Clinical Practice Guideline
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Background: Sore throat is a common reason for consultation of primary care physicians, pediatricians, and ENT specialists. The updated German clinical practice guideline on sore throat provides evidence-based recommendations for treatment in the framework of the German healthcare system.
Methods: Guideline revision by means of a systematic search of the literature for international guidelines and systematic reviews. All recommendations were developed by an interdisciplinary guideline committee and agreed by formal consensus. The updated guideline applies to patients aged 3 years and over.
Results: In the absence of red flags such as immunosuppression, severe comorbidity, or severe systemic infection, acute sore throat is predominantly self-limiting. The mean duration is 7 days. Chronic sore throat usually has noninfectious causes. Laboratory tests are not routinely necessary. Apart from non-pharmacological self-management, ibuprofen and naproxen are recommended for symptomatic treatment. Scores can be used to assess the risk of bacterial pharyngitis: one point each is assigned for purulent or inflamed tonsils, palpable cervical lymph nodes, patient age, disease course, and elevated temperature. If the risk is low (<3 points), antibiotics are not indicated; if at least moderate (3 points), delayed prescribing is recommended; if high (>3 points), antibiotics can be taken immediately. Penicillin remains the first choice, with clarithromycin as an alternative for those who do not tolerate penicillin. The antibiotic should be taken for 5–7 days.
Conclusion: After the exclusion of red flags, antibiotic treatment is unnecessary in many cases of acute sore throat. If administration of antibiotics is still considered in spite of patient education on the usual course of tonsillopharyngitis and the low risk of complications, a risk-adapted approach using clinical scores is recommended.
Sore throat is No. 6 on the list of most common reasons for visiting a primary care physician and accounts for 2.7% of all primary care consultations in Germany (1). Acute sore throat is usually caused by viral infections of the pharynx. Bacterial pathogens, such as streptococci, are detected in tonsillopharyngitis in only 20.2%–34% of cases, depending on the seasonal and regional conditions and age group (2, 3). A German study conducted in 2018 with 61 primary care practices found group A streptococci (GAS) in only 15% of patients with sore throat (4). While GAS are nearly always the cause of bacterial tonsillopharyngitis in children, group C and G streptococci are found in up to 12% of cases in adults. Only a handful of primary studies on the prescribing practice of general practitioners in cases of suspected bacterial tonsillopharyngitis are available for Germany and have low case numbers. A 2005 survey found an antibiotic prescription rate of approximately 90% in primary care patients with suspected tonsillitis, whereas a 2016 study found a rate of 41% on initial presentation (5, 6). Non-beneficial prescribing of antibiotics represents an unnecessary risk for patients and promotes the development of resistance (7).
Sore throat is defined as chronic if it persists for more than 14 days, in which case noninfectious causes are more likely. From a differential diagnostic perspective, one should consider physicochemical factors (post-intubation status, smoking, snoring, medications, reflux), voice strain and overuse, concomitant diseases, and adverse drug effects (8).
The German clinical practice guideline “Sore Throat,” which was updated in 2020, takes into account a newly developed clinical score, as well as the principle of delayed prescribing, and presents a revised treatment algorithm.
To compile the evidence base, a literature search was performed to find current versions of the source guidelines, which were evaluated using the AGREE-II instrument (9). A systematic search was also conducted for review articles, which were evaluated using the AMSTAR-2 instrument. Search strategies and evaluations are described in the eMethods.
The recommendations were discussed and agreed upon in the consensus committee. For any remaining recommendations and text passages on which no consensus had previously been reached, consensus was subsequently established by means of a Delphi procedure. All parties that participated in the development of the guideline are listed in the eBox. The guideline recommendations are given here with strength of recommendation and level of evidence, while statements are accompanied by level of evidence (eTable 1).
A total of 19 source guidelines (eFigure 1) were evaluated, as were 14 guidelines following a search in guideline portals (eFigure 2) and 122 guidelines following a systematic search in Medline via PubMed (eFigure 3). Altogether, seven guidelines of high methodological quality and relevance for the key questions were identified (10, 11, 12, 13, 14, 15, 16).
The search for reviews and meta-analyses in Medline via PubMed and in the Cochrane Database yielded 334 hits, of which 29 systematic reviews of high quality and relevance were included (eFigure 4). Since guidelines and reviews provided a sufficient evidence base, no systematic search for original papers was performed.
In all, 10 statements and 17 recommendations were unanimously adopted, while there was one abstention each for four guideline recommendations (17).
Preventable high-risk disease courses: specific problems
In addition to tonsillopharyngitis with typical symptoms and findings (such as sore throat and pain swallowing, elevated temperature, pharyngeal erythema, possible tonsillar exudates, and cervical lymph node swelling), fulminant courses, systemic diseases, as well as other differential diagnoses requiring individualized decision-making or referral to another level of care need to be differentiated in the case of corresponding symptoms or underlying disease (Table 1).
