Listening to Placebo in Clinical Trials for Female Sexual Dysfunction

被引:29
作者
Bradford, Andrea [1 ]
机构
[1] Univ Texas MD Anderson Canc Ctr, Dept Gynecol Oncol & Reprod Med, Houston, TX 77230 USA
关键词
Sexual Dysfunction; Placebo; Clinical Trial Design; Hypoactive Sexual Desire Disorder; Female Sexual Arousal Disorder; DESIRE DISORDER; ALTERNATIVE MEDICINE; METAANALYSIS; WOMEN; EXPECTANCIES; ALCOHOL; BLIND; EXPECTATIONS; PREDICTORS; DEPRESSION;
D O I
10.1111/j.1743-6109.2012.02941.x
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Introduction. Placebo responses are substantial in many clinical trials of treatments for female sexual dysfunctions (FSDs). Recent studies from other fields suggest a need to reconceptualize placebo response and to design future trials accordingly. Aim. The aims of this review are to (i) summarize current conceptualizations of placebo response in the literature; (ii) identify potential mechanisms of placebo response that are relevant to the study of FSD; and (iii) provide recommendations for incorporating this knowledge into design of future trials. Methods. Narrative review of literature relevant to the topic of placebo response and FSD. Main Outcome Measures. Possible predictors and mechanisms of placebo response in women with FSD are described based on the synthesis of empirical findings in studies of placebo. Results. Placebo response is a complex phenomenon that represents cognitive, behavioral, motivational, and possibly relational mediating factors. Instructions given to trial participants, behavioral changes required to participate in a trial, changes in partner behavior, and interactions with study staff may influence participants' expectations of benefit and therefore their responses to placebo treatment. Side effects may enhance placebo response within active treatment arms. At present, it is unclear to what extent to which specific factors affect outcomes of clinical trials in FSD. Conclusions. Procedural and methodological factors are likely to contribute to placebo response in trials for FSD, though additional research is needed to clarify these effects. Study designs should be reevaluated to avoid unnecessary creation or exaggeration of placebo responses and to draw appropriate conclusions from trial results. Bradford A. Listening to placebo in clinical trials for female sexual dysfunction. J Sex Med 2013;10:451-459.
引用
收藏
页码:451 / 459
页数:9
相关论文
共 68 条
[1]   Outcome measurement in female sexual dysfunction clinical trials: Review and recommendations [J].
Althof, SE ;
Rosen, RC ;
DeRogatis, L ;
Corty, E ;
Quirk, F ;
Symonds, T .
JOURNAL OF SEX & MARITAL THERAPY, 2005, 31 (02) :153-166
[2]  
[Anonymous], NOT GUID CLIN INV ME
[3]  
[Anonymous], SEXUAL MED SEXUAL DY
[4]   Neurobiological mechanisms of the placebo effect [J].
Benedetti, F ;
Mayberg, HS ;
Wager, TD ;
Stohler, CS ;
Zubieta, JK .
JOURNAL OF NEUROSCIENCE, 2005, 25 (45) :10390-10402
[5]   Understanding placebo, nocebo, and latrogenic treatment effects [J].
Bootzin, RR ;
Bailey, ET .
JOURNAL OF CLINICAL PSYCHOLOGY, 2005, 61 (07) :871-880
[6]   Correlates of placebo response in the treatment of sexual dysfunction in women: A preliminary report [J].
Bradford, Andrea ;
Meston, Cindy .
JOURNAL OF SEXUAL MEDICINE, 2007, 4 (05) :1345-1351
[7]   Behavior and Symptom Change Among Women Treated with Placebo for Sexual Dysfunction [J].
Bradford, Andrea ;
Meston, Cindy M. .
JOURNAL OF SEXUAL MEDICINE, 2011, 8 (01) :191-201
[8]   Placebo Response in the Treatment of Women's Sexual Dysfunctions: A Review and Commentary [J].
Bradford, Andrea ;
Meston, Cindy M. .
JOURNAL OF SEX & MARITAL THERAPY, 2009, 35 (03) :164-181
[9]  
Brown CA., 2006, BMC MED RES METHODOL, V6, P54, DOI DOI 10.1186/1471-2288-6-54
[10]   Magnitude of the placebo effect in randomized trials of antiepileptic agents [J].
Burneo, JG ;
Montori, VM ;
Faught, E .
EPILEPSY & BEHAVIOR, 2002, 3 (06) :532-534