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Intervenciones quirúrgicas versus médicas para la rinosinusitis crónica con pólipos nasales

Appendices

Appendix 1. Search strategies

PubMed

EMBASE (Ovid)

CINAHL (EBSCO)

#1 "Nasal Polyps"[Mesh]
#2 "Polyps"[Mesh]
#3 polyp* [tiab]
#4 #2 OR #3
#5 "Nose"[Mesh
#6 nose* [tiab] OR nasal* [tiab] OR nasi [tiab] OR intranasal* [tiab] OR sinonasal* [tiab] OR paranasal* [tiab]
#7 #5 OR #6
#8 #4 AND #7
#9 #1 OR #8

1 Nose Polyp/
2 exp Polyp/
3 polyp*.tw.
4 3 or 2
5 exp Nose/
6 (nose* or nasal* or nasi or intranasal* or sinonasal* or paranasal*).tw
7 6 or 5
8 4 and 7
9 8 or 1

S1 (MH "Nasal Polyps")
S2 (MH "Polyps")
S3 TX polyp*
S4 (MH "Nose+")
S5 TX nose* OR nasal* OR nasi OR intranasal* OR sinonasal* OR paranasal*
S6 (S2 OR S3) AND (S4 OR S5)
S7 S1 OR S6

Web of Science (Web of Knowledge)

ICTRP

Clinicaltrials.gov

#1 TS=polyp*
#2 TS=(nose* OR nasal* OR nasi OR intranasal* OR sinonasal* OR paranasal*)
#3 #2 AND #1

nasal polyp

(nose or nasal) AND polyp

Process for sifting search results and selecting studies for inclusion.
Figuras y tablas -
Figure 1

Process for sifting search results and selecting studies for inclusion.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Endonasal surgery compared with medical treatment for chronic rhinosinusitis with nasal polyps

Patients: adults with chronic rhinosinusitis with nasal polyps, receiving concurrent topical steroids

Settings: otorhinolaryngology clinics and/or hospital departments

Intervention: endoscopic sinus surgery

Comparison: systemic steroids

Outcomes (at 12 months)

Illustrative comparative risk

Relative effect

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Patient‐reported disease‐specific symptom scores

  • Symptom score with scale of 0 to 3 (0 = no symptoms, 3 = severe symptoms)

N/A

  • Nasal obstruction: MD ‐0.30 (95% CI ‐0.6 to 0.0)

  • Nasal discharge: MD ‐0.2 (95% CI ‐0.5 to 0.1)

  • Sneezing: MD ‐0.2 (95% CI ‐0.5 to 0.1)

  • Loss of smell: MD ‐0.4 (95% CI ‐0.7 to ‐0.1)

95 (1 study)

⊕⊕⊝⊝
low1,2

Negative values indicate lower scores (less severe symptoms) in the surgical group. The range of values corresponds to effect sizes that are small to large (SMD 0.2 represents a small effect, 0.5 a moderate effect and 0.8 a large effect size):

  • Nasal obstruction: SMD ‐0.4 (95% CI ‐0.8 to 0.0)

  • Nasal discharge: SMD ‐0.3 (95% CI ‐0.7 to 0.1)

  • Sneezing: SMD ‐0.3 (95% CI ‐0.7 to 0.1)

  • Loss of smell: SMD ‐0.6 (95% CI ‐1.0 to ‐0.2)

Health‐related quality of life scores, measured by SF‐36 (range 0 to 100)

N/A

  • PCS: MD ‐1.4 (95% CI ‐5.0 to 2.2)

  • MCS: MD 0.6 (95% CI ‐2.9 to 4.1)

95 (1 study)

⊕⊕⊝⊝
low1

These effect sizes are negligible and correspond to a SMD of ‐0.15 and 0.07 respectively (a SMD of 0.2 corresponds to a small effect size)

Endoscopic appearances

  • 0 to 3 (0 = no polyps, 3 = severe polyposis)

N/A

MD ‐1.5 (95% CI ‐1.2 to ‐1.8)

95 (1 study)

