A Pilot Study to Examine a Combination Botanical for the

Treatment of Menopausal Symptoms

Debi Smolinski, N.D., Debra Wollner, Ph.D., Jennifer Orlowski N.D., Jessica Curico N.D., Jennifer Nevels N.D.,

and Linda S Kim, N.D.

By Anne Swinson

BackgroundMenopause- cessation of menses > 1 yearChanges in levels of progesterone and estrogen40 million postmenopausal women in the USAverage age of menopause is 51 yearsEarly menopause can be triggered

SmokingHysterectomyOophorectomy

SymptomsCan have unbearable symptoms

Hot flashesMood changesDepressionCognitive changesDecreased libidoVaginal drynessUrinary Tract infectionsDecreased energySleep disturbancesWeight gainOsteoporosis

Staying HealthyDon't smoke- it’s never too late to quitEat a healthy diet, low in fat, high in fiber, with plenty of

fruits, vegetables, and whole-grain foods, as well as all the important vitamins and minerals

Make sure you get enough calcium and vitamin D—in your diet or with vitamin/mineral supplements

Learn what your healthy weight is, and try to stay there.Do weight-bearing exercise, such as walking, jogging, or

dancing, at least 3 days each week for healthy bones. Take medicine as it’s prescribedUse a water-based lubricant for vaginal discomfortsGet regular check-ups- Pap tests, breast exams, and

mammograms

Current TherapyHormone Replacement Therapy

Estrogen and progesteroneBirth control pillsStill has risks and side effects

StrokeCardiovascular diseaseHeart DiseaseBreast Cancer

Complementary and Alternative Care (CAM)Natural estrogenic activity

Purpose“The purpose of this pilot study was to evaluate

a combination of botanical formulation comprised of whole herbs for efficacy in reducing the severity of symptoms associated with menopause.”

Previously used botanicals studied individuallyCombination could be more effective

Latin Name Common NameDose per day

% of mixture

Cimicifuga racemosa Black cohosh root 300mg 14Viburnum opulus Cramp bark 240mg 11Mitchella repens Squaw vine 220mg 10Valeraina officinalis Valerian root 140mg 6Polygonatum multiflorum King Solomon seed 140mg 6Taraxacum officinalis Dandelion root 140mg 6Vitex agnus-castus Chaste tree berry 140mg 6Rosemarinus officinalis Rosemary leaves 140mg 6Nigella sativa Black seed 140mg 6Eupatorium purpureum Queen of the meadow 140mg 6Epimedium gradiflorum Epimedium leaf 100mg 5Ligusticum chuanxiong Chuanxiong rhizome 100mg 5Schisandra chinensis Schizandra berry 100mg 5Menth piperita Peppermint leaves 80mg 4Rubus idaeus Red raspberry leaves 80mg 4

Subjects8 women with menopausal symptomsRecruitment through newspaper advertisementWritten consent was obtainedInclusion Criteria

Age 40- 65 yearsNatural menopauseModerate severity of hot flashesAvoidance of other treatmentsAbility to take daily doses of botanicals for 3

monthsGynecological check-up prior to enrollment

Exclusion CriteriaExclusion Criteria

Menopause due to chemical or surgical proceduresAbnormal blood/urine chemistry

Hepatic, blood, or renal disordersChronic constipationMajor disease

Heart, cancer, renal, or psychiatric disordersConcurrent prescription or OTC drug useCAM therapies for menopause treatmentAllergies or sensitivities

TreatmentOne single treatment groupNo placebo groupBlend of 15 whole herbs in 550 mg capsules

taken twice daily between mealsProvided a total of 2200 mg/day

Outcome MeasurementHealth history questionnaire and symptom

instrumentRoutine complete blood chemistry and urine

analysis Weekly telephone calls in the 1st monthBiweekly calls in the 2nd and 3rd monthsKupperman Index (KI)

Completed at baseline, 1, 2, and 3 monthsDaily hot flash recording- VAS scale

Kupperman Index

Hot flashes Weight change Insomnia Irritability Depression Low sex drive

Fatigue Muscle or joint pain Headache Heart palpitation Vaginal dryness Forgetfulness

Rating ScaleO = no symptoms1 = slight2 = moderate3 = severe

SF-36 Health SurveyAssessed at baseline and 3 monthsResponses were categorized in 8 domains

Physical functioning Role physical Bodily pain General health Vitality Social functioning Role emotionalMental health

StatisticsAnalyzed using

MeanStandard deviationPaired t-testWilcoxon signed rank test

Two-tailed testConfidence interval of 95%α of 0.05

Improvement of 40% in daily hot flashes

ResultsMean age of 54 + 6 years8 enrolled, 7 completed the trialNo blood abnormalitiesKI scores decrease was significant- 24.4%

Baseline: 30.3 + 7.5 3rd month: 22.9 + 8.4

Hot flashes decrease was significant- 41.9% Baseline: 68.1 + 14.3 3rd month: 39.6 + 9.7

Mean changes in 4 domains indicate improved health Physical function, role physical, general health, role

emotional

ConclusionAll indicators proved significant improvement

indicating reduced menopause-related symptoms

KI: 30.3 to 22.9 24.4%Hot Flashes: 68.1 to 39.6 41.9%More data is needed for efficacy, safety, toxicity,

and long-term consequences

LimitationsSmall sample sizeNo placebo groupCombination of botanicals- which one worked?Lack of measurement tool/scaleExclusion criteria

Any other Limitations?

Suggestions for the future…

Use a more objective scaleTrack hormone changesLarger study groupHave a placebo group

Any others?

QuestionsVictoria:

“The greatest limitation that I immediately thought of while reading the method is the measurement of hot flash severity, forgetfulness, and irritability…. Even irritability is relative to the person reporting. It may also be difficult for subjects to define their severity of forgetfulness. In trying to think of a different way to measure this however, nothing really comes to mind. Is there another possible method that could have been used?”

Sarah“My suggestion for future studies on the effects of

supplementation for menopause symptoms would be to measure the women's follicle-stimulating hormone(FSH), estrogen (estrodial), and thyroid-stimulating hormone (TSH) before, during, and after the treatment. I am aware that there are fluctuations to these hormones during menopause, however, I am only assuming that these suggested markers could also, accurately represent severity. Do you know if this is true?”

Karen“The researchers failed to provide any background

information on this specific formulation except that they had been used before in treating hormone irregularities. Did you investigate whether more recent research/studies were available?”

Kirstie“If further studies could look into the idea of this

study and produce similar results, combination botanical's could replace costly and potentially harmful hormone treatment therapies in treating menopausal symptoms.”

Any other comments?

References: Smolinski, Debi; Wollner, Debra; Orlowski, Jennifer; Curcio Jessica;

Nevels, Jennifer; Kim, Linda. “A pilot study to examine a combination botanical for the treatment of menopausal symptoms.” Journal of Alternative and Complementary Medicine. Vol 11, No 3. June 2005.

http://www.nia.nih.gov/health/publication/menopause. Accessed online March 17, 2013.

Low Dog, Tieraona. Menopause: A review of botanical dietary supplements. The American Journal of Medicine (2005) Vol 118 (12B), 98S–108S.

Doyle, Brian, Jonna Frasor, Lauren Bellows, Tracie Locklear, Alice Perez, Jorge Gomez-Laurito, Gai Mahady. Estrogenic effects of herbal medicines from Costa Rica used for the management of menopausal symptoms. Menopause. Issue 16, Volume 4. p 748-755. August 2009.