Measurement of hot flashes by sternal skin conductance and subjective hot flash report in Puebla, Mexico

Abstract Study Objectives For most women, the menopause is accompanied by hot flashes and sleep problems. Although hot flashes reportedly wake women from sleep, in the few studies that have used objective measures of both sleep and hot flashes, links between hot flashes and nocturnal awakening have been inconsistent. In a well-characterized cohort of midlife women, we examined the association between objectively assessed hot flashes and actigraphically defined wake from sleep. We hypothesized that wake episodes would be more likely during an objective hot flash relative to minutes without a hot flash. Methods Peri- and postmenopausal midlife women underwent simultaneous objective measurement of hot flashes (sternal skin conductance) and sleep (actigraphy) over 24 hours in the home. The likelihood of waking in the minutes during the hot flash relative to the minutes preceding the hot flash was compared using generalized estimating equations. Results We studied 168 women with at least one objective nocturnal hot flash and actigraphy data. Actigraphy-assessed wake episodes were concurrent with 78% of the objective hot flashes. We found an increased likelihood of wake in the minutes during the objective hot flash (0 to +5 min: OR [95% CI] = 5.31 (4.46 to 6.33); p < .0001) relative to the minutes preceding it (–10 to –1 min). The increased likelihood of wake occurred irrespective of whether the women reported the objective hot flash. Conclusion Among these women who underwent objective measurement of sleep and hot flashes, nocturnal wakefulness was observed with the majority of hot flashes.

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Hot Flashes and Cardiovascular Disease Risk Indices Among Women With HIV

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab011 ◽

2021 ◽

Vol 8 (2) ◽

Author(s):

Mabel Toribio ◽

Evelynne S Fulda ◽

Sarah M Chu ◽

Zsofia D Drobni ◽

Magid Awadalla ◽

...

Keyword(s):

Cardiovascular Disease ◽

General Population ◽

Disease Risk ◽

Cardiovascular Disease Risk ◽

Hot Flashes ◽

Cvd Risk ◽

Hot Flash ◽

Risk Indices ◽

Women With Hiv

Abstract Women with HIV (WWH) transitioning through menopause have heightened cardiovascular disease (CVD) risk. In the general population, hot flash burden relates to CVD risk indices. We found higher hot flash burden among women with vs without HIV. Further, among WWH, hot flash burden related to select CVD risk indices. ClinicalTrials.gov Registration NCT02874703.

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0482 A Preliminary Study on the Efficacy of Forehead-Cooling for Relieving Menopausal Sleep Difficulties and Hot Flashes

SLEEP ◽

10.1093/sleep/zsaa056.479 ◽

2020 ◽

Vol 43 (Supplement_1) ◽

pp. A185-A185

Author(s):

F C Baker ◽

M de Zambotti ◽

L Chiappetta ◽

E Nofzinger

Keyword(s):

Sleep Quality ◽

Hot Flashes ◽

Severity Index ◽

Cooling Device ◽

Hot Flash ◽

Subjective Sleep ◽

Preliminary Study ◽

Insomnia Symptoms ◽

Sleep Difficulties ◽

Insomnia Severity

Abstract Introduction Many women experience sleep difficulties in the approach to menopause and post-menopause, with about 25% experiencing severe symptoms that impact daytime functioning and quality of life. Hot flashes contribute to these sleep difficulties, being associated with nocturnal awakenings, poorer sleep quality, and chronic insomnia. New non-pharmacological sleep solutions have become available, including a forehead cooling device designed to target elevated brain metabolism in insomnia sufferers. Here, we explored whether this device was effective in improving subjective sleep and hot flashes in menopausal-age women with insomnia symptoms. Methods This study was an open-label, in-home investigation of the efficacy of nightly treatment with a forehead cooling device in 20 women (55.1 ± 4.2 years) with insomnia symptoms and daily hot flashes. Participants completed daily diaries assessing sleep quality and hot flashes across a baseline week (no treatment) followed by 4 weeks of treatment. They also completed questionnaires before and after treatment including the insomnia severity index and the hot flash related daily interference scale. Results Women reported better sleep quality with a shorter sleep onset latency and fewer awakenings (between 14-30% improvement) during the first week of device use, with further improvements over time, relative to baseline (p <0.001). Women also reported fewer nocturnal hot flashes that were less severe during treatment (p<0.001). They had lower insomnia severity scores post-treatment (9.3±5.8) compared to pre-treatment (20.0±5.7) (p<0.001), with 17 participants showing a reduction of 6 points or greater on the insomnia severity index. There was also a significant reduction in hot flash related daily interference post-treatment (p<0.001). Conclusion Use of a forehead cooling device during the night improved subjective sleep quality and reduced insomnia symptoms and hot flash frequency and severity in this preliminary study of menopausal-age women. Further large scale randomized controlled trials are required to determine efficacy. Support Ebb Therapeutics

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Transdermal clonidine for ameliorating tamoxifen-induced hot flashes.

Journal of Clinical Oncology ◽

10.1200/jco.1994.12.1.155 ◽

1994 ◽

Vol 12 (1) ◽

pp. 155-158 ◽

Cited By ~ 212

Author(s):

R M Goldberg ◽

C L Loprinzi ◽

J R O'Fallon ◽

M H Veeder ◽

A W Miser ◽

...

Keyword(s):

Breast Cancer ◽

Prospective Study ◽

Hot Flashes ◽

Estrogen Therapy ◽

Crossover Design ◽

Double Blind ◽

Hot Flash ◽

Mouth Dryness ◽

History Of ◽

Protocol Study

PURPOSE To determine the efficacy of transdermal clonidine for alleviating tamoxifen-induced hot flashes in women with a history of breast cancer. PATIENTS AND METHODS A randomized, double-blind, crossover design was used in this prospective study. Women with a history of breast cancer who were receiving tamoxifen and suffering from hot flashes were potentially eligible for this protocol study. RESULTS Clonidine did reduce hot-flash frequency to a degree that was statistically impressive (P < .0001), but clinically moderate (20% reduction from baseline). It also decreased hot-flash severity (P = .02, 10% reduction from baseline). Clonidine was related to increased mouth dryness (P < .001), constipation (P < .02), itchiness under the patch (P < .01), and drowsiness (P < .05). CONCLUSION Better means are needed to alleviate hot flashes among patients in whom estrogen therapy is contraindicated.

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Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial of Black Cohosh in the Management of Hot Flashes: NCCTG Trial N01CC1

Journal of Clinical Oncology ◽

10.1200/jco.2005.05.4296 ◽

2006 ◽

Vol 24 (18) ◽

pp. 2836-2841 ◽

Cited By ~ 116

Author(s):

Barbara A. Pockaj ◽

James G. Gallagher ◽

Charles L. Loprinzi ◽

Philip J. Stella ◽

Debra L. Barton ◽

...

Keyword(s):

Crossover Trial ◽

Hot Flashes ◽

Black Cohosh ◽

Phase Iii ◽

Patient Treatment ◽

Treatment Preferences ◽

Cimicifuga Racemosa ◽

Double Blind ◽

Hot Flash ◽

Time Period

Purpose Hot flashes can cause significant morbidity in postmenopausal women undergoing or finished with breast cancer treatment. Black cohosh has been used to treat hot flashes, but definitive clinical data about efficacy have been equivocal. Methods A double-blind, randomized, cross-over clinical trial with two 4-week periods, was used to study the efficacy of black cohosh (1 capsule, Cimicifuga racemosa 20 mg BID) for the treatment of hot flashes in women. Participants kept a daily hot flash diary during a baseline week and then during two 4-week crossover treatment periods. Hot flash scores were measured by assigning points (1 to 4 for mild to very severe) to each hot flash based on severity and then adding the points for a given time period. Results Between October 31, 2003, to March 4, 2004, 132 patients were randomly assigned. Toxicity was minimal and not different by treatment group. Patients receiving black cohosh reported a mean decrease in hot flash score of 20% (comparing the fourth treatment week to the baseline week) compared with a 27% decrease for patients on placebo (P = .53). Mean hot flash frequency was reduced 17% on black cohosh and 26% on placebo (P = .36). Patient treatment preferences were measured after completion of both treatment periods by ascertaining which treatment period, if any, the patient preferred. Thirty-four percent of patients preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment. Conclusion This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.

