Back to resultsClinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Reflexology plus conventional treatment
Homeopathy plus conventional treatment
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Complementary and alternative medicine, Reflexology, Homeopathy, Asthma, Randomized controlled trial
Eligibility 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)
- a positive bronchodilator reversibility test, defined as increase in FEV1≥10% after 400 µg inhaled salbutamol;
- a positive methacholine test, defined as a PD20 of <1000 μg;
- a positive test for exercise induced asthma defined as a fall in FEV1>15% after a standardised 6 min exercise test; and
- 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.
Sites / Locations
- Department of Respiratory Diseases, University Hospital of Aarhus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Reflexology plus conventional treatment
Homeopathy plus conventional treatment
Conventional treatment
Arm Description
Outcomes
Primary Outcome Measures
The change in the Asthma Quality of Life Questionnaire(AQLQ)
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)
EuroQol(EQ-5D)
Forced expiratory volume in 1 second
Asthma symptoms
Daytime and nighttime symptoms were recorded in patients diaries.
Peak expiratory flow
Morning and evening Peak expiratory flow(PEF) were performed before inhalation medication
Rescue medication usage
Total medication score
Total medication score was created by combaning a score given to each prescribed controller and reliever medication.
Blood eosinophils count
Exhaled nitric oxide
Serum eosinophil cationic protein
PD20
The provocotive dose of Methacholine causing a 20% fall in FEV1
Full Information
NCT ID
NCT01426061
First Posted
August 18, 2011
Last Updated
August 29, 2011
Sponsor
University of Aarhus
Collaborators
GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Danish Classical Homeopathy Society, Danish Reflexologist Association
1. Study Identification
Unique Protocol Identification Number
NCT01426061
Brief Title
Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management
Official Title
Effect of Reflexology, Homeopathy and Conventional Medical Treatment in Asthma: A Randomised Controlled, Parallel Group Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Danish Classical Homeopathy Society, Danish Reflexologist Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Complementary and alternative medicine, Reflexology, Homeopathy, Asthma, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reflexology plus conventional treatment
Arm Type
Experimental
Arm Title
Homeopathy plus conventional treatment
Arm Type
Experimental
Arm Title
Conventional treatment
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Reflexology plus conventional treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Homeopathy plus conventional treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in the Asthma Quality of Life Questionnaire(AQLQ)
Description
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.
Time Frame
Assesment of quality of life was perfomed at baseline, at week 26 and at week 52.
Secondary Outcome Measure Information:
Title
Asthma control questionnaire (ACQ)
Time Frame
At baseline, week 26 and week 52
Title
EuroQol(EQ-5D)
Time Frame
At baseline, week 26 and week 52
Title
Forced expiratory volume in 1 second
Time Frame
At baseline, week 26 and week 52
Title
Asthma symptoms
Description
Daytime and nighttime symptoms were recorded in patients diaries.
Time Frame
Two weeks prior to week 2, 26 and 52.
Title
Peak expiratory flow
Description
Morning and evening Peak expiratory flow(PEF) were performed before inhalation medication
Time Frame
Two weeks prior to week 2, 26 and 52.
Title
Rescue medication usage
Time Frame
To weeks prior to week 2, 26 and 52
Title
Total medication score
Description
Total medication score was created by combaning a score given to each prescribed controller and reliever medication.
Time Frame
At baseline, at week 26 and week 52.
Title
Blood eosinophils count
Time Frame
At baseline, at week 26 and week 52
Title
Exhaled nitric oxide
Time Frame
At baseline, at week 26 and week 52
Title
Serum eosinophil cationic protein
Time Frame
At baseline, at week 26 and week 52
Title
PD20
Description
The provocotive dose of Methacholine causing a 20% fall in FEV1
Time Frame
At baseline, at week 26 and week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
a positive bronchodilator reversibility test, defined as increase in FEV1≥10% after 400 µg inhaled salbutamol;
a positive methacholine test, defined as a PD20 of <1000 μg;
a positive test for exercise induced asthma defined as a fall in FEV1>15% after a standardised 6 min exercise test; and
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Dahl, MD
Organizational Affiliation
Department of Respiratory Diseases, University Hospital of Aarhus, DK-8000 Aarhus C
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Respiratory Diseases, University Hospital of Aarhus
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
14500861
Citation
Ng TP, Wong ML, Hong CY, Koh KT, Goh LG. The use of complementary and alternative medicine by asthma patients. QJM. 2003 Oct;96(10):747-54. doi: 10.1093/qjmed/hcg121.
Results Reference
background
PubMed Identifier
12614092
Citation
Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med. 2003 Mar 4;138(5):393-9. doi: 10.7326/0003-4819-138-5-200303040-00009.
Results Reference
background
PubMed Identifier
14973954
Citation
McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic asthma. Cochrane Database Syst Rev. 2004;2004(1):CD000353. doi: 10.1002/14651858.CD000353.pub2.
Results Reference
background
PubMed Identifier
19740047
Citation
Ernst E. Is reflexology an effective intervention? A systematic review of randomised controlled trials. Med J Aust. 2009 Sep 7;191(5):263-6. doi: 10.5694/j.1326-5377.2009.tb02780.x.
Results Reference
background
PubMed Identifier
11266233
Citation
Brygge T, Heinig JH, Collins P, Ronborg S, Gehrchen PM, Hilden J, Heegaard S, Poulsen LK. Reflexology and bronchial asthma. Respir Med. 2001 Mar;95(3):173-9. doi: 10.1053/rmed.2000.0975.
Results Reference
background
PubMed Identifier
11872551
Citation
Lewith GT, Watkins AD, Hyland ME, Shaw S, Broomfield JA, Dolan G, Holgate ST. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial. BMJ. 2002 Mar 2;324(7336):520. doi: 10.1136/bmj.324.7336.520.
Results Reference
background
PubMed Identifier
12668794
Citation
White A, Slade P, Hunt C, Hart A, Ernst E. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax. 2003 Apr;58(4):317-21. doi: 10.1136/thorax.58.4.317.
Results Reference
background
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Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management
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