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In early July, 2014, the American College of Physicians (ACP) issued guidelines challenging the need for a vaginal speculum and bimanual (internal) pelvic exam as an integral part of a routine well-woman office visit. The ACP reviewed the evidence and concluded that the routine pelvic examination is not useful in screening for malignancies other than cervical cancer, and can lead to unnecessary evaluation and surgery, while also often causing discomfort and embarrassment and may actually be a deterrent to some women seeking gynecological care. Their recommendations are summarized as follows:

  • Routine pelvic exam is not recommended in asymptomatic non-pregnant adult women
  • This recommendation does not apply to the timing and need for cervical cancer screening

The cervical cancer screening tests… pap smears, liquid based paps and/or human papilloma virus (HPV) testing should include a vaginal speculum exam while visualizing the cervix and collection of samples, but does not need to include bimanual examination

  • Screening for chlamydia and gonorrhea can be done with urine tests or vaginal swabs


As a Naturopathic Physician women’s health practitioner, I think these recommendations from the ACP are worrisome for women. Routine annual pelvic exams (yes still annually even when it is not the year to collect the pap smear), including visualizing the external genitalia, inserting the speculum and visualizing the cervix and vaginal walls, and a bimanual exam provide a wealth of important information even in women who do not have any symptoms. Many women have bacterial vaginosis or some other vaginal or cervical infection, severe vulvovaginal atrophy, cervical polyps, uterine fibroids, ovarian enlargement, vaginal wall growths, and/or vulvar skin disorders. Any of these can occur without symptoms and the only way we would know it is if the full exam was performed. The asymptomatic woman is indeed the woman who might benefit most from the routine annual pelvic exam. It has been hard enough to communicate to women Doctor checking woman blood pressurethe need for continued annual exams (which also include height, weight, blood pressure, temperature, pulse, breast exam, thyroid exam, heart/lung/abdominal exam and more) even when they don’t need a pap smear or HPV test that year. Too many women have ceased seeing their health care provider every year and only come every 3 years when the need a pap smear.

The ACP guidelines also differ from women’s health practitioners such as the American College of Obstetricians and Gynecologists. In 2012, they reaffirmed that the speculum and bimanual examination is a part of annual well-women visits in women 21 y.o. and older.

In addition, as a Naturopathic Physician, the annual visit is used to check in on nutrition, alcohol, nicotine, recreational and prescription drugs, stressors, exercise, sleep, dietary supplements, other health issues, changes in their health including weight gain or weight loss, and an eye towards prevention of diseases based on family history, aging, habits and select routine or specific testing.

With these ACP recommendations (which I will ignore), I am certain that we can predict that even less women will seek annual visits with their health care provider. I will encourage my patients to seek annual visits and be clear in communicating the value of each exam and each test if/when needed.


Bloomfield H, et al. Screening pelvic examinations in asymptomatic, average-risk adult women: An evidence report or a clinical practice guideline from the American College of Physicians. Ann Intern Med 2014 Jul 1;161:46

The purpose of this study was to determine whether a combination of valerian/lemon balm could improve sleep problems in menopausal women. A total of 100 postmenopausal women aged 50-60 years with sleep disorders were studied. Women were selected randomly after fulfilling the entrance criteria. The Pittsburgh Sleep Quality Index (PSQI) questionnaire was completed to assess the status of their sleep disorder in the month prior. The PSQI consists of 7 measurements : general description of individual sleep quality and patterns, delay in the onset of sleep, sleep duration and pattern as well as waking in the night, use of tranquilizers, daily performance problems due to lack of sleep. A score of 5 or greater constitutes a sleep disorder and the 100 women selected were those with a scoring. Women were randomly divided into two groups with 50 women in the herbal treatment group and 50 in the control group containing starch. The herbal group received two capsules containing 160 mg of valerian and 80 mg of lemon balm. Participants and investigators and the statistician were all blinded. The duration of the intervention was one month and then followed by another PSQI questionnaire.Woman lying in bed sleeping

One month following the use of the valerian/lemon balm supplement, 36% of the treatment group and 8% of the placebo group showed an improvement in the quality of their sleep. Sleep disorder scores decreased by 5 points which was statistically significant.

