Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management
NCT ID: NCT01426061
Last Updated: 2011-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
98 participants
INTERVENTIONAL
2006-05-31
2009-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Reflexology plus conventional treatment
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.
Homeopathy plus conventional treatment
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.
Conventional treatment
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.
Interventions
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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.
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.
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 Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GCP-unit at Aarhus University Hospital, Aarhus, Denmark
OTHER
Danish Classical Homeopathy Society
UNKNOWN
Danish Reflexologist Association
OTHER
University of Aarhus
OTHER
Responsible Party
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Ayfer Topcu
M.D.
Principal Investigators
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Ronald Dahl, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Respiratory Diseases, University Hospital of Aarhus, DK-8000 Aarhus C
Locations
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Department of Respiratory Diseases, University Hospital of Aarhus
Aarhus, , Denmark
Countries
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References
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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.
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.
McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic asthma. Cochrane Database Syst Rev. 2004;2004(1):CD000353. doi: 10.1002/14651858.CD000353.pub2.
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.
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.
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.
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.
Other Identifiers
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20040206
Identifier Type: -
Identifier Source: org_study_id