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The North American EPD Study

73 physicians participated in the study at different centers (multi-center) in the USA and Canada.  Patients were selected randomly for this study in many or most instances.  However, a quite significant percentage of these of patients were selected because they had previously failed on treatment with both medications and conventional immunotherapy.

            EPD treatment was administered every two to three months, generally by one to five small (1/20 c.c.) intradermal (in the first layer of skin) injections which were generally administered in the skin of the inner aspect of the forearm.

Patients were evaluated by the use of initial and interim questionnaires.  The initial questionnaires were completed by patients prior to receiving EPD, and the interim questionnaires were completed immediately prior to receiving each subsequent treatment.  Patients evaluated how they responded to EPD "overall" and how they responded to each specific condition they had recorded.  Overall and individual categories were evaluated for both the effect on the frequency of their symptoms and the effect upon severity of symptoms.

Patients were allowed to evaluate as few as one and as many as six conditions for which they were being treated.  Patients were required to choose one of the following categories for both their "overall" response for each evaluation and their response to EPD treatment for each specific condition were evaluated:

Excellent

Very good

Good

Fair

Poor

Terrible (worse than the before starting treatment)

Patients also recorded their frequency of use of self-selected medications at the onset of treatment and for their evaluation after each treatment (over 600 medications were listed by patients).

EPD - Frequency of Treatment

            EPD treatments were given every 2 to 3 months at first, then less often.  Generally, patients with multiple problems were treated every two to three months for six to eight times.  After that, treatments usually decreased to every four to six months and then less often as needed.  Once therapy reached once yearly, treatments were often stretched to as little as once every 6-12 months.  68,428 treatments were given to 10,372 patients.  Since "treatments" consisted of 1 to as many as 7 injections, the total number of actual injections given is not known exactly, but was between 175,000 and 179,000.

EPD - Conditions Treated

            Over 60 conditions were treated with EPD in this study.  The conditions treated are listed here 

EPD - Complications and Adverse Reactions

            There were 3 patients reported with possible complications to EPD to the IRB over the period of 1994-1999.  None of these complications were serious or life threatening.

Results

The study evaluated 10,372 patients over 7 years.  Of those patients, 60% (6261) were female and 40% (4111) were male.  Average age of females was 45, and the average for males was 33.

            Of the 10,372 patients enrolled in the study, 6030 were evaluated as to overall response, response as to improvement in frequency (see Table I below) and response as to improvement in severity (see Table II below).  The "dropout" rate was 41% over the 7-year period of the study.  This compares to 50% for much shorter-term studies of escalating dose immunotherapy, where only very few conditions (4 or less) were studied.

            It has been established by previous studies that it may take up to three treatments with EPD to determine whether the therapy may be effective.  Considering this, the 1160 patients who stopped treatment prior to three treatments were counted as dropouts, but really cannot be counted as treatment failures.

Responses were scored numerically by computer.  For specific conditions evaluated, for the purposes of this paper, patients who reported a response of "excellent", "very good" or "good" were grouped together as "satisfactory").  Patients who reported "fair" results were classified as "fair", and patients who reported "poor" or "terrible" were reported as "no change" or "worse".

The "overall" response showed that 20% of patients reported excellent, 30% reported very good and 26% good, with an overall "satisfactory" response rate of 76%.  Fourteen percent (14%) reported fair and 8% reported no change.  Two percent (2%) of patients felt they were worse after receiving EPD than they had been prior to starting EPD; most investigators suspected that many of these patients worsened despite EPD, rather than as a result of EPD, though this could not be determined.

Discussion

            The American EPD Society study is the largest outcome-based study ever undertaken of any type of immunotherapy, with over 10,000 patients.  We believe that this study demonstrated the significant clinical value of EPD as a treatment tool.  We have listed a brief comparison of EPD immunotherapy to conventional immunotherapy in Table IV.