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A double-blind, randomized cross-over trial of venlafaxine versus clonidine to treat hot flashes in breast cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.9083 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 9083-9083

Author(s):

C. Mom ◽

C. Buijs ◽

P. H. Willemse ◽

H. Boezen ◽

J. Maurer ◽

...

Keyword(s):

Breast Cancer ◽

Side Effects ◽

Cancer Patients ◽

Hot Flashes ◽

Breast Cancer Patients ◽

Double Blind ◽

Hot Flash ◽

History Of ◽

Loss Of Appetite ◽

To Receive

9083 Background: Breast cancer patients who become postmenopausal due to their treatment can experience more frequent and severe hot flashes than healthy postmenopausal women. Estrogens are considered to be contra-indicated. Venlafaxine and clonidine are both used to alleviate hot flashes, with different side effects. This study compared side effects, efficacy and patient preference. Methods: In a double-blind, cross-over study women <60 years, with a history of breast cancer, and experiencing at least 14 hot flashes/week were randomized to receive venlafaxine 75 mg od (and placebo bid) for 8 weeks, followed by a 2 week wash-out period, and 8 weeks of clonidine 0.025 mg bid (and placebo od) or vice versa. Hot flash frequency and hot flash score (frequency × severity) were recorded in a diary and side effects were scored using a questionnaire during the 2nd and 8th week of both treatment periods, and these were compared to a baseline week. Results: Sixty patients were randomized to start with venlafaxine (n=30) and clonidine (n=30), 40 completed both treatment periods. Premature treatment discontinuation occurred in 15/59 patients during venlafaxine and in 5/53 during clonidine due to side effects (p<0.05). The main side effects of venlafaxine were nausea and headache, and of clonidine dry mouth. In the 8th week of treatment women reported more loss of appetite (24% vs 4%; p=0.03) and improved sleeping (55% vs 75%; p=0.03) with venlafaxine. A =50% reduction in hot flash score was found in 21 (49%) and 26 (55%) of the patients with venlafaxine and clonidine respectively (ns). The decrease in hot flash score was most marked in the first treatment period. At study completion 20 (33%) of the patients chose to continue clonidine, and 17 (29%) preferred venlafaxine (ns), whereas 23 (38%) declined further treatment. Conclusions: Venlafaxine and clonidine are both moderately and equally effective in the reduction of hot flashes. Side effects are the main reason for discontinuation, occurring more often during treatment with venlafaxine. No significant financial relationships to disclose.

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Gabapentin for hot flashes in men: NCCTG trial N00CB

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.9005 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 9005-9005 ◽

Cited By ~ 2

Author(s):

C. L. Loprinzi ◽

B. S. Khoyratty ◽

A. Dueck ◽

D. L. Barton ◽

S. Jafar ◽

...

