Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Reflexology, Homeopathy and Conventional Medical Treatment in Asthma: A Randomised Controlled, Parallel Group Trial.

Conditions
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Asthma

Intervention / Treatment
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* Other: Reflexology plus conventional treatment
* Other: Homeopathy plus conventional treatment
* Other: Conventional treatment


Participation Criteria
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Eligibility Criteria
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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) a positive bronchodilator reversibility test, defined as increase in FEV1≥10% after 400 µg inhaled salbutamol; a positive methacholine test, defined as a PD20 of <1000 μg; a positive test for exercise induced asthma defined as a fall in FEV1>15% after a standardised 6 min exercise test; and 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: Hospitalization for asthma within 3 months, 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reflexology plus conventional treatment<br> | Other: Reflexology plus conventional treatment<br>* 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.<br>|
| Experimental: Homeopathy plus conventional treatment<br> | Other: Homeopathy plus conventional treatment<br>* 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.<br>|
| No Intervention: Conventional treatment<br> | Other: Conventional treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Complementary and alternative medicine, Reflexology, Homeopathy, Randomized controlled trial