The fourth paper (Frei et al, 2006) is very comprehensive, investigating modifications of classical homeopathic diagnostic procedure and Boenninghausen’s methodology in designing high quality RCT’s for ADHD.  Frie et al develop an analytical method termed polarity analysis to improve case analysis and remedy choice, and overcome poor reporting/paucity of evaluating symptoms for case management, as identified in their previous study (Frei 2001). ‘Polarity analysis’ is a good objective guide to optimize the choice of remedy in differential diagnosis that could extrapolate into other homeopathic research designs. The identification of specific ‘perception symptoms in ADHD’ is a strength allowing better clinical evaluation. Again, analysis of each case with basic homeopathic management tools like Hering’s Law of cure (Little, 2006) and Miasmatic state (D’Souza, 2006) would have added homeopathic strength to case evaluation, but here investigation remained centered on achieving high quality in RCT analysis. The presentation does not follow a logical sequence of explanation, though various points are adequately explained. The decision to skip Q potencies in therapeutics is not explained. A specific questionnaire designed, was restricted to obtaining quantitative data on ADHD. If designed in an open-ended way (Wood, 2001: 88) it would be a qualitative tool contributing to a mixed method study (Verhoef, 2005:209). Hard work in previous studies helped design a high quality RCT trial with modified Boenninghausen’s methodology contributing to the success of the next cross-over RCT in the University of Berne (Frei et al, 2007).

The fifth paper (Frei et al, 2007) was designed as an open-labeled homeopathic treatment preceding the ADHD placebo-controlled, randomized, double blind, crossover trial. The researchers considered this an unconventional design. The main intentions were to demonstrate whether homeopathy had a significant beneficial effect compared to placebo, observed through an appropriately designed RCT, and to find out at what point respondents reached randomization eligibility. The conclusion stated that the significant beneficial effect of homeopathy (p= 0.0006) was observed only 5 months into the treatment during the screening phase, which should be the point of randomization eligibility. Randomization in an RCT for homeopathy at the start of treatment had a high risk of failure to demonstrate a specific treatment effect. The paper is well written, with high quality technical (statistical) analysis using various accepted statistical standards.  It is presented in logical sequence. Its strengths include an innovative methodology developed over 5 years of clinical research (polarity analysis, perception symptoms questionnaire), yet sticking to an acceptable RCT design (Greenhalgh, 2001: 44). All patients were treated with verum during the course of the trial, facilitating patient recruitment. Also, use of other treatment for ADHD was prohibited or stopped during the homeopathic treatment, adding reliability to homeopathic observations.

The weakness is a paucity in the use of supportive homeopathic analytical methods, like delusion analysis (Sankaran, 1991), pathogenetic analysis (Boger 1915), periodic table analysis (Scholten, 1996), essence analysis (Vithoulkas, 1980), and others, to enhance accuracy in selection of individual remedies. Understanding the pathogenicity (Boger, 1915) of indicated homeopathic remedies for an ADHD diagnosis a reliable confirmatory support, and is mentioned by the researcher quoting Caroll Dunham’s opinion on pathognomic symptoms (Frie et al, 2006: 169). Hence a median of 3 for reaching an accurate simillimum is high and could be reduced to 2. A lower median time with screening phase of 3 months instead of 5 and earlier randomization eligibility with quicker achievement of optimal phase of treatment, will result from greater accuracy in first remedy choice.  Limiting the study to an RCT ignores the possibility of a mixed methods study with qualitative and quantitative aspects supporting each other. The quality of evidence so obtained will help facilitate better and more comprehensive research designs applicable in other disease conditions as well.

Critical analysis of these five studies/trials is summarized in Table 2.

Table 2: Summary of critical examination on 5 controlled studies on ADHD with individualized homeopathy

The potential contribution other research designs could make to understanding the topic

Future research design in the homeopathic treatment of ADHD could be modified to incorporate qualitative analysis of information obtained during a RCT. Variations of RCT design, like pragmatic trials, factorial designs, preference trails are possible (Verhorf 2005).  Neither quantitative nor qualitative methods are sufficient in themselves, to capture the trends and details of the situation (Cresswell: 2004).

Homeopathic methodology lends itself to a variety of qualitative methods, generating data through questionnaires, interview techniques, observational studies, documents and audio-visual techniques. Designing homeopathic qualitative methodology should be based on accepted and reliable homeopathic principles of assessment, namely Hering’s Law of Cure (Little, 2006) and Miasmatic Expression (D’Souza, 2006). Rigorous interrelated design criteria have already been suggested (Cresswell, 2004) which include:

1) identifying the reasons for mixing qualitative and quantitative methods,

2) types of data collected and analysed,

3) the priority given to either research method in the study,

4) the implementation sequence,

5) the phase of research when the data was integrated or related.

