DÄ internationalArchive10/2017Mental Disorders in People Affected by Thalidomide

Original article

Mental Disorders in People Affected by Thalidomide

A cross-sectional study of prevalence and psychosocial needs

Dtsch Arztebl Int 2017; 114: 168-74. DOI: 10.3238/arztebl.2017.0168

Niecke, A; Peters, K; Samel, C; Forster, K; Lüngen, M; Pfaff, H; Albus, C

Background: More than 50 years after the withdrawal of thalidomide from the market, subsequent orthopedic damages and psychosocial impairments dominate the complaints of thalidomide-affected individuals. The aim of the study was to determine the prevalence of mental disorders in this group.

Methods: A total of 193 thalidomide-affected individuals from North Rhine– Westphalia (mean age 50.5 years, 56.5% women) underwent personal and comprehensive psychodiagnostic testing, which was based on the Structured Clinical Interview for DSM-IV disorders (SCID-I & SCID-II) and self-reporting questionnaires.

Results: Overall, the four-week prevalence of mental disorders was 47.2%. Multiple mental disorders were present in 45.1% among the 91 participants with diagnosed mental disorders. The most frequent diagnoses were unipolar depressive disorders (16.5%), somatoform disorders (14.0%), phobic disorders (12.4%), and alcohol-related disorders (6.2%). Immediate mental health care was indicated in 80.2% of participants with current mental disorders, but only 29.7% had used some form of psychosocial treatment in the 12 months preceding the study.

Conclusions: Mental disorders occur approximately twice as often (relative risk [RR]: 1.77; 95% confidence interval [1.49; 2.10]) in thalidomide-affected individuals as in the age-matched German population. Together with a very low rate of utilization of mental health care, this finding implies an underuse of psychosocial healthcare. The development of specialized psychosocial treatment services may remove barriers that impede access to the healthcare system.

LNSLNS

The introduction of thalidomide on 1 October 1957 led to “the drug disaster with the most serious repercussions in the 20th century” (1). The substance, synthesized by the company Chemie Grunenthal, was first approved in Germany under the trade name Contergan, and sold as an over-the-counter sedative, and went on to be marketed in 46 countries around the world. It took all of four years for the devastating embryotoxicity of thalidomide to come to light, leading to the drug being withdrawn from market on 27 November 1961.

In the years between 1957 and 1962, an estimated 5000 “thalidomide children” were born in West Germany and more than 10 000 worldwide. The numbers of unreported spontaneous abortions and stillbirths remain unknown (18). The first publications appeared shortly thereafter, strongly suggesting the use of thalidomide by pregnant women to be the cause for a huge increase of infant malformations (9, 10).

Following the devastating consequences for damaged individuals and their families, the thalidomide case had a major impact on modern medicine. In Germany, for example, it led to the establishment of a State Department of Health. Today, the medical and ethical aspects of the situation still need to be debated in light of the resumption of thalidomide use i.e. in leprosy and multiple myeloma, and cases of thalidomide embryopathy in low income countries (1117).

There are some 2400 thalidomide-impaired individuals currently living in Germany (18), 804 of them in North Rhine–Westphalia (49.8% women; written communication from “Conterganstiftung für behinderte Menschen e.V.” of 27 April 2016). They are increasingly suffering from the consequences of their disability, manifesting in particular as chronic pain and functional limitations and movement impairments of the skeletal system (19). The original and the consequent damage have led to far-reaching psychosocial consequences, so that their way of life is often characterized by reduced working and earning capacity, dependence on assistive equipment (e.g. wheelchair), personal assistance and care, and the threat of social isolation (20).

Several studies on the quality of life of thalidomide-affected subjects were carried out in the past, describing reduced satisfaction with their life. However, apart from one Japanese interview study (n = 22), which estimates a prevalence of 40.9% for a possible mental disorder, the literature contains little evidence on mental health in this group (2128). Even though increased mental stress was measured in the most extensive study to date, using a depression inventory and aimed at the special needs and care shortcomings of 870 German thalidomide-impaired individuals, no psychodiagnostic interviews were carried out (20).

The aim of this study was to systematically determine the prevalence of mental disorders among subjects with prenatal thalidomide embryopathy by a methodologically high-quality structured interview, as well as to assess the rate of utilization of mental health care and of psychosocial health care needs.

