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These are a few of my favorite things: research highlights from 2015.

Throughout 2015, I have reported monthly in this column on research important to women's health. I have selected several of those research studies here as well as others, that have influenced my clinical practice in gynecological and primary care for women. In case you missed reading them this past year, I hope that these current selections benefit you and your patients.

Maca for Antidepressant-Induced Sexual Dysfunction

This study included 45 women aged 18 to 65 and a mean age of 41.5 years, who were in remission from their depression but suffering from antidepressant-induced sexual dysfunction (AISD). Patients received either 1500 mg maca root or placebo twice daily for 12 weeks. Sexual function was evaluated using the Massachusetts General Hospital-Sexual Functioning Questionnaire (MGHSFQ) and the Arizona Sexual Experience Scale (ASEX). Improvement was assessed with the Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement scales (CGI-I)

These women met the following criteria: [less than or equal to]9 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17) and a score of [less than or equal to]9 on the Hamilton Rating Scale for Anxiety (HAM-A), which indicated that they were in remission. These patients were on current and stable doses of SSRI, venlafaxine, or a triheterocyclic antidepressant for depression for at least 4 weeks. They also had clinically significant arousal dysfunction or orgasmic dysfunction of 4 weeks or less, and the onset of these symptoms had to coincide with the subsequent use of their antidepressant. In addition, they participated in regular sexual activity at least twice monthly prior to antidepressant use and needed to be open to continued sexual activity at least once weekly during the study.

Results: The mean change in total ASEX and MGHSFQ for maca vs. placebo was not statistically significant overall, whether premenopausal or postmenopausal women. The remission rates however were higher for the maca group than the placebo group for an ASEX total score of 10 or less (maca = 9.5% and placebo = 4.8%) achieving a MGHSFQ score of 12 or less (30% vs. 20%). The higher remission rates occurred in postmenopausal women and the premenopausal women had no significant difference in remission rates between treatment groups on both of the sexual function questionnaires.

It was only the postmenopausal women who were taking the maca who had an improvement in orgasm compared with placebo and only premenopausal women taking the maca who had an improvement in arousal disorder compared with placebo. There was also a significant correlation between the testosterone levels and sexual functioning at the endpoint, on the ASEX questionnaire in women in the maca group, with a trend toward significant on the MGHSFQ in the maca group. No other significant differences were seen in the other hormones that were tested, including estrogen.

Comment: Maca root, in this dose of 1500 mg twice daily may alleviate antidepressant-induced sexual dysfunction specifically in postmenopausal women. It appears that the explanation for this is due to the maca root's altering androgen levels.

Dording C, Schettler P, Dalton E, et al. A double-blind placebo controlled trial of maca root as treatment for antidepressant induced sexual dysfunction in women. Evid Based Complement Altern Med. 2015. Article ID 949036.

Black Cohosh for Perimenopause Symptoms induced by GnRH-a Treatment of Endometriosis

This study was designed as a prospective, randomized, controlled trial to compare the efficacy and safety of black cohosh standardized extract (Remifemin) versus tibolone. All women were treated with GnRH-a after laparoscopic ovarian cyst removal and were injected 1 week after surgery, 4 weeks later, and then a third injection before the end of the study. The black cohosh group received 20 mg tablets of a standardized extract of black cohosh, twice daily for 12 weeks. Tibolone was given 2.5 mg daily for 12 weeks. The total duration of follow-up was 12 weeks, and follow-up started 4 weeks after the first GnRH-a injection.

A total of 125 women who had undergone laparoscopic surgical treatment for their endometriosis and then were treated with GnRH-a (gonadotropin-releasing hormone agonist). In the final count, 116 women were surveyed and analyzed after 9 women discontinued treatment or were lost to follow-up. There were 56 women in the black cohosh group and 60 women in the Tibolone group.

Results: For both groups, the Kupperman menopausal index (KMI) scores after GnRH-a were significantly increased. After therapy with black cohosh or tibolone, the KMI scores and hot flash/sweating decreased in both and there was no significant difference at each juncture, between the two. Both had a very good and similar effectiveness in alleviating perimenopausal symptoms that were caused by the GnRH-a therapy. After GnRH-a therapy, the hot flash/sweating scores were 2.87 for black cohosh and 2.70 in the tibolone groups. After black cohosh, the scores were 0.94 and with tibolone 1.06. No statistical difference occurred between the two groups after black cohosh or tibolone with liver or renal functions or lipid profiles. Estrogen levels were lower in the black cohosh group and FSH and LH levels were higher than the tibolone group, a predictable finding. No significant difference was seen in endometrial thickness. The black cohosh though had far fewer adverse events than the tibolone group in the areas of vaginal bleeding/spotting and breast pain. The incidence of nausea, emesis, and abdominal discomfort was not significantly different between groups.

