Rita Ismail, RN, MPH, MTD (HE) (PhD Student) Nancy Fugate Woods, PhD, RN, FAAN (Professor)

Herbal Therapies for Symptom Clusters during the Menopausal Transition and

Early Postmenopause: A Systematic Review

Rita Ismail, RN, MPH, MTD (HE) (PhD Student)Nancy Fugate Woods, PhD, RN, FAAN (Professor)

Ellen Mitchell, PhD (Associate Professor Emeritus) Janet Schnall, MS, AHI (Librarian)

2012 State of the Science Congress on Nursing ScienceSeptember 14th, 2012, Washington, DC

Background

• Women in Western countries have more experience menopausal symptoms particularly than in Asia

• Complementary and Alternative Medicine (CAM) is an alternative solution due to the negative effects of hormonal therapy

• Numerous studies about the effects of herbal therapies on hot flashes and other symptoms have been conducted with inconsistent results

• To date no published systematic reviews of effects of herbal therapies on multiple symptoms

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Purpose

To determine the effects of herbal preparations on hot flashes and at least one of other symptoms including sleep, cognitive function, mood, and pain symptoms that women experience during the menopausal transition and early postmenopause.

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Description of the Studies

• 18 studies eligible for review :

- 7 black cohosh

- 2 black cohosh mixed with other herbs

- 9 other herbals (Pueraria mirifica, Rheum rhaponticum,

herbal medicine, French maritime pine bark, Diascorea

alata, and femal)

• Study population : Community-based and clinics• Number of participants: 34 – 309 (46.7 – 59.3 years old)• Research designs: RCT, 12 weeks – 12 months• Conducted in 13 countries

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Measurement

• Measurement of Hot Flash- The Greene Climacteric Scale - The Kupperman Menopause Index (KMI)- The Menopause Rating Scale I- Diaries

• Measurement of Other Outcomes- The Menopause Rating Scale - The Women’s Health Questionnaire- The Hamilton Anxiety Rating Scale - The Women’s Health Questionnaire- The Beck Anxiety Inventory - The Symptom Rating Test

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Results….Black Cohosh

Study Intervention

Hot Flashes Sleep Cog Mood Pain

B W B W B W B W B W

Amsterdam, 2009

64 mg NS NR NM NM NR NR NS NR NR NR

Geller, 2009

28 mg NS NS NR NR NR NS NR NS NR

Maki, 2009,

128 mg NS +/NS NM NM NS NR NM NM NM NM

Bai, 2007,

40 mg NS + NS + NM NM NS + NS +Wuttke, 2006

40 mg + + + NR NR NR + + NR NR

Nappi, 2005

40 mg NS + NM NM NM NM NM + NM NM

Osmers, 2005,

40 mg + NR NR NR NR NR NR NR NS NR

+: Significant, NS: Not Sig, NR: Not Reported, NM: Not Measured, : p-value not provided


Study Intervention


B W B W B W B W B W

Amsterdam, 2009


Geller, 2009


Maki, 2009,


Bai, 2007,



Nappi, 2005


Osmers, 2005,




Study Intervention


B W B W B W B W B W

Amsterdam, 2009


Geller, 2009


Maki, 2009,


Bai, 2007,



Nappi, 2005


Osmers, 2005,



Results…Black Cohosh Mixed with Other Herbs

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Study InterventionHot Flashes Sleep Cognitive Mood Pain

B W B W B W B W B W

Rotem, 2007

Oral Phyto-Female

+ + + + NM NM NM NM NM NM

Uebelhack, 2006

Black cohosh and St.John’s wort

+ + NR NR NR NR + + NR NR


Results…Other Herbs

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B W B W B W B W B W

Hsu, CC, 2011

Diacorea alata NS + + + NR NR + + NR +Van Die, 2009

H. perforatum L plus V. agnus-castus L

NS + NS + NR NR NS + NR NR

Kaszkin-Bettag, 2009

Rheum rhaponticum dry extract + + + NR NR + +

Heger, 2006 Rheum rhaponticum + + + + NR NR + + + +Yang, 2007 French maritime pine

bark extract + + + + + + + + NR NR

Green, 2007 Consultations & herbal medicines + + NM NM NR NR + NR NR

Chandeying, V 2007

Pueraria mirifica 50 mg

NS NS NR NR NS NS

Lamlertkittikul, S, 2004

50 and 100 mg Puerari mirifica

NM NS/NS NM NM NR NR NM +/+ NM -/ +Winther et al 2005 Femal + + NS NR NR NR NS + NS +


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B W B W B W B W B W

Hsu, CC, 2011









Chandeying, V 2007


NS NS NR NR NS NS





12


B W B W B W B W B W

Hsu, CC, 2011









Chandeying, V 2007


NS NS NR NR NS NS





13


B W B W B W B W B W

Hsu, CC, 2011









Chandeying, V 2007


NS NS NR NR NS NS





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B W B W B W B W B W

Hsu, CC, 2011









Chandeying, V 2007


NS NS NR NR NS NS




Summary

Outcomes B Group W Group

1. Hot Flash 52%(7/17)

93%(13/14)

2. Sleep 55%(6/11)

100%(6/6)

3. Mood 54%(7/13)

100%(9/9)

4. Cognitive 50%(1/2)

100%(1/1)

5. Pain 29%(2/7)

100%(5/5)

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Conclusion

• Herbal therapies may offer promise in management of multiple symptoms, particularly black cohosh mixed with Phyto-female complex or St. John wort; Rheum rhaponticum; and French maritime pine bark

• Mostly herbal therapies showed significant effects on sleep and mood symptoms, especially black cohosh, mixed black cohosh, Rheum rhaponticum, and French maritime pine bark

• Black cohosh alone showed less significant results on hot flashes and other symptoms

• Dose? Duration of study? Number of participants?

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Limitation & Future Studies

• Limitation

- Variety of dose, duration, measurement- Small number of studies and participants- Unreported symptoms especially cognitive symptoms

• Future Studies - More studies with adequate sample size and longer

duration of treatment - Using standardized instruments and provide specific

information for each symptom

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Acknowledgments

• Data were collected with support from grants from the National Institute for Nursing Research, NIH, NR01 04141 and NINR, NIH, P50-NR-02323, P30-NR04001

• The Nursing Scholarship Fund, School of Nursing, University of Washington

• Donna M. Fraser Endowed Scholarship Fund

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Thank You

Rita Ismail, RN, MPH, MTD (HE) (PhD Student) Nancy Fugate Woods, PhD, RN, FAAN (Professor)

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