Effectiveness of thyme honey in the management of xerostomia in geriatric patients with end-stage renal disease: a randomized controlled clinical trial with a biochemical assessment.

BACKGROUND: Taking into consideration the value of the oral health condition in geriatric people with end-stage renal disease (ESRD) associated with xerostomia and believing that salivary stimulants or substitutes could potentially be used to manage this condition. This study aimed to evaluate the clinical effectiveness of thyme honey as oral rinse in geriatric patients with ESRD using the subjective dry mouth score as a primary objective and to assess the effect of thyme honey on the salivary nitric oxide level, salivary flow rate, and salivary ph in addition to objective dry mouth score as a secondary objective. METHODS: This was a single blinded randomized controlled trial with two equal arms, the interventional arm (thyme honey oral rinse) and the control arm (saline). Twenty-eight geriatric patients with ESRD undergoing hemodialysis complained of xerostomia were recruited from the renal dialysis center. Patients in both arms followed the same administration protocol either with thyme honey oral rinse or saline. The following clinical parameters (the subjective and objective dry mouth scores, salivary flow rate, salivary ph, and salivary nitric oxide (NO) levels) were evaluated for both groups at different intervals (baseline, 1 week, and 1 month). RESULTS: In the current study, it was found that both the subjective and objective dry mouth scores were significantly lower after one month of using thyme honey oral rinse (1.86 ± 0.66B) and (2.21 ± 0.43B) respectively, than the control group (3.07 ± 0.73B) and (3.07 ± 0.83B), respectively with a (p < 0.001). Also, the salivary flow rate was significantly higher after one month of using thyme honey oral rinse (1.56 ± 0.51A), than the control group (0.78 ± 0.27A) with a (p < 0.001). For the NO levels, there was a significant increase in measured value after 1 month in the intervention group (p < 0.001), while for the control group the change was not statistically significant (p = 0.166). CONCLUSIONS: The results of the current study have revealed the efficacy of Thyme honey oral rinse in the management of xerostomia in geriatric patients with ESRD. Trial registration The ClinicalTrials.gov Identifier for this study is NCT05247008.

Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis.

bladder based on a systematic review and network meta-analysis approach. METHODS: Pubmed, Embase, Web of Science, and the Cochrane Register of Clinical Trials databases were systematically searched. The search time frame was from database creation to June 2, 2022. Randomized controlled double-blind trials of oral medication for overactive bladder were screened against the protocol's entry criteria. Trials were evaluated for quality using the Cochrane Risk of Bias Assessment Tool, and data were statistically analyzed using Stata 16.0 software. RESULT: A total of 60 randomized controlled double-blind clinical trials were included involving 50,333 subjects. Solifenacin 10mg was the most effective in mean daily micturitions and incontinence episodes, solifenacin 5/10mg in mean daily urinary urgency episodes and nocturia episodes, fesoterodine 8mg in urgency incontinence episodes/d and oxybutynin 5mg in voided volume/micturition. In terms of safety, solifenacin 5mg, ER-tolterodine 4mg, mirabegron, vibegron and ER-oxybutynin 10mg all showed a better incidence of dry mouth, fesoterodine 4mg, ER-oxybutynin 10mg, tolterodine 2mg, and vibegron in the incidence of constipation. Compared to placebo, imidafenacin 0.1mg showed a significantly increased incidence in hypertension, solifenacin 10mg in urinary tract infection, fesoterodine 4/8mg and darifenacin 15mg in headache. CONCLUSION: Solifenacin showed better efficacy. For safety, most anticholinergic drugs were more likely to cause dry mouth and constipation, lower doses were better tolerated. The choice of drugs should be tailored to the patient's specific situation to find the best balance between efficacy and safety.

Impact of salivary hypofunction on incidence of orofungal infections with use of topical steroids for management of oral lichen planus and xerostomia.