Commentary: Perimenopausal and menopausal women are faced with hormonal changes that can result in not only night time hot flashes that can disrupt sleep, but lengthening in the time it takes to fall asleep, frequent awakenings, waking and poor return to sleep, early morning waking and non-restorative sleep. Botanical options that can improve any or all aspects of sleep disruption are an important part of a comprehensive approach to treating this. However, addressing sleep disorders in this population usually also involves strategies that target the fundamental issue, which is hormonal changes and the impact on neurotransmitters, cortisol, stress adaptation and sleep cycle physiology.

In 2011, another study of valerian and insomnia was published on the impact of valerian for sleep quality in postmenopausal women who were experiencing insomnia.[i] The postmenopausal women studied were generally healthy women aged 50 to 60 years who were menopausal for at least 1 year, were not using hormone therapy and were experiencing insomnia. One group of women were given capsules containing 530 mg of concentrated valerian extract twice per day and the other group was given placebo twice per day, for 4 weeks. A statistically significant change was reported in the quality of the sleep in the valerian group when compared to the placebo group. The average scored on the sleep scale before valerian was 9.8 and after valerian it was 6.02. The placebo group had an initial average sleep scale score of 11.1 and after placebo, 9.4. Overall, 30% of the women taking valerian and 4% taking placebo reported an improvement in their sleep quality.

Although not all research on valerian and insomnia have resulted in positive results, the current study with the valerian in combination with the lemon balm in menopausal women, along with the 2011 valerian study in menopausal women, bring more focus to using valerian in menopausal women for sleep disorders.


Taavoni S, Nazem ekbatani N, Haghani H. Valerian/lemon balm use for sleep disorders during menopause. Comp Therapies in Clinical Practice 2013;19:193-196

[i] Taavoni S, Ekbatani N, Kashaniyan M, Haghani H. Effect of valerian on sleep quality in postmenopausal women: a randomized placebo-controlled clinical trial. Menopause 2011; 18(9): 951-955.


The relationship between the microbiota in the gut and the etiology (cause) of irritable bowel syndrome (IBS) is becoming increasingly clear. IBS is one of the Young casual girl woman is having stomach ache.most common gastrointestinal conditions, and more common in women. It is characterized by abdominal discomfort or pain and variable types of other symptoms including episodic diarrhea and/or constipation, bloating, and even non-gut symptoms such as backache, muscle pains, joint pains, anxiety and mood issues and fatigue. The use of probiotics has received much interest in that different probiotics species and strains can effect intestinal motility, visceral hypersensitivity, secretion of immune chemicals and increase anti-inflammatory populations. While clinical trials with probiotics for IBS still yields conflicting results, improved research designs and research quality are warranted. That said, two large meta-analyses of 2008 and 2009 concluded that probiotics may be of benefit in the treatment of IBS. For practitioners of alternative and integrative medicine in particular, probiotics are becoming one of the mainstays of treatment for IBS. The current study is supportive of that practice.


This recent randomized, double-blind, placebo-controlled trial of adult women and men with symptomatic IBS was undertaken for 12 weeks. A total of 152 patients completed the 12 week study with 100 in the probiotic group and 52 in the placebo group. The four species/strains of probiotic were Lactobacillus rhamnosus NCIMB 30174, L. plantarum NCIMB 30173, L. acidophilus NCIMB 30175 and Enterococcus faecium NCIMB 30176. The bacteria were in a water based suspension of barley extract with each 50mL dose containing 10 billion live organisms.


The primary outcome showed a highly significant result in favor of the probiotic. Improvements in individual symptoms of pain and bowel habits were noted, rather than in bloating or quality of life issues. The pain symptoms improved in severity from moderate/severe to mild/no symptoms, although the difference was not considered statistically significant. Four weeks after completing the 12 week treatment, the difference in the IBS symptom severity scores between the probiotic and placebo groups were no longer apparent.

