Antibacterial and antiplaque efficacy of a lactoperoxidase-thiocyanate-hydrogen-peroxide-system-containing lozenge.

BACKGROUND: Antimicrobial agents are considered valuable adjuncts to mechanical methods of plaque control. However, their long-term use can be limited because of side effects. Therefore, using physiological substances is promising due to no risk of development, for example, of microbial resistances, allergies or DNA damaging. The lactoperoxidase-thiocyanate-hydrogen peroxide system (LPO-system) is a highly effective antimicrobial system. This study aimed to evaluate in a randomized study with a four-replicate cross-over design the effectiveness of two oral hygiene lozenges containing LPO-system in oral hygiene. RESULTS: After using the mouth rinse as positive control (A) and allocated test lozenges (B) (0.083% H2O2) & (C) (0.04% H2O2) for 4 days instead of the normal oral hygiene procedures (tooth brushing etc.), Listerine rinse (A) was statistically significantly more effective than the LPO-system-lozenge with 0.083% H2O2, the LPO-system-lozenge with 0.04% H2O2, and the placebo lozenge (D) in inhibiting plaque. Lozenges B and C were statistically significantly more effective than the placebo lozenge, but no statistically significant differences could be observed between them. The LPO-system-lozenge (B) reduced statistically significantly more S. mutans than the LPO-system-lozenge with (C) and the placebo lozenge (D). The LPO-system-lozenge (C) reduced statistically significantly more Lactobacilli than Listerine (A), the LPO-system-lozenge (B) and the placebo lozenge (D). There were no statistically significant differences in the total CFUs between Listerine rinse, the LPO-system-lozenge with 0.083% H2O2 (B), the LPO-system-lozenge with 0.04% H2O2 (C), and the placebo lozenge (D). On day 5 there were no differences of the OSCN--values between all A, B, C, and D. However, the SCN--values increased over the days in both LPO-system-lozenges (B/C). The statistically significant differences between B/C and A/D on day 5 were as followed: A to B p = 0.0268; A to C p = 0.0035; B to D p = 0.0051; C to D p = 0.0007. Only in the group of Listerine (A) increased the NO3-/NO2--quotient over the test time, which indicates a reduction of nitrate-reducing bacteria. On Day 5 the statistically significant difference between A and B was p = 0.0123. CONCLUSIONS: The results indicate that lozenges containing a complete LPO-system, inhibiting plaque regrowth and reducing cariogenic bacteria, may be used in the daily oral hygiene.

Synergistic anti-candida activities of lactoferrin and the lactoperoxidase system.

Candida albicans is a commensal fungus in human mucosal surfaces, including the oral cavity. Lactoferrin (LF) and the lactoperoxidase (LPO) system, which are host protection components in exocrine secretions, each exhibit weak anti-candida activity. We herein examined the effects of the combination of LF and the LPO system on C. albicans. Morphological observations indicated that the combination of LF and the LPO system reduced the mycelial volume of C. albicans and changed the size and shape of cells more than each agent alone. The combination of LF and the LPO system also exerted strong inhibitory effects on the cellular metabolic activity and adhesive hyphal form of C. albicans. A checkerboard analysis revealed that the anti-candida activity of LF and the LPO system was synergistic. These results suggest that the combination of LF and the LPO system is useful for preventing candidiasis.

Treatment strategy by lactoperoxidase and lactoferrin combination: Immunomodulatory and antibacterial activity against multidrug-resistant Acinetobacter baumannii.

Lactoperoxidase (Lpo) and Lactoferrin (Lf) were extracted from camel colostrum milk and purified. The antibacterial activity of the two purified proteins was estimated against 14 isolates of multidrug resistance Acinetobacter baumannii. A combination of Lpo and Lf exhibited bactericidal action against A. baumannii in vitro. A mouse model of acute A. baumannii pneumonia was improved. The injection of combined Lpo and Lf after infection leads to significant clearance of A. baumannii rates in lung as well as blood culture P < 0.05 in comparing with control. Furthermore, the results showed a significant P < 0.05 reduction in the Bronchoalveolar lavage albumin concentration, lung injury and lactate dehydrogenase activity in comparing with control. In addition, the combination of Lpo and Lf treatment induced substantial elevation of IL-4 and IL10 concentrations p < 0.0 5 that helped to prevent damage caused by the inflammatory response. We concluded that combination of Lpo and Lf had a major inhibition effect against A. baumannii in comparing with imipenem as well as their immunomodulatory activity against resistant A. baumannii was increased by a synergistic effect of them as a crude combination. This study indicated two combined proteins consider as crucial strategy for practical treatment of pneumonia in the future.