Complications and sequelae
High-risk complications of sore throat are very rare in countries such as Germany, Great Britain, and the Netherlands (Statement, 1a).
Suppurative complications (otitis media, peritonsillar abscess, sinusitis, bacterial skin infections) occur in less than 1.4% of cases of acute sore throat (18). The most common non-suppurative complications worldwide that can develop as a result of GAS tonsillopharyngitis include acute rheumatic fever (ARF) and acute poststreptococcal glomerulonephritis (APSGN). The annual incidence of ARF in Germany is estimated to be less than 1/1 000 000 inhabitants (19). The incidence in many developing countries is far higher. Rheumatic heart disease (RHD), which develops in 30–80% as a result of ARF, represents the most frequent cause of acquired heart diseases in high-incidence countries. Patients at high risk for the development of ARF include:
- ARF or RHD in the patient’s own or family history
- Crowding (an above average number of persons per household/dwelling) (20)
- Current positive migration history for regions with a high incidence of ARF (≥ 2/100 000 schoolchildren) or high prevalence of RHD (≥ 1/1000 population-years), for example, sub-Saharan Africa, South and Central Asia, as well as Oceania
- Belonging to population groups with a high incidence of ARF (≥ 2/100 000 schoolchildren) or high prevalence of RHD (≥ 1/1000 population-years), for example, populations in sub-Saharan Africa, South and Central Asia, Oceania, as well as Maoris in New Zealand) (21).
APSGN is rare in Germany and generally has a good prognosis for complete resolution. It has not been demonstrated that antibiotic treatment of the primary infection is able to prevent APSGN (22).
From a clinical perspective, it is not possible to reliably distinguish between viral, bacterial, and noninfectious pharyngitis (Statement, Ia). However, the ascertainment of symptoms and findings may increase the likelihood of a viral or bacterial etiology in acute sore throat (11, 14), meaning that a shared decision can be made on the initiation of antibiotic therapy on this basis.
Clinical scores estimate the probability of microbiological detection of beta-hemolytic streptoccici in a throat swab in acute tonsillopharyngitis. One point each is assigned for defined findings in the medical history and clinical examination, such as elevated temperature, patient age, disease course, pharyngeal and tonsillar findings, as well as cervical lymph node swelling (Box 1). New to the guideline is a consideration of the FeverPAIN score published in 2013 (23). For the Centor and McIsaac scores, external validation with high case numbers is now available (24). Use of the FeverPAIN score in a British study resulted in a 27–29% reduction in antibiotic administration with no increase in complications or readmissions (23, 25). The guideline recommends that a clinical score be determined in patients (aged ≥ 3 years) with acute sore throat and no red flags (Table 1) if antibiotic therapy is being considered (B, Ib). A comparison of the three scores made it possible, irrespective of the score used, to define a low risk (≤ 2 points: 0–20%), a medium risk (3 points: 30–50%), and a high risk (≥ 4 points: over 50%) for the presence of bacterial tonsillopharyngitis (Table 2).
Determination of laboratory parameters
Laboratory parameters, such as leukocytes, C-reactive protein, erythrocyte sedimentation rate, and procalcitonin, should not be routinely determined as part of the diagnostic work-up in patients with acute sore throat (lasting < 14 days) in the absence of red flags (Statement, Good Clinical Practice [GCP]).
Rapid tests for group A streptococci
In randomized controlled trials, the use of rapid GAS testing conferred no benefits in terms of symptom duration or readmission and complication rates compared to the use of scores alone (23, 25). However, in contrast to adults, children and adolescents in Germany have a very low prevalence of tonsillopharyngitis caused by non-group-A streptococci. Therefore, the guideline supports the use of rapid tests in the case of medium to high clinical probability of streptococcal tonsillopharyngitis (≥ 3 score points) in children aged 3–15 years. In the case of a negative GAS rapid test, unnecessary antibiotic treatment can be dispensed with.
Microbiological culture detection is not routinely recommended either before or after antibiotic therapy. Exceptions apply to patients with signs of notifiable diseases, diseases requiring treatment, atypical pathogens in known immunosuppression, and risk constellations for ARF (see Sect. “Complications and sequelae”) (26).
Since 2020, COVID-19 needs to be considered in the differential diagnosis of all new-onset respiratory symptoms. The suspicion is supported primarily by the concomitant occurrence of acute sore throat and symptoms typical for COVID-19, such as cough, elevated temperature, difficulty breathing, and sudden loss of sense of smell and taste, as well as by the occurrence of sore throat on its own following contact with individuals that have tested positive. The current regional incidence rate also needs to be included in the testing strategy. If COVID-19 is suspected, additional diagnostic testing and treatment in line with the current guidelines need to be initiated (27).