            Conventional escalating dose immunotherapy is the immunotherapy most widely used in the United States.  Most classically trained allergists employ this type of treatment in some form.  It should be made clear, however, that this type of immunotherapy is effective for only a relatively few conditions.  According to the medical literature, these conditions are fairly limited to seasonal hay fever, dust mite allergy, cat (and perhaps dog) allergy, and possibly seasonal asthma.

            Most studies done of patients treated with conventional immunotherapy for classical pollen allergy claim an overall success rate of between about 60 and 80 percent for highly selected patients.

            Although every condition evaluated in our study did not necessarily appear to respond dramatically to EPD immunotherapy, most responded quite favorably.  Most importantly, a large number of conditions which do not respond at all to conventional immunotherapy, and many which do not respond well to any type of therapy - appear to have responded to EPD.

            For example, there is no effective immunotherapy for angioedema, which consists of facial swelling, swelling of the lips or eyes or swelling of other parts of the body, primarily as a result of acute food allergy.  78% of 180 patients reported satisfactory (excellent, very good or good) results with EPD immunotherapy.  Conventional therapy dictates treatment primarily with drugs.

            Likewise, immediate food allergy, which includes anaphylaxis (a condition that is generally life-threatening) has no effective treatment except for emergency drug treatment and avoidance of the offending food or foods.  This includes such potentially fatal problems as peanut and shrimp or shellfish allergy.  In the group of 519 patients who had some type of immediate food allergy, EPD was effective in 72%.  Conventional immunotherapy has no effect for anaphylaxis to foods or chemicals, and is in fact dangerous and contraindicated.  The only exception is a type of immunotherapy (Rush desensitization) that has been employed for penicillin, bee sting and a few other problems.

            Several conditions that are difficult to treat don't respond extremely well to drug therapy and cannot be treated with conventional immunotherapy.  Yet many appeared to respond well to EPD in this study.  The quite successful response (in regards to severity) of such conditions as perennial asthma, (732 patients with 75% success), headaches (1186 patients with 75% success), food intolerance - or food reactions, which in most cases was moderate to moderately severe (2857 patients with 74% success), chronic perennial rhinitis (2258 patients with 74% success), hyperactivity/attention deficit disorder (578 patients with 70% success) and eczema or severe dermatitis (669 patients with 69% success), are just a few conditions that response to any type of immunotherapy should be considered dramatic.

            Although the results of treatment with EPD of some of the autoimmune diseases studied here may not appear to be dramatic, treatment of these conditions with any type of immunotherapy has been extremely disappointing or has not been considered possible.

            Results for certain autoimmune conditions varied from center to center, primarily as a result of specific treatment protocols employed by physicians that were used in addition to the fundamental study protocol.  For example, in this study, 14 patients with ankylosing spondylitis (severe, debilitating arthritis of the spinal column) had a modest success rate of 64%.  However, in one treatment center, likely as a result of the specific protocol chosen by the physician, all four patients treated for ankylosing spondylitis with EPD responded extremely well.

            The same case can be made for rheumatoid arthritis.  This is a typically debilitating and progressive disease for which the only available treatment is the employment of a specific regimen of drug therapy.  For the 76 patients with rheumatoid arthritis in the study, most would consider a 57 percent rate of success - which means patients were satisfied with the results - remarkable.  79% of patients with rheumatoid arthritis in the study reported a decrease in the medications needed to treat symptoms.

            Although the final statistics of this study have not yet been published, the considerably large numbers of patients in fairly well defined groups gives a strong indication that the conclusions are reliable.  Also, the success rate of EPD (78%) for seasonal rhinitis (1361 patients) compares favorably to that of conventional immunotherapy.

            The results for the treatment, listed by response to Frequency and Severity, appear below, sorted from greatest to least effect.  Groups of patients with less than 20 individuals (N< 20) should not be considered accurate enough to be statistically significant.

            A comparison of EPD immunotherapy and conventional immunotherapy appears in Table III.

