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New approaches to treating pollenosis — a pilot study
New approaches to treating pollenosis - a pilot study M.Wiesenauer, R. Heidl Homeopathy- Naturopathy, In der Geiss 8, D - 71 384Weinstadt, Germany
S U M M A R Y Objectives:To evaluate the effectiveness and safety ofa homoeopathic drug combination in the treatment of pollenosis under condition of daily practice. Design: Care review. Setting:A general practice in Germany. Patients: 35 patients with pollenosis. Main outcome measures: Objective and subjective symptoms of acute pollenosis. Results: During an average treatment period of 61 days it was found that 28 of 35 patients experienced an improvement in pollenosis symptoms.The medication was well tolerated thought patients preserved oral to subcutaneous administration. Conclusion: Patients receiving the homoeopathic drug combination experienced improvements without side effects.Whether this improvement is clue to the medicine or some other factor would need to be determined in a controlled trial.© 1999 Harcourt Publishers Ltd
or analogues, including biological drugs as well as local application of steroids; 1 week after intake of systematic steroids; 8 weeks after application of depot steroids. Patients who had been treated with corticosteroid and/or antiallergic agents for other complaints were excluded from the study. Patients admitted to the study were treated with a fixed combination of individual homoeopathic agents for subcutaneous or oral administration. All additional medication was documented. The combination is a mixture of liquid dilutions in conformity with specification 16 of the German homoeopathic pharmacopoeia I: 0.4 ml Apis mellifica D6; 0.4 rnl Acidum formicicum D6; 0.6 ml Thryallis glauca D6; 0.6 ml Cardiospermum halicacabum D4. In accordance with the design of the study, only descriptive statistical procedures were employed. At the start of the treatment and at each subsequent consultation the patients were asked to rate the symptoms 'conjunctival irritation', 'tear flow', 'itching', 'urge to sneeze', 'running nose', 'blocked nose' and 'asthmatic complaints' on the following scale:
INTRODUCTION The effectiveness of fixed combinations of individual homoeopathic agents as used in practice, can be documented using careful patient assessments) Patients can be asked to record their experience with individual preparations in order to provide information about their effectiveness and safety. Out-patient treatment is particularly suitable for monitoring by means of standard questionnaires. In this way, 'quality of life' can be recorded as an important parameter in patient assessment. The purpose of this study is to evaluate the effectiveness and safety of a homoeopathic drug combination for pollenosis as used in primary care.
METHODS
Markus W i e s e n a u e r
Specialist in General Hedicine, HomeopathyNaturopathy, In der Geiss 8, D-71384 Weinstadt, Germany
During the pollen season of 1993, a total of 35 patients of a general medical practice were included in a monitoring program. The patients had all suffered for years or longer from clinically established pollenosis which satisfied the relevant inclusion criteria. The included patients were of both sexes, and were suffering from acute hay fever with symptoms affecting eyes, nose and, in some cases, lungs; the acute symptoms had been evident for no longer than 7 days. If antiallergic treatment had been given on account of the acute symptoms, the following periods had to be allowed to elapse before inclusion in the study: 24 h after antihistamines, cromoglycate
ComplementaryTherapiesin Medicine(1999), 7, 222-224 © 1999HarcourtPublishersLtd
l. Symptom-free, i.e. the patient showed no symptoms at all ('none') 2. Obvious relief, i.e. noticeable and soothing relief ('light') 3. Only slight improvement, i.e. the symptoms were only slightly mitigated ('medium') 4. No improvement at all ('severe'). 222
New approaches to treating pollenosis
Female n=21 (60%), mean age 19.0, (range 12-26) Male n= 14 (40%), mean age 24.2, (range 16-33) years Duration of illness: mean 9.5 years (range 4-20 years) First manifestation: mean I 1.6 years of age (3rd to 29th year of age) Hyposensitization n = 7 Other therapies n = 9
223
ration. These included five patients who only took terfenadine, three who only took astemizole, one who took eye drops, one who took a herbal drug, and one who took a homoeopathic medicine. Only one patient took terfenadine over the whole monitoring period; all other patients took the specific accompanying medication transiently, seven of them only in the period up to the first follow-up examination and two others until the second followup examination.