Comment: Endometriosis is a very common gynecological disorder and can range from mild to severe. In those women with either severe symptoms that significantly affect her quality of life and/ or those for whom the endometriosis is the cause of their infertility, current conventional treatment options include pain management with analgesics, hormonal contraception for symptom and disease management (but not cure), surgery, and medical agents that suppress ovarian function at least temporarily (e.g., gonadotropin-releasing hormone agonists = GnRH-a). With surgery or ovarian suppressive treatments, the risk of symptom recurrence is from a low of 21.5% at 2 years to 50% at 5 years after treatment. One of the problems with GnRH-agonists is that they reduce estrogen levels that then lead to perimenopausal symptoms including hot flashes, sexual dysfunction, bone loss, and others. This definitely limits the use of these agents to short term use, usually up to 6 months and usually post endometriosis surgery. Add-back estrogen therapy is then used at low doses to mitigate these effects of the GnRH-agonist, which then has not only benefits, but potential risks. A nonhormonal alternative, such as a botanical that can alleviate the menopause symptoms, is a logical and potentially effective first approach rather than the medication tibolone (not available in the US), which has more adverse events than black cohosh, and does not have any estrogenic effect.

Chen J, Gao H, Li Q, et al. Efficacy and safety of Remifemin on perimenopausal symptoms induced by post-operative GnRH-a therapy for endometriosis: a randomized study versus tibolone. Med Sci Monit. 2014;20:1950-1957.

Burning Mouth Syndrome: A New Study on Alpha-Lipoic Acid

Burning mouth syndrome is one of those occasional but difficult problems that I see in my women's health practice. This syndrome occurs more frequently in middle-aged and elderly individuals and is more prominent in women, about a 7:1 ratio. The precise cause of burning mouth syndrome is unknown, although multiple local and systemic factors exist. Local factors associated with burning mouth syndrome include hyposalivation and/ or xerostomia, parafunctional habits, contact allergies, poorly fitting oral devices, Candida albicans oral infection, smoking, alcohol, caffeine, and hot or spicy foods. Systemic factors associated with burning mouth syndrome include menopause, nutritional deficiencies (B vitamins, iron, folic acid), type 2 diabetes, hypothyroid, and select medications (e.g., antihypertensive drugs).

Given the limited published evidence for natural medicine solutions to this condition, I was attracted to this new study on the use of alpha-lipoic acid (ALA) as a treatment, although it's not the first study on ALA for burning mouth syndrome.

This double-blind, placebo-controlled study was conducted in Madrid, Spain, in which patients were randomly allocated to either placebo or ALA. All participants were assessed for salivary flow rates, complete blood count, ferritin, vitamin B12, and folic acid. Treatment was 600 mg/day of ALA at 200 mg every 8 hours for 2 months, or placebo every 8 hours for 2 months. Patients were assessed every 15 days for changes in symptomatology and for side effects. Final results were obtained after 2 months.

Most of the patients were 55 women and 5 men over age 18, with a mean of 62 years, who had burning mouth syndrome for more than 4 months and no clinical objective signs. The duration of symptoms in patients was between 4 months and 20 years. The average intensity was 6.6, with a range of 2.5 to 10. Burning symptoms were the most common symptom in 63.3% of the patients and stinging in 20%. The rest reported itching or other symptoms, with the tongue being the most affected site. In addition to burning, 10 patients had dysgeusia, 13 had xerostomia, and 24 reported both symptoms that occurred concurrently. Stimulated and unstimulated salivary flow was found in 25 patients. About one-third of the participants associated the onset of their burning mouth syndrome symptoms with a dental treatment.

Patients were excluded if they had local oral lesions or alterations or unmanaged systemic diseases; were on cisplatin, cyclophosphamide, gentamicin, or amikacin; or were already undergoing any type of treatment for their burning mouth syndrome.