Efficacy of GUM® Hydral versus Biotène® Oralbalance mouthwashes plus gels on symptoms of medication-induced xerostomia: a randomized, double-blind, crossover study.

OBJECTIVES: The objective of this study is to determine the efficacy of GUM® Hydral versus Biotène® Oralbalance (both a mouthwash plus gel) on the subjective burden and clinical symptoms of patients with medication-induced xerostomia. MATERIALS AND METHODS: Subjects (N = 40) with medication-induced xerostomia (minimum 4/10 mm visual analog scale [VAS]) were randomized to treatment with GUM Hydral or Biotène Oralbalance mouthwash, both with gel, for 28 days. Subjects then entered a 21-day wash-out period, before crossing over to the other treatment for 28 days. Outcomes measured included the VAS, German Oral Health Impact Profile (OHIPG)-14, Xerostomia Questionnaire (XQ), after-use questionnaire, and clinical parameters. RESULTS: Both GUM Hydral and Biotène Oralbalance significantly (p < 0.05) reduced VAS, OHIPG-14 total score and single items, and XQ Part 1 (oral dryness, oral pain, taste loss) and Part 2 items. GUM Hydral also significantly reduced the XQ Part 1 dysphagia score, while Biotène Oralbalance significantly reduced the halitosis organoleptic score and plaque index. Significant increases in saliva secretion did not reach clinical relevance. No significant between-group differences were observed, apart from OHIPG-14 items "trouble pronouncing words" and "uncertainty" in favor of GUM Hydral. No adverse effects were reported. CONCLUSIONS: Both products effectively improve oral health and xerostomia-related quality of life. However, they cannot completely substitute the continuous in-mouth secretion of saliva, and symptomatic relief is temporary. Product selection will be based on personal preference. CLINICAL RELEVANCE: Both products diminish xerostomic burden and should be part of the management strategy. Affected patients should be informed of these treatments, since no adverse effects were reported.

Efficiency of novel nanocombinations of bovine milk proteins (lactoperoxidase and lactoferrin) for combating different human cancer cell lines.

Bovine lactoperoxidase (LPO) and lactoferrin (LF) are suitable proteins to be loaded or adsorbed to chitosan nanoparticles (NPs) for preparing stable nanoformulations with potent anticancer activity. In the present study, nanocombinations of LPO and LF revealed improvement in their stability and activity compared to single (free or nanoformulated) bovine proteins. The coating or loading of LPO-loaded NPs with LF resulted in the highest synergistic cytotoxicity effect against Caco-2, HepG-2, MCF-7 and PC-3 cells in comparison with other NPs and free proteins without causing toxicity toward normal cells. This synergistic improvement in the anticancer activity was apoptosis-dependent that was confirmed by severe alterations in cellular morphology, high percentage of annexin-stained cells and sub-G1 populations as well as nuclear staining with orange fluorescence of treated cancer cells. Additionally, significant alterations in the expression of well characterized cellular proliferation and apoptosis guards (NF-κB, Bcl-2 and p53) in these NPs-treated cancer cells compared to 5-fluorouracil (5-FU) treated cells. Our findings provide for the first time that these new synergistic nanoformulated forms of LPO and LF were superior in their selective apoptosis-mediating anticancer effect than free form of these proteins and 5-FU. LF coating or loading of LPO-loaded NPs present as promising therapy for cancer.

Two novel roles of buffalo milk lactoperoxidase, antibiofilm agent and immunomodulator against multidrug resistant Salmonella enterica serovar Typhi and Listeria monocytogenes.

The increasing occurrence of multidrug resistant bacteria causing bacteremia infection, constitutes a major health problem, difficult-to-treat bacteremia due to its ability to form biofilm. Buffalo milk lactoperoxidase (BMLpo) is effective and safe to use as bacteriostatic agent. The MIC of BMLpo and amikacin were used to evaluate the antibiofilm activity against resistant L. monocytogenes and S. typhi. Prophylactic effects of BMLpo against L. monocytogenes and S. typhi bacteremia in vivo have been tested and ELISA test used to evaluate serum cytokines. Significant antibiofilm activity of BMLpo observed against the highest biofilm producer isolates. Our results showed that the prophylactic effect of BMLpo in BALB/c mice bacteremic model. A significant clearance of L. monocytogenes and S. typhi, investigated in blood and different organs tissues in BMLpo-treated infected groups when compared to the non-treated groups. Further, analysis of serum cytokines levels revealed that BMLpo prophylaxis modulates their release in different way when it compared to the control. This study showed, BMLpo effects as an alternative antibiofilm agent to compact gram negative pathogens, and protects the host against bacteremia infection. Moreover, the BMLpo role as an immunomodulatory. These investigations indicated the BMLpo crucial role in the practical clinical applications.

