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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
98
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.
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.
Department of Respiratory Diseases, University Hospital of Aarhus
Aarhus, Denmark
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.
Time frame: Assesment of quality of life was perfomed at baseline, at week 26 and at week 52.
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
Daytime and nighttime symptoms were recorded in patients diaries.
Time frame: Two weeks prior to week 2, 26 and 52.
Peak expiratory flow
Morning and evening Peak expiratory flow(PEF) were performed before inhalation medication
Time frame: Two weeks prior to week 2, 26 and 52.
Rescue medication usage
Time frame: 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.
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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.
Time frame: At baseline, at week 26 and week 52.
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
The provocotive dose of Methacholine causing a 20% fall in FEV1
Time frame: At baseline, at week 26 and week 52