Childhood psychological disorders which include diagnoses like Hyperkinetic Syndrome (HKD) or ADHD, ADD, Learning Disabilities, Autism Spectrum 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). Richard 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)
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 sticking 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.
Identification of existing literature on this topic
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. and 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’, ‘hyperactive’, ‘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.
Table 1: A summary of studies in ADHD with homeopathy and other alternative forms of medicine.
|Type of Literature||Author, Year, Journal||Title||Objective||Method||Results|
|Homeopathic Trial (Individualized homeopathy)||John Lamont1997|
British Journal of Homeopathy
|Homoeopathic treatment of attention deficit hyperactivity disorder:|
A controlled study
|To determine the effectiveness of homeopathy in ADHD.||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.||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.|
|Homeopathic Trial (Individualized Homeopathy)||H Frei and A Thurneysen2001|
|Treatment for hyperactive children: Homeopathy and methylphenidate compared in a family setting||Purpose of this prospective trial was to assess the efficacy of homeopathy in hyperactive patients and to compare it MPD.||Participants received individual homeopathic treatment; improvement of 50%, parents reevaluated symptoms; did not improve sufficiently changed to MPD, re-evaluated after 3 months.||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|
|Homeopathic Trial (Individualized Homeopathy)||Jacobs J,Williams AL,|
Journal of Alternative and Complementary Medicine
|Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial.||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)||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||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|
|Homeopathic Trial (Individualized Homeopathy)||Frei H,Everts R,|
European Journal of Pediatrics
|Homeopathic Treatment of children with attention deficit hyperactivity disorder: a randomised, double blind, placebo controlled crossover trial||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.||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)|
|Homeopathic Trial (Individualized Homeopathy)||H Frei,|
K von Ammon A Thurneysen2006Homeopathy
|Treatment of hyperactive children: Increased efficiency through modifications of homeopathic diagnostic procedure||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||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.
|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%|
|Homeopathic Trial (Individualized Homeopathy)||H. Frei, R. Everts, K. von Ammon, F. Kaufmann, D. Walther, S-F Hsu Schmitz, M. Collenberg, M. Steinlin, C. Lim and A. Thurneysen2007|
|Experience with open-label homeopathic treatment preceding the Swiss ADHD placebo controlled, Randomised, double-blind, cross-over trial||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.||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).|
|Study of alternative treatments||Arnold LE||Alternative treatments for adults with attention-deficit hyperactivity (ADHD)||Review of evidence in alternative treatments for ADHD||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.|
|Study of Alternative treatments||Gross-Tsur V,Lahad A,||Use of complementary medicine in children with attention deficit hyperactivity disorder and epilepsy||To identify the prevalence of use, the referral patterns and the perceived benefit of alternative therapy in children with attention-deficit hyperactivity disorder (ADHD)||A mailed questionnaire survey was undertaken in June 1993, of the use of various therapies by families of 381 children with ADHD.||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.|
|Study of various homeopathic methods with identifying food substances contributing to hyperactivity.||Julian N. Kenyon1993|
Complementary Therapies in Medicine
|Hyperactivity: a consideration of the alternatives||Identifying various reactions to food, dairy products, food additives in addition to homeopathy in the treatment of Hyperactivity||Methods of identifying offending foods are described, together with the treatment of homoeopathy using supplementation of vitamins and minerals and evening primrose oil.||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.|
|Study of Alternative treatments||Neal L. Rojas, Eugenia Chan2005||Old and new controversies in the alternative treatment of attention-deficit hyperactivity disorder||We review the purported mechanism of action and available evidence for selected CAM therapies for ADHD||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 plan|
Critical examination of selected studies on this topic.
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 weaknesses and gaps discussed. The selected studies used accepted principles from both homeopathic theoretical and therapeutic standpoints, 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.
The first paper (Lamont, 1997) is the first recent serious work documenting evidence through a partial cross-over clinical trial, 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. The 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 simillimum. 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.
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 the clinical reality of classical homeopathic prescribing, using basic homeopathic methodology (Boenninghausen). None of the participants were on pharmacological treatment, hence a better chance for unmasked observation of homeopathic symptoms. It is possible that some preference bias was introduced with the 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.
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. Second, the research design alienates homeopathic perspective by focusing too much on statistical measurement of outcomes without a deeper 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 could 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 would have doubtful reliability when method of case analysis, remedy choice, remedy response and case management (Oberbaum et al 2003; Vithoulkas, 1980) i.e. methodology used, is based on new methods that haven’t stood the test of time. Without these basic requirements, there cannot be homeopathic credibility to RCT design. Homeopaths “guessing” whether the participant was on medication or placebo is inappropriate. It would have been preferable if the homeopaths had clear criteria to gauge improvement following the remedy, following clear guiding principles of evaluation (Oberbaum et al, 2003; Vithoulkas, 1980) The researchers suggest investigating ‘non-local’ entanglement (Milgrom, 2002) effects of the homeopathic interview. These effects are not restricted to homeopathy. Hence, ‘entanglement’ would not obtain statistically reliable information on homeopathic remedy therapeutics.