Treating patients with dyspepsia with acupuncture and homeopathy: a randomised pilot study of effectiveness and costs.

ISRCTN	ISRCTN92205535
DOI	https://doi.org/10.1186/ISRCTN92205535
Protocol serial number	RS/08/04.98
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South West (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Charlotte Paterson
Scientific

Department of Social Medicine
Canynge Hall
University of Bristol
Whiteladies Road
Bristol
BS8 2PR
United Kingdom

Phone	+44 (0)117 331 3901
Email	C.Paterson@bristol.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	For patients 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?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Peptic ulcer disease
Intervention	Patients chose between acupuncture and homeopathy and were then randomised to this preference or to the control group of normal GP care: 1. Homeopathy versus placebo 2. Acupuncture versus placebo Treatment and follow-up were for six months.
Intervention type	Other
Primary outcome measure(s)	Clinical outcome will be measured by validated outcome questionnaires: 1. The 36-item short form health survey (SF-36) 2. Measure Yourself Outcome Profile (MYMOP) 3. The General Well-Being Index Follow-up will be six-months. NHS costs collected for each patient will be prescribing costs, referral costs, and number of general practitioner consultations. Complementary practitioner costs will be their fees and homeopathy prescriptions.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	12/06/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	Sixty patients with dyspepsia presenting in one UK general practice. Participants expressed their preference for homeopathy or acupuncture before being randomised to receive their choice or be in the control group receiving normal GP care.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	21/11/1998
Date of final enrolment	12/06/2000

Department of Social Medicine

Bristol
BS8 2PR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/06/2003		Yes	No