Effects of an integrative treatment, therapeutic acupuncture and conventional treatment in alleviating psychological distress in primary care patients - a pragmatic randomized controlled trial

BACKGROUND: To evaluate and compare effects of an integrative treatment (IT), therapeutic acupuncture (TA), and conventional treatment (CT) in alleviating symptoms of anxiety and depression in psychologically distressed primary care patients. METHODS: An open, pragmatic randomized controlled trial comparing the three treatment regimens at four and eight weeks after treatment. The study sample consisted of 120 adults (40 per treatment arm) aged 20 to 55 years referred from four different primary health care centres in western Sweden for psychological distress. Psychological distress was evaluated at baseline, and after 4 and 8 weeks of treatment using the Hospital Anxiety and Depression scale (HAD). Treatment sessions lasted about 60 minutes in IT and 45 minutes in TA. RESULTS: No baseline differences were found between groups on HAD depression or anxiety. HAD anxiety and depression decreased significantly more in the IT and TA groups than in the CT group both after 4 and 8 weeks of treatment, but not between IT and TA. Improvements in the TA and IT groups were large and clinically significant, whereas CT effects were small and clinically non-significant. CONCLUSIONS: Both IT and TA appear to be beneficial in reducing anxiety and depression in primary care patients referred for psychological distress, whereas CT does not. These results need to be confirmed in larger, longer-term studies addressing potentially confounding design issues in the present study. TRIAL REGISTRATION: ISRCTN trial number NCT01631500.