Basic characteristics of the included studies
| First author (year), country | Mean age (range) | Duration of disease (range) | Sample size (male/female) | Unilateral/bilateral | Experimental intervention (regimen) | Control intervention (regimen) | Outcome measure | Adverse effects |
|---|---|---|---|---|---|---|---|---|
| Chen (2013), China22 | (A) 39.7±6.0 (6–60) (B) 37.2±6.2 (7–58) | (A) 31.2±9.2 months (8–42 weeks) (B) 29.8±9.6 months (8–39 weeks) | (A) 30 (16/14) (B) 30 (13/17) | (A) 17/13 (B) 21/9 | (A) HM (Tongqiao huoxue decoction) 150 mL once a day for 14 days plus (B) | (B) 1% Ephedrine hydrochloride and nitrofurazone nasal drops 2 times a day, roxithromycin 150 mg 2 times a day plus prednisone 30 mg once a day for 14 days (PRN) Glucocorticoid and chymotrypsin injection | Clinical symptoms evaluation | n.r. |
| Guo (2004), China23 | (A) 38.2 (6–54) (B) 42.4 (8–67) | (A) n.r. (1 week–2 years) (B) n.r. (1 week–2 years) | (A) 53 (26/27) (B) 42 (20/22) | (A) 44/9 (B) 36/6 | (A) HM (Biyan Qingdu granule) 20 g each time 2 times a day plus (B) for 2 weeks | (B) Ambroxol hydrochloride 30 mg each time 3 times a day for 2 weeks | Clinical symptoms evaluation | n.r. |
| He (2013), China24 | (A) n.r (10–72) (B) n.r (9–70) | (A) n.r. (B) n.r. | (A) 55 (27/28) (B) 55 (38/17) | (A) 46/9 (B) 43/12 | (A) HM (Tongqiao huoxue decoction) 500 mL divided into 3, 3 times a day for 14 days (half dose for those younger than 14 years) | (B) Roxithromycin 0.15 g 2 times a day (5 mg/kg for kids) plus prednisolone acetate 20 mg once a day for 14 days | Clinical symptoms evaluation | n.r. |
| Hu (2000), China25 | (A) 45 (19–61) (B) 38 (16–68) (C) 43 (16–70) | (A) n.r. (6 months–15 years) (B) n.r. (3 months–12 years) (C) n.r. (4 months–15 years) | (A) 40 (22/18) (B) 34 (14/20) (C) 36 (14/22) | (A) 27/13 (B) 25/9 (C) 26/10 | (A) HM 2 times a day for 2–4 weeks (C) (A) plus (B) | (B) Ear inflation treatment once per 3 days for 15 days plus chymotrypsin 1 mg injection once a week for 2–4 weeks | Clinical symptoms evaluation | n.r. |
| Jiang (2013), China26 | (A) 35.15±12.7 (12–50) (B) 33.49±11.8 (12–50) | (A) n.r. (>8 weeks) (B) n.r. (>8 weeks) | (A) 30 (17/13) (B) 30 (15/15) | (A) 14/16 (B) 12/18 | (A) HM (Shenling baizhu powder) 9 g 3 times a day for 15 days | (B) Cefetamet pivoxil hydrochloride dispersible tablets 500 mg 2 times a day plus ambroxol hydrochloride tablets 60 mg 3 times a day for 15 days | Clinical symptoms evaluation | n.r. |
| Li (2014), China27 | (A) 32.2±1.4 (8–56) (B) 33.2±1.3 (8–57) | (A) 5.6±2.1 months (5 days–9 months) (B) 5.3±2.2 months (5 days–9 months) | (A) 60 (34/26) (B) 60 (29/31) | (A) n.r./n.r. (B) n.r./n.r. | (A) HM 100 mL 2 times a day plus (B) for 14 days | (B) Roxithromycin 150 mg 2 times a day plus prednisone 10 mg 3 times a day plus triamcinolone acetonide 20 mg injection for 14 days | Clinical symptoms evaluation | n.r. |
| Liao (1998), China28 | (A) 35.7 (6–59) (B) 32.5 (6–59) | (A) 4.3 months (2 weeks–2 years) (B) 4.2 months (2 weeks–2 years) | (A) 52 (24/28) (B) 44 (20/24) | (A) 40/12 (B) 38/6 | (A) HM (Tongqiao tablets) 2 g 3 times a day for 4 weeks | (B) Amoxicillin 0.25 g 4 times a day plus terfenadine 60 mg, 2 times a day for 4 weeks | Clinical symptoms evaluation, AE | none |
| Liu (2005), China29 | (A) 37.40±11.73 (15–60) (B) 38.85±11.33 (25–65) | (A) 14.40±6.57 days (B) 18.10±6.14 days | (A) 20 (14/6) (B) 20 (15/5) | (A) 13/7 (B) 15/5 | (A) HM 2 times a day plus (B) for 14 days | (B) 1% ephedrine hydrochloride nasal drops, 2 drops 3 times a day plus cefradine 0.5 g/kg 4 times a day for 14 days | Clinical symptoms evaluation, AE | none |
| Liu (2014), China30 | (A) 37.2±8.3 (12–62) (B) 36.9±8.1 (11–60) | (A) n.r. (2–40 days) (B) n.r. (3–37 days) | (A) 54 (28/26) (B) 54 (29/25) | (A) 46/8 (B) 43/11 | (A) HM 2 times a day for 21 days | (B) Cephradine 0.75 mg 3 times a day, plus prednisone 5 mg and mucosolvan 10 mL 2 times a day for 21 days | Clinical symptoms evaluation, AE | (A) Headache and dizziness (1) (B) Headache and dizziness (2), nausea and vomiting (2), xerostomia (1) |