Methods

The study was targeted at all thalidomide-impaired individuals either currently resident or born in North Rhine–Westphalia, Germany, and recognized by the foundation that manages the compensation pensions (“Conterganstiftung für behinderte Menschen e.V.)”. The recruitment process was supported by a patient support group (“Interessenverband Contergangeschädigter Nordrhein-Westfalen e.V.”). Main outcome measures were the nature and extent of mental disorders according to the International Classification of Diseases (30) by testing with the Structured Clinical Interview for DSM-IV disorders (SCID-I & SCID-II) (29). Further methodological information pertaining to patient involvement, recruitment, study instruments, statistical analysis, and ethical approval is published in the eBox.

Methodological Details
Methodological Details
eBox
Methodological Details

Results

Of the 453 letters mailed to individuals with a known postal address by the patient support group, 67 could not be delivered and were returned, while 192 individuals responded and were willing to participate. Additionally, 13 individuals responded to alternative recruitment methods. Three of these 205 participants had no recognized thalidomide impairment and were subsequently excluded. For the overall study, 202 thalidomide-impaired participants were recruited (response rate 44.6%). Among these, a psychological examination could not be conducted in 9 cases (n = 8 on account of refusal, n = 1 for logistical reasons). Results on mental disorders were therefore available for 193 participants, which is about a quarter of the total affected population in North Rhine–Westphalia. Results will be reported only for this part of the sample. In 6 cases, where a SCID interview was not feasible due to substantial mental impairment, the diagnosis was based on a clinical assessment (n = 4 intellectual disability, n = 1 dementia, n = 1 paranoid schizophrenia).

Sociodemographic and somatic characteristics

The average age of all study participants who underwent the psychological examination (n = 193) was 50.5, with a range of 48 to 54 years. Most of the participants were born in 1961. There were more women (56.5%) than men (43.5%). The original damage caused by thalidomide consisted of dysmelia of the upper extremities in 154 cases (79.3% “twofold damage”) and dysmelia of both upper and lower extremities in 18 cases (9.8% “fourfold damage”). In 21 cases there was no dysmelia, but instead damage in the facial region (10.9% “damage without dysmelia”), most of which were associated with deafness or pronounced loss of hearing (n=13). More of the subjects lived with their relatives (73.1%) than independently in single households (26.9%). More than a third had received higher education (34.2%) and only a small proportion (4.1%) had not completed their schooling. At the time of the study, most of the subjects (71.5%) were in paid employment, but the percentage in full-time employment was low (18.8%). The disability was classified as severe by the pension offices in nearly all cases (Table 1).

Sociodemographic and somatic characteristics of study participants (n = 193 thalidomide-impaired individuals)
Sociodemographic and somatic characteristics of study participants (n = 193 thalidomide-impaired individuals)
Table 1
Sociodemographic and somatic characteristics of study participants (n = 193 thalidomide-impaired individuals)

Prevalence of mental disorders

In a total of 91 participants, at least one mental disorder was present within the four weeks preceding the examination (four-week prevalence [FWP] 47.2%, 95% CI [40.2; 54.2]). The occurrence of a mental disorder during the entire lifespan was documented for 115 participants (lifetime prevalence [LTP] 59.6%). In a sex comparison, mental disorders were found more often among men than among women, which particularly became evident on comparison of the LTP rates (63.1% vs 56.9%, p = 0.383). The simultaneous presence of more than one mental disorder in one and the same individual in the group of thalidomide-impaired subjects with current mental disorders was found in 45.1% (Table 2).

Prevalences of mental disorders*1
Prevalences of mental disorders*1
Table 2
Prevalences of mental disorders*1

In four-fifths at least one diagnosis fell into one of the following three diagnostic ICD-10-clusters:

  • Neurotic, stress, and somatoform disorders with the highest FWP (26.9%)
  • Affective disorders with the highest LTP (39.4%)
  • Substance-related disorders.

In women, neurotic, stress, and somatoform disorders occurred more commonly than in men (FWP: 30.3% vs 22.6%, p = 0.234), in whom the percentage of substance-related disorders was significantly higher (LTP: 29.8% vs 3.7%, p<0.001), whereas in affective disorders there was no relevant difference between the sexes (FWP: 22.6% vs 22.9%, p = 0.958).

