Is somatosensory amplification a risk factor for an increased report of side effects? Reference data from the German general population

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Highlights

  • Not all side effects are explained by pharmacological actions of the drug.

  • Symptom interpretation and attribution contribute to side effect reporting.

  • We examined these processes in a representative German sample.

  • Somatosensory amplification contributes to bodily symptoms being rated as side effects.

  • Somatosensory amplification may represent a cognitive bias in side effect reporting.

Abstract

Objective

The study investigates the association between somatosensory amplification and the reporting of side effects. It establishes a German version of the Somatosensory Amplification Scale and examines its psychometric properties in a representative sample of the German population.

Methods

Sample size was 2.469, with 51% taking any medication. Participants answered the Somatosensory Amplification Scale, Generic Assessment of Side Effects Scale, and indicated whether they were taking any medication and the type of medication. Correlational analysis and binary logistic regression were performed.

Results

When examining a subsample reporting both medication intake and general bodily symptoms, participants higher in somatosensory amplification rated more of their general bodily symptoms as medication-attributed side effects. However, somatosensory amplification scores were not associated with the intake of any type of medication. In the overall sample, higher somatosensory amplification scores were associated with an increased report of bodily symptoms. Additionally, participants with higher somatosensory amplification reported intake of a greater number of different medications. The psychometric properties of the translated scale were good, and previously established associations of somatosensory amplification with demographic variables (age, sex) were replicated.

Conclusion

Results suggest a possible attributional bias concomitant to somatosensory amplification which in turn may increase the reporting of side effects after medication intake.

Introduction

Many patients experience and report side effects after medication intake. In clinical practice, patients frequently discontinue drug treatments because of side effects, even though the reported symptoms cannot be fully explained by the pharmacological activity of the drug [1]. Additionally, patients taking the same drug may vary widely concerning the subsequent report of side effects. These observations may be explained by a more differentiated analysis of side effects. Although certain side effects are drug-specific, others are nonspecific, ambiguous bodily symptoms that are attributed to the drug [2]. Both components are based on bodily sensations that a person experiences after the intake of a drug and that are subsequently attributed to the drug. Symptom interpretation is thus an important aspect in the development of medication side effects. We suggest that somatosensory amplification (SSA) may help to explain these inter-individual differences in side effects that cannot be accounted for by drug-specific activity.

Somatosensory amplification describes the tendency to experience bodily sensations as intense, noxious, and disturbing [3], [4]. This refers to sensations that may be harmless such as normal physiologic processes, somatic reactions to affective states, and benign complaints. However, it also applies to sensations that may be symptoms of a serious medical disease. SSA operates via three processes [4]: First, it implies a hypervigilance for bodily sensations. Thus even minor somatic changes will be perceived. Secondly, “amplifiers” focus on relatively mild and infrequent bodily sensations. Thirdly, the perceived sensations are often followed by emotional and cognitive responses such as fear which in turn intensify the sensations. Thus, “amplifiers” tend to catastrophize bodily sensations instead of normalizing them. The significant association between SSA and various measures of hypochondriasis [5], [6] supports this assumption. The high temporal stability of SSA scores argues for a trait-conception as a perceptual style [7]; on the other hand, affective states are known to influence the extent of amplification [8]. It is assessed via self-report with the Somatosensory Amplification Scale [4].

SSA may explain inter-individual differences in symptom report that cannot be accounted for by disease severity. Empirical evidence has linked SSA cross-sectionally to increased reporting of somatic symptoms. This association holds true for various instruments of symptom self-report and for patients with varying diseases [4], [9], [10], [11], [12], [13], [14], [15], [16]. Originally, the SSA-related somatic sensitivity was thought to mediate this association. Of late, this view has been challenged. Studies that have employed signal detection tasks to quantify somatic sensitivity have failed to find a significant relationship between SSA and detection ability [8], [17], [18], [19], [20]. Instead, the increased symptom reporting that is associated with higher SSA may better be accounted for by higher-order cognitive processes of symptom interpretation. A recent study investigated the relationship between somatosensory amplification and cortical evoked potentials [21], and found that SSA reflects long-latency processes of cognitive appraisal rather than short-latency processes of interoception. This aligns with recent research in health anxiety which stresses the importance of cognitively-biased symptom interpretation over interoceptive sensitivity [22].

These interpretative processes may also be of importance to the reporting of side effects after drug intake, thus establishing an association between SSA and side effects. This association has already been examined in a small-scale study in rheumatoid arthritis [9]. In this longitudinal study SSA scores at baseline significantly predicted the subsequently reported side effects. Similar results have been obtained in a double-blind placebo-controlled trial of moclobemide [23], and in an experimental study of non-specific adverse effects of non-steroidal anti-inflammatory drugs [24]. Recently, a cross-sectional study demonstrated that SSA is associated with the report of drug-specific, as well as general side effects in a sample of healthy males [25].

Thus, prior research supports an association between SSA and the reporting of bodily symptoms and purported side effects after drug intake. Unfortunately however, most of the aforementioned studies employed ad-hoc devised instruments to assess side effects. In consequence, no data concerning the reliability or validity of these assessments are available, even though the importance of a structured assessment of side effects has been repeatedly highlighted [26], [27]. Most studies also fail to differentiate between the report of bodily symptoms after drug intake (general symptom load) and the attributional component of ascribing a symptom to the drug (medication attributed side effects). Furthermore, the existing studies are based on limited sample sizes.

Therefore, the current study aims to examine the relation between SSA, medication intake, and the reporting of side effects in a large sample with validated instruments. The study uses a standardized and validated measure to assess side effects. This questionnaire is able to differentiate the general symptom load from medication-attributed side effects. We assume that SSA correlates positively with a general symptom load. Concerning the attribution of the symptoms to the drug, we hypothesize that participants higher in SSA should demonstrate an attributional bias: a greater proportion of experienced symptoms would be interpreted as “pathological” and thus rated as medication-induced side effects. SSA could represent one mechanism whereby some individuals report side effects that are not really drug specific. Secondly, a German version of the Somatosensory Amplification Scale is established and the scale's reliability is examined. Reference scores from a representative sample of the German population are presented.

Section snippets

Study design and participants

In order to collect a representative sample of the German population, the area of Germany was separated into 258 sample areas representing the whole country. With the assistance of a demographic consulting company (USUMA, Berlin, Germany) households of the respective area and members of the household fulfilling the inclusion criterion (participants being older than 13 years) were selected randomly. A total of 4572 valid household addresses were contacted; 864 households declined participation

Somatosensory amplification, general bodily symptoms and medication intake

In the overall sample, bivariate correlational analysis (Spearman's ρ) demonstrates that somatosensory amplification relates significantly to the general symptom load in the GASE (ρ = .32, p < .001, R2 = .10). Participants higher in SSA report a greater number and higher intensity of bodily symptoms. Additionally, somatosensory amplification correlates significantly but modestly with the number of different drugs being taken currently (ρ = .26, p < .001, R2 = .07). Participants who were using several

Discussion

In the overall sample, SSA was significantly associated with an increased general symptom load. This aligns with previous findings in various medical conditions, but also in healthy university students [30]. It also parallels the predictive power of Somatosensory Amplification for other conditions that are characterized by medically unexplained symptoms. It predicted symptoms report in somatoform disorder and in idiopathic environmental intolerance [31], and discriminated well between

Conflict of interest

The authors have no competing interests to report.

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