Does Amoxicillin Improve Outcomes in Patients with Purulent Rhinorrhea?

,

Original Research

Does Amoxicillin Improve Outcomes in Patients with Purulent Rhinorrhea?

J Fam Pract. 2002 April;51(4):317-323

PDF Download

References

1. Okkes IM, Oskam SK, Lamberts H. Van klacht naar diagnose. Episodegegevens uit de huisartspraktijk. Coutinho, Bussum, Nl; 1998.

2. De Maeseneer J. Het voorschrijven van antibiotica bij luchtwegproblemen. Een explorerend onderzoek. Huisarts Wet 1990;33:223-6.

3. De Melker RA, Kuyvenhove MM. Management of upper respiratory tract infection in Dutch general practice. Br J Gen Pract 1991;41:504-7.

4. van Buchem L, Peeters M, Beaumont J, Knottnerus JA. Acute maxillary sinusitis in general practice: the relation between clinical picture and objective findings. Eur J Gen Pract 1995;1:155-60.

5. Hansen JC, Schmidt H, Rosborg J, Lund E. Predicting acute maxillary sinusitis in a general practice population. BMJ 1995;311:233-6.

6. Stalman W, Van Essen GA, Gubbels JW, De Melker RA. Difficulties in diagnosing acute sinusitis in a Dutch group practice. Relative value of history, radiography and ultrasound. Eur J Gen Pract 1997;3:12-5.

7. Hueston WJ, Mainous AG, Dacus EN, Hopper JE. Does acute bronchitis really exist? A reconceptualization of acute viral respiratory infections. J Fam Pract 2000;49:401-6.

8. Ferranti de SD, Ioannidis JPA, Lau J, Anninger WV, Barza M. Are amoxicillin and folate inhibitors as effective as other antibiotics for acute sinusitis? A meta-analysis. BMJ 1998;317:632-7.

9. Williams JW, Jr, Aguilar C, Makela M, et al. Antibiotic therapy for acute sinusitis: a systematic literature review. In: Douglas R, Bridges-Webb C, Glasziou P, Lozano J, Steinhoff M, Wang E, eds. Acute respiratory infections module of the Cochrane Database of Systematic Reviews. The Cochrane Library. Oxford, England: Updated Software; 1997.

10. Zucker DR, Balk E, Engels E, Barza M, Lau J. Agency for Health Care Policy and Research Publication No. 99-E016. Evidence report/technology assessment number 9. Diagnosis and treatment of acute bacterial rhinosinusitis. Available at www.ahrq.gov/clinic/sinussum.htm.

11. van Buchem FL, Knottnerus JA, Scrhrijnemaekers VJJ, Peeters MF. Primary-care-based randomised placebo-controlled trial of antibiotic treatment in acute maxillary sinusitis. Lancet 1997;349:683-7.

12. Lindbaek M, Hjortdahl P, Johnsen UL-H. Randomised, double blind, placebo controlled trial of penicillin V and amoxycillin in treatment of acute sinus infections in adults. BMJ 1996;313:325-9.

13. Hansen JG, Schmidt H, Grinsted P. Randomised, double blind, placebo controlled trial of penicillin V in the treatment of acute maxillary sinusitis in adults in general practice. Scand J Prim Health Care 2000;18:44-7.

14. Haye R, Lingaas E, Hoivik HO, Odegard T. Azithromycin versus placebo in acute infectious rhinitis with clinical symptoms but without radiological signs of maxillary sinusitis. Eur J Clin Microbiol Infect Dis 1998;17:309-12.

15. Kaiser L, Lew D, Hirschel B, et al. Effects of antibiotic treatment in the subset of common-cold patients who have bacteria in nasopharyngeal secretions. Lancet 1996;347:1507-10.

16. Stalman W, van Essen GA, van der Graaf Y, de Melker RA. The end of antibiotic treatment in adults with acute sinusitis-like complaints in general practice? A placebo-controlled double-blind randomized doxycycline trial. Br J Gen Pract 1997;47:794-9.

17. Axelsson A, Runze U. Symptoms and signs af acute maxillary sinusitis. ORL J Otorhinolaryngol Relat Spec 1976;38:298-308.

18. Berg O, Carenfelt C. Analysis of symptoms and clinical signs in the maxillary sinus empyema. Acta Otolaryngol (Stockholm) 1988;105:343-9.

19. Lindbaek M, Hjortdahl HR, Johnsen UL-H. Use of symptoms, signs and bloodtests to diagnose acute sinus infections in primary care: comparison with computed tomography. Fam Med 1996;28:181-6.

20. Van Duyn NP, Brouwer HJ, Lamberts H. Use of symptoms and signs to diagnose maxillary sinusitis in general practice: comparison with ultrasonography. BMJ 1992;305:684-7.

21. Williams JW, Simel DL, Leroy R, Samsa GP. Clinical evaluation for sinusitis. Making the diagnosis by history and physical examination. Ann Int Med 1992;117:705-10.

