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The purposes of this study were to evaluate the effects of a walking routine on bone mineral density (BMD) at the lumbar spine, at the femoral neck (a part of the hip), at the radius (wrist) and for the whole body in perimenopausal and postmenopausal women and to identify the optimal duration of a walking program. The study reported on randomized and non randomized clinical trials through systematic review and meta-analysis of those clinical trials.

Ten data bases were searched from their origin through December 2012. All randomized and nonrandomized controlled studies on walking interventions in perimenopausal and postmenopausal women were considered. Efforts were made in the analysis to avoid double counting of participants in the meta-analysis papers. Only studies that evaluated walking alone as the sole exercise program were included. The outcomes were defined as BMD at the lumbar spine, femoral neck, radius and whole body, as measured by single-photon absorptiometry (SPA), dual-photon absorptiometry (DPA), or dual x-ray absorptiometry (DXA).

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From these searches, 229 articles for potential inclusion in the review were found and identified but in the end, only 10 trials were eligible for inclusion. Among those 10, seven were randomized controlled trials. Participants were predominantly from the U.S., UK and Japan. Walking for 40 to 60 minutes per session was reported in 8 of the trials, with one being two levels of 45 and 30 minutes per session and another only 30 minutes per session. The frequency of the walking was approximately 3-4 times per week in 9 of the 10 trials. A meta-analysis of trials evaluating lumbar spine BMD showed no significant effects regardless of the length of the exercise program. When all the ten trials were taken into account, walking interventions with durations of 3 months to 2 years were NOT found to have beneficial effects. However, two of the meta-analysis did observe a significant positive effect of walking on the BMD at the femoral neck. These two that showed this increase were the programs that were at least 6 months (vs 3 months) up to 2 years. It is thought the difference between the negative results and the positive results is in fact duration of the walking program. The effects of walking on the radius and whole body were not significant.

Commentary: Menopause is a major risk factor for bone loss in women due to the lowering of the body’s natural estrogen level. Low BMD increases the risk for osteoporosis and fractures. Several recent reviews have investigated the effects of walking but the conclusions were inconsistent. Two randomized controlled trials have demonstrated significant effects of walking on BMD preservation. A Cochrane Review based on 3 randomized controlled trials showed not significant effect except in the spine. The Nurse’s Health Study suggested that the risk of fracture was reduced by regular walking and others have shown no benefits or just modest benefits on BMD after 1 year of walking.

In this systematic review, walking for 40 to 60 minutes per day, 3-4 days per week showed almost no benefit to BMD except after 6 months and at the femoral neck only. If that were just the whole story, it would not be that compelling as a treatment strategy to preserve postmenopausal BMD. However, walking has been shown to decrease the risk of many diseases such as congestive heart failure, stroke, type II diabetes, high blood pressure, high cholesterol and even some cancers, and even as a fundamental treatment for weight management, PMS, depression, high blood pressure, type II diabetes, high cholesterol. Women don’t have just bones of course, and have many compelling reasons to walk a minimum of 40 minutes, 4 days per week.

Reference

BS D, Wu L, He Zhong. Effects of walking on the preservation of bone mineral density in perimenopausal and postmenopausal women: a systematic review and meta-analysis. Menopause 2013;20(11): 1216-1226.

Hot flashes and/or night sweats are the most common symptoms that perimenopause/menopause women seek relief for. They can be mild, moderate or severe and can be infrequent or daily and many times a day if not several times per hour and can last an unpredictable amount of months/years. Some women are affected greatly and this can impact mood, sleep, social encounters, work and general quality of life. About 70-80% of women who go through normal natural menopause have hot flashes/night sweats and 90-100% of women with surgical menopause (both ovaries removed) experience them.

