Efficacy of aloe vera gel as an adjuvant treatment of oral submucous fibrosis. Effectiveness of Aloe Vera and Antioxidant along with Physiotherapy in the Management of Oral Submucous Fibrosis. Evaluation of efficacy of aloe vera in the treatment of oral submucous fibrosis – a clinical study Phase II double-blind randomized study comparing oral aloe vera versus placebo to prevent radiation-related mucositis in patients with head-and-neck neoplasms. Comparison of therapeutic response of lycopene and curcumin in oral submucous fibrosis: A randomized controlled trial. A Randomised, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy of MF 5232 (Mucotrol™), a Concentrated Oral Gel Wafer, in the Treatment of Oral Mucositis Prospective, randomized, double-blind, clinical evaluation of Aloe vera Barbadensis, applied in combination with a tongue protector to treat burning mouth syndrome. Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial. Treatment of mucositis with combined 660- and 808-nm-wavelength low-level laser therapy reduced mucositis grade, pain, and use of analgesics: a parallel, single-blind, two-arm controlled study Prophylaxis with GM-CSF mouthwashes does not reduce frequency and duration of severe oral mucositis in patients with solid tumors undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue: a double blind, randomized, placebo-controlled study. A randomised controlled trial of Caphosol mouthwash in management of radiation-induced mucositis in head and neck cancer. Low-level laser therapy in the prevention and treatment of chemotherapy-induced oral mucositis in young patients. Mycophenolate mofetil as first-line treatment improves clinically evident early scleroderma lung disease. A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy. Efficacy and safety of granulocyte macrophage-colony stimulating factor (GM-CSF) on the frequency and severity of radiation mucositis in patients with head and neck carcinoma. Treatment of post-operative pain. Effect of topical oral G-CSF on oral mucositis: a randomised placebo-controlled trial
OBJECTIVE Definitive therapy is not defined for the management of oral submucous fibrosis ( OSMF ) . This study evaluated the efficacy of aloe vera gel as an adjuvant treatment of OSMF . STUDY DESIGN A double-blind , placebo-controlled , parallel-group r and omized controlled trial was conducted on 60 subjects with OSMF divided into medicinal treatment ( submucosal injection of hyaluronidase and dexamethasone , n = 30 ) and surgical treatment ( n = 30 ) categories . Each category was r and omly divided into groups A ( with aloe vera , n = 15 per category ) and B ( without aloe vera , n = 15 per category ) . Follow-up assessment for various symptoms was performed , and results were analyzed using paired and unpaired Student t tests . RESULTS The group receiving aloe vera had a significant improvement in most symptoms of OSMF ( P < .01 ) compared with the non-aloe vera group , in both the medicinal and surgical categories . CONCLUSIONS Aloe vera gel was effective as an adjuvant in treatment of OSMF BACKGROUND Oral submucous fibrosis ( OSMF ) is a well-established precancerous condition affecting the oral mucosa . It is a disease that causes significant morbidity ( in terms of loss of mouth function as tissues become rigid and mouth opening becomes difficult ) and mortality ( when transformation into squamous cell carcinoma occurs ) . AIM The aim of the study is to compare the efficacy of Aloe vera with antioxidant when given along with physiotherapy in the management of OSMF . MATERIAL S AND METHODS Forty patients presenting with clinical signs and symptoms of OSMF were included for the study after informed consent . Group A included 20 patients who received Aloe vera gel ( forever living gel ) along with physiotherapy . Group B included 20 patients who received antioxidant capsules twice daily for 3 months along with physiotherapy exercises four times in a day . The following parameters , that is , burning sensation , mouth opening , tongue protrusion and cheek flexibility were recorded at each visit . RESULTS Majority of the participant enrolled were in the age range of 30 to 35 years . Improvement in all the parameters was seen with the individuals receiving Aloe vera gel in comparison to antioxidants . CONCLUSION So , Aloe vera being a soothing , simple and safe mode of treatment along with proper habit restriction can be considered to be an effectual protocol in the management of OSMF . The analgesic effects of Aloe vera with the physiotherapy exercises provide better results in reducing burning sensation and improving mouth opening , tongue protrusion and cheek flexibility in comparison to antioxidants BACKGROUND Oral submucous fibrosis is a chronic disease , treatment of which has largely been symptomatic . Aloe vera has immunomodulatory , anti-inflammatory , wound healing , antioxidant , and antineoplastic activities . All such properties of aloe vera suggest the possibility of its use in the management of oral submucous fibrosis . METHODS Seventy-four patients of oral submucous fibrosis were r and omly divided into 2 groups . Group A patients were treated with systemic ( juice ) and topical aloe vera ( gel ) for 3 months . Group B patients were treated with intralesional injection of hydrocortisone and hyaluronidase for 6 weeks with antioxidant supplements for 3 months . Patients were assessed for reduction in burning sensation and increase in mouth opening , cheek flexibility , and tongue protrusion at an interval of 1 , 2 , and 3 months . RESULTS Both the groups showed statistically significant improvements in all the study parameters at the end of study period ( P < 0.001 ) . The clinical response to aloe vera was comparable to that of intralesional injections of hydrocortisone and hyaluronidase with antioxidant supplementation . CONCLUSION The study concludes that aloe vera can be an alternative , safe , and effective treatment regime in the management of oral submucous fibrosis . Long-term follow-up studies with larger sample size are recommended PURPOSE In a single-institution , double-blind , prospect i ve , r and omized trial , we determined whether oral aloe vera gel can reduce radiation-induced mucositis in head- and -neck cancer patients . METHODS AND MATERIAL S We r and omized 58 head- and -neck cancer patients between oral aloe vera and placebo .  To be included in this Phase II protocol , patients had to be treated with radiotherapy with curative intent at Stanford University between February 1999 and March 2002 . We examined patients biweekly for mucositis at 15 head- and -neck subsites and administered quality -of-life question naires . RESULTS Patients in the aloe and placebo groups were statistically identical in baseline characteristics . By the end of treatment , the two groups were also statistically identical in maximal grade of toxicity , duration of Grade 2 or worse mucositis , quality -of-life scores , percentage of weight loss , use of pain medications , hydration requirement , oral infections , and prolonged radiation breaks . CONCLUSION In our r and omized study , oral aloe vera was not a beneficial adjunct to head- and -neck radiotherapy . The mean quality -of-life scores were greater in the aloe vera group , but the differences were not statistically significant . Oral aloe vera did not improve tolerance to head- and -neck radiotherapy , decrease mucositis , reduce soreness , or otherwise improve patient well-being OBJECTIVES To evaluate and compare the therapeutic response of lycopene and curcumin with placebo in patients suffering from oral submucous fibrosis ( OSMF ) and to correlate the habit variables of smoked and smokeless tobacco products in OSMF . METHODS A r and omized placebo-controlled parallel clinical study was conducted on ninety OSMF patients , who were divided into three treatment groups using computer-generated r and omization . Group A patients ( n = 30 ) were given curcumin tablet ( 300 mg ) twice daily , Group B patients ( n = 30 ) received lycopene capsules ( 8 mg ) twice daily , and for Group C ( n = 30 ) , placebo capsules were given once daily for a period of six months . Both the participant and outcome assessor were blinded . Pre- and post-treatment comparison of mouth opening , burning sensation , tongue protrusion , and cheek flexibility was analyzed at periodic follow-up of 9 months . RESULTS The overall improvement in mouth opening , burning sensation , tongue protrusion , and cheek flexibility was 3.9 ± 4.9 mm , 4.8 ± 2.6 , 5.0 ± 7.2 mm , & 0.36 ± 0.71 mm , respectively , for curcumin and 4.1 ± 4.2 mm , 5.0 ± 2.3 , 2.4 ± 3.5 mm , & 0.66 ± 0.80 mm , respectively , for lycopene with the p value < 0.05 . CONCLUSION Statistically significant improvement in clinical findings was observed in both curcumin and lycopene treatment groups in comparison with placebo . However , the therapeutic efficacy of curcumin and lycopene was found to be almost equal in OSMF patients Abstract Objective : Oral mucositis is a major complication of cytotoxic chemotherapy and radiotherapy associated with significant morbidity , pain , odynophagia , dysgeusia and subsequent dehydration and malnutrition , and effective prophylaxis and /or treatment of this condition is essential . The currently available palliative treatment shows improvement only in patients with mild to moderate mucositis . The primary aim of this study was to compare the clinical efficacy of MF 5232 ( Mucotrol ™ ) , a concentrated oral polyherbal gel wafer formulation , with placebo in the management of chemoradiation-induced mucositis in cancer patients . Patients and design : In this r and omised , double-blind , pilot study a total of 30 patients of either sex with chemoradiation-induced oral mucositis were r and omised to receive MF 5232 ( n = 15 ) or a matching placebo ( n = 15 ) after food three times a day for 7–10 days . Patients were evaluated using vali date d and st and ardised scoring systems at baseline and after 7–10 days of treatment . Results : There were 11 evaluable patients in each treatment group . There was a significant reduction in mean mucositis scores with MF 5232 as follows : WHO ( from 3.0 to 1.8 ) , Radiation Therapy Oncology Group ( gross score : from 2.8 to 1.8 ; functional score : from 2.9 to 1.0 ) , and Objective Scoring System ( ulceration score : from 7.4 to 4.4 ; erythema score : from 13.7 to 7.0 ) . There were no significant changes in scores for placebo recipients . The treatments were well tolerated , with the exception of two patients in the treatment group who reported a burning sensation in the mouth after dissolving the wafer . Conclusion : This pilot study provided positive evidence for the efficacy of MF 5232 therapy in chemoradiation-induced mucositis . This was probably a result of its local analgesic , antioxidant and immunomodulatory activity and wound-healing properties . Further in-depth analysis in a larger number of patients is required to confirm these positive results OBJECTIVES The aim of this study was to evaluate the efficacy of aloe vera ( AV ) applied in combination with a tongue protector , comparing this with a placebo . METHODS A total of 75 patients with burning mouth syndrome ( BMS ) were divided into three groups r and omly : Group I ( tongue protector three times a day ) , Group II ( tongue protector and 0.5 ml AV at 70 % three times a day ) and Group III ( tongue protector and 0.5 ml placebo three times a day ) . Symptoms were evaluated by visual analogue scale ( VAS ) , while patient psychological profiles were assessed using the Hospital Anxiety-Depression scale and their quality of life using the Oral Health Impact Profile 49 ( OHIP-49 ) . Treatment continued for 3 months . RESULTS Visual analogue scale pain values improved for all three study groups but without statistically significant differences between the groups ( P = 0.210 ) . Regarding quality of life , no significant differences were found between groups with the exception of the OHIP-49 score for h and icap . The overall clinical improvement was greater for Group II , with a difference almost reaching significance . CONCLUSIONS The concomitant prescription of tongue protector and AV is effective for treating patients with BMS PURPOSE To compare the efficacy of an Aloe vera mouthwash with a benzydamine mouthwash in the alleviation of radiation- induced mucositis in head and neck cancer patients using a triple-blind , r and omised controlled trial . MATERIAL S AND METHODS Twenty-six eligible head and neck cancer patients who were to receive conventional radiation therapy at the radiation oncology department were r and omised to receive an Aloe vera mouthwash or a benzydamine mouthwash .  Mucositis severity was assessed during the course of radiation therapy using the WHO grading system . RESULTS At baseline , there was no difference in the distribution of mucositis severity between the two groups . The mean interval between radiation therapy and onset of mucositis was similar for both groups ( Aloe vera 15.69±7.77 days , benzydamine 15.85±12.96 days ) . The mean interval between the start of radiation therapy and the maximum severity of mucositis were was also similar in both the Aloe vera and benzydamine groups ( Aloe vera 23.38±10.75 days , benzydamine 23.54±15.45 days ) . Mean changes of mucositis severity over time in both groups were statistically similar and the effect of both treatments did not change signficantly with time ( p=0.09 ) . CONCLUSION Aloe vera mouthwash was as beneficial as benzydamine mouthwash in alleviating the severity of radiation-induced mucositis and showed no side effects .  The Aloe vera mouthwash could be an alternative agent in the treatment of radiation-induced mucositis in patients with head and neck cancers Oral squamous cell carcinoma ( OSCC ) is the most frequent oral malignant neoplasia . As consequence of OSCC treatment , oral mucositis ( OM ) is one of the most common adverse effects of OSCC treatment . Currently , there is no consensus for OM treatment . The purpose of the current study was to test the combination of red and infrared low-level laser therapy ( LLLT ) for OM treatment . Primary culture of human fibroblast was performed to identify LLLT dose . After laboratory tests , a two-arm parallel , single-blind , controlled study was conducted . The two arms were group 1 , both 660- and 808-nm wavelengths ( 300 J/cm2 , 9 J of total energy , 100 mW , spot size 3 mm2 ) , and group 2 , only 660-nm wavelength ( 300 J/cm2 , 9 J of total energy , 100 mW , spot size 3 mm2 ) . Both treatments were performed twice a week . Group 1 presented a reduction of mucositis grade in comparison to group 2 . Group 1 also presented reduction of analgesics prescription . But no significant differences between groups 1 and 2 were observed according to the pain scale . In conclusion , the current study demonstrated that a combination of red and infrared at a higher dose ( 300 J/cm2 ) reduced both oral mucositis grade and analgesics prescription . The effects of the combination of RT and LLLT are unclear and need more studies BACKGROUND The aim of this study was to evaluate the effectiveness of granulocyte-macrophage colony-stimulating factor ( GM-CSF ) mouthwashes in the prevention of severe mucositis induced by high doses of chemotherapy . PATIENTS AND METHODS Ninety consecutive patients affected by solid tumors and undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue were r and omized to receive placebo versus GM-CSF mouthwash 150 micro g/day . Patients were stratified on the basis of the conditioning treatment and the consequent different risk of severe oral mucositis . Treatment was administered from the day after the end of chemotherapy until the resolution of stomatitis and /or neutrophil recovery . RESULTS The statistical analyses were intention-to-treat and involved all patients who entered the study . The severity of stomatitis was evaluated daily by the physicians according to National Cancer Institute Common Toxicity Criteria . Both study and control groups were compared with respect to the frequency [ 30 % versus 36 % , chi(2 ) exact test , not significant ( NS ) ] and mean duration ( 4.8 + /- 4.7 versus 4.4 + /- 2.7 days , t-test , NS ) of severe stomatitis ( grade > or = 3 ) . Oral pain was evaluated daily by patients themselves by means of a 10 cm analog visual scale : the mean ( + /- st and ard error of the mean ) maximum mucositis scores were 4.8 + /- 3.5 versus 4.2 + /- 3.5 cm ( t-test , NS ) . Furthermore , 15/46 patients in the study group ( 33 % ) and 19/44 patients in the control group experienced pain requiring opioids ( chi(2 ) exact test , NS ) . CONCLUSION We did not find any evidence to indicate that prophylaxis with GM-CSF mouthwash can help to reduce the severity of mucositis in the setting of the patients we studied PURPOSE This phase III , non-blinded , parallel-group , r and omised controlled study evaluated the efficacy of Caphosol mouthwash in the management of radiation-induced oral mucositis ( OM ) in patients with head and neck cancer ( HNC ) undergoing radical (chemo)radiotherapy . PATIENTS AND METHODS Eligible patients were r and omised at 1:1 to Caphosol plus st and ard oral care ( intervention ) or st and ard oral care alone ( control ) , stratified by radiotherapy technique and use of concomitant chemotherapy .  Patients in the intervention arm used Caphosol for 7weeks : 6weeks during and 1-week post-radiotherapy . The primary endpoint was the incidence of severe OM ( CTCAE ⩾ grade 3 ) during and up to week 8 post-radiotherapy . Secondary endpoints include pharyngeal mucositis , dysphagia , pain and quality of life . RESULTS The intervention ( n=108 ) and control ( n=107 ) arms were well balanced in terms of patient demographics and treatment characteristics . Following exclusion of patients with missing data , 210 patients were available for analysis .  The incidence of severe OM did not differ between the intervention and control arms ( 64.1 % versus 65.4 % , p=0.839 ) . Similarly , no significant benefit was observed for other secondary endpoints . Overall , compliance with the recommended frequency of Caphosol was low . CONCLUSION Caphosol did not reduce the incidence or duration of severe OM during and after radiotherapy in HNC OBJECTIVE A pilot clinical study was conducted to evaluate the efficacy and feasibility of low-level laser therapy ( LLLT ) in the prevention and treatment of chemotherapy (CT)-induced oral mucositis ( OM ) in young patients . BACKGROUND DATA Besides compromising the patient 's nutrition and well-being , oral mucositis represents a portal of entry into the body for microorganisms present in the mouth , which may lead to sepsis if there is hematological involvement . Oncologic treatment tolerance decreases and systemic complications may arise that interfere with the success of cancer treatment . LLLT appears to be an interesting alternative to other approaches to treating OM , due to its trophic , anti-inflammatory , and analgesic properties . MATERIAL S AND METHODS Patients undergoing chemotherapy ( 22 cycles ) without mucositis were r and omized into a group receiving prophylactic laser-irradiation ( group 1 ) , and a group receiving placebo light treatment ( group 2 ) . Patients who had already presented with mucositis were