Predictors of placebo response in a randomized, controlled trial of phytotherapy in menopause

Menopause

Volumn 16, Issue 4, 2009, Pages 792-796

  Van Die, Margaret Diana ^a   Teede, Helena J ^b,c   Bone, Kerry M ^d,e   Reece, John E ^a   Burger, Henry G ^f  

^a RMIT UNIVERSITY   (Australia)

^b Jean Hailes Foundation for Women's Health   (Australia)

^c MONASH UNIVERSITY   (Australia)

^d MediHerb   (Australia)

^e UNIVERSITY OF NEW ENGLAND   (Australia)

^f HUDSON INSTITUTE OF MEDICAL RESEARCH   (Australia)

Author keywords

Herbal medicine; Menopause; Phytotherapy; Placebo response; Predictors; Randomized controlled trial (RCT)

Indexed keywords

HYPERICUM PERFORATUM EXTRACT; PLACEBO; VITEX AGNUS CASTUS EXTRACT;

ADULT; ANXIETY; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; FLUSHING; FOLLOW UP; GREENE CLIMACTERIC SCALE; HAMILTON SCALE; HUMAN; MENOPAUSAL SYNDROME; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; PHYTOTHERAPY; PLACEBO EFFECT; POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS;

ADULT; ANXIETY; DEPRESSION; DOUBLE-BLIND METHOD; FEMALE; HOT FLASHES; HUMANS; HYPERICUM; MENOPAUSE; MIDDLE AGED; MULTIVARIATE ANALYSIS; PHYTOTHERAPY; PLACEBOS; POSTMENOPAUSE; REGRESSION ANALYSIS; VITEX;

EID: 68349114394     PISSN: 10723714     EISSN: None     Source Type: Journal    
DOI: 10.1097/GME.0b013e318199d5e6     Document Type: Article

References (29)

1. Montgomery SA. The failure of placebo-controlled studies. ECNP Consensus Meeting, September 13, 1997, Vienna European College of Neu- ropsychopharmacology. Eur Neuropsychopharmacol 1999;9:271-276.
2. Bender KJ. New assessments improve research. Psychiatr Times 2003;20:90.
3. Walach H, Jonas WB. Placebo research: the evidence base for harnessing self-healing capacities. J Altern Complement Med 2004;10:S103-S112.
4. Stein DJ, Baldwin DS, Dolberg OT, et al. Which factors predict placebo response in anxiety disorders and major depression? An analysis of placebo-controlled studies of escitalopram. J Clin Psychiatry 2006;67:1741-1746.
5. Papakostas YG, Daras MD. Placebos, placebo effect, and the response to the healing situation: the evolution of a concept. Epilepsia 2001;42:1614-1625.
6. Walsh BT, Scidman SN, Sysko R, et al. Placebo response in a study of major depression: variable, substantial, and growing. JAMA 2002:287:1840-1847.
7. Linde K, Berner M, Egger M, et al. St John's wort for depression: metaanalysis of randomised controlled trials. Br J Psychiatry 2005;186:99-107.
8. MacLennan QH, Broadbent JL, Lester S, et al. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database Syst Rev 2004:CD002978.
9. McRae C, Cherin E, Yamazaki TG, et al. Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry 2004;61:412-420.
10. Moseley JB Jr, Wray NP, Kuykendall D, et al. Arthroscopic treatment of osteoarthritis of the knee: a prospective, randomized, placebo-controlled trial. Results of a pilot study. Am J Sports Med 1996;24:28-34.
11. Freeman EW, Rickeis K. Characteristics of placebo responses in medical treatment of premenstrual syndrome. Am J Psychiatry 1999;156:1403-1408.
12. Wilcox CS, Cohn JB, Linden RD, et al. Predictors of placebo response: a retrospective analysis. Psychopharmacol Bull 1992;28:157-162.
13. Talley NJ, Locke GR, Lahr BD, et al. Predictors of the placebo response in functional dyspepsia. Aliment Pharmacol Ther 2006;23:923-936.
14. Brown WA, Dornseif BE, Wernicke JF. Placebo response in depression: a search for predictors. Psychiatry Res 1988;26:259-264.
15. Brown WA, Johnson MF, Chen MG. Clinical features of depressed patients who do and do not improve with placebo. Psychiatry Res 1992;41:203-214.
16. Linde K, Witt CM, Streng A, et al. The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain. Pain 2007;128:264-271.
17. McNair DM, Gardos G, Haskell DS, et al. Placebo response, placebo effect, and two attributes. Psychopharmacology 1979;63:245-250.
18. Van Die MD, Burger HG, Bone KM, et al. Hypericum perforatum with Vitex agnus-castus in menopausal symptoms. Menopause 2009;16:156-163.
19. Shapiro AK, Shapiro E. Patient-provider relationships and the placebo effect. In: Matarazzo J, Weiss SM, Herd JA, eds. Behavioural Health: A Handbook Enhancement of Health and Disease Prevention. New York: Wiley Interscience, 1984:371-383.
20. Bialik RJ, Ravindran AV, Bakish D, et al. A comparison of placebo responders and nonresponders in subgroups of depressive disorder. J Psychiatry Neurosci 1995;20:265-270.
21. Wasan AD, Kaptchuk TJ, Davar G, et al. The association between psychopathology and placebo analgesia in patients with discogenic low back pain. Pain Med 2006;7:217-228.
22. Alexopoulos GS, Kanellopoulos D, Murphy C, et al. Placebo response and antidepressant response. Am J Geriatr Psychiatry 2007;15:149-158.
23. Grady D, Herrington D, Bittner V, et al. Cardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA 2002;288:49-57.
24. Di Blasi Z, Harkness E, Ernst E, et al. Influence of context effects on health outcomes: a systematic review. Lancet 2001;357:757-762.
25. Montgomery SA. Alternatives to placebo-controlled trials in psychiatry. ECNP Consensus Meeting, September 26, 1996, Amsterdam. European College of Neuropsychopharmacology. Eur Neuropsychopharmacol 1999;9:265-269.
26. Freeman EW, Sammel MD, Lin H, et al. The role of anxiety and hormonal changes in menopausal hot flashes. Menopause 2005;12:258-266.
27. Irvin JH, Domar AD, Clark C, et al. The effects of relaxation response training on menopausal symptoms. J Psychosom Obstet Gynaecol 1996;17:202-207.
28. Freedman RR, Woodward S. Behavioural treatment of menopausal hot flushes: evaluation by ambulatory monitoring. Am J Obstet Gynecol 1992;167:436-439.
29. US Department of Health and Human Services FDA, Center for Drug Evaluation and Research (CDER). Guidance for industry: labelling guidance for noncontraceptive estrogen drug products for the treatment of vasomotor symptoms and vulvar and vaginal atrophy symptoms - prescribing information for health care providers and patient labeling [revision 1]. Rockville, MD: Division of Drug Information, Center for Drug Evaluation and Research, 2004.