Commentary: In the current study, 94% of the patients enrolled had at least moderate to severe symptoms of IBS… indicating that probiotics can help even these folks. The significant improvement in pain scores in the probiotics group is especially relevant given that pain is most often the single most important bothersome symptoms of IBS.

Multi-species/strain probiotics are one of the four pillars in my treatment strategies for IBS which includes a probiotic combination of 10 billion per day, plus enteric coated peppermint oil, a fiber supplement and lifestyle changes (diet and stress reduction). I typically have a first follow-up in 6-8, which most often results in good improvement, with great improvement by 12 weeks. Adjustments can be made accordingly, with some individuals needing fine tuning on the kind of fiber supplement that best suits them. If they also have reflux, I would avoid the enteric coated peppermint oil. I do not hesitate to continue the probiotic combination long term.


Sisson G, Ayis S, Sherwood R, Bjarnason I. Randomised clinical trial: a liquid multi-strain probiotic vs placebo in the irritable bowel syndrome- a 12 week double-blind study. Aliment Pharmacol Ther 2014; 40:51-62.

Migraine headaches are one of the most common causes of pain and can vary from a minimal impact on activities of daily living to even incapacitating. Numerous over the counter and prescription drugs exist for acute migraine headaches but problems abound with poor satisfaction in many cases and varied side effects in others. In addition, some migraine sufferers have very frequent chronic and recurrent attacks, necessitating the frequent use of some of these acute intervention drugs and thus again, side effects can become an issue. An effective herbal intervention for acute pain relief would be a welcome addition to the list of options.

This double-blind randomized controlled clinical trial compared the efficacy of Ginger root and powderginger to sumatriptan, a standard conventional prescription treatment, in the treatment of common migraine. Study subjects were randomly delivered either one ginger capsule of 250 mg upon onset of headache or 50 mg of sumatriptan. Questionnaires were completed for each headache attack, recording time of headache onset, severity, timing of drug taking and response self-assessments at 30, 60, 90 and 120 minutes and 24 hours. Any adverse effects were also recorded. The overall study duration was one month.

One hundred sufferers of common migraine headaches, from a Hospital in Iran were the study subjects. The average age of participants was 35.1 in the sumatriptan group and 33.9 in the ginger group. Women comprised 68% of the sumatriptan group vs. 74% of the ginger group. The average duration of a migraine diagnosis was similar in both groups at approximately 7 years. The average number of headache attacks in the sumatriptan groups were 5.8 and 4.9 in the ginger treated group. Inclusion criteria for the study included a confirmed diagnosis of migraine without aura by a neurologist, 18 years and older, high school diploma or higher and a frequency of 2 to 10 headaches/month.

Both sumatriptan and ginger powder decreased the mean severity of common migraine attacks within 2 hours of use. No significant difference existed between the two treatments. Before taking the medication, 22% of the sumatriptan group and 20% of the ginger group had severe headaches. The mean headache severity at 2 hours after sumatriptan or ginger use demonstrated similar effectiveness for both groups. There was 4.7 unit reduction in the headache severity in the sumatriptan group and a 4.6 reduction in the ginger group. Favorable relief was achieved in 70% of the sumatriptan treated headache individuals and 64% of the ginger treated patients at 2 hours following intake. Both the sumatriptan and ginger significantly provided pain relief and no significant differences were achieved.

There were more side effects from sumatriptan using including dizziness, sedation, vertigo and heartburn. The only clinical adverse effect of ginger was dyspepsia.

Commentary: Ginger products have a long tradition of use for joint pain, nausea and vomiting, motion sickness, lipid lowering and a broad range of anti-inflammatory implications. For migraines, a previous study in 2005 demonstrated that ginger completely alleviated migraine headache in 48% of individuals and partially in 34% of individuals within 2 hours. Another study demonstrated that the ginger treated group had a higher pain relief rate at 65% for ginger versus 36% for the placebo.

I am quite impressed that the current study reveals both sumatriptan at 50 mg and ginger powder at 250 mg decreased the mean severity of a common migraine attack and within 2 hours of use. Pain relief and patient satisfaction did not show any significant difference, although side effects due to ginger were far less than those with sumatriptan.

