The effect of beta-glucan on recurrent aphthous stomatitis. A randomized double-blind trial of levamisole in the therapy of recurrent aphthous stomatitis. Norwegian LongoVital and recurrent aphthous ulceration: a randomized, double-blind, placebo-controlled study. Recurrent aphthous stomatitis unresponsive to topical corticosteroids: a study of the comparative therapeutic effects of systemic prednisone and systemic sulodexide. Double-blind trial of tetracycline in recurrent aphthous ulceration. Homeopathic treatment of minor aphthous ulcer: a randomized, placebo-controlled clinical trial. Subantimicrobial dose doxycycline in the treatment of recurrent oral aphthous ulceration: a pilot study. Effect of levamisole on the incidence and prevalence of recurrent aphthous stomatitis. A double-blind clinical trial. The effect of bee propolis on recurrent aphthous stomatitis: a pilot study. Effectiveness of vitamin B12 in treating recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled trial. A randomized, double-blind, placebo-controlled trial of pentoxifylline for the treatment of recurrent aphthous stomatitis. [Levamisole does not prevent lesions of recurrent aphthous stomatitis: a double-blind placebo-controlled clinical trial]. Comparison of colchicine versus prednisolone in recurrent aphthous stomatitis: A double-blind randomized clinical trial. Levamisole in aphthous stomatitis: evaluation of three regimens. Effects of cooking plant oils on recurrent aphthous stomatitis: a randomized, placebo-controlled, double-blind trial. Pilot study on recurrent aphthous stomatitis (RAS): a randomized placebo-controlled trial for the comparative therapeutic effects of systemic prednisone and systemic montelukast in subjects unresponsive to topical therapy. Therapeutic evaluation of levamisole in recurrent aphthous stomatitis. Double-blind comparison of two dosage schedules of levamisole and placebo. Levamisole in the treatment of recurrent aphthous stomatitis. Multivitamin therapy for recurrent aphthous stomatitis: a randomized, double-masked, placebo-controlled trial. Randomized, double-blind study of levamisole in recurrent aphthous stomatitis. Effects of camel thorn distillate on recurrent oral aphthous lesions. Treatment of recurrent aphthous stomatitis with clofazimine. Double-blind study of levamisole therapy in recurrent aphthous stomatitis.
nan A Controlled, double-blind study was performed to compare the effects of levamisole and placebo in eighteen patients with recurrent aphthous stomatitis. Levamisole is a drug which enhances defective cellular immune responses. It was administered in a flexible dosage schedule: 50 mg. three times daily for three consecutive days at the start of an aphthous lesion but with an interval of at least 2 weeks between courses of therapy. Placebo consisted of pills that were identical in appearance, taken according to the same schedule. Statistical evaluation showed decreased frequency of lesions, shorter duration, and diminished pain of lesions in the group receiving levamisole. Subsequent follow-up in an open trial confirmed these results. LongoVital (LV) is a herbal-based tablet enriched with the recommended daily doses of vitamins. The present study was undertaken to investigate possible prevention of recurrent aphthous ulceration (RAU) during 4 months daily intake of the Norwegian LV.
                The study was a placebo-controlled, double-blind, randomized, clinical trial.
                Sixty otherwise healthy patients with at least one attack of minor RAU per 2 months were included in the study.
                After an introduction period (IP) of 60 days, the patients were randomly divided into three groups and given either LV, the herbs of LV only, or placebo. Three test tablets were taken every day together with breakfast for 4 months [tablet period (TP)] and the patients followed up for another 4 months (F-UP). The number of new ulcers (NU) and ulcer-free days (UFD) were observed.
                Fifty-two patients completed the study. Neither NU nor UFD showed any statistical significant differences between any of the groups in any of the periods. All three groups, however, showed a significant increase in UFD during the first 2 months of TP compared to IP. Within the LV group only, there was a further increase in UFD after 2 months intake of the tablets. The number of NU and UFD decreased significantly in both the LV and the herbal group in F-UP compared with TP.
