Marie Pirotta

Probiotic Effects on Late-onset Sepsis in Very Preterm Infants: A Randomized Controlled Trial

BACKGROUND AND OBJECTIVE: Late-onset sepsis frequently complicates prematurity, contributing to morbidity and mortality. Probiotics may reduce mortality and necrotizing enterocolitis (NEC) in preterm infants, with unclear effect on late-onset sepsis. This study aimed to determine the effect of administering a specific combination of probiotics to very preterm infants on culture-proven late-onset sepsis. METHODS: A prospective multicenter, double-blinded, placebo-controlled, randomized trial compared daily administration of a probiotic combination (Bifidobacterium infantis, Streptococcus thermophilus, and Bifidobacterium lactis, containing 1 × 109 total organisms) with placebo (maltodextrin) in infants born before 32 completed weeks’ gestation weighing <1500 g. The primary outcome was at least 1 episode of definite late-onset sepsis. RESULTS: Between October 2007 and November 2011, 1099 very preterm infants from Australia and New Zealand were randomized. Rates of definite late-onset sepsis (16.2%), NEC of Bell stage 2 or more (4.4%), and mortality (5.1%) were low in controls, with high breast milk feeding rates (96.9%). No significant difference in definite late-onset sepsis or all-cause mortality was found, but this probiotic combination reduced NEC of Bell stage 2 or more (2.0% versus 4.4%; relative risk 0.46, 95% confidence interval 0.23 to 0.93, P = .03; number needed to treat 43, 95% confidence interval 23 to 333). CONCLUSIONS: The probiotics B infantis, S thermophilus, and B lactis significantly reduced NEC of Bell stage 2 or more in very preterm infants, but not definite late-onset sepsis or mortality. Treatment with this combination of probiotics appears to be safe.

A national census of medicines use: a 24-hour snapshot of Australians aged 50 years and older.

Objective: To explore the current use of conventional and complementary medicines in Australians aged ≥ 50 years.

Chlamydia trachomatis Incidence and Re-Infection among Young Women – Behavioural and Microbiological Characteristics

Background This study aimed to estimate rates of chlamydia incidence and re-infection and to investigate the dynamics of chlamydia organism load in prevalent, incident and re-infections among young Australian women. Methods 1,116 women aged 16 to 25 years were recruited from primary care clinics in Australia. Vaginal swabs were collected at 3 to 6 month intervals for chlamydia testing. Chlamydia organism load was measured by quantitative PCR. Results There were 47 incident cases of chlamydia diagnosed and 1,056.34 person years of follow up with a rate of 4.4 per 100 person years (95% CI: 3.3, 5.9). Incident infection was associated with being aged 16 to 20 years [RR = 3.7 (95%CI: 1.9, 7.1)], being employed [RR = 2.4 (95%CI: 1.1, 4.9)] and having two or more new sex partners [RR = 5.5 (95%CI: 2.6, 11.7)]. Recent antibiotic use was associated with a reduced incidence [RR:0.1 (95%CI: 0.0, 0.5)]. There were 14 re-infections with a rate of 22.3 per 100 person years (95%CI: 13.2, 37.6). The median time to re-infection was 4.6 months. Organism load was higher for prevalent than incident infections (p<0.01) and for prevalent than re-infections (p<0.01). Conclusions Chlamydia is common among young women and a high proportion of women are re-infected within a short period of time, highlighting the need for effective partner treatment and repeat testing. The difference in organism load between prevalent and incident infections suggests prevalent infection may be more important for ongoing transmission of chlamydia.