In my experience, the natural medicine strategies for reducing the frequency and severity and duration of migraines are quite effective and include basic lifestyle and nutritional plans, but more robustly involve a multi-factorial approach using riboflavin, ginger, feverfew, 5-HTP, butterbur, magnesium, CoQ10, and sometimes cyclic estrogen patches in women with menstrual migraines. I have never felt very optimistic about acute intervention with these supplements or others in reducing the severity of an acute migraine. I am encouraged by this study, that acute use of ginger capsules for acute migraines may provide pain reduction, with an overall 44% palliation in all headache attacks within 2 hours.


Maghbooli M, Golipour F, Esfandabadi A, Yousefi M. Comparison between the efficacy of ginger and sumatriptan in the ablative treatment of the common migraine. Phytotherapy Res 2014;28:412-415.

Current study: Xi S, Liske E, Wang S, et al. Effect of isopropanolic Cimicifuga racemosa extract on uterine fibroids in comparison with tibolone among patients of a recent randomized, double blind, parallel-controlled study in Chinese women with menopausal symptoms.


An original menopause study, published in 2007[1] enrolled 244 Chinese women aged 40-60 years with menopause symptoms who were treated with either black cohosh extract, 40 mg/day (n=122) or tibolone 2.5 mg/day (n=122) for 3 months. The current study investigated the subset of women from that study (n=62) who had at least one uterine fibroid at the onset of the study, and compared the effect of black cohosh extract (n=34) on fibroid size compared with tibolone (n=28), using transvaginal ultrasound.

The patients were treated for 12 weeks with iCR (isopropanolic Cimicifuga Racemosa) or tibolone. Study visits were at entry, 4 weeks and 12 weeks. Clinical variables including the Kupperman Index (KI), vital signs, body weight, co-existing diseases, adverse events and co-existing medications were recorded. In addition to blood samples for follicle stimulating hormone (FSH), estrogen, standard hematology and biochemistry and urine samples, transvaginal ultrasound was also performed before onset of study and at the end of treatment.

In the black cohosh group, the median volume of the largest individual fibroid decreased from 1787 mm3 at visit one to 1086 mm3 after 12 weeks. The mean diameter of the largest fibroid per patient significantly decreased during the treatment with a decrease of the total myoma volume of – 30.3% on average observed in 24 of the women in the black cohosh group (70.1%) during the 12 weeks. In the tibolone group, the median volume of the largest individual fibroid changed from 1063 mm to 1096 mm after 12 weeks, actually slightly larger. No statistically significant difference was found for the mean diameter of the individual largest fibroid as well, from baseline to 12 weeks. There was a decrease in the myoma volume in 10 of the women in the tibolone group (35.7%), but on average, it increased by +4.7% in the tibolone group.

In summary, the key results were that the percentage of volume change in the black cohosh extract group (-30.3% decrease) was significantly superior to the tibolone group, a 4.7% increase and the percentage of mean diameter change in the herbal group was significantly superior to tibolone as well. Lastly, the superior response rate of black cohosh 70.1% vs. tibolone 35.7% was important.

Other questions about the effect of black cohosh on hormone sensitive tissues might be considered here as well. A 12 month study showed that after 12 months of treatment with black cohosh extract, no increase in the risk of malignant change of the breast or endometrium was observed.[2] In another study, black cohosh extract did not increase the risk of tumor recurrent in patients with early endometrial cancer after 24 months of treatment for menopausal symptoms and after surgery.[3] In another study, 6 months of treatment with black cohosh daily did not cause change in the mammographic density and breast cell proliferation.[4] And yet another found that isopropanolic black cohosh extract did not increase the risk of breast cancer recurrence. [5]

To my knowledge, the current clinical study analysis is the first of its kind evaluating the effect of iCR on uterine fibroids. I will add this to my eager approach to helping perimenopausal women in particular, decrease their fibroid growth. We now have two recent botanical studies of import for uterine fibroids, this one, and the green tea extract study I wrote in an earlier blog posting. [6]


[1] W. Bai, H.-H. Henneicke-von Zepelin, S. Wang, et al. Efficacy and tolerability of a medicinal product containing an isopropanolic Cimicifuga racemosa, aka black cohosh (iCR) extract was in Chinese women from five hospitals in China, with menopausal symptoms: a randomized, double blind, parallel-controlled study versus tibolone. Maturitas 2007;58(1):31-41)

[2] Geller S, Shulman L, van Breemen R, et al. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause 2009;16(6):1156-1166.

