Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management

Not Applicable

Completed

Interventions: Other: Reflexology plus conventional treatment
Other: Homeopathy plus conventional treatment
Other: Conventional treatment

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.

Recruitment & Eligibility

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)
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

Arm && Interventions

Group	Intervention	Description
Reflexology plus conventional treatment	Reflexology plus conventional treatment	-
Homeopathy plus conventional treatment	Homeopathy plus conventional treatment	-
Conventional treatment	Conventional treatment	-

Primary Outcome Measures

Name	Time	Method
The change in the Asthma Quality of Life Questionnaire(AQLQ)	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.

Secondary Outcome Measures

Name	Time	Method
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	At baseline, week 26 and week 52
Asthma symptoms	Two weeks prior to week 2, 26 and 52.	Daytime and nighttime symptoms were recorded in patients diaries.
Peak expiratory flow	Two weeks prior to week 2, 26 and 52.	Morning and evening Peak expiratory flow(PEF) were performed before inhalation medication
Rescue medication usage	To weeks prior to week 2, 26 and 52
Total medication score	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	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	At baseline, at week 26 and week 52	The provocotive dose of Methacholine causing a 20% fall in FEV1

Locations (1): Department of Respiratory Diseases, University Hospital of Aarhus
🇩🇰
Aarhus, Denmark

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