Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management
|ClinicalTrials.gov Identifier: NCT01426061|
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : August 30, 2011
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 or disease||Intervention/treatment||Phase|
|Asthma||Other: Reflexology plus conventional treatment Other: Homeopathy plus conventional treatment Other: Conventional treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Reflexology, Homeopathy and Conventional Medical Treatment in Asthma: A Randomised Controlled, Parallel Group Trial.|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
|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.
- 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. ]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.
- Asthma control questionnaire (ACQ) [ Time Frame: At baseline, week 26 and week 52 ]
- EuroQol(EQ-5D) [ Time Frame: At baseline, week 26 and week 52 ]
- Forced expiratory volume in 1 second [ Time Frame: At baseline, week 26 and week 52 ]
- Asthma symptoms [ Time Frame: Two weeks prior to week 2, 26 and 52. ]Daytime and nighttime symptoms were recorded in patients diaries.
- Peak expiratory flow [ Time Frame: Two weeks prior to week 2, 26 and 52. ]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 ]
- Total medication score [ Time Frame: At baseline, at week 26 and week 52. ]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 ]
- Exhaled nitric oxide [ Time Frame: At baseline, at week 26 and week 52 ]
- Serum eosinophil cationic protein [ Time Frame: At baseline, at week 26 and week 52 ]
- PD20 [ Time Frame: At baseline, at week 26 and week 52 ]The provocotive dose of Methacholine causing a 20% fall in FEV1
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426061
|Department of Respiratory Diseases, University Hospital of Aarhus|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Ronald Dahl, MD||Department of Respiratory Diseases, University Hospital of Aarhus, DK-8000 Aarhus C|