Looking at individual diagnoses, unipolar depression was equally present in both sexes and was the most commonly diagnosed condition in both time intervals. One-third of subjects had gone through a phase of major depression at least once in their lives (LTP 33.2%). Including dysthymic disorders and minor depressive syndromes, the frequency was 39.4%. Besides unipolar depressive disorders, the most commonly diagnosed individual conditions were somatoform disorders (FWP 14.0%, LTP 14.0%), phobic disorders (FWP 12.4%, LTP 14.0%), and alcohol-related disorders (FWP 6.2%, LTP 13.0%). In women, somatoform disorders had a FWP as high as that for unipolar depression, and at the time of this study they had in all cases become chronic (FWP 16.5%, LTP 16.5%) and were almost without exception of the pain-dominant type. Over a quarter of male participants had at least once had an alcohol-related disorder in the past (LTP 27.4%). Phobic disorders often manifested themselves as specific phobias relating to the healthcare system, for example as phobias relating to doctors, injections, or drugs with corresponding avoidance behavior or adherence problems (Table 2).

As far as the utilization of psychosocial treatment services is concerned, in total 32 participants of the whole sample reported that they had accessed some form of professional help in the preceding 12 months (16.6% [12.0; 22.5]). Of these, 27 participants currently had a mental disorder and 5 had none. On the other hand, the researchers identified 73 cases in immediate need for psychosocial treatment services (80.2% of the participants with current mental disorders). Based on a clinical judgment, the most commonly recommended treatments were psychotherapy (54 cases) and psychiatric treatment (24 cases).

Discussion

Strengths and limitations of the study

The original damage and its consequential effects, including comorbid mental disorders, were determined systematically for the first time in 202 thalidomide-damaged individuals—so far the largest such population of patients with thalidomide syndrome worldwide. Nearly a quarter of the total affected population of North Rhine–Westphalia was included. This study has shown the high degree of mental comorbidity in people with thalidomide-related, prenatal physical disabilities by using the methodological gold standard.

This study has certain limitations. The lack of basic data on the affected population as a whole does not allow providing robust information on the representativeness of the data. Most thalidomide-impaired subjects have been recruited as members of a patient support group, which might induce a self-selection bias into the sample. Since a classical epidemiological approach was not feasible, our results have to be interpreted with caution. Although sex ratios for thalidomide embryopathy are essentially evenly distributed, slightly more women than men took part in the study. However, at least as far as age is concerned, a distribution pattern typical of the thalidomide epidemic between the years 1957 and 1962 is observed (4).

Comparison with other studies

Comparing this study with the numerically largest thalidomide study by Kruse et al. (20), both show corresponding sociodemographic characteristics and a predominance of women in the studied sample. Similar to the data presented here, Kruse et al. found that thalidomide-impaired people are far below average in terms of full earning capacity, although they are highly educated. Furthermore, a high proportion of them are on a pension. Moreover, in the general population, it is known that professional exclusion/marginalization is associated with an increased rate of mental disorders (31).

Another finding of our study is that among people affected by thalidomide, both men and women live by themselves in single households much more frequently compared with the German population as a whole (26.9% vs 18.2%); this is an indicator of social isolation (32). On the other hand Kruse et al. reported that thalidomide-affected subjects often rely on parents, partners, or children to cover their needs for personal assistance and care. With the passage of time, however, the parents‘ generation is increasingly dying out while the children of the impaired grow up and leave home, so that the familial helper system is currently at risk of falling apart (20).

Large-scale representative population studies, such as the German Federal Health Survey—Mental Health Module (DEGS-MH) have shown that mental disorders occur in a substantial section of the general population (33, 34). Thus, in the German age cohort of 50 to 64-year-olds, the 12-month prevalence of mental disorders of 27.1% is slightly below the value for the age-averaged German population as a whole, with these conditions being diagnosed more often in women than in men (31.9% vs 22.4%). Compared with this reference data our findings show some striking differences: The FWP of comorbid mental disorders in individuals with thalidomide embryopathy is almost twice as high than the 12-month prevalence found in DEGS-MH (47.2% vs 27.1%, p<0.001; relative risk [RR]: 1.77 [1.49; 2.10]). In comparison with same-sex reference data, the prevalence of mental disorders in men with thalidomide damage is even more than twice as high than that in thalidomide-affected women (RR: 2.25 [1.74; 2.96]), which might indicate that men have more difficulties coping with congenital physical impairment than women.