In this double blind clinical trial, 76 menopausal women with the chief symptom of hot flashes were enrolled with the treatment group receiving a 225 mg valerian capsule three times per day and the other group placebo, for 8 weeks. Five women from the placebo and 3 from the valerian groups were excluded due to irregular use, inaccurate recording, mild side effects or taking other medications that affect hot flashes. A total of 68 women completed the study. Symptom diaries (although the questionnaire and specifics of this were not reported in the study) were kept. Results were recorded by the participants and collected by the researchers. After 4 and 8 weeks of treatment, the evaluation of results showed a meaningful difference between the valerian group and the placebo group.

At week 4 and week 8 post-treatment, the valerian group had significantly less severe hot flashes (9.82 + 1.87 pre-treatment and 5.23 + 1.52 after 8 weeks) compared with the placebo group (9.96 + 1.84 pre-treatment and 9.86 + 1.95 after 8 weeks). There was no significant change in severity of hot flashes in the placebo group compared with baseline. In addition, at week 4 and week 8 post-treatment the valerian group had significantly fewer hot flashes compared with the placebo group. Valerian pre-treatment was a mean frequency of 7.91 + 30.0 and 4.83 + 0.52 after 8 weeks vs. placebo pre-treatment 7.73 + 42.0 and after 8 weeks 7.75 + 0.32. There was no significant change in frequency of hot flashes in the placebo group compared with baseline.

Commentary:valerian

The purpose of this randomized, double-blind, placebo-controlled study was to evaluate the effect of valerian treatment for 8-weeks on hot flashes. Valerian is an interesting choice, but it does contain some flavonoids, which are phytoestrogenic components and therefore it is a reasonable hypothesis that it may reduce menopause symptoms.

Currently available conventional treatments include various regimens of hormone therapy, conventional non hormonal options such as an SNRI or SSRI, gabapentin, clonidine and possibly an anti-histamine. Efficacy of the non hormonal treatments are less than with adequate doses of estrogen. However, all of these have a benefit and risk profile that needs to be considered by patient and menopause practitioner. Natural treatments that have scientific support span all kinds of plants and nutraceuticals. Some of the plants are phytoestrogen containing plants such as soy, red clover, kudzu, hops and others. Some of the plants that do not contain phytoestrogens include black cohosh, maca, Siberian rhubarb, St. John’s wort, pine bark and kava. Even fish oils have shown some efficacy in treating hot flashes. These herbal/nutraceutical treatments can be quite effective in reducing severity and frequency of hot flashes, but are also sometimes not effective, or some times not effective enough. Having more options to help women with hot flashes and/or night sweats is extremely helpful in order to address the diverse array of clinical situations and individual needs/choices based on benefits and risks.

There seems to be quite a bit of herbal research in women’s health coming out of Iran which I am pleased about. I will add this study and this tool to my list of options.

Reference

Mirabi P, Mojab F. The effects of valerian root on hot flashes in menopausal women. Iran J Pharm Res. 2013;12(1):217-222.

Peanuts to the Rescue!

clip_image002In this study, children of women who participated in the Nurses Health Study II (NHSII) and the Growing Up Today Study 2 (GUTS2) and were born between January 1990 and Dec 31, 1994 were identified. A questionnaire was sent out in 2009 to the mother of every child in these two studies in order to identify children with food allergies. The children themselves had already been surveyed in 2006, on whether or not they had a food allergy. The researchers evaluated the results of these two questionnaires and identified cases of allergies to either peanuts or tree nuts. These cases were then divided into seven levels ranging from likely food allergy to possible food allergy based on the review of the medical information. The mothers had also previously reported on their diet in 1991 and 1995 on the NHSII questionnaires. The questionnaire closest to the birthday of each child was selected to determine the maternal peanut intake.

A total of 8205 children with 140 cases of peanut/tree nut allergy were identified. Over 95% of the NHSII and GUTS2 participants were Caucasian and 2% of the mothers reported a nut allergy. Women with the highest consumption of peanuts/tree nuts in their peripregnancy (typically 5 months before, during pregnancy and 1 month after pregnancy) diet were more likely to introduce these items into their child’s diet at < 2 years old. The odds of having a child with peanut/tree nut allergy among the mothers without these allergies and who consumed these food 5 or more times/week had the lowest incidence.

