Evidence map›Paper›PMID 34031759›Full record

Trial reportClinical rheumatology2021

Expectancies as predictors of symptom improvement after antimicrobial therapy for persistent symptoms attributed to Lyme disease.

Henriët van Middendorp, Anneleen Berende, Fidel J Vos, Hadewych H M Ter Hofstede, Bart Jan Kullberg, Andrea W M Evers

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical rheumatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01207739 (Persistent Lyme Empiric Antibiotic Study Europe. A Prospective, Randomised Study Comparing Two Prolonged Oral Antibiotic Strategies After Initial Intravenous Ceftriaxone Therapy for Patients With Symptoms of Proven or Possible Persistent Lyme Disease), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01207739 phase4completednot on this map

Persistent Lyme Empiric Antibiotic Study Europe. A Prospective, Randomised Study Comparing Two Prolonged Oral Antibiotic Strategies After Initial Intravenous Ceftriaxone Therapy for Patients With Symptoms of Proven or Possible Persistent Lyme Disease

TypeinterventionalSponsorRadboud University Medical CenterRan2010 to 2014Enrolled280ConditionsLyme Disease, Borrelia InfectionArmsDoxycycline, Clarithromycin and hydroxychloroquine, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Guideline
  2. Lyme borreliosis.Nature reviews. Disease primers · 2026
    Review
  3. Article
  4. Persistent Symptoms After Treatment of Lyme Disease.Infectious disease clinics of North America · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Henriët van MiddendorpHealth, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, PO Box 9555, 2300 RB, Leiden, The Netherlands. h.vanmiddendorp@fsw.leidenuniv.nl.ORCID http://orcid.org/0000-0003-4575-0895
Anneleen BerendeDepartment of Medicine, Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID http://orcid.org/0000-0002-9079-9519
Fidel J VosDepartment of Medicine, Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.
Hadewych H M Ter HofstedeDepartment of Medicine, Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.
Bart Jan KullbergDepartment of Medicine, Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.
Andrea W M EversHealth, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, PO Box 9555, 2300 RB, Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-0090-5091
Radboud University Nijmegen · NLLeiden University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION/

objectiveExpectancies about symptom improvement or deterioration are reliable predictors of symptom progression and treatment outcomes (symptom resolution or symptomatic improvement) in many (non-)pharmacological studies and treatments. This study examined predictors of symptom improvement after antimicrobial therapy for persistent symptoms attributed to Lyme disease, hypothesizing particularly pre-treatment expectancies regarding symptom improvement to be predictive.

methodsA predictive study was performed on pre-treatment and post-treatment individual characteristics, including expectancies, and physical and mental health-related quality of life (HRQoL) from the PLEASE-trial comparing randomized 12-weeks of doxycycline, clarithromycin-hydroxychloroquine, or placebo following 2 weeks of intravenous ceftriaxone. At end-of-treatment (14 weeks after trial start) and follow-up (52 weeks), complete data of 231 and 170 (of initial 280) patients with persistent symptoms temporally related to a history of erythema migrans or otherwise confirmed symptomatic Lyme disease, or accompanied by B. burgdorferi IgG or IgM antibodies, were examined through hierarchical regression analyses.

resultsIn addition to pre-treatment HRQoL, pre-treatment expectancies regarding symptom improvement were consistently associated with stronger physical and mental HRQoL improvements at both end-of-treatment and follow-up (95% CI range: .09;.54, p < .01 to .27;.92, p < .001). Post-treatment expectancies regarding having received antibiotics vs. placebo was associated with more HRQoL improvement at end-of-treatment, but not at follow-up (95% CI-range 1.00;4.75, p = .003 to -7.34; -2.22, p < .001).

conclusionsThe present study shows that, next to pre-treatment functioning, patients' pre-treatment and post-treatment expectancies regarding improvement of persistent symptoms attributed to Lyme disease relate to a more beneficial symptom course. Expectancies of patients may be relevant to explain and potentially improve patient outcomes (e.g., by optimized communication about treatment success).

trial registrationClinicalTrials.gov, NCT01207739 (Registration date: 23-09-2010) Key Points • As there is currently no sufficient symptom resolution or symptomatic improvement for many patients with persistent symptoms attributed to Lyme disease, it is relevant to know which factors determine symptom progression and predict heterogeneity in treatment response. • Next to pre-treatment functioning, expectancies regarding symptom improvement and having received antimicrobial study medication are associated with a more beneficial symptom course after both shorter-term and longer-term antimicrobial treatment. • Expectancies are relevant to consider in treatment studies and may be useful in clinical settings to improve symptom course and treatment outcome (e.g., by optimized communication about treatment success).

Indexed as

Lyme DiseaseQuality of LifeAnti-Bacterial AgentsCeftriaxoneDoxycyclineHumansAnti-Bacterial AgentsCeftriaxoneDoxycyclineAntibiotics treatmentExpectanciesLyme diseasePsychologyTreatment outcome

Identifiers

PMID34031759
PMCPMC8463383
OpenAlexW3164422396

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.