Sublingual immunotherapy for allergic rhinitis

Suzana Radulovic; Moises A Calderon; Duncan Wilson; Stephen Durham

doi:10.1002/14651858.CD002893.pub2

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Figure 1

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

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Figure 2

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

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Figure 3

Funnel plot of comparison: 1 SLIT versus placebo ‐ all, outcome: 1.1 Allergic rhinitis symptom scores.

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Figure 4

Funnel plot of comparison: 1 SLIT versus placebo ‐ all, outcome: 1.2 Medication scores.

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Analysis 1.1

Comparison 1 SLIT versus placebo ‐ all, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 1.2

Comparison 1 SLIT versus placebo ‐ all, Outcome 2 Medication scores.

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Analysis 2.1

Comparison 2 SLIT versus placebo ‐ seasonal allergen, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 2.2

Comparison 2 SLIT versus placebo ‐ seasonal allergen, Outcome 2 Medication scores.

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Analysis 3.1

Comparison 3 SLIT versus placebo ‐ perennial allergen, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 3.2

Comparison 3 SLIT versus placebo ‐ perennial allergen, Outcome 2 Medication scores.

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Analysis 4.1

Comparison 4 SLIT versus placebo ‐ adults, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 4.2

Comparison 4 SLIT versus placebo ‐ adults, Outcome 2 Medication scores.

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Analysis 5.1

Comparison 5 SLIT versus placebo ‐ children, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 5.2

Comparison 5 SLIT versus placebo ‐ children, Outcome 2 Medication scores.

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Analysis 6.1

Comparison 6 SLIT versus placebo < 6 months, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 6.2

Comparison 6 SLIT versus placebo < 6 months, Outcome 2 Medication scores.

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Analysis 7.1

Comparison 7 SLIT versus placebo 6 to 12 months, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 7.2

Comparison 7 SLIT versus placebo 6 to 12 months, Outcome 2 Medication scores.

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Analysis 8.1

Comparison 8 SLIT versus placebo > 12 months, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 8.2

Comparison 8 SLIT versus placebo > 12 months, Outcome 2 Medication scores.

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Analysis 9.1

Comparison 9 Major allergen content < 5 mcg, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 9.2

Comparison 9 Major allergen content < 5 mcg, Outcome 2 Medication scores.

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Analysis 10.1

Comparison 10 Major allergen content 5 to 20 mcg, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 10.2

Comparison 10 Major allergen content 5 to 20 mcg, Outcome 2 Medication scores.

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Analysis 11.1

Comparison 11 Major allergen content > 20 mcg, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 11.2

Comparison 11 Major allergen content > 20 mcg, Outcome 2 Medication scores.

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Analysis 12.1

Comparison 12 SLIT versus placebo ‐ immunoglobulins, Outcome 1 IgE levels ‐ post‐treatment.

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Analysis 12.2

Comparison 12 SLIT versus placebo ‐ immunoglobulins, Outcome 2 IgG levels ‐ post‐treatment.

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Analysis 12.3

Comparison 12 SLIT versus placebo ‐ immunoglobulins, Outcome 3 IgG4 levels‐ post‐treatment.

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Analysis 13.1

Comparison 13 SLIT v placebo ‐ house dust mite, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 13.2

Comparison 13 SLIT v placebo ‐ house dust mite, Outcome 2 Medication scores.

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Analysis 14.1

Comparison 14 SLIT versus placebo ‐ grass pollen, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 14.2

Comparison 14 SLIT versus placebo ‐ grass pollen, Outcome 2 Medication scores.

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Analysis 15.1

Comparison 15 SLIT versus placebo ‐ ragweed, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 15.2

Comparison 15 SLIT versus placebo ‐ ragweed, Outcome 2 Medication scores.

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Analysis 16.1

Comparison 16 SLIT versus placebo ‐ Parietaria, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 16.2

Comparison 16 SLIT versus placebo ‐ Parietaria, Outcome 2 Medication scores.

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Analysis 17.1

Comparison 17 SLIT versus placebo ‐ tree, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 17.2

Comparison 17 SLIT versus placebo ‐ tree, Outcome 2 Medication scores.

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Analysis 18.1

Comparison 18 Allergen sensitivity, Outcome 1 Skin reactivity after treatment.

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Analysis 18.2

Comparison 18 Allergen sensitivity, Outcome 2 Nasal reactivity after treatment.

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Analysis 19.1

Comparison 19 Quality of life, Outcome 1 Adults.

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Analysis 20.1

Comparison 20 SLIT versus placebo ‐ tablets, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 20.2

Comparison 20 SLIT versus placebo ‐ tablets, Outcome 2 Medication scores.

