Clinical trial NCT01426061: Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management
Official title: Effect of Reflexology, Homeopathy and Conventional Medical Treatment in Asthma: A Randomised Controlled, Parallel Group Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Complementary and alternative medicine
Reflexology
Homeopathy
Asthma
Randomized controlled trial
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: GCP-unit at Aarhus University Hospital, Aarhus, Denmark
name: Danish Classical Homeopathy Society
name: Danish Reflexologist Association
First posted: 2011-08-30
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change in the Asthma Quality of Life Questionnaire(AQLQ)
timeFrame: Assesment of quality of life was perfomed at baseline, at week 26 and at week 52.
Secondary outcomes:
measure: Asthma control questionnaire (ACQ)
timeFrame: At baseline, week 26 and week 52
measure: EuroQol(EQ-5D)
timeFrame: At baseline, week 26 and week 52
measure: Forced expiratory volume in 1 second
timeFrame: At baseline, week 26 and week 52
measure: Asthma symptoms
timeFrame: Two weeks prior to week 2, 26 and 52.
measure: Peak expiratory flow
timeFrame: Two weeks prior to week 2, 26 and 52.
measure: Rescue medication usage
timeFrame: To weeks prior to week 2, 26 and 52
measure: Total medication score
timeFrame: At baseline, at week 26 and week 52.
measure: Blood eosinophils count
timeFrame: At baseline, at week 26 and week 52
measure: Exhaled nitric oxide
timeFrame: At baseline, at week 26 and week 52
measure: Serum eosinophil cationic protein
timeFrame: At baseline, at week 26 and week 52
measure: PD20
timeFrame: At baseline, at week 26 and week 52
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Respiratory Diseases, University Hospital of Aarhus
Study officials:
affiliation: Department of Respiratory Diseases, University Hospital of Aarhus, DK-8000 Aarhus C
name: Ronald Dahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic asthma. Cochrane Database Syst Rev. 2004;2004(1):CD000353. doi: 10.1002/14651858.CD000353.pub2.
citation: 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.
citation: 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.
citation: 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.
citation: 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.