Table I.  American EPD Trial Outcome Results

Improvement in Frequency of Symptoms (Nov., 1993 - Nov., 2000)

 

Description

Patients

No response

Patients

evaluated

Excellent, Very Good, Good

 

%

Fair

%

No change

%

 

 

to question

 

 

 

 

 

 

or worse

 

Repeated Ear Infections

281

15

266

236

 

89%

16

6%

14

5%

Secretory Otitis Media

39

9

30

26

 

87%

2

7%

2

7%

Repeated Chest Infections

251

13

238

192

 

81%

24

10%

22

9%

Asthma, seasonal only

210

3

207

163

 

79%

19

9%

25

12%

Angioedema

180

18

162

127

 

78%

12

7%

23

14%

Rhinitis, Seasonal

1361

67

1294

1011

 

78%

152

12%

131

10%

Allergic Conjunctivitis

1017

48

969

746

 

77%

125

13%

98

10%

Chronic Cough, not asthma

303

8

295

228

 

77%

37

13%

30

10%

Chronic Face ache

484

39

445

336

 

76%

61

14%

48

11%

Asthma

732

46

686

512

 

75%

91

13%

83

12%

Contact Dermatitis

176

11

165

124

 

75%

23

14%

18

11%

Headaches, Other

1186

89

1097

818

 

75%

149

14%

130

12%

Nasal Polyps

112

10

102

75

 

74%

13

13%

14

14%

Rhinitis, Perennial

2258

128

2130

1570

 

74%

297

14%

263

12%

Food Allergy, Other

2857

140

2717

1958

 

72%

399

15%

360

13%

Immediate Food Allergy

519

38

481

348

 

72%

59

12%

74

15%

Plugged Ears, moderately severe

402

14

388

276

 

71%

53

14%

59

15%

Chronic Anal Irritation

132

4

128

89

 

70%

20

16%

19

15%

Chronic Sinusitis

352

21

331

233

 

70%

49

15%

49

15%

Eczema

669

29

640

444

 

69%

91

14%

105

16%

Emotional/behavioral problems

488

15

473

327

 

69%

65

14%

81

17%

Irritable Bowel

613

38

575

397

 

69%

88

15%

90

16%

Candida-Related Complex

940

59

881

598

 

68%

156

18%

127

14%

Hyperactivity

578

34

544

372

 

68%

81

15%

91

17%

Mental confusion (brain "fog")

1650

77

1573

1065

 

68%

263

17%

245

16%

Migraine/Severe Headache

691

36

655

448

 

68%

85

13%

122

19%

Chronic severe post-nasal drip

561

5

556

374

 

67%

102

18%

80

14%

Pruritis

177

4

173

116

 

67%

25

14%

32

18%

Chemical Sensitivity

1413

83

1330

858

 

65%

252

19%

220

17%

Gut Fermentation

699

35

664

431

 

65%

124

19%

109

16%

Ankylosing spondylitis

14

 

11

9

 

64%

2

14%

3

21%

CFIDS

152

9

143

91

 

64%

24

17%

28

20%

Chronic Fatigue, Other

887

55

832

535

 

64%

163

20%

134

16%

Constipation

399

22

377

237

 

63%

68

18%

72

19%

Hypertension

109

6

103

65

 

63%

17

17%

21

20%

Depression, significant

452

8

444

276

 

62%

80

18%

88

20%

Epilepsy

45

3

40

26

 

62%

3

7%

13

31%

Psoriasis

65

4

61

38

 

62%

11

18%

12

20%

Arthritis, Non-Specific

689

43

646

393

 

61%

124

19%

129

20%

Chronic Vaginal Symptoms

179

8

171

103

 

60%

32

19%

36

21%

Muscle Pains

561

35

526

318

 

60%

117

22%

91

17%

Rheumatoid Arthritis

76

3

73

43

 

59%

13

18%

17

23%

Crohn's Disease

29

1

28

16

 