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Analysis 21.1

Comparison 21 SLIT versus placebo ‐ drops, Outcome 1 Allergic rhinitis symptom scores.

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Analysis 21.2

Comparison 21 SLIT versus placebo ‐ drops, Outcome 2 Medication scores.

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Table 1. Adverse events: data not suitable for analysis

Study ID	Sublingual immunotherapy	Placebo	Additional comments
Study ID	N	N	Additional comments
Bowen 2004	43	40	Report by SOC
Casanovas 1994	9	6	Grading according to EAACI
Cao 2007	85	91	Insufficient data
Dahl 2006a	61	32	AE reported as percentage of patients
de Blay 2003	33	42	AE reported as percentage of patients
Di Rienzo 2006	19	15	Insufficient data
Drachenberg 2001	49	19	AE reported as difference between SLIT and placebo group (P values)
Dubakiene 2003	59	60	Insufficient data
Durham 2006			AE reported by severity
Feliziani 1995	18	16	Insufficient data
Guez 2000	36	36	Insufficient data
Hirsch 1997	15	15	Insufficient data
Hordijk 1998	27	30	AE reported SOC
Ippoliti 2003	47	39	Insufficient data
Lima 2002	28	28	Data reported in percentages
Malling 2005	36	11	Trial design Data reported in percentages
Marcucci 2005	13	11	Insufficient data
Mungan 1999	15	11	Insufficient data
Ott 2009	142	67	Insufficient data
Palma Carlos 2006	17	16	Insufficient data
Panzner 2008	20	15	Insufficient data
Passalacqua 1998	10	10	Insufficient data
Sanchez 2001	20	20	Insufficient data
Tari 1990	34	32	Insufficient data
Voltolini 2001	15	15	Insufficient data

Table 1. Adverse events: data not suitable for analysis

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Table 2. No adverse events reported

Study ID	Sublingual immunotherapy	Placebo
Study ID	N	N
Ariano 2001	10	10
Bahceciler 2001	8	7
D'Ambrosio 1999	14	16
Passalacqua 1998	15	15
Passalacqua 1999	15	15
Pradalier 1999	63	63

Table 2. No adverse events reported

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Table 3. Adverse events ‐ local reactions

Type of reaction	No of studies reported the event	Sublingual immunotherapy		Placebo
Type of reaction	No of studies reported the event	Total No of patients	Total No of events	Total No of patients	Total No of events
Labial oedema	11	604	55	536	7
Buccal pruritus	21	1126	1798	1075	492
Bucco‐ lingual oedema	8	648	143	606	2
Throat irritation	10	770	243	747	29
Oral ‐ non‐specified	3	68	143	71	24
Non‐specified	3	119	7	116	3

Table 3. Adverse events ‐ local reactions

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Table 4. Adverse events ‐ systemic reactions

Type of reaction	No of studies reported the event	Sublingual immunotherapy		Placebo
Type of reaction	No of studies reported the event	Total No of patients	Total No of events	Total No of patients	Total No of events
Urticaria	8	204	7	199	9
Pruritus/rash	10	363	13	222	9
Conjunctivitis	8	262	774	238	786
Rhinitis	16	965	1403	912	1034
Rhino‐conjunctivitis	6	184	60	176	58
Asthma/wheezing	15	488	51	450	42
Cough	8	337	313	304	211
Gastro‐intestinal	20	630	88	561	10
Headache	6	535	70	548	68
Anaphylaxis	6	291	0	288	0
Systemic ‐ non‐specified	5	330	4	36	0

Table 4. Adverse events ‐ systemic reactions

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Table 5. Adverse events leading to treatment discontinuation

Study ID	Sublingual immunotherapy			Placebo
Study ID	N	n	AE description	N	n	AE description
Andre 2003	53	4	Sublingual burning Oral pruritus, vomiting, headache Pruritus, lingual oedema, gastralgia, diarrhoea Asthma and gastralgia	53	1	Gastralgia
Dahl 2006b	316	5	Angioedema on the base of the tongue Inferior lip angioedema pharyngeal hyperemia, cough, mild dyspnoea Pharynx oedema, voice changes Swelling throat Angioedema of lips	318	0	Not applicable
Durham 2006	141	8	Not described	136	1	Not described
Khinchi 2004	23	3	Pain in fingers and visible veins Gastrointestinal complaints Itching in the mouth	24	1	Pain and weakness in both arms
La Rosa 1999	20	4	Not described	21	1	Not described
Lima 2002	28	1	Troublesome local side effects	28	0	Not applicable
Malling 2005	12	1	Sting and blisters in the mouth	11	1	Mouth itching
Pajno 2003	15	1	Systemic reaction (abdominal pain, shortness of breath, wheezing)	15	0	Not applicable
Pradalier 1999	63	2	Worsening symptoms Marked reactions	63	2	Worsening symptoms Marked reactions
Rolinck‐Werninghaus 2004	49	1	Acute asthma exacerbation needed hospitalisation	48	3	Not described
Smith 2004	44	7	4 patients with systemic but not life‐threatening AE	45	‐	Insufficient data
Tonnel 2004	15	1	Itching/burning of the mouth	17	1	Respiratory tract infection
Vervloet 2006	38	1	Gastric pain and vomiting	38	0	Not applicable
Vourdas 1998	33	1	Worsening of allergic disease	29	0	Not applicable
Voltolini 2001	15	1	Exacerbation of rhinitis and OAS	15	1	Dyspnoea