Taking red flags into consideration
An important step in the treatment of acute sore throat is the identification of red flags in the clinical history and examination (Box 1).
Patients with red flags may belong to groups whose risk for severe disease courses is difficult to assess since these groups are often excluded from controlled trials:
- Conditions with severe immunosuppression, such as long-term use of systemic steroids, organ transplantation, stem cell transplantation, AIDS, neutropenia, and other congenital or acquired immune defects
- Severe comorbidities.
The presence of red flags may also point to other diseases for which there are different guidelines or treatment recommendations:
- Scarlet fever
- Infectious mononucleosis
- Respiratory infections, such as pneumonia, bronchitis, sinusitis, otitis media.
Therefore, the evidence-based recommendations described below for the treatment of sore throat are only applicable once red flags have been ruled out.
A medical consultation is indispensable for a shared decision-making process. A consensus was reached in the guideline on recommendations relating to the content of the consultation. In addition to what is likely to be a self-limiting 1-week disease course, the low risk of complications should also be mentioned and guidance on self-management provided. If antibiotic therapy is desired, its individual benefit needs to be weighed up against adverse events prior to administration (Box 2).
Symptomatic treatment with throat preparations
The guideline endorses with only a weak level of recommendation the use of throat preparations (lozenges, gargle solutions, sprays) containing local anesthetics and/or non-steroidal anti-inflammatory drugs (NSAIDs). Cases of methemoglobinemia have been described with local anesthetics (28). Although these adverse events are rare, one should take into account the fact that, at best, throat preparations offer low efficacy for a very limited period of time against what are already self-limiting symptoms.
The guideline explicitly advises against local antiseptic- and/or antibiotic-containing throat preparations with a strong level of recommendation since the vast majority of cases of acute sore throat are viral infections. These substances can cause severe allergic reactions (29, 30). However, there is no data available on the frequencies of these events.
Symptomatic treatment with oral corticosteroids
Corticosteroids should not be used for analgesic treatment of sore throat (A, 1a). The evidence for any efficacy of oral corticosteroids in acute sore throat is derived almost exclusively from studies that tested the administration of corticosteroids in addition to an established treatment. A 2017 study showed evidence for an earlier resolution of sore throat after 48 h with a single dose of dexamethasone (31). This evidence was considered to be an insufficient basis on which to recommend the administration of oral corticosteroids for symptoms treatable by self-management and over-the-counter substances.
Symptomatic treatment with non-steroidal anti-inflammatory drugs and paracetamol
Ibuprofen or naproxen can be offered for the short-term symptomatic treatment of sore throat (O, Ib). A Cochrane review conducted in 2013 found insufficient evidence of efficacy for paracetamol in resolving symptoms of the common cold (32). A 2011 systematic review described efficacy of NSAIDs for sore throat in the first 24 h (12 randomized controlled trials [RCTs]; significant improvement in 25–75% of patients) and after 2–5 days (six RCTs, significant improvement in 33–93% of patients) (33). The longest experience with ibuprofen has been gained in pediatrics. Among the NSAIDs, diclofenac is associated with a higher risk for cardiovascular events (34).
Benefits of antibiotic treatment
Sore throat (even of bacterial etiology) does not represent a general indication for antibiotic administration (Statement, Ia). Therefore, the updated guideline explicitly supports foregoing antibiotic treatment in the German healthcare context, even in the case of strong clinical suspicion of bacterial tonsillopharyngitis. The “number needed to treat” (NNT) to avoid suppurative complications through antibiotic administration is extremely high at 194 patients (18). A Cochrane meta-analysis calculated that antibiotics shorten symptoms by on average 16 h (35). Thus, the primary goal of antibiotic treatment in patients aged ≥ 3 years with acute sore throat is to shorten the duration of the disease rather than to prevent complications.
If the physician is considering—or the patient is expecting—antibiotic treatment in the absence of red flags, the guideline recommends that the treatment decision be made on the basis of one of the three clinical scores (strength of recommendation B, II) (Box 1). Antibiotic treatment is not recommended in the case of a point score of < 3. From a point score of 3, the principle of delayed prescribing (DP) is recommended; immediate antibiotic therapy should only be offered from a point score of 4 at the earliest. DP refers to the issuing of a prescription that is only redeemed by the patient if symptoms worsen or do not improve after 3–5 days. In controlled studies, only around a third of these prescriptions were used, thereby significantly reducing antibiotic use without causing an increase in complications (25, 36).
Selection of the active substance and treatment duration
If antibiotic treatment is to be performed, either by DP or by immediate administration, the following active substances are recommended (strength of recommendation A, Ia):
- Adolescents (> 15 years) and adults:
– Penicillin V 0.8–1.0 million IU orally three times daily for 5–7 days
– In the case of penicillin intolerance: clarithromycin 250–500 mg orally twice daily for 5 days.
