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You can get the German original at  http://www.umweltdaten.de

Here the parts in English and the Literature:

The  report Cover-Sheet: (original page  4)

1. Report No.: ---

2., 3. ---

4. Report Title: Multicenter Study on MCS: (examinations for the causes of the MCS-syndrome

(Multiple Chemical Sensitivity) or IEI (Idiopathic Environmental Intolerances) under special
consideration of the contribution of environmental chemicals

5. Author(s), Family Name(s), First Name(s): Eis, Dieter; Beckel, Tilman; Birkner, Norbert; Renner,
Bertold and the members of the project group (p. 5)

6. Performing Organisation (Name, Adress): Robert Koch-Institut, Seestr. 10, D-13353 Berlin

7. Funding Agency (Name, Adress): Umweltbundesamt (Federal Environmental Agency)
Postfach 33 00 22, D-14191 Berlin

8. Report Date: 26.11.2002

9. Publication Date: 03.03.2003

10. UFOPLAN ­ Nr.: 298 62 274

11. No. of Pages: 343

12. No. of References: 141

13. No. of Tables, Diagrams: 128

14. No. of Figures: 61

15. Supplementary Notes: ---

16. Abstract: With the first multicentre MCS study in Germany a research network could be established: Six
environmental medicine outpatient clinics took part in the project, five of which were linked to
university clinics (Aix-la-Chapelle, Berlin, Freiburg, Giessen, Munich) and one located at a specialised
hospital in Bredstedt. The department of environmental medicine at the Robert Koch-Institut (RKI) in
Berlin served as the study-centre. The main focus of the study consisted of a precise description and
detailed analysis of the "Multiple Chemical Sensitivity" (MCS). The causes, triggers and risk factors of
MCS were to be studied. The project is based primarily on a cross-sectional design. The division of
the outpatients into MCS- and non-MCS-groups also corresponds to a case-control situation with
outpatient clinic based cases and controls. The specially designed documentation instruments were
developed and tested in 1999. 234 (80%) of the approximately 300 patients examined at the six
centres in the year 2000 with completed examination instruments could be included in the study. 19
patients with suspected MCS and a matched control group underwent extensive olfactometric
examinations in a separate project. Methods and results of basic data-analysis are presented in this
report. An addendum contains forms and questionnaires as well as the complete report on the
olfactometric examinations.

17. Keywords: MCS, IEI, Multiple Chemical Sensitivity, Multicenter Study, Environmental Outpatient Unit, Clinical
Examination, Questionnaires, Olfactometry, CIDI, Pollutants, Illnesses, Psychometric Analysis, BSKE
21, SF-36, SCL-90-R, MCS-Questionnaire, B-L, WI, LZI, IRES, FKV-LIS, IPQ, SAQ, FGB/SUB, SOZU
K-22, FPI-R, SWOP K-9, Allergies, Somatoform Disorders.

Report Cover sheet 06/2000

=======================

-pages 31ff-

The number of the patients with self-attributed MCS ("Multiple Chemical Sensitivity") has grown considerably within the last few years. Reports in the press estimate the number of MCS-patients in Germany to exceed one million.

MCS case criteria are as follows:

- initial symptoms are associated with a verifiable exposure (albeit sometimes beginning slowly)

- symptoms are provoked by different chemical substances at very low concentrations (other people usually do not react)

- symptoms occur in recognizable association with the exposure (reproducible; recovery after avoidance of exposure)

- symptoms appear in more than one physiological apparatus (not mandatory in all case definitions)

- symptoms are chronic in nature

- symptoms cannot be explained by known illnesses.

 

The case criteria suggested in the literature so far vary in different points. As their theoretical and empirical basis is inadequate they tend to be hypothetical in character. Moreover the criteria allow for considerable scope in the diagnosis. In this multicentre MCS study the criteria used for the final individual case assessments were based on those described by Cullen.

The MCS pathogenesis models discussed by experts are based hypothetically, for example, on

toxically induced tolerance loss, neural inflammation, a neural sensitisation process or a

complex psychosomatic phenomenon.

In view of this situation it remained unclear whether the MCS phenomenon has to be delineated

from apparently similar health problems and possibly considered as an independent dysfunction

and to what degree it is caused or triggered by environmental pollutants. In addition, there was

an urgent need for adequate diagnostics, effective therapy and effective prevention strategies.