Acupuncture for Chronic Knee Pain: A Randomized Clinical Trial

IMPORTANCE There is debate about benefits of acupuncture for knee pain. OBJECTIVE To determine the efficacy of laser and needle acupuncture for chronic knee pain. DESIGN, SETTING, AND PARTICIPANTS Zelen-design clinical trial (randomization occurred before informed consent), in Victoria, Australia (February 2010-December 2012). Community volunteers (282 patients aged ≥50 years with chronic knee pain) were treated by family physician acupuncturists. INTERVENTIONS No acupuncture (control group, n = 71) and needle (n = 70), laser (n = 71), and sham laser (n = 70) acupuncture. Treatments were delivered for 12 weeks. Participants and acupuncturists were blinded to laser and sham laser acupuncture. Control participants were unaware of the trial. MAIN OUTCOMES AND MEASURES Primary outcomes were average knee pain (numeric rating scale, 0 [no pain] to 10 [worst pain possible]; minimal clinically important difference [MCID], 1.8 units) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 [no difficulty] to 68 [extreme difficulty]; MCID, 6 units) at 12 weeks. Secondary outcomes included other pain and function measures, quality of life, global change, and 1-year follow-up. Analyses were by intention-to-treat using multiple imputation for missing outcome data. RESULTS At 12 weeks and 1 year, 26 (9%) and 50 (18%) participants were lost to follow-up, respectively. Analyses showed neither needle nor laser acupuncture significantly improved pain (mean difference; -0.4 units; 95% CI, -1.2 to 0.4, and -0.1; 95% CI, -0.9 to 0.7, respectively) or function (-1.7; 95% CI, -6.1 to 2.6, and 0.5; 95% CI, -3.4 to 4.4, respectively) compared with sham at 12 weeks. Compared with control, needle and laser acupuncture resulted in modest improvements in pain (-1.1; 95% CI, -1.8 to -0.4, and -0.8; 95% CI, -1.5 to -0.1, respectively) at 12 weeks, but not at 1 year. Needle acupuncture resulted in modest improvement in function compared with control at 12 weeks (-3.9; 95% CI, -7.7 to -0.2) but was not significantly different from sham (-1.7; 95% CI, -6.1 to 2.6) and was not maintained at 1 year. There were no differences for most secondary outcomes and no serious adverse events. CONCLUSIONS AND RELEVANCE In patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients. TRIAL REGISTRATION anzctr.org.au Identifier: ACTRN12609001001280.

Genital Candida Species Detected in Samples from Women in Melbourne, Australia, before and after Treatment with Antibiotics

ABSTRACT Vulvovaginal candidiasis (VVC) remains a common cause of morbidity, with three-quarters of women affected during their lifetimes. Use of antibiotics is an acknowledged trigger for VVC, which adversely affects womens physical and emotional health. Knowledge of patterns of genital Candida species-level identification is important for management, as Candida species other than Candida albicans often fail first-line treatment. A community sample of women with no vaginal symptoms, and who were prescribed antibiotics, was recruited into this study, where the incidence of genital colonization by various Candida species was documented, as well as symptoms of VVC plus relevant associations, before and after treatment with antibiotics. Self-collected low vaginal swabs were taken prior to and 8 days after completion of antibiotic treatment, and data on various potential risk factors for VVC were collected simultaneously, with complete data being available for 233 participants. Baseline Candida species colonization was present in 21% of women (95% confidence intervals [CI], 17% to 27%), rising to 37% (95% CI, 31% to 44%) after antibiotic treatment. The primary species detected for either period was C. albicans (73%), with Candida glabrata detected in around 20%. Self-assessed proneness to VVC after antibiotic treatment and baseline colonization with Candida spp. were significantly associated with symptomatic VVC after antibiotic treatment. For microbiologically proven candidiasis, VVC symptoms had a sensitivity of 57% and a specificity of 91%. When physicians prescribe antibiotics, the history of risk of VVC is one issue that physicians should discuss with women, particularly those who are self-identified as being prone to VVC. Furthermore, we recommend that definitive microbiological diagnoses be made for women with recurrent symptoms or those failing initial treatment, to guide appropriate therapy.

The psychosocial burden of human papillomavirus related disease and screening interventions

Objectives: (i) To assess the psychosocial burden of testing for human papillomavirus (HPV) related genital disease or of a HPV-related diagnosis; (ii) to compare an instrument specifically designed to measure HPV-related psychosocial burden with other generic quality of life (QoL) instruments. Methods: A cross-sectional design. Researchers recruited women from outpatient clinics at a major tertiary women’s hospital and a sexual health centre who completed surveys within 3 months of receiving results: 331 women, 18–45 years, who had experienced a normal cervical Papanicolaou (Pap) result, an abnormal Pap result, biopsy confirmed cervical intraepithelial neoplasia (CIN) or external genital warts (EGW). Main outcome measures: the HPV impact profile (HIP) designed to assess the psychosocial impact of HPV; two general health-related QoL surveys—the EuroQoL VAS and the Sheehan disability scale; and a HPV knowledge survey. Results: Response rate was 78%. Significant psychosocial impacts were found for women screened for, or having a diagnosis of, HPV-related genital disease. The largest impact was in women with CIN 2/3 and EGW. This HPV-related psychosocial impact was most sensitively detected with the HIP. Relative to generic measures of QoL, the HIP provided insight into the full range of psychosocial impacts of HPV testing and diagnoses. Conclusions: Clinicians need to be aware of the potential psychosocial impact of testing for or diagnosing HPV-related genital disease, in particular CIN 2/3 and EGW. The HIP survey is a more sensitive measure of the psychosocial impact of HPV-related genital disease than generic QoL surveys.

