Effectiveness of CT in Treatment

For each therapy and for each of the clinically relevant outcomes, the available evidence was summarised as shown in the following table:

Strong evidence for effectiveness
3+		 Systematic review finding a statistically significant and clinically important effect (without significant heterogeneity)
OR
More than one randomised controlled trial finds a statistically significant and clinically important effect and there are no equivalent trials showing absence
of effect
Probably effective
2+		 More than one controlled trial available. A majority, but not all, of which show a statistically significant and clinically important effect
Possibly effective
1+		 One controlled trial available shows a statistically significant effect
Equivocal evidence of effect
+/-		 Randomised or non-randomised clinical trials yield conflicting results, demonstrated effects are probably not clinically important
Possibly ineffective
1-		 One small controlled trial available shows no significant effect
Probably ineffective
2-		 More than one controlled trial available. A majority, but not all, of which exclude a clinically important effect (absence of effect)
OR
One large controlled trial excludes a clinically important effect
Strong evidence of lack of effect
3-		 Systematic review excludes a clinically important effect (without significant heterogeneity)
OR
More than one randomised controlled trial excludes a clinically important effect
Insufficient evidence
0		 Available evidence does not meet the above criteria

Results

The results of this review of effectiveness are summarised in the accompanying table. In addition, the table describes the patient group in which effectiveness was assessed; that is, the age group, the level of asthma control of the subjects, and their concomitant therapy. In particular, it should be noted that there are difficulties in translating effects observed with treatment of adults to those that could be expected when the same treatment is applied to children.

The table also cites evidence of adverse effects and other safety considerations, such as potential interactions with other treatments, which are relevant to the therapies. Additional information for medicinal therapies listed in this table was gained by searching the databases listed at the end of this paper.

Therapies for which there is insufficient evidence for all clinically relevant outcomes of asthma are not included in the table.

Methodology

Systematic reviews of the literature were undertaken for each of the complementary therapies that were identified as being of interest. The following databases were searched: Medline, Embase, Cinahl, Amed (Allied and Complementary Medicine database, www.bl.uk/services/information/amed.html), and the Cochrane Library (www.update-software.com/clibng/cliblogon.htm), Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews). For the Cochrane Databases, a simple search strategy combining the therapy descriptor(s) with the term ‘asthma’ was used. The following methodological filters, adapted from those recommended by Haynes et al.1 for the purpose of identifying citations relevant to therapy2, were used in the other database:

Medline
randomised controlled trial.pt. OR dt.fs. OR tu.fs. OR random$.tw.

Embase
randomised controlled trial/ OR dt.fs. OR random$.tw.

Cinahl
dt.fs. OR tu.fs. OR random$.tw.

Amed
random$.tw.

Each search combined terms for the therapy under consideration, the term ‘asthma’, and the methodological filter. Searches were limited to those articles with English language abstracts in which human subjects were studied.

Available evidence was ranked according the following levels of evidence3:

I     Evidence obtained from a systematic review of all relevant randomised trials.
II    Evidence obtained from at least one properly designed randomised trial.
III   Evidence obtained from other non-randomised controlled trials.

Abstracts reporting lower levels of evidence (non-systematic reviews, uncontrolled studies, case series, case reports or expert opinion) were excluded. Only those studies reporting one or more of the clinically relevant outcomes, described in the section ‘Aims of treatment for people with asthma’ in this paper, were included.

Where Level I evidence for the effect of a therapy was available, further evidence was not considered unless it was published after the last update of the systematic review or it reported outcomes not encompassed by the systematic review. Where Level II evidence was available, Level III evidence was not considered unless it was published later or reported outcomes not included in the randomised controlled trial. Where conflicting evidence at the same level was reported, higher quality studies were given precedence.

Effectiveness of complementary therapies in the treatment of people with asthma

Symp = Symptoms
Lung func = Lung function
Med = Medication required
Safety = Safety considerations

A Age group (children or adults), level of severity or control, concomitant medications.
B 3+ Strong evidence for effectiveness;
2+  Probably effective;   
1+ Possibly effective;    
+/- Equivocal evidence of effect;
1-  Possibly ineffective;
2-   Probably ineffective;
3-  Strong evidence of lack of effect;
0    No evidence for this outcome
C Including operator dependent, dose dependent and other adverse effects and potential interactions with other treatments.
D Includes measures of quality of life and other subjective measures of asthma control.
E In addition to the interventions listed here, there are several studies, not reviewed here, which have demonstrated that individuals with asthma and proven food chemical sensitivity benefit from avoidance of the specific food chemical(s) to which they are sensitive. There is no evidence that specific food avoidance is beneficial for people with asthma without proven food or food chemical sensitivity. Any advice on food avoidance should be given by health professionals with expertise in nutritional and dietary advice.