Effectiveness and tolerability Month
Patients
Symptoms
March March April May
4 3 20
prophylactic acute acute acute
8
* * *
* Duration: mean 3.7 days (range 3-7 days). Treatment period 3--4 weeks 5-6 weeks
7-8 weeks 9-12 weeks > 12 weeks
Patients (n) 6 (17%) 2 (6%)
14 (40%) 8 (23%) 5 (14%)
Additionally the physician had to note the patients' subjective statements on the results of the therapy, measured on the same scale. An 'intention to treat' assessment was carded out, i.e. all patients who had received at least one dose of the remedy were entered into the analysis.
RESULTS A total of 35 patients participated in the study. Patients' baseline characteristics are described in Table l a and b. The total duration of the monitoring, consisting of the treatment period and the post-treatment monitoring period, was 108 days. The average treatment time was 61 days. After the end of the treatment, 27 patients were monitored for an average of 61 days.
Dosage All the patients who initially took the drug orally continued to do so, but only 2 of the 15 patients to whom the drug was initially administered by injection received all the remaining doses in this form. As early as the second consultation, 11 'injection patients' switched to oral administration. Dosages are shown in Table 3.
Additional antiallergic medication Only 11 patients (31.4%) took specific accompanying medication during treatment with the test prepa-
The frequency of the symptoms and their severity before the start of the treatment and at the following consultations are shown in Table 2 and Figure 1. Of the total of 35 patients who were included in the study, 26 had no symptoms when the study was concluded, even though the airborne pollen season was not yet finished. Two other patients stated that the course of the illness had been much milder than in previous years. These two, and the previously mentioned 26 (a total of 28 patients) described the efficacy of the treatment as 'good' or 'very good'. Seven of these patients remarked that their experience of the airborne pollen season had been 'better than ever before'. Seven patients were dissatisfied with the effectiveness of the treatment. These included four patients who stated that the treatment had no effect, two who characterized effectiveness as questionable and wanted a different therapy for the following year, and one patient who described the treatment as 'not convincing'. This patient had reported an improvement in his symptoms during the treatment, but this was not maintained. Two patients terminated the treatment after the third consultation. While 22 of the 28 patients who were satisfied with the effectiveness of the treatment required no further specific therapy, this was only true of two of the group of seven patients who were not convinced by the efficacy of the therapy. Three of the seven patients who were dissatisfied had already been hyposensitized, while this was only true of four of the 28 satisfied patients. It was noted that five of the seven dissatisfied patients suffered from not only a severe urge to sneeze, but also severe itching at the start of the treatment. This applied to only six of the 28 satisfied patients. No correlation was detected between sex, age, duration of acute symptoms (in days) or duration of susceptibility to hay fever (in years) and the success of the treatment. At the conclusion of the study, doctor and patient provided an assessment of tolerability as 'good', 'moderate' or 'poor'. In one case neither the doctor nor the patient provided an assessment because the treatment had been terminated on account of 'ineffectiveness'. In all other cases the doctor assessed compatibility as 'good' and, with one exception, this was also the verdict of the patients. Only one
ComplementaryTherapies in Medicine
224
Begin Patients
I n=35
Consultation no. 2 3 n=35 n=35
4 n=32
5 n=30
6 n=23
Conju nctival irritation Tear flow Itching Urge to sneeze Running nose Blocked nose
57, I 71,4 68,6 88,6 80,0 65,7
40,0 71,4 77, I 100,0 82,9 71,4
17, I 60,0 60,0 8S,7 62,9 60,0
6,3 25,0 46,9 62,5 21,9 50,0
Asthmoid complaints
22,9
11,4
0,0
3, I
3,3 l O,O 26,7 30,0 16,7 30,0 3,3
0,0 4,3 17,4 13,0 4,3 17,4 0,0
100 90 80 70 60 (Percent)
50 40 30 20 10 0 Conjunctional Tear flow irritation
Itching
Urge to sneeze
Running nose
Blocked nose
Asthmoid complaints
[ ] Consultation No. 1 17"AConsultationNo. 2 [ ] Consultation No. 3 I [ ] Consultation No. 4 mConsuitation No. 5 [-I Consultation No. 6 Fig. I
I
Severity of symptoms.