                Neither the Norwegian LV nor the herbal component alone was superior to placebo in the prevention of RAU. The results, however, indicate that neither the LV nor the herbal group benefited from the treatment. Recurrent aphthous stomatitis (RAS) is a common oral condition, the etiology of which remains largely unclear. Numerous therapeutic protocols have been tried. Apart from immunomodulators, no therapy is unequivocally effective, and many systemic therapies have potential adverse effects.
                To compare, in patients with frequent RAS unresponsive to conventional therapies, the therapeutic effectiveness of systemic prednisone with that of systemic sulodexide, a low-molecular-weight heparin with immunosuppressive activity but few adverse effects.
                The study involved a group of 30 patients suffering from frequent minor RAS over >or= 4 months unresponsive to topical corticosteroids. Patients were randomly assigned to one of three study groups: blind therapy with systemic sulodexide or systemic prednisone and control (no treatment). The outcomes were assessed blind on the basis of the days to recovery from pain and days to recovery from ulceration (epithelialization) during the first month of therapy; the number of aphthae appearing during the second month of therapy; and the number of aphthae appearing in the 2 months after the end of the 2-month treatment cycle.
                The effectiveness of systemic sulodexide was almost comparable with that of systemic prednisone in patients with frequent RAS, without significant adverse effects. A double-blind trial of a tetracycline suspension was carried out in 25 patients with recurrent aphthous oral ulcerations. A combined topical-systemic treatment procedure was used. Both the placebo and tetracycline group experienced reductions in ulcer incidence during the treatment period, whereas only the tetracycline group showed significant reductions in ulcer duration, size, and pain. Tetracylcine treatment apparently alters the severity of the ulcer, but does not appear to affect those factors responsible for recurrences. The side effects recorded in patients taking tetracycline were comparable to those in patients on placebo. The objectives of this study were to clinically determine the efficacy of individualised homeopathy in the treatment of minor recurrent aphthous ulceration (MiRAU).
                A randomized, single blind, placebo-controlled clinical trial of individualised homeopathy. One hundred patients with minor aphthous ulcer were treated with individualised homeopathic medicines or placebo and followed up for 6 days. Patients received two doses of individualised homeopathic medicines in the 6C potency as oral liquid at baseline and 12 h later. Pain intensity and ulcer size were recorded at baseline during and at the end of the trial (mornings of days 4 and 6).
                All 100 patients completed treatment. Between group differences for pain intensity and ulcer size were statistically significant at day 4 and at day 6 (P<0.05). No adverse effects were reported.
                The results suggest that homeopathic treatment is an effective and safe method in the treatment of MiRAU. Recurrent oral aphthous ulceration (ROAU) is a common problem that can result in considerable pain and distress for patients. The aim of this pilot study was to evaluate the role of subantimicrobial dose doxycycline (SDD - 20 mg doxycycline twice daily) in the management of patients with ROAU.
                50 patients with ROAU were randomly allocated to treatment with SDD or placebo for 90 days. Daily ulcer diaries were completed by the participants to record the number of new ulcers and the pain associated with the ulcers.
                There were significantly more days with no new ulcers in the SDD group (80.4 +/- 5.9) than the placebo group (69.8 +/- 18.7; P=0.04). Strong trends were observed towards fewer new ulcers per day, fewer new ulcers over the 90-day period, and more days with no pain in the SDD group compared with the placebo group (P=0.06-0.08).