Effectiveness of casein phosphopeptide-amorphous calcium phosphate and lysozyme, lactoferrin, and lactoperoxidase in reducing Streptococcus mutans counts in dentinal caries.

This study compared the capacity of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) to that of a combination of lysozyme, lactoferrin, and lactoperoxidase (LLL) in root canal disinfectant for reducing the Streptococcus mutans counts from dentinal caries. Forty human permanent third molars were selected, and flat dentin surfaces were created. Carious lesions were induced using a microbiological model. The specimens were randomly divided into 2 groups (n = 20) according to the type of agent used: group 1, CPP-ACP; group 2, LLL. The S mutans counts were performed before application and after the first, second, and third applications of the agents. The duration of each application was 3 minutes. Carious dentin specimens were homogenized, diluted, and seeded onto mitis salivarius-bacitracin plates for viable counts of S mutans. Results showed that there was no significant reduction in the number of S mutans in group 1 after the applications of CPP-ACP (P > 0.05). In group 2, a significant reduction of S mutans was observed after the third application of LLL (P < 0.01). These results indicate that 3 applications of LLL enzymes can be used to reduce the number of S mutans in dentinal caries lesions.

A randomized clinical trial in subjects with dry mouth evaluating subjective perceptions of an experimental oral gel, an oral rinse and a mouth spray compared to water.

PURPOSE: This multicenter, randomized, parallel group study analyzed the effectiveness of an experimental oral gel, a commercially available oral rinse and a commercially available mouth spray versus water alone at relieving self-reported symptoms of dry mouth over a 28-day home use treatment period. The effects of the study treatments on dry mouth-related quality of life (QoL) were also investigated. METHODS: Eligible subjects were stratified by dry mouth severity (mild, moderate or severe) and randomized to receive one of the study treatments. Prior to first use they completed a questionnaire designed to assess their baseline dry mouth-related QoL. Following first use and on Day 8 (2 hours post-treatment only) and Day 29, subjects completed the modified Product Performance and Attributes Questionnaire (PPAQ) I at 0.5, 1, 2 and 4 hours post-treatment. Subjects further assessed treatment performance using the PPAQ II questionnaire on Days 8 and 29 and the dry mouth-related QoL questionnaire on Day 29. RESULTS: In 396 randomized subjects almost all comparisons of responses to PPAQ I, including those for the primary endpoint (response to PPAQ I Question 1 'Relieving the discomfort of dry mouth' after 2 hours on Day 29), were statistically significant in favor of active treatment groups versus water (P < 0.05). All comparisons of responses to PPAQ II on Days 8 and 29 were statistically significant in favor of active treatments versus water (P < 0.05). Moreover, nearly all comparisons for dry mouth-related QoL scores on Day 29 were statistically significant in favor of the active treatments versus water. All the dry mouth management strategies in this trial were well tolerated.

Efficacy and safety of a new oral saliva equivalent in the management of xerostomia: a national, multicenter, randomized study.

OBJECTIVE AND STUDY DESIGN: The clinical efficacy, safety, and acceptability of a new oral saliva equivalent (Novasial) administered four times daily in the treatment of xerostomia in various medical conditions was compared with that of oxygenated glycerol triester oral spray (Aequasyal) and a moisturizing spray (Biotene) in a 2-week, multicenter, randomized, crossover study. Assessment included patient-based evaluation of mouth dryness score (primary endpoint) with a visual analog scale (VAS), blinded assessment of the oral tissue condition by a four-point ordinal scale, and patient-based assessment of tolerability and acceptability. RESULTS: At day 14, Novasial decreased oral mouth dryness by 19.5%, (12.5 ± 22.6 mm, P < .0001 versus baseline), versus 10% (6.6 ± 17.9 mm with Aequasyal, P < .0001 versus Baseline; and P < .0156 versus Novasial) and 13% (8.6 ± 18.9 mm) with Biotene (P < .0001 versus baseline). The 50% decrease in the primary endpoint was not achieved, and the overall efficacy of Novasial and Aequasyal were similar with respect to xerostomia. Novasial was preferred to Aequasyal and Biotene in alleviating taste alteration and chewing difficulty. Treatment compliance was higher with Novasial (P = .0014 versus Aequasyal). The treatments improved the oral condition with equal efficacy and were safe and well tolerated (VAS 72-77 mm). CONCLUSIONS: Novasial was a safe, well-tolerated, and acceptable treatment in patients with xerostomia induced by various treatments or pathologic conditions.

