishy odor is likely related to a vaginal infection and can be tested and treated appropriately. Women should be encouraged not to douche. If they resist this advice, then I would advise tap water.
Tribulus terrestris for Low Libido in Postmenopausal Women
This clinical study evaluated the effects of treating postmenopausal women with hypoactive sexual desire disorder (HSDD) using Tribulus terrestris. All women received testing including mammography, vaginal ultrasounds, and serum levels of prolactin, thyroid stimulating hormone, total testosterone, and sex hormone binding globulin before enrollment. Study participants were randomized to two groups with the treatment group receiving three pills of 250 mg of Tribulus terristris for 120 days and the control group receiving placebo for 120 days.
The Female Sexual Function Index (FSFI) and the Sexual Quotient Female Version (QS-F) questionnaires were used to assess female sexual function. A total of 36 healthy postmenopausal women with low libido were selected to participate in this study in Brazil with 20 in the study group and 16 in the placebo group, with three drop outs in each group. All women were between one and ten years postmenopausal and were between 43 and 65 years old. Women were excluded if they had interpersonal relationship problems or had partners with sexual problems.
The total mean score and scores of each of the six FSFI questionnaire domains before and after treatment did not show any significant difference between the two groups. Women receiving the T. terrestris scored significant improvements in all six domains as did the placebo, with the exception of lubrication which did not improve in the placebo group. After 120 days of treatment with T. terrestris, the QS-F indicated significant improvement in the domains of desire, arousal/lubrication, pain and anorgasmia with the placebo group showing no improvements in any of these domains. The initial testosterone levels in both groups did not vary before and after the treatment, although there was a significant increase in the levels of free and bioavailable testosterone in the T. terrestris group with no increase in the placebo group.
Commentary: To my knowledge, this is the first study suggesting a treatment effect of T. terrestris for HSDD in postmenopausal women. While there was improvement, yet no difference between treatment group and placebo for the FSFI domains except lubrication was observed. Improvement in lubrication in the treatment group is in fact important in comfort during vaginal penetration. If sex is anticipated to be comfortable and pain free, then the desire to have sex tends to improve. The other scale, the QS-F questionnaire is a tool designed to assess sexual function in Brazilian women specifically. It could be interpreted that this questionnaire is more representative of results in Brazilian women, which might explain the difference in results between the questionnaires.
Saffron Similar to Fluoxetine in the Treatment of Postpartum Depression
Women with mild to moderate postpartum were enrolled in this study in Tehran, Iran, the site of many botanical studies in the last few years. Women were ages 18-45 and were 4-12 weeks post-childbirth. To be included in the study they had to have a score of 10 or more and 18 or less on the 17-item Hamilton Depression Rating Scale (HDRS). A total of 68 women entered the study, and received either 15 mg of saffron (1.65-1.75 mg crocin/capsule) twice daily or 20 mg of fluoxetine, a common selective serotonin reuptake inhibitor (SSRI), for six weeks. Other therapies such as psychotropic drugs or behavior therapy were not permitted during the study. Symptoms of postpartum depression were assessed with the HDRS at baseline and then at the end of weeks 1, 3, and 6. If a patient had a partial response, it was defined as having a 25-50% reduction in her HDRS score. A responder was defined as having a score of 50% or more reduction in the HDRS score. For those with total remission, they had to achieve a score of 7 or less.
At the end of the six weeks, 18.8% of the saffron group and 21.9% of the fluoxetine group were in remission, which is not statistically significant. Of the responders, the saffron group was 40.6% and 50% in the fluoxetine group, which again is not statistically significant. In total, all patients had at least a partial response. Two women from each group discontinued due to progressing from moderate to severe depression. There were more frequent headaches, dry mouth, daytime drowsiness, constipation, and sweating in the fluoxetine group.
Commentary: Postpartum depression is experienced by an estimated 10-15% of postpartum women. The standard of conventional medicine care included fluoxetine as a first-line therapy; however, remission rates are low and adverse effects are problematic. In other research, saffron flowers, have improved depression and premenstrual symptoms. Since this study was a randomized, double-blind, controlled study comparing saffron with fluoxetine in the treatment of mild to moderate postpartum depression, and no placebo group, it is not clear what the absolute antidepressant effects of these therapies would be. Saffron is considered to be safe postpartum and with lactation.
A longer and larger study, with a placebo group added, would be important to confirm the full value of saffron in mild to moderate postpartum depression.
Vitamin E Suppositories for Genitourinary Atrophy in Menopause
One of the most common experiences of menopause are the changes that occur on the external genital tissue and intravaginal tissue that can then also affect urinary function. This is called genitourinary atrophy, and most recently coined, genitourinary syndrome of menopause. Symptoms can include one or more of the following: vulvovaginal discomfort, itching, burning, tingling, dryness, thinning of tissue, pain, pain with vaginal penetration related to dryness and/or tightness of vaginal opening, post coital bleeding, vaginal discharge, bladder leakage, urinary incontinence. These symptoms can affect comfort and quality of life with up to 40% of menopausal women being affected in their sex life, 17% their confidence, 13% their partner relationship, and 7% their social life.
