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Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management

This study has been completed.
Sponsor:
Collaborators:
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Danish Classical Homeopathy Society
Danish Reflexologist Association
Information provided by (Responsible Party):
Ayfer Topcu, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01426061
First received: August 18, 2011
Last updated: August 29, 2011
Last verified: August 2011
History of Changes
  Purpose

There is a lack of scientific evidence that homeopathy and reflexology is effective treatment of asthma. Systematic reviews have found that many clinical trials testing homeopathy and reflexology have major flaws, such as small number of participants, lack of control groups or inadequate allocation concealment.

The aim of the present study was to assess the effect of reflexology and individualised homeopathy as an adjuvant treatment in asthma. In order to address this issue, the investigators conducted an investigator-blinded, randomized, controlled parallel group study.


Condition Intervention
Asthma
 Other: Reflexology plus conventional treatment
Other: Homeopathy plus conventional treatment
Other: Conventional treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Reflexology, Homeopathy and Conventional Medical Treatment in Asthma: A Randomised Controlled, Parallel Group Trial.

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • The change in the Asthma Quality of Life Questionnaire(AQLQ) [ Time Frame: Assesment of quality of life was perfomed at baseline, at week 26 and at week 52. ] [ Designated as safety issue: No ]
    AQLQ is self-administered questionnaire which consists of 32 questions in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). Patients responded to each question on a seven point scale (7=no impairment 1=maximal impairment) and recalled their experiences during the previous 2 weeks. The overall AQLQ score was the mean of all 32 questions. A change in score of ≥0.5 indicates the minimal important difference (MID) in AQLQ.


Secondary Outcome Measures:
  • Asthma control questionnaire (ACQ) [ Time Frame: At baseline, week 26 and week 52 ] [ Designated as safety issue: No ]
  • EuroQol(EQ-5D) [ Time Frame: At baseline, week 26 and week 52 ] [ Designated as safety issue: No ]
  • Forced expiratory volume in 1 second [ Time Frame: At baseline, week 26 and week 52 ] [ Designated as safety issue: No ]
  • Asthma symptoms [ Time Frame: Two weeks prior to week 2, 26 and 52. ] [ Designated as safety issue: No ]
    Daytime and nighttime symptoms were recorded in patients diaries.

  • Peak expiratory flow [ Time Frame: Two weeks prior to week 2, 26 and 52. ] [ Designated as safety issue: No ]
    Morning and evening Peak expiratory flow(PEF) were performed before inhalation medication

  • Rescue medication usage [ Time Frame: To weeks prior to week 2, 26 and 52 ] [ Designated as safety issue: No ]
  • Total medication score [ Time Frame: At baseline, at week 26 and week 52. ] [ Designated as safety issue: No ]
    Total medication score was created by combaning a score given to each prescribed controller and reliever medication.

  • Blood eosinophils count [ Time Frame: At baseline, at week 26 and week 52 ] [ Designated as safety issue: No ]
  • Exhaled nitric oxide [ Time Frame: At baseline, at week 26 and week 52 ] [ Designated as safety issue: No ]
  • Serum eosinophil cationic protein [ Time Frame: At baseline, at week 26 and week 52 ] [ Designated as safety issue: No ]
  • PD20 [ Time Frame: At baseline, at week 26 and week 52 ] [ Designated as safety issue: No ]
    The provocotive dose of Methacholine causing a 20% fall in FEV1


Enrollment: 98
Study Start Date: May 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reflexology plus conventional treatment Other: Reflexology plus conventional treatment
Patients in the reflexology group received reflexology treatment in addition to usual care of asthma.Patients received treatments weekly for four to six weeks, followed by two treatments for one month. Treatments were then given monthly until the end of the study.
Experimental: Homeopathy plus conventional treatment Other: Homeopathy plus conventional treatment
Patients in the homeopathy group received homeopathic treatment in addition to usual care of asthma.Homeopathic treatment was decided on an individual basis by the homeopath and prescribed as an oral treatment. Patients received homeopathic product with potency between C30 (dilution by a factor 10030 =1060) and M10 (dilution by a factor 100010 =1030). The number of homeopathy sessions attended was six to twelve during one year.
No Intervention: Conventional treatment Other: Conventional treatment
Patients in the conventional treatment group received usual care of asthma. This treatment was monitored and adjusted as usual by the patient's general practitioner.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Forced expiratory volume in 1 second (FEV1) ≥60% predicted
  • A history of bronchial asthma for minimum 6 months prior to baseline

  • An objective measure of abnormal variation in bronchial calibre(The objective measure were defined as at least one of the following)

    1. a positive bronchodilator reversibility test, defined as increase in FEV1≥10% after 400 µg inhaled salbutamol;
    2. a positive methacholine test, defined as a PD20 of <1000 μg;
    3. a positive test for exercise induced asthma defined as a fall in FEV1>15% after a standardised 6 min exercise test; and
    4. a positive peak expiratory flow (PEF) variability , defined by ≥3 days or 2 consecutive days with a differences between morning and evening PEF of >20% during a 2-week period.

Exclusion Criteria:

  • Hospitalization for asthma within 3 months,
  • Asthma exacerbation during the last month,
  • Changes in asthma medication within 30 days of screening
  • A smoking history > 10 pack-years and smoking within the last year.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426061

Locations
Denmark
Department of Respiratory Diseases, University Hospital of Aarhus
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Danish Classical Homeopathy Society
Danish Reflexologist Association
Investigators
Principal Investigator: Ronald Dahl, MD Department of Respiratory Diseases, University Hospital of Aarhus, DK-8000 Aarhus C
  More Information

Publications:

Responsible Party: Ayfer Topcu, M.D., University of Aarhus
ClinicalTrials.gov Identifier: NCT01426061     History of Changes
Other Study ID Numbers: 20040206
Study First Received: August 18, 2011
Last Updated: August 29, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Complementary and alternative medicine
Reflexology
Homeopathy
Asthma
Randomized controlled trial

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013