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NCT Number: NCT01426061

Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Respiratory Diseases, University Hospital of Aarhus

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reflexology plus conventional treatment

Other

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.

Homeopathy plus conventional treatment

Other

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.

conventional treatment

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Asthma control questionnaire (ACQ)

    Time frame: At baseline, week 26 and week 52

  2. EuroQol(EQ-5D)

    Time frame: At baseline, week 26 and week 52

  3. Forced expiratory volume in 1 second

    Time frame: At baseline, week 26 and week 52

  4. Asthma symptoms

    Time frame: Two weeks prior to week 2, 26 and 52.

    Daytime and nighttime symptoms were recorded in patients diaries.

  5. 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

  6. Rescue medication usage

    Time frame: To weeks prior to week 2, 26 and 52

  7. 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.

  8. Blood eosinophils count

    Time frame: At baseline, at week 26 and week 52

  9. Exhaled nitric oxide

    Time frame: At baseline, at week 26 and week 52

  10. Serum eosinophil cationic protein

    Time frame: At baseline, at week 26 and week 52

  11. PD20

    Time frame: At baseline, at week 26 and week 52

    The provocotive dose of Methacholine causing a 20% fall in FEV1

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 30, 2011
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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