There are many options to address these genitourinary atrophic changes and symptoms; the most studied and effective is vulvovaginal estrogen, which can be used with complete safety and effectiveness. Nonetheless, some women seek other options including over-the-counter lubricants, over-the-counter moisturizers, and herbal/nutrient agents. One such item that has been subject to a small amount of research are vitamin E suppositories.
The study I refer to here investigated vitamin E 100 IU suppositories, which were compared to vaginal estrogen cream in 52 menopausal women with symptoms of vulvovaginal atrophy and a vaginal pH above 5.0. Laboratory studies included the assessment of the vaginal maturation value (VMV), and Menopause-Specific-Quality of Life (MENQOL) questionnaire. Participants in the study were given 12 weeks of either vitamin E vaginal suppository or conjugated estrogen vaginal cream (0.625 mg; 0.5 gm is equivalent to 1.8 gm of the cream in the applicator). They were instructed to insert the item nightly for the first two weeks and then twice per week for the next 10 weeks.
Results showed that the quality of life scores were not significantly different in the two groups after 4, 8, and 12 weeks of treatment.
Commentary: While this sounds positive, that the vitamin E suppository worked basically as well as the vaginal estrogen product, there were no specifics comparing burning, dryness, pain, itching, urinary incontinence, but rather physical symptoms were lumped together as one of the overall four categories of quality of life assessment: vasomotor symptoms (hot flashes/night sweats), psychosocial, physical and sexual. From my understanding of the tables, the physical symptoms did score about 20 points better in the vaginal estrogen group than the vitamin E group.
What do I think? I think vaginal estrogen is completely safe with this kind of regimen: nightly for two weeks then twice weekly maintenance. Even for breast cancer survivors, vaginal estrogen in the form of tablets or a ring or a suppository is not associated with a meaningful or lingering elevation in blood levels of estrogen, whereas cream raises blood levels more and is usually avoided in breast cancer patients. For women with a history of uterine or ovarian cancer, the published research would support the use of vaginal estrogen tablets/suppositories and a local dosing of a vaginal estrogen ring (eg., ESTRING), as safe.
Other natural products for vulvovaginal atrophy with a small amount of published research includes a fennel cream, a hyaluronic acid/E/A suppository, and a Pueraria mirifica vaginal gel.
Lactobacillus rhamnosus Use in Pregnancy Can Significantly Reduce Postpartum Depression-Anxiety According to the Centers for Disease Control, postpartum depression in the US is between 11%-20%. Postpartum depression is a disorder that affects the mother’s ability to care for and bond with her new infant, as well as her functioning in day-to-day life. It can also produce long-lasting consequences in children’s cognitive, social-emotional, and physical health outcomes. The depression does not come alone though; it is associated with insomnia, fatigue, agitation, appetite problems, low self-esteem, and anxiety. The anxiety often co-exists with the depression in postpartum states. If breastfeeding is occurring, it is even more important to explore prevention strategies as many women will not take pharmaceuticals while breastfeeding; they may have adverse effects on the breastfed infant. It can take several weeks for the therapeutic effect of pharmaceutical antidepressants to occur.
The current study is a two-center, randomized, double-blind, placebo-controlled trial testing the effect of Lactobacillus rhamnosus HN001 on atopic disorders including eczema, but also on pregnancy outcomes and postpartum symptoms of depression and anxiety. Pregnant women were randomized to receive either placebo of 1 billion colony forming units Lactobacillus rhamnosus HN001 daily, over a period of six months if breastfeeding. Mothers in the probiotic group reported significantly lower depression and anxiety scores than the placebo group.
Commentary: There is a growing body of literature linking the gut microbiota to brain chemistry and thus mood and behavior. The list of pathways involved in a bi-directional microbiome-gut-brain axis are multiple; and many health problems, including mental-emotional disorders, are associated with altered gastrointestinal function and alterations in gut microbial make-up. The findings of the current study are consistent with two previous clinical studies of the effects of probiotics on mood. One was a randomized clinical trial in a population of 40 individuals with major depressive disorder treated with Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum or placebo, which found a significant reduction in symptoms of depression in the probiotic group. Another study in 39 individuals with chronic fatigue and anxiety were randomized to Lactobacillus casei or placebo and found a reduction in anxiety, but not in depression. Not all studies have demonstrated a significant therapeutic effect of probiotics on mood; but larger studies are being done to better understand this gut flora-brain connection and it will be interesting to watch this unfold and to better understand the possibilities for both prevention and treatment. In time, we will also better understand what might be the most effective choice of probiotics species and strains, duration, and dose.
- Gonzalez N, et al. Epidemiology. 2016:20.
- Dias de Souza K, et al. . Menopause. 2017; 23;(11): 1252-1256
- Kashani L, et al. Pharmacopsychiatry. 2017;50(2):64-68.
- Emamverdikhan A, et al. JMRH. 2014;2(4):253-261.
- Slykerman R, et al. EBioMedicine. 2017.