⊕⊕⊝⊝
low1,2

Negative values indicate lower scores (less severe polyposis) in the surgical group. The SMD is ‐2.2 (95% CI ‐2.7 to ‐1.7), which corresponds to a large effect size

Complications

N/A

Epistaxis: 3.6%

Orbital: 7.1%

Intracranial: 1.8%

95 (1 study)

⊕⊝⊝⊝
very low1

Orbital complications: orbital fat exposed

Intracranial complications: CSF leak with meningitis

Objective physiological measures

N/A

Not reported

Other comparison pairs did not show an important difference

Olfactory tests

N/A

Not reported

Other comparison pairs did not show an important difference

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

CI: confidence interval; CSF: cerebrospinal fluid; MCS: mental component score; MD: mean difference; N/A: not applicable; PCS: physical component score; SMD: standardised mean difference

1Downgraded twice due to limitations in the study design (unclear randomisation, non‐blinded outcome assessment), and some concerns about imprecision (small sample sizes) and indirectness of evidence (the medical treatment regimes used in the study differ from current standards). Additional downgrading for imprecision and lack of comparative data for the complications outcome.
2Not reported whether scales were validated, sensitive or reliable.

Figuras y tablas -
Table 1. Health‐related quality of life instruments for rhinosinusitis

Instrument

Details

Rhinosinusitis Outcome Measure (RSOM‐31) (Piccirillo 1995)

31 items in 7 domains: nasal, eye, ear, sleep, general, practical and emotional problems. 2 rating scales: magnitude and importance of each item. Each item is measured on a 0 to 10 cm visual analogue scale (VAS). The minimal important difference (MID) is greater than 1. Time‐consuming and complex scoring system

20‐item Sino‐Nasal Outcome Test (SNOT‐20) (Piccirillo 2002)

20‐item modification of RSOM‐31, in 5 domains. Patients rate the magnitude of each item and the 5 most important items. Each item is rated on a 6‐point scale (0 = no problem, 5 = most serious problem) (range 0 to 100). Complex scoring system because of weighting for important symptoms. Excludes nasal blockage and anosmia

22‐item Sino‐Nasal Outcome Test (SNOT‐22) (Hopkins 2009)

Modification of SNOT‐20 including nasal blockage and anosmia. Patients rate the magnitude of each item. Each item is rated on a 6‐point scale (0 = no problem, 5 = most serious problem) (range 0 to 110). Excludes weighting for most important symptoms. The minimal important difference (MID) is greater than 8.9

Figuras y tablas -
Table 1. Health‐related quality of life instruments for rhinosinusitis
Table 2. Interventions

Study

Surgical treatment

Medical treatment

Comparison description

Alobid 2005

GA endoscopic sinus surgery (variable extent) then topical budesonide 400 µg bd for 1 year

Oral prednisolone for 14 days (30 mg od 4 days then reduced by 5 mg every 2 days) then topical budesonide 400 µg bd for 1 year

Endoscopic sinus surgery versus systemic steroids

Lildholdt 1988

LA polypectomy then topical beclomethasone dipropionate 100 µg bd for 1 year

14 mg im betamethasone then topical beclomethasone dipropionate 100 µg bd for 1 year

Polypectomy versus systemic steroids

Lildholdt 1997

LA snare polypectomy then topical budesonide 400 µg or 800 µg od for 11 months

14mg im betamethasone then topical budesonide 400 µg or 800 µg od for 11 months

Polypectomy versus systemic steroids

Ragab 2004

GA endoscopic sinus surgery (variable extent) then antibiotics for 2 weeks plus topical fluticasone propionate spray 100 µg bd for 12 weeks, then "tailored treatment"

Antibiotics plus topical fluticasone propionate drops 400 µg bd for 12 weeks, then "tailored treatment"

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

bd: twice daily
GA: general anaesthesia
im: intramuscular
LA: local anaesthesia
od: once daily

Figuras y tablas -
Table 2. Interventions
Table 3. Primary outcomes ‐ nasal symptom scores

