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D.N. Andreev

Burdenko Neurosurgical Center

Yu.A. Kucheryavy

Evdokimov Moscow State Medical and Dentistry University;
Ilya Hospital

I.V. Maev

A.I. Yevdokimov Moscow State University of Medicine and Dentistry

The prevalence and risk of sleep disorders in patients with functional dyspepsia: a meta-analysis

Authors:

D.N. Andreev, Yu.A. Kucheryavy, I.V. Maev

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To cite this article:

Andreev DN, Kucheryavy YuA, Maev IV. The prevalence and risk of sleep disorders in patients with functional dyspepsia: a meta-analysis. S.S. Korsakov Journal of Neurology and Psychiatry. 2021;121(1):26‑30. (In Russ., In Engl.)
https://doi.org/10.17116/jnevro202112101126

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Functional dyspepsia (FD) is a gastrointestinal disease of unknown etiology based on motor and sensory disorders of the gastroduodenal zone. This disease manifested by epigastric pain or burning, feeling of fullness or early satiety without clear data on organic (secondary) lesion [1, 2]. There are 2 clinical forms of FD depending on predominant symptoms: epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS) [1]. According to recent epidemiological data on FD in the world, prevalence of this disease is 9.8—20.2% in western population and 5.3—12.8% in eastern population [3].

In accordance with the Rome IV criteria (2016), functional diseases of the gastrointestinal tract are considered as disorders of interaction "brain — gastrointestinal tract" [4]. These nosologies are characterized by common association with psychological disorders, including depression, anxiety and sleep disorders [5-8]. Bi-directional relationships of depression and sleep disorders were observed in some large trials [9, 10]. Recent meta-analyses have shown that patients with irritable bowel syndrome (IBS) more often have depressive disorders (odds ratio (OR) 2.72, 95% confidence interval (CI) 2.45—3.02) and sleep disorders (OR 2.618, 95% CI 2.052—3.341) compared to healthy people [11, 12]. A positive association between FD and depression was found in another meta-analysis that summarized the results of 23 observational trials (OR 2.28, 95% CI 2.02—3.81) [6]. At the same time, incidence of sleep disorders in patients with FD has been studied to a lesser extent. Some earlier studies have demonstrated a relationship between FD and dyssomnia [13—15]. Moreover, cross-sectional studies revealed more significant symptoms of FD and regression of the quality of life in people with sleep disorders [16, 17].

The purpose of this meta-analysis was to systematize data on the prevalence and risk of sleep disorders in patients with FD.

Material and methods

Data searching was carried out in MEDLINE/PubMed, EMBASE, Cochrane databases until October 2020. We analyzed headings and abstracts in the above-mentioned databases. The following keywords were used: “functional dyspepsia [Title] sleep [Title / Abstract]”, or “functional dyspepsia [Title] insomnia [Title / Abstract]”, or “functional gastrointestinal [Title] sleep [Title / Abstract]) ", or "functional gastrointestinal [Title] insomnia [Title / Abstract])" and several equivalents. In case of duplication of certain report in different electronic databases, only one manuscript was selected for the final analysis.

Inclusion criteria were relevant reports in periodicals; manuscripts with a detailed descriptive statistics (sample size, number of sleep-impaired patients) and available inclusion of data into meta-analysis; trials of adults with FD.

Two researchers extracted data independently using the standardized forms. We analyzed the year of publication, country, diagnostic criteria of FD, methods for assessing sleep disorders, total sample size and number of patients with sleep disorders. Any disagreement was resolved by consensus.

Statistical analysis was carried out using MedCalc 19.5.3 software package (Belgium) on Microsoft Windows 10 (USA). The results are shown as frequencies of sleep disturbances in patients with FD (%) and 95% CI. Between-study heterogeneity was assessed using Cochrane's Q test and I2 test. Significant heterogeneity was determined by p <0.05 and I2> 50. The probability of significant publication bias was assessed using funnel plot, Begg-Mazumdar correlation test and Egger’s test.

Results

Analysis of electronic databases revealed 62 manuscripts for further analysis. Fourteen studies were excluded as not original articles (11 — reviews; 3 — other irrelevant works). Other 48 studies were comprehensively analyzed for compliance with inclusion criteria and duplicate results. After that, 38 studies were excluded (Fig. 1). Ten original trials were included in this meta-analysis (Table) [13—15, 17—23].

Fig. 1. CONSORT-chart detailing the research selection strategy.

Table. Characteristics of selected studies

Reference

Country

FD criteria

Assessment of sleep disorders

Number of patients with FD

Number of control people

[13]

USA

Chronic upper abdominal pain or discomfort associated with bloating, nausea, and / or early satiety lasting at least 3 months

Sleep disorder questionnaire for 6 months

65

43

[14]

USA

Chronic upper abdominal pain or discomfort associated with bloating, nausea, and / or early satiety lasting at least 3 months

Sleep disorder questionnaire for 6 months

75

205

[15]

Taiwan

Rome II criteria

Sleep disorder questionnaire for 6 months

239

1249

[18]

Japan

Rome III criteria

PSQI >5.5

94

57

[17]

Japan

Rome III criteria

PSQI >5.5

79

44

[19]

Taiwan

Rome III criteria

BSRS-5

491

1031

[20]

China

Rome III criteria

PSQI >8

920

No

[21]

South Korea

Rome III criteria

PSQI >6

62

1800

[22]

South Korea

Rome III criteria

PSQI ≥8.5

201

325

[23]

China

Rome IV criteria

Insomnia questionnaire

128

631

The final analysis included 10 studies involving 7739 people (2354 patients with FD, 5385 — control group). These trials were performed in the USA [13, 14], Japan [17, 18], South Korea [21, 22], China [20, 23] and Taiwan [15, 19]. In most studies, the authors used the Rome II — IV criteria to diagnose FD [15, 17—23] and the validated Pittsburgh Sleep Qualitative Index (PSQI) questionnaire for assessment of sleep disorders [17, 18, 20—22].