These 5 criteria have become a coding template for mixed method study.

In the study of ADHD, one reason for mixing would be to enhance the chances of establishing the holistic beneficial effect of homeopathy. Qualitative Data obtained through field study and from other professionals involved, besides the parents, could be conducted sequentially, with data from independent groups of observers informing subsequent data collection and analysis (Johnson et al 2004). Integration of data could occur at various points, possibly timed following each scheduled clinical follow-up. The Instrument Design model suggested by Cresswell (2004) would suit a further development of the ADHD study of Frie et al (2007).

Other adaptations of RCT include combining pragmatic trails (that have high external validity) and factorial design (that has high internal validity), paying adequate attention to assessing appropriate outcome measures (Verhoef et al, 2005). Qualitative method, ideally based on a phenomenological approach that examines phenomena from the individual human’s consciousness, separate from researcher’s preconceptions or presuppositions (Wood, 2001:86) and compatible with homeopathic philosophy, could be nested within rigorous adaptations of RCT trails. ME Dean (2000) makes a case for the consideration of pragmatic trails against placebo controlled trails as they are by nature collaborative and oriented towards health service requirements. They incorporate patient requirements and preferences where possible and satisfy scientific and homeopathic claims without compromising on the values of either. From the homeopathic standpoint, the methodology for constructing a randomized pragmatic trail (Oberbaum, 2003) could be appropriately chosen to avoid the effect of entanglement (Milgrom, 2002) and also suit the case presentation of various diseases.

In addition, information that suits homeopathic theory is Cohort Study of participants of trials. These cases, if included in an inception cohort (Greenhalgh, 2001:50) study and followed up over years, would give an idea of prognosis and influence of homeopathic treatment on disease progression, control or cure. This could be analysed from the Miasmatic perspective and Laws of homeopathic direction of cure.

Chatfield (2006) wisely perceives the emergence of a new paradigm embracing holism, vitalism and homeopathy which need not reject rationalism. Rather we could expect a re-direction of the rationalistic tradition that encompasses a better explanation of known anomalies (like homeopathy).

Conclusion

ADHD as a childhood disorder is becoming increasingly prevalent today. Children are put on controversial medication like Methylphenidate and amphetamine that have serious side effects. It is imperative that healthcare systems have adequate evidence to prove that homeopathy and other complementary systems offer reliable, inexpensive and curative alternatives for parents in the treatment of this disease. With this information healthcare systems may support alternative therapy like homeopathy for patients, in addition to allopathic drugs.

Lamont (1997) was able to document that homeopathic treatment demonstrated a statistically significant positive response in comparison to the placebo. Frie et al (2001) demonstrated a clinical improvement rating with homeopathy to be 73% against a 55% with MPD. Easy administration of remedies and continuous effect over 24 hours and no side effects of the individual remedy could make homeopathy the first choice treatment. Jacobs et al’s (2004) experience suggests one should avoid conducting trials with inadequate homeopathic focus and methodology. Frie et al (2006) highlighted the development of independent thought and design like ‘polarity analyses’ to optimize the choice of remedy in differential diagnosis; and use of ‘perception symptoms in ADHD’ for better clinical evaluation. With this they (Frei et al, 2007) showed significant beneficial effect of homeopathic treatment in comparison to placebo (p= 0.0006) 5 months into the screening phase of the RCT.

Mixed methods study should be the next step of development for future trial design. Bazeley (2004) refers to Chen (1997), stating that where the purpose of the research is made clear, and is theory driven (i.e. presented through a logical chain of evidence) then that substantive focus becomes a super ordinate goal which limits tensions in mixing of methods. When methods are mixed, careful consideration must be given to the particular assumptions of rules and expectations regarding their conduct, otherwise corruptions of those methods can occur such that results obtained by them become subject to question. (Bazeley, 2004). Homeopathic methodology properly understood could underpin modification of well accepted research methods both qualitative and quantitative. This is a major field of knowledge generation to explore.

With reference to good quality RCT’s critiqued above, a 5 coded template of mixed method study suggested by Cresswell (2004) using the Instrument Design Model (Cresswell 2004) would suit future homeopathic ADHD study if appropriately modified and designed.

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