With this background a "Workshop on Multiple Chemical Sensitivities (MCS)" was held in Berlin

in February 1996, with the support of the Department of the Environment and the participation

of the World Health Organization. It was there that experts recommended intensifying research

32

into the MCS/IEI phenomenon by means of double blind placebo controlled provocation trials

and through clinical epidemiological studies. As a result of this conference the Department of

the Environment appointed three working groups (diagnosis, pathogenesis, therapy) with the

mandate to develop a research strategy suitable for the situation in Germany. At a final meeting

of all working groups in September 1998 the establishment of a supraregional multicentre MCS

research project was proposed to the Department of the Environment. It finally announced the

support of "Studies to identify the causes of MCS syndrome (multiple chemical hypersensitivity)

and IEI (idiopathic environmental intolerance) with special consideration to the contribution of

environmental chemicals" in the context of an epidemiological study.

This study was carried out by the Robert Koch-Institut with the participation of numerous

partners between 1999 and 2001, resulting in the final report presented here in two volumes:

report and addendum. The report volume describes and discusses the methodology and results

of the multicentre MCS study, restricted to the descriptive data analysis. Additional publications

presenting the results of the multivariate data analysis are in preparation. The forms,

questionnaires and additional documents used in the study plus a detailed description of the

project "Evaluation of reactions at the mucous membranes of the nose and sensory apparatus

in patients with MCS after low dose chemical stimulation" are contained in the addendum. This

project was carried out under subcontract at the Friedrich-Alexander-University of Erlangen-Nuremberg.

 

Study aim and problems under investigation

The initial aim of the project was to establish a MCS research network involving six

environmental medicine centres (outpatient clinics). Several years of experience in the area of

clinical environmental medicine and the necessary means for clinical diagnostics were

mandatory for participation. An advisory board consisting of representatives from different

medical disciplines was formed at the same time to oversee the project from the beginning.

The main focus of the study consisted of a precise description and detailed analysis of the

"Multiple Chemical Sensitivity" phenomenon. The causes and triggers of MCS and the

associated health problems were to be closely studied. It was necessary to determine whether

MCS could be defined as an independent illness, caused or triggered by environmental

pollutants. In this respect it was essential to learn to what extent MCS patients differ from

patients suffering from other environmental health problems and which characteristics of the

different groups are distinctive. These questions concerned both patients with self-attributed

MCS (sMCS) as well as - in the context of the study – those with "medically confirmed MCS

disturbances" (MCS level 2). Finally, whether and in which form the MCS symptom profile could

33

be verified, which environmental factors are responsible and how frequently it appears in

outpatients of environmental medicine clinics was to be addressed.

Furthermore it was of interest to know how patients attending environmental medicine clinics,

especially MCS patients, differ from comparable clinical groups and age- and sex-matched

groups from the general population.

Supplementary questions of a methodological nature dealt with in the supplementary

publications include: The consistency of patient statements (intra- and interinstrumental), the

differences between patients’ and doctor assessments (with regard to the severity of illness),

discrepancies in diagnoses from different doctors (regarding MCS2) and a detailed analysis of

the influence of the different study centres.

In addition, the project allowed the further development of the enquiry procedures, the collection

of valid case criteria and an optimisation of the diagnostic process. Therapeutic interventions

were not addressed in this project.

A separate project titled "Evaluation of reactions at the mucous membranes of the nose and

sensory apparatus in patients with MCS after low dose chemical stimulation" was performed in

co-operation with the institute for experimental and clinical pharmacology at the Friedrich-Alexander-

University of Erlangen-Nuremberg. To address to the "neurogenic inflammation

hypothesis" as well as the "central nervous information processing hypothesis" extensive

olfactometric examinations were carried out. Selected results of this project are integrated into

this report and the detailed results are presented in the addendum. The studies on neurogenic

inflammation are still ongoing.

 

Methods

The research project largely had the character of a pilot study: A research network and a

uniform co-ordinated investigation procedure had to be established, including the

questionnaires, the case-related examination schedule and the judgement criteria. In addition,

as the form of the multicentre clinical epidemiological approach was unique at the time of

starting the studies it was necessary to clarify numerous methodical problems of MCS research

(including a reliable case characterisation).

Study-concept and -course

Six environmental medicine outpatient clinics took part in the project, five of which were linked

to university clinics (Aix-la-Chapelle, Charité at Humboldt-University Berlin, Freiburg, Giessen,

Ludwig-Maximilians-University Munich) and one located at the specialised hospital in

Nordfriesland (Bredstedt). The department of environmental medicine at the Robert Koch-

34

Institut (RKI) in Berlin served as the study-centre. Altogether half of all university environmental

medicine clinics in Germany were included, an exceptionally high participation rate. In addition,

the inclusion of the Bredstedt clinic, a facility considered to be representative of environmental

medicine clinics, extended the spectrum in this direction.