57%

6

21%

6

21%

Insomnia, moderately severe

423

9

414

225

 

54%

90

22%

99

24%

Autism

134

6

128

68

 

53%

31

24%

29

23%

Meniere's Disease

47

 

41

25

 

53%

11

23%

11

23%

Dermatographia, dermagraphia

17

 

12

8

 

47%

3

18%

6

35%

Sjogren's Syndrome

16

 

18

7

 

44%

4

25%

5

31%

Anosmia

116

5

111

48

 

43%

25

23%

38

34%

Multiple Sclerosis

5

 

4

1

 

25%

3

50%

1

25%

 Table II: American EPD Trial Outcome Results

Improvement in Severity of Symptoms (Nov., 1993 - Nov., 2000)

 

Description

Patients

No response

Patients

evaluated

Excellent, Very Good, Good

%

Fair

%

No change

%

 

 

to question

 

 

 

 

 

or worse

 

Repeated Ear Infections

281

5

276

243

88%

18

7%

15

5%

Secretory Otitis Media

39

2

37

32

86%

3

8%

2

5%

Repeated Chest Infections

251

5

246

196

80%

22

9%

28

11%

Chronic Cough, not asthma

303

6

297

234

79%

33

11%

30

10%

Contact Dermatitis

176

3

173

135

78%

23

13%

13

8%

Rhinitis, Seasonal

1361

22

1339

1041

78%

162

12%

136

10%

Urticaria

230

6

224

175

78%

23

10%

26

12%

Allergic Conjunctivitis

1017

23

994

770

77%

126

13%

98

10%

Nasal Polyps

112

5

107

82

77%

11

10%

14

13%

Asthma, seasonal only

210

1

209

158

76%

22

11%

29

14%

Chronic Face ache

484

14

470

358

76%

61

13%

51

11%

Angioedema

180

9

171

128

75%

21

12%

22

13%

Asthma

732

17

715

539

75%

93

13%

83

12%

Headaches, Other

1186

24

1162

868

75%

154

13%

140

12%

Food Allergy, Other

2857

55

2802

2060

74%

385

14%

357

13%

Rhinitis, Perennial

2258

33

2225

1644

74%

307

14%

274

12%

Chronic Sinusitis

352

10

342

245

72%

47

14%

50

15%

Immediate Food Allergy

519

15

504

364

72%

65

13%

75

15%

Plugged Ears, moderately severe

402

7

395

281

71%

56

14%

58

15%

Hyperactivity

578

16

562

392

70%

84

15%

86

15%

Candida-Related Complex

940

30

910

630

69%

150

16%

130

14%

Eczema

669

10

659

457

69%

104

16%

98

15%

Emotional/behavioral problems

488

11

477

331

69%

61

13%

85

18%

Irritable Bowel

613

10

603

419

69%

96

16%

88

15%

Chronic Anal Irritation

132

3

129

88

68%

19

15%

22

17%

Migraine/Severe Headache

691

14

677

458

68%

83

12%

136

20%

Chronic severe post-nasal drip

561

6

555

370

67%

104

19%

81

15%

Mental confusion (brain "fog")

1650

27

1623

1095

67%

286

18%

242

15%

Chemical Intolerance

1413

28

1385

918

66%

240

17%

227

16%

Gut Fermentation

699

20

679

450

66%

116

17%

113

17%

Urinary Tract Symptoms

152

6

146

96

66%

20

14%

30

21%

Constipation

399

9

390

252

65%

62

16%

76

19%

Pruritis

177

2

175

114

65%

31

18%

30

17%

Ankylosing spondylitis

14

 

14

9

64%

1

18%

4

36%

Chronic Fatigue, Other

887

21

866

554

64%

168

19%

144

17%

Depression, significant

452

6

446

286

64%

67

15%

93

21%

Hypertension

109

3

106

67

63%

17

16%

22

21%

Arthritis, Non-Specific

689

21

668

413

62%

121

18%

134

20%

CFIDS

152

5

147

89

61%

29

20%

29

20%

Chronic Vaginal Symptoms

179

1

178

108

61%

34

19%

36

20%

Muscle Pains

561

10

551

333

60%

130

24%

88

16%

Crohn's Disease

29

 

