Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charlotte Paterson

ORCID ID

Contact details

Department of Social Medicine
Canynge Hall
University of Bristol
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
+44 (0)117 331 3901
C.Paterson@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RS/08/04.98

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

21/11/1998

Overall trial end date

12/06/2000

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

21/11/1998

Recruitment end date

12/06/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Social Medicine
Bristol
BS8 2PR
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/12801492

Publication citations

  1. Results

    Paterson C, Ewings P, Brazier JE, Britten N, Treating dyspepsia with acupuncture and homeopathy: reflections on a pilot study by researchers, practitioners and participants., Complement Ther Med, 2003, 11, 2, 78-84.

Additional files

Editorial Notes