In 1999 the questionnaires and documentation instruments were developed (environmental

medicine questionnaire and baseline documentation) or templates adapted and collated (health

questionnaire and Composite International Diagnostic Interview, CIDI). A criteria catalogue for

case definition was worked out, as was the co-ordinated methodical procedure for the centres

involved, as far as this was possible and desirable in the given context.

During the year 2000 data collection for the project was carried out: During this period all

patients examined for the first time at the six clinics were asked to participate. Patients under

the age of 18 were excluded. Complete questionnaires (environmental medicine questionnaire,

UmedFB, health questionnaire, GesFB; medical baseline documentation, BDB) were obtained

for 234 of the approximately 300 environmental medicine outpatients during the year 2000.

These constituted the so-called "core sample".

The examination concept consisted of identifying – by means of differential diagnostic

procedures using the MCS case criteria described by Cullen – those patients with a pollutant

induced MCS illness. This delimitation of the MCS cases was achieved using a diagnostic

scheme divided into three steps or levels. At level 0, the initial level of the study, the

classification was based on self-assessment by the patient and the group of self-reported MCS

patients (sMCS) was compared with the remaining environmental medicine outpatients (non-sMCS).

This category was included to ensure that those persons who, with their subjective

illness concept, regarded themselves to be suffering from MCS were taken sufficiently seriously.

In the next stage, study-level 1, a MCS criteria catalogue was used by doctors to assign

patients to MCS1- or non-MCS1-groups in a post-anamnestic, but pre-diagnostic manner.

Finally, after complete diagnostics and an obligatory case conference in the regional centre for

every patient, a final assessment and a diagnostic classification (level 2) into the MCS2- or the

non-MCS2-group took place. The term "diagnostic" is used here in a broader sense as it is still

unclear whether MCS is a clinical entity or not.

Study design

The study is based primarily on a cross-sectional design. The division of the study-population

into MCS-patients and non-MCS-patients and their comparison with respect to various

exposure- or risk factors can be regarded as a stratification in the context of the cross-sectional

design. The division of the outpatients into MCS- and non-MCS-groups also corresponds to a

35

case-control situation with outpatient clinic based cases and controls. The corresponding

analysis is also a case-control study. Therefore the relevant study segment can be interpreted

as having a case-control approach.

Questionnaires

In the first year of the project uniform questionnaires were developed.

The 46-page "questionnaire for patients of the environmental medicine outpatient clinic" (short:

Environmental medicine questionnaire, UmedFB) was completed by every environmental

medicine outpatient. The UmedFB contains groups of questions concerning the physical

complaints and of the suspected environmental toxicants and living conditions.

The 34-page "questionnaire about health for environmental medicine patients" (short: health

questionnaire, GesFB) had also to be filled out by every environmental medicine outpatient.

This health questionnaire consists of 15 independent psychometric instruments regarding

different dimensions and aspects of emotional, social and physical health (including a MCS

questionnaire about complaint triggering substances and the associated health problems).

The 27-page "medical baseline documentation" (BDB) was filled out by the doctor in charge for

every outpatient who participated in the study using all available information and results

including the final case conference. It includes the MCS classifications at the levels 0, 1 and 2.

The judgement and the diagnostic procedure were left to the discretion of the responsible

doctors, but agreement in the context of regional case conferences was mandatory.

Clinical diagnostics

 

Individual diagnostics

Due to the wide range of health problems suffered by the individual patients the extensive

clinical diagnostic procedures had to be carried on a strictly individual basis taking into

consideration the pre-study results. It would not have been possible to replace these specific

individual diagnostics by diagnostic screening-programmes that anyway could not be funded

within the context of the study. The somatic medical examinations carried out therefore varied

from patient to patient. This is why a "standard program", as used for the psychometric

evaluation, was not used for clinical medical examination.

Due to their diversity, the extensive somatic results were not evaluated statistically. However,

they provided the basis for the clinical assessment, the results of which are presented in the

baseline documentation. For the psychometric evaluation the uniform data obtained from all

patients could be statistically analysed in detail. The clinical diagnostics could only be

36

statistically analysed at a "concentrated" diagnostic level, due to the complexity and hetero-geneity

of the problems involved. This could give the impression of an imbalance between the

size of the psychometric and emotional evaluation on the one hand and the somatological

diagnostics on the other. In reality the somatic medical examinations were clearly dominant

(case history, physical examination, laboratory medical examinations, allergy diagnostics,

technical diagnostics, individual diagnostic judgement, case conference and final assessment).