Diet modificationE

Therapy Highest level of evidence available Patient groupA Effective-nessB - SympD Effective-nessB - Lung func Effective-nessB - Med Comments SafetyC
Omega-3 fatty
acids (fish oil)4, 5		 I: Cochrane Review Adults and children with asthma 2- 2- 2- Less than 200 subjects have participated in all 6 trials. Various doses Toxic effects have been observed with some vitamin and mineral supplements when administered at high dosages
Selenium supplements6 II: RCT Non-atopic patients with asthma 1+ 1- 0 Single 14 wk trial in 24 pts. Clinical benefit in 6/12 Rx sodium selenite 100µg/d vs 1/12 placebo As above
Vitamin C supplementation7 I: Cochrane Review Adults and children with asthma 0 +/1 0 Two single dose studies (2g and 500mg Vit C) only available for lung function outcome (total N = 46) As above
Vitamin C and E supplementation combined8 II: RCT Children living in Mexico City (high ozone environment) 0 +/- 0 Attenuation of the negative effect of ozone on lung function As above
Oral magnesium supplements9 II: RCT People with asthma on low Mg diet 1+ 1- 1- Dose was 400mg/day As above
Lactobacillus acidophilus10 II: RCT Adults with asthma and atopy 1- 1- 0 Dose was 225g twice daily As above
Dietary salt11 I: Cochrane Review Adults with allergic asthma 0 +/1 +/1 Small numbers of subjects, no significant effect but wide confidence intervals As above

Physical therapies

Therapy Highest level of evidence available Patient groupA Effective-nessB - SympD Effective-nessB - Lung func Effective-nessB - Med Comments SafetyC
Chiropractic (spinal manipulation to treat mechanical dysfunction of the joints with consequent effects on the nervous system)12, 13 II: RCT 2 trials in adults and in children with persistent asthma 2- 2- 2- Total 124 subjects in the two trials No side effects reported by subjects in these trials
Massage14 II: RCT Children with asthma 0 0 1+ Parent delivered 20-minute massage v progressive muscle relaxation therapy None reported. Reduced anxiety in massage arm
Swimming15 II: RCT Children with asthma 0 1- 1- One trial in 14 subjects. Indoor swimming 2-3x/week for 3 months.  
Physical training16 I: Cochrane Review Adults and children with asthma 1- 2- 0 Physical training for 20-30 mins, 2-3 times/week for 4 weeks. Various programs. Cardiopulmonary fitness improved  

Medicinal therapies: homeopathy

Therapy Highest level of evidence available Patient groupA Effective-nessB - SympD Effective-nessB - Lung func Effective-nessB - Med Comments SafetyC
Homeopathy (remedies derived from plants and minerals, given in extremely diluted forms according to individual patient needs)17-19 I: Cochrane Review Adults and children with asthma on concomitant medication +/1 1+ 1+ N = 452  

Medicinal therapies: traditional Chinese herbal medicines20, 21

Therapy Highest level of evidence available Patient groupA Effective-nessB - SympD Effective-nessB - Lung func Effective-nessB - Med Comments SafetyC
Ginkgo biloba extract (ginkgolides BN 52021 and BN 52063)22-24 II: 2 RCTs People with asthma aged 13-48 years +/1 1+ 0 One study was in 61 people for 8 weeks; the second in 8 atopic adult asthmatics with effects measured immediately Reports of headache, nausea, dizziness, palpitations and allergic skin reactions; rare reports of bleeding (AusDI, 2003) Drug interactions likely (AusDI, 2003)
Ligusticum wallichii (also called chuan xiong in China and senkyu in Japan)25 II: 1 RCT Adults with moderate to severe asthma 1- 1+ 0 Measured at one month  
Chanbei Kechuanping (CBKCP)26 II: 1 RCT People with asthma 0 1+ 0 Effects measured immediately  
Xuan Fei Ding Chuan Wan and Xiao Chuan Gu Ben Wan27 II: 1 RCT People with asthma +/1 1+ 0    
Reinforcing kidney and invigorating spleen decoction28 II: 1 RCT ‘Severe’ asthma taking inhaled steroids 1- 1- 0 4-6 months  
Invigorating kidney for preventing asthma tablets29 II: 1 RCT Adults with asthma taking inhaled corticosteroids +/- 1+ 0 3 months  
Strengthening body decoction mahuang Ephedra sinica mixture31 II: 1 RCT ‘Cold and heat type’ adult asthmatics 1- 1+ 0 Two weeks mahuang is ephedrine 30-90% Reports of headache, nausea, irritability, motor restlessness, insomnia, tachycardia (AusDI, 2003) Rare case reports of hepatotoxicity (Am J Gastroenterol 1996; 96: 1436-8)
mahuang (Ephedra) Wenyang Tongulo mixture (WTM)31 II: 1 RCT Adults with asthma 1- 1+ 0 8 weeks Comparison was with oral salbutamol and inhaled corticosteroid As above
Chinese herbal medicines32 Ill: non-randomisd CT Children with asthma +/- +/- 0 Some TCM medicinals contain ephedrine, a sympathomimetic amine, which may be responsible for observed effects  

