TY - JOUR
T1 - A critical appraisal of vasomotor symptom assessment tools used in clinical trials evaluating hormone therapy compared to placebo
AU - Christakis, Marie K.
AU - Strobino, Donna M.
AU - Shen, Wen
N1 - Funding Information:
Received April 11, 2019; revised and accepted May 28, 2019. From the 1Department of Obstetrics and Gynaecology, St. Michael’s Hospital, Toronto, Canada; 2Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; 3University of Toronto, Toronto, Canada; 4The Johns Hopkins University School of Medicine, Baltimore, Maryland; and 5Johns Hopkins School of Nursing, Baltimore, Maryland. This work was previously presented as an oral abstract entitled ‘‘A critical appraisal of vasomotor symptom assessment tools used in clinical trials evaluating estrogen therapy compared to placebo’’ at The North American Menopause Society Annual Meeting in San Diego, USA, October 2018. Funding/support: None reported. Financial disclosure/conflicts of interest: Dr Shen has received a CDC grant ‘‘Increase awareness and support among women diagnosed with breast cancer’’; FOA DP14-1408; CDC/ONDIEH/NCCDPHP. Dr Shen also has received grant funding from Pfizer. The other authors have nothing to disclose. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Website (www.menopause.org). Address correspondence to: Marie K. Christakis, MD, FRCSC, NCMP, MPH, Department of Obstetrics & Gynaecology, St. Michael’s Hospital, 61 Queen St East – 5th Floor, Toronto, M5C 2T2 Ontario, Canada. E-mail: christakism@smh.ca
Publisher Copyright:
© 2019 by The North American Menopause Society.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - Objective:Vasomotor symptoms (VMS) have been consistently reported as the leading predictor of health-related quality of life (HRQOL) among menopausal women, and the strongest indication for treatment. The North American Menopause Society endorses the use of oral estrogen for the treatment of VMS based on a Cochrane meta-analysis. The Cochrane review concludes that oral hormone therapy reduces the frequency and severity of VMS. The objective of this review is to critically appraise the outcome measures used in these clinical trials to evaluate whether there is adequate evidence that oral hormone therapy improves HRQOL.Methods:Each trial in the 2004 Cochrane review of oral hormone therapy for the management of VMS was evaluated with respect to study design, outcome measures, and method of analysis.Results:Twenty-four randomized, double-blind, placebo-controlled clinical trials were appraised. Six trials were excluded from the Cochrane meta-analysis due to inadequate reporting of outcome measures. Of the remaining trials, 15 trials assessed only symptom frequency and/or severity. One trial used a subscale of the General Health Questionnaire. Two trials used the Greene Climacteric Scale, a validated outcome measure in menopausal women, to directly assess the impact of hormone therapy on HRQOL. Both studies showed an improvement in HRQOL in the hormone-treated group, although the sample size was small (n=118) and the effect was modest.Conclusion:Although oral hormone therapy improves VMS scores, there is a paucity of evidence on whether it improves HRQOL in menopausal women. Future studies using validated, patient-reported outcome measures that directly assess HRQOL are needed.
AB - Objective:Vasomotor symptoms (VMS) have been consistently reported as the leading predictor of health-related quality of life (HRQOL) among menopausal women, and the strongest indication for treatment. The North American Menopause Society endorses the use of oral estrogen for the treatment of VMS based on a Cochrane meta-analysis. The Cochrane review concludes that oral hormone therapy reduces the frequency and severity of VMS. The objective of this review is to critically appraise the outcome measures used in these clinical trials to evaluate whether there is adequate evidence that oral hormone therapy improves HRQOL.Methods:Each trial in the 2004 Cochrane review of oral hormone therapy for the management of VMS was evaluated with respect to study design, outcome measures, and method of analysis.Results:Twenty-four randomized, double-blind, placebo-controlled clinical trials were appraised. Six trials were excluded from the Cochrane meta-analysis due to inadequate reporting of outcome measures. Of the remaining trials, 15 trials assessed only symptom frequency and/or severity. One trial used a subscale of the General Health Questionnaire. Two trials used the Greene Climacteric Scale, a validated outcome measure in menopausal women, to directly assess the impact of hormone therapy on HRQOL. Both studies showed an improvement in HRQOL in the hormone-treated group, although the sample size was small (n=118) and the effect was modest.Conclusion:Although oral hormone therapy improves VMS scores, there is a paucity of evidence on whether it improves HRQOL in menopausal women. Future studies using validated, patient-reported outcome measures that directly assess HRQOL are needed.
KW - Hormone therapy
KW - Hot flashes
KW - Quality of life
KW - Randomized controlled trials
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U2 - 10.1097/GME.0000000000001387
DO - 10.1097/GME.0000000000001387
M3 - Review article
C2 - 31567867
AN - SCOPUS:85072344373
SN - 1072-3714
VL - 26
SP - 1334
EP - 1341
JO - Menopause
JF - Menopause
IS - 11
ER -