                SDD shows promise as potential therapy in the management of ROAU, though this needs to be confirmed in further studies. Twenty patients with severe recurrent aphthous stomatitis were treated with a new drug, levamisole, to determine its effects upon the incidence and prevalence of recurrent aphthous stomatitis. The trial, conducted in a non-crossover, double-blind fashion, did not demonstrate any statistically significant differences when levamisole and placebo groups were compared over time either in the number of ulcers, number of ulcer-days, mean duration of ulcers, or mean number of ulcers per day. Positive subjective results were experienced by the 10 patients receiving levamisole but these were not of sufficient magnitude to affect group mean differences. Recurrent aphthous stomatitis (RAS) is a common, painful, and ulcerative disorder of the oral cavity of unknown etiology. No cure exists and medications aim to reduce pain associated with ulcers through topical applications or reduce outbreak frequency with systemic medications, many having serious side effects. The purpose of this pilot study was to evaluate the potential of a product to reduce the number of outbreaks of RAS ulcers. Propolis is a bee product used in some cultures as treatment for mouth ulcers. In this randomized, double-blind, placebo-controlled study, patients were assigned to take 500 mg of propolis or a placebo capsule daily. Subjects reported a baseline ulcer frequency and were contacted biweekly to record recurrences. Data were analyzed to determine if subjects had a decrease of 50% in outbreak frequency. The data indicated a statistically significant reduction of outbreaks in the propolis group (Fisher's exact test, one sided, p = 0.04). Patients in the propolis group also self-reported a significant improvement in their quality of life (p = 0.03). This study has shown propolis to be effective in decreasing the number of recurrences and improve the quality of life in patients who suffer from RAS. Propolis should be evaluated further in a larger sample clinical trial. The frequency of recurrent aphthous stomatitis (RAS), the most common oral mucosa lesions seen in primary care, is up to 25% in the general population. However, there has been no optimal therapeutic approach. Our objective was to confirm our previous clinical observation of the beneficial treatment of RAS with vitamin B(12).
                A randomized, double-blind, placebo-controlled trial was done using primary care patients. A sublingual a dose of 1000 mcg of vitamin B(12) was used in patients in the intervention group for 6 months.
                In total, 58 patients suffering from RAS participated in the study: 31 were included in the intervention group and 27 were included in control group. All parameters of RAS among patients in the intervention group were recorded and compared with the control group. The duration of outbreaks, the number of ulcers, and the level of pain were reduced significantly (P < .05) at 5 and 6 months of treatment with vitamin B(12), regardless of initial vitamin B(12) levels in the blood. During the last month of treatment a significant number of participants in the intervention group reached "no aphthous ulcers status" (74.1% vs 32.0%; P < .01).
                Vitamin B(12) treatment, which is simple, inexpensive, and low-risk, seems to be effective for patients suffering from RAS, regardless of the serum vitamin B(12) level. To evaluate pentoxifylline for the treatment of recurrent aphthous stomatitis.
                A 60-day, randomized, double-blind, placebo-controlled trial with a 60-day no treatment follow-up.
                An oral medicine specialist referral center in Manchester.
                Forty-nine volunteers who passed the initial assessment for recurrent aphthous stomatitis entered a pretrial phase in which their eligibility for the trial phase of the study was assessed. Sixteen subjects were deemed ineligible, and 7 failed to attend or withdrew. The remaining 26 subjects were randomized to placebo or treatment. Six subjects withdrew because of adverse effects, and 1 was unavailable for follow-up.
                Pentoxifylline (also called oxpentifylline), 400 mg 3 times daily, or matching placebo.
                A reduction in the median pain score, ulcer size, number of ulcers, or total number of ulcer episodes.
                Patients taking pentoxifylline had less pain and reported smaller and fewer ulcers compared with baseline. Patients taking placebo reported no improvement in these variables. Patients taking pentoxifylline also reported more ulcer-free days than those taking placebo. However, the differences were small and, with the exception of median ulcer size (P = .05), did not reach statistical significance. Adverse effects were common with pentoxifylline, but not significantly different from those experienced by patients taking placebo.
                Although pentoxifylline may have some benefit in the treatment of recurrent aphthous stomatitis, the benefit is limited. It may have a role in the treatment of patients unresponsive to other treatments, but cannot yet be recommended as a first-line treatment. to utilize a double-blind protocol to provide clarification about the safety and effectiveness of levamisole in the treatment of recurrent aphthous stomatitis.
