Randomized Trial of Black Cohosh for the Treatment of Hot Flashes Among Women With a History of Breast Cancer

2001 ◽  
Vol 19 (10) ◽  
pp. 2739-2745 ◽  
Author(s):  
Judith S. Jacobson ◽  
Andrea B. Troxel ◽  
Joel Evans ◽  
Lorissa Klaus ◽  
Linda Vahdat ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Breast Cancer Survivors ◽  
Herbal Remedy ◽  
Hot Flashes ◽  
Menopausal Symptoms ◽  
Black Cohosh ◽  
Final Visit ◽  
Blood Levels ◽  
Hot Flash

PURPOSE: Most breast cancer survivors experience hot flashes; many use complementary or alternative remedies for these symptoms. We undertook a randomized clinical trial of black cohosh, a widely used herbal remedy for menopausal symptoms, among breast cancer patients. PATIENTS AND METHODS: Patients diagnosed with breast cancer who had completed their primary treatment were randomly assigned to black cohosh or placebo, stratified on tamoxifen use. At enrollment, patients completed a questionnaire about demographic factors and menopausal symptoms. Before starting to take the pills and at 30 and 60 days, they completed a 4-day hot flash diary. At the final visit, they completed another menopausal symptom questionnaire. Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels were measured in a subset of patients at the first and final visits. RESULTS: Of 85 patients (59 on tamoxifen, 26 not on tamoxifen) enrolled in the study, 42 were assigned to treatment and 43 were assigned to placebo; 69 completed all three hot flash diaries. Both treatment and placebo groups reported declines in number and intensity of hot flashes; the differences between the groups were not statistically significant. Both groups also reported improvements in menopausal symptoms that were, for the most part, not significantly different. Changes in blood levels of FSH and LH also did not differ in the two groups. CONCLUSION: Black cohosh was not significantly more efficacious than placebo against most menopausal symptoms, including number and intensity of hot flashes. Our study illustrates the feasibility and value of standard clinical trial methodology in assessing the efficacy and safety of herbal agents.

Pilot evaluation of venlafaxine hydrochloride for the therapy of hot flashes in cancer survivors.

1998 ◽  
Vol 16 (7) ◽  
pp. 2377-2381 ◽  
Author(s):  
C L Loprinzi ◽  
T M Pisansky ◽  
R Fonseca ◽  
J A Sloan ◽  
K M Zahasky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Low Dose ◽  
Hot Flashes ◽  
Daily Diary ◽  
Clinical Problem ◽  
Baseline Period ◽  
Hot Flash ◽  
Venlafaxine Hydrochloride

PURPOSE Hot flashes can be a prominent clinical problem for breast cancer survivors and men who undergo androgen-deprivation therapy. Anecdotal information suggested a low dose of a relatively new antidepressant, venlafaxine, could abrogate this clinical problem. MATERIALS AND METHODS This study included 28 consecutive assessable patients entered onto a phase II clinical trial. Hot flash data were collected by daily diary questionnaires during a 1-week baseline period and then for 4 weeks, during which time patients received venlafaxine 12.5 mg orally twice daily. RESULTS Fifty-eight percent of patients who completed the study had a greater than 50% reduction in hot flash scores (frequency times severity) during the fourth treatment week as compared with the baseline week. Median weekly hot flash scores were reduced by 55% from baseline during the fourth week of venlafaxine therapy. Therapy was generally well tolerated and appeared to alleviate fatigue, sweating, and trouble sleeping. CONCLUSION Venlafoxine appears to represent an efficacious new method to alleviate hot flashes. Further evaluation of this compound for alleviating hot flashes is indicated.

Internet based double-blind cross-over clinical trial to test efficacy of high dose isoflavone soy in controlling breast cancer survivor hot flashes

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 636-636 ◽  
Author(s):  
W. C. Dooley ◽  
C. Hendricks ◽  
Y. Gusev ◽  
L. Shockney
Keyword(s):  
Breast Cancer ◽  
Cancer Survivor ◽  
Breast Cancer Survivor ◽  
Breast Cancer Survivors ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Time Of Day ◽  
High Dose ◽  
Double Blind ◽  
Hot Flash