29

17

59%

6

21%

5

17%

Psoriasis

65

5

60

35

58%

13

22%

12

20%

Ulcerative Colitis

40

 

40

23

58%

8

20%

9

23%

Meniere's Disease

47

1

46

26

57%

10

17%

10

14%

Rheumatoid Arthritis

76

2

74

42

57%

15

20%

17

23%

Insomnia, moderately severe

423

8

415

232

56%

89

21%

94

23%

Autism

134

7

127

70

55%

31

24%

26

20%

Epilepsy

45

6

39

21

54%

2

4%

16

36%

Dermatographia, dermagraphia

17

 

17

9

53%

3

50%

5

29%

Multiple Sclerosis

5

 

5

2

40%

1

0%

2

100%

Sjogren's Syndrome

16

 

16

6

38%

4

33%

4

22%


 

Table III: Comparison of EPD Immunotherapy to Conventional Immunotherapy

 

Conventional Immunotherapy

EPD Immunotherapy

Strength (dosage) at start of therapy

1:10,000

1:1,000,000,000,000,000 (quadrillion) to 1:1,000,000

Strength (dosage) at maintenance (highest)

1:10 to 1:100 (approx.)

1:1,000,000

Conditions treatable

Limited

Diverse

Autoimmune disease

Not treatable

Often treatable

Life-threatening food allergy (peanut, shellfish, others)

Not treatable, and immunization is contraindicated

Treatable (success rate of 72% of 519 patients)

Frequency of treatment

Twice weekly, usually for 6 months, then once every 1-2 weeks, then less often

Every 2 months for 12 months, then every 2-24 months

Ability to stop therapy

Often not possible

Half of all patients can stop after 16-18 treatments

Drug Usage

Very little changed

Considerably decreased, 50% of patients were able to stop medications

Cost

Moderate - long term

30-60% less than conventional

Safety

Fatalities recorded due to high dosages needed

safe; no fatalities ever recorded

Efficacy

Proven for certain pollen and other limited types of allergy.  Not satisfactory for patients with allergy to multiple inhalants.  Ineffective for patients with autoimmune diseases, food allergy and intolerance and most others.  Efficacy said to be approx. 80% for treatable allergy.

Effective for all types of allergy and intolerance to inhalants, foods and chemicals. Effective for some types of  autoimmune diseases.  The only immunotherapy available for treatment of anaphylaxis to foods.  Virtually all patients with allergy treatable.  Overall efficacy for all conditions treated (approx. 60 diverse conditions, American EPD Study) was 75%.

Conclusions

            At the end of this 7-year study of 10,372 patients who received at least 175,000 injections of EPD, the physicians who participated in this study concluded that the healing and health potential of EPD for use to treat allergy and autoimmune disease is significant.

As a result of the findings of this study, and in comparison to conventional immunotherapy, we must conclude that EPD:

Is extremely safe, without incidence of fatality or serious side effects

Is virtually the only option available to actually prevent the occurrence of life-threatening reactions or death as a result of acute food allergy

Is as successful as conventional immunotherapy for the very limited conditions for which conventional immunotherapy is used to treat.

Can be used to successfully treat a vastly greater number of conditions, and is more convenient than conventional immunotherapy (i.e. treatment every 2 weeks)

Reduces the amount and/or number of drugs required to be taken by patients by at least 50 percent on the average.

Has several major advantages over conventional escalating dose immunotherapy:

o       is 30-60% more cost-effective

o       is administered far less frequently with an earlier and more complete endpoint

o       can be discontinued without complete relapse of symptoms, or treatments can be extended to very long intervals of a year or more

 

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Last modified: October 23, 2013