An alternative approach for the treatment of vaginal atrophy.

AIM: The aim of this study was to determine the efficacy of a new topic non-hormonal treatment for postmenopausal women complaining of symptoms of vaginal atrophy. METHODS: Patients included in the study were prescribed Sinecol gel (AM PHARMA Srl, Vimercate, Monza and Brianza, Italy) application once a day for 20 consecutive days. Sinecol gel is a topic compound for vaginal atrophy containing hyaluronic acid, that is known to improve vaginal elasticity, lactoperoxidase, Xantham gum and glucose oxidase, which have protective and antibacterial action. We evaluated each patient before and after treatment, both subjectively with the "Visual Analogical Scale" (VAS) and objectively with the "Vaginal Health Index" (VHI). RESULTS: We observed a significant clinical improvement of the subjective and objective assessment of symptoms severity with a p value <0.001 at the end of the treatment compared to baseline. CONCLUSION: Sinecol gel appears to be an effective and valid non-hormonal alternative to the estrogen therapy for vaginal atrophy.

Flaminal enzyme alginogel: a novel approach to the control of wound exudate, bioburden and debridement.

A multidisciplinary panel of Woundcare experts of international repute was assembled to review the clinical evidence and advise on the classification of the Flaminal products. This is based on their exact role in wound management and is to be defined on the basis of clinical efficacy, evidence and utility. Experts of international repute from Australia, Belgium, Czech Republic, France, Germany, Italy, Netherlands, and UK participated in this exercise.

Effects of a composition containing lactoferrin and lactoperoxidase on oral malodor and salivary bacteria: a randomized, double-blind, crossover, placebo-controlled clinical trial.

We report a clinical trial of the effects of test tablets containing bovine lactoferrin and lactoperoxidase on oral malodor and salivary bacteria. Fifteen subjects with volatile sulfur compounds (VSCs) in mouth air above the olfactory threshold (H(2)S >1.5 or CH(3)SH >0.5 ng/10 ml) as detected by gas chromatography were enrolled in the trial. Either a test or a placebo tablet was ingested twice at 1-h intervals in two crossover phases. Mouth air was monitored for VSC levels at the baseline before ingestion of a tablet, 10 min after the first ingestion, 1 h (just before the second ingestion), and 2 h after the first ingestion. Whole saliva was analyzed at the baseline and at 2 h for bacterial numbers. At 10 min, the level of CH(3)SH was significantly lower in the test group (median [interquartile range] = 0.28 [0.00-0.68] ng/10 ml) compared to that in the placebo group (0.73 [0.47-1.00] ng/10 ml; P = 0.011). The median concentration of CH(3)SH in the test group was below the olfactory threshold after 10 min until 2 h, whereas the level in the placebo group was above the threshold during the experimental period. No difference in the numbers of salivary bacteria was detected by culturing or quantitative PCR, but terminal restriction fragment length polymorphism detected one fragment with a significantly lower copy number at 2 h in the test group (mean ± standard error, 4.89 ± 0.11 log(10) copies/10 µl) compared to that in the placebo group (5.38 ± 0.15 log(10) copies/10 µl; P = 0.033). These results indicate a suppressive effect of the test composition on oral malodor and suggest an influence on oral bacteria.

Different therapeutic strategies for burning mouth syndrome: preliminary data.

BACKGROUND: To compare different therapeutic supportive approaches in patients with burning mouth syndrome. A prospective study was carried out for this purpose. MATERIALS AND METHODS: The study involved 56 patients with burning mouth syndrome. They were randomly assigned to treatment with capsaicin, alpha-lipoic acid or lysozyme-lactoperoxidase (test drugs) or boric acid (control group). Symptoms were scored after 60 days treatment and 60 days after drug discontinuation. RESULTS: At the end of the treatment period, there was a significant reduction in the symptom scores of all of the patients who received the test drugs (P<0.01), and at the end of the follow-up period in the test groups as a whole (P<0.01); the reduction was not significant when considering each test group separately after the treatment period. All of the treatments were more effective than boric acid and there was no significant difference in the symptom scores of the control group at either of the study time-points. CONCLUSIONS: Our results demonstrate the similar effectiveness of capsaicin and alpha-lipoic acid in controlling the symptoms of burning mouth syndrome. Lysozyme-lactoperoxidase may be effective in the supportive care of BMS patients with xerostomia. The transitory effect observed after discontinuing drug administration justifies the use of prolonged therapy in chronically affected patients.