Pooled incidence of sleep disorders in patients with FD was 53.23% (95% CI 37.738—68.419) (Fig. 2). We used random-effect model due to significant heterogeneity of data (p <0.0001; I2 = 98.05%). We found a significant association of sleep disorders and FD compared to the control group (OR 2.884, 95% CI 2.518—3.304; I2 = 28.35%) (Fig. 3). Pooled incidence of sleep disorders was 49.62% in the studies used the Rome II — IV criteria for FD diagnosis (95% CI 31.746—67.547; I2 = 98.48%).

Fig. 2. Forest diagram showing the generalized frequency of sleep disorders in patients with PD.

Fig. 3. Forest diagram showing the total number of sleep disorders in patients with PD.

Incidence of sleep disorders in patients with different clinical forms of FD was analyzed in 3 studies [17, 19, 22]. Pooled incidence of sleep disorders in patients with EPS was 40.6% (95% CI 34.267—47.181; I2 = 0%), with PDS — 51.82% (95% CI 26.479—76.666; I2 = 94.76%), with a combination of EPS and PDS — 51.67% (95% CI 23.497—79.270; I2 = 95.34%).

The probability of significant publication bias was assessed using funnel plot, Begg-Mazumdar correlation test and Egger’s test. Visual analysis of funnel plot (Fig. 4) revealed no significant asymmetry. Moreover, significant publication bias was excluded according to Begg-Mazumdar test (Kendall's tau 0.1667; p = 0.5316) and Egger's test (p = 0.7296).

<

Fig. 4. Funnel-shaped scatter plot for estimating the probability of publication bias in the calculation OSH of sleep disorders in patients with PD.

Discussion

FD is one of the most common diseases of the gastrointestinal tract. This disease significantly impairs the patient's quality of life [1]. Sleep disorders are common in patients with FD, while several studies have shown that people with dyssomnia have more severe symptoms of disease [16, 17].

According to modern data, incidence of sleep disorders in patients with FD varies over a wide range (25.8 — 87%) [13—15, 17—23]. This meta-analysis of 10 studies has shown that the incidence of sleep disturbances in patients with FD is 53.23% (95% CI 37.738—68.419). Moreover, a significant association was revealed between sleep disorders and FD (OR 2.884, 95% CI 2.518—3.304). Our results are similar to the data of a recent meta-analysis devoted to the incidence of sleep disorders in patients with IBS. This value was 37.6% (95% CI 31.4—44.3%) with OR 2.618 (95% CI 2.052—3.341) [12]. These findings once again demonstrate that psychological disorders are common in patients with functional gastrointestinal diseases. At the same time, the mechanisms underlying these associations are still unclear. Perhaps, chronic pain pattern in patients with FD and IBS can directly lead to dyssomnia. Moreover, experimental studies of healthy volunteers revealed that induced sleep disturbances can result some changes in pain thresholds followed by hyperalgesia. The last one is typical for functional gastrointestinal disorders [24]. Thus, correction of sleep disorders in patients with FD can be considered as one of the objectives in complex treatment of these patients. No significant advantages of melatonin were observed compared to placebo in a recent pilot randomized controlled trial of patients with FD [25]. A meta-analysis revealed an efficacy of psychotropic drugs in FD therapy (RR 0.78, 95% CI 0.68—0.91; NNT 6, 95% CI 4—16). However, this efficacy was limited by antipsychotics and tricyclic antidepressants [26]. These drugs are often used to correct dyssomnia in some countries.

Importantly, all studies included in this meta-analysis were represented by case-control trials and cohort studies. These researches did not analyze an efficacy of certain psychotropic drugs in correction of insomnia in patients with FD. However, the identified risk of sleep disorders in patients with this functional disease should orient the scientific community to the need for further study of this issue in prospective controlled studies. At the same time, modern hypnotics with a shorter half-life are advisable for correction of sleep disorders. Zaleplon is one of these drugs. Zaleplon was synthesized by the last of the so-called Z-drugs and characterized by selective action on α1 subunit of GABAA receptor complex [27, 28]. This mechanism ensures a “pure” hypnotic effect in contrast to conventional benzodiazepine drugs. Zaleplon has the shortest half-life (1 hour). Therefore, its administration is not associated with post-hypnotic effects the next morning [27, 28]. This drug does not disturb the architecture of sleep and contributes to endogenous melatonin release. These processes ensure more physiological sleep [29]. Regarding the safety profile, Zaleplon has optimal characteristics. Indeed, this drug does not affect cognitive functions, memory, psychomotor reactions and ability to drive a car [30]. In a 12-month analysis, Zaleplon did not cause addiction and rebound insomnia [31]. Sonata Adamed is the only Zaleplon in the Russian Federation. This drug is produced in Poland in accordance with EU GMP standards. Unlike other Z-drugs, Zaleplon is prescribed on a standard prescription No. 107-1/U.

There are several limitations of our study. First, the analyzed studies were characterized by significant heterogeneity regarding diagnostic criteria of FD and assessment of sleep disorders. Second, all studies used subjective sleep quality analysis tools (questionnaires) rather objective ones (polysomnography). At the same time, this meta-analysis is the first research summarizing various studies on the prevalence of sleep disorders in patients with FD.

Conclusion

Thus, sleep disorders are often associated with FD and observed in approximately every the 2nd patient with this functional gastrointestinal disease. Further studies are required to investigate the possible causal relationships between sleep disorders and FD.

The authors declare no conflicts of interest.

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