Nonhormonal and Alternative Treatments

Since publication of the WHI study, there has been an increase in the use of alternative and nonhormonal therapies for the management of menopausal symptoms. Particularly for women with CHD and/or breast cancer risk factors, these therapies may offer another option to assist with symptom management. A wide range of therapies, both prescription and herbal, have been studied with varying degrees of success. In choosing a particular therapy, it is important to match patient symptoms with a therapy that is not only effective but also safe.

A variety of nonhormonal and alternative therapies (Table 50-3) have been studied for symptomatic management of vasomotor symptoms, including antidepressants (e.g., selective serotonin reuptake inhibitors [SSRIs] and venlafaxine), herbal products (e.g., soy/isoflavones, black cohosh, evening primrose oil and dong quai),

37 38

and a group of miscellaneous agents (e.g., gabapentin, clonidine). ' The limited and often conflicting evidence demonstrates that these agents are only modestly effective. It is also widely assumed that these agents are safer than HT, when in reality, few have been evaluated in randomized trials.

SSRIs and venlafaxine are theorized to reduce the frequency of hot flashes by increasing serotonin in the central nervous system and by decreasing LH. Of the SSRIs, fluoxetine, citalopram, paroxetine, and sertraline have been studied and demonstrated a reduction in hot flashes while treating other symptomatic complaints such as de-37

pression and anxiety. It is important to note that many of these trials were conducted in women with breast cancer who were also on antiestrogen therapy. Overall, these antidepressant medications offer a reasonable option for women who are unwilling or cannot take hormonal therapies, particularly those who suffer from depression or anxiety.

Alternative therapies used for the relief of menopausal symptoms are purported to act by a number of different mechanisms. Phytoestrogens are plant sterols that are structurally similar to human and animal estrogen. Soy protein is a common source of phytoestrogens.37-39 There has been conflicting results as to the efficacy of phytoestrogens in treating hot flashes and if used, at least 45 to 60 g/day of isoflavone content is necessary for any possible benefit. Because the effect of isoflavones on breast cancer and other female-related cancers, bone mass, and vaginal dryness is unknown, phytoestrogens should not be considered in women with a history of estrogen-dependent cancers.41

Black cohosh has been one of the most studied alternative therapies for vasomotor symptoms, but it has not demonstrated a substantial benefit over placebo. The mechanism of action, safety profile, drug-drug interactions, and adverse effects of black cohosh remain unknown. In non-placebo-controlled trials conducted for 6 months or less, black cohosh (40-80 mg/day) demonstrated a small, nonstatistically significant

37 38 40

reduction in vasomotor symptoms. ' ' In addition, there have been case reports of

hepatotoxicity with the use of black cohosh. Caution should be exercised when considering the use of this product, especially in patients with liver dysfunction. There is insufficient evidence to determine the effectiveness of black cohosh and due to safety concerns, it should not be recommended at this time.41,43

Dong quai, evening primrose oil and several other alternative therapies, including passion flower, sage, valerian root, flaxseed, and wild yam, have not demonstrated efficacy with regard to the relief of vasomotor symptoms, and the safety of these products is also questionable.37,38,40 Therefore, these products should not be recommended for the relief of vasomotor symptoms in postmenopausal women.

There are a number of other prescription products that have been studied for the management of menopausal symptoms. Gabapentin is thought to exert its effect by affecting the thermoregulatory process of the pituitary-hypothalamic region through modulation of calcium currents that, in turn, affect adrenergic and serotonergic pathways. In RCTs, gabapentin at doses of 900 mg/day demonstrated significant reductions in severity and frequency of hot flashes compared to placebo. Clonidine is thought to work by reducing small-vessel response, both centrally and peripherally, to various stimuli. It has been studied in several small RCTs at doses of 0.1 to 0.4 mg/day and has demonstrated statistically significant reductions in hot flashes.40 This agent may be considered in women with a history of hypertension, but the adverse effects may outweigh the benefits.

Table 50-3 Nonhormonal Therapies for Menopause

Agent

DtHHiumteJ Efficaty tuning

Adverse Effwtl/hwjutlow

CHakiptam Fluoxetine

SatilM Vlenliisxin^ Soy protein

Bbck whosti

Giaperrtin

Cltink1in#

Dong quai

Non<andom.'«J 1rial demonstrated effk«y ifi hot 1EiiJs iffTu^tiOrt One RCT demonstrated significant "eduction in hot ¡lashes; one RCT found dmq iva bfflW thanplicito Wit} RCR dwnrtit iis) liynriiidnt wltiftioniii sfvd sievffityof hot flwlies tSppnerimfltfif Jim) Caseieflei demonstrating efficacy in hot flas-ti neduciion

Iwofe f( nfpcwfl sh(*T-ii?rm signrfkrant (eductions in and ievei-ty ol hoi flash« tghteert smalt fiCTi demonstrate conflk1-ng evidence; systematic revews dtmonMrrtle tip tiinicsl supc« i|y pfecebo

Srtltfl ikKl-ttrm FttTi deiHi*T5|ril«J Iwnefn m mild-moderate hot llajheSi tipeuolly when oisot Jbwl will sleep and mood disiurbanett four RtTs oonduded llhai drug was signriicantly ntote eHetliwe than placebo

■it 11 ■: 11ji iex; 11 ii 111> ■■ :m- i.. v * I L,i ■■.'I ly i hot flashes (approximately Including thoM." tfcvnl carccr I kwen midiei, sewn of wihch doiuriilrjlcid significant rvdutlknifs in fr«n>ificy if«! se--efi(y<)f hot fillies Uti demonstrated elficacy in one ACT

l-venlng pi imrcKe oil, pawlon Ho demonsKated efficacy fnr any product flowfts, sago, valerian tool, in RC Tv wild yam nig daily JO ring dai|y

10-30 mg CUily

IS-SO mg daily

NY) twice in'aily ■IS ill mg isoflavones daily vjrieii dsiini)

herbal product uombiruliun inoit iludied-

fiemlnfemin ^fl-SO ring Iwicv daily

900 ring tfaily

HI-0.4 mg dai|y Hoi ieccanrtiended

Nol recommended

Natrtea, diz?lrness, somnolence

Nausea insomnia. neiviausnessv tantgue

Hcudxi*:, njujitii. imiumnii

Nausea, diiiHttii, sonmolenoe

Njuwadry nvxirh

¿1 upset other ad-.^rsioitats unknown; do not use in those ™(hhiHcry Dior hirjh 115kof eHmogen-dependent cancer Gi upser Cisfce-^itti fcodit potential he|i>i™s<;it\; rn>t reeoirmendid to be ukLn o^er a fi-month peiicd of tkne

DCuneii and somnofence

[>y mouth, blood pipwurf1 loweiing: monilor blood pnsiuie 5tructt*ally similar 10 owmr inn-^avotd with warfarin because INR can increase Caution vrnih all plant products in women wMi luy revet jnd plane allirjjiiii ftfX randmriJKl mnrmllfld mal.

fr(irtl fcfii,

Overall, alternative and nonhormonal therapies are less effective in treating vasomotor symptoms than HT but do offer another option for women experiencing meno-pausal symptoms who cannot or are unwilling to take HT. SSRIs and clonidine have the best evidence for efficacy, however, health care providers should weigh the benefits and risks of all therapies, and women should be advised to discuss their options with physicians and pharmacists.

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