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Effectiveness of Vitamin B12 on Recurrent Aphthous Stomatitis in long term care: a Systematic Review

Centre conducting review The Taiwan Joanna Briggs Institute Collaborating Centre : A Collaborating Centre of the Joanna Briggs Institute, National Yang-Ming University, Taipei, Taiwan

Primary reviewer/contact Hsin-Li Liu, RN, MSN. 1.2 Contact: sinliliu@gmail.com Reviewer panel: Ruo-ping Han, PhD. 1 Yueh-Juen Hwu, PhD. 1.2 Shu Chin Chiu, RN. 2.3 Kai-Yu Tseng, PhD. 1.2 Lee-Wen,Pai RN, MSN. 1.2 1. Central Taiwan University of Science and Technology. 2. A Collaborating Centre of the Joanna Briggs Institute, National Yang-Ming University, Taipei, Taiwan 3. Feng-Yuan Hospital Department of Health

Background
Recurrent Aphthous Stomatitis (RAS) also known as canker sores, is one of the most common oral mucosa inflammatory ulcerative diseases worldwide. RAS is also an idiopathic condition in most patients.
1

The Aphthous ulcer condition is characterized by localized,

shallow, rounded, painful, small, clean borders, a peripheral erythematous halo, and a yellow or grayish, base. Aphthous ulcers usually occur in recurrent bouts at intervals of a few days to a few months. 1.2.3 Aphthous ulcers are painful sores that can occur anywhere inside the mouth, include the skin covering the inside of the lips and cheeks, the floor of the mouth, the tip or underside of the tongue, the soft palate, and the tonsillar areas. 4 It is one of the most painful oral mucosal
398

inflammatory ulcerative conditions and frequently impacts on daily life 5 include activities such as eating, swallowing and speaking. 4.6 An Aphthous ulcer usually heals within 7 to 14 days, however they often recur. If the ulcer persists for more than 3 weeks or there is recurrent formation of new aphthous ulcers, may other clinical abnormal, may arise in multisystemic disease.1 including Behcets disease,7.8.9.10.11.12.13 Sweets syndrome, neutropenia, some
21.22. 14.15.16.17

cyclic neutropenia,1.18-20. benign familial

25 26.27.28

Magic syndrome,

23.24.

a periodic syndrome with fever and pharyngitis,

29.30.31.32

various nutritional deficiencies with or without underlying gastrointestinal disorders, other

35

primary or nicorandil

immunodeficiencies,
33.34 36

and

infection

with

human

immunodeficiency virus. (NSAIDS)

Rarely, drugs such as nonsteroidal anti-inflammatory drugs

can give rise to oral ulcers, similar to RAS.

Epidemiological studies indicate that RAS is prevalent worldwide and may affect up between 2% and 50% in the general population; most estimates fall between 5% and 25% and the three-month recurrence rates can be as high as 50%. 37.38.39 The Aphthous ulcers symptoms can present in three main forms minor, major or herpetiform ulcers: Minor Aphthous ulcers is the most common, and appear as small (less than 10 mm in diameter), round, clearly defined, painful ulcers. Healing occurs in 10 to 14 days without scarring.
40

Major Aphthous ulcers lesions are larger (greater than 1 cm in

41 40

diameter). Healing may take 20 to 30 days or longer, and frequently results in scarring. Healing usually takes place within 7 to 15 days which generally results in scarring.

The

third and least common variety of RAS is herpetiform ulcers, presents with multiple small and painful ulcers, clusters of pinpoint lesions which often occur in multiples from 1 to 100, each being 23 mm although they tend to fuse, producing large irrgular ulcers. It might have female predisposition and tends to have an onset older age than other types of RAS. 42.43.44 The cause of aphthous ulcers remains unknown, however factors may include systemic diseases, nutritional deficiencies, food allergies, genetic predisposition, immune disorders, medications, and human immunodeficiency virus infection and environment.
45.46 1.2.

Nutritional

deficiencies or hemotologic diseases have been documented in 20% of patients with RAS. When Studies have found that patients to physicians for treatment for deficiencies of iron,
47.48

folate, and vitamin B12, record a 71% improvement in aphthous ulcer following replacement therapy. The lack of clarity regarding the aetiology of aphthous ulcers has resulted in treatments that are largely empirical. A medline search, starting at the year 1951, found 578
399

articles related to the treatment of RAS, including 110 clinical trials. Medical preparations from Licorice herbs pastes,
54 49.50.51

Myrtus communis (myrtle) herbs

55 57

52

and multivitamins,
56

53

adhesive

local antiseptics,

local and systemic antibiotics,

58

topical non-steroidal were among the

anti-inflammatory drugs,

topical corticosteroids,

and even topical and systemic

59.60.61

immunomodulators, immunosuppressants, and corticosteroids treatments given to patients with RAS.