Commentary:

The U.S. has seen an increase in the incidence of peanut allergy from 0.4% in 1997 to 1.4% in 2010. It’s become significant enough that some preschools and school settings ban peanuts in snacks and lunches. Frequently occurring together, 80-90% of peanut and tree nut allergies that have an onset in childhood then persist into the adult years. Media and schools and magazines and practitioners have been telling women for many years to avoid giving their children peanuts in the first 3 years of life. Some have even recommended to women that they avoid peanuts during pregnancy and lactation. However, these guidelines changed due to lack of evidence in that several studies demonstrated that peanut consumption during pregnancy and lactation had no effect on subsequent peanut/tree nut allergies in offspring. The current study is attempting to clarify further, any association with peripregnancy consumption of peanuts/tree nuts by mothers and the development or not, of these allergies in their children. This is the first study to my knowledge, actually showing that ingestion during pregnancy may actually be protective for their children, at least that is the case in women who do have any known peanut/tree nut allergy themselves. While this study is not a pure prospective study where diet records are controlled more diligently during pregnancy, and this study did not included information on exclusive breastfeeding rates or duration, I still find it useful, and logical actually. Pediatric guidelines currently states that there is not enough evidence that maternal dietary restrictions during pregnancy will play any role in the prevention of atopic allergic disease in infants. And, although there is not enough evidence to say that consumption of dietary food allergens in pregnancy can reduce the chance of infants developing allergies to those allergens, the current study supports that possibility, and at least gives license for pregnant women who do not themselves have these allergens, to feel free to enjoy the health benefits and yummy goodness of peanuts, peanut butter, and other nuts/nut butters. I would add though, steer clear of sugar containing, hydrogenated fat containing, and even the “creamy” versions, due to palm oil and the usual practice of destructive deforestation, illegal forest fires and the devastating impact on animal species and the destruction of their habitat and endangerment to their survival. You might be interested in reading about some of the multinational corporation practices in this regard, and the Greenpeace investigations and efforts to halt these practices. Oh, and while we are at it, try to choose organic.

Reference: Frazier A, et al. Prospective study of peripregnancy consumption of peanuts or tree nuts by mothers and the risk of peanut or tree nut allergy in their offspring. JAMA Pediatrics Dec 23, 2013 (Epub ahead of print).

Breast Milk

Some mothers are unable to successfully provide breast milk to their infants, and thus use pasteurized donor milk, which is considered an acceptable and even recommended source for preterm infants in particular. There are regulated milk banks of donor milk, which is available. These regulated milk banks screen donors and pasteurize milk to remove potential pathogens. The demand for this is great enough that there are several human milk sharing websites that connect donors and recipients that allow purchase of the milk directly from the donor. However, the method of milk collection and transport of the milk is at the discretion of the seller.

clip_image002An investigation was conducted and published in the journal, Pediatrics, in which researchers compared the bacterial and viral contamination in 101 Internet samples that were obtained from individual sellers. These were then compared to 20 samples that were obtained from a licensed milk bank before pasteurization.
One finding was that the Internet shipments of samples varied with longer transit times and also had increased bacterial counts. Gram-negative organisms and Staphylococcus species were more frequently found and in higher numbers in the Internet samples than the licensed milk bank samples. None of the samples tested positive for HIV, but 21% of the Internet samples and 5% of the milk bank samples did test positive for cytomegalovirus. Some of the milk sellers claimed organic. This did not correlate with lower bacterial or viral counts.

Commentary: There are many important health benefits short term and long term to support the use of human breast milk feeding of infants. It is especially beneficial in preterm infants. However, given that it is a bodily fluid, it does have the potential to transmit infectious agents. Based on the results of this study, I would recommend avoiding raw breast milk purchased from unregulated Internet sites as it may put infants at risk for infection and this could even outweigh the benefits. This study did not address environmental contamination of breast milk that is a result of our modern world. I am definitely not an expert on this topic, but I have read from experts, that even given the environmental pollutant contamination of human breast milk, the benefits of human breast milk for infants, does indeed outweigh the concerns and risks of these pollutants as we understand it today. It’s shameful to me, that we have allowed our world to progress in such a way that historically, one of the most pure and critically important nutrient sources also then exposes infants and young children to pollutants at such a young age.