[3] Li W, Sun N, Chen X, et al. Cimicifuga racemosa for the treatment of menopausal symptoms in patients with eaerly endometrial cancer after operation. Academic Journal of Second Military Medical University 2012;33(5):562-564.

[4] Hirschberg A, Edlund M, Svane G, et al. An isopropanolic extract of black cohosh does not increase mammographic breast density or breast cell proliferation in postmenopausal women. Menopause 2007;14(1):89-96.

[5] Henneicke-von Zepelin H, Meden H, Kostev K, et al. Isopropanolic black cohosh extract and recurrence-free survival after breast cancer. International J of Clinical Pharmacology and Therapeutics 2007;45(3):143-154.

[6] Roshdy E, Rajaratnam V, Maitra S, et al. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study. Int J Womens Health. 2013;5:477-486.


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Nearly 50% of women who undergo screening mammography are classified as having either heterogeneously dense or extremely dense breast tissue. Dense breast tissue is defined as a greater amount of fibrous or glandular tissue than fatty tissue in the breasts. Women with dense breast tissue have a modestly elevated risk for breast cancer and the sensitivity of screening mammography is reduced. One 2007 report states a four to five fold increased likelihood of developing breast cancer in women with dense breast versus women with low breast density. [i] Due to this data, and some assertive women’s health scientists and activists, certain states now require that women found to have dense breast tissue on screening mammography be provided a letter informing them of these findings and are then encouraged to follow up with their primary care provider to discuss risk and screening guidelines. While this is dictated by at least 11 state jurisdictions, and more to come, most physicians have yet to urge patients to get further testing. Even the American College of Obstetrics and Gynecologists (ACOG) is currently not offering guidelines to physicians, for further testing when the mammogram detects heterogeneously dense or extremely dense (grade 3 and 4 density respectively).

In a recent evidence based review, ACOG noted that “the assessment of breast breast scandensity is subjective and affected by the perspective of individual radiologists.”[ii] Their statement also indicates that “use of supplemental imaging such as ultrasound, magnetic resonance imaging (MRI), tomosynthesis, or thermography has not been associated with meaningful benefits for women found at screening to dense breasts.” They support further research on the topics but as of this writing, ACOG does not recommend use of alternative tests for dense breast detected on screening mammography


As a practicing clinician providing healthcare for women these last 30 years, I am currently recommending a more proactive approach and not waiting for guidelines from ACOG. I advise my patients to have additional imaging if they have heterogeneously dense or extremely dense breasts. If they have no other risk factors for breast cancer, I am likely to just recommend a screening breast ultrasound. If they also have other risk factors for breast cancer (ex/ first degree relative with breast cancer, obesity, an intake of greater than 7 alcohol drinks per week, history of estrogen/progestin for greater than 4 years), then I may consider an MRI, in consultation with the radiologist and a breast surgeon.


[i] Boyd, N.F., et al. (2007). Mammographic breast density and the risk and detection of breast cancer. N Engl J Med. 356(3):227-36.

[ii] Committee on Gynecologic Practice. Committee Opinion No. 593: Management of women with dense breasts diagnosed by mammography.  Obstet Gynecol 2014 Apr; 123:910

This randomized, double-blind, 2-group parallel, clinical trial conducted in Brazil compared the effects of melatonin compared with a placebo on endometriosis-associated pelvic pain, brain derived neurotrophic factor level and sleep quality. Forty women were randomized into melatonin 10 mg/day (n=20) or placebo (n=20) groups for 8 weeks.

clip_image002Forty women with chronic pelvic pain, who were between 18 and 45 y.o. were recruited from gynecology outpatient clinics. Chronic pelvic pain was defined as a moderate-to-severe pain lasting for more than 6 months and eliciting pain scores of at least 4 or greater on a 10 point pain scale that required regular analgesic use. All patients had a diagnosis of endometriosis as confirmed on laparoscopy and included patients with any stage from stage 1 to stage 4. Three patients in the melatonin group and one in the placebo group withdrew due to treatment inefficacy.