22. Axelsson A, Runze U. Comparison of subjective and radiological findings during the course of acute maxillary sinusitis. Ann Otol Rhinol Laryngol 1983;92:75-7.

23. Gonzales R, Barrett PH, Steiner JF. The relation between purulent manifestations and antibiotic treatment of upper respiratory tract infections. J Gen Intern Med 1999;14:151-6.

24. Little DR, Mann BL, Sherk DW. Factors influencing the clinical diagnosis of sinusitis. J Fam Pract 1998;46:147-52.

25. Mainous AG, Hueston WJ, Eberlein C. Colour of respiratory discharge and antibiotic use. Lancet 1997;350:1077.-

26. De Sutter AI, De Meyere MJ, De Maeseneer JM, Peersman WP. Antibiotic prescribing in acute infections of the nose or sinuses: a matter of personal habit? Fam Pract 2001;18:209-13.

27. Gray WC, Blanchard CL. Sinusitis and its complications. Am Fam Physician 1987;35:232-43.

28. Williams JW, Roberts L, Distell B, Simel DL. Diagnosing sinusitis by X-ray: is a single Waters view adequate? J Gen Intern Med 1992;7:481-5.

29. Piccirillo JF, Edwards D, Haiduk A, et al. Psychometric and clinimetric validity of the 31-item rhinosinusitis outcome measure (RSOM-31). Am J Rhinol 1995;9:297-306.

30. Bhattacharyya T, Piccirillo J, Wippold FJ, II. Relationships between patient-based descriptions of sinusitis and paranasal sinus computed tomographic findings. Arch Otolaryngol Head Neck Surg 1997;123:1189-92.

31. Altman DG. Practical statistics for medical research. London, England: Chapman & Hall; 1991;455-60.

32. De Meyere M. Acute keelpijn in de eerste lijn. [dissertatie]. 1990 Rijksuniversiteit Gent, Faculteit Geneeskunde.

33. Verheij TJM, Hermans J, Mulder JD. Effects of doxycycline in patients with acute cough and purulent sputum: a double blind placebo controlled trial. Br J Gen Pract 1994;44:400-4.

34. Burke P, Bain J, Robinson D, Dunleavy J. Acute red ear in children: controlled trial of non-antibiotic treatment in general practice. BMJ 1991;303:558-62.

35. Damoiseaux RAMJ, Balen van FAM, Hoes AW, Melker de RA. Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years. BMJ 2000;320:350-4.

36. Little P, Could C, Williamson I, Moore M, Warner G, Dunleavy J. Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media. BMJ 2001;322:336-42.

37. Little P, Williamson I, Warner G, Gould C, Gantley M, Kinmonth AL. Open randomised trial of prescribing strategies in managing sore throat. BMJ 1997;314:722-7.

38. Wilson S, Delaney BC, Roalfe A, et al. Randomised controlled trials in primary care: case study. BMJ 2000;321:24-7.

39. De Bock GH, Van Duijn NP, Dagnelie CF, et al. NHG-Standaard Sinusitis. Huisarts Wet 1993;36:255-7.

40. Low DE, Desrosiers M, McSherry J, et al. A practical guide for the diagnosis and treatment of acute sinusitis. CMAJ 1997;156(suppl 6):S1-14.

41. Snow V, Mottur-Pilson C, Hickner JM. Principle of appropriate antibiotic use for acute sinusitis in adults. Ann Intern Med 2001;134:495-7.

42. Pierard D, De Meyer A, Vanzeebroeck A, Lauwers S. In vitro evaluatie van de gevoeligheid van 205 recente klinische isolaten van streptococcus pneumoniae voor minocycline en andere antibiotica. Tijdschr Geneesk 1996;52:281-5.

Complete or partial follow-up data were obtained for 374 patients (90%) after 10 days (mean 10.3 days, standard deviation 1.44): 334 patients completed the questionnaire, 348 returned the diary, and 338 underwent a physical examination. In 265 (71%) patients, data (questionnaire, diary, and physical examination) were complete; in 109 (29%), data at day 10 were partly missing. The two treatment groups were very similar in terms of sex, age, duration of preinclusion complaints, and frequency of various physical signs and symptoms (Table 1).*

TABLE 1
BASELINE CHARACTERISTICS

General (placebo = 205, amoxicillin = 204)	Placebo	Amoxicillin
Mean age (SD)	39 (15)	37 (14)
Mean days of complaint before contact (SD	7.2 (5.5)	7.6 (5.4)
Women (%)	54	55
Mean Score on SNOT-20 (placebo = 196, amoxicillin = 192)	40.8 (SD 15.9)	38.4 (SD 16.1)
History (placebo = 196, amoxicillin = 192)
Generally ill to very ill (%)	46	53
Unilateral facial pain (%)	56	53
Pain on bending forward (%)	70	66
Pain in upper teeth or when chewing (%)	44	41
Examination (placebo = 209, amoxicillin = 207)
Sinus tenderness (%)	61	67
Pain on bending forward (%)	60	60
Postnasal discharge on throat inspection (%)	55	50
Purulent rhinorrhea on rhinoscopy (%)	47	40
Body temperature > 37°C (%)	38	41
SD denotes standard deviation; SNOT, Sino-Nasal Outcome Test.