OBJECTIVES: The aim of this study was to determine if salivary hypofunction increases the incidence of oral fungal infections (OFIs) after topical steroid use for the management of oral lichen planus (OLP). STUDY DESIGN: Patients with a diagnosis of OLP, treated for at least 2 weeks with topical steroids, had baseline salivary flow evaluations completed, and had a follow-up visit within 5 weeks of steroids being prescribed were assessed. Patients were evaluated for clinical signs of fungal infection at follow-up visits. RESULTS: Forty-Seven patients (91% female) met the inclusion criteria, with 21.3% developing an OFI after topical steroid use. Demographic characteristics, type of OLP, steroid used, and antifungal used did not impact the development of an OFI. The mean stimulated salivary flow was significantly lower in the group that developed an OFI compared with the group that did not develop an OFI (8.31 mL/15 min vs 15.4 mL/15 min, respectively; P = 0.0006). A higher incidence of OFIs occurred in the low stimulated flow group versus the normal flow group (39% vs 4%, respectively). Most patients in the OFI group received a preventative antifungal (90%). CONCLUSIONS: OFIs increased after steroid treatment in patients with OLP who had low stimulated salivary flows. Antifungals (90%) were not effective in preventing OFIs in patients with OLP who had salivary hypofunction and were treated with topical steroids.

Randomized Controlled Trial of Rituximab and Cost-Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjögren's Syndrome.

OBJECTIVE: To investigate whether rituximab, an anti-B cell therapy, improves symptoms of fatigue and oral dryness in patients with primary Sjögren's syndrome (SS). METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial that included health economic analysis. Anti-Ro-positive patients with primary SS, symptomatic fatigue, and oral dryness were recruited from 25 UK rheumatology clinics from August 2011 to January 2014. Patients were centrally randomized to receive either intravenous (IV) placebo (250 ml saline) or IV rituximab (1,000 mg in 250 ml saline) in 2 courses at weeks 0, 2, 24, and 26, with pre- and postinfusion medication including corticosteroids. The primary end point was the proportion of patients achieving a 30% reduction in either fatigue or oral dryness at 48 weeks, as measured by visual analog scale. Other outcome measures included salivary and lacrimal flow rates, quality of life, scores on the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index and EULAR Sjögren's Syndrome Disease Activity Index, symptoms of ocular and overall dryness, pain, globally assessed disease activity, and cost-effectiveness. RESULTS: All 133 patients who were randomized to receive placebo (n = 66) or rituximab (n = 67) were included in the primary analysis. Among patients with complete data, 21 of 56 placebo-treated patients and 24 of 61 rituximab-treated patients achieved the primary end point. After multiple imputation of missing outcomes, response rates in the placebo and rituximab groups were 36.8% and 39.8%, respectively (adjusted odds ratio 1.13 [95% confidence interval 0.50, 2.55]). There were no significant improvements in any outcome measure except for unstimulated salivary flow. The mean ± SD costs per patient for rituximab and placebo were £10,752 ± 264.75 and £2,672 ± 241.71, respectively. There were slightly more adverse events (AEs) reported in total for rituximab, but there was no difference in serious AEs (10 in each group). CONCLUSION: The results of this study indicate that rituximab is neither clinically effective nor cost-effective in this patient population.

Subjective Assessment of Enamelon® Preventive Treatment Gel in a Self-Reported Dry-Mouth Population.