The primary outcome of the trial was pain, as assessed by pain score diaries within the last 24 hours, painful menstrual periods or dyspareunia, as well as the amount of analgesics used each week throughout the treatment period and the level of brain derived neurotrophic factor (BDNF). Secondary outcomes were pain during urination or defecation and sleep quality.

The melatonin group had significantly lower pain visual analogue scale (VAS) scores than the placebo-treated group with a mean pain reduction of 39.3% in the melatonin group vs the placebo group. The melatonin group also had significantly lower pain score during menstruation with mean reduction in analgesic use of 42.2% in the placebo group and 22.9% of patients in the melatonin group. The placebo group was 80% more likely to require additional analgesics than the melatonin group. In the placebo group, acetaminophen was used by 66.7%, NSAIDS by 60% and codeine or tramadol by 60%. In the melatonin group, 33.3% used acetaminophen, 40% used tramadol or codeine and 35% used NSAIDS.

The reduction in BDNF, greater with melatonin than placebo, suggests that melatonin has a direct effect on pain pathways or on the levels of chemicals that are signals for pain. Patients in the melatonin group also had better sleep quality than the placebo group and melatonin produced a mean improvement of 42% in how patients felt upon waking in the morning.

Commentary: This study demonstrated that melatonin at 10 mg/day reduces endometriosis associated chronic pelvic pain, including a reduction in pelvic pain, pelvic pain during menses, pain during vaginal penetration, pain during urination and pain during defecation that is statistically and clinically significant. This reduction in pelvic pain due to melatonin was of a magnitude > 35% overall, as well as an 80% reduction in analgesic use.

This study is consistent with evidence from animal studies in which melatonin caused regression and atrophy of endometriotic lesions. The current study also corroborates other randomized clinical trials on melatonin and pain in particular, in treating fibromyalgia and acute postoperative pain.

Melatonin is well tolerated by most patients and appears to represent an effective option for pain symptoms related to endometriosis. A 2013 observational study on N acetyl cysteine also resulted in significant pain reduction and ovarian cyst size reduction associated with endometriosis. I consider these two nutrients as mainstays in our treatment strategies for endometriosis.


Schwertner A, Conceicao dos Santos C, Costa G, et al. Efficacy of melatonin in the treatment of placebo endometriosis: A phase II, randomized, double-blind, placebo controlled trial. PAIN 2013;154(6):874-881.

Safari II Le ContadourAnother quality study has emerged using the oral encapsulated lavender essential oil. This randomized, double-blind, placebo-controlled trial investigated two doses of oral lavender essential oil in comparison to a selective serotonin reuptake inhibitor, paroxetine, in patients who have been diagnosed with generalized anxiety disorder (GAD). Individuals were given a lavender essential oil made from the steam-distilled fresh flowering top of lavender that has then been standardized to contain approximately 70% of two constituents, linalool and linalyl acetate. The product was given as either an 80 or 160 mg dose and then 1 placebo or 2 placebo pills daily. The paroxetine was given in capsules of 20 mg. Treatment was given for 10 weeks, and measurements of safety and efficacy were done at 2, 4, 6, 8, and 10 weeks. During a week of "down-titration" following the study, patients who were on the paroxetine, took the treatments every other day to account for any withdrawal problems caused by paroxetine. Patients in the lavender essential oil group took placebo.

