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Integrating patient preferences in clinical trials: a pilot study of acupuncture versus midazolam for gastroscopy
Dieter Melchart1, Hans-Gerhard Steger, Klaus Linde
1Department of Internal Medicine II, Centre for Complementary Medicine Research, Technische Universität, Munich, Germany.
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.