636 Background: Severe hot flashes are common after completion of allopathic breast cancer treatment. Hot flashes are rare in the Orient where high isoflavone soy diets are common. Methods: We enrolled breast cancer survivors experiencing hot flashes after the completion of surgery, radiation and chemotherapy into a 16 week double blind cross-over casein placebo controlled trial of a 160 mg isoflavone soy dietary supplement. Hot flash frequency, severity, and time of day, exercise time and patient journaling was recorded by an internet diary placed on a HIPPA compliant server with password access. Results: Of 168 patients enrolled, 117 actually participated in taking supplementation and completing internet diaries giving adequate data for analysis. Of this group 13 patients dropped out of study for failure to finish all dietary supplements throughout the study period. The hot flash data during the last 4 weeks on each supplement was compared to determine benefit. There was no statistical difference in hot flash frequency, intensity or duration between either supplement independent of exercise level. Interestingly, 82% of patients reported a decrease in hot flashes in the first 4 weeks of study independent of which supplement they were randomized to receive. The journal entries report during this “induction” period that the majority of patients had identified emotional or dietary or other triggers for their hot flashes. The avoidance of the triggers seemed to substantially reduce their reported menopausal symptoms. Conclusions: High dose soy isoflavone dietary supplementation is ineffective in reducing breast cancer survivor hot flashes. Journaling may have a benefit in allowing survivors to find their individual triggers for the most severe hot flashes. Internet patient data entry provides a unique and highly compliant tool for obtaining direct patient reporting in survivorship clinical trials. [Table: see text]

Comparison of Menopausal Symptoms During the First Year of Adjuvant Therapy With Either Exemestane or Tamoxifen in Early Breast Cancer: Report of a Tamoxifen Exemestane Adjuvant Multicenter Trial Substudy

2007 ◽  
Vol 25 (30) ◽  
pp. 4765-4771 ◽  
Author(s):  
Stephen E. Jones ◽  
James Cantrell ◽  
Svetislava Vukelja ◽  
John Pippen ◽  
Joyce O'Shaughnessy ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vaginal Bleeding ◽  
Vaginal Discharge ◽  
Hot Flashes ◽  
Menopausal Symptoms ◽  
Low Energy ◽  
First Year ◽  
Hot Flash ◽  
Cancer Symptoms ◽  
Vaginal Dryness

Purpose Hormonal breast cancer treatment increases menopausal symptoms in women. This study investigated differences between the symptoms associated with either adjuvant tamoxifen or exemestane. Patients and Methods Ten common symptoms were assessed by self-report questionnaire administered to 1,614 consecutive patients at baseline and every 3 months during the first year of a double-blind, randomized trial of postmenopausal women with early hormone receptor–positive breast cancer. Symptoms were categorized as none, mild, moderate, or severe. A hot flash score was calculated at each time point. Symptoms were analyzed by repeated-measures analysis of variance. Each time period was tested repeatedly against the baseline; an overall P value was assigned for each reported symptom. Results Compliance was excellent, with 7,286 questionnaires analyzed. Baseline symptom prevalence ranged from 2% (vaginal bleeding) to 60% to 70% (bone/muscle aches and low energy). There were no significant differences in vaginal bleeding, mood alteration, or low energy. Patients receiving tamoxifen had significantly more vaginal discharge (P < .0001). Exemestane patients reported more bone/muscle aches (P < .0001), vaginal dryness (P = .0004), and difficulty sleeping (P = .03). In both groups, the hot flash score peaked at 3 months and decreased thereafter. At 12 months, patients receiving tamoxifen had a significantly higher mean hot flash score (P = .03), with daily hot flashes increasing from baseline by 33% compared with a 7% increase from baseline with exemestane. Conclusion At 12 months, exemestane was associated with fewer hot flashes and less vaginal discharge than tamoxifen, but with more vaginal dryness, bone/muscle aches, and difficulty sleeping. Symptoms were common in both groups.

Multicenter, Randomized, Cross-Over Clinical Trial of Venlafaxine Versus Gabapentin for the Management of Hot Flashes in Breast Cancer Survivors

2010 ◽  
Vol 28 (35) ◽  
pp. 5147-5152 ◽  
Author(s):  
Louise Bordeleau ◽  
Kathleen I. Pritchard ◽  
Charles L. Loprinzi ◽  
Marguerite Ennis ◽  
Olivera Jugovic ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Patient Preference ◽  
Breast Cancer Survivors ◽  
Negative Mood ◽  
Hot Flashes ◽  
Baseline Period ◽  
Open Label ◽  
Group Sequential ◽  
Hot Flash