Study

Intervention/comparison

Outcome measure

(scale)

Timing

Outcome

Alobid 2005

Endoscopic sinus surgery versus systemic steroids

Nasal obstruction (0 to 3)

12 months

MD ‐0.3 (95% CI ‐0.6 to 0.0); standardised mean difference (SMD) ‐0.4 (95% CI ‐0.8 to 0.0) (negative values indicate lower scores (less severe symptoms) in the surgical group)

Alobid 2005

Endoscopic sinus surgery versus systemic steroids

Rhinorrhoea/nasal discharge (0 to 3)

12 months

MD ‐0.2 (95% CI ‐0.5 to 0.1); SMD ‐0.3 (95% CI ‐0.7 to 0.1) (negative values indicate lower scores (less severe symptoms) in the surgical group)

Alobid 2005

Endoscopic sinus surgery versus systemic steroids

Sneezing (0 to 3)

12 months

MD ‐0.2 (95% CI ‐0.5 to 0.1); SMD ‐0.3 (95% CI ‐0.7 to 0.1) (negative values indicate lower scores (less severe symptoms) in the surgical group)

Alobid 2005

Endoscopic sinus surgery versus systemic steroids

Loss of smell (0 to 3)

12 months

MD ‐0.4 (95% CI ‐0.7 to ‐0.1); SMD ‐0.6 (95% CI ‐1.0 to ‐0.2) (negative values indicate lower scores (less severe symptoms) in the surgical group)

Lildholdt 1988

Polypectomy versus systemic steroids

Sense of smell (not known)

12 months

Improved with medical and surgical treatment (P value > 0.05); no statistical difference between groups (exact data not given)

Lildholdt 1997

Polypectomy versus systemic steroids

Nasal obstruction (0 to 3)

12 months

Improved with medical and surgical treatment (P value > 0.05); no statistical difference between groups (exact data not given)

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

Nasal obstruction

Nasal discharge

Facial pain/pressure

Headache

Overall discomfort

(VAS 0 to 10 for each)

12 months

Improved with medical treatment (61.2% change from baseline (SD = 19.1), P value < 0.01) and surgical treatment (54.7% change from baseline (SD = 27.3), P value < 0.01); no statistical difference between groups (data not given separately)

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

Olfactory disturbance

12 months

Improved with medical and surgical treatment (P value < 0.05); no statistical difference between groups (exact data not given)

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

SNOT‐20

12 months

Improved with medical and surgical treatment (P value < 0.01); no statistical difference between groups (exact data not given)

CI: confidence interval
MD: mean difference
SD: standard deviation
SNOT‐20: Sino‐Nasal Outcome Test‐20
VAS: visual analogue scale

Figuras y tablas -
Table 3. Primary outcomes ‐ nasal symptom scores
Table 4. Primary outcomes ‐ quality of life scores

Study

Intervention/comparison

Outcome measure

Timing

Outcome

Alobid 2005

Endoscopic sinus surgery versus systemic steroids

SF‐36 (0 to 100 each domain)

12 months

The MD was ‐1.4 (95% CI ‐5.0 to 2.2) for the physical component summary score, and 0.6 (95% CI ‐2.9 to 4.1) for the mental component scores. Effect sizes are negligible and correspond to a SMD of 0.07 and ‐0.15 respectively (a SMD of 0.2 corresponds to a small effect size)

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

SF‐36 (0 to 100 each domain)

12 months

Improved with surgical and medical treatment (P value < 0.01), except physical domain (P value > 0.05); no statistical difference between groups (exact data not given)

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

SNOT‐20

12 months

Actual results not reported; only stated that there were no statistically significant differences between groups

CI: confidence interval
MD: mean difference
SF‐36: Short Form‐36 Health Survey
SMD: standardised mean difference

Figuras y tablas -
Table 4. Primary outcomes ‐ quality of life scores
Table 5. Secondary outcomes ‐ endoscopic appearances

Study

Intervention/comparison

Outcome measure

Timing

Outcome

Alobid 2005

Endoscopic sinus surgery versus systemic steroids

Polyp size score (0 to 3)