Several Vitamin B12 (cobalamin) treatment for RAS have addressed this, the goals being to decrease pain, healing time, number and size of the ulcer, and to increase disease-free periods, vitamin B12may play an important role for Aphthous ulcers. A study by Brachmann (1954)
62

first suggested Vitamin B12 deficiency could be associated with

63

Aphthous ulcers.

The most common etiology of Vitamin B12 deficiency is food-cobalamin malabsorption Studies which examined the impact of age suggest a
64

resulting from gastric dysfunction.

high prevalence of subnormal cobalamin concentrations,

and in some reports, an inverse

relationship between age and serum cobalamin concentrations. 65.66 Burgan and colleagues, in their study of 143 patients experiencing recurrent aphthous stomatitis, found that 26.6% of aphthous subjects demonstrated B12 deficiency in contrast to 12.6% of the controls.
67

Piskin

et al. found 35 patients with RAS who have vitamin B12 levels were found to be significantly lower than 26 healthy controls, while significant differences were not found for the other assessed hematological factors.
48

Volkov et al. was used a randomized, double-blind,

placebo-controlled trial to confirmed the vitmin B12 in the RAS of treatment. Study suggests that daily 1000mcg vitamin B12 under the tongue may be preventive for Aphthous ulcers after 5 and 6 months of use, incidence of ulcers. 69 Burgress and Haley suggest that 500mcg Vitamin B12 30 discs with instructions to use two initially and then one each succeeding day, placing into saliva via adherent discs adhered to the buccal side of a tooth and disc dissolved over 20 to 40 minutes, it near an ulcer when present. All were instructed to make careful observations of their ulcers and report their observations at least once each week over a 30-day period. can result in the seven subjects who received the active discs, all seven (100%) reported a benefit. Six out of seven reported reduced duration of each ulcer, four out of seven reported less peak pain from each ulcer, and four out of seven reported lower frequencies of ulcers. This initial data suggested that the discs might reduce frequency of minor RAU and reduce duration and peak pain levels of
400
68

it was found that high levels of vitmin B12 seemed to reduce the

ulcers. 67 Treatment with vitamin B12 by oral supplementation is safe, inexpensive and effective for RAS.
36.37.38

Nonetheless, despite the results of the above studies, the potential effect of

Vitamin B12 on Aphthous ulcers is not well established. The purpose of this review was to study whether the daily used Vitamin B12 via oral supplements may be an effective strategy for reducing the number, duration, and pain of Aphthous ulcers. The Cochrane Library, Joanna Briggs Institute (JBI) database and CINAHL databases have been searched and no previous systematic reviews on this specifc topic were identified as being published or underway.

REVIEW QUESTION(S)/OBJECTIVES
The review objective is to synthesize the best available evidence on the effectiveness of daily orally taken vitamin B12 on the incidence, duration or severity of Recurrent Aphthous Stomatitis RAS.

Inclusion criteria

Types of Studies The review will consider any randomized controlled trials undertaken in in-patient and out-patient settings. In the absence of RCTs, other research study designs, such as non-randomized or quasi-randomized controlled trials and before-and-after studies, will be considered for inclusion.

Types of Participants Adults 18 + years old With Recurrent Aphthous Stomatitis RAS of either gender will be considered eligible.

Types of Interventions
daily orally taken vitamin B12

Types of Outcome measures

The outcome measures will include:
401

(1) Incidence of RAS

expressed as the proportion of participants experiencing one or more

Aphthous ulcers or expressed as number and size of the ulcer during the study period (2) Duration of RAS episodes expressed as the average number of days of RAS episodes. (3) Severity of these RAS episodes

Search strategy The search strategy is designed to identify all published and unpublished papers in English language from 1970 to present. The search will proceed in three stages, as follows; An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. The databases to be search include: Cochrane Central Register Controlled Trials (CENTRAL), Joanna Briggs Institute Library of Systematic Reviews Database of Abstracts of Reviews of Effectiveness. CINAHL PubMed ScienceDirect MEDNAR Dissertation International Conference Proceedings The specific disease descriptor to be added to the search strategy for each database is 1.Recurrent Aphthous Stomatitis 2.Canker sore 3.Oral ulcer 4.Mouth sore 5.cobalamin

Search term and keywords included 1.Vitamin B12 2.Recurrent Aphthous Stomatitis
402

3.Mouth sore 4.Aphthae 5.Canker sore 6. cobalamin 7. Vitamin B12 RCT 8. cobalamin RCT 9. Combine 1 or 2 10. Combine 3 or 4 11. Combine 5 or 6 12. Combine 2 or 7 13. Combine 2 or 8 14. Combine 7 and 8 15. Combine 2 or 3 or 7 16. Combine 2 or 3 or 8

Assessment of Methodological Quality Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using two standardized critical appraisal instruments from the JBI-MAStARI (Joanna Briggs Institute-Meta-Analysis of Statistics Assessment and Review Instrument) (Appendix I) will be used. Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

Data Collection/Extraction Data will be extracted from papers included in the review using standardized data extraction tools from the JBI-MAStARI. (Appendix II) Data extracted from experimental/observational studies will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives.

