OBJECTIVE: To conduct a pilot study to assess the feasibility of a proposed design of an acupuncture trial to relieve symptoms of infantile colic. METHOD: An open randomised single-blinded controlled trial, using standardised bilateral treatment of the acupuncture point ST36. Infants fulfilling Wessel's definition of infantile colic were included. PATIENTS: were randomised to active treatment or to no-treatment control. General practitioners (GPs) educated in Western medicalacupuncture did the interventions. Parents and GPs' assistants were blinded. Active treatment was the bilateral insertion of 0.20×15 mm Seirin needles to 12 mm depth at ST36. The intervention consisted of daily treatments of 30 s duration for three consecutive workdays. Blinding was done with a red point mark on the skin and circular adhesive dressing covering. The parents were asked two blinding validation questions in the course of the study period. The primary end point was the effect of the intervention assessed as change in crying time per 24 h measured with a crying registration form. RESULTS: The authors improved the standardisation and changed the blinding procedure as a result of the pilot study. Blinding validation questions were considered necessary. The changes made in the main study protocol are discussed. CONCLUSION: The pilot study led to important changes that were implemented into the final trial protocol. Blinding validation is essential in no-treatment controlled trials of acupuncture on infants, where the parents are blinded assessors of symptom reduction. The authors suggest that blinding validation questions, and the answers to these questions, should be reported. Clinical Trial Registry Identifier: NCT00907621.
RCT Entities:
OBJECTIVE: To conduct a pilot study to assess the feasibility of a proposed design of an acupuncture trial to relieve symptoms of infantile colic. METHOD: An open randomised single-blinded controlled trial, using standardised bilateral treatment of the acupuncture point ST36. Infants fulfilling Wessel's definition of infantile colic were included. PATIENTS: were randomised to active treatment or to no-treatment control. General practitioners (GPs) educated in Western medical acupuncture did the interventions. Parents and GPs' assistants were blinded. Active treatment was the bilateral insertion of 0.20×15 mm Seirin needles to 12 mm depth at ST36. The intervention consisted of daily treatments of 30 s duration for three consecutive workdays. Blinding was done with a red point mark on the skin and circular adhesive dressing covering. The parents were asked two blinding validation questions in the course of the study period. The primary end point was the effect of the intervention assessed as change in crying time per 24 h measured with a crying registration form. RESULTS: The authors improved the standardisation and changed the blinding procedure as a result of the pilot study. Blinding validation questions were considered necessary. The changes made in the main study protocol are discussed. CONCLUSION: The pilot study led to important changes that were implemented into the final trial protocol. Blinding validation is essential in no-treatment controlled trials of acupuncture on infants, where the parents are blinded assessors of symptom reduction. The authors suggest that blinding validation questions, and the answers to these questions, should be reported. Clinical Trial Registry Identifier: NCT00907621.
Authors: Wolfgang Raith; Gerhard Litscher; Iris Sapetschnig; Sebastian Bauchinger; Evelyne Ziehenberger; Wilhelm Müller; Berndt Urlesberger Journal: Evid Based Complement Alternat Med Date: 2012-05-14 Impact factor: 2.629
Authors: Wolfgang Raith; Gerhard Pichler; Iris Sapetschnig; Alexander Avian; Constanze Sommer; Nariae Baik; Martin Koestenberger; Georg M Schmölzer; Berndt Urlesberger Journal: Evid Based Complement Alternat Med Date: 2013-05-15 Impact factor: 2.629