The primary outcome was measured using a visual analogue scale as mild improvement (50%-75%), great improvement (>75%), or complete amelioration of symptoms. Results were divided into three categories: slight improvement, decided improvement/ resolution, and no change or worse. Eight of the 20 patients (27.5%) who received placebo showed some level of improvement, 5 worsened (17.2%), and 16 had no change (55.2%). Sixteen of the 5 patients who received ALA (64%) improved, 9 (36%) had no change, and none worsened. One month after the end of the treatment, 4 of the 8 patients who had improved in the placebo group had a relapse of burning. About one-third (5 of 16 patients) with signs of improvement taking ALA worsened 1 month after treatment was discontinued.

Previously published research on ALA has demonstrated efficacy and is probably one of the most effective treatments for burning mouth syndrome. The most common dose studied is 600 mg/day, as in the current study. Based on the current study as well as at least 6 other studies, ALA at a total day's dose of 600 mg/day should be at the top of every practitioner's list for treating burning mouth syndrome.

Palacios-Sanchez B, Moreno-Lopez L, Cerero-Lapiedra R, et al. Alpha-lipoic acid efficacy in burning mouth syndrome. A controlled clinical trial. Med Oral Patol Oral Cir Bucal. July 1, 2015;20(4):e435-440.

Cinnamon for Primary Dysmenorrhea

In a randomized, double-blind trial, with 114 women with moderate dysmenorrhea, 38 received placebo, 38 ibuprofen, and 38 cinnamon. Ibuprofen was given in a dose of 400 mg three times daily and cinnamon was given 420 mg three times daily, as was placebo. The visual analogue scale (VAS) was used to determine the severity of pain and the Cox Menstrual Scale was used to determine the duration of pain. A VAS rating of 0 means no pain and 10 means maximum pain. Pain intensity and duration of pain were monitored during the first 72 hours of the menstrual period. Severity of pain was assessed using VAS at hourly time intervals for the first 4 hours, then 8 hours, 16 hours, 24, 28, 48, and 72 hours. Duration of pain was assessed once daily. The Cox Menstrual Scale includes 17 symptoms and gauges the severity of each symptom from 0 (no symptoms) to 4 (very severe). Duration is rated from 0 (asymptomatic) to a 4 (continued symptoms for multiple days).

Women were 18 to 30 years old, had regular menstrual cycles, moderate primary dysmenorrhea, lack of chronic disease, no vaginal discharge/itching/ burning, no pelvic inflammatory disease, no pelvic masses, no recent stress, and a body mass index of 19-26. Women were excluded if they were using hormonal contraception, or had medicine or plant allergies or only mild dysmenorrhea.

Results: The mean pain severity score and mean duration of pain in ibuprofen and cinnamon were less than placebo. Four hours after intervention, there were no statistically significant differences between the cinnamon and placebo group. Eight hours after treatment, the mean severity of pain in the cinnamon group was significantly lower than the placebo group and at various time intervals the mean pain severity in the ibuprofen group was significantly less than the cinnamon and placebo groups.

Comment: While cinnamon significantly reduced the severity and duration of pain during menses, the effect was less than that of ibuprofen.

Jaafarpour M, Hatefi M, Khani A, Khajavikhan J. Comparative effect of cinnamon and ibuprofen for treatment of primary dysmenorrhea: a randomized double-blind clinical trial. J Clin Diag Res. 2015; Aprll 9(4):QC04-QC07.

Green Tea Effects on Weight Reduction

Green tea has been studied for its beneficial effects on cardiovascular and metabolic diseases. Epigallocatechin gallate (EGCG) is the most abundant green tea catechin and is considered the most bioactive constituent that can reduce body weight by decreasing fat cell differentiation and proliferation. One study has demonstrated that green tea extracts and drinks could reduce body weight and body mass index in obese individuals in 2 months. (1) On the other hand, a previous study by those authors found that 302 mg of EGCG daily did not reduce weight in obese women. (2) The currently published study set out to increase the concentration of EGCG to a daily dose of 856.8 mg/day to see if this increased amount would result in weight loss in obese individuals.

This randomized, double-blind trial was conducted in 115 women with central obesity with 102 of them having a body mass index (BMI) [greater than or equal to] 27 kg/[m.sup.2] and a waist circumference [greater than or equal to] 80 cm. Women were randomized to either a high-dose green tea group or placebo group for 12 weeks. One capsule of green tea or placebo was given 3 times per day, 30 minutes after meals for a total daily dose of 856.8 mg EGCG.

