Identifying meaningful differences in vasomotor symptoms among menopausal women

Menopause

Volumn 15, Issue 4, 2008, Pages 698-705

  Wyrwich, Kathleen W ^a   Spratt, Daniel I ^b   Gass, Margery ^c   Yu, Holly ^d   Bobula, Joel D ^d  

^a SAINT LOUIS UNIVERSITY   (United States)

^b Maine Medical Center Research Institute   (United States)

^c UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^d PFIZER INC   (United States)

Author keywords

Hot flushes; Menopause; Minimal important difference; Nonhormonal; Serotonin norepinephrine reuptake inhibitor; Treatment satisfaction

Indexed keywords

DESVENLAFAXINE; PLACEBO; CYCLOHEXANOL DERIVATIVE; NEUROTRANSMITTER UPTAKE INHIBITOR; O-DESMETHYLVENLAFAXINE;

ADULT; AGED; ARTICLE; ASTHENIA; CLINICAL TRIAL; COMPARATIVE STUDY; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; FEMALE; HEART INFARCTION; HOT FLUSH; HUMAN; INSOMNIA; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NAUSEA; PATIENT SATISFACTION; POSTMENOPAUSE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; STATISTICAL SIGNIFICANCE; VASOMOTOR DISORDER; WAKEFULNESS; XEROSTOMIA; MENOPAUSE; MIDDLE AGED;

CYCLOHEXANOLS; DOUBLE-BLIND METHOD; FEMALE; HOT FLASHES; HUMANS; MENOPAUSE; MIDDLE AGED; NEUROTRANSMITTER UPTAKE INHIBITORS; PATIENT SATISFACTION;

EID: 51449094363     PISSN: 10723714     EISSN: None     Source Type: Journal    
DOI: 10.1097/gme.0b013e31815f892d     Document Type: Article

References (43)

