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From the Townsend Letter
February / March 2016

These are a Few of My Favorite Things:
Research Highlights from 2015

by Tori Hudson, ND
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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: ≤9 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17) and a score of ≤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.
: 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.
: Maca root, in this dose of 1500 mg twice daily may alle-viate antidepressant-induced sexual dysfunction specifically in post-menopausal 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.
: 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.
: 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 peri-menopausal 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;April 9(4):QC04–QC07.

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