Homeopathic Research Evidence for the Treatment of ADHD

Positive Outcome Research Evidence in Homeopathy proves that Classical Homeopathy can effectively treat ADHD for the long term.

A critical examination of research evidence for treating Attention deficit hyperactive disorder (ADHD) in children using individualized (classical) homeopathy. 

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Introduction:

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 Childhood psychological disorders which include diagnoses like Hyperkinetic Syndrome (HKD) or ADHD, ADD, Learning Disabilities, Autism Spectrum of disorders, etc are disorders that homeopathy has successfully treated but not adequately documented.  ADHD has existed as a separate diagnosis since 1980 following the publication of the Diagnostic and Statistical Manual Version (DSM) III (Barkley 1990). Today the DSMV IV criteria recognize 3 core signs of inattention, hyperactivity and impulsiveness. They also recognize 3 subgroups: i) Predominantly hyperactive type ii) Predominantly inattentive type iii) a combination of both inattentive and hyperactive impulsivity (APA 2000).

The need is to document adequate research and treatment evidence to support appropriate homeopathic therapeutics of this group of childhood problems.  This especially as the number of children affected is growing. Drugs like Methylphenidate (MPD) have numerous side effects and their long term use remains controversial (Timini, 2003). Based on UCD-10 criteria (WHO, 1992) the prevalence in U.K. is about 1%, while with DSMV-IV (APA 2000) the prevalence is about 5. Homeopathy is more likely to be integrated into the prevailing heath care system (giving people a choice of therapies), if there is clear evidence of its clinical utility in common diseases and prescribing strategies are simplified (Jacobs: 2000). Richarg Liang observing the high quality work done by Frei et al in ADHD, expects that this will “open a new area of homeopathic research which may be called ‘evidence-based’ homeopathy.”(Liang, 2006: 95)

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In this assignment five articles enumerated below have been chosen for analysis. These have been included as their purpose is documenting evidence for treating ADHD using individualized homeopathy. The author did not find any AHDH trials pertaining to other forms of homeopathic prescribing.

1. Lamont J, (1997); British Homeopathic Journal, (1997) 86; p. 196-200

2. Frie, H, et al (2001); British Homeopathic Journal (2001) 90; p. 183-18.

3. Jacobs et al (2005); J Alternative and Complimentary Medicine (2005) 11:5, p. 779-806 .

4. Frie H, et al; Homeopathy (2006) 95, p. 163-170

5. Frie H, et al; Homeopathy (2007) 96, p. 35-41

All papers are from credible journals that are peer-reviewed. The three papers by Frei et al are a developing assessment of therapeutics and research in ADHD and of excellent homeopathic value, demonstrating an intention to develop research design for ‘evidence-based’ homeopathy while stickling to basic homeopathic principles in Hahnemann’s Organon (1921) and Chronic Diseases (1896). The next step will be to develop a mixed methods study (Cresswell, 2004) where qualitative study and analysis supports quantitative evidence of RCT’s, the author’s interest for future research.

[2] Identification of existing literature on this topic

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Databases like Biomed, Medline, Cochrane Library, AMED, EMBASE, CISCOM, ERIC, BIOSIS, included journals like Homeopathy (British Journal of  Homeopathy), Complementary Therapeutics in Medicine, Pediatric journals of Europe and North America, Journal of Complementary and Alternative Medicine,  etc. were searched for literature relevant to the topic. Search engines used: Ovid Online, Science Direct, Blackwell Synergy, Wily Interscience, PubMed. Search words used were ‘homeopath$’, ‘hyperactiv$’, ‘child$’, ‘ADHD’ with a restriction to English articles. Any systematic reviews in progress were also included in the search. Those that pertained to non therapeutic discussions were excluded.

Compiled into a word document, relevant articles were explored in detail. Several articles could not be freely accessed or were unavailable electronically. Focused research in ADHD and homeopathy and investigation of the effective alternative treatments for ADHD has been going on over the last 15-20 years, summarized in Table 1. There was one study that identified the use of complex homeopathy for hyperactivity.