 

Composite International Diagnostic Interview (CIDI)

The CIDI was used to recording emotional disturbances. This computer-assisted psychiatric

interview and diagnosis system is suitable for epidemiological studies.

 

The Erlangen project examining the olfactory system

The project focused on testing and establishing methods that allow the "neurogenic

inflammation hypothesis" and the "central nervous information processing hypothesis" to be

tested. The pilot study should also provide initial examination results from a sample of patients

with suspected MCS (level 1) in comparison with a control group of healthy individuals.

The following examination methods were used: subjective tests for smelling with Sniffin'Sticks;

determination of nose geometry by acoustic rhinometry before and after provocation with 2-

propanol or damp air; EEG measurements with olfactory evoked potentials (OEP);

measurement of EEG background activity; evaluation of the subjects' attention during EEG

measurement using a "Tracking performance" test; use of psycho-physiologic questionnaires

with visual analogue scales. The day of the provocation (day 1 or day 2) and the side of the

nose stimulated (right or left) were randomised. For every patient or control only one side of the

nose was used for the stimulation. The examination was carried out double-blinded, i.e. neither

the subject nor the examiner knew on which of the two examination days the provocation with 2-

propanol had taken place.

Study population and target population

The study population (sample) should be as representative as possible of the patients attending

the environmental medicine outpatient clinics. Recruitment was carried out mainly by the

patients themselves. Of interest to this outpatient clinic study were only those environmental

medicine outpatients who physically turned up at the clinic for examination and not those

seeking advice by telephone.

The relatively low number of patients in some centres was due neither to a low demand nor to

inadequate participation quotas but primarily to capacity problems at the respective facilities

(e.g. unexpected staff absenteeism). Patients who could not be attended to for capacity reasons

37

were referred to other environmental medicine facilities outside the research area. A strict

randomisation was not applied because part of the normal practice in outpatient clinics –

intended to be included in the study – leaves room for discretion, e.g. taking into account the

urgency of the medical problems. A certain over-representation of self-reported MCS patients

(sMCS) occurred in the Munich centre, since these patients have been preferentially included in

the study. With respect to the complete sample this skewing of the sMCS section is not

particularly significant. It might influence the cross-sectional analysis, but the case-control

comparison is relatively unaffected by such distortions.

Data processing

The data were saved in anonymous form in several Access databases at the Robert Koch-Institut.

In addition, data examination and processing was carried out at the study centre using

predominantly the statistics program SPSS 10 for Windows.

 

Results

Sociodemographic features

234 (80%) of the approximately 300 patients examined at the six centres in the year 2000 could

be included in the study. 93 (40%) of the 234 environmental medicine outpatients described

themselves as suffering from MCS (sMCS), 141 patients (60%) did not relate their environment-associated

health problems primarily with MCS and were therefore classified as the non-sMCS

group. Women were represented more frequently than males in the sample with a share of

approx. 70%. In comparison with the general female population (German Health Survey 1998,

short: BGS 98) women between the ages of 31 and 70 years were clearly over-represented.

Significant differences in comparison with the BGS 98 were also found with respect to academic

qualifications (higher school qualifications, though this might be due to specific features of the

education-structure in the region of one centre), as well as for employment (less employed) and

marital status (more singles).

Health problems and exposure to different substances from the

environment

Non-specific general symptoms dominated the health problems indicated by patients in the

UmedFB, followed by problems of the locomotive apparatus and stomach/intestinal problems.

Study participants reported a higher frequency of pain (time period: 7 days/12 months),

particularly headaches but also pain in other parts of the body, than that reported the BGS 98.

In addition, the lifetime prevalence of many illnesses, including allergies, digestive and

38

respiratory tract illnesses and emotional illnesses but not other illnesses such as cancer, stroke,

diabetes and high blood pressure were named more frequently than in the BGS 98. In

comparison with the general population (BGS 98) the environmental outpatients had a

drastically higher score for the list of complaints (B-L, v. Zerssen) and judged their health-related

quality of life according to eight criteria of the SF-36 to be considerably lower.

