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Background: Evidence on the impact of expectancy on acupuncture treatment response is conflicting. Objectives: This secondary analysis of a randomized sham-controlled trial on acupuncture for menopausal hot flashes investigated whether treatment expectancy score was associated with hot flash score at end-of-treatment. Secondary analyses investigated whether there were associations between other pre-specified factors and hot flash score. Study design: Women experiencing moderately-severe hot flashes were randomized to receive 10 sessions of real or sham acupuncture over eight weeks. Hot flash score was collected using a seven-day hot flash diary, and expectancy using the modified Credibility and Expectancy Questionnaire immediately after the first treatment. Linear mixed-effects models with random intercepts were used to identify associations between expectancy score and hot flash score at end-of-treatment. Regression was also used to identify associations between pre-specified factors of interest and hot flash score. Because there was no difference between real and sham acupuncture for the primary outcome of hot flash score, both arms were combined in the analysis. Results: 285 women returned the Credibility and Expectancy Questionnaire, and 283 women completed both expectancy measures. We found no evidence for an association between expectancy and hot flash score at end-of-treatment for individual cases in either acupuncture or sham group. Hot flash scores at end-of-treatment were 8.1 (95%CI, 3.0 to 13.2; P = 0.002) points lower in regular smokers compared to those who had never smoked, equivalent to four fewer moderate hot flashes a day. Conclusion: In our study of acupuncture for menopausal hot flashes, higher expectancy after the first treatment did not predict better treatment outcomes. Future research may focus on other determinants of outcomes in acupuncture such as therapist attention. The relationship between smoking and hot flashes is poorly understood and needs further exploration. [ABSTRACT FROM AUTHOR]

Objective To evaluate the evidence from randomized controlled trials ( RCTs) on the efficacy and safety of soy/isoflavones in men with prostate cancer ( PCa) or with a clinically identified risk of PCa., Patients and Methods MEDLINE, EMBASE, the Allied and Complementary Medicine ( AMED), the Cumulative Index to Nursing and Allied Health Literature ( CINAHL) and the Cochrane Library databases were searched., We identified RCTs investigating soy/soy isoflavones as dietary supplements or dietary components for the secondary prevention or treatment of PCa in men with PCa or with a clinically identified risk of developing PCa. Studies of multi-component formulations were excluded., Six authors were contacted for further information for the meta-analyses., Methodological quality was assessed using the Cochrane Collaboration's risk-of- bias tool., The PRISMA statement for reporting systematic reviews was followed., Results Of the eight RCTs that met the inclusion criteria, six restricted recruitment to men diagnosed with PCa, while two included men with clinically identified risk of PCa., A large degree of heterogeneity was found with respect to dosages and preparations of soy/isoflavones administered., Most studies had small sample sizes and were of short duration., The risk of bias was assessed as low in all assessed studies except for one, for which the risk of bias was unclear. Meta-analyses of the two studies including men with identified risk of PCa found a significant reduction in PCa diagnosis after administration of soy/soy isoflavones (risk ratio = 0.49, 95% CI 0.26, 0.95)., Meta-analyses indicated no significant differences between groups for prostate-specific antigen ( PSA) levels or sex steroid endpoints (sex hormone-binding globulin [ SHBG], testosterone, free testosterone, oestradiol and dihydrotestosterone)., Conclusions The results of a meta-analysis of two studies suggest there may be support for epidemiological findings of a potential role for soy/soy isoflavones in PCa risk reduction; however, a clear understanding of the impact of soy/isoflavones on PSA, total testosterone, free testosterone and SHBG levels in men with, or at identified risk of, PCa could not be derived from these data, given the limitations of sample size and study duration in individual trials., A good safety profile is shown by this meta-analysis for soy/soy isoflavones supplementation. [ABSTRACT FROM AUTHOR]