placed in a group receiving irradiation for therapeutic purpose s ( group 3 , with 10 cycles of CT ) . Serum granulocyte levels were taken and compared to the progression of mucositis . RESULTS In group 1 , most patients ( 73 % ) presented with mucositis of grade 0 ( p = 0.03 when compared with the placebo group ) , and 18 % presented with grade 1 . In group 2 , 27 % had no OM and did not require therapy . In group 3 , the patients had marked pain relief ( as assessed by a visual analogue scale ) , and a decrease in the severity of OM , even when they had severe granulocytopenia . CONCLUSION The ease of use of LLLT , high patient acceptance , and the positive results achieved , make this therapy feasible for the prevention and treatment of OM in young patients OBJECTIVE To find an effective , safe immunosuppressive regimen as an alternative to cyclophosphamide ( Cy ) for the treatment of clinical ly evident diffuse scleroderma (dSSc)-associated alveolitis of recent onset . METHODS Five consecutive patients with dSSc and recent-onset alveolitis were enrolled and treated with mycophenolate mofetil ( MMF ) and small ( < or = 10 mg/day ) doses of predinisolone in this open-label trial . One patient with long-st and ing fibrosing alveolitis was later added to our cohort . Pulmonary function tests [ carbon monoxide diffusing capacity ( DLCO ) and forced vital capacity ( FVC ) ] , pulmonary high-resolution computed tomography ( H RCT ) scans and clinical assessment were performed before and at specified time-points after enrolment . Cases of significant infections , leucopenia and abdominal pain were recorded . RESULTS After 4 - 6 months of MMF therapy , DLCO improved significantly compared with pre-treatment ( mean DLCO 75.4 % vs 64.2 % of predicted value , respectively , P = 0.033 ) . Values of FVC also improved , with the difference almost reaching levels of statistical significance ( mean FVC 76.2 % vs 65.6 % of predicted value , P = 0.057 ) . Ground glass opacities cleared in three of four patients with recent-onset alveolitis and were reduced in one patient after 6 - 8 months of treatment . Breathlessness and cough improved by 3 months . A possible treatment failure was seen in one patient . However , in five patients functional and clinical improvement was sustained during the study period . No adverse events were recorded in this ongoing clinical trial . CONCLUSION Our preliminary data suggest that in patients with dSSc and recent , clinical ly apparent alveolitis , early treatment with MMF and small doses of corticosteroids ( CS ) may represent an effective , well-tolerated and safe alternative therapy The invasion and colonization of oral cavity mucosal tissues by microflora may contribute to the pathophysiology of ulcerative oral mucositis ( UOM ) . Iseganan is an analog of protegrin-1 , a naturally occurring peptide with broad-spectrum microbicidal activity . A r and omized , double-blind , placebo-controlled study was conducted to evaluate the efficacy and safety of iseganan in preventing UOM after stomatotoxic therapy . Patients received an oral rinse , consisting of iseganan 9 mg or placebo , to be swished/swallowed six times daily , starting with stomatotoxic therapy and continuing up to 21 days . Patients were assessed for stomatitis and UOM , and administered a question naire evaluating mouth pain and difficulty swallowing thrice weekly . The primary study efficacy endpoint was the proportion of patients who did not have peak stomatitis NCI-CTC grade > or=2 . Between November 2001 and June 2002 , 502 patients were r and omized to receive iseganan  ( 251 ) or placebo ( 251 ) . Equivalent numbers of patients in both cohorts received bone marrow or peripheral blood allogeneic or autologous stem cell transplantation ( SCT ) . Forty-three percent and 37 % of iseganan and placebo patients , respectively , did not have peak stomatitis grade = 2 ( P = 0.182 ) . There was no significant difference between the cohorts in stomatitis severity , incidence of UOM , peak mouth pain , peak difficulty swallowing , amount of opiate analgesics used , or adverse event type or incidence . A major impact of Iseganan on reducing stomatitis , UOM , or its clinical sequelae in patients receiving stomatotoxic therapy was not detected on this study PURPOSE Based on the clinical evidence of mucosal protection by GM-CSF during cytotoxic chemotherapy , a pilot study was undertaken to determine the safety and mucosal reaction of patients receiving GM-CSF while undergoing definitive conventional fractionated radiotherapy in head and neck carcinoma . METHODS AND MATERIAL S Patients were considered eligible if buccal mucosa and oropharynx were included in the teleradiation field . Ten adult patients with squamous cell carcinoma of head and neck ( buccal mucosa--8 and posterior 1/3 tongue--2 ) were