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Table 1: A summary of studies in ADHD with homeopathy and other alternative forms of medicine.

1, Type of Literature

2. Author, Year, Journal

3. Title

4. Objective

5. Method

6. Results

1. Homeopathic Trial (Individualized homeopathy)

2. John Lamont, 1997, British Journal of Homeopathy

3. Homoeopathic treatment of attention deficit hyperactivity disorder:
4. A controlled study : To determine the effectiveness of homeopathy in ADHD.

5. Participants were alternately assigned to either placebo or homoeopathic treatment in a double blind, partial crossover study. Medicines or placebos administered to children; after 10 days placebo group were given homoeopathic medicines.

6. Statistically significant differences were found in comparative scores of each cross over group, supporting the hypothesis that homoeopathic treatment is superior to placebo treatment for ADHD.

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1. Homeopathic Trial (Individualized Homeopathy)

2. H Frei and A Thurneysen, 2001, Homeopathy

3. Treatment for hyperactive children: Homeopathy and methylphenidate compared in a family setting

4. Purpose of this prospective trial was to assess the efficacy of homeopathy in hyperactive patients and to compare it MPD.

5. Participants received individual homeopathic treatment; improvement of 50%, parents reevaluated symptoms; did not improve sufficiently changed to MPD, re-evaluated after 3 months.

6. After an average treatment time of 3.5 months 86 children (75%) had responded to homeopathy, reaching a clinical improvement rating of 73% and an amelioration of the CGI of 55%. Twenty-five children (22%) needed MPD; Results of homeopathic treatment appear to be similar to the effects of MPD

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1. Homeopathic Trial (Individualized Homeopathy)

2. Jacobs J, Williams AL,Girard C, Njike VY, Katz D. 2005, Journal of Alternative and Complementary Medicine

3. Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial.

4. The aim of this study was to carry out a preliminary trial evaluating the effectiveness of homeopathy in the treatment of attention-deficit/hyperactivity disorder (ADHD)

5. This work was a randomized, double-blind, placebo-controlled trial. Forty-three subjects were randomized to receive a homeopathic consultation;  individualized homeopathic remedy or placebo; Patients seen every 6 weeks for 18 weeks

6. There were no statistically significant differences between homeopathic remedy and placebo groups on the primary or secondary outcome variables. However, there were statistically and clinically significant improvements in both groups on many of the outcome measures

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1. Homeopathic Trial (Individualized Homeopathy)

2. Frei H, Everts R, von Ammon K, Kaufmann F, Walther D, Hsu-Schmitz SF, Collenberg M, Fuhrer K, Hassink R, Steinlin M, Thurneysen , 2005; European  Journal of  Pediatrics

3. Homeopathic Treatment of children with attention deficit hyperactivity disorder: a randomised, double blind, placebo controlled crossover trial

4. The aim of this study was to obtain scientific evidence of the effectiveness of homeopathy in ADHD

The responders were split into two groups and received either verum for 6 weeks followed by placebo for 6 weeks (arm A), or vice-versa (arm B). Prior to the randomised, double blind, placebo controlled crossover study, they were treated with individually prescribed homeopathic medications.

5. At entry to the crossover trial, cognitive performance such as visual global perception, impulsivity and divided attention, had improved significantly under open label treatment (P<0.0001). During the crossover trial, CGI parent-ratings were significantly lower under verum (average 1.67 points) than under placebo (P =0.0479). Long-term CGI improvement reached 12 points (63%, P <0.0001)

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1. Homeopathic Trial (Individualized Homeopathy)

2. H Frei, K von Ammon  A Thurneysen, 2006, Homeopathy

3. Treatment of hyperactive children: Increased efficiency through modifications of homeopathic diagnostic procedure.

4. The rigorous test to which homeopathy was subject in previous  double-blind clinical trail of homeopathic treatment of attention deficit hyperactivity disorder (ADHD) necessitated optimized treatment meeting the highest standards

5. Optimization in three steps: (1) In successfully treated, prescriptions of insufficient response analyzed by questionnaire for unreliable symptoms.
(2) Polarity analysis, introduced in response to one-sided symptoms; specific symptoms to identify remedy genius symptoms to match patient's characteristics.
(3) Investigated influence of primary perception symptoms on repertorization.

