Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426061
• Other study ID #: 20040206
• Status: Completed
• Phase: N/A
• First received: August 18, 2011
• Last updated: August 29, 2011
• Start date: May 2006
• Est. completion date: October 2009

Study information

• Verified date: August 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Respiratory Diseases, University Hospital of Aarhus	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Danish Classical Homeopathy Society, Danish Reflexologist Association, GCP-unit at Aarhus University Hospital, Aarhus, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. — View 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. Review. — View Citation

Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med. 2003 Mar 4;138(5):393-9. Review. — View 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. — View Citation

McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic asthma. Cochrane Database Syst Rev. 2004;(1):CD000353. Review. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Asthma control questionnaire (ACQ)		At baseline, week 26 and week 52	No
Secondary	EuroQol(EQ-5D)		At baseline, week 26 and week 52	No
Secondary	Forced expiratory volume in 1 second		At baseline, week 26 and week 52	No
Secondary	Asthma symptoms	Daytime and nighttime symptoms were recorded in patients diaries.	Two weeks prior to week 2, 26 and 52.	No
Secondary	Peak expiratory flow	Morning and evening Peak expiratory flow(PEF) were performed before inhalation medication	Two weeks prior to week 2, 26 and 52.	No
Secondary	Rescue medication usage		To weeks prior to week 2, 26 and 52	No
Secondary	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.	No
Secondary	Blood eosinophils count		At baseline, at week 26 and week 52	No
Secondary	Exhaled nitric oxide		At baseline, at week 26 and week 52	No
Secondary	Serum eosinophil cationic protein		At baseline, at week 26 and week 52	No
Secondary	PD20	The provocotive dose of Methacholine causing a 20% fall in FEV1	At baseline, at week 26 and week 52	No