Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management

University of Aarhus

Status: Completed

Conditions: Asthma

Treatments: Other: Reflexology plus conventional treatment; Other: Conventional treatment; Other: Homeopathy plus conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01426061

20040206

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 3 patient groups

Reflexology plus conventional treatment

Experimental group

Treatment:

Other: Reflexology plus conventional treatment

Homeopathy plus conventional treatment

Experimental group

Treatment:

Other: Homeopathy plus conventional treatment

Conventional treatment

No Intervention group

Treatment:

Other: Conventional treatment