Purpose Nonhormonal pharmacologic interventions are recommended for the treatment of hot flashes in breast cancer survivors. Antidepressants and gabapentin have been shown to be both effective and well tolerated; however, it is not clear which is preferred. Patients and Methods This was a group-sequential, open-label, randomized, cross-over trial of 4 weeks of venlafaxine (37.5 mg daily for 7 days followed by 75 mg daily for 21 days) versus gabapentin (300 mg once per day for 3 days, then 300 mg twice per day for 3 days, then 300 mg three times per day for 22 days), with patient preference as the primary outcome. Postmenopausal women with at least 14 bothersome hot flashes per week for the prior month were eligible. A 2-week baseline period and a 2-week tapering/washout time was used before the first and second treatment periods, respectively. Diaries were used to measure hot flashes and potential toxicities throughout the study. Participants completed a preference questionnaire at the end of the study. A predefined Pocock stopping rule was applied. Patient preference and hot flash and toxicity outcomes were compared between treatments. Results Sixty-six patients were randomly assigned, 56 of whom provided a preference (eight dropped out and two had no preference); 18 (32%) preferred gabapentin and 38 (68%) preferred venlafaxine (P = .01). Both agents reduced hot flash scores to a similar extent (66% reduction). Venlafaxine was associated with increased nausea, appetite loss, constipation, and reduced negative mood changes compared with gabapentin, whereas gabapentin was associated with increased dizziness and appetite compared with venlafaxine (all P < .05). Conclusion Breast cancer survivors prefer venlafaxine over gabapentin for treating hot flashes.

Prospective evaluation of vitamin E for hot flashes in breast cancer survivors.

1998 ◽  
Vol 16 (2) ◽  
pp. 495-500 ◽  
Author(s):  
D L Barton ◽  
C L Loprinzi ◽  
S K Quella ◽  
J A Sloan ◽  
M H Veeder ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vitamin E ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Hot Flashes ◽  
Clinical Problem ◽  
Baseline Period ◽  
Similar Reduction ◽  
Hot Flash ◽  
Crossover Analysis

PURPOSE Hot flashes represent a substantial clinical problem for some breast cancer survivors. Although estrogen or progesterone preparations can alleviate these symptoms in many patients, concern remains regarding the use of hormonal preparations in such women. Thus, there is a perceived need for nonhormonal treatments for hot flashes for breast cancer survivors. Based on anecdotal evidence that vitamin E was helpful, we designed a trial to investigate this matter. METHODS We developed and conducted a placebo-controlled, randomized, crossover trial where, after a 1 week baseline period, patients received 4 weeks of vitamin E 800 IU daily, then 4 weeks of an identical-appearing placebo, or vice versa. Diaries were used to measure potential toxicities and hot flashes during the baseline week and the two subsequent 4-week treatment periods. RESULTS The 120 patients evaluated for toxicity failed to show any. The 105 patients who finished the first treatment period showed a similar reduction in hot flash frequencies (25% v 22%; P = .90) for the two study arms. A crossover analysis, however, showed that vitamin E was associated with a minimal decrease in hot flashes (one less hot flash per day than was seen with a placebo) (P < or = .05). At the study end, patients did not prefer vitamin E over the placebo (32% v 29%, respectively). CONCLUSION Although this trial was able to show a statistically significant hot flash reduction with vitamin E compared to a placebo, the clinical magnitude of this reduction was marginal.

The assessment of randomized double blind clinical trial of Shugan-liangxue prescription used for the treatment of hot flashes in breast cancer patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8584-8584
Author(s):  
P. Li
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Placebo Group ◽  
Sleep Disturbance ◽  
Hot Flashes ◽  
Oral Solution ◽  
Double Blind ◽  
Hot Flash ◽  
Double Blind Clinical Trial ◽  
Significant Difference

8584 Background: Hot flashes are a common side effect for breast cancer (BC) pts with TAM treatment. Traditional Chinese medicine (TCM) is typically given to BC pts in China. This trial is to assess the effects of TCM for relieving hot flashes. TCM oral solution is prescribed for clearing heat and cooling blood. The compound was tested and contained no phytoestrogen. A randomized, double blind clinical trial was designed to examine the effects of TCM over a 3-week period. Methods: From October 2004 to October 2005, 49 BC pts undergoing treatment with TAM who having hot flashes at least 3 times a day involved the study. Daily average of hot flashes was recorded by the pts for a week as a baseline. TCM or placebo liquid (100 ml) was administered orally three times a day for 3 weeks by a randomized double-blind method. The number of hot flashes and quantity of sleep disturbance in the two groups were evaluated. Results: 45 pts were evaluated in TCM group (n = 22) and the placebo group (n = 23). The severity of the hot flash symptoms was evaluated according to the Kupperman menopausal index (KI). Pts were distributed approximately equally between the two groups. There were 31% (7/22) and 26% (6/23)pts with mild hot flashes in TCM and placebo groups, and 68% (15/22) and 73% (17/23) with severe hot flashes in TCM and placebo groups. Hot flash relief was described as either symptom disappearing, a decrease from severe to mild symptoms, or no change. In TCM group, 50% showed no change, 27% decrease and 23% symptoms disappearing. In the placebo group, 70% no change, 30% decrease and no pts reporting symptoms disappearing. A statistically significant difference exists between the two groups (P < 0.05). In TCM group, 73% of pts sleep improvement compared to 35% in the placebo group (P < 0.05). No adverse events or any side effects were reported. Conclusion: The oral solution of TCM is effective in alleviating tamoxifen-induced hot flashes and sleep disturbance. The study of the drug’s mechanism and an expanded clinical trial are underway. No significant financial relationships to disclose.