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.

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

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.

Recurrence of Bacterial Vaginosis Is Significantly Associated With Posttreatment Sexual Activities and Hormonal Contraceptive Use

BACKGROUND Bacterial vaginosis (BV) recurrence posttreatment is common. Our aim was to determine if behaviors were associated with BV recurrence in women in a randomized controlled trial (RCT). METHODS Symptomatic 18- to 50-year-old females with BV (≥3 Amsel criteria and Nugent score [NS] = 4-10) were enrolled in a 3-arm randomized double-blind RCT Melbourne Sexual Health Centre, Australia, in 2009-2010. All 450 participants received oral metronidazole (7 days) and were equally randomized to vaginal clindamycin, lactobacillus-vaginal probiotic or vaginal placebo. At 1, 2, 3, and 6 months, participants self-collected vaginal smears and completed questionnaires. Primary endpoint was NS = 7-10. Cox regression was used to estimate hazard ratios (HRs) for risk of BV recurrence associated with baseline and longitudinal characteristics. RESULTS Four hundred four (90%) women with postrandomization data contributed to analyses. Cumulative 6-month BV recurrence was 28% (95% confidence interval [CI], 24%-33%) and not associated with treatment. After stratifying for treatment and adjusting for age and sex frequency, recurrence was associated with having the same pre-/posttreatment sexual partner (adjusted HR [AHR] = 1.9; 95% CI, 1.2-3.0), inconsistent condom use (AHR = 1.9; 95% CI, 1.0-3.3), and being non-Australian (AHR = 1.5; 95% CI, 1.0-2.1), and halved with use of an estrogen-containing contraceptive (AHR = 0.5; 95% CI, .3-.8). CONCLUSIONS Risk of BV recurrence was increased with the same pre-/posttreatment sexual partner and inconsistent condom use, and halved with use of estrogen-containing contraceptives. Behavioral and contraceptive practices may modify the effectiveness of BV treatment. CLINICAL TRIALS REGISTRATION ACTRN12607000350426.

Explaining variation in cancer survival between 11 jurisdictions in the International Cancer Benchmarking Partnership: a primary care vignette survey

Objectives The International Cancer Benchmarking Partnership (ICBP) is a collaboration between 6 countries and 12 jurisdictions with similar primary care-led health services. This study investigates primary care physician (PCP) behaviour and systems that may contribute to the timeliness of investigating for cancer and subsequently, international survival differences. Design A validated survey administered to PCPs via the internet set out in two parts: direct questions on primary care structure and practice relating to cancer diagnosis, and clinical vignettes, assessing management of scenarios relating to the diagnosis of lung, colorectal or ovarian cancer. Participants 2795 PCPs in 11 jurisdictions: New South Wales and Victoria (Australia), British Columbia, Manitoba, Ontario (Canada), England, Northern Ireland, Wales (UK), Denmark, Norway and Sweden. Primary and secondary outcome measures Analysis compared the cumulative proportion of PCPs in each jurisdiction opting to investigate or refer at each phase for each vignette with 1-year survival, and conditional 5-year survival rates for the relevant cancer and jurisdiction. Logistic regression was used to explore whether PCP characteristics or system differences in each jurisdiction affected the readiness to investigate. Results 4 of 5 vignettes showed a statistically significant correlation (p<0.05 or better) between readiness to investigate or refer to secondary care at the first phase of each vignette and cancer survival rates for that jurisdiction. No consistent associations were found between readiness to investigate and selected PCP demographics, practice or health system variables. Conclusions We demonstrate a correlation between the readiness of PCPs to investigate symptoms indicative of cancer and cancer survival rates, one of the first possible explanations for the variation in cancer survival between ICBP countries. No specific health system features consistently explained these findings. Some jurisdictions may consider lowering thresholds for PCPs to investigate for cancer—either directly, or by specialist referral, to improve outcomes.