Presence of pain and pain intensity [on visual analog scale (VAS) from 0: no pain to 10: the strongest possible pain] in participants experiencing presence of pain. The lysozyme group was treated with a spray containing lysozyme hydrochloride + cetylpyridinium chloride + lidocaine, control group was treated with a compounded preparation containing gentamicin sulfate + dexamethasone + lidocaine
Visit
Parameter
All participants(n = 56)
Lysozyme group(n = 26)
Control group(n = 30)
p-value lysozyme vs. control group
Eating solid food
Baseline
Presence of pain
52 (93)
23 (88)
29 (97)
0.328
Pain intensity
4.0 (3.0–5.3)
4.0 (3.0–4.5)
5.0 (3.0–6.0)
0.181
After 7 days
Presence of pain
52 (93)
24 (92)
28 (93)
> 0.900
Pain intensity
4.0 (3.0–5.3)
4.0 (3.0–5.3)
4.0 (4.0–5.3)
0.509
After 14 days
Presence of pain
53 (95)
25 (96)
28 (93)
> 0.900
Pain intensity
4.0 (3.0–6.0)
3.0 (3.0–5.0)
5.0 (3.0–6.5)
0.062
After 21 days
Presence of pain
51 (91)
25 (96)
26 (87)
0.358
Pain intensity
4.0 (2.3–6.0)
3.0 (2.0–4.0)
6.0 (3.3–7.0)
0.001
Eating soft food
Baseline
Presence of pain
25 (45)
11 (42)
14 (47)
> 0.900
Pain intensity
2.0 (2.0–4.0)
2.0 (2.0–3.5)
2.5 (2.0–5.0)
0.440
After 7 days
Presence of pain
28 (50)
11 (42)
17 (57)
0.422
Pain intensity
3.0 (2.0–4.0)
3.0 (2.0–4.0)
2.0 (2.0–4.0)
0.434
After 14 days
Presence of pain
23 (41)
7 (27)
16 (53)
0.059
Pain intensity
4.0 (2.8–6.0)
3.0 (2.5–7.0)
4.0 (2.9–6.0)
0.892
After 21 days
Presence of pain
21 (38)
7 (27)
14 (47)
0.170
Pain intensity
5.0 (3.0–7.0)
3.0 (2.0–6.5)
5.5 (3.0–7.0)
0.327
During speech
Baseline
Presence of pain
9 (16)
3 (12)
6 (20)
0.481
Pain intensity
4.0 (3.0–4.5)
3.0 (2.5–4.0)
4.0 (4.0–4.4)
0.356
After 7 days
Presence of pain
10 (18)
3 (12)
7 (23)
0.310
Pain intensity
3.0 (2.0–4.8)
2.0 (1.5–3.5)
4.0 (2.0–5.0)
0.345
After 14 days
Presence of pain
7 (13)
2 (8)
5 (17)
0.436
Pain intensity
6.0 (4.0–7.0)
5.5 (4.8–6.3)
6.0 (4.0–7.0)
0.839
After 21 days
Presence of pain
10 (18)
3 (12)
7 (23)
0.310
Pain intensity
6.0 (5.0–7.0)
5.0 (5.0–6.5)
6.0 (5.5–7.0)
0.728
Data are presented as an absolute number (percentage of the total number of respondents in the subject group) or as a median (interquartile range, IQR)
Declarations
Author contributions
ZG, JR, and NG: Investigation, Writing—review & editing. AŠ: Conceptualization, Resources, Methodology, Supervision. MM: Conceptualization, Methodology, Supervision, Writing—original draft. ATA: Conceptualization, Writing—original draft. UG: Conceptualization, Data curation, Software, Formal analysis, Supervision, Visualization, Methodology, Writing—original draft. All authors approved the final version of the manuscript.
Conflicts of interest
Aziz Šukalo, Meliha Mehić, Amna Tanović Avdić, and Una Glamočlija disclose the following relationships—employees of Bosnalijek d.d., a pharmaceutical company producing lysozyme-based products.
Ethical approval
The study was registered with the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina under the protocol number LCS-OM-01. The clinical study was approved by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, number 08-07.5-6730-1/20 on July 20, 2020.
Consent to participate
Informed consent to participate in the study was obtained from all participants.
Consent to publication
Not applicable.
Availability of data and materials
The datasets generated for this study are available from the corresponding author upon reasonable request.
Funding
The authors declare that this study was supported by Bosnalijek d.d. (a company that is a producer of lysozyme-based products). Bosnalijek d.d. had a role in the design of the study; in the collection, analyses, and interpretation of data; in the writing of the manuscript, and in the decision to publish the results. The data and results of this study are not affected by the interest of the Bosnalijek d.d.
Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.
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