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| Name | Class |
|---|---|
| GCP-unit at Aarhus University Hospital, Aarhus, Denmark | OTHER |
| Danish Classical Homeopathy Society | UNKNOWN |
| Danish Reflexologist Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reflexology plus conventional treatment | Experimental |
| |
| Homeopathy plus conventional treatment | Experimental |
| |
| Conventional treatment | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflexology plus conventional treatment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assesment of quality of life was perfomed at baseline, at week 26 and at week 52. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control questionnaire (ACQ) | At baseline, week 26 and week 52 | |
| EuroQol(EQ-5D) | At baseline, week 26 and week 52 | |
| Forced expiratory volume in 1 second |
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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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Dahl, MD | Department of Respiratory Diseases, University Hospital of Aarhus, DK-8000 Aarhus C | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Respiratory Diseases, University Hospital of Aarhus | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14500861 | Background | 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. | |
| 12614092 | Background | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D006705 | Homeopathy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| Homeopathy plus conventional treatment | Other | 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 | Other | 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. |
|
| At baseline, week 26 and week 52 |
| Asthma symptoms | Daytime and nighttime symptoms were recorded in patients diaries. | Two weeks prior to week 2, 26 and 52. |
| Peak expiratory flow | Morning and evening Peak expiratory flow(PEF) were performed before inhalation medication | Two weeks prior to week 2, 26 and 52. |
| Rescue medication usage | To weeks prior to week 2, 26 and 52 |
| Total medication score | Total medication score was created by combaning a score given to each prescribed controller and reliever medication. | At baseline, at week 26 and week 52. |
| Blood eosinophils count | At baseline, at week 26 and week 52 |
| Exhaled nitric oxide | At baseline, at week 26 and week 52 |
| Serum eosinophil cationic protein | At baseline, at week 26 and week 52 |
| PD20 | The provocotive dose of Methacholine causing a 20% fall in FEV1 | At baseline, at week 26 and week 52 |
| 14973954 | Background | McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic asthma. Cochrane Database Syst Rev. 2004;2004(1):CD000353. doi: 10.1002/14651858.CD000353.pub2. |
| 19740047 | Background | 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. |
| 11266233 | Background | 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. |
| 11872551 | Background | 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. |
| 12668794 | Background | 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |