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Evidence/Resources | Clinical Trials


Clinical Trials re
Irritable Bowel Syndrome
Crohn's Disease
Epilepsy and Migraine
Rheumatoid Arthritis
Polysymptomatic States
Asthma and Rhinitis
Behavioural Disorders
Genitourinary Problems
Chronic Fatigue
Neutralisation/ Desensitisation
Nutritional Medicine




A Selection of Clinical Trials Validating this Approach to Medicine

There are over 1000 studies in the worldwide literature correlating food sensitivity to a whole range of chronic illness. There are a small number of papers exploring the role of candida hypersensitivity/ fungal type dysbiosis with some human illness. There are several thousand papers in nutritional journals exploring the role of trace minerals, vitamins, essential fatty acids, and amino acids in the aetiology of many medical problems.

The following is a small selection of papers to give a flavour of some of the evidence to support the view that allergy, environmental medicine and nutritional medicine has a major role to play in the modern medical practice.

Please note that there are no medical conditions except a rare condition called 'Dermatitis Herpetiformis' (always a Gluten sensitivity) which are always caused by food sensitivity. Eczema, for example, can be caused by food sensitivity, chemical sensitivity, candida hypersensitivity and biological inhalant sensitivity. It can also be caused by zinc deficiency and essential fatty acid deficiency. Frequently, a combination of these factors are at fault.

Editions of Medical Journals will insist that submitted papers only explore the role of one factor in the causation of any one condition. This of course, leads to the understatement of the value of the multi-factorial approach, which is used in practice.

Clinical Trials  re: Migraine
[1] Is Migraine Food Allergy?  Soothil et al. Great Ormond Street. Lancet 1983: 2; pp865-9
93% of 88 children with severe, frequent migraine recovered on oligo-antigenic (low risk) diets. The role of foods provoking migraine was established by double blind controlled trials.

[2] Food Allergies and Migraine.  Ellen Grant. Charring Cross Hospital. Lancet 1979: 1; pp966-8
85% of 60 patients became headache free.

[3] Food Allergy in Migraine.  Munro J., Brostoff J., National Hospital for Nervous Diseases & Middlesex Hospital. Lancet 1980: 2; pp1-4

[4] Migraine is a Food Allergic Disease.  Munro J., Brostoff J,. Lancet 1984: Sept. 29th pp719-24

Clinical Trials  re: Irritable Bowel Syndrome
[5] Food Intolerance: A Major Factor in the Pathogenesis of Irritable Bowel Syndrome.  Hunter J., et al. Lancet 1982: 2; pp1117-1120
Specific foods provoked irritable bowel syndrome in 65% of the patients. Double blind challenges confirmed results.

Clinical Trials  re: Crohn's Disease
[6] Crohn's Disease: Maintenance of Remission by Diet.  Hunter et al. Lancet: 1985: 2; pp177-80
51 out of 77 patients remained well on an exclusion diet, for over four years.

[7] Treatment of Active Crohn's Disease by Exclusion Diet: East Anglian Multicentre Controlled Trial.  Lancet 1993: 342; pp1131-4
Positive results, as above.

Clinical Trials  re: Epilepsy and Migraine
[8] Oligo Antigenic Diet Treatment of Children with Epilepsy & Migraine.  Eggar J. et al. Great Ormond Street Hospital. Journal Pediatric 1989: 114; pp52-8
Of 45 children who had epilepsy with recurring headaches 25 children ceased to have seizures and a further 11 had significantly fewer seizures during dietary therapy. Of 18 children who had epilepsy alone, none improved.

Clinical Trials  re: Rheumatoid Arthritis
[9] Placebo-Controlled Blind Study of Dietary Manipulation Therapy in Rheumatoid Arthritis.  Darlington G., Epsom District Hospital, Mansfield J., The Burghwood Clinic, Banstead. Lancet 1986: Feb 1st; pp236-8.
75% of 44 patients improved substantially or totally on dietary elimination.

[10] Controlled Trial of Fasting and One-year Vegetarian Diet in Rheumatoid Arthritis.  Kjeldson-Kragh et al. (Oslon Norway). Lancet 1991: 338; pp899-902
Most patients responded to restricted diet and responded adversely to the reintroduction of specific foods.

Clinical Trials  re: Polysymptomatic States
[11] Food Allergy in Polysymptomatic Patients.  Radcliffe M. et al. Practitioner 1981: 225; pp1651
Very positive results from Double Blind Feeding Tests.

Clinical Trials  re: Asthma and Rhinitis
[12] Children with Allergic Rhinitis and/or Bronchial Asthma treated with Elimination Diet.  Ogle K., Annals of Allergy 1980 May: 44; pp273-8.
91% of 322 children showed significant improvement in trial

[13] Food Sensitivity and Asthma.  Wraith D.G., Brostoff, and Challacombe. Food Allergy and Intolerance, London Bailliere, Tindall 1987; pp486-97
Study of 265 patients on avoidance of incriminated foods led to a huge reduction in the use of inhalers and steroids

[14] Asthma Induced by Sulphur Dioxide, Benzoate and Tartrazine contained in Orange Drinks.  Freedman B.J., Kings College Hospital, Clin. Allergy 1997: 7; pp407-415
18% of 272 patients with asthma reacted to one or more of the constituents of of orange drinks

Clinical Trials  re: Behavioural Disorders
[15] Effects of a Few Food Diet in Attention Deficit Disorder.  Carter C. et al. Archives of Disease in Childhood 1993: 69; pp564-8

[16] Controlled Trial of Oligoantigenic Treatment in the Hyperlinetic Syndrome.  Soothill et al. Great Ormond Street. Lancet 1985: March 9th; pp540-5
Of 76 selected overactive children treated with Oligoantigenic diet, 62 improved, 21 of which becoming totally normal.