The internal comparison between sMCS and non-sMCS patients revealed the following

essential differences: sMCS patients reported a significantly higher frequency of health

problems such as: smell sensitivity, taste disturbances, ringing in the ears and chronic fatigue

for more than 6 months. They affirmed a more frequent susceptibility to infections, intolerances

to textiles and a general intolerance to chemical substances. The frequency of irritation caused

by a variety of household smells, particularly from building materials, wall coatings, paints and

pieces of furniture, was significantly higher in sMCS patients. According to the medical records,

they felt themselves to be more frequently burdened by contact with dental products, general

environmental chemicals and living necessities as well as by their living environments and their

previous and present working environments. In addition, they reported a significantly more

frequent preference for staying at home to protect themselves from environmental influences.

When questioned about possible causes of their health problems, sMCS patients named

pollutants, electromagnetic fields, food, fungal diseases of the intestines and passive smoking

with a significantly higher frequency.

sMCS patients and non-sMCS patients ruled out emotional and social causes for their health

problems (e.g. financial worries, loneliness, relationship and/or family problems, neighbourhood

problems) to the same degree.

sMCS patients, according to their own evaluations, used significantly fewer household

chemicals such as disinfectant toilet blocks, universal cleaners, conditioners and chemical

pesticides. Their case histories revealed a significantly lower frequency of amalgam fillings but a

higher frequency of other dental implants and a higher number of environmental medicine-based

preliminary examinations (biomonitoring, "detoxication enzyme tests" and functional

imaging of the brain).

When asked about their sources of information concerning environment-induced health

problems, all patients predominantly named doctors, newspapers/magazines and

broadcast/television. sMCS patients obtained significantly more information from self-help

groups and books than did non-sMCS patients.

39

 

MCS questionnaire

Compared with non-sMCS patients, the sMCS patients declared a significantly higher frequency

of severe to very severe health problems for all 28 items ("MCS substances") listed in the MCS

questionnaire (part 1). Of the five allergens listed "moulds" and "nuts" triggered severe to very

severe problems more frequently in sMCS patients. Of the five newly introduced substances in

this study "natural perfume" and "unknown substances" caused severe/very severe problems

more frequently in sMCS patients. In comparison to the results from allergy patients and MCS

patients in a different study, both sMCS and MCS patients claimed that all "MCS substances"

triggered severe/very severe health problems more frequently than did the allergy patients.

Those allergens that did not trigger any reactions in people suffering from allergy were

nevertheless more frequently declared by sMCS patients to be connected with severe/very

severe reactions. With respect to the 11 areas of complaint listed in the MCS questionnaire

(Part 2), the sMCS patients identified a causal connection between environmental substances

and health problems to be more likely than did non-sMCS patients. The differences are highly

significant.

The Erlangen project examining the olfactory system

Since MCS patients frequently report an increased sense of smell, 19 patients of the multicentre

study with suspected MCS (level 1) and self reported olfactory disturbances as well as 19

corresponding healthy controls were examined by olfactometry. As well as the standard

examination of the olfactory system using Sniffin' Sticks, the question of a "central sensory

information processing disturbance", including EEG measurements with olfactory evoked

potentials (P300 component) was addressed. In addition, examinations of reactions at the nasal

mucous membrane and sensory apparatus after low dose chemical stimulation were carried out

with these patients and controls.

In this study, as in earlier examinations, a heightened sense of smell could not be detected in

the patient group. It should be noted, however, that the examination time for the MCS group,

due to breaks for recovery, was longer and that testing without breaks would certainly have

resulted in lower values (scores). That frequent stimulation with olfactory substances represents

a special problem for the MCS patients was clear not only for testing with the Sniffin' Sticks, but

also for assessing the trigeminal-nerve quality after frequent stimulation with PEA (phenylic

ethylic alcohol rose-smell) as a standard stimulus (quality "burn" or "sharp pain"). In contrast,

such differences between the groups could not be found using H2S (hydrogen sulphide) as a

rare and unpleasant stimulation.

40

With regard to the provocation with 2-propanol (Verum) an unexpected improvement in nasal

breathing appeared on the non-stimulated side of the nose, both subjectively as well as after

acoustic rhinometry. These results should at least be the subject for future examinations, since

an altered interaction at the neural level between the two sides of the nose cannot be excluded.

The significant effect of 2-propanol on the background EEG clearly showed that pharmaco-logical

or sensory effects can play a role in provocation testing even at threshold levels.

The results also demonstrated that the measurement of evoked potentials by "odd-ball" stimuli

for the generation of olfactoric P300 appear less suitable for the routine examination of MCS

patients. This is due on the one hand to overloading the patients with odours over two days of

experiments, which can lead to a certain pre-selection of patient group. On the other hand,

these late potentials proved to be very susceptible to artefacts caused by eye movements, a

problem that cannot always be avoided in inexperienced persons (patients and controls). In

addition, the problem of muscular activity was particularly prevalent in the patient group, again

causing artefacts in the EEG. For future studies it is therefore important that a larger number of

patients and controls be included to allow for the P300 measurements invalidated by artefacts.