Keyword(s):

Prostate Cancer ◽

Androgen Deprivation Therapy ◽

Hot Flashes ◽

Baseline Period ◽

Androgen Deprivation ◽

Hot Flash ◽

Treatment Termination ◽

Patient Reported ◽

Double Blinded ◽

To Receive

9005 Background: Hot flashes can be a major problem in men with prostate cancer; effective non-hormonal options are needed. Methods: A four-arm, double-blinded, placebo-controlled randomized trial was developed to evaluate gabapentin for hot flashes. Men with bothersome hot flashes (at least 14/week) related to androgen deprivation therapy were randomized to receive either a placebo or gabapentin doses of 300 mg qd, 300 mg bid or 300 mg tid; men were treated for 4 weeks. Hot flashes numbers and scores (hot flash number times mean severity) were measured using a validated daily hot flashes diary. A one-week baseline period preceded initiation of study tablets. The primary endpoint was the average intrapatient difference in hot flash score between baseline and treatment termination. With the planned sample size of 50 evaluable patients per arm, the study provided 80% power to detect a difference in change from baseline at 4 weeks between each gabapentin arm and the placebo arm of 1.3 hot flashes per day or 3.3 points in hot flash score. Results: 223 patients were randomized between 12/21/2001 and 11/10/2006. The study arms were well balanced. The following table illustrates the percentage of baseline hot flash scores and frequencies during the fourth treatment week, compared to the baseline week for 179 eligible patients, utilizing the data available at time of this abstract preparation. Patients receiving 900 mg/d dose of gabapentin also reported significantly less hot flash distress and more hot flash control satisfaction than did the placebo group. The gabapentin was remarkably well tolerated, without any statistically significantly worse patient-reported side effects on the gabapentin arms. Conclusion: Gabapentin at the 900 mg/d dose can reduce hot flashes, in men receiving androgen deprivation therapy for prostate cancer. No significant financial relationships to disclose. [Table: see text]

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Hot flash placebo responses: Related to baseline hot flash frequency?

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.9628 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 9628-9628

Author(s):

J. M. Jones ◽

C. L. Loprinzi ◽

R. Qin ◽

D. L. Barton

Keyword(s):

Significant Positive Correlation ◽

Hot Flashes ◽

Placebo Response ◽

Correlation Coefficients ◽

Baseline Period ◽

Percent Reduction ◽

Hot Flash ◽

Positive Correlation ◽

Pubmed Search ◽

Multiple Treatments

9628 Background: As multiple treatments have been studied for the management of hot flashes in randomized, controlled trials, hot flash placebo responses have been quite variable across trials. Based on observations of trial reports, it was hypothesized that the magnitude of placebo effect might correlate with the number of baseline hot flashes in different studies. The current project examines the effect of the baseline hot flash frequency required for study participation and also the actual number of baseline hot flashes observed as these individually relate to the eventual reductions of hot flash frequency observed in patients receiving placebos. Methods: Data were collected from placebo-controlled, double-blinded, randomized trials, identified by a PubMed search, which reported hot flash frequency at baseline, 4–6 weeks and 12 weeks. Trials were excluded if they had less than 20 participants completing the placebo arm. Data gathered, in each study, included the number of hot flashes required to enroll in the study, the average hot flash number during the baseline period, and the hot flash changes in the placebo arms of each study (percent reduction from the baseline period). A simple statistical analysis was conducted in a descriptive fashion since standard deviation was not available in many trials. Scatter plots and Pearson's correlation coefficients demonstrated the relationships between the placebo hot flash percent reduction from baseline and both the minimum required number of hot flashes at baseline, and the mean number of hot flashes at baseline. Results: 45 trials with 49 placebo arms were included in this analysis. A significant positive correlation was seen between the number of hot flashes required to enroll in a study and the percent reduction of hot flashes from baseline at 4–6 weeks (Rho = 0.481, p = 0.003). There was also a significant positive correlation between the number of hot flashes at baseline and the percent reduction of hot flashes from baseline at 4–6 weeks (Rho = 0.481, p= 0.002) and at 12 weeks (Rho = 0.573, p= 0.003). Conclusions: These data support that higher baseline hot flash enrollment requirements and also higher baseline hot flash frequencies are associated with an increased placebo response. No significant financial relationships to disclose.

