Use of the oral sialogogue “Oryza tablet” in reducing drug-induced xerostomia in patients with overactive bladder or neurogenic bladder: randomized clinical study

Viseshsindh W1, Tancharoen S1, Sirisreetreerux P1, Rattanapornsompong W1, Somboonpun K1, Piyawannarat S1

Research Type

Clinical

Abstract Category

Pharmacology

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Abstract 36
Overactive Bladder and Neuromodulation
Scientific Podium Short Oral Session 6
Wednesday 27th September 2023
15:15 - 15:22
Theatre 102
Pharmacology Overactive Bladder Quality of Life (QoL) Prospective Study
1. Mahidol university
Presenter
S

Surawach Piyawannarat

Links

Abstract

Hypothesis / aims of study
Treatment of NB and OAB is behavioral therapy, such as bladder-training strategies, pelvic-floor physiotherapy, fluid management, and medications. The most common side-effects of antichomuscarinic drugs are dry mouth (xerostomia). Xerostomia is a major factor affecting patient compliance for taking antimuscarinic drugs. The complications of xerostomia can lead to speech problems, taste disorders, chewing difficulties, swallowing difficulties, and ill-fitting dentures. Consequently, these complications lead to a poor QoL and increase the risk of developing infectious oral diseases such as caries, oral mucositis, periodontitis, and oral candidiasis. To improve patient compliance and avoid the side-effect of xerostomia, an oral sialogogue, “Oryza tablet” (OT), was developed. Here, we investigated the efficacy of OT in improving xerostomia in patients with NB or OAB who received antimuscarinic drugs.
Study design, materials and methods
This was a randomized clinical trial. Twenty-eight patients (median age = 64 years) with xerostomia were divided into two groups: OT (intervention group) and placebo (control) group. Both groups comprised 14 patients each. We assessed severity using a questionnaire for the subjective evaluation of xerostomia. Objective evaluation was undertaken for the stimulated salivary flow rate (SSFR). Xerostomia evaluation took place before treatment (baseline) as well as 2 weeks and 4 weeks after treatment.
Results
The xerostomia score decreased significantly (p < 0.05) compared with that of the placebo group after treatment (score at 2 weeks was 4.4 in the placebo group compared with 2.75 in the OT group; score at 4 weeks was 4.13 in the placebo compared with 2.19 in the OT group). The SSFR increased significantly at 2 weeks and 4 weeks after treatment (1.2 and 1.1 in the placebo group compared with 2 and 1.85 in the OT group, respectively, p < 0.05). No patient stopped taking antimuscarinic drugs during the study. No adverse events were reported.
Interpretation of results
Continuous daily use of OT for 4 weeks led to an improvement in overall subjective xerostomia symptoms and saliva production (p < 0.05). With respect to xerostomia symptoms after treatment, longer use of antimuscarinic medications led to improvements in lip dryness and speaking difficulty (comparison between 2 weeks and 4 weeks after treatment). The SSFR of all patients at baseline was 1.13 mL/min (SSFR was considered to be low at 0.7–1.0 mL/min), which was considered to be within the normal range. However, an improvement in saliva production was observed which correlated with the clinical outcome of xerostomia symptoms after treatment. All patients were instructed to take medication four times per day. The average number of tablets remaining after a full course of treatment was 8.9. Therefore, a further study on the optimal daily dose (e.g., three times per day or as-needed use) may increase patient with treatment.
Concluding message
Continuous daily use of Oryza tablet for 4 weeks reduced xerostomia symptoms and increased saliva production in patients suffering from NB or OAB who received antimuscarinic medications.
References
  1. Macdiarmid SA. Concomitant medications and possible side effects of antimuscarinic agents. Rev Urol. 2008;10(2):92–98
  2. Suh KI, Lee JY, Chung JW, Kim YK, Kho HS (2007) Relationship between salivary flow rate and clinical symptoms and behaviours in patients with dry mouth. J Oral Rehabil 34, 739-744.
  3. Niklander S, Veas L, Barrera C, Fuentes F, Chiappini G, Marshall M (2017) Risk factors, hyposalivation and impact of xerostomia on oral health-related quality of life. Braz Oral Res 31, e14
Disclosures
Funding Ramathibodi Hospital, Mahidol university. Clinical Trial No Subjects Human Ethics Committee Human Research Ethics Committee, Faculty of Medicine Ramathibodi Hospital, Mahidol University Helsinki Yes Informed Consent Yes
Citation

Continence 7S1 (2023) 100754
DOI: 10.1016/j.cont.2023.100754

05/05/2024 07:40:43