Reference

Keim S, et al. Microbial contamination of human milk purchased via the Internet. Pediatrics 2013 Nov; 132:e1227.

clip_image002This small randomized, double-blind, placebo-controlled clinical trial was conducted in 30 breast cancer patients to assess curcumin’s ability to reduce the severity of radiation dermatitis. Women with non-inflammatory breast cancer or carcinoma in situ and were receiving radiotherapy, were randomized to receive either 2.0 grams three times per day of curcumin or placebo during their course of radiation treatments. The Radiation Dermatitis Severity (RDS) score was assessed weekly along with the presence of moist desquamation, redness, the McGill Pain Questionnaire-Short Form and Symptom Inventory questionnaires. The average age of the women was 58.1 and 90% were Caucasian.

Curcumin reduced RDS at the end of radiation therapy compared to placebo. The mean RDS scores for curcumin patients were 0.8 lower than the placebo-treated patients, i.e. 2.6 vs. 3.4. There were also fewer curcumin treated patients with moist desquamation (28.6% vs. 87.5%). There were no significant differences in pain scores in total sensory pain or intensity of pain at the treatment site and oral curcumin did not reduce erythema. Curcumin was not effective at reducing the severity of radiation dermatitis in those women who had a total mastectomy prior to radiotherapy.

Commentary: Radiation dermatitis is one of the most common side effects patients acquire from radiotherapy. It occurs in approximately 95% of women receiving radiotherapy for breast cancer and 10% of those are severe cases. Current conventional treatments include washing with lukewarm water and mild soap; applying unscented lanolin-free, water-based moisturizers, hyaluronate cream and possibly topical corticosteroids. Practitioners of natural medicine have been using many options including topical aloe preparations, topical vitamin E, and topical calendula lotion. Calendula lotion in particular has one French study demonstrating efficacy.

Oral curcumin has low bioavailability and according to at least one publication, an oral dose less than 4.0 grams is not detectable in the blood. In the current study, patients had to take 12 capsules per day to achieve the 6.0 grams per day. There are at least 3 technologies that enhance the bioavailability and thus would then require much less number of capsules. These 3 technologies include lecithin bound to curcumin- a “phytosome” process, (ex/ Meriva), curcuminoids/ turmeric essential oil/ lecithin (ex/BCM-95), and a curcumin nanoparticular colloidal dispersion (ex/ Theracurmin).

Reference

Ryan J, Heckler C, Ling M, et al. Curcumin for radiation dermatitis: A randomized, double-blind, placebo-controlled clinical trial of thirty breast cancer patients. Radiation Research 2013;180:34-43.

Researchers for the Iowa Women’s Health Study assessed health related issues including dietary habits and intake, and the relationship with type I (estrogen related) and type II (estrogen independent) endometrial cancer. A total of 23,039 were evaluated with an average age at study onset of 62 years. A total of 592 invasive endometrial cancers were identified, 506 type I and 89 type II. After an adjustment calculation was made for body mass index, due to the association of obesity and endometrial cancer, those women who consumed the most sugar sweetened beverages compared with women who consumed the least, had a 78% higher risk for type I endometrial cancer. Fruit juice and sugar free beverages were not associated with the risk for type I endometriosis and none of the dietary ingredients studied were associated with the risk for type II endometrial cancer.