Medicinal therapies: traditional Ayurvedic (Indian) medicines20, 21

Therapy Highest level of evidence available Patient groupA Effective-nessB - SympD Effective-nessB - Lung func Effective-nessB - Med Comments SafetyC
Boswellia serrata33 II: 1 RCT Adults with asthma 1+ 1+ 0   2/40 patients reported epigastric discomfort on Boswellia
Coleus forskohlii (forskolin)34 II: RCT People with asthma 0 1+ 0 Immediate effect tested. Less effective than ß agonist but more than placebo  
Picrorrhiza kurroa35 II: 1 RCT   1- 1- 0 Over 14 weeks  
Solanum xanthocarpum/ S. trilobatu (kantakari)36, 37 II: 1 RCT Adults with asthma and with COPD 1+ 1- 0 Single dose study  
Tylophora Indica38-43 II: 5 RCTs Adults with asthma, generally on no other treatment 2+ 1+ 0 Effects reduced after several weeks Sore mouth, nausea and vomiting, loss of taste

Medicinal therapies: traditional Japanese medicines20, 21

Therapy Highest level of evidence available Patient groupA Effective-nessB - SympD Effective-nessB - Lung func Effective-nessB - Med Comments SafetyC
Tsumura saiboku-to (TJ-96)44, 45 II: 2 RCTs Adults with asthma 2+ 2+ 1+ (oral steroids)    

Medicinal therapies: herbs (miscellaneous)20, 21

Therapy Highest level of evidence available Patient groupA Effective-nessB - SympD Effective-nessB - Lung func Effective-nessB - Med Comments SafetyC
Ivy leaves (dried) (Hedera helix L.)46, 47 II: 5 RCTs Adults and children with chronic airway obstruction due to asthma +/- +/- 0 Only one trial was placebo controlled  

Breathing and yoga

Therapy Highest level of evidence available Patient groupA Effective-nessB - SympD Effective-nessB - Lung func Effective-nessB - Med Comments SafetyC
Buteyko breathing technique (system of breathing exercises focusing on nasal route of breathing, hypoventilation and avoidance of deep breaths)48, 49 II: 5 RCTs Short-term studies in adults 2+ 0 2+    
Yoga (ancient Indian practice using physical postures, discipline of breathing, and concentration during practice)50-54 II: 4 RCTs Patients with asthma +/- 0 +/- Two studies showed reduced airway hyper-responsiveness  
Breathing exercises55 I: Cochrane Review   0 1+ 1+ 5 studies reviewed including one study on Buteyko. No standard breathing technique used  

Other therapies

Therapy Highest level of evidence available Patient groupA Effective-nessB - SympD Effective-nessB - Lung func Effective-nessB - Med Comments SafetyC
Acupuncture (laser or fine needles used to puncture the skin at defined points)56, 57 I: 2 systematic reviews (1 Cochrane)   +/- +/- +/- Short-term studies. Questionable use of sham acupuncture as comparator. 7 trial of 174 people reviewed by Cochrane  
Hypnotherapy (creating a trance-like state) I: Systematic review Adults and older children with severity ranging from mild-moderate/severe +/- +/- +/- Dependent on hypnosis ‘susceptibility’. Several published studies have not provided sufficient detail to assess effect.  
Ionisation (instrumentally boosting the positive and negative ion content of the air)64-68 II: RCT Adults and children with asthma 2- 0 2- Total N = 92 One trial demonstrated positive ionisation aggravated EIA
Meditation (techniques used to calm the mind and body)69 II: 1 RCT Adults with ‘stable’ asthma 0 1+ 0 Only half the respondents completing the full trial. Airways resistance decreased  
Music therapy70 II: 1 RCT Stable asthmatics 1+ 1- 0 Data from a single trial (n = 72) with relaxation and no treatment as the comparator  
Osteopathy (physical manipulative therapy used to adjust misalignments of the muscles, joints and bones)71, 72 II: 1 pilot RCT and 1 controlled comparative study Adults with asthma. Comparative group in second trial included non-asthmatics 1- +/- 0 Total number of participants = 18  
Reflexology (application of pressure, usually to the feet, to produce therapeutic effects on other parts of the body)73, 74 II: 2 RCTs Adults with asthma +/- 1- +/– (SABA use decreased) Total N = 70 Peak flows increased in one study, but neither study showed improvements in FEV1.  
Speleotherapy (use of subterranean environments as a therapeutic measure)75 I: Cochrane Review (3 RCTs) Children with asthma 0 1+ 1+ Results may vary from cave to cave Total N = 118 Lung function effects were described as transient  
Relaxation therapy76-82 I: 1 systematic review and other RCTs Adults and children with asthma ranging from mild to severe 2- +/- 2- May be of greatest benefit for those with asthma exacerbated by anxiety. Has also been demonstrated to be useful in acute attacks