Expectancy after the first treatment and response to acupuncture for menopausal hot flashes.

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.

A Placebo-Controlled Double-Blinded Randomized Pilot Study of Combination Phytotherapy in Biochemically Recurrent Prostate Cancer.

BACKGROUND: Men with biochemical recurrence of prostate cancer following local therapies often use natural supplements in an attempt to delay metastases and/or avoid the need for more aggressive treatments with undesirable side-effects. While there is a growing body of research into phytotherapeutic agents in this cohort, with some promising results, as yet no definitive recommendations can be made. This pilot study was undertaken to assess the feasibility of a fully-powered study to examine the effects of this phytotherapeutic intervention (containing turmeric, resveratrol, green tea and broccoli sprouts) on PSA doubling time in men with biochemical recurrence with a moderate PSA rise rate. METHODS: A double blind, randomized, placebo-controlled parallel trial was conducted with 22 men with biochemically recurrent prostate cancer and a moderate rise rate (PSA doubling time of 4-15 months and no evidence of metastases from conventional imaging methods). Patients were randomized to either the active treatment arm or placebo for 12 weeks. The primary endpoints were feasibility of study recruitment and procedures, and measurement of proposed secondary endpoints (prostate symptoms, quality of life, anxiety, and depression as measured on the EORTC QLQ-C30 and PR-25, the IPSS and HADS). Data were collected to estimate PSA-log slopes and PSA-doubling times, using a mixed model, for both the pre-intervention and post-intervention periods. RESULTS: Adherence to study protocol was excellent, and the phytotherapeutic intervention was well-tolerated, with similar numbers of mild-to-moderate adverse events in the active and placebo arms. Both the intervention and data collection methods were acceptable to participants. No statistical difference between groups on clinical outcomes was expected in this pilot study. There was between-subject variation in the PSA post treatment, but on average the active treatment group experienced a non-significant increase in the log-slope of PSA (pre-treatment doubling time = 10.2 months, post-treatment doubling time = 5.5 months), and the placebo group experienced no change in the log-slope of PSA (pre-treatment doubling time = 10.8 months, post-treatment doubling time = 10.9 months). CONCLUSION: The findings suggest that a fully powered study of this combination is feasible in men with biochemically recurrent prostate cancer and a moderate PSA rise rate. Prostate 77:765-775, 2017. © 2017 Wiley Periodicals, Inc.

Phytotherapeutic interventions in the management of biochemically recurrent prostate cancer: a systematic review of randomised trials.

OBJECTIVE: To evaluate the evidence from randomised trials for the efficacy and safety of phytotherapeutic interventions in the management of biochemically recurrent (BCR) prostate cancer, indicated by prostate-specific antigen (PSA) progression, numbers progressing to/time to initiation of androgen-deprivation therapy or salvage therapy. PATIENTS AND METHODS: MEDLINE (Ovid), EMBASE (Ovid), AMED (Ovid), CINAHL (EBSCO) and the Cochrane Library databases were searched. Clinical trials investigating phytotherapeutic interventions as dietary supplements or dietary components, including multi-component herbal formulations, in men with BCR prostate cancer were located. Eight of nine authors contacted for further information responded. Methodological quality was assessed using the Cochrane Collaboration's risk of bias assessment tool. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for reporting systematic reviews was followed. RESULTS: Of 23 full-text articles assessed for eligibility, five met the criteria for inclusion. Two studies were placebo controlled; two were active control trials; and one a high-/low-dose trial. The interventions were administered as isolated phytochemicals (sulphoraphane), phytotherapeutic extracts [Pomi-T (pomegranate, turmeric, green tea and broccoli sprout extract), soy, lycopene, and POMx (pomegranate extract)], or plant-derived dietary items (soy and lycopene). All studies found serum PSA levels to stabilise, decrease or rise more slowly in a significant number of men, and three studies reported stabilising or lengthening of PSA-doubling time. Studies were generally of good quality, but sample sizes were predominantly small, and durations short. CONCLUSIONS: High-quality studies in this area are lacking. Sulphoraphane, lycopene, soy isoflavones, POMx, and Pomi-T are safe and well tolerated. There is limited evidence that they can affect PSA dynamics. No recommendation can be made for the use of these agents in managing prostate cancer morbidity and mortality until high-quality, fully powered studies are available. Recommendations are made for improving reproducibility and translation of findings with regard to study population, study endpoints, design, and the reporting of phytotherapeutic interventions.