Only after observation of significant group differences would the development of a shortened

protocol for routine examination be possible.

The increased suffering felt subjectively by MCS-patients (level 1) was demonstrated during the

Erlangen studies by the high degree of self-assessed fatigue compared with the control group.

From the recording of "tracking performance" after even mild provocation with 2-propanol it can

be assumed that attentiveness and possibly motor coordination might be impaired during

everyday activities. Further research is needed, as many questions remain unanswered.

Psychometric Analysis

The sMCS patients did not differ from the rest of the patients on the BSKE 21 scales and

designated subscales "current positive condition" or "current negative condition". However,

"physical malaise" was higher for sMCS patients than for non-sMCS patients. Of the criteria

concerning quality of life (SF 36) those referring to the body ("physical function ability", "physical

role function" and "physical pain") as well as the criteria "general health perception" and "social

function ability" were judged to be significantly lower by sMCS patients than by non-sMCS

patients. sMCS patients scored significantly higher than non-sMCS patients on the

"somatisation" and "anxiety" scales of the SCL 90-R. These differences tended to appear in six

of seven other scales, with the exception of "paranoid thinking", so that both patient groups also

differ significantly with regard to the global index-values GSI and PSDI. The study patients

scored higher on the scale compared to the standardised sample for the German version of the

41

SCL 90-R as well as in comparison with a normally healthy sample from the English version.

The difference is particularly clear on the scales "somatisation", "compulsiveness" and

"depressiveness". The study patients, however, score lower on all scales – except for

occasionally in the area "somatisation" – when compared to general psychiatric patients and

patient groups with personality disturbances, neuroses, depressions, anxiety disorders and

somatisation disorders, so that the profile of the environmental medicine outpatients (including

the sMCS patients) is clearly different from that of psychosomatic/psychiatric patients.

The sMCS patients scored higher than non-sMCS patients for 22 of the 24 items on the ailment

list (B-L, v. Zerssen). The B-L sum-score in total was significantly higher for sMCS patients than

for non-sMCS patients. The sum-score of the sMCS patients is also significantly higher than

that of the sample used to calibrate the questionnaire and higher than all other comparison

collectives (different body illnesses, functional heart disturbances, different psychiatric illnesses,

schizophrenia, neuroses, neurotic and endogenous depression) reported by v. Zerssen. The

sum-score of the core sample (all environmental medicine outpatients together) was higher than

the calibrating sample and the sample with various body illnesses, but lower than the sum-score

of patients with neurotic and endogenous depressions.

Relationship between environmental influences and health problems

Doctors at the outpatient clinics suspected that the proportion of patients previously or currently

exposed to environmental substances at a hygienically relevant degree was 34% and 20%

respectively. The proportion previously or currently exposed at a toxicologically relevant degree

was judged to be 15% and 6% respectively. These assessments clearly differed between the

centres: Toxicologically relevant exposure was reported – except for a very few percent of

cases – in one centre exclusively. While the frequency with which doctors judged sMCS

patients to have had previous hygienically relevant exposures was significantly higher, non-sMCS

patients were more often evaluated as being currently exposed at a hygienically relevant

level. sMCS patients were significantly more frequently assessed as being strongly impaired in

"social" and "everyday and professional" life, while the assessments did not particularly differ in

the categories "physical" and "mental" impairment compared to the non-sMCS patients. A

causal relationship between the suspected environmental agent and the health problems

related by the patient was classified by the doctors as rather improbable for 66% of the cases

and an illness caused, in a strict sense, by the environment was affirmed for only 22% of the

patients. These assessments were made almost exclusively in two centres. A multiple chemical

sensitivity in the strict sense (i.e. not psychosomatic, but rather a real somatic hypersensitivity

towards different environmental agents) was diagnosed exclusively in two centres. This

suggests that the criteria given for the MCS syndrome are not sufficiently defined enough to

41

SCL 90-R as well as in comparison with a normally healthy sample from the English version.

The difference is particularly clear on the scales "somatisation", "compulsiveness" and

"depressiveness". The study patients, however, score lower on all scales – except for

occasionally in the area "somatisation" – when compared to general psychiatric patients and

patient groups with personality disturbances, neuroses, depressions, anxiety disorders and

somatisation disorders, so that the profile of the environmental medicine outpatients (including

the sMCS patients) is clearly different from that of psychosomatic/psychiatric patients.