Levetiracetam for the treatment of hot flashes: A pilot study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9116-9116
Author(s):  
S. L. Thompson ◽  
A. Bardia ◽  
A. Tan ◽  
D. Barton ◽  
L. Kottschade ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Pilot Study ◽  
Breast Cancer Survivors ◽  
Hot Flashes ◽  
Estrogen Therapy ◽  
Active Agent ◽  
Study Drug ◽  
Hot Flash ◽  
Increased Risk

9116 Background: Hot flashes affect 75 % to 90 % of women transitioning to menopause and are a major cause of morbidity among breast cancer survivors. Levetiracetam, a popular anticonvulsant, is a centrally active agent that anecdotally appeared to reduce hot flashes in clinical practice. This phase II trial sought to evaluate the efficacy of levetiracetam in reducing hot flashes among women with a history of breast cancer or women who did not wish to take estrogen therapy for fear of an increased risk of breast cancer. Methods: Women who were experiencing bothersome hot flashes (≥ 14 times per week, for ≥ 1 month) were eligible. A single arm pilot study design based on previous work was used with a planned sample size of 30 patients. The patients did not receive any study medication during the first week (baseline week). At the beginning of the second week, patients were started on levetiracetam (500 mg), and were to increase the dose by 500 mg each week to a goal of 1,000 mg twice daily. Hot flash diaries were completed daily. The primary endpoint was hot flash score (frequency times average severity). The change from week 1 (baseline) to week 5, the last treatment week, was analyzed by paired t-test and related Wilcoxon procedures. Results: A total of 30 women were enrolled onto this study in eight months. All patients were eligible. 19 women completed all 4 weeks of the study treatment and provided complete data. After treatment with levetiracetam for 4 weeks, mean hot flash scores were reduced by 57% (95% CI 39%-75%), while mean hot flash frequencies were reduced by 53% (95% CI 38%-68%), reductions being greater than what would be expected with a placebo. There were significant improvements, compared to baseline week data, in sweating, hot flash distress, and satisfaction with hot flash control. Eight subjects stopped the study drug due to treatment related adverse events (grade I/II), with the most frequently reported being somnolence, fatigue and dizziness. Conclusions: While levetiracetam appears to be a promising therapy for the treatment of hot flashes, further study is needed to better substantiate the toxicity and efficacy of this drug before it can be more definitively recommended for use in clinical practice. No significant financial relationships to disclose.

scholarly journals Randomized Trial of a Hypnosis Intervention for Treatment of Hot Flashes Among Breast Cancer Survivors

2008 ◽  
Vol 26 (31) ◽  
pp. 5022-5026 ◽  
Author(s):  
Gary Elkins ◽  
Joel Marcus ◽  
Vered Stearns ◽  
Michelle Perfect ◽  
M. Hasan Rajab ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Hot Flashes ◽  
Female Breast Cancer ◽  
Daily Activities ◽  
Secondary Outcome ◽  
Control Group ◽  
Hot Flash ◽  
History Of

Purpose Hot flashes are a significant problem for many breast cancer survivors. Hot flashes can cause discomfort, disrupted sleep, anxiety, and decreased quality of life. A well-tolerated and effective mind-body treatment for hot flashes would be of great value. On the basis of previous case studies, this study was developed to evaluate the effect of a hypnosis intervention for hot flashes. Patients and Methods Sixty female breast cancer survivors with hot flashes were randomly assigned to receive hypnosis intervention (five weekly sessions) or no treatment. Eligible patients had to have a history of primary breast cancer without evidence of detectable disease and 14 or more weekly hot flashes for at least 1 month. The major outcome measure was a bivariate construct that represented hot flash frequency and hot flash score, which was analyzed by a classic sums and differences comparison. Secondary outcome measures were self-reports of interference of hot flashes on daily activities. Results Fifty-one randomly assigned women completed the study. By the end of the treatment period, hot flash scores (frequency × average severity) decreased 68% from baseline to end point in the hypnosis arm (P < .001). Significant improvements in self-reported anxiety, depression, interference of hot flashes on daily activities, and sleep were observed for patients who received the hypnosis intervention (P < .005) in comparison to the no treatment control group. Conclusion Hypnosis appears to reduce perceived hot flashes in breast cancer survivors and may have additional benefits such as reduced anxiety and depression, and improved sleep.

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