A total of 616 patients were recruited and then 536 patients randomized to treatment. These were men and women, between ages 18 and 65 year old, from 57 general practice and psychiatric practices in Germany, who had a diagnosis of moderate to marked severity of GAD for an average of 2.5 years. Psychiatric medications other than the paroxetine were not allowed during the study and for 30 days prior to entering the study. A total of 128 were in the 160 mg Lavender group, 135 in the 80 mg/day group, 137 in the paroxetine group and 136 in the placebo group.

After 4 weeks of the study and at other study time points, the intake of 160 mg/day of lavender essential oil resulted in a significantly greater change in the HAMA (Hamilton Anxiety Scale) score compared to placebo (P< 0.01). After 6 weeks and beyond, those taking the 80 mg/day of lavender essential oil had a significantly greater change in the HAMA scores compared to placebo. At week 6 the HAMA score in those taking paroxetine approached significance but they were not significantly better than placebo after that point.

Significantly more patients in the 160 mg/d lavender group showed an improvement in the HAMA score of 50% or more compared to the placebo group (60.3% vs. 37.8%). This was also observed in the 80 mg/d group (51.9% vs. 37.8%). The HAMA score was < 10 in significantly more of those patients taking the lavender product compared to the placebo (46.3% vs. 29.6%). All three treatment groups, the 80 mg/day, 160 mg/day and the paroxetine contained a greater percentage of patients who were "much/very much improved" or had a "moderate/marked" therapeutic effect as compared to the placebo group. The adverse events that were reported were 25% of those in the 160 mg/day lavender group, oddly higher of 34.8% in the 80 mg/day group, 40.9% in the paroxetine group and 30.9% in the placebo group. These adverse events were reported as gastrointestinal disorders, infections, and nervous system problems.

Commentary: Both doses of oral essential oil of lavender were effective in treating GAD and were more effective than the conventional medicine, paroxetine. In terms of adverse events, those taking lavender were similar to placebo and lower than paroxetine. This study is another welcomed positive study in using an oral lavender essential oil standardized to linalool and linalyl acetate in the treatment of GAD. Conventional medications, whether anti-depressants or anxiolytics or barbiturates are fraught with side effects, which makes the lavender essential oil product that much more appealing. That said, there are nonresponders to natural medicine, including this lavender oil and we all must recognize that some individuals will need the conventional medications for anxiety, at least until other efforts are made in assessing the complexities of causation and then addressing those.


Kasper S, Gastpar M, Müller WE, et al. Silexan is effective in generalized anxiety disorder – a randomized, double-blind comparison to placebo and paroxetine. Int J Neuropsychopharmacol. January 23, 2014:1-11. [epub ahead of print]. doi: 10.1017/S1461145714000017.

soybeans fresh

The authors of this study were testing the hypothesis that Asian women may have fewer health complaints and that this may be due to higher consumption of soy products. This double-blind, placebo-controlled randomized study assessed the effect of soy isoflavones on menopausal symptoms, bone mineral density (BMD), serum cytokines, and bone metabolism indices.

Chinese menopausal women were recruited from 3 medical centers in China. Women were between the ages of 45 and 55, had moderate menopause symptoms based on a questionnaire and were excluded if they had menopausal symptoms for more than 5 years, high blood pressure, endocrine disorders, cardiovascular disease, or were currently on hormone replacement therapy (HRT), pregnant, obese, or allergic to soy products.

Women were given capsules of soy isoflavone (22.5 mg, 52.2% genistein, 47.8% daidzein) or placebo, 2 capsules twice a day for 6 months. They were asked to limit their soy dietary consumption. A menopause symptom questionnaire and BMD of the radius and tibia (using ultrasound measurement) were done at baseline and at 6 months. Blood tests included genistein, daidzein, calcium, phosphorus, alkaline phosphatase (ALP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α).

A total of 70 women completed the study (37 in treatment group and 33 in placebo group). There were overall significant decreases in menopausal symptoms such as hot flashes, insomnia, restlessness and tantrums, dizziness, lassitude, headache, heart palpitations, feeling of crawling skin, urinary tract infection, and state of sexual life of 11.5 points in the treatment group vs. 7.3 points in the placebo group. And, for almost all of the same symptoms in the placebo group (all P<0.05). Hot flashes specifically, significantly decreased in the isoflavone group vs. no significant decrease in the placebo group.