Soy and soy isoflavones in prostate cancer: a systematic review and meta-analysis of randomized controlled trials.

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.

Fibromyalgia--should we be testing and treating for vitamin D deficiency?

AIM: This review aims to synthesise the evidence regarding any association between vitamin D deficiency and fibromyalgia, addressing whether general practitioners should be testing and treating these patients for vitamin D deficiency. METHODS: A systematic literature review was performed, using MEDLINE as the primary database, to find and critically appraise all relevant research fulfilling inclusion criteria from January 1990 until September 2010. RESULTS: There were conflicting results in the cross sectional studies obtained, with no association in studies using control groups and mixed results in larger population based studies. One adequately powered randomised controlled trial suggests fibromyalgia pain is not improved by vitamin D supplementation. DISCUSSION: The evidence for an association between fibromyalgia and vitamin D deficiency is inconclusive, with no improvement in pain on supplementation. However, patients with concurrent risk factors for deficiency should be tested and treated for vitamin D deficiency to minimise osteoporosis risk and maximise muscular strength.

Acupuncture for pelvic and back pain in pregnancy: a systematic review.

The objective of our study was to review the effectiveness of needle acupuncture in treating the common and disabling problem of pelvic and back pain in pregnancy. Two small trials on mixed pelvic/back pain and 1 large high-quality trial on pelvic pain met the inclusion criteria. Acupuncture, as an adjunct to standard treatment, was superior to standard treatment alone and physiotherapy in relieving mixed pelvic/back pain. Women with well-defined pelvic pain had greater relief of pain with a combination of acupuncture and standard treatment, compared to standard treatment alone or stabilizing exercises and standard treatment. We used a narrative synthesis due to significant clinical heterogeneity between trials. Few and minor adverse events were reported. We conclude that limited evidence supports acupuncture use in treating pregnancy-related pelvic and back pain. Additional high-quality trials are needed to test the existing promising evidence for this relatively safe and popular complementary therapy.

Her choice: dealing with lactobacilli, vaginitis, and antibiotics.

Vulvovaginal candidiasis is a common problem for women, yet there are many gaps in knowledge about candida's pathogenesis, immunity, and its reputed association with antibiotic use. Women often self-diagnose and self-manage the problem, yet one of the most common folk remedies used, the probiotic lactobacillus, has no biologically plausible mechanism to explain any beneficial actions and no rigorous evidence to support its effectiveness. This paper explores these issues and summaries potential areas for further research.

"Not thrush again!" Women's experience of post-antibiotic vulvovaginitis.

OBJECTIVES: To examine the frequency of post-antibiotic vulvovaginitis (PAV); describe how women prevent and treat PAV; and determine whether concern about PAV affects their decisions about taking antibiotics. DESIGN: Cross-sectional survey using a written questionnaire. SETTING AND PARTICIPANTS: Five general practice waiting rooms in north-western Melbourne, in February 2000. 1298 women aged 18-70 years were surveyed. MAIN OUTCOME MEASURES: Self-reported symptoms and management of vulvovaginitis and PAV. RESULTS: The response rate was 86%. Thirty-five per cent of women reported ever having PAV and 73% reported ever having symptoms suggestive of vulvovaginal candidiasis. Antifungal medications and lactobacillus products or yoghurt were most popular for both prevention (49%, 40%) and treatment (63%, 43%) of PAV. Other home remedies such as tea tree oil, vinegar, and dietary and clothing modification were infrequently used by the women surveyed. Twenty-three per cent of women who had taken antibiotics in the previous month had experienced symptoms of vulvovaginitis. Of women who had ever had vulvovaginitis, 35% were moderately to very concerned about developing PAV when prescribed antibiotics. Because of this concern, around a fifth of these women would not take prescribed antibiotics. CONCLUSIONS: Concern about PAV affects women's decision-making regarding antibiotic use. Many women use unproven complementary therapies to prevent or treat PAV. When prescribing antibiotics, doctors should discuss the risks of PAV and its management with patients.