Evaluation of a mucoadhesive lipid-based bioerodable tablet compared with Biotène mouthwash for dry mouth relief--a pilot study.

OBJECTIVE: Salivary gland impairment is a major problem that can result in hyposalivation and a decrease in quality of life. Causes for mouth dryness can be grossly classified into three major groups: iatrogenic, immunogenic, and metabolic. At present, insufficient therapies exist to ease morbidity in this growing number of affected individuals. A need for new products to relieve oral dryness is mandatory. The aim of this study was to evaluate a mucoadhesive lipid-based bioerodable tablet as a novel device to decrease signs and symptoms associated with mouth dryness. METHOD AND MATERIALS: Twenty xerostomic patients were divided into two groups. In group 1, the mucoadhesive tablet was applied to the hard palate, while in group 2, Biotène mouthwash was applied and served as a control. Sialometry measurements, as well as a questionnaire assessing mouth dryness, were obtained before and after treatment. RESULTS: Application of the mucoadhesive tablets resulted in a significant reduction in the sensation of the mouth dryness (P = .016) compared to Biotène. Moreover, a 1.5-fold increase in unstimulated whole saliva flow was obtained after 30 minutes in the treatment group. CONCLUSION: A lipid-based mucoadhesive tablet has a beneficial role in reducing the sensation of dryness in patients with xerostomia.

Orally administered lactoperoxidase ameliorates dextran sulfate sodium-induced colitis in mice by up-regulating colonic interleukin-10 and maintaining peripheral regulatory T cells.

We previously demonstrated orally administered bovine lactoperoxidase (LPO) ameliorated dextran sulfate sodium-induced colitis in mice. Here, we examine the mechanism of action of LPO. Three days after colitis induction, expression of interferon-gamma mRNA in colonic tissue was significantly decreased in mice administered LPO; while mRNA expression of interleukin (IL)-10 and regulatory T cell (Treg) marker, Foxp3, were significantly increased. The proportion of CD4+CD25+ Tregs in peripheral CD4+ T cells was also significantly elevated when LPO was administered. Nine days after colitis induction, the severity of colitis symptoms, including body weight loss and colon shortening, was reduced and expression of IL-10 mRNA was increased in mice administered LPO. The proportion of CD4+CD25+ Tregs in peripheral leukocytes was also significantly elevated when LPO was administered. These results suggest LPO ameliorates colitis by up-regulating colonic anti-inflammatory cytokines and maintaining peripheral regulatory T cells.

Effects of orally administered bovine lactoperoxidase on dextran sulfate sodium-induced colitis in mice.

The effect of lactoperoxidase (LPO) on dextran sulfate sodium-induced colitis was examined in mice. After 9 d of colitis induction, weight loss, colon shortening, and the histological score were significantly suppressed in mice orally administered LPO (62.5 mg/body/d) as compared to a group administered bovine serum albumin. These results suggest that LPO exhibits anti-inflammatory effects in the gastrointestinal tract.

Orally administered lactoperoxidase increases expression of the FK506 binding protein 5 gene in epithelial cells of the small intestine of mice: a DNA microarray study.

Lactoperoxidase (LPO) is a component of milk and other external secretions. To study the influence of ingested LPO on the digestive tract, we performed DNA microarray analysis of the small intestine of mice administered LPO. LPO administration upregulated 78 genes, including genes involved in metabolism, immunity, apoptosis, and the cell cycle, and downregulated nine genes, including immunity-related genes. The most upregulated gene was FK506 binding protein 5 (FKBP5), a glucocorticoid regulating immunophilin. The upregulation of this gene was confirmed by quantitative RT-PCR in other samples. In situ hybridization revealed that expression of the FKBP5 gene in the crypt epithelial cells of the small intestine was enhanced by LPO. These results suggest that ingested LPO modulates gene expression in the small intestine and especially increases FKBP5 gene expression in the epithelial cells of the intestine.

A double-blind, crossover study of Biotène Oralbalance and BioXtra systems as salivary substitutes in patients with post-radiotherapy xerostomia.