                Fourteen patients took a decreasing dose of oral levamisole for six months (initial dose 150mg three times a week) and ten others were placebo control patients. All were evaluated monthly.
                The number of crises had a tendency to decrease in both groups, but without a difference between groups. The number of lesions diminished significantly in the two groups, but upon comparison the difference was not significant. Duration of the lesions diminished significantly in the placebo, however when compared to the levamisole group, difference was not significant during treatment. The intensity of pain was significantly lower in the two groups, but upon comparison, pain was significantly lower in the placebo group. The final global evaluation showed improvement in 50% of patients of the levamisole group and in 70% of the placebo, without a significant difference between treatments. No difference in the frequency of collateral effects was observed between groups.
                Levamisole, as used in this protocol, is a safe drug. When compared with the placebo, levamisole is not effective in the prophylactic treatment of recurrent aphthous stomatitis. The placebo effect is important in diseases where emotional factors affect recurrence or expression of symptoms. Recurrent aphthous stomatitis (RAS) is one of the most common ulcers of the oral cavity with a reported prevalence of 5- 50%. There is still no definitive treatment for RAS; however, immunosuppressive and immunomodulant agents have been proposed. In this study, we compared the therapeutic effects of 5 mg/d prednisolone with 0.5 mg/d colchicine in the treatment of RAS.
                In a double-blind randomized clinical trial, 34 patients with RAS were randomly divided into two groups for treatment with prednisolone or colchicine. All patients took the medication for three months and were assessed at two weeks intervals. The groups were compared for size and number of lesions, severity of pain and burning sensation, duration of pain-free episodes and any side effects of the prescribed medicines. Both colchicine and prednisolone treatments significantly reduced RAS (p < 0.001). No significant differences in size and number of lesions, recurrence and severity of pain and duration of pain-free period were seen between the two treatment groups. Colchicine (52.9%) had significantly more side effects than prednisolone (11.8%).
                Low dose prednisolone and colchicine were both effective in treating RAS. Given that the two therapies had similar efficacy, yet colchicine was associated with more side effects, , 5mg/d of prednisolone seems to be a better alternative in reducing the signs and symptoms of the disease. One hundred and twenty-four patients who had had recurrent aphthous stomatitis (RAS) for two to 53 years took part in three studies to assess the effectiveness of levamisole and determine an adequate regimen. In study 1 and the first half of study 2 both of which were double-blind, levamisole 150 mg/day (or placebo) was given on three consecutive days in every fortnight. In the second two months of study 2 and in the open trial (study 3) three-day courses were given only when an episode of RAS occurred. The drug was well tolerated. The signs and symptoms of RAS improved gradually and significantly in those treated with levamisole but not in those on placebo, and intergroup differences were also significantly in favour of the active drug. Improvement occurred earlier in study 3 than in the other two studies. Hence levamisole may prevent new episodes of RAS. One-third of the total population seems to develop minor recurrent aphthous stomatitis (RAS) during their lifetime. However, well-controlled dietary intervention studies to prevent minor RAS are very rare. The objective of the present study was to investigate whether the prevalence of RAS decreased with perilla oil (rich in alpha-linolenic acid).
                Thirty subjects (8 men and 22 women) who had minor RAS at least once a month were randomly allocated to a soybean oil group or a perilla oil group in a double-blind manner (experimental phase) after a run-in phase of 4 mo during which subjects used a reference oil, the most popular cooking oil in Japan, or a 50/50 mixture of soybean oil and rapeseed oil. During the experimental phase, subjects were asked to use soybean oil or perilla oil as the sole cooking oil for 8 mo. Blood samples were collected at the start and end of the experimental phase for fatty acid analysis of total plasma phospholipid fraction. Occurrence and needed days for healing of minor RAS were recorded during the two phases and compared.
                alpha-Linolenic acid concentrations in the plasma phospholipid fraction increased significantly in both groups during the experimental phase to a similar extent. The prevalence of minor RAS in the experimental phase decreased significantly in both groups compared with the run-in phase to a similar extent, without intergroup differences.