Table 5. Adverse events leading to treatment discontinuation

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Comparison 1. SLIT versus placebo ‐ all

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	49	4589	Std. Mean Difference (IV, Random, 95% CI)	‐0.49 [‐0.64, ‐0.34]

2 Medication scores Show forest plot	38	3379	Std. Mean Difference (IV, Random, 95% CI)	‐0.32 [‐0.43, ‐0.21]

Comparison 1. SLIT versus placebo ‐ all

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Comparison 2. SLIT versus placebo ‐ seasonal allergen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	39	4084	Std. Mean Difference (IV, Random, 95% CI)	‐0.34 [‐0.44, ‐0.25]

2 Medication scores Show forest plot	32	3014	Std. Mean Difference (IV, Random, 95% CI)	‐0.30 [‐0.41, ‐0.19]

Comparison 2. SLIT versus placebo ‐ seasonal allergen

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Comparison 3. SLIT versus placebo ‐ perennial allergen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	10	505	Std. Mean Difference (IV, Random, 95% CI)	‐0.93 [‐1.69, ‐0.17]

2 Medication scores Show forest plot	6	365	Std. Mean Difference (IV, Random, 95% CI)	‐0.43 [‐0.89, 0.02]

Comparison 3. SLIT versus placebo ‐ perennial allergen

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Comparison 4. SLIT versus placebo ‐ adults

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	34	3197	Std. Mean Difference (IV, Random, 95% CI)	‐0.44 [‐0.56, ‐0.31]

2 Medication scores Show forest plot	26	2235	Std. Mean Difference (IV, Random, 95% CI)	‐0.40 [‐0.53, ‐0.26]

Comparison 4. SLIT versus placebo ‐ adults

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Comparison 5. SLIT versus placebo ‐ children

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	15	1392	Std. Mean Difference (IV, Random, 95% CI)	‐0.52 [‐0.94, ‐0.10]

2 Medication scores Show forest plot	12	1144	Std. Mean Difference (IV, Random, 95% CI)	‐0.16 [‐0.32, 0.00]

Comparison 5. SLIT versus placebo ‐ children

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Comparison 6. SLIT versus placebo < 6 months

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	17	1772	Std. Mean Difference (IV, Random, 95% CI)	‐0.54 [‐0.86, ‐0.21]

2 Medication scores Show forest plot	15	1366	Std. Mean Difference (IV, Random, 95% CI)	‐0.32 [‐0.45, ‐0.18]

Comparison 6. SLIT versus placebo < 6 months

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Comparison 7. SLIT versus placebo 6 to 12 months

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	16	1736	Std. Mean Difference (IV, Random, 95% CI)	‐0.31 [‐0.46, ‐0.16]

2 Medication scores Show forest plot	13	1398	Std. Mean Difference (IV, Random, 95% CI)	‐0.31 [‐0.50, ‐0.12]

Comparison 7. SLIT versus placebo 6 to 12 months

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Comparison 8. SLIT versus placebo > 12 months

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	16	1089	Std. Mean Difference (IV, Random, 95% CI)	‐0.63 [‐0.92, ‐0.34]

2 Medication scores Show forest plot	10	615	Std. Mean Difference (IV, Random, 95% CI)	‐0.34 [‐0.64, ‐0.04]

Comparison 8. SLIT versus placebo > 12 months

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Comparison 9. Major allergen content < 5 mcg

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	8	275	Std. Mean Difference (IV, Random, 95% CI)	‐0.32 [‐0.69, 0.05]

2 Medication scores Show forest plot	6	219	Std. Mean Difference (IV, Random, 95% CI)	‐0.59 [‐0.94, ‐0.24]

Comparison 9. Major allergen content < 5 mcg

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Comparison 10. Major allergen content 5 to 20 mcg

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	12	1972	Std. Mean Difference (IV, Random, 95% CI)	‐0.34 [‐0.45, ‐0.24]