Ampoules /week
Consultation I
2
3
4
5
6
3 2
31 4
24 10
5 22
4 II
I
0
I
S
8
3
0
0
0
0
4
12
25
32
2 5
0 3
patient assessed the compatibility as 'moderate', on the grounds that he felt a buming sensation on his tongue when he took the preparation with water. DISCUSSION
Evidence of effectiveness must be obtained under realistic conditions. If a preparation is mainly used in general practice, then that is where it should be evaluated. Pollenosis exhibits a well-documented clinical picture: it is an acute illness, self-limited by exogenic factors, which offers the opportunity of a long follow-up monitoring period. The comprehensive
case history and clinical picture facilitate reliable diagnosis, especially for patients with whom the general practitioner has been acquainted for a long time. We carried out a study with a homoeopathic preparation which was administered subcutaneously or on the tongue. Our objective was to determine the acceptability of such methods of application and to look for evidence of effectiveness under practice conditions. During the course of the treatment the effectiveness of the preparation seemed to be comparable to that of antihistamines. The time which elapsed before the preparation took effect, the amelioration of the symptoms and the minimal appearance of acute symptoms when the preparation was administered prophylactically, all suggest a beneficial effect of the preparation. The preparation was were tolerated, though it seem that patients prefer. . However, in the absence of comparative control, it is not possible to make a definitive statement about efficacy. Further research, particularly a controlled trial is warranted. REFERENCE
l.
KellerK Nonprescriptiondrugs in Germany.Drug InformationJournal 1994;28:453-459.
S U M M A R Y Objectives:To evaluate the effectiveness and safety ofa homoeopathic drug combination in the treatment of pollenosis under condition of daily practice. Design: Care review. Setting:A general practice in Germany. Patients: 35 patients with pollenosis. Main outcome measures: Objective and subjective symptoms of acute pollenosis. Results: During an average treatment period of 61 days it was found that 28 of 35 patients experienced an improvement in pollenosis symptoms.The medication was well tolerated thought patients preserved oral to subcutaneous administration. Conclusion: Patients receiving the homoeopathic drug combination experienced improvements without side effects.Whether this improvement is clue to the medicine or some other factor would need to be determined in a controlled trial.© 1999 Harcourt Publishers Ltd
or analogues, including biological drugs as well as local application of steroids; 1 week after intake of systematic steroids; 8 weeks after application of depot steroids. Patients who had been treated with corticosteroid and/or antiallergic agents for other complaints were excluded from the study. Patients admitted to the study were treated with a fixed combination of individual homoeopathic agents for subcutaneous or oral administration. All additional medication was documented. The combination is a mixture of liquid dilutions in conformity with specification 16 of the German homoeopathic pharmacopoeia I: 0.4 ml Apis mellifica D6; 0.4 rnl Acidum formicicum D6; 0.6 ml Thryallis glauca D6; 0.6 ml Cardiospermum halicacabum D4. In accordance with the design of the study, only descriptive statistical procedures were employed. At the start of the treatment and at each subsequent consultation the patients were asked to rate the symptoms 'conjunctival irritation', 'tear flow', 'itching', 'urge to sneeze', 'running nose', 'blocked nose' and 'asthmatic complaints' on the following scale:
INTRODUCTION The effectiveness of fixed combinations of individual homoeopathic agents as used in practice, can be documented using careful patient assessments) Patients can be asked to record their experience with individual preparations in order to provide information about their effectiveness and safety. Out-patient treatment is particularly suitable for monitoring by means of standard questionnaires. In this way, 'quality of life' can be recorded as an important parameter in patient assessment. The purpose of this study is to evaluate the effectiveness and safety of a homoeopathic drug combination for pollenosis as used in primary care.