6. Introducing the questionnaire, polarity analysis, and including perception symptoms, lead to an improvement in the success rate of the first prescription from 21% to 54%, of the fifth prescription from 68% to 84%

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1. Homeopathic Trial (Individualized Homeopathy)

2. H. Frei, R. Everts, K. von Ammon, F. Kaufmann, D. Walther, S-F Hsu Schmitz, M. Collenberg, M. Steinlin, C. Lim and A. Thurneysen, 2007, Homeopathy

3. Experience with open-label homeopathic treatment preceding the Swiss ADHD placebo controlled.

4.  Randomised, double-blind, cross-over trial.

5. Randomised, placebo controlled, cross-over trial with an open-label screening phase prior to the randomised controlled phase; to explore the screening phase data with respect to the risk of failure to demonstrate a specific effect of RCT with randomization at the start.

6. Screening phase, 84% (70/83) of the children responded to treatment and reached eligibility for the randomized trial after a median time of five months; the difference in Conners Global Index (CGI) rating between responders and non-responders became highly significant (p=0.0006); Improvement in CGI much greater following  optimal medication. (p<0.0001).

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1. Study of alternative treatments

2. Arnold LE,  Alternative treatments for adults with attention-deficit hyperactivity (ADHD)

3. Review of evidence in alternative treatments for ADHD

4. Some alternative Tx of ADHD are effective or probably effective, in some cases, they are the Tx of choice, a few have failed to prove effective in controlled trials, most need research to determine effectiveness.

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1. Study of Alternative treatments

2. Gross-Tsur V, Lahad A, Shalev RS, 2003; Pediatric Neurology

3. Use of complementary medicine in children with attention deficit hyperactivity disorder and epilepsy

4. To identify the prevalence of use, the referral patterns and the perceived benefit of alternative therapy in children with attention-deficit hyperactivity disorder (ADHD)

5. A mailed questionnaire survey was undertaken in June 1993, of the use of various therapies by families of 381 children with ADHD.

6. Diet therapies were the most commonly used (60%), non-medicated group reported more benefit from some alternative therapies, physicians commonly involved in modified diet, school teachers, family and friends were the main source of suggestions.

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1. Study of various homeopathic methods with identifying food substances contributing to hyperactivity.

2. Julian N. Kenyon, 1993, (Available online2004), Complementary Therapies in Medicine

3. Hyperactivity: a consideration of the alternatives

4. Identifying various reactions to food, dairy products, food additives in addition to homeopathy in the treatment of Hyperactivity

5. Methods of identifying offending foods are described, together with the treatment of homoeopathy using supplementation of vitamins and minerals and evening primrose oil.

6. Milk and dairy products, sugar and chocolate, food colorants and food additives, salicylate containing foods are important cause of hyperactivity in some children. These supplement the use of homeopathy in treatment of hyperactivity.

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1. Study of Alternative treatments

2. Neal L. Rojas, Eugenia Chan, 2005

3. Old and new controversies in the alternative treatment of attention-deficit hyperactivity disorder

4. We review the purported mechanism of action and available evidence for selected CAM therapies for ADHD

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6. The initial evidence for some emerging CAM therapies, such as essential fatty acid supplementation, yoga, massage, homeopathy, and green outdoor spaces, suggests potential benefits as part of overall ADHD treatment pln 

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[3] Critical examination of selected studies on this topic

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Referring to the 5 selected studies, the researchers appear to be highly qualified as academicians as well as clinicians in their field of work re: homeopathy, psychological analysis, pediatric group of disorders, and statistical analysis. Objectives and outcomes were clearly stated in all the articles and obvious weakness and gaps discussed. The selected studies used accepted principles from both homeopathic theoretical and therapeutic standpoint, with research into the medical background of ADHD disease expression.