| Lu, (2013) China31 | (A) n.r. (18–60) (B) n.r. (18–60) | (A) n.r. (2–24 weeks) (B) n.r, (2–24 weeks) | (A) 30 (B) 30 | (A) 20/10 (B) 23/7 | (A) HM 150 mL 2 times a day for 14 days plus (B) | (B) Cephradine 0.25 g 3 times a day plus mucosolvan 30 mL 3 times a day for 14 days (PRN) chymotrypsin 4000 U and prednisolone acetate injection 0.5 mL once a week | Clinical symptoms evaluation | n.r. |
| Qu (2013), China32 | (A) 30.3 (16–70) (B) 33.7 (18–72) | (A) 2.9 months (7 days–14 weeks) (B) 2.5 months (2 days–12 weeks) | (A) 85 (51/34) (B) 85 (53/32) | (A) 71/14 (B) 74/11 | (A) HM 150 mL 3 times a day plus (B) for 14 days | (B) Roxithromycin 150 mg 2 times a day for 14 days plus triamcinolone acetonide 40 mg plus chymotrypsin 4000 U injection once a week | Clinical symptoms evaluation | n.r. |
| Sato (1988), Japan38 | (A) 5.2±0.9 (4–7) (B) 5.0±0.9 (4–7) | (A) 7.7±6.2 months (0–24 months) (B) 8.9±7.4 months (0–24 months) | (A) 21 (12/9) (B) 21 (16/5) | (A) 10/11 (B) 10/11 | (A) HM (Tsumura-Saireito) 1.5 g 2 times a day for 4 weeks | (B) Cepharanthin 5–7.5 mg 2 times a day for 4 weeks | Clinical symptoms evaluation, pure tone audiometry, tympanometry, AE | none |
| Shi (2005), China33 | (A) 30.13 (6–71) (B) 29.51 (7–69) | (A) n.r. (1 day–18 years) (B) n.r. (1 day–16 years) | (A) 860 (540/320) (B) 810 (520/290) | (A) 770/90 (B) 730/80 | (A) HM (Huanglong tonger pill) 10 g 2 times a day plus (B) | (B) Roxithromycin 150 mg 2 times a day and prednisone 10 mg 3 times a day for 3 days plus 1% ephedrine hydrochloride and nitrofurazone nasal drops 3 times a day plus tympanic inflation once per 2 days plus auripuncture | Clinical symptoms evaluation | n.r. |
| Sun (2005), China34 | (A) 34.4±14.6 (5.9–68) (B) 27.9±17.0 (4–64) | (A) 81.96±124.64 days (1–730 days) (B) 130.12±157.25 days (1–730 days) | (A) 45 (23/22) (B) 45 (26/19) | (A) n.r./n.r. (B) n.r./n.r. | (A) HM (Qingqiao capsule) 5 capsules 3 times a day for 10–14 days(adjust dosage according to age) | (B) Cefaclor capsule 0.5 g for adults per each time (20 mg/kg per day for child), 3 times a day for 10–14 days | Clinical symptoms evaluation, pure tone audiometry, AE | (A) No AE (B) Nausea, vomiting and diarrhoea (1), urticaria (1) |
| Tian (2014), China35 | (A) 42.48±11.90 (21–65) (B) 43.21±12.21 (22–67) | (A) 7.71±2.59 months (3–12 months) (B) 7.73±2.38 months (4–12 months) | (A) 34 (20/14) (B) 33 (17/16) | (A) 26/8 (B) 24/9 | (A) HM (Shenling baizhu powder) 9 g 3 times a day for 21 days plus (B) | (B) Povidone iodine disinfection, plus 2% tetracaine 1 mL injection, plus mucosolvan 15 mg and dexamethasone 5 mg injection for 21 days | Clinical symptoms evaluation | n.r. |
| Zhang (2013), China36 | (A) n.r. (1–5) (B) n.r. (1–5) | (A) n.r. (≤2 weeks) (B) n.r. (≤2 weeks) | (A) 32 (B) 31 | (A) 24/8 (B) 23/8 | (A) HM (Erzhang decoction) 150 mL 2 times a day plus (B) for 7 days | (B) Clarithromycin 0.25 g 2 times a day plus chymotrypsin 4000 U plus triamcinolone acetonide injection once a week plus for 7 days | Clinical symptoms evaluation | n.r. |
| Zhao (2012), China37 | (A) 30.67 (7–70) (B) 30.34 (8–68) | (A) n.r. (1 day–16 years) (B) n.r. (1 day–15 years) | (A) 100 (55/45) (B) 100 (58/42) | (A) 31/69 (B) 37/63 | (A) HM (Huanglong tonger pill) 2 times a day plus (B) for 10 days | (B) Roxithromycin 150 mg 2 times a day for 10 days plus prednisone 10 mg 3 times a day for 10 days plus tympanic inflation once per 2 days plus auripuncture | Clinical symptoms evaluation | n.r. |
AE, adverse event; HM, herbal medicine; n.r., not reported; PRN, pro re nata.
(A), Experimental intervention; (B), Control intervention; (C), Combination of experimental and control intervention.