M E Coyle | PubMed Health

PubMed2005

Recruitment and implementation strategies in randomised controlled trials of acupuncture and herbal medicine in women's health.

INTRODUCTION: Recruitment of subjects to clinical trials is known to be difficult and there is little research describing recruitment and implementation strategies to CAM clinical trials. This paper describes the experiences from recruitment and implementation for five randomised controlled trials in women's health conducted in South Australia. METHODS: Descriptive study reporting on trial documentation and questionnaires completed by women. RESULTS: Recruitment rates varied between trials and a variety of recruitment strategies were used between studies. Promotion of the trials to the wider community were facilitated by issuing press releases and subsequent reporting by the media. Women found the trial acceptable suggesting factors motivating and preventing women from participating were well addressed. CONCLUSION: It is hoped that the experiences described here will give some insight to recruitment and implementation strategies. There is a need for more systematic research and evaluation of these strategies, and dissemination of these findings to assist with successful implementation of trials.

Acupuncture Therapy↗

PubMed2005

Cephalic version by moxibustion for breech presentation.

BACKGROUND: Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin) to the acupuncture point Bladder 67 (BL67) (Chinese name Zhiyin), located at the tip of the fifth toe, has been proposed as a way of correcting breech presentation. As caesarean section is often suggested for breech babies due to the potential difficulties during labour, it is preferable to turn the baby before labour starts. OBJECTIVES: To examine the effectiveness and safety of moxibustion on changing the presentation of an unborn baby in the breech position, the need for external cephalic version (ECV), mode of birth, and perinatal morbidity and mortality for breech presentation. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (30 August 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2004), MEDLINE (1966 to March 2004), EMBASE (1980 to March 2004), CINAHL (1982 to March 2004), MIDIRS (1982 to March 2004), CISCOM (9 March 2004) and bibliographies of relevant papers. SELECTION CRITERIA: The inclusion criteria were published and unpublished randomised controlled trials comparing moxibustion (either alone or in combination with acupuncture) with a control group (no moxibustion), or other methods (e.g. external cephalic version, acupuncture) in women with a singleton breech presentation. DATA COLLECTION AND ANALYSIS: Both authors assessed eligibility and quality of trials independently. The outcome measures were baby's presentation at birth, need for external cephalic version, mode of birth, perinatal morbidity and mortality, maternal complications and maternal satisfaction, and adverse events. MAIN RESULTS: Three trials involving a total of 597 women were included. Due to differences in interventions and sample size it was not appropriate to perform a meta-analysis for the main outcome. Only one trial reported on other outcome measures relevant to this review. Moxibustion reduced the need for ECV (relative risk (RR) 0.47, 95% confidence interval (CI) 0.33 to 0.66) and resulted in decreased use of oxytocin before or during labour for women who had vaginal deliveries (RR 0.28, 95% CI 0.13 to 0.60). AUTHORS' CONCLUSIONS: There is insufficient evidence to support the use of moxibustion to correct a breech presentation. Moxibustion may be beneficial in reducing the need for ECV, and decreasing the use of ocytocin, however there is a need for well-designed randomised controlled trials to evaluate moxibustion for breech presentation which report on clinically relevant outcomes as well as the safety of the intervention.

Breech Presentation↗