There is no information about funding or sponsors of these trials/studies; two were conducted through the University of Berne, Switzerland.

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The first paper (Lamont, 1997) is the first recent serious work documenting evidence through a partial cross over clinical trail, to prove that treatment with individualized homeopathic remedies is superior to placebo. The trial design is simple, with inclusion criteria based on DSMV-IV criteria. There was a partial cross over of the placebo group into verum group allowing the verum group following cross over to be compared to itself. The verum group demonstrated a statistically significant positive response compared to the placebo group. The strength of the study is an elimination of placebo effect in the verum group as the homeopathic interview was taken for every child along with psychological testing once at the beginning.  Following this, no further direct contact with the researching homeopath was done. Variables were easily comparable and statistical calculations were simple. The double blind approach avoids any practitioner bias or participant preference in the outcome, though the possibility of influencing carers during follow up is considered.  The need for change of prescriptions reflects the reality of the clinical situation and an alertness of clinical observation to remedy response. The weakness of the trial is the short timeframe which does not adequately assess long term homeopathic effect of the medications given i.e. to assess whether homeopathic treatment is curative or palliative in ADHD. Homeopathic methodology used is not described. Though the rationale for choice remedies is explained, the tendency to focus only on mental state and not on the complete constitutional characteristics of the child, may inadequately inform the choice of similimum’s. The reason stated was that most of these children were in foster-care. Carers were unaware of many deeper aspects of the child’s history. The paper was able to reject the null hypothesis to prove that homeopathy was more effective than placebo, but was unable to state a homeopathic case for cure of ADHD. More rigorous application of homeopathic methodology in constructing study design would be able to overcome this inadequacy.

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The second paper (Frei et al, 2001) assessed the percentage efficacy of homeopathic treatment for ADHD vis a vis the allopathic alternative of Methylphenidate (MPD).  Frie et al investigated the effectiveness of homeopathy as a valid treatment alternative to parents of ADHD children based on CGI rating, parent rating and time frame required for improvement. Homeopathic individualization of prescription was the method of simillimum choice with a flexible time frame of response. Clinical improvement in children on homeopathy was 73%, against 65% on MPD. The strength is that this study represents clinical reality of classical homeopathic prescribing, using basic homeopathic methodology (Boenninghausen). None of the participants were on pharmacological treatment hence better chance for unmasked observation of homeopathic symptoms. It is possible that some preference bias was introduced with first choice being homeopathic treatment. The interview could have some palliative placebo effect (Milgrom, 2002). Those that did not respond to homeopathy were considered for MPD, hence the true beneficial effect of MPD is not clear. Other limitations include a lack of information about individual symptom assessment with a timeline to determine a curative direction (Little, 2006) homeopathically.  From the perspective of ADHD, the homeopathic assessment was superficial but Frie et al were able to support their argument of superior clinical response to homeopathy. The major advantage of homeopathic remedies over MPD proved by the study is easy administration, continuous effect over 24 hours, and no side effects of the individual remedy as against those caused by MPD, making homeopathy a good first choice treatment. Research design needs modification; homeopathic evidence stated is basic and needs more elaboration. Homeopathic tools for case analysis and management (D’Souza, 2006) used were unclear in terms of expectations of cure with homeopathy – which caused the researcher to wonder if homeopathic remedies were producing a palliative effect.

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The third paper (Jacobs et al, 2005) is an RCT designed to evaluate the effectiveness of homeopathy in ADHD. The researchers were able to conclude that there was a therapeutic effect in the homeopathic encounter through case taking interview and physician interaction, but no obvious therapeutic benefit of remedy against placebo. The strength of the trial appears to be a myriad of validated statistical outcome measures to obtain a computable statistical result. Also adequate allowance was given for individual prescribing, change of remedies and posology (potency/repetition of remedy). Unfortunately beyond these strengths, the trial has numerous weaknesses. The researchers themselves suggest the insufficient statistical power for analysis, all too obvious when the major focus of the paper appears to be statistical testing and analysis. How could their conclusion be reliable?  Second, the research design alienates homeopathic perspective by focusing too much on statistical measurement of outcomes without a true understanding on the individuality of the ADHD expression, or the direction of homeopathic healing expected (Little 2006, D’Souza 2006). All participants were already on stable doses of MPD or dexamphetamine. This can effectively mask individual characteristics required for accurate homeopathic prescriptions, besides interfering with accurate observation and analysis of remedy-response. In addition, a “new” homeopathic method recently in vogue was used.