METHODS
Markus W i e s e n a u e r
Specialist in General Hedicine, HomeopathyNaturopathy, In der Geiss 8, D-71384 Weinstadt, Germany
During the pollen season of 1993, a total of 35 patients of a general medical practice were included in a monitoring program. The patients had all suffered for years or longer from clinically established pollenosis which satisfied the relevant inclusion criteria. The included patients were of both sexes, and were suffering from acute hay fever with symptoms affecting eyes, nose and, in some cases, lungs; the acute symptoms had been evident for no longer than 7 days. If antiallergic treatment had been given on account of the acute symptoms, the following periods had to be allowed to elapse before inclusion in the study: 24 h after antihistamines, cromoglycate
ComplementaryTherapiesin Medicine(1999), 7, 222-224 © 1999HarcourtPublishersLtd
l. Symptom-free, i.e. the patient showed no symptoms at all ('none') 2. Obvious relief, i.e. noticeable and soothing relief ('light') 3. Only slight improvement, i.e. the symptoms were only slightly mitigated ('medium') 4. No improvement at all ('severe'). 222
New approaches to treating pollenosis
Female n=21 (60%), mean age 19.0, (range 12-26) Male n= 14 (40%), mean age 24.2, (range 16-33) years Duration of illness: mean 9.5 years (range 4-20 years) First manifestation: mean I 1.6 years of age (3rd to 29th year of age) Hyposensitization n = 7 Other therapies n = 9
223
ration. These included five patients who only took terfenadine, three who only took astemizole, one who took eye drops, one who took a herbal drug, and one who took a homoeopathic medicine. Only one patient took terfenadine over the whole monitoring period; all other patients took the specific accompanying medication transiently, seven of them only in the period up to the first follow-up examination and two others until the second followup examination.
Effectiveness and tolerability Month
Patients
Symptoms
March March April May
4 3 20
prophylactic acute acute acute
8
* * *
* Duration: mean 3.7 days (range 3-7 days). Treatment period 3--4 weeks 5-6 weeks
7-8 weeks 9-12 weeks > 12 weeks
Patients (n) 6 (17%) 2 (6%)
14 (40%) 8 (23%) 5 (14%)
Additionally the physician had to note the patients' subjective statements on the results of the therapy, measured on the same scale. An 'intention to treat' assessment was carded out, i.e. all patients who had received at least one dose of the remedy were entered into the analysis.
RESULTS A total of 35 patients participated in the study. Patients' baseline characteristics are described in Table l a and b. The total duration of the monitoring, consisting of the treatment period and the post-treatment monitoring period, was 108 days. The average treatment time was 61 days. After the end of the treatment, 27 patients were monitored for an average of 61 days.
Dosage All the patients who initially took the drug orally continued to do so, but only 2 of the 15 patients to whom the drug was initially administered by injection received all the remaining doses in this form. As early as the second consultation, 11 'injection patients' switched to oral administration. Dosages are shown in Table 3.