entered into the trial . Radiation therapy was delivered with telecobalt machine at conventional 2 Gy fraction and 5 fractions/week . The radiation portals consisted of two parallel opposing lateral fields . GM-CSF was given subcutaneously at a dose of 1 microg/kg body weight , daily , after 20 Gy until the completion of radiation therapy . Patients were evaluated daily for mucosal reaction , pain , and functional impairment . RESULTS The median radiation dose was 66 Gy . Eight patients received > or = 60 Gy . The tolerance to GM-CSF  was good . All 10 patients completed the planned daily dose of GM-CSF without interruption . Mucosal toxicity was Grade I in four patients till the completion of radiotherapy ( dose range 50 - 66 Gy ) . Six patients developed Grade II reaction , fibrinous mucosal lesions of maximum size 1.0 - 1.5 cm , during radiotherapy . None developed Grade III mucositis . The maximum mucosal pain was Grade I during GM-CSF therapy . In two patients after starting GM-CSF the pain reduced in intensity . Functional impairment was mild to moderate . All patients were able to maintain adequate oral intake during the treatment period . Total regression of mucosal reaction occured within 8 days following completion of radiotherapy . CONCLUSIONS GM-CSF administration concurrently with conventional fractionated radiotherapy was feasible without significant toxicity . The acute side effects of radiotherapy namely mucositis , pain , and functional impairment were nil to minimal . The results are suggestive of mucosal protection by GM-CSF during radiotherapy and warrants further study in r and omized double blind trial The effectiveness of three treatments for alveolar osteitis was compared . It was found that chlorhexidine gluconate mouthwash treatment and 2.5 percent Lidocaine ointment treatment reduced the number of days a patient was symptomatic compared to the conventional eugenol-impregnated iodoform gauze treatment . With the conventional use of eugenol-impregnated iodoform gauze , the severity of the patient 's symptoms were reduced more effectively than with the other two treatments , but the symptoms lasted longer Oral mucositis is a dose-limiting toxicity of intensive chemotherapy . It is caused directly by the cytotoxic effect of chemotherapeutic agents and indirectly by sustained neutropenia . Severe oral mucositis is an important predisposing factor for life-threatening septic complications during aplasia . It also reduces quality of life . At present , no effective causal prophylaxis or treatment against oral mucositis is established . We performed a prospect i ve r and omised placebo-controlled trial using topical oral r-metHuG-CSF ( filgrastim ) in high- grade lymphoma patients treated according to the B-NHL protocol , which contains high-dose methotrexate and causes severe oral mucositis ( WHO grade s I – IV ) in > 50 % of patients . Between August 1996 and July 1997 , a total of 32 chemotherapy cycles were documented in eight patients ( four male , four female ) . Mucosal erythema and ulceration were recorded . All patients assessed their oral pain and impact on swallowing daily , using a subjective scale from no to maximal discomfort ( 1–10 ) . In addition , oral mucositis was assessed according to the WHO score  . Filgrastim was administered in 16 cycles as a viscous mouthrinse ( carboxymethyl- cellulose 2 % , oleum citrii ) 4 × 120 μg/day from days 10 to 16 . Sixteen cycles were given to control patients , of these 14 with placebo , and another two cycles with no treatment . Severe mucositis ( WHO grade III/IV ) was documented in 21 of 32 cycles ( 65.5 % ) . A difference of borderline significance was observed for the reduction of maximum severity of oral mucositis  between G-CSF vs placebo ( P = 0.058 ) , with a reduction of WHO grade IV of 50 % ( four G-CSF vs eight control ) . The number of days in hospital was reduced significantly in the G-CSF group ( P = 0.02 ) . In conclusion , topical oral G-CSF mouthrinses may be beneficial to reduce oral mucositis
The results of meta- analysis showed statistically significant differences between aloe vera and control groups in alleviating pain/burning sensation at the end of the first and second month , in favor of aloe vera , but no significant differences were found at the end of the third month .
With regard to objective clinical outcomes , no statistically significant differences were found between the groups .
Aloe vera has a promising effect in reducing pain/burning sensation and clinical improvement in patients with OSF .
The management of oral submucous fibrosis ( OSF ) is quite challenging , and as yet , no effective therapy is available for its management .
The present systematic review and meta- analysis sought to assess the effectiveness of aloe vera in alleviating pain and clinical signs of OSF .