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AzTrials

AsthmaNCT01426061

Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management

A study testing Reflexology plus conventional treatment, Homeopathy plus conventional treatment and Conventional treatment in people with Asthma, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Reflexology plus conventional treatment, Homeopathy plus conventional treatment and Conventional treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteDenmark
Study dates
May 2006to Oct 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Respiratory Diseases, University Hospital of Aarhus

    Aarhus, 8000

Other trials in Denmark

About this study

Official title: 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.

Conditions
Asthma
Being tested
Reflexology plus conventional treatment, Homeopathy plus conventional treatment, Conventional treatment
Keywords
Complementary and alternative medicine, Reflexology, Homeopathy, Asthma, Randomized controlled trial
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reflexology plus conventional treatmentOther

    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 treatmentOther

    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 treatmentOther

    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.

Study groups in NCT01426061
Study groupRoleWhat they receive
Reflexology plus conventional treatmentExperimentalNot described
Receives: Other: Reflexology plus conventional treatment
Homeopathy plus conventional treatmentExperimentalNot described
Receives: Other: Homeopathy plus conventional treatment
Conventional treatmentNo interventionNot described
Receives: Other: Conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assesment of quality of life was perfomed at baseline, at week 26 and at week 52.

Secondary outcomes (11)

  1. Asthma control questionnaire (ACQ)

    Measured: At baseline, week 26 and week 52

  2. EuroQol(EQ-5D)

    Measured: At baseline, week 26 and week 52

  3. Forced expiratory volume in 1 second

    Measured: At baseline, week 26 and week 52

  4. Asthma symptoms

    Daytime and nighttime symptoms were recorded in patients diaries.

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

  5. Peak expiratory flow

    Morning and evening Peak expiratory flow(PEF) were performed before inhalation medication

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

  6. Rescue medication usage

    Measured: To weeks prior to week 2, 26 and 52

  7. Total medication score

    Total medication score was created by combaning a score given to each prescribed controller and reliever medication.

    Measured: At baseline, at week 26 and week 52.

  8. Blood eosinophils count

    Measured: At baseline, at week 26 and week 52

  9. Exhaled nitric oxide

    Measured: At baseline, at week 26 and week 52

  10. Serum eosinophil cationic protein

    Measured: At baseline, at week 26 and week 52

  11. PD20

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

    Measured: At baseline, at week 26 and week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2011 (estimated)
  2. Study startMay 2006
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01426061
Sponsor's protocol ID
20040206
Status last verified
Aug 2011
First submitted
18 Aug 2011
Last updated
30 Aug 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Ng TP, Wong ML, Hong CY, Koh KT, Goh LG. The use of complementary and alternative medicine by asthma patients. QJM. 2003 Oct;96(10):747-54. doi: 10.1093/qjmed/hcg121.

    PubMed 14500861

  • Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med. 2003 Mar 4;138(5):393-9. doi: 10.7326/0003-4819-138-5-200303040-00009.

    PubMed 12614092

  • McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic asthma. Cochrane Database Syst Rev. 2004;2004(1):CD000353. doi: 10.1002/14651858.CD000353.pub2.

    PubMed 14973954

  • Ernst E. Is reflexology an effective intervention? A systematic review of randomised controlled trials. Med J Aust. 2009 Sep 7;191(5):263-6. doi: 10.5694/j.1326-5377.2009.tb02780.x.

    PubMed 19740047

  • Brygge T, Heinig JH, Collins P, Ronborg S, Gehrchen PM, Hilden J, Heegaard S, Poulsen LK. Reflexology and bronchial asthma. Respir Med. 2001 Mar;95(3):173-9. doi: 10.1053/rmed.2000.0975.

    PubMed 11266233

  • Lewith GT, Watkins AD, Hyland ME, Shaw S, Broomfield JA, Dolan G, Holgate ST. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial. BMJ. 2002 Mar 2;324(7336):520. doi: 10.1136/bmj.324.7336.520.

    PubMed 11872551

  • White A, Slade P, Hunt C, Hart A, Ernst E. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax. 2003 Apr;58(4):317-21. doi: 10.1136/thorax.58.4.317.

    PubMed 12668794

Questions about this trial

What is this clinical trial studying?

A study testing Reflexology plus conventional treatment, Homeopathy plus conventional treatment and Conventional treatment in people with Asthma, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01426061, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011.

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