12 months

Polyp size scores improved significantly in both groups at 12 months, and were significantly better in the endoscopic sinus surgery group (P value < 0.05): MD ‐1.5 (95% CI ‐1.8 to ‐1.2, n = 95). This corresponds to a large effect size

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

Endoscopic score (0 to 3)

12 months

Polyp size scores improved significantly in both groups at 12 months, but there was no important difference between groups (P value > 0.05): MD ‐2.3% (95% CI ‐17.4 to 12.8, n = 34)

CI: confidence interval
MD: mean difference
SD: standard deviation

Figuras y tablas -
Table 5. Secondary outcomes ‐ endoscopic appearances
Table 6. Secondary outcomes ‐ complications

Study

Intervention/comparison

Outcome measure

Timing

Outcome

Alobid 2005

Endoscopic sinus surgery versus systemic steroids

Epistaxis (nosebleed)

12 months

3.6% (endoscopic sinus surgery)

Lildholdt 1988

Polypectomy versus systemic steroids

Epistaxis

12 months

"1 patient failed the study because of bleeding" (no further information)

Lildholdt 1997

Polypectomy versus systemic steroids

Epistaxis

12 months

21% (all patients were on medical treatment throughout; polypectomy versus systemic steroids comparison not reported separately)

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

Epistaxis

12 months

2.2% (endoscopic sinus surgery plus topical steroid) versus 4.4% (antibiotics plus high‐dose topical steroid)

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

Infection

12 months

4.4% (endoscopic sinus surgery plus topical steroid)

Alobid 2005

Endoscopic sinus surgery versus systemic steroids

Orbital complications

12 months

7.1% (endoscopic sinus surgery ‐ exposure of orbital fat)

Alobid 2005

Endoscopic sinus surgery versus systemic steroids

Intracranial complications

12 months

1.8% (endoscopic sinus surgery ‐ CSF leak with meningitis)

CSF: cerebrospinal fluid

Figuras y tablas -
Table 6. Secondary outcomes ‐ complications
Table 7. Secondary outcomes ‐ objective physiological measures

Study

Intervention/comparison

Outcome measure

Timing

Outcome

Lildholdt 1988

Polypectomy versus systemic steroids

Nasal expiratory peak flow

12 months

Improved with surgical and medical treatment; no statistical difference between groups (P value > 0.05) (exact data not given)

Lildholdt 1997

Polypectomy versus systemic steroids

Peak expiratory flow rate index

12 months

Improved in all groups; no statistical difference between groups (surgical versus medical groups not reported separately, no exact data given)

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

Total nasal volume

12 months

Improved with surgical (58.8% change from baseline, SD = 40) and medical treatment (50.3% change from baseline, SD = 50.7), P value < 0.01; no statistical difference between groups although medical group tended towards greater improvement (P value > 0.05)

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

Nasal cross‐sectional area

12 months

No statistical difference between groups (P value > 0.05, Mann Whitney‐U test, not normally distributed data, median not reported)

Ragab 2004

Endoscopic sinus surgery plus topical steroid versus antibiotics plus high‐dose topical steroid

Nasal nitric oxide levels

12 months

No statistical difference between groups (P value > 0.05, Mann Whitney‐U test, not normally distributed data, median not reported)

SD: standard deviation

Figuras y tablas -
Table 7. Secondary outcomes ‐ objective physiological measures
Table 8. Secondary outcomes ‐ olfactory tests

Study

Intervention/comparison

Outcome measure

Timing

Outcome

Lildholdt 1988

Polypectomy versus systemic steroids

Proportion of patients "expressing intact smell"

2 to 12 months

No important difference between groups: risk ratio 0.96 (95% CI 0.71 to 1.31, n = 53)

Lildholdt 1997

Polypectomy versus systemic steroids

Semi‐quantitative smell test

12 months

No statistical difference between any treatment groups

(surgical versus medical groups not reported separately, exact data not given)

Figuras y tablas -
Table 8. Secondary outcomes ‐ olfactory tests