                Perilla oil, which is rich in alpha-linolenic acid, was not superior to soybean oil in preventing minor RAS. There was a possibility that avoiding rapeseed oil might be beneficial for prevention of minor RAS. Recurrent aphthous stomatitis (RAS) is characterized by recurrent painful oral ulcers whose etiology remains largely unknown. Numerous therapeutic protocols have been tried so far, but effectiveness remains an issue.
                To test a new drug for patients with recurrent oral aphthae nonresponsive to local corticosteroid therapy, we compared the therapeutic effectiveness and adverse effects of systemic prednisone and systemic montelukast in a placebo-controlled trial.
                Sixty patients suffering from minor RAS for > or =6 months were studied and randomly assigned to 3 groups of 20 each in a double-blind study. Patients of group A took 25 mg prednisone orally daily for 15 days, 12.5 mg daily for 15 days, 6.25 mg daily for 15 days, then 6.25 mg on alternate days for 15 days. Patients of group B took 10 mg montelukast orally every evening and then on alternate days for the second month. Patients of group C took 100 mg cellulose (placebo) by mouth daily for the first month and on alternate days for the second month. Outcomes assessed were days til pain cessation, days to ulcer healing, and number of aphthae occurring during the follow-up period.
                Both prednisone and montelukast were effective in reducing the number of lesions and improving pain relief and ulcer healing when compared with placebo. Prednisone was more effective than montelukast in pain cessation (P < .0001) and in accelerating ulcer healing (P < .0001). However, adverse drug reactions recorded during the entire trial were more common in the prednisone group compared with montelukast (10%) and placebo (10%).
                These data suggest that the effectiveness of systemic montelukast is similar to that of systemic prednisone in patients with RAS. The lack of serious side effects makes montelukast a candidate drug to use in cases of RAS where pharmacologic therapy for long periods is needed.
                Copyright 2010 Mosby, Inc. All rights reserved. nan In a pilot study as well as in a double-blind placebo-controlled study, 21 patients suffering from recurrent aphthous stomatitis were treated with the immunotherapeutic agent, levamisole. The results obtained confirm previous studies that levamisole has a beneficial effect on the symptoms of recurrent aphthous stomatitis and is well-tolerated. Recurrent aphthous stomatitis (RAS) is a painful condition of unknown etiology, affecting more than 2.5 billion people worldwide. Vitamin deficiencies have been implicated as a possible cause.
                The authors conducted a single-center, randomized, parallel-arm, double-masked, placebo-controlled study to examine the effect of daily multivitamin supplementation on the number and duration of RAS episodes. The authors randomly assigned 160 adults who had a validated history of at least three episodes of idiopathic minor RAS within the previous 12 months to one of two groups: the first group (n = 83) received a once-daily multivitamin containing 100 percent of the U.S. reference daily intake (RDI) of essential vitamins, and the second group (n = 77) received once-daily placebo for up to 365 days.
                The results showed no significant difference in the mean number of new RAS episodes between the multivitamin (4.19 episodes) and placebo (4.60 episodes) arms during the study period (P = .69). The mean duration of new RAS episodes also was similar for the multivitamin (8.66 days) and placebo (8.99 days) arms (P = .60). Furthermore, the authors found no differences between the two arms with regard to mouth pain, normalcy of diet or compliance with the study medication regimen.
                Daily multivitamin supplementation, with the RDI of essential vitamins, did not result in a reduction in the number or duration of RAS episodes.
