| Integrating patient preferences in clinical trials: a pilot study of acupuncture versus midazolam for gastroscopy. | |
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MedLine Citation:
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PMID: 12165184 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND AND OBJECTIVES: Patient preferences play an important role when choosing between different treatment options and may have an influence on outcome. We performed a study to investigate (1) to what extent patients make use of the offer to receive acupuncture as a pretreatment for gastroscopy, (2) whether this is perceived as being as effective as sedation, and (3) whether characteristics and outcomes differ between patients giving consent to random allocation and patients choosing their pretreatment. DESIGN: Partially randomized patient preference trial. Patients who gave consent to randomization were allocated randomly while patients who had a preference received the treatment of their choice. PATIENTS: One hundred and six (106) inpatients of a district hospital in southern Germany undergoing gastroscopy for diagnostic purposes. INTERVENTIONS: Pretreatment with a sedative (midazolam) or acupuncture. MAIN OUTCOME MEASURE: Patient's overall assessment on a visual analogue scale (VAS). RESULTS: Twenty-eight (28) patients (26%) agreed to be randomized, 21 (20%) chose acupuncture, 51 (47%) midazolam, and 8 (7%) did not want pretreatment. Patients receiving midazolam rated the examination as slightly less troublesome than those receiving acupuncture. Oxygen saturation, blood pressure, and heart rate were significantly lower in patients receiving midazolam. Characteristics and outcomes of randomized and nonrandomized patients did not differ significantly. CONCLUSIONS: Because of the low number of patients giving consent to random allocation conclusions on effectiveness are difficult to draw. The partially randomized patient preference design is recommended for use in future trials of acupuncture for gastroscopy. Such trials should be performed in an outpatient setting. |
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Authors:
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Dieter Melchart; Hans-Gerhard Steger; Klaus Linde; Karina Makarian; Ziad Hatahet; Rainer Brenke; Reinhard Saller |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Journal of alternative and complementary medicine (New York, N.Y.) Volume: 8 ISSN: 1075-5535 ISO Abbreviation: J Altern Complement Med Publication Date: 2002 Jun |
Date Detail:
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Created Date: 2002-08-07 Completed Date: 2002-10-16 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 9508124 Medline TA: J Altern Complement Med Country: United States |
Other Details:
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Languages: eng Pagination: 265-74 Citation Subset: IM |
Affiliation:
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Department of Internal Medicine II, Centre for Complementary Medicine Research, Technische Universität, Munich, Germany. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Acupuncture Therapy*
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methods,
psychology Aged Aged, 80 and over Decision Making Female Gastroscopy* Germany Humans Hypnotics and Sedatives / therapeutic use* Male Midazolam / therapeutic use* Middle Aged Patient Satisfaction* Pilot Projects Premedication* Questionnaires Research Design Statistics, Nonparametric Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Hypnotics and Sedatives; 59467-70-8/Midazolam |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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