- Children (3–15 years):
– Penicillin V 0.05–0.1 million IU/kg body weight/day divided into three single oral doses for 5–7 days
– In the case of penicillin intolerance: clarithromycin 15 mg/kg body weight/day divided into two single oral doses for 5 days.
The risk of adverse drug reactions and the development of resistance increases with increasing duration of antibiotic use (7). Therefore, the guideline recommends restricting the duration of use to between 5 and a maximum of 7 days. Pathogen eradication with 10-day penicillin should be reserved for individual cases at increased risk for a severe course (GCP). Taking penicillin at midday may be difficult in patients aged 3–15 years (for example, if they attend community facilities). In these cases, it is possible to divide the daily dose of penicillin V into two doses (mornings and evenings) (Statement; Ia).
The recommendations on the approach to sore throat are summarized in a clinical algorithm (Figure).
Recurrent acute tonsillitis
Frequent or recurrent episodes of sore throat can be burdensome for the patient and justify the desire for causal treatment. When considering surgical treatment, an assessment of (ideally medically documented and treated) episodes of sore throat, defined as follows, is recommended:
- Elevated temperature > 38.3 ºC (oral) or
- Purulent tonsils or
- New-onset painful cervical lymph node swelling or
- Detection of streptococcus in the swab.
From a frequency of six episodes or more in the preceding 12 months, tonsillectomy or tonsillotomy is a therapeutic option (GCP). Given the heterogeneous quality of data, the basis for decision-making in this regard is consensus-based and applies to patients aged 3 years and older (37).
If tonsillectomy is not possible or undesired, a one-off attempt at pharmacological eradication of the pathogens with amoxicillin/clavulanic acid or clindamycin can be made during the sore throat episode (0, Ia). If data on long-term effects are lacking, adverse events and complications with the two treatment options must always be weighed against the spontaneous recovery rate for recurrent acute tonsillitis.
The process of updating the guideline gave rise to further research questions:
- How high is the age-dependent pretest probability for group A streptococcal versus non-group A streptococcal tonsillopharyngitis in Germany?
- How high is the age-dependent incidence of poststreptococcal disease in Germany?
- How effective is delayed prescribing for acute respiratory infections in terms of avoiding unnecessary antibiotic use in Germany?
- What are the long-term effects of tonsillectomy and tonsillotomy for recurrent acute tonsillitis?
The guideline was funded by resources of the German College of General Practitioners and Family Physicians (Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin, DEGAM), the Department of General Practice and Primary Care (Institut und Poliklinik für Allgemeinmedizin) at the University Medical Center Hamburg-Eppendorf (UKE), and the Institute of General Practice (Institut für Allgemeinmedizin) at the Charité.
We would like to thank all authors of and participants in the DEGAM Clinical practice guideline on Sore Throat:
Prof. Dr. med. Jean-François Chenot, PD Dr. med. Markus Bickel, Prof. Dr. med. Rainer Laskawi, PD Dr. med. Guido Schmiemann, Prof. Dr. Gesine Weckmann, Dr. med. Petra Jung, Dr. rer. nat. Karin Ettlinger, Dr. med. Anton Wartner, Dr. med. Hannelore Wächtler, Dr. med. Felix Holzinger, Dr. rer. hum. Cathleen Muche-Borowski, Prof. Dr. med. Erika Baum, Dr. med. Achim Mainz, Dr. med. Günther Egidi.
Conflict of interest statement
Prof. Berner received speaker’s fees from Infectopharm.
The remaining authors declare that no conflict of interest exists.
Manuscript submitted on 23 November 2020, revised version accepted on 12 January 2021.
Clinical practice guidelines in the Deutsches Ärzteblatt, as in numerous other specialist journals, are not subject to a peer review procedure, since clinical practice guidelines represent texts that have already been evaluated, discussed, and broadly agreed upon multiple times by experts (peers).
Translated from the original German by Christine Rye.
Dr. med. Jan Hendrik Oltrogge
Institut und Poliklinik für Allgemeinmedizin
Universitätsklinikum Hamburg-Eppendorf (UKE)
20251 Hamburg, Germany
Cite this as:
Krüger K, Töpfner N, Berner R, Windfuhr J, Oltrogge JH: linical practice guideline: Sore throat. Dtsch Arztebl Int 2021; 118: 188–94. DOI: 10.3238/arztebl.m2021.0121
eBox, eMethods, eFigures, eTables:
Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universität Dresden: Dr. med. Nicole Töpfner, Prof. Dr. med. Reinhard Berner
Department of Otolaryngology, Kliniken Maria Hilf Mönchengladbach: Prof. Dr. med. Jochen Windfuhr
Department of General Practice and Primary Care, Hamburg University Medical School, Universitätsklinikum Hamburg-Eppendorf (UKE): Dr. med. Jan Hendrik Oltrogge
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