| Macchi A. et al. [13] |
Prospective, open label, rnd, controlled, parallel group |
46 patients: SH group (23); Control group (23) |
SH group (37); Control group (40) |
Patients affected by chronic sinusitis undergoing FESS |
Eligible patients started aerosol therapy with nasal washes. Intermittent treatment was administered twice daily for 15 consecutive days per month, for three consecutive months. The patients in the SH group receive 9 mg vial of sodium hyaluronate plus 3 ml saline, or 6 ml saline alone (control group). |
Endoscopic evaluations: (1) improvment of endoscopic parameters (opening of paranasal sinuses, oedema, respiratory patency, sinechiae; (2) appearence of mucosa (3) appearence of nasal secretions. Cytology:(1) ciliary motility (2) neutrophils (3) eosinophils (4) mast cells (5)bacteria (6) mycetes |
Intermittent treatment with SH solution was associated with significant improvements in terms of endoscopic appearance (reduction of nasal edema, crusting and secretions). Nasal secretions in control group were more catarrhal, purulent or hematic than in the SH group. Significant differences which favoured SH group, were observed for ciliary motility and presence of mycetes. |
|
| Casale M, et al [14] |
Prospective,open label, rnd, controlled, parallel group |
57 Patients: SH group(22) Control group (35) |
SH group (42) Control group (48) |
Patients affected by chronic inferior turbinate hypertrophy undergoing radiofrequency for turbinate volume reduction (RFTVR) |
SH group received SH (3 ml of SH is dissolved in 2 ml of isotonic solution) twice a day through Rinowash. Ccntrol group received standard saline nasal irrigation twice a day. The treatment in both groups was applied from the 1st postoperative day and continued during 14 days. |
Nasal subjective symptoms were graded using a VAS. Endoscopic nasal score
|
Mean VAS score of the SH group at week 1 was significantly lower than control group. VAS score remained significantly lower in SH group also at week 2, becoming similar to the control group at week 4. SH group showed lower endoseopic nasal scores (statistically significant in the first 2 weeks) than control group, especially for crusts. |
|
| Gelardi M. et al [15] |
Prospective,blinded, rnd, controlled, parallel group |
36 patients: SH group(19); Control group (17) |
SH group (47); Control group(47) |
Patients affected by grade II nasal polyposis undergoing FESS. |
SH group was treated with SH (9mg nebulized in 3mL sodium chloride 0.9%) twice a day. Control group was treated with 5mL sodium chloride 0.9% twice a day. After surgery patients were treated for 30 days starting on the second day after surgery. |
Clinical outcomes: burning, dryness, nasal obstruction, rhinorrhea. Endoscopic outcome: exudate. Functional outcome: t MCT time to mucous ciliary clearance. |
|
|
| Cantone E. et al [16] |
Prospective,double blind, rnd, controlled, parallel group |
122 Patients: SH group (62); Control group (60) |
SH group (41); Control group (42) |
Patients affected by grade II nasal polyposis undergoing to FESS |
SH group was treated with intranasal administration of 9mg SH nebulized in 2 ml sodium chloride 0,9%. Control group was treated with 5 mL sodium chloride 0.9% alone. In both groups, treatments were administered twice a day for 30 consecutive days starting on the first day after surgery. |
The following test were used for the assessment of QoL in CRS patients: Short Form-36 (SF-36) test, Sino-Nasal Outcome Test-22 (SNOT-22),Visual Analogue Scale (VAS). Endoscopic score. |
After postoperative treatment, the endoscopic score, the total VAS score, the mean SNOT-22 sum score, and SF-36 results were better in SH group than in control group. |
|
| Soldati D. et al.[17] |
Prospective,open label, rnd, controlled, parallel group |
56 Patients: SH group (27); Control group (29) |
SH (33); Ccontrol group (33) |
56 patients undergoing FESS |
The patients were recruited 2 days after surgery. The patients in both group were instructed to apply the product in a sufficient amount on the nasal mucosa and to make it penetratethe wings of the nose by gently massage. SH group was treated with SH creamgroup (hyaluronic acid in the form of 0,2% nasal cream Rhinogen) while control group was treated with (nasal ointment H.E.C). The apllication were repeated 3–4 times a day during the whole duration of the study period (42 days). |
