Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management

August 29, 2011 updated by: Ayfer Topcu, University of Aarhus

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Respiratory Diseases, University Hospital of Aarhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
Time Frame: At baseline, week 26 and week 52
At baseline, week 26 and week 52
EuroQol(EQ-5D)
Time Frame: At baseline, week 26 and week 52
At baseline, week 26 and week 52
Forced expiratory volume in 1 second
Time Frame: At baseline, week 26 and week 52
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.
Two weeks prior to week 2, 26 and 52.
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
Two weeks prior to week 2, 26 and 52.
Rescue medication usage
Time Frame: To weeks prior to week 2, 26 and 52
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.
At baseline, at week 26 and week 52.
Blood eosinophils count
Time Frame: At baseline, at week 26 and week 52
At baseline, at week 26 and week 52
Exhaled nitric oxide
Time Frame: At baseline, at week 26 and week 52
At baseline, at week 26 and week 52
Serum eosinophil cationic protein
Time Frame: At baseline, at week 26 and week 52
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
At baseline, at week 26 and week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Danish Classical Homeopathy Society
Danish Reflexologist Association

Investigators

  • Principal Investigator: Ronald Dahl, MD, Department of Respiratory Diseases, University Hospital of Aarhus, DK-8000 Aarhus C

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (ESTIMATE)

August 30, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2011

Last Update Submitted That Met QC Criteria

August 29, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20040206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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