Data Synthesis Quantitative papers will, where possible, be pooled using the JBIMAStARI. All results will be subject to double data entry. Odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed using the standard Chi-square. Where statistical
403

pooling is not possible the findings will be presented in narrative form.

Potential Conflict(s) of Interest No conflict of interest.

404

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properties

and

therapeutic

efficacy

in

peptic

ulcer.

Drugs

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69. Volkov I, Rudoy I, Abu-Rabia U, et al. Case report: Recurrent aphthous stomatitis

responds to vitamin B12 treatment. Can Fam Physician. 2005;51: 844-845.

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Appendix I Critical Appraisal Checklist for Experimental Studies Reviewer __________________________________ Date _____________ Author ____________________________________ Year _____________ Record Number ____________________
1. Was the assignment to treatment groups random? 2. Were participants blinded to treatment allocation? 3. Was allocation to treatment groups concealed from the allocator? 4. Were the outcomes of people who withdrew described and included in the analysis? 5. Were those assessing the outcomes blind to the treatment allocation? 6. Were the treatment and control group comparable at entry? 7. Were the outcomes measured in the same way for all groups? 8. Were outcomes measured in a reliable way? 9. Was there adequate follow-up (>80%)? 10. Was appropriate statistical analysis used?

Yes

No

Unclear

N/A

Overall Appraisal: Include Exclude Seek further info. Reviewers Comments (Including reasons for exclusion):
___________________________________________________________________ ___________________________________________________________________

410

Appendix II Data Extraction Form for Experimental/Observational Studies Reviewer __________________________________ Date _____________ Author _____________________________________Year _____________ Record Number ___________________ Study Method: RCT Quasi-RCT Longitudinal Retrospective Observational Other Participants: Setting: ______________________________________________________________ Population: ______________________________________________________________ Sample size: ______________________________________________________________ Intervention: Intervention 1: ______________________________________________________________ Intervention 2: ______________________________________________________________ Intervention 3: ______________________________________________________________

Clinical Outcome Measures: Outcome Description Scale/Measure

411

Study Results: Dichotomous Data Outcome Intervention ( ) Number/Total Number Intervention ( ) Number/Total Number

Continuous Data Outcome Intervention ( ) Mean and SD (Number) Intervention ( ) Mean and SD (Number)

Authors Conclusions:
___________________________________________________________________ ___________________________________________________________________ ___________________________________________________________________

Reviewers Comments:
___________________________________________________________________ ___________________________________________________________________

412

Appendix III Critical Appraisal Checklist for Narrative, Expert opinion & text Reviewer _________________________________Date _____________ Author ___________________________________ Year _____________ Record Number ____________________________ Yes
1. Is the source of the opinion clearly identified? 2. Does the source of the opinion have standing in the field of expertise? 3. Are the interests of patients/clients the central focus of the opinion? 4. Is the opinions basis in logic/experience clearly argued? 5. Is the argument developed analytical? 6. 6. Is there reference to the extant literature/evidence and any incongruence with it logically defended? 7. Is the opinion supported by peers?

No

Unclear

Overall Appraisal: Include Exclude Seek further info. Reviewers Comments (Including reasons for exclusion): ______________________________________________________________ ______________________________________________________________ ______________________________________________________________

413

Appendix IV Data Extraction Form for Narrative, Expert opinion & text Reviewer _________________________________ Date ______________ Author ___________________________________ Year ________________ Journal _____________________ Record Number ________________

Study Description: Type of Text: ______________________________________________________________ Those Represented: _____________________________________________ Stated: _______________________________________________________ _____________________________________________________________ Allegiance/Position: _____________________________________________________________ ______________________________________________________________ Setting: ______________________________________________________________ Geographical: ______________________________________________________________ Cultural: _______________________________________________________ Logic of Argument: _____________________________________________________________ ______________________________________________________________ Data Analysis:_______________________________________________________ Authors Conclusions:
___________________________________________________________________ ___________________________________________________________________ ___________________________________________________________________

414

 Conclusions Illustration from Publication (page number)

Unequivocal

Evidence Credible

Unsupported

Extraction of findings complete: Yes Reviewers Comments:

___________________________________________________________________ ___________________________________________________________________ ___________________________________________________________________

415