The sMCS patients scored higher than non-sMCS patients for 22 of the 24 items on the ailment

list (B-L, v. Zerssen). The B-L sum-score in total was significantly higher for sMCS patients than

for non-sMCS patients. The sum-score of the sMCS patients is also significantly higher than

that of the sample used to calibrate the questionnaire and higher than all other comparison

collectives (different body illnesses, functional heart disturbances, different psychiatric illnesses,

schizophrenia, neuroses, neurotic and endogenous depression) reported by v. Zerssen. The

sum-score of the core sample (all environmental medicine outpatients together) was higher than

the calibrating sample and the sample with various body illnesses, but lower than the sum-score

of patients with neurotic and endogenous depressions.

Relationship between environmental influences and health problems

Doctors at the outpatient clinics suspected that the proportion of patients previously or currently

exposed to environmental substances at a hygienically relevant degree was 34% and 20%

respectively. The proportion previously or currently exposed at a toxicologically relevant degree

was judged to be 15% and 6% respectively. These assessments clearly differed between the

centres: Toxicologically relevant exposure was reported – except for a very few percent of

cases – in one centre exclusively. While the frequency with which doctors judged sMCS

patients to have had previous hygienically relevant exposures was significantly higher, non-sMCS

patients were more often evaluated as being currently exposed at a hygienically relevant

level. sMCS patients were significantly more frequently assessed as being strongly impaired in

"social" and "everyday and professional" life, while the assessments did not particularly differ in

the categories "physical" and "mental" impairment compared to the non-sMCS patients. A

causal relationship between the suspected environmental agent and the health problems

related by the patient was classified by the doctors as rather improbable for 66% of the cases

and an illness caused, in a strict sense, by the environment was affirmed for only 22% of the

patients. These assessments were made almost exclusively in two centres. A multiple chemical

sensitivity in the strict sense (i.e. not psychosomatic, but rather a real somatic hypersensitivity

towards different environmental agents) was diagnosed exclusively in two centres. This

suggests that the criteria given for the MCS syndrome are not sufficiently defined enough to41

SCL 90-R as well as in comparison with a normally healthy sample from the English version.

The difference is particularly clear on the scales "somatisation", "compulsiveness" and

"depressiveness". The study patients, however, score lower on all scales – except for

occasionally in the area "somatisation" – when compared to general psychiatric patients and

patient groups with personality disturbances, neuroses, depressions, anxiety disorders and

somatisation disorders, so that the profile of the environmental medicine outpatients (including

the sMCS patients) is clearly different from that of psychosomatic/psychiatric patients.

The sMCS patients scored higher than non-sMCS patients for 22 of the 24 items on the ailment

list (B-L, v. Zerssen). The B-L sum-score in total was significantly higher for sMCS patients than

for non-sMCS patients. The sum-score of the sMCS patients is also significantly higher than

that of the sample used to calibrate the questionnaire and higher than all other comparison

collectives (different body illnesses, functional heart disturbances, different psychiatric illnesses,

schizophrenia, neuroses, neurotic and endogenous depression) reported by v. Zerssen. The

sum-score of the core sample (all environmental medicine outpatients together) was higher than

the calibrating sample and the sample with various body illnesses, but lower than the sum-score

of patients with neurotic and endogenous depressions.

Relationship between environmental influences and health problems

Doctors at the outpatient clinics suspected that the proportion of patients previously or currently

exposed to environmental substances at a hygienically relevant degree was 34% and 20%

respectively. The proportion previously or currently exposed at a toxicologically relevant degree

was judged to be 15% and 6% respectively. These assessments clearly differed between the

centres: Toxicologically relevant exposure was reported – except for a very few percent of

cases – in one centre exclusively. While the frequency with which doctors judged sMCS

patients to have had previous hygienically relevant exposures was significantly higher, non-sMCS

patients were more often evaluated as being currently exposed at a hygienically relevant

level. sMCS patients were significantly more frequently assessed as being strongly impaired in

"social" and "everyday and professional" life, while the assessments did not particularly differ in

the categories "physical" and "mental" impairment compared to the non-sMCS patients. A

causal relationship between the suspected environmental agent and the health problems

related by the patient was classified by the doctors as rather improbable for 66% of the cases

and an illness caused, in a strict sense, by the environment was affirmed for only 22% of the

patients. These assessments were made almost exclusively in two centres. A multiple chemical

sensitivity in the strict sense (i.e. not psychosomatic, but rather a real somatic hypersensitivity

towards different environmental agents) was diagnosed exclusively in two centres. This

suggests that the criteria given for the MCS syndrome are not sufficiently defined enough to

42

allow comparable medical assessments in the six environmental medical centres. This result

shows the need for further research.

