Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management

NCT01426061 | Completed DMC

• 1 other identifier: 20040206
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Complementary and alternative medicine; Reflexology; Homeopathy; Asthma; Randomized controlled trial

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (11)

• Asthma control questionnaire (ACQ)

  At baseline, week 26 and week 52

• EuroQol(EQ-5D)

  At baseline, week 26 and week 52

• Forced expiratory volume in 1 second

  At baseline, week 26 and week 52

• Asthma symptoms

  Two weeks prior to week 2, 26 and 52.

• Peak expiratory flow

  Two weeks prior to week 2, 26 and 52.

Study Arms (3)

Reflexology plus conventional treatment

EXPERIMENTAL

Other: Reflexology plus conventional treatment

Homeopathy plus conventional treatment

EXPERIMENTAL

Other: Homeopathy plus conventional treatment

Conventional treatment

NO INTERVENTION

Other: Conventional treatment

Interventions

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.

Reflexology plus conventional treatment

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.

Homeopathy plus conventional treatment

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.

Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Department of Respiratory Diseases, University Hospital of Aarhus

Aarhus, 8000, Denmark

Location

Related Publications (7)

• 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.

  PMID: 14500861 BACKGROUND

• 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.

  PMID: 12614092 BACKGROUND

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

  PMID: 14973954 BACKGROUND

• 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.

  PMID: 19740047 BACKGROUND

• 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.

  PMID: 11266233 BACKGROUND

• 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.

  PMID: 11872551 BACKGROUND

• 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.

  PMID: 12668794 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Musculoskeletal Manipulations; Homeopathy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ronald Dahl, MD

  Department of Respiratory Diseases, University Hospital of Aarhus, DK-8000 Aarhus C

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 30, 2011
• Study Start: May 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 30, 2011

Record last verified: 2011-08

Locations

DK (1)