Commentary: You would not be surprised to know that sugar-sweetenedsugar drinks beverages are a major source of sugar in the diet of U.S. women (and men and children). These beverages affect insulin and glucose levels more significantly than the sugars in whole foods. The intake of sugar sweetened beverages seems to parallel the rise in obesity. What is interesting here is that increased consumption of sugar sweetened beverages contribute to the risk for type I endometrial cancer, independent of body weight/obesity. That said, women who are obese and women with polycystic ovarian syndrome are at increased risk, and therefore our advice to avoid sugar sweetened beverages for these women can hold even more punch (and not the sweetened party drink!!!)

Reference

Inoue-Choi M, Robien K, Mariana A, et al. Sugar-sweetend beverage intake and the risk of type I and type II endometrial cancer among postmenopausal women. Cancer Epidemiol Biomarkers Prev 2013;22(12): 2384-2394

Soy and Breast Density

soy foodsThis randomized, double-blind, placebo-controlled study conducted in 80 women aged 45 and older and with amenorrhea of > 12 months with vasomotor symptoms (hot flashes and/or night sweats). Women were randomized to receive either 250 mg of standardized soy extract equal to 100 mg/day of isoflavones or placebo for 10 months. There were 40 women in each group. The follow-up period was a duration of 10 months. A total of 32 women in the isoflavone group and 34 women in the placebo group completed the study. No participants were on hormone therapy (HT) or any phytoestrogen within the preceding 6 months.

The purpose of the study was to evaluate the effects of soy isoflavones on breast tissue in postmenopausal women. Breast density was evaluated with mammography and breast parenchyma was evaluated with ultrasound. Each were done at baseline and 10 month follow-up.

At baseline, there were no significant differences between the isoflavone group and the placebo group. After 10 months, the groups did not differ in mammographic density or breast parenchyma by ultrasound. The use of soy isoflavones at 100 mg/day for 10 months did not affect breast density in postmenopausal women.

Commentary: Breast density as characterized on mammography is an independent risk factor for breast cancer. In addition, breast density limits the accuracy of mammography. Results of other randomized, placebo-controlled studies analyzing soy and breast density also did not find breast modifications with soy. An additional insight offered by the results of this study, is that the breast ultrasound also did not detect any increase in fibrosis or fibroglandular tissue with the use of soy isoflavones.

Breast density is influenced by many factors including age, parity, menopause status, body composition, exogenous and endogenous hormones, and genetic factors. The results of the current study lend yet one more comforting piece of data on the safety of soy foods and soy isoflavone extracts on breast health.

Reference

Delmanto A, Nahas-Neto J, Traiman P, et al. Effects of soy isoflavones on mammographic density and breast parenchyma in postmenopausal women: a randomized, double-blind, placebo-controlled clinical trial.

This double-blinded, placebo-controlled randomized clinical trial evaluated the efficacy and safety of green tea extract on uterine fibroid burden and quality of life in reproductive aged women with symptomatic uterine fibroids.

A total of 39 reproductive aged women ages 18-50 y.o. with symptomatic uterine fibroids were recruited. Eligible women included those with a follicle-stimulating hormone (FSH) less than 10mIU/L, at least moderately severe uterine fibroid related symptoms with a score of > 25 on the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire subscale (UFS-QOL). All the women had at least one fibroid measuring 2 cm or larger based on transvaginal and/or transabdominal ultrasound and a total uterine volume of > 160 mL by vaginal and abdominal ultrasound.

Twenty two were randomized to receive green tea extract and 17 to receive placebo.

Study subjects were randomized to oral green tea Green tea in teapotextract (45% epigallocatechin gallate= EGCG) or placebo of brown rice, daily, for 4 months. Each green tea capsule contained 95% polyphenols and 45% EGCG. Women received two capsules daily of either green tea or placebo.

Uterine fibroid volumes were measured at beginning and end of the study. The fibroid specific symptom severity and quality of life questionnaires were scored at each monthly visit.

The mean change in both the volume and number of uterine fibroids was assessed by transvaginal ultrasound (TVU) and/or transabdominal ultrasound at baseline and at the end of the 4 month treatment period.