BACKGROUND: The efficacy of stannous fluoride toothpastes is well established for reducing caries, plaque, and gingivitis and relieving the discomfort of dentin hypersensitivity. Management of dry mouth may include relief remedies in addition to usual oral hygiene methods to maintain oral health and improve quality of life. This 6-week, single-blind, randomized, two-period crossover clinical study was designed to evaluate the oral tolerance and potential of Enamelon® Preventive Treatment Gel (EPTG), with 0.4% stannous fluoride, to relieve subject-perceived dry-mouth symptoms in a self-reported dry-mouth population, after 14 days of use, compared to a marketed over-the-counter (OTC) artificial saliva gel product (Biotene® Oral Balance Gel [BOBG]). METHODS: Following a 7-day washout period, 52 qualified subjects with self-reported dry-mouth symptoms received EPTG or BOBG for once-daily use for 14 days. All subjects brushed each morning and evening with a standard fluoride toothpaste (Sensodyne® ProNamel). Each evening and following brushing with the Sensodyne ProNamel, subjects used their assigned gel product (EPTG or BOBG) as directed. On Days 1, 8, and 15, subjects received an oral examination and assessed relief of dry-mouth symptoms using a product-performance questionnaire (PPQ). Procedures were repeated with the alternate product for another 14-day period, following a 7-day washout. Data for each efficacy endpoint were analyzed using crossover ANOVA model. RESULTS: No treatment-related adverse events were reported in this study, and both products were well tolerated by the subjects. Compared to pre-study ratings of usual dry-mouth remedies, both BOBG and EPTG significantly reduced dry-mouth symptoms following 14 days of use. BOBG was statistically significantly better than EPTG in relieving many of the principal dry-mouth symptoms such as providing immediate relief, having an immediate moisturizing and immediate lubricating effect, feeling comfortable in the mouth, soothing the mouth, effectively lubricating the mouth, and protecting the mouth from drying out (P < .05). Compared with subjects' ratings of their usual dry-mouth remedies, EPTG also provided relief of several dry-mouth symptoms at both Days 8 and 15 (P < .05). CONCLUSION: Based on subjective measures of dry mouth and compared with pre-study ratings of usual remedies, subjects perceived that EPTG helped to manage symptoms such as relieving the discomfort of dry mouth, immediately moisturizing and lubricating, effectively lubricating, protecting from drying out, and providing long-lasting moisturization and long-lasting lubrication, and was not irritating to dry-mouth tissues. BOBG, the positive control, was significantly better than EPTG in relieving dry-mouth symptoms over a 2-week period and was not irritating. PRACTICAL IMPLICATIONS: Patients with dry-mouth symptoms may benefit from daily use of a non-irritating, OTC fluoride preventive treatment gel product to relieve symptoms while also reducing the risks of developing dental caries, demineralization, dentin hypersensitivity, and gingivitis.

Assessment of the use of sialogogues in the clinical management of patients with xerostomia.

This study was conducted to assess the clinical efficacy and adverse effects of pilocarpine, bethanechol and cevimeline in patients with xerostomia. In this open-label crossover assessment in 20 patients with xerostomia, a one- to two-week course of each medication with a one-week washout period was prescribed. Side effects, symptoms, whole stimulated and unstimulated saliva were measured. Each sialogogue was found to increase saliva and decrease symptoms. A mixed-effects analysis showed a greater increase in stimulated saliva on bethanechol compared to pilocarpine (0.106, p = 0.0272). Increased sweating was the most common side effect, experienced more frequently with pilocarpine as compared to bethanechol (p = 0.0588) or cevimeline (p = 0.0143). A carryover effect beyond the washout period was seen. Effects on saliva and side effects vary between sialogogues, suggesting a benefit of trials with different sialogogues to determine individual patient preference. The observed carryover effect suggests that intermittent treatment may be an alternative to continuous treatment with sialogogues.

Evaluation, prevention and management of radiotherapy-induced xerostomia in head and neck cancer patients.

PURPOSE OF REVIEW: As part of the multidisciplinary approach to head and neck cancer patients, radiation therapy plays an essential role, improving locoregional control. Radiation therapy-induced xerostomia is a late side-effect that increases the risk for developing dental caries and compromises oral mucosal integrity, resulting in oral pain, loss of taste, difficulties with swallowing and chewing, sleep disorders and worse quality of life. This review focuses on evaluation, prevention and management of radiation therapy-induced xerostomia. RECENT FINDINGS: In terms of xerostomia prevention, some clinical trials evaluating amifostine and intensity-modulated radiation therapy have shown positive results. Pilocarpine is a useful agent as a treatment of radiation-induced xerostomia in head and neck cancer patients. SUMMARY: Despite some advances in radiation therapy-induced xerostomia prevention, its treatment is an area in which advances are urgently needed.

Efficacy and economic evaluation of pilocarpine in treating radiation-induced xerostomia.