2 Medication scores Show forest plot	11	1940	Std. Mean Difference (IV, Random, 95% CI)	‐0.21 [‐0.35, ‐0.07]

Comparison 10. Major allergen content 5 to 20 mcg

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Comparison 11. Major allergen content > 20 mcg

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	12	1041	Std. Mean Difference (IV, Random, 95% CI)	‐0.33 [‐0.49, ‐0.17]

2 Medication scores Show forest plot	10	661	Std. Mean Difference (IV, Random, 95% CI)	‐0.22 [‐0.43, 0.00]

Comparison 11. Major allergen content > 20 mcg

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Comparison 12. SLIT versus placebo ‐ immunoglobulins

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 IgE levels ‐ post‐treatment Show forest plot	14	1334	Std. Mean Difference (IV, Random, 95% CI)	0.27 [‐0.01, 0.55]

2 IgG levels ‐ post‐treatment Show forest plot	3	590	Std. Mean Difference (IV, Random, 95% CI)	0.95 [0.78, 1.12]

3 IgG4 levels‐ post‐treatment Show forest plot	13	1187	Mean Difference (IV, Fixed, 95% CI)	0.46 [0.29, 0.63]

Comparison 12. SLIT versus placebo ‐ immunoglobulins

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Comparison 13. SLIT v placebo ‐ house dust mite

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	9	464	Std. Mean Difference (IV, Random, 95% CI)	‐0.97 [‐1.80, ‐0.13]

2 Medication scores Show forest plot	5	189	Std. Mean Difference (IV, Random, 95% CI)	‐0.52 [‐1.09, 0.05]

Comparison 13. SLIT v placebo ‐ house dust mite

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Comparison 14. SLIT versus placebo ‐ grass pollen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	23	3013	Std. Mean Difference (IV, Random, 95% CI)	‐0.35 [‐0.45, ‐0.24]

2 Medication scores Show forest plot	17	2308	Std. Mean Difference (IV, Random, 95% CI)	‐0.23 [‐0.37, ‐0.10]

Comparison 14. SLIT versus placebo ‐ grass pollen

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Comparison 15. SLIT versus placebo ‐ ragweed

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	2	175	Std. Mean Difference (IV, Random, 95% CI)	‐0.44 [‐0.74, ‐0.14]

2 Medication scores Show forest plot	2	175	Std. Mean Difference (IV, Random, 95% CI)	‐0.30 [‐0.60, ‐0.00]

Comparison 15. SLIT versus placebo ‐ ragweed

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Comparison 16. SLIT versus placebo ‐ Parietaria

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	5	151	Std. Mean Difference (IV, Random, 95% CI)	‐0.36 [‐0.69, ‐0.04]

2 Medication scores Show forest plot	5	151	Std. Mean Difference (IV, Random, 95% CI)	‐0.62 [‐1.00, ‐0.24]

Comparison 16. SLIT versus placebo ‐ Parietaria

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Comparison 17. SLIT versus placebo ‐ tree

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	9	380	Std. Mean Difference (IV, Random, 95% CI)	‐0.42 [‐0.77, ‐0.06]

2 Medication scores Show forest plot	9	380	Std. Mean Difference (IV, Random, 95% CI)	‐0.38 [‐0.62, ‐0.13]

Comparison 17. SLIT versus placebo ‐ tree

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Comparison 18. Allergen sensitivity

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Skin reactivity after treatment Show forest plot	6	331	Std. Mean Difference (IV, Random, 95% CI)	0.12 [‐0.26, 0.51]

2 Nasal reactivity after treatment Show forest plot	7	220	Std. Mean Difference (IV, Random, 95% CI)	0.32 [‐0.13, 0.78]

Comparison 18. Allergen sensitivity

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Comparison 19. Quality of life

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Adults Show forest plot	2	397	Mean Difference (IV, Fixed, 95% CI)	‐0.42 [‐0.73, ‐0.12]

Comparison 19. Quality of life

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Comparison 20. SLIT versus placebo ‐ tablets

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	11	1881	Mean Difference (IV, Fixed, 95% CI)	‐0.48 [‐0.58, ‐0.38]

2 Medication scores Show forest plot	9	1578	Mean Difference (IV, Fixed, 95% CI)	‐0.33 [‐0.46, ‐0.20]

Comparison 20. SLIT versus placebo ‐ tablets

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Comparison 21. SLIT versus placebo ‐ drops

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Allergic rhinitis symptom scores Show forest plot	35	2464	Mean Difference (IV, Fixed, 95% CI)	‐0.35 [‐0.42, ‐0.28]

2 Medication scores Show forest plot	27	1653	Mean Difference (IV, Fixed, 95% CI)	‐0.01 [‐0.05, 0.04]

Comparison 21. SLIT versus placebo ‐ drops

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