The secondary measure at each visit was the mean change in fibroid specific health related quality of life (UFS-QOL), and the health related quality of life (HRQL) questionnaire. Blood loss was also assessed monthly with a menstrual log and visual assessment of quantity.

Of the 39 women, 33 were compliant and completed the five visit study over the 4 month period. Of the final 11 women who completed the placebo group, fibroid volume increased by 24.3% over the study period. Of the final 22 women in the green tea extract group, a significant uterine fibroid total volume reduction of 32.6% was observed. The green tea extract group also had a significant reduction in fibroid specific symptom severity of 32.4% and a significant improvement in HRQL of 18.53% compared to the placebo group. Anemia improved significantly by 0.7 g/dL in the green tea group and the average blood loss significantly decreased from 71 mL/month to 45 mL/month. There were no adverse effects or endometrial hyperplasia or pathology in either group.

Commentary:

Green tea, especially its epigallocatechin gallate (EGCG) constituent has anti-inflammatory, antiproliferative and antioxidant effects. The study’s authors attributed the reduction in fibroid size from EGCG due to an inhibitory effect on leiomyoma tumor cell proliferation and apoptosis induction.

More than half of women ages 35-49 in the U.S. are affected by uterine fibroids and are more prevalent in African American women. These benign growths can cause acute and chronic pelvic pain, excessive uterine bleeding, dyspareunia, iron deficiency anemia, miscarriage, infertility, constipation and/or irregular bowel habits and urinary incontinence. The impact of these complications on a woman’s health can be significant and currently, there is no effective long-term medical treatment for these common benign tumors. Short term conventional management options include gonadotropin-releasing hormone analogues but are only approved for short term preoperative adjuvant use due to their risk of significant and irreversible bone loss, osteoporosis and other major side effects. Progestogen or hormonal contraceptive management is sometimes helpful to control bleeding. If symptoms impact quality of life significantly, or fibroid removal could improve miscarriage and/or fertility, or there is medical urgency due to bleeding, then management options range include hysteroscopic resection of submucosal fibroids, hysterectomy, myomectomy, uterine artery embolization or image-guided focused ultrasound thermal therapy. Milder cases usually involve just observation, especially in asymptomatic fibroids, or the patient putting up with her symptoms.

This study, of a simple and safe botanical option such as green tea extract, is a welcomed noninvasive intervention for treatment and/or prevention of uterine fibroids and could be a game changer for many women suffering from uterine fibroids.

Reference

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.

uterine painEndometriosis is one of the most common gynecological diseases and can cause chronic pelvic pain and chronic lower abdominal pain, menstrual cramps, pain with vaginal penetration during sex, abnormal bleeding and infertility. Available conventional therapies include hormonal therapies, pain medication and surgery. A natural substance that is free of side effects, and one that shows efficacy would be a very appealing option. A well known supplement, N-acetylcysteine (NAC), which is the acetylated form of the amino acid cysteine, occurs naturally in some substances such as garlic.

This observational cohort study was designed to compare the progression of ovarian endometriomas in N-acetyl cysteine (NAC) treatment patients and untreated control patients. Patients were given either NAC 600 mg three times daily, 3 consecutive days per week or not, for an observation period of 3 months. At the end of the 3 month observation period, endometriomas (ovarian cysts or chocolate cysts related to endometriosis), were evaluated by pelvic ultrasound, by a trained physician, who was blinded as to which group the patients had been in.

A total of 92 Italian women, 47 in the NAC treated group and 45 in the untreated group were ultimately included. Women were enrolled to select inclusion criteria: 1) an ultrasound diagnosis of ovarian endometrioma 2) no hormonal treatment in the previous 2 months 3) laparoscopic surgery scheduled due to the presence of either a large endometrioma 30 mm or greater, pain or infertility.

