Objectives: For people with dyspepsia who are receiving orthodox general practice care, what is the effect on outcome and on NHS costs of adding treatment by a choice of acupuncture or homeopathy? This paper describes and reflects upon a pilot study with user involvement.
Design: A randomised pilot study. Patients chose between acupuncture and homeopathy and were then randomised to this preference or to the control group of normal GP care.
Setting and participants: Sixty people with dyspepsia (>/=2 weeks) presenting in one UK general practice were recruited in consultations and by letter to those on repeat prescriptions. There were few exclusion criteria. The homeopath and the acupuncturist treated the patient individually according to their normal practice for up to 6 months. After the trial there was a focus group for participants.
Outcome measures: SF-36 health survey, Measure Yourself Medical Outcome Profile (MYMOP), and General Well-being Index (GWBI). Counts of prescriptions, consultations and referrals from practice computer records.
Results: No trend or significant difference between the groups for clinical outcome or NHS costs. Major costs for the 6 months, mean (S.D.) cost per patient, were general practitioner consultations pound 8 (18), prescriptions pound 64 (73), acupuncture pound 175 (52), homeopathy pound 105 (33). Participants gave insights and suggestions which will inform the full trial design.
Conclusions: Reflection on the pilot study data and experience by participants, treating practitioners and researchers led to modifications in the design and a sample size calculation. How to demonstrate individual responses to treatment remains a problem.