OBJECTIVE: The aim was to study the effect of tactile massage versus relaxation exercises on health-related quality of life (HRQoL) in patients with type 2 diabetes, at primary-health-care centres in Stockholm county. DESIGN: The study was carried out as a parallel-arm clinical trial. Patients with type 2 diabetes and HbA1c of 6-8%, aged 35-75, with oral anti-diabetic treatment were included. In all, 26 and 27 attendants in the TM and relaxation group, respectively, entered the study and were included in the intention-to-treat analysis. The attendants were offered one weekly session of TM or the use of relaxation exercises at least once weekly for a total of 10 weeks. MAIN OUTCOME MEASURES: HRQoL was measured using the SF-36 questionnaire at baseline, after 10 weeks of therapy and 3 months after the completion of the study. Owing to multiple comparisons the level of statistical significance was set at p<0.01, and values of p>0.01 and <0.05 were regarded as borderline values. RESULTS: One difference over time between the groups was reaching a borderline value in favour of the relaxation group, i.e. the scale of "Role functioning, physical" (p<0.05). CONCLUSIONS: Based on the findings in this study, we conclude that stress-relieving techniques with TM or relaxation CD have limited, if any, beneficial effects on health-related quality of life in Swedish-born patients with type 2 diabetes. We cannot, however, rule out that specific patient groups with higher levels of perceived stress could show benefits with this kind of treatment.
RCT Entities:
OBJECTIVE: The aim was to study the effect of tactile massage versus relaxation exercises on health-related quality of life (HRQoL) in patients with type 2 diabetes, at primary-health-care centres in Stockholm county. DESIGN: The study was carried out as a parallel-arm clinical trial. Patients with type 2 diabetes and HbA1c of 6-8%, aged 35-75, with oral anti-diabetic treatment were included. In all, 26 and 27 attendants in the TM and relaxation group, respectively, entered the study and were included in the intention-to-treat analysis. The attendants were offered one weekly session of TM or the use of relaxation exercises at least once weekly for a total of 10 weeks. MAIN OUTCOME MEASURES: HRQoL was measured using the SF-36 questionnaire at baseline, after 10 weeks of therapy and 3 months after the completion of the study. Owing to multiple comparisons the level of statistical significance was set at p<0.01, and values of p>0.01 and <0.05 were regarded as borderline values. RESULTS: One difference over time between the groups was reaching a borderline value in favour of the relaxation group, i.e. the scale of "Role functioning, physical" (p<0.05). CONCLUSIONS: Based on the findings in this study, we conclude that stress-relieving techniques with TM or relaxation CD have limited, if any, beneficial effects on health-related quality of life in Swedish-born patients with type 2 diabetes. We cannot, however, rule out that specific patient groups with higher levels of perceived stress could show benefits with this kind of treatment.