The accuracy of individual remedy choice and its effects may be shaky when method of case analysis, remedy choice, remedy response and case management (Oberbaum et al 2003; Vithoulkas, 1980) i.e. methodology used, is unclear or based on ‘new’ methods. In such situations homeopathic credibility of the RCT design may be questioned.  It is also difficult for homeopath to “guess” whether a participant is on medication or placebo. Even with clear criteria to gauge improvement following remedy it can be confusing. Clear guiding principles for evaluation of homeopathic remedy response (Oberbaum et al, 2003; Vithoulkas, 1980) exist, were they applied? The researchers suggest investigating ‘non-local’ entanglement (Milgrom, 2002) effects of the homeopathic interview. How would ‘entanglement’ obtain statistically reliable information on homeopathic remedy therapeutics?

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).

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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, 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, 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 loses 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/trails is summarized in Table 2.

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

1. Authors, year, journal

2. Conclusions based on Objective

3. Strengths

4. Weaknesses/Limitations

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1. John Lamont, 1997, British Journal of Homeopathy

2. Conclude that verum group demonstrated statistically significant positive response compared to placebo group.
Objective: Individualized homeopathic treatment for ADHD, superior to placebo

3. 1) Elimination of placebo as the homeopathic interview was taken for every child along with psychological testing.
 2) Variables easily comparable, statistical calculations simple.
 3) Double blind approach avoids practitioner bias or participant preference in the outcome.
4) Need for change of prescriptions reflects reality of clinical situation, alertness of clinical observation to remedy response

4. 1) Short timeframe does not adequately assess long term homeopathic effect; whether curative or palliative in ADHD.
2) Homeopathic methodology used is not described.
3) Though rationale for choice of group of remedies explained,  tendency to focus only on mental state without complete constitutional characteristics inadequate to inform choice of simillimum’s

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1. H Frei and A Thurneysen, 2001, Homeopathy

2. Conclude that clinical improvement in children on homeopathy was 73% against 65% on MPD.
Objective: To assess the efficacy of homeopathy in ADHD vis a vis the allopathic alternative of Methylphenidate (MPD)

3. 1) Study represents clinical reality of classical homeopathic prescribing.
2) Uses basic homeopathic methodology (Boenninghausen)
3) Flexible time frame of response and focus on individual remedy choice for each participant.
4) Participants were not on any ADHD medication.

4. 1) Some preference bias as homeopathy first choice. 2) Possible palliative placebo effect of interview.
3) True beneficial effect of MPD is not clear.  4) Lack of information about individual symptom assessment with a timeline to determine a curative direction. 5) Homeopathic assessment superficial

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1. Jacobs J, Williams AL, Girard C, Njike VY, Katz D. 2005 Journal of Alternative and Complementary Medicine

2. Conclude the possible therapeutic effect in homeopathic encounter through entanglement, but no obvious therapeutic benefit of remedy against placebo
3. Objective:  to evaluate the effectiveness of homeopathy in ADHD

1) A myriad of validated statistical outcome measures to obtain a computable statistical result.
2) Adequate allowance given for individual prescribing, change of remedies and posology.

4. 1) Insufficient statistical power for analysis 2) The research design alienates the homeopathic approach by focusing too much on statistical measurement. 3) All participants already on stable doses of MPD or dexamphetamine which can mask individual characteristics required and interfere with observation/ analysis of remedy-response. 4) A “new” unexplained homeopathic method used, without reliable homeopathic methodology.