Body weight decreased from 76.8 kg to 75.7 kg after 12 weeks in the EGCG group. BMI and waist circumference were reduced from 31.0 cm to 30.6 cm and 95.1 cm to 92.8 cm respectively. In the placebo group, only waist circumference and hip circumference reached significant reduction, from 95.7 cm to 91.5 cm and 107.2 cm to 103.7 cm respectively. No differences were seen in weight or BMI.

The study also demonstrated a trend of decreased total cholesterol and decreased LDL cholesterol. Significantly lower ghrelin levels and elevated adiponectin levels were also seen in the green tea group than in the placebo group.

Comment: Obesity is one of the most challenging issues in women's health care. No one strategy produces consistent results in all women. Nutritional modifications, exercise programs, behavioral therapy, and agents that can affect insulin resistance, fat burning, fat oxidation, and metabolic rates occupy central roles in efforts. Green tea and its main components, the catechins, including EGCG, are thought to influence body weight through mechanisms of thermogenesis and fat oxidation. The results of the current study with significant weight reduction and decreased ghrelin levels after EGCG treatment implies that a high dose of EGCG might increase energy metabolism and interrupt lipid accumulation and directly inhibit ghrelin secretion.

For perspective on dosing, one might look for a capsule of green tea extract of approximately 300 mg of EGCG. If 1 capsule 30 minutes after each meal (3 times per day), this would then be 900 mg of EGCG per day, slightly more than the 856.8 mg in the current study.

Chen I, Liu C, Chiu J, Hsu C. Therapeutic effect of high-dose green tea extract on weight reduction: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2015:1-8 (in press).

Notes

(1.) Basu A et al. Green tea supplementation affects body weight, lipids, and lipid peroxidation in obese subjects with metabolic syndrome. J Am Coll Nutr. 2010;29:31-40.

(2.) Hsu C, Sai T, Kao Y, et al. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008;27:363-370.

Comparison of Myo-Inositol and D-Chiro-Inositol in PCOS Women

Both myo-inositol and D-chiro-inositol have been shown to affect ovarian function and metabolic factors in women with polycystic ovarian syndrome (PCOS). They have been shown to improve androgen levels, increase the action of insulin, reduce systolic blood pressure, and more.

The purpose of the current study was to compare the effects of myo-inositol and D-chiro-inositol in women with PCOS. Fifty women with a diagnosis of PCOS according to the Rotterdam criteria were enrolled. They were randomized into two groups; 25 were treated with 4 g of myo-inositol plus 400 meg of folic acid daily for 6 months, and the other 25 were treated with 1 g of D-chiro-inositol plus 400 meg/ folic acid per day.

In the myo-inositol group, there were statistically significant reductions of diastolic and systolic blood pressure; lowering of luteinizing hormone (LH); lowering of the LH/FSH (follicle stimulating hormone) ratio; and lowering of total testosterone and free testosterone, androstenedione, prolactin, and the HOMA (homeostatic model assessment) to check for insulin resistance. These same patients also had a statistically significant Increase of sex hormone binding globulin (SHBG) and the glycemia/immunoreactive insulin ratio.

In the D-chiro-inositol group, there was a statistically significant reduction of systolic but not diastolic blood pressure and a statistically significant reduction of the Ferriman-Gallwey Score (a measure of hirsutism), LH, LH/FSH ratio, total testosterone, free testosterone, androstenedione, prolactin, and the HOMA.

Both inositols reduced systolic blood pressure, LH, LFH/FSH ratio, circulating androgens, and prolactin, and increased insulin sensitivity and SHBG. Myo-inositol may decrease the LH/FSH ratio, total testosterone, and the HOMA in a more statistically significant way. D-chiro-inositol is likely to reduce mostly, but not statistically significantly, the LH and free testosterone levels and may increase, but not significantly, the glycemia/IRI ratio.

It could be concluded from this comparison that both the inositol isoforms are effective in improving the ovarian function and metabolism of women with PCOS, although myo-inositol showed the greater impact on the metabolic profile and D-chiro-inositol affected more positively the hyperandrogenism measurements. In comparing the two products pre- and posttreatment, there was a higher regularization of menstrual cycles in those treated with D-chiro-inositol compared with those with myo-inositol, although this was not statistically significant.