Mucosa dryness, crusting, presence of blood crusts and lesion of nasal mucosa were assessed by the investigators; mucosa dryness, crusting, nasal breathing, tolerability and organoleptic parameters were assessed by the patients. |
With regard to nasal breathing patiens in the SH cream group showed a faster and greater improvement than those in the control group. Furthermore, SH cream prevented extensive crust formation during the first week of wound healing. The analysis of efficacy, showed the overall superiority of Rhinogen after 6 weeks of treatment. Furthermore, SH cream scored significantly better than nasal ointment H.E.C. with respect to the organoleptic parameters (smelling and sensation of cooling). |
Neither adverse reactions were reported nor observed for Rhinogen, whereas three patients in the H.E.C. -treated group complained of sore throat and burning sensation when the ointment flowed down into the pharynx. |
| Gouteva I. et al.[18] |
Prospective, observational parallel group |
49 pts divided in SH group (27) and in control group (22) |
mean age of the total population was 33.12 ±11.0. |
49 patients affected bychronic rhinosinusitis undergoing to FESS |
The control group received customary conditioning preparations that were not documented. The nasal spray group received Hysan Pflegespray, a solution containing 0.25mg/mL SH, 2% dexpanthenol. One to two puffs of nasal spray to each nostril were to be administered three times, distributed evenly throughout the day. In both group, treatments were administered for 6 weeks after surgery in the nasal cavity. |
Rhino/Endoscopic mucosal findings. (nasal dryness, dried nasalmucus, fibrin deposition, and development of obstructions); Patient evaluation of nasal breathing and foreign body sensation. pre- and pos-toperative. Rhinomanometry (8th–10th Post-operative Day). |
Regarding all RSS parameters, mucosal regeneration achieved good final results in both groups, tending to a better improvement through the spray application, without statistically significant differences during the whole assessment period. No statistically significant benefit was identified for nasal breathing, foreign body sensation, and average rhinomanometric volume flow, which improved by 12.31% (control group) and 11.24% (nasal spray group). |
|
| Macchi A. et al. [19] |
Prospective, open label, rnd, controlled, parallel group |
75 Patients: SH group (38); Control group (37) |
SH group (6); Control group (7) |
Recurrent upper respiratory tract infections |
Selected patients started aerosol therapy with nasal washes. Intermittent treatment was administered twice daily for 15 consecutive days per month, for three consecutive months. Patients in SH group received 9 mg vial of sodium hyaluronate plus 3 ml of saline solution, while patients in control group were only treated with 6 ml of saline solution. |
Dichotomic variables: (1) rhinitis (2) post nasal drip (3) nasal dysponea (4) mycetes (5) biofilm. Quantitative variables: (1) ciliary motility (2) adenoid hypertrophy (3) presence of bacteria (4) neutrophils (5) eosinophils (6) Mast cells |
Treatment with SH was associated with significant improvements compared to saline solution alone for rhinitis, nasal dyspnoea and biofilm. The results showed significant differences which favoured SH group for ciliary motility, adenoid hypertrophy, presence of bacteria and neutrophilis. |
|
| Di Cicco M et al.[20] |
Prospective, double blind, rnd, controlled, parallel group |
27 Patients: SH group (14); Control group(13) |
SH + tobramycin group (16); SH group (15) |
Patients affetced by cystic fibrosis and nasal infection (pseudomonas aeruginosa and/or staphylococcus aureus) |
The test nasal spray formulation consisted of a 10-mL aqueous solution containing 0.2% SH and 3% tobramycin sulphate. Control nasal spray formulation was identical in presentation but contained only 0.2% SH. Each patient nebulized 100 μL of the assigned product into each nostril 3 times a day for 14 days. |
Endoscopic evaluation (eutrophic, hyperemic, dystrophic nasal mucosa, mucopurulent secretion, hypertrophy of the left and right turbinate). Symptoms of nasal obstruction (mucopurulent rhinorrhea, hyposmia, /anosmia, snoring, headache, /facial pain). Positive pseudomonas aeruginosa and positive staphylococcus aureus (sputum, nasal swab). |
Combination of SH and tobramycin reduced hyposmia/anosmia, headache/facial pain, and nasal mucopurulent secretion, and improved the status of the nasal mucosa. More patients in the SH and tobramycin group had negative nasal swab culture for S. aureus at the end of treatment, while all the patients with positive nasal swab culture for P. aeruginosa showed a reduction of bacterial load. |