A limitation in the comparison with reference data for the general German population is that, whereas both studies were based on methodologically high-quality structured interviews, a different psychodiagnostic interview (M-CIDI) was used in the Federal Health Survey. The prevalence figures given in the two studies also referred to different time intervals (4 weeks vs 12 months). The M-CIDI covered a slightly narrower spectrum of diagnoses than the SCID. Nevertheless, only by looking at the SCID-I and after removing “minor depression” and “drug dependence” from the data set in order to make the data comparable between the two studies, the four-week prevalence of mental disorders in the group of people impaired by thalidomide remains significantly higher than the twelve-month prevalence in the age-matched general population (p<0.001).

Conclusion

The results regarding prevalence of psychological comorbidity in thalidomid-affected people indicate that this is at least as high as reported for chronic physical diseases (35, 36) or physical disabilities (37). In people affected by thalidomide, the prevalence of a single diagnosis of unipolar depression—the most commonly established mental health diagnosis in both sexes in this group (33.2%)—is nearly twice as high as that reported in the German National Care Guideline for unipolar depression (33.2% vs ~18% LTP; RR: 2.31[1.61; 3.33]) (38). The high proportion of multiple mental disorders in one and the same person in thalidomide-affected people is, moreover, associated with an increased tendency towards chronification and an unfavorable prognosis (39). The high prevalence of mental disorders in thalidomide-impaired individuals may be explained by biological factors (i.e. neurotoxicity) as well as by psychological factors (i.e. stress arising from restrictions of physical function and restricted social participation), social mortification and the specific historic context (i.e. stigmatization, “thalidomide scandal”).

In our study, the percentage of thalidomide-impaired individuals receiving treatment for mental disorders was much lower than that for the general German population, with both analyses using the same methodological criteria (16.6% vs 36.4%, p<0.001 [12.0; 22.5]) (40). This finding, which is in contrast with the increased prevalence of mental disorders compared to the reference population, suggests that mental healthcare is insufficient or, in many cases, lacking. In poeple seriously damaged by a pharmaceutical agent, this may be due to skepticism towards healthcare and medication as such. In addition, thalidomide-impaired individuals might fear stigmatization not only as physically impaired, but also as mentally ill. Developing specialized health care services might reduce these barriers.

Acknowledgements

We are indebted to all study participants. For their support we thank the staff of the “Association of Thalidomide victims North Rhine–Westphalia”, as well as the members of the peer-to-peer-project. We thank Frank Jacobi and Jens Strehle for providing additional data from the DEGS-MH.

Funding

The study was funded by the NRW Centre for Health (Grant No. 2010/S250–
288194). The funding sources played no part in the study design, in the collection, analysis, and interpretation of the data, in writing the paper, or in the decision to submit it for publication.

Conflict of interest statement
Prof. Peters has received lecture honoraria from Amgen, Alexion, and Pfizer, reimbursement of travel and accomodation costs from UCB Pharma and Amgen, and a consulting fee from Gedeon Richter Pharma.

The remaining authors declare that no conflicts of interest exists.

Manuscript received on 12 July 2016, revised version accepted on 29 November 2016

Corresponding author
Alexander Niecke
Klinik und Poliklinik für Psychosomatik und Psychotherapie
Universitätsklinikum Köln,
Kerpener Str. 62
50937 Köln, Germany
alexander.niecke@uk-koeln.de

Supplementary material
For eReferences please refer to:
www.aerzteblatt-international.de/ref1017