[17] Controlled Trial of Hyposensitisation in Children with Food-Induced Hyperkinetic Syndrome.  Egger J., Lancet 1992: 339; pp1150-53
Results showed that enzyme potentiated desensitisation permitted children to eat foods previously identified as responsible for their symptoms.

Clinical Trials  re: Eczema
[18] Double Blind Controlled Cross-Over Trial of an Antigen-Avoidance Diet in Atopic Eczema.  Atherton D.J. at al., Great Ormond Street. Lancet: Feb 1978; pp401-3
With the avoidance of just two foods (milk and eggs), 14 out of 20 children improved.

Clinical Trials  re: Genitourinary Problems
[19] Food Sensitivity. The Kidney and Bladder.  Sandberg D., Brostoff J. & Challacombe S. Food Allergy & Intolerance, London Bailliere, Tindall 1987; pp755-76
Recurrent cystitis and bladder pain respond frequently to elimination diets. Food sensitivity also a possible cause of nephrotic syndrome.

Clinical Trials  re: Chronic Fatigue
[20] The Role of Food Intolerance in Chronic Fatigue Syndrome in Hyde B.M. Ed.
Lobley R.

[21] The Clinical and Scientific Basis of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
Ottowa. The Nightingale Research Foundation 1992; pp521-38

Clinical Trials supporting the Value of Neutralisation / Desensitisation to Food and Inhalant Sensitivities
[22] Double-Blind Study of Food Extract Injection Therapy.  Miller J.B. Annals of Allergy March 1977: 38; pp185-192
A double-blind cross-over study. In most cases the response if lifelong severe intractable symptoms was rapid and dramatic (within 3-4) days. Symptoms returned within 3 of the 4 days on placebo injections

[23] Elimination of Oral Challenge Reaction with Patients by Injection of Food Extracts. A Double-Blind Evaluation.  Rea W.J. et al. Archives of Otolaryngology April 1984: Vol 110; pp248-252
The phenomenon of Subcutaneous Food Neutralisation can be scientifically endorsed for clinical treatment of food reactions.

[24] Low Dosage Sublingual Therapy in Patients with Allergic Rhinitis due to House dust Mite.  Scadding G. & Brostoff J. Department of immunology, Middlesex Hospital. Clinical Allergy 1986: Vol 16; pp483-491

[25] Provocation - Neutralisation: A Two Part Study. Part I - The Intracutaneous Provocative Food Test : A Multi-Center Comparison Study.  King W. et al. Otolaryngology - Head and Neck Surgery Sept. 1988: Vol 99 no.3; pp263-71

[26] Provocation - Neutralisation: A Two Part Study. Part II - The Subcutaneous Neutralisation Therapy : A Multi-Center Comparison Study.  King W. et al. Otolaryngology - Head and Neck Surgery Sept. 1988: Vol 99 no.3; pp263-71

Triple Blind Studies provide evidence that subcutaneous neutralisation treatment is an effective form of food hypersensitivity therapy. These two studies led by the American Academy of Otolarynigic Allergy to recommend neutralisation as the treatment of choice to Ear, Nose and Throat Specialists treating Rhinitis. Most ENT specialists in the USA now use neutralisation as the preferred choice for perennial rhinitis.

[27] Treatment of Equine Allergic Disease with Allergy neutralisation: A Field Study.  Mansfield J., Valler B., Burrel M. & Curl V. The Burghwood Clinic, Banstead. Journal of Nutritional & Environmental Medicine 1998: 8; pp329-334
The first study worldwide of neutralisation on an animal model. 87% of horses with COPD (equine asthma) responded well after neutralisation. 92% of horses with urticaria responded well.

Nutritional Medicine

Early work in the area of nutritional medicine received criticism due to the premature advocacy of certain treatments despite the lack of adequate scientific validation.

Laboratory test can now provide evidence of inadequate nutrition despite the lack of clinical findings of classical nutritional deficiency syndromes, which are uncommon in western civilizations and which represent only the most extreme forms of nutritional deficiency. Even in the absence of laboratory validation of nutritional deficiencies, numerous studies using rigorous scientific designs have demonstrated impressive benefits from nutritional supplementation.

It is now well established, for example, that nutritional factors are of major importance in the pathogenisis of both arteriosclerosis and cancer, the two leading causes of death in western countries. There are, in fact, numerous published studies demonstrating the role of trace mineral deficiency in conditions as varied as asthma, hyperactivity, migraine, acne, chronic fatigue syndrome, rheumatoid arthritis, osteoarthritis, hypertension, kidney stones and premenstrual syndrome, to name but a few. There is a classic major reference book in which over 3000 clinical trials detailed. It is entitled 'Nutritional influences on illness' by Melvyn R. Werbach, MD - 3rd Line Press. This should be obtainable through most good libraries or can be purchased from The Nutri-Centre Bookshop, Hale Clinic, 7 Park Crescent, London, W.1 [020 7323 2382]

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