|
| Gelardi M, et al.[9] |
Prospective, blindedl, rnd, controlled, parallel group |
78 Patients: SH group (39); Control group (39) |
SH group (21–63); Control group (22–61) |
Patients affected by allergic and non-allergic vasomotor rhinitis |
Treatments were administered for 30 days. SH group: mometasone furoate nasal spray 50 μg/spray, oral desloratadine (5 mg once daily)SH (9mg twice a day aerosolized in 3mL sodium chloride 0.9%)administered 30 minutes after the mometasone. Control group: mometasone furoate,oral desloratadine, sodium chloride 6 mL twice a day aerosolized. |
Cytologic outcomes (neutrophils, eosinophils, mast cells, lymphocytes, bacteria spores, infectious stains biofilms); Clinical outcomes (cough, asthma, rhinorrhea, postnasal drip, halitosis, itch, sneezing, nasal congestion);Endoscopic outcomes (edema, hyperemia, deepithelialization,exudate, nasal hyperactivity). |
Significant improvement in nasal neutrophil cytology scores was seen in patients receiving SH. The addition of SH to mometasone furoate and desloratadine significantly improved sneezing, rhinorrhea, and nasal obstruction at 1 month. A significant improvement in exudate was observed in SH recipients compared to those in the control group at 1 month. |
|
| Cassandro E, et al.[10] |
Prospective,open label, rnd, controlled, parallel group |
80 Patients: 4 treatment groups of 20 pts |
group 1 (38); group 2 (38); group 3 (39); group 4 (39) |
Patients affected by CRS and nasal polyps undergoing FESS |
group1) nebulized saline aerosl therapy bid; group2) intranasal corticosteroid spray mometasone furoate nasal spray 200 ¼g dbid; group3) nebulized SH: aerosol therapy with 3ml SH 9mg and 2 saline bid; group4) intranasal corticosteroid spray + nebulized SH. The treatment period was 3 months. |
Nasal symptom score, endoscopic apparence score, radiologic score, rhinomanometry and saccharine clearence tests before, during and after the treatment period. |
Significant improvements in nasal symptom score, endoscopic apparence score, radiologic score, rhinomanometry and saccharine clearence test were observed in the nSH, ICS and in ICS+nSH group after 1 month of treatment, these effect were also seen after 3 months after treatment. The treatment ICS + nSH appeared to be the most effective therapy, reaching a statistically improvments in the control of nasal symptoms. |
|
| Modrzyński M.[11] |
Prospective, open label |
3 pts in SH group, no control, group |
3 patients (48) |
Patients affected by empty nose symdrome and atrophic rhinitis |
The patients were locally anesthetized by inserting drains filled with 2% lidocaine and adrenalin. The next step was performed under magnification: a CO2 laser, 2 W, contact mode was applied to make tiny punctures into the mucosa under nasal concha membrane. Next, while withdrawing the needle and under careful inspection, a preparation of 0.3–0.4 mL of SH was administered. SH was also injected to a similar depth on both sides, under the perichondrium of the nasal septum, opposite to bottom nasal concha. |
Clinical outcomes, rhinoscopy and acoustic rhinometry outcomes
|
All patients achieved significant improvements in terms of increased airflow sensation throuh the nose, dryness of secretion, and crusting. |
|
| Casale M, et al [12] |
Prospective,open label, rnd, controlled, parallel group |
39 Patients: SH group (21); Control group (18) |
SH group (44); Control group (38) |
Patients affected by chronic rhinosinusitis |
SH group received SH (3ml of SH were dissolved in 2 ml of isotonic solution) twice a day for 10 days per months over 3 months by Rinowash. The control group received standard saline solution (5 cc) by Rinowash twice a day for 3 months |
CRS questionnaire about main CRS symptoms shown. Endoscopic nasal examination performed by a flexible nasal fiberendoscope. The findings were scored with respect to middle turbinate edema and nasal secretions. |
SH significantly improved quality of life in patients with sinonasal symptoms in the CRS questionnaire score, unlike control group that showed post-treatment CRS questionnaires similar to the pre-treatment questionnaire. Both the reduction of mucosal edema of the middle turbinate and the reduction of nasal secretions were statistically significant in the SH group. |
|
| JH Lee et al.[13] |
Prospective, open label |
33 Patients in SH group, no control group |
SH group (40) |
