ARIX: a randomised trial of acupuncture v oral care sessions in patients with chronic xerostomia following treatment of head and neck cancer.

BACKGROUND: Radiation treatment of head and neck cancer can cause chronic xerostomia which impairs patients' quality of life. The study reported here examined the efficacy of acupuncture in alleviating xerostomia symptoms especially dry mouth. PATIENTS AND METHODS: A total of 145 patients with chronic radiation-induced xerostomia >18 months after treatments were recruited from seven UK cancer centres. The study employed a randomised crossover design with participants receiving two group sessions of oral care education and eight of acupuncture using standardised methods. Patient-reported outcome (PROs) measures were completed at baseline and weeks 5, 9, 13, 17, and 21. The primary outcome was improvement in dry mouth. OBJECTIVE: saliva measurements were also carried out. RESULTS: Acupuncture compared with oral care, produced significant reductions in patient reports of severe dry mouth (OR = 2.01, P = 0.031) sticky saliva (OR = 1.67, P = 0.048), needing to sip fluids to swallow food (OR = 2.08, P = 0.011) and in waking up at night to drink (OR = 1.71, P = 0.013). There were no significant changes in either stimulated or unstimulated saliva measurements over time. CONCLUSION: Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia.

Randomised controlled trials of yoga interventions for women with breast cancer: a systematic literature review.

PURPOSE: Yoga is increasingly used as a complementary therapy to manage disease and treatment-related side effects in patients with cancer and has resulted in an increase in the number of studies exploring the effectiveness of yoga interventions. This systematic review examines whether yoga interventions provide any measurable benefit, both physically and psychologically, for women with breast cancer. The results will inform future research in this field and advance the development of yoga programmes. METHODS: We performed electronic searches of MEDLINE, PsychINFO, the Cochrane Library, Embase, CINAHL, AMED, Web of Science and Scopus for articles published up to June 2012. Only randomised controlled trials (RCTs) were included and methodological quality rating scores were determined using the PEDro (Physiotherapy Evidence Database) Scale. RESULTS: One hundred thirty-two studies were identified through a systematic search of eight electronic databases. Only published manuscripts that employed a RCT design were included (n = 18). The sample sizes for these studies varied widely from 18 to 164 participants and the associated PEDro scores ranged from 1 (poor) to 8 (good). All 18 studies reported positive effects for treatment-related side effects in favour of the yoga interventions, with the greatest impact on global quality of life (QoL) scores and emotional well-being. CONCLUSION: Results from the few RCTs suggest there is moderate to good evidence that yoga may be a useful practice for women recovering from breast cancer treatments. Large-scale RCTs using objective measures and patient-reported outcomes with long-term follow-up are needed to substantiate whether the benefits are true and sustainable.

The attitudes of 1066 patients with cancer towards participation in randomised clinical trials.

BACKGROUND: barriers to randomised clinical trial (RCT) recruitment include failure to identify eligible patients, reluctance of staff to approach them and attitudes of some health-care professionals and patients. As part of a larger UK prospective study examining the communication and involvement in RCTs of 22 multidisciplinary teams in Wales, we also assessed the attitudes of patients they treat towards trials. METHODS: out of 1146 patients attending outpatient departments who were approached, 1146 (93%) completed the seven-item Attitudes to Randomised Trials Questionnaire (ARTQ), probing their general attitudes towards medical research and likely participation in a hypothetical two-arm RCT. RESULTS: randomisation initially deterred many patients from endorsing a willingness to participate. However, if information about the trial logic, voluntary nature and rights to withdraw were provided, together with further treatment details, 83% (886 out of 1066) would potentially participate. Other variables associated with a positive inclination towards participation included previous trial experience (P<0.01), male gender (P<0.01) and younger age, with patients > or =70 years less likely to consider trial entry (P<0.01). CONCLUSION: the majority of patients were receptive to RCT participation. Many of those initially disinclined because of randomisation would consider joining if given further details that form part of standard GCP consent guidelines. These data show the importance and need for clear communication and information to encourage RCT participation. Evidence-based training courses are available to assist with this.