FIGURE 1
PATIENTS’ PROGRESS THROUGH THE TRIAL

Primary Outcomes

Of the 374 patients with follow-up data on day 10, 334 completed the symptom questionnaire twice. Treatment was successful—defined as a score of 0 (absent) or 1 (very mildly present) for all symptoms that had been included as “the most important item affecting my health”—in 35% of patients in the amoxicillin group (59/170) and 29% in the placebo group (47/164) (Table 2). Relative risk of success was 1.14 (95% CI, 0.92-1.42, P = .24): more patients were cured in the amoxicillin group, but this difference was not statistically significant.

In 82 (19.7%) of the 416 randomized patients (37 amoxicillin, 45 placebo), data on this main outcome are missing. In 40 of these 82 patients, follow-up data are available from the diary (n = 38) or physical examination (n = 2). According to these data, in 13/17 of the amoxicillin group and 11/23 of the placebo group the outcome was favorable: in the diary, the patient reports feeling “well” again at day 10 or sooner, or on physical examination, all signs of respiratory infection have cleared). Eight patients withdrew for clinical exacerbation and 2 patients after full recovery. Adding the 50 patients with a known course of illness to those in the treatment and result groups does not alter the overall result (RR 1.20, 95% CI, 0.98-1.47, P = .08). Furthermore, when considering the 24 nonexcluded patients (13 amoxicillin, 11 placebo) with total lack of follow-up in their allocated treatment group, first as treatment failures (RR 1.18, 95% CI, 0.97-1.44, P = .11) and then as successes (1.20, 95% CI, 0.99-1.46, P = .07), the result also remains the same. Regarding the success rate from the complete diary data (n = 348) and the results of physical examinations (n = 338) (Table 3), we find no significant difference between treatment groups.

Duration of purulent rhinorrhea was significantly shorter in the amoxicillin group than in the placebo group (75% of patients were free of purulent rhinorrhea after 9 days versus after 14 days in the placebo group, log rank P = .007). There is no difference between treatment groups in the duration of general illness or pain (Figure 2).

TABLE 2
MAIN OUTCOME: RATE OF TREATMENT SUCCESS AT 10-DAY FOLLOW-UP

Outcome Measure	N*	Number with Successful Therapy (%)		Relative Risk of Success (95% CI)	p
		Amoxicillin	Placebo
Survey†	334	59/170 (35)	47/164 (28)	1.14 (0.92-1.42)	.24
Diary ‡	348	92/174 (52)	97/174 (55)	0.94 (0.77-1.16)	.59
Physical signs §	338	97/170 (57)	86/168 (51)	1.13 (0.91-1.40)	.28
All ║	384	73/189 (39)	59/195 (30)	1.2 (0.98-1.47)	.08
Sensitivity analysis^¶
Best case	408	86/202	70/206	1.2 (0.99-1.46)	.07
Worst case	408	73/202	59/206	1.18 (0.97-1.44)	.11
* Data on at least one of these outcome measures were obtained in 374 patients (90% of the total population).
† All symptoms indicated by the patients at inclusion as “most important item affecting my health” score 0 (absent) or 1 (very mildly present) on day 10.
‡ Patient states in diary that he or she feels generally “well” again on day 10 or sooner.
§ All physical signs have disappeared at day 10 (pain on bending, sinus tenderness, postnasal drip, purulent rhinorrhea on rhinoscopy, elevated body temperature).
║Incorporating all available information from the questionnaire, diary, physical examination, and dropouts.
Patients without data are considered, respectively, as treatment success (best case) or treatment failures (worst case).

TABLE 3
MEAN SYMPTOM CHANGE BETWEEN BASELINE AND 10-DAY FOLLOW-UP

	Mean Score Reduction
Symptom	Amoxicillin n = 170	Placebo n = 164	P *
Unilateral facial pain	1	1.1	.56
Pain on bending forward	1.21	1.32	.55
Pain in upper teeth or when chewing	0.7	0.93	.17
Need to blow nose	1.73	1.70	.85
Sneezing	1.13	1.05	.63
Runny nose	1.47	1.55	.33
Cough	1.0	1.11	.46
Thick nasal discharge	2.2	1.5	< .0001
Postnasal discharge	1.29	1.09	.26
Ear fullness	1.13	1.31	.32
Dizziness	0.95	0.87	.63
Ear pain	0.64	0.77	.36
Facial pain or pressure	1.54	1.61	.69
Difficulty falling asleep	1.14	1.26	.54
Wake up at night	1.39	1.44	.79
Lack of a good night’s sleep	1.24	1.44	.28
Wake up tired	1.34	1.65	.09
Fatigue	1.46	1.61	.38
Reduced productivity	1.45	1.63	.29
Reduced concentration	1.24	1.46	.19
Frustrated, restless, irritable	0.87	1.41	.91
Sad	0.38	0.52	.18
Embarrassed	0.36	0.76	.36
* Student’s t test.