Patients with recurrent oral ulcers (17 Behcet's disease, 16 recurrent aphthous ulcerations) |
0.2% SH gel twice a day for 2 weeks. |
Subjective assessment: number of ulcers, healing period and VAS; Objective assessment: number and maximal size of ulcer. |
A subjective reduction in the number of ulcers was reported by 72.7% of the patients. A decrease in the ulcer healing period was reported by 72.7%of the patients; 75.8% of patients experienced improvement in VAS for pain. Objective inspection of the ulcers showed a reduction of numbers in 57.6% of the patients, and 78.8% of the ulcers showed a decrease in area. Among the inflammatory signs, swelling and local heat were significantly improved after treatment. |
|
| A.Nolan et al. [14] |
Prospective,double blind, rnd, controlled, parallel group |
120 Patients: SH group (60); Control group (56) |
SH group (37); Control group (36) |
Patients with recurrent aphthous ulcerations |
For these patients a topical application of SH gel 0.2% or placebo was applied by a Clinician. Patients were instructed how to apply gel for subsequent applications. After the first 60 min, patients were given a sufficient supply of gel to apply two to three times per day for the next 7 days. |
Mean number of ulcers; ulcer history during 7-day investigation period; number of patients with ulcer occurrence during 7-day investigation period; distribution of scores from patients overall assessment of their treatment (very good, good, moderate, poor, very poor, not recorded) |
Patients in both groups reported a rapid reduction in their discomfort scores arising for their ulcers. This level of reduction was sustained for both treatment groups for about 30 min. There after scores started to return to baseline. There was a slight decline in the number of ulcers, irrespective of treatments over the 7 day. On day 5 patients in the SH group had significantly fewer ulcers than those treated with placebo. In both treatment groups, new ulcers occurred throughout the investigation period but on day 4 the incidence of new ulcer occurrence was significantly lower in the SH group. |
|
| Barber C. et al. [15] |
Prospective, open label, rnd, controlled, parallel group |
20 Patients: Gelclair group (10); Control group (10) |
Gelclair group (64); Control group (59) |
Patients with radiotherapy-induced oral mucositis |
Patients in both groups were instructed to use their medication four times during the 24-h period, 30 min before meals. Those randomised to Gelclair were told to stir well and immediately swish and gargle for at least 1 min. Those randomised to the Sucralfate and Mucaine (control group) were instructed to swish 10 ml of Sucralfate around the mouth for at least 1 min. |
Primary outcome measures: general pain and pain on speaking VAS. Secondary outcome measures: swallowing assessment (self-recording swallowing scales: saliva only, liquids only, soft foods only, can eat anything but hard). Compliance
|
No relevant observations with regard to general pain, pain on speaking, or ability to eat and drink, were observed for patients with higher grades of OM (i.e. grades III and IV). |
Only 1 patient reported mild inflammation and stinging in the oral cavity using Gelclair |
| Palmieri B et al. [16] |
Prospective,double blind, cross over, pbo controlled |
20 pts divided in 2 groups according to c.o. design, receiving SH +CS or placebo |
SH+CS/Pbo group (55) |
Patients with heartburn and/or acid regurgitation |
Patients were randomized to one of the two treatment periods and received the first study drug for 14 days. Patients could received either one spoon of syrup containing SH + CS or placebo, administered, far from meals, every 8 hours during daytime and two spoons at bedtime. After a wash out period, patients received either the drug or placebo for a second period of 14 days. |
1
) Sum of Symptoms Score Intensity(SSSI), 2) Symptoms Score Intensity Difference (SSID), 3) Heartburn and acid regurgitation score intensity difference, 4) Complete symptom disappearance, 5) Rate of patients reporting good speed of action.
|
At the end of SH + CS treatment both SSSI and SSID were significantly lower as a result of significant changes in terms of heartburn intensity and acid regurgitation intensity. Symptoms complete disappearance was higher after SH+CS treatment and the time to disappearance of symptoms was significantly shorter. An higher, percentage of patients reporting good speed of action. |
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