 

Conclusions and perspectives

With the first multicentre MCS study in Germany a research network could be established which

allowed scientific research into the clinical epidemiological, diagnostic, pathogenic and – possib-ly

in future, therapeutic – aspects of the Idiopathic Environmental Intolerance (IEI) phenomena

and in particular of the Multiple Chemical Sensitivity (MCS) syndrome. In this project, which can

be considered a pilot study, suitable questionnaires were developed and optimised for the

clinical epidemiological investigation of MCS and the subsequent project that has in the

meantime already commenced.

Data analysis until now confirms the features of environmental medicine outpatients described

in earlier studies, especially of those with self-attributed MCS: a high burden of suffering;

multiple (subjective) intolerances to chemical substances with emphasis on interior pollutants; a

wide spectrum of complaints subjectively linked to exposures; a predomination of middle-aged

women; a high proportion of singles and of people not (or no longer) employed or on extended

sick leave; and a high number of preliminary examinations. For a considerable proportion of the

environmental medicine patients it can be speculated that their complaints overlap with similarly

ill-defined syndromes such as the chronic pain syndrome, the chronic fatigue syndrome and the

somatoform disorders.

Furthermore it can be concluded from the psychometric data analysis that the environmental

medicine outpatients (particularly the sMCS patients) score higher than the normal samples but

clearly lower than psychosomatic and psychiatric patients (apart from somatisation criteria,

where they score higher).

The experiences gathered during this study indicate that for the assessment of environmental

medicine patients the inclusion of the emotional and social aspects of environment-associated

suffering in addition to the general clinical and environmental medicine diagnostics is man-datory.

Therefore an integrated medical care with the participation of psychomedical specialists

seems necessary for many cases. This applies in particular to IEI- or MCS-research projects

since an underestimation of the emotional and social illness components is otherwise likely.

The increased smell sensitivity claimed by many patients could only rarely be confirmed in a

partial sample using orientating smell tests (Sniffin' Sticks). Thorough olfactometric examination

failed to demonstrate a clear disturbance of the smell sensitivity in a small sub-sample of 19

patients with suspected MCS (level 1).

43

The environmental medicine assessment regarding an earlier or current exposure to pollutants

and its consequences for the health problems differed enormously in the six centres involved.

Only one centre (Bredstedt) attributed the etiologic involvement of environmental chemicals.

The other centres estimated the etiopathogenic relevance of foreign substances for their cases

to be low to nil.

There were therefore also considerable differences between the centres with regard to their

medical assessments of "MCS". These differences are not only the result of variations in the

composition of the patient collectives but are also based on different medical assessments or

insufficient conformity of judgement. Therefore a supraregional case conference with a

diagnostic post-judgment of a random sub-sample of patients’ files by centres with discordant

MCS2-assessments would be desirable. A study designed to assess interrater agreement

would be methodically more satisfactory. This would, however, require a large effort (double

examinations of the patients in two centres) and separate financing.

The clinical exclusion diagnostics and the application of pre-existing MCS criteria together with

the demonstration of inter-centre differences in the MCS2 proportions and a discussion of the

reasons for these differences constitute one important part of the study. The next stage will be

to go beyond the predefined case criteria, the psychometric scores, and the doctors’ diagnostic

assessments, and to start again at the level of the raw data or items: From this basis explorative

data analyses (the search for patterns of items) will be carried out and the hypothesis-driven

analysis will be conducted. It was decided by the research network to report these multivariate

data analyses in separate scientific publications.

In future it is absolutely essential that the conceptional basis for the diagnostic assignments is

always stated in MCS studies and in medical practice. In the simplest case this can be achieved

by naming of the underlying "model class", e.g.:

A) somatic model

B) psychosomatic model

Since yes-/no-decisions are frequently impossible without some compulsion a trichotomic

answer classification (with the alternative answer "yes/no/unclear") would be preferred.

For future studies, supraregional case conferences should be mandatory prior to the potential

MCS classification and, in addition to the environmental doctor, at least one experienced

clinician (preferably internist, allergist, neurologist) and a specialist in psychosomatic or

psychiatric medicine should participate. The decision process should be documented at every

important step.

===================

321
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