Comment: PCOS is one of the most common endocrine disorders in reproductive-aged women. The majority of women with PCOS (about 74%) do not ovulate, almost half (about 42%) have insulin resistance, and almost half (48%) have hyperandrogenism. It's important to remember that PCOS is a syndrome and not all women with PCOS have any one sign or symptom. Not all actually have multiple cysts on the ovaries, not all have excess body hair, and not all have abnormal menstrual cycles. In women with PCOS, though, the insulin resistance is commonly associated with hyperinsulinemia, which then enhances the production of androgens by the ovarian theca cells, leading to a reduction in circulating levels of SHBG, which leads to increased levels of free testosterone. Nutritional, lifestyle, supplemental, and pharmaceutical strategies try to address the syndrome by targeting this core issue of improving insulin sensitivity, which thereby addresses the signs and symptoms of PCOS. Both myo-inositol and D-chiro-inositol, in the doses used in this study, improve ovarian function and metabolism in PCOS, but myo-inositol showed the most effect on the metabolic profile and D-chiro-inositol reduced the hyperandrogenism better.

Pizzo A, Lagana A, Barbara O. Comparison between effects of myo-inositol and D-chiro-inositol on ovarian function and metabolic factors in women with PCOS. Gynecol Endrocrinol. 2014;30(3):205-208.

Vulvar Lichen Sclerosus: Treatment with Topical Avocado and Soybean Extracts

Lichen sclerosus is a chronic inflammatory dermatosis condition that has no certain etiology. Treatment options are few, and topical corticosteroid creams are the mainstay of conventional treatment, although not the only treatment. Evidence-based natural treatments are essentially nonexistent, although many anecdotal and case reports reflect attempts at reducing inflammation with dietary changes, supplements, and topical herbal preparations such as licorice, MSM, and others. None of the natural medicine approaches has a very robust track record. Topical steroids are often needed to reduce itching and/or pain, reduce ulcerations/fissures, and slow or halt the progression of the disease.

The current single-center, prospective cohort, open-label study was designed to assess the efficacy of a topical product containing avocado and soybean extracts (ASE) along with several antioxidant, softening, and emollient ingredients. Patients in the study were those with mild to moderate disease-related clinical signs of lichen sclerosus, lichen sclerosus relapse, or recurrence after at least one previous treatment with topical steroids, or intolerance to topical corticosteroids. Patients were excluded if they were taking systemic and/or topical lichen sclerosus treatments during the 4 weeks before enrollment, or had active vulvar infections or other vulvar dermatoses or cancer. Women were also excluded if pregnant or breast-feeding.

After screening, 23 women met the eligibility criteria and entered the study, applying ASE cream on the affected vulvar area twice daily for 24 weeks. The ASE cream used was Repasine cream (Pharmaday, Italy). It contains extracts of avocado and soybean, hyaluronic acid, vitamin E, sodium carboxymethyl beta glucan, dimethylmethoxy chromanol, and trimethylglycine. During the first 12 weeks, patients also took two ASE capsules daily between meals, containing 300 mg extracts of avocado, soybean, vitamin E, para-aminobenzoic acid, and phytosterols.

By the end of the 24 weeks of treatment, 12 (70.5%) of symptomatic patients, and 13 (72.2%) of asymptomatic patients but those who had objective signs of lichen sclerosus achieved an improvement of at least 75% in subjective and objective global scores, respectively.

Comment: The authors of this study reported In the discussion that the rates of partial to complete symptom and sign remission is not easily comparable to rates with topical corticosteroids. But, while the ASE-containing products did not achieve as rapid a response of at least 75% as is seen with topical steroids, after the 24 weeks, the improvement attained was essentially the same as a 12-week course of the potent topical corticosteroids. Of note though is that the patients in this study were those with mild to moderate disease.

It appears that the topical and oral ASE products exerted anti-inflammatory, antifibrotic, emollient, and soothing effects on patients with mild to moderate lichen sclerosus.

Borthi A, Corazza Mingheti G, Toni G, Virgili A. Avocado and soybean extracts as active principles in the treatment of mild-to-moderate vulvar lichen sclerosus: results of efficacy and tolerability. J Eur Acad Dermatol Venereol. 29; 2015:1225-1230.

by Tori Hudson, ND

Dr. Tori Hudson graduated from the National College of Naturopathic Medicine (NCNM) in 1984 and has served the college in many capacities over the last 28 years. She is currently a clinical professor at NCNM and Bastyr University; has been in practice for over 30 years; and is the medical director of the clinic A Woman's Time in Portland, Oregon, and director of research and development for Vitanica, a supplement company for women. She is also a nationally recognized author, speaker, educator, researcher, and clinician.
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Title Annotation:Research Highlights; innovations in women's health
Author:Hudson, Tori
Publication:Townsend Letter
Date:Feb 1, 2016
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