Xerostomia, resulting from therapeutic irradiation of the head and neck, can be debilitating and destructively impact the patient's quality of life. The first priority of treatment of radiation-induced xerostomia should be to preserve oral and dental health. Therapeutic doses of fluoride and meticulous dental hygiene are the treatments of choice for this purpose. Measures taken to prevent superinfection with cariogenic bacteria and fungi are also important. In addition to minimising damage to the dentition, it is important to provide palliative therapy to help the patient live a more normal life. Salivary substitutes help some patients but muscarinic, cholinergic sialogogues provide a more physiological replacement in those patients who have measurable residual salivary function. An oral formulation of pilocarpine hydrochloride is approved to treat radiation-induced xerostomia. In such cases, it has been shown to effectively stimulate salivary flow and relieve subjective symptoms associated with oral dryness. Administration of this drug is associated with predictable, but generally tolerable, adverse effects. Similar drugs, approved for other indications, have been shown to produce comparable results. These drugs are generally less expensive than the oral formulation of pilocarpine. As treatment of irradiation-induced xerostomia with muscarinic, cholinergic sialogogues is palliative, not curative, administration of these drugs should be individualised and guided by the patient's willingness to balance symptomatic efficacy with adverse effects and the expense of treatment.

Oral pilocarpine: new preparation. Xerostomia after radiation therapy: moderately effective but costly.

(1) Dry mouth (xerostomia) is a frequent complication of radiation therapy for cancers of the ear nose and throat. Local measures such as saliva substitutes and anetholtrithione are either moderately effective, inadequately evaluated or little better than placebo. (2) Marketing authorization has been granted in France for an oral formulation of pilocarpine, an old parasympathomimetic agent, in the treatment of radiotherapy-induced xerostomia. (3) According to the results of two double-blind trials, pilocarpine (15-30 mg/day) improves symptoms in about 50 % of patients, compared to improvement in 25% of patients taking placebo. The drug is slow to take effect and has little impact on daily life. It is not known whether pilocarpine helps prevent the complications of xerostomia. (4) Most adverse effects of pilocarpine are due to its parasympathomimetic effects, such as sweating, urinary frequency, flushing, rhinitis and nausea. Pilocarpine must therefore be used with caution in patients with asthma, cardiac arrhythmia, iridocyclitis, and closed-angle glaucoma. (5) In France, this pilocarpine formulation costs 18 times more than a preparation of pilocarpine 2% eye drops used orally (off licence). (6) In practice, patients needing symptomatic treatment of xerostomia after radiotherapy may benefit from oral pilocarpine but, given its limited efficacy and its adverse effects, other local treatments should be tried first.

First effective drug for dry mouth.

AIDS: The Food and Drug Administration (FDA) approved oral pilocarpine (Salagen) for the treatment of dry mouth in patients receiving radiation therapy for head and neck cancer. There are possible drug interactions with the beta blockers that are often used by cardiac patients. Other side effects are sweating, nausea, and inflammation of the mucous membranes.^ieng

Assessment of the effects of aging and medication on salivary gland function in patients with xerostomia using 99mTC-scintigraphy.

To examine the effect of aging and medication on xerostomia, the salivary gland function was evaluated in 20 patients with xerostomia using 99mTc-scintigraphy and the measurement of unstimulated whole saliva (USWS). All of the patients showed USWS volume of less than 2ml/10min. The patients were divided into 2 subgroups based on age (under 65 and 65 and older) and medication status (patients who were on medication which reduced salivary secretion and patients who were not on such medication). The scintigraphic results, such as the maximum radioisotope (RI) count, RI secretion velocity and the volume of USWS, were compared between the subgroups. The maximum RI count and the RI secretory velocity in the submandibular gland and the volume of USWS revealed significantly different functional disturbances between relatively younger patients (under 65) and older patients (65 and older). There was no difference when the scintigraphic results and the volume of USWS measurements in medicated patients were compared with the results of similar tests performed on non-medicated patients. When the medicated and non-medicated groups were separated by age, an increase in age still diminished the volume of USWS in medicated patients. This result might be related to an organic change in the submandibular gland in older patients which was suggested by the scintigraphic results.