                Clinicians should not recommend multi-vitamin supplementation routinely as prophylaxis for RAS. A randomized double-blind study was designed to evaluate the safety and efficacy of levamisole in the treatment of recurrent aphthous stomatitis (RAS). Thirty patients, aged 9-65 years, were selected, based on a documented history of three or more episodes of RAS. Patients were instructed to take 150 mg of levamisole (or placebo) daily for 3 days at the onset of the first prodromal symptoms of an ulcer. The regimen was to be repeated for each new episode, but not more than once per week. At each episode patients were examined and evaluated as to number and duration of ulcers, interval between episodes, pain associated with ulcers, and side effects. Data on 24 patients were suitable for analysis. Of those patients receiving levamisole, six showed slight improvement and five were unchanged. Of those patients receiving the placebo, one showed a marked improvement, four slight improvement, six were unchanged, and two deteriorated. There was neither a clinical nor a statistically significant difference between the groups. It is concluded that levamisole, in this study protocol, had no effect on the incidence or severity of aphthous ulcers. Near 20 % of people suffer from recurrent oral aphthous ulcers. These painful ulcers are found on the oral mucosa. We conducted this study to evaluate the effect of the camel thorn distillate on this condition.
                93 patients with recurrent aphthous ulcers were selected and divided into two groups. One group was given a placebo (n = 44) and the other was given camel thorn distillate (n = 49). The diameter of the lesions and the severity of the pain were measured 3, 5, 7, 10 and 14 days after initiation of therapy. The lesion diameters and pain scores of the two groups were compared using the t-test.
                Complete resolution time ranged from 3 to 7 days (mean = 4.02) in the group treated with camel thorn distillate, whereas in the control group, complete resolution time ranged from 7 to 14 days (mean = 8.9, p < 0.001).
                The efficacy of camel thorn distillate is comparable to that of other drugs used to treat oral aphthous ulcers. Its therapeutic effect may be due to the flavanones (alhagitin and alhagidin) that are present in this plant. The aim was to investigate the safety and efficacy of clofazimine for the treatment of recurrent aphthous stomatitis.
                In this randomized controlled partially blind study, 23 patients received clofazimine 100 mg daily for 30 days and then 100 mg every other day. Twenty-three patients received colchicine 0.5 mg 3 times daily. Twenty patients received 1 placebo pill 2 times daily. All subjects received medications for 6 months. The chi-squared or Fisher exact tests were used to assess drug efficacy with respect to objective findings and symptoms.
                A greater percentage of individuals in the clofazimine group had no further aphthous episodes (17%-44% compared with <or=6% in the other groups). A significantly greater percentage of treatment interruption occurred in the colchicine group because of gastrointestinal effects (23%-45%). Individuals in the clofazimine group who continued to suffer from aphthous stomatitis presented with better results for the evaluated variables.
                Clofazimine should be considered for the treatment of recurrent aphthous stomatitis. Forty-eight patients with diagnosed recurrent aphthous stomatitis participated in a randomized double-blind study of levamisole therapy. Each patient's response to treatment was determined by the following criteria: (1) days between attacks, (2) duration of lesions, (3) patient's self-evaluation of pain, (4) investigator's clinical evaluation of patient's subjective treatment response. Statistical analysis of the levamisole and placebo groups of criteria 1 and 2 above revealed no significant difference. In contrast to the above findings, analysis of the investigator's recordings of patient's subjective treatment response showed that 26% of the levamisole patients experienced marked or moderate improvement. None of the placebo patients were recorded as having experienced the same degree of benefit. Fourteen of 15 patients who complained of side effects were taking levamisole. The most common side effects were dysgeusia and hyperosmia.
No single treatment was found to be effective and therefore the results remain inconclusive in regard to the best systemic intervention for RAS. This is likely to reflect the poor methodological rigour of trials, and lack of studies for certain drugs, rather than the true effect of the intervention. It is also recognised that in clinical practice, individual drugs appear to work for individual patients and so the interventions are likely to be complex in nature. In addition, it is acknowledged that systemic interventions are often reserved for those patients who have been unresponsive to topical treatments, and therefore may represent a select group of patients.