eBox:
www.aerzteblatt-international.de/17m0168

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Faculty of Business Management and Social Sciences, Osnabrück University of Applied Sciences: Prof. Dr. rer. pol. Lüngen
Institute of Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), University of Cologne & University Hospital Cologne: Prof. Dr. phil. Pfaff
Department of Psychosomatics and Psychotherapy, University Hospital Cologne:
Alexander Niecke, Dipl.-Psych. Forster, Prof. Dr. med. Albus
Department of Orthopedics and Osteology, Dr. Becker Rhein-Sieg-Klinik Nümbrecht:
Prof. Dr. med. Peters
Institute of Medical Statistics, Informatics and Epidemiology and Institute for Health Economics and Clinical Epidemiology, University of Cologne: Dipl.-Stat. Samel
Key messages
Sociodemographic and somatic characteristics of study participants (n = 193 thalidomide-impaired individuals)
Sociodemographic and somatic characteristics of study participants (n = 193 thalidomide-impaired individuals)
Table 1
Sociodemographic and somatic characteristics of study participants (n = 193 thalidomide-impaired individuals)
Prevalences of mental disorders*1
Prevalences of mental disorders*1
Table 2
Prevalences of mental disorders*1
Methodological Details
Methodological Details
eBox
Methodological Details
1.Kirk B: Der Contergan-Fall: eine unvermeidliche Katastrophe? Zur Geschichte des Arzneistoffs Thalidomid. Stuttgart: Greifswalder Schriften zur Geschichte der Pharmazie und Sozialpharmazie 1999.
2. Sjöström H, Nilsson R: Thalidomide and the power of the drug companies. Harmondsworth: Penguin 1972.
3. Knightley P, Evans H, Potter E, Wallace M: Suffer the children: the story of thalidomide. London: André Deutsch Limited 1979.
4.Lenz W: A short history of thalidomide embryopathy. Teratology 1988; 38: 203–15 CrossRef MEDLINE
5. Stephens T, Brynner R: Dark remedy. The impact of thalidomide and its revival as a vital medicine. Cambridge, Massachusetts: Perseus publishing 2001.
6. Franks ME, McPherson GR, Figg WD: Thalidomide. Lancet 2004; 363: 1802–11 CrossRef
7. Friedrich C: Contergan – zur Geschichte einer Arzneimittelkatastrophe. In: Zichner L, Rauschmann MA, Thomann KD (eds.): Die Contergankatastrophe – Eine Bilanz nach 40 Jahren. Darmstadt: Steinkopff 2005; 3–12 CrossRef
8.Thomann KD: Die Contergan-Katastrophe: Die trügerische Sicherheit der „harten“ Daten. Dtsch Arztebl 2007; 104: A2778–8 VOLLTEXT
9. McBride WG: Thalidomide and congenital abnormalities. Letter to the editor. Lancet 1961; 44: 1358 CrossRef
10. Lenz W: Kindliche Missbildungen nach Medikamenteneinnahme während der Gravidität? Dtsch Med Wochenschr 1961; 52: 2555–6.
11. Dally A: Thalidomide: Was the tragedy preventable? Lancet 1998; 351: 1197–9 CrossRef
12.Emanuel M, Rawlins M, Duff G, Breckenridge A: Thalidomide and its sequelae. Lancet 2012; 9844: 781–3 CrossRef
13.Annas GJ, Elias S: Thalidomide and the titanic: Reconstructing the technology tragedies of the twentieth century. Am J Pub Health 1999; 89: 98–101 CrossRef
14.Maio G: Ethische Überlegungen zur Contergankatastrophe. In: Zichner L, Rauschmann MA, Thomann KD (eds.): Die Contergankatastrophe – Eine Bilanz nach 40 Jahren. Darmstadt: Steinkopff 2005; 129–33 CrossRef
15. Kim JH, Scialli R: Thalidomide: The tragedy of birth defects and the effective treatment of disease. Toxicol Sci 2011; 122: 1–6 CrossRef MEDLINE
16.Rocha J: Thalidomide given to women in Brazil. BMJ 1994; 308: 1061 CrossRef
17.Schuler-Faccini L, Soares RC, de Sousa AC, et al.: New cases of thalidomide embryopathy in Brazil. Birth Defects Res A Clin Teratol 2007; 79: 671–2 CrossRef MEDLINE
18. Bundesverband Contergangeschädigter e. V.: www.contergan.de (last accessed on 28 June 2016).
19.Peters KM: Thalidomid-Embryopathie: Eine vielfältige Katastrophe. Orthopädie & Rheuma 2012; 15: 23–8 CrossRef
20.Kruse A, Ding-Greiner C, Becker G, Stolla C, Becker AM, Baiker D: Contergan – Wiederholt durchzuführende Befragungen zu Problemen, speziellen Bedarfen und Versorgungsdefiziten von contergangeschädigten Menschen. Endbericht an die Conterganstiftung für behinderte Menschen. Heidelberg 2012.
21.Kennelly C, Kelson M, Riesel J: Thalidomide impaired people: quality of life. Report of a community fund project on behalf of the thalidomide society. College of Health and the Thalidomide Society 2002.
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