The BMD of the tibia increased significantly with soy isoflavone ingestion, although the radial BMD did not change. Alkaline phosphatase, IL-6, and TNF-α decreased significantly in the treatment group as well.

Commentary: Common perimenopause and postmenopausal symptoms include hot flashes, insomnia, and night sweats. There is also a normal bone loss, especially in the first 4 years, associated with the decline of estrogen, which can increase the risk of osteoporosis and fractures. Soy isoflavones have been shown to decrease bone loss in animal and human studies, likely due to the phytoestrogens that have weak estrogenic activity. Not all published reports confirm that Asian women have less menopause symptoms than Western Caucasian women, but if they do in fact, it is hypothesized that one reason may be the higher consumption of soy products in Asia.

To summarize, in this study, soy isoflavones had a significant, positive effect on a number of subjective and objective markers of menopause including the decrease in overall symptoms of menopause and an increase in the tibia BMD. Alkaline phosphatase levels and TNF-alpha normally rise after menopause and IL-6 is partially regulated by estrogen. Because soy isoflavones possess weak estrogen-like properties, they may alter bone formation and resorption in a manner similar to estrogen. Soy isoflavones appear to decrease blood levels of ALP, IL-6, and TNF-α, suggesting again their weak estrogenic effect and favorable influence on bone metabolism. This study should not be construed as concluding that soy isoflavones have equivalent effects of estrogen therapy, on either menopause symptoms or on slowing bone loss, but this simple intervention does have endocrine effects that have clinical meaning in menopause management.


Chi X-X, Zhang T. The effects of soy isoflavone on bone density in north region of climacteric Chinese women. J Clin Biochem Nutr. September 2013;53(2):102-107

clip_image002There has been interest for some time now about the role of vitamin D levels in the blood and the potential protective benefits of adequate levels in the prevention of breast, colon and other adenocarcinomas.

This meta-analysis was conducted using a PUBMED search for observational studies of serum 25(OH)D and risk of breast cancer between 1966 and 2010. Articles were included if they were published in medical journals, were prospective or historical follow-up studies and if they articles reported survival or mortality rates in relationship to quintiles of serum 25(OH)D. A total of 77 studies were identified but after review by these two researchers, only five studies were eligible for inclusion.

A higher serum concentration of 25(OH)D was associated with lower case- fatality rates in breast cancer patients. Three of the five studies found that serum vitamin D in the highest quantile was associated with significantly lower mortality rates than serum vitamin D levels in the lowest quantile. Two other studies found a trend in that same direction. Breast cancer patients with the highest concentration of 25(OH)D had approximately half the mortality rate compared to those with the lowest concentration.

Commentary: Laboratory studies have found anticancer benefits of metabolites of vitamin D on cell differentiation, apoptosis (cell death) and angiogenesis (blood supply to tumor sites) of breast tumors. The hypothesis is that breast cancer survival may be influenced by serum levels of vitamin D and its effect on maintaining cell differentiation, promoting apoptosis and inhibiting angiogenesis. In terms of clinical trials of vitamin D for prevention, I am aware of one such trial where 1,000 IU of vitamin D daily with calcium, showed a 77% reduction in incidence of all combined invasive cancer, including breast cancer.

Vitamin D testing is a simple test, called a serum 25(OH)D. I routinely test breast cancer patients for this and assure that they have adequate vitamin D levels of 30-80 ng/ml. That said, there has been some concern about levels > 40 ng/ml and increased risk of pancreatic cancer. My goal therefore, is 30-40 ng/ml. Vitamin D supplementation is by and large safe and definitely one of the most inexpensive vitamins to take. And don’t forget the sunshine— just harder to determine exposure necessary for adequate serum levels– plus potential negative effects of too much exposure and increased skin aging, and precancerous and cancerous skin lesions.


Mohr S, Gorham E, Kim J, et al. Meta-analysis of Vitamin D sufficiency for improving survival of patients with breast cancer. Anticancer Research 2014;34:1163-1166.

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