1. Dennerstein L. Well-being, symptoms and the menopausal transition. Maturitas 1996;23:147-157.
2. Mohyi D, Tabassi K, Simon J. Differential diagnosis of hot flashes. Maturitas 1997;27:203-214.
3. Hardy R, Kuh D. Change in psychological and vasomotor symptom reporting during the menopause. Soc Sci Med 2002;55:1975-1988.
4. Bachmann GA. Menopausal vasomotor symptoms: a review of causes, effects and evidence-based treatment options. J Reprod Med 2005;50: 155-165.
5. Blumel JE, Castelo-Branco C, Cancelo MJ, et al. Relationship between psychological complaints and vasomotor symptoms during climacteric. Maturitas 2004;49:205-210.
6. Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes 2005;3:47-56.
7. National Institutes of Health. National Institutes of Health State-of-the-Science Conference statement: management of menopause-related symptoms. Ann Intern Med 2005;142:1003-1013.
8. Speroff L, Gass M, Constantine G, et al. Efficacy and tolerability of desvenlafaxine succinate treatment for menopausal vasomotor symptoms. Obstet Gynecol 2008;111:77-87.
9. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989;10:407-415.
10. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Rockville, MD: US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research, 2006.
11. Utian WH, Gass ML, Pickar JH. Body mass index does not influence response to treatment, nor does body weight change with lower doses of conjugated estrogens and medroxyprogesterone acetate in early post-menopausal women. Menopause 2004;11:306-314.
12. Hill CD, Fehnel SE, Bobula JD, Yu H, McLeod LD. Development and preliminary validation of the Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ). Menopause 2007;14:1047-1055.
13. Wyrwich KW, Wolinsky FD. Identifying meaningful intra-individual change standards for health-related quality of life measures. J Eval Clin Pract 2000;6:39-49.
14. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status measures. Mayo Clin Proc 2002;77:371-383.
15. Butt DA, Deng LYR, Lewis JE, Lock M. Minimal decrease in hot flashes desired by postmenopausal women in family practice. Menopause 2007;14:203-207.
16. Nelson HD, Vesco KK, Haney E, et al. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA 2006;295:2057-2071.
17. Nagamani M, Kelver ME, Smith ER. Treatment of menopausal hot flashes with transdermal administration of clonidine. Am J Obstet Gynecol 1987;156:561-565.
18. Pandya KJ, Raubertas RF, Flynn PJ, et al. Oral clonidine in postmenopausal patients with breast cancer experiencing tamoxifen-induced hot flashes: a University of Rochester Cancer Center Community Clinical Oncology Program study. Ann Intern Med 2000;132:788-793.
19. Nesheim BI, Saetre T. Reduction of menopausal hot flushes by methyldopa. A double blind crossover trial. Eur J Clin Pharmacol 1981;20:413-416.
20. Pandya KJ, Morrow GR, Roscoe JA, et al. Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet 2005;366:818-824.
21. Loprinzi L, Barton DL, Sloan JA, et al. Pilot evaluation of gabapentin for treating hot flashes. Mayo Clin Proc 2002;77:1159-1163.
22. Pandya KJ, Thummala AR, Griggs JJ, et al. Pilot study using gabapentin for tamoxifen-induced hot flashes in women with breast cancer. Breast Cancer Res Treat 2004;83:87-89.
23. Barton DL, Loprinzi CL, Novotny P, et al. Pilot evaluation of citalopram for the relief of hot flashes. J Support Oncol 2003;1:47-51.
24. Loprinzi CL, Sloan JA, Perez EA, et al. Phase III evaluation of fluoxetine for treatment of hot flashes. J Clin Oncol 2002;20: 1578-1583.
25. Loprinzi CL, Barton DL, Carpenter LA, et al. Pilot evaluation of paroxetine for treating hot flashes in men. Mayo Clin Proc 2004;79:1247-1251.
26. Stearns V, Isaacs C, Rowland J, et al. A pilot trial assessing the efficacy of paroxetine hydrochloride (Paxil) in controlling hot flashes in breast cancer survivors. Ann Oncol 2000;11:17-22.
27. Stearns V, Beebe KL, Iyengar M, Dube E. Paroxetine controlled release in the treatment of menopausal hot flashes: a randomized controlled trial. JAMA 2003;289:2827-2834.
28. Stearns V, Slack R, Greep N, et al. Paroxetine is an effective treatment for hot flashes: results from a prospective randomized clinical trial. J Clin Oncol 2005;23:6919-6930.
29. Weitzner MA, Moncello J, Jacobsen PB, Minton S. A pilot trial of paroxetine for the treatment of hot flashes and associated symptoms in women with breast cancer. J Pain Symptom Manage 2002;23:337-345.
30. Loprinzi CL, Pisansky TM, Fonseca R, et al. Pilot evaluation of venlafaxine hydrochloride for the therapy of hot flashes in cancer survivors. J Clin Oncol 1998;16:2377-2381.
31. Loprinzi CL, Kugler JW, Sloan JA, et al. Venlafaxine in management of hot flashes in survivors of breast cancer: a randomised controlled trial. Lancet 2000;356:2059-2063.
32. Barton D, La VB, Loprinzi C, Novotny P, Wilwerding MB, Sloan J. Venlafaxine for the control of hot flashes: results of a longitudinal continuation study. Oncol Nurs Forum 2002;29:33-40.
33. Biglia N, Torta R, Roagna R, et al. Evaluation of low-dose venlafaxine hydrochloride for the therapy of hot flushes in breast cancer survivors. Maturitas 2005;52:78-85.
34. US Food and Drug Administration. Guidance for Industry. Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms - Recommendations for Clinical Evaluation. Rockville, MD: US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, 2003.
35. Simon JA, Stevens RE, Ayres SA, Phelps KV. Perimenopausal women in estrogen vasomotor trials: contribution to placebo effect and efficacy outcome. Climacteric 2001;4:19-27.
36. Price DD, Fields HL. The contribution of desire and expectation to placebo analgesia: implications for new research strategies. In: Harrington A, ed. The Placebo Effect: An Interdisciplinary Exploration. Cambridge, MA: Harvard University Press, 1997:117-137.
37. Kirsch I. Specifying nonspecifics: psychological mechanisms of placebo effects. In: Harrington A, ed. The Placebo Effect: An Interdisciplinary Exploration. Cambridge, MA: Harvard University Press, 1997:166-186.
38. Vase L, Riley JL III, Price DD. A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain 2002;99:443-452.
39. Notelovitz M, Lenihan JP, McDermott M, Kerber IJ, Nanavati N, Arce J. Initial 17β-estradiol dose for treating vasomotor symptoms. Obstet Gynecol 2000;95:726-731.
40. Speroff L, Symons J, Kempfert N, Rowan J. The effect of varying low-dose combinations of norethindrone acetate and ethinyl estradiol (femhrt) on the frequency and intensity of vasomotor symptoms. Menopause 2000;7:383-390.
41. Suvanto-Luukkonen E, Koivunen R, Sundstrom H, et al. Citalopram and fluoxetine in the treatment of postmenopausal symptoms: a prospective, randomized, 9-month, placebo-controlled, double-blind study. Menopause 2005;12:18-26.
42. Utian WH, Shoupe D, Bachmann G, Pinkerton JV, Pickar JH. Relief of vasomotor symptoms and vaginal atrophy with lower doses of conjugated equine estrogens and medroxyprogesterone acetate. Fertil Steril 2001;75:1065-1079.
43. Guyatt GH, Norman GR, Juniper EF, Griffith LE. A critical look at transition ratings. J Clin Epidemiol 2002;55:900-908.