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1. H Frei, K von Ammon, A Thurneysen, 2006, Homeopath

2. Develop method called polarity analysis to improve case analysis and remedy choice; identifies ‘perception symptoms in ADHD’; suggests use of Q potencies for ADHD.
Objective: Investigating various aspects of modifying classical homeopathic diagnostic procedure and methodology (Boenninghausen) to design a high quality RCT for ADHD.

3. 1) Develop polarity analysis to improve case analysis and remedy choice, and overcome poor reporting/paucity of evaluating symptoms that could extrapolate into other homeopathic research designs.
2) The identification of specific ‘perception symptoms in ADHD’ for better clinical evaluation.
3) Results in design of high quality RCT trial with modified Boenninghausen’s methodology contributing to success of subsequent cross-over RCT.

4. 1) Analysis with homeopathic tools like Hering’s Law and Miasmatic state unavailable while investigation centered on high quality RCT analysis. 2) Presentation does not follow a logical sequence of explanation. 3) Reason for skipping Q potencies in therapeutics not explained. 4) Use of questionnaire restricted to obtaining quantitative data not in an open-ended way as a qualitative tool

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1. H. Frei, R. Everts, K. von Ammon, F. Kaufmann, D. Walther, S-F Hsu Schmitz, M. Collenberg, M. Steinlin, C. Lim and A. Thurneysen, 2007, Homeopathy

2. 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

Objective: Demonstrate beneficial effect of homeopathy compared to placebo through appropriately designed RCT; find point of randomization eligibility reached by participants

3. 1) Paper well written, with high quality statistical analysis. 2) Presented in logical sequence.  3) Uses innovative methodology developed over five years of clinical research (polarity analysis, perception symptoms questionnaire). 4)  All patients treated with verum facilitating patient recruitment. 5) Other treatment for ADHD was prohibited or stopped during the homeopathic treatment increasing reliability of homeopathic observations.
4. 1) A median of 3 in selecting accurate simillimums is high and is due to paucity in use of supportive homeopathic analytical methods; a lower median time with screening phase of 3 months instead of 5, earlier randomization eligibility with quicker achievement of optimal phase of treatment results from greater accuracy in first remedy choice.
2) Limiting the study to an RCT ignores the possibility of a mixed methods study with qualitative and quantitative aspects supporting each other.

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

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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).

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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.

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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.

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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, 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).

 [5] Conclusion

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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, 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.

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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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References:

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American Psychiatric Association (APA 2000); Diagnostic and Statistical manual for mental disorders; 4th Edition; Text revision (DSM-IV-TR), Washington DC, American Psychiatric Publishing Inc, 2000.

Barklay R.A (1990); Attention-deficit hyperactivity disorder – a handbook for treatment and diagnosis; New York and London: Guilford Press 1990

Bazeley, P (2002); Issues in mixing qualitative and quantitative approaches to research; Applying qualitative methods to marketing management research; Ed: Buber, Gadner, Richards; 2004: 141-156

Boger, C. M. (1915); A Synoptic Key of the Materia Medica; Foreword, 5th Edition: BJain Publishers.

Chatfield, Kate (2006); In Pursuit of Evidence; The Homeopath; Winter 2006, 25:3, p. 81

Chen, H (1997); Applying mixed Methods under the framework of theory-driven evaluations; Advanced in mixed-methods evaluation: the challenges and benefits of integrating diverse paradigms; p. 19-32; Ed: Greene, Caracelli; San Francisco: Jossey-Brass.

Cresswell J., Fetters M, Ivankova N, (2004) Designing a mixed Methods Study in Primary Care; Annals of Family Medicine, 2004; 2 p. 7-12

Dean M.E. (2001); More trials, fewer placebo’s please; British Homeopathic Journal 2000, 89: 191-194

D’Souza, L (2006): Miasms in Case Management, Part 2: Disease Evolution and its Miasmatic Management, 3rd edition, 2006; https://www.homeopathy2health.com/disease-evolution-and-its-miasmatic
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