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
Secondary identifying numbers RS/08/04.98
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
22/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study objectivesFor 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) studiedPeptic ulcer disease
InterventionPatients 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 typeOther
Primary outcome measureClinical 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.
Secondary outcome measuresNot provided at time of registration
Overall study start date21/11/1998
Completion date12/06/2000

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants60
Key inclusion criteriaSixty 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 criteriaNot provided at time of registration
Date of first enrolment21/11/1998
Date of final enrolment12/06/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Social Medicine
Bristol
BS8 2PR
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South West (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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