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The evaluation of flaxseed for hot flashes: Results of a randomized, controlled trial, NCCTG study N08C7.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.18_suppl.cra9015 ◽

2011 ◽

Vol 29 (18_suppl) ◽

pp. CRA9015-CRA9015 ◽

Cited By ~ 1

Author(s):

S. Pruthi ◽

R. Qin ◽

S. A. Terstriep ◽

H. Liu ◽

C. L. Loprinzi ◽

...

Keyword(s):

Placebo Group ◽

Side Effects ◽

Controlled Trial ◽

Hot Flashes ◽

Group Versus ◽

Abdominal Distension ◽

Self Report ◽

Phase Iii ◽

Common Symptom ◽

Hot Flash

CRA9015 Background: Hot flashes are a common symptom during the menopause transition or following breast cancer treatment that can negatively impact the quality of life for many women. Preliminary data have suggested that flaxseed, a rich source of dietary lignans, may be a potentially effective treatment for hot flashes. Methods: A phase III randomized, placebo controlled trial was conducted to evaluate the efficacy of flaxseed in reducing hot flashes. Postmenopausal women were randomly assigned to a flaxseed bar (providing 410 mg of lignans) for 6 weeks vs a placebo bar. Participants completed daily prospective, self report hot flash diaries during the baseline week and then began eating one study bar per day for 6 weeks, while continuing to record their daily hot flashes. The intra-patient difference in hot flash activity between baseline and the last treatment week was the primary endpoint. Side effects of the bars were evaluated through self report and CTC assessment. Results: Between October and December 2009, 188 women were enrolled onto this trial. Mean hot flash scores were reduced by 4.9 units in the flaxseed group and 3.5 in the placebo group (p=0.29). In both groups, a little over a third of the women received a 50% reduction in their hot flash scores. Only one side effect was significantly different between groups, that being grade 1 pruritis, which was more common (7%) in the placebo group versus 1% in the flaxseed group. Both groups reported increased abdominal distension, flatulence, diarrhea and nausea. Adherence and ability to detect treatment assignment did not differ between groups. Conclusions: The results of this trial do not support the use of 410 mg of flaxseed lignans for the reduction of hot flashes. The gastrointestinal side effects seen in both groups were likely due to the fiber content in the flaxseed and placebo bars.

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Thermoregulatory physiology of menopausal hot flashes: a review

Canadian Journal of Physiology and Pharmacology ◽

10.1139/y87-208 ◽

1987 ◽

Vol 65 (6) ◽

pp. 1312-1324 ◽

Cited By ~ 78

Author(s):

Fredi Kronenberg ◽

John A. Downey

Keyword(s):

Current Knowledge ◽

Hot Flashes ◽

Underlying Mechanism ◽

Peripheral Circulation ◽

The Body ◽

Primate Model ◽

Hot Flash ◽

Significant Research ◽

Endogenous Rhythmicity ◽

Thermoregulatory Function

Hot flashes during the climacteric years have long been a frequent clinical complaint, generally considered within the realm of the internist, gynecologist, or endocrinologist. Yet the underlying mechanism of hot flashes remains unknown. Only within the past 10 years has there been significant research on hot flashes as a disturbance of thermoregulation. This paper focuses on thermoregulatory aspects of hot flashes, reviewing current knowledge of the thermoregulatory physiology and endocrinology of hot flashes and discussing future avenues for research. Hot flashes are compared with fever in terms of thermoregulatory changes and speculated mechanisms. Although several substances in the peripheral circulation are found in increased concentrations during hot flashes, none is a trigger for a hot flash. The pattern of hot flash occurrence is striking in its regularity, and the possibility of endogenous rhythmicity is discussed. Recently, investigators have begun to explore a primate model of menopausal hot flashes. These studies are summarized. Finally, the multiple effects of estrogen on various systems of the body and their interrelationships are discussed. An understanding of the mechanism of hot flashes would not only be of importance to women suffering with hot flashes but would further our knowledge of thermoregulatory function and the interactions between thermoregulatory and reproductive systems.

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