In the NAC treated group, 24 patients cancelled their scheduled laparoscopy due to a decrease or disappearance of cysts, pain reduction or pregnancy. Again, in the NAC treated group, 14 women had decreased ovarian cysts (-1.5 mm average), 8 had a complete disappearance, 21 had pain reduction and 1 became pregnant. In the control group, only 1 patient cancelled surgery. There were 4 endometriomas that disappeared. Overall, more cysts reduced and fewer cysts increased in size in the NAC group. There were 4 newly formed cysts in the NAC group vs. 4 in the untreated group. After the observation period, a total of 8 pregnancies occurred in the NAC treated group and 6 in the untreated group.

Commentary: Up to 10% of reproductive aged women have endometriosis. In women with infertility, the numbers may be as high as 50%. The results of this study are impressive and actually compares to the results reported in a randomized placebo controlled study on 100 women treated for 4 months with oral contraceptives. In addition, there was one pregnancy during the study period and more after, which is of course a contrast with women who stay on oral contraceptives to manage their endometriosis. NAC does not negatively affect fertility, and if one looks to other research on insulin resistance and PCOS, we will find that NAC improves ovulation and thus fertility, similar to metformin, in PCOS patients. Previous evidence shows that NAC modulates the pathogenesis of endometriosis via several pathways. NAC decreases abnormal cell proliferation, decreases the invasive behavior of the endometriosis cells, decreases inflammatory substances, regulates expression of inflammation related genes, and stimulates cell differentiation. I will be interested in using NAC for not only treatment of current endometriomas, as well as endometriosis, as well as prevention of recurrence after a surgery.

Reference:

Porpora M, Brunelli R, Costa G, et al. A promise in the treatment of endometriosis: an observational cohort study on ovarian endometrioma reduction by N-acetylcysteine. Evidence-Based Complementary and Alternative Medicine. 2013; April. Article ID 240702, 7 pages http://dx.doi.org/10.1155/2013/240702

A randomized double blind placebo controlled trial was conducted in patients with chronic primary insomnia in West Bengal, India. Individuals were randomly assigned to receive 1 tablet of an herbal combination or 10 mg of zolpidem for 2 weeks. The herbal combination contained 300 mg valerian extract (standardized to 0.8% total valerenic acid), 80 mg passionflower extract (standardized to 4% isovitexin), and 30 mg hops extract (standardized to 0.35% rutin). Dosing was 1 tablet at bedtime and a sleep diary was conducted along with the Insomnia Severity Index and Epworth Sleepiness Scale.

Individuals ranged in age from 20-80 y.o. Of the 91 patients enrolled, 78 completed the study with 39 in each group. Eligibility was determined if they had an average of < 6 hours of sleep per night and a score of > 7 on the Insomnia Severity Index. Patients were excluded if they were taking medications that affect sleep, had a psychiatric diagnosis, had a history of substance abuse, had a dependence on sedative-hypnotic drugs, or if they worked night shifts.

The average sleep duration increased significantly from 3.4 to 5.9 hours in the herbal combination group and from 3.5 to 5.7 hours in the zolpidem group after the 2 week study period, which was considered similar results for both treatments. The average amount of time it took to fall asleep, called sleep latency, was also similar in both groups and decreased significantly from 84.0 to 23.6 minutes in the herbal group and from 90.0 to 26.4 minutes in the zolpidem. Night time awakenings decreased and quality of life scores improved in both groups, compared to baseline and with no significant differences between the two treatment groups. Daytime sleepiness was not a problem in either group, adverse events were similar in both groups, and no serious adverse events were reported in either group.

Commentary: Chronic insomnia is fraught with significant quality of life issuesmore insomnia including mood and cognitive changes. The results of this study indicate that this combination of valerian, hops and passion flower is a safe and effective alternative to zolpidem, at least for short term treatment of insomnia. Chronic insomnia is more common in women, with an exacerbation in perimenopause and early menopause. This herbal combination, along with seeing their insomnia as a perimenopause/menopause symptom and addressing the core physiological changes, bodes well for using these three herbs to treat insomnia.

Reference

Maroo N, Hazra A, Das T. Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: A randomized controlled trial. Indian J Pharmacol. January-February 2013;45(1):34-39.

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