Additional antiallergic medication Only 11 patients (31.4%) took specific accompanying medication during treatment with the test prepa-
The frequency of the symptoms and their severity before the start of the treatment and at the following consultations are shown in Table 2 and Figure 1. Of the total of 35 patients who were included in the study, 26 had no symptoms when the study was concluded, even though the airborne pollen season was not yet finished. Two other patients stated that the course of the illness had been much milder than in previous years. These two, and the previously mentioned 26 (a total of 28 patients) described the efficacy of the treatment as 'good' or 'very good'. Seven of these patients remarked that their experience of the airborne pollen season had been 'better than ever before'. Seven patients were dissatisfied with the effectiveness of the treatment. These included four patients who stated that the treatment had no effect, two who characterized effectiveness as questionable and wanted a different therapy for the following year, and one patient who described the treatment as 'not convincing'. This patient had reported an improvement in his symptoms during the treatment, but this was not maintained. Two patients terminated the treatment after the third consultation. While 22 of the 28 patients who were satisfied with the effectiveness of the treatment required no further specific therapy, this was only true of two of the group of seven patients who were not convinced by the efficacy of the therapy. Three of the seven patients who were dissatisfied had already been hyposensitized, while this was only true of four of the 28 satisfied patients. It was noted that five of the seven dissatisfied patients suffered from not only a severe urge to sneeze, but also severe itching at the start of the treatment. This applied to only six of the 28 satisfied patients. No correlation was detected between sex, age, duration of acute symptoms (in days) or duration of susceptibility to hay fever (in years) and the success of the treatment. At the conclusion of the study, doctor and patient provided an assessment of tolerability as 'good', 'moderate' or 'poor'. In one case neither the doctor nor the patient provided an assessment because the treatment had been terminated on account of 'ineffectiveness'. In all other cases the doctor assessed compatibility as 'good' and, with one exception, this was also the verdict of the patients. Only one
ComplementaryTherapies in Medicine
224
Begin Patients
I n=35
Consultation no. 2 3 n=35 n=35
4 n=32
5 n=30
6 n=23
Conju nctival irritation Tear flow Itching Urge to sneeze Running nose Blocked nose
57, I 71,4 68,6 88,6 80,0 65,7
40,0 71,4 77, I 100,0 82,9 71,4
17, I 60,0 60,0 8S,7 62,9 60,0
6,3 25,0 46,9 62,5 21,9 50,0
Asthmoid complaints
22,9
11,4
0,0
3, I
3,3 l O,O 26,7 30,0 16,7 30,0 3,3
0,0 4,3 17,4 13,0 4,3 17,4 0,0
100 90 80 70 60 (Percent)
50 40 30 20 10 0 Conjunctional Tear flow irritation
Itching
Urge to sneeze
Running nose
Blocked nose
Asthmoid complaints
[ ] Consultation No. 1 17"AConsultationNo. 2 [ ] Consultation No. 3 I [ ] Consultation No. 4 mConsuitation No. 5 [-I Consultation No. 6 Fig. I
I
Severity of symptoms.
Ampoules /week
Consultation I
2
3
4
5
6
3 2
31 4
24 10
5 22
4 II
I
0
I
S
8
3
0
0
0
0
4
12
25
32
2 5
0 3
patient assessed the compatibility as 'moderate', on the grounds that he felt a buming sensation on his tongue when he took the preparation with water. DISCUSSION
Evidence of effectiveness must be obtained under realistic conditions. If a preparation is mainly used in general practice, then that is where it should be evaluated. Pollenosis exhibits a well-documented clinical picture: it is an acute illness, self-limited by exogenic factors, which offers the opportunity of a long follow-up monitoring period. The comprehensive
case history and clinical picture facilitate reliable diagnosis, especially for patients with whom the general practitioner has been acquainted for a long time. We carried out a study with a homoeopathic preparation which was administered subcutaneously or on the tongue. Our objective was to determine the acceptability of such methods of application and to look for evidence of effectiveness under practice conditions. During the course of the treatment the effectiveness of the preparation seemed to be comparable to that of antihistamines. The time which elapsed before the preparation took effect, the amelioration of the symptoms and the minimal appearance of acute symptoms when the preparation was administered prophylactically, all suggest a beneficial effect of the preparation. The preparation was were tolerated, though it seem that patients prefer. . However, in the absence of comparative control, it is not possible to make a definitive statement about efficacy. Further research, particularly a controlled trial is warranted. REFERENCE
l.
KellerK Nonprescriptiondrugs in Germany.Drug InformationJournal 1994;28:453-459.