This study assessed the efficacy of the Bioxtra (BX) and Biotène Oralbalance (OB) systems in the treatment of post-radiotherapy xerostomia. In a double-blind, crossover study, 20 patients with post-radiotherapy xerostomia were randomly allocated to receive either OB then BX, or vice versa, each product for 2 weeks, with a 1 week wash-out period in between. Subject-based dry mouth scores derived from 100-mm visual analogue scales were recorded at days 0 and 14 of each 2-week period, together with subjective perception of changes in dry mouth symptoms. Both treatments were effective, resulting in reduction of visual analogue scale scores from day 0-14. Between-groups comparisons identified that BX achieved significantly better improvements compared with OB for the perception of dry mouth and improvements in speech and was also rated as more pleasant to use than OB (P < 0.05). In conclusion, both treatments were effective in alleviating the symptoms of post-radiotherapy xerostomia, although BX achieved superiority in some of the outcomes assessed compared with OB.

Effects of orally administered bovine lactoferrin and lactoperoxidase on influenza virus infection in mice.

Milk contains a wide variety of host protective factors against infectious microbes. Among these protective factors, lactoferrin (LF) and lactoperoxidase (LPO) have been reported to exhibit antiviral activities as well as immuno-modulatory effects. In the present study, the effects of orally administered LF and LPO were assessed in a mouse influenza virus infection model. BALB/c mice were intranasally infected with 6.6x10(2) p.f.u. of influenza virus A/PR/8/34(H1N1). Bovine LF or LPO was administered once daily at a dose of 62.5 mg per mouse by gavage, starting 1 day before infection. Mice given LF or LPO showed a significantly lower lung consolidation score on day 6 after infection compared with the control mice that were given water instead. Concurrently, the number of infiltrated leukocytes recovered from bronchoalveolar lavage fluid (BALF) on day 6 was significantly lower in mice given LF or LPO. However, the virus yield in the BALF was not affected by these treatments. The serum level of IL-6, a pro-inflammatory cytokine, positively correlated with the lung consolidation score in each group and was significantly lower on day 6 in the mice given LPO. These results suggest the potential of oral administration of LF or LPO to attenuate pneumonia in influenza-virus-infected mice through the suppression of infiltration of inflammatory cells in the lung.

A phase II study of Biotene in the treatment of postradiation xerostomia in patients with head and neck cancer.

One of the major side effects of radical radiation therapy for head and neck malignancies is xerostomia, or dryness of the mouth. There is no clearly effective treatment for this condition, but we have observed that patients in our practice believe that their symptoms improve significantly when using two "over-the-counter" oral comfort products - Biotene (toothpaste, mouthwash and chewing gum) and Oralbalance gel. We decided to study these agents in a formal phase II study to evaluate their usefulness in patients with postirradiation xerostomia. Twenty-eight patients with post-irradiation xerostomia were entered on the study. All had biopsy-proven carcinoma of the nasopharynx, oropharynx, oral cavity, hypopharynx or larynx, and had received primary radiotherapy with curative intent (> or =50 Gy in 20 fractions) more than 4 months before study entry. More than 75% of both parotid glands were included in the primary radiation field. There was no clinical evidence of recurrent disease. Patients were provided with a 2-month supply of Biotene mouthwash, toothpaste, chewing gum and Oralbalance gel. Response was evaluated 1 and 2 months after study entry using a patient-completed visual analogue scale to assess the severity of xerostomia and its effects on quality of life. For analysis, the scored baseline was subtracted from the later scores to assess change. Patients with an increase of 10 mm from their baseline score on the visual analogue scale were classified as having responded to the treatment intervention, and those with an increase of > or =25 mm from their baseline score were classified as having experienced a major improvement in their symptoms. After 2 months of treatment, 15 patients (54%) reported an improvement in intraoral dryness and 10 of these patients (36%) reported a major improvement. Similar proportions of patients (46% some improvement, 25% major improvement) reported an improvement in their ability to eat normally. Seventeen patients (61%) reported an improvement in oral discomfort, and 12 of these (43%) had a major improvement in their symptoms. The results of this study suggest that the use of Biotene (mouthwash, toothpaste and chewing gum) and Oralbalance gel can improve many of the symptoms of radiation-induced xerostomia. A placebo effect could account for many of the observed improvements in symptoms, and in order to assess the role of these agents in the management of patients with postirradiation xerostomia a randomised phase III study is needed.