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(五) 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

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399

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 Behcet’s

disease,7.8.9.10.11.12.13 Sweet’s syndrome, 14.15.16.17 cyclic neutropenia,1.18-20. benign familial

neutropenia, 21.22. Magic syndrome, 23.24. a periodic syndrome with fever and pharyngitis, 25

various nutritional deficiencies with or without underlying gastrointestinal disorders, 26.27.28

some other primary immunodeficiencies, 29.30.31.32 and infection with human

immunodeficiency virus. 33.34 Rarely, drugs such as nonsteroidal anti-inflammatory drugs

(NSAIDS) 35 or nicorandil 36 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

diameter). Healing may take 20 to 30 days or longer, and frequently results in scarring. 41

Healing usually takes place within 7 to 15 days which generally results in scarring. 40 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 2–3 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. 1.2.Nutritional

deficiencies or hemotologic diseases have been documented in 20% of patients with RAS. 45.46 When Studies have found that patients to physicians for treatment for deficiencies of iron,

folate, and vitamin B12, record a 71% improvement in aphthous ulcer following replacement

therapy. 47.48 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

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articles related to the treatment of RAS, including 110 clinical trials. Medical preparations

from Licorice herbs 49.50.51 Myrtus communis (myrtle) herbs 52 and multivitamins, 53 adhesive

pastes, 54 local antiseptics, 55 local and systemic antibiotics, 56 topical non-steroidal

anti-inflammatory drugs, 57 topical corticosteroids, 58 and even topical and systemic

immunomodulators, immunosuppressants, and corticosteroids 59.60.61 were among the

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) first suggested Vitamin B12 deficiency could be associated with Aphthous ulcers.

62 The most common etiology of Vitamin B12 deficiency is food-cobalamin malabsorption

resulting from gastric dysfunction. 63 Studies which examined the impact of age suggest a

high prevalence of subnormal cobalamin concentrations, 64 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, 68 it was found that high levels of vitmin B12 seemed to reduce the

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

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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:

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402

(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

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403

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

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404

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

Potential Conflict(s) of Interest

No conflict of interest.

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405

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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? Yes No Unclear N/A

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?

Overall Appraisal: □ Include □ Exclude □ Seek further info.

Reviewer’s Comments (Including reasons for exclusion):

___________________________________________________________________

___________________________________________________________________

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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

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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)

Author’s Conclusions:

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

Reviewer’s Comments:

___________________________________________________________________

___________________________________________________________________

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Appendix III

Critical Appraisal Checklist for Narrative, Expert opinion & text

Reviewer _________________________________Date _____________

Author ___________________________________ Year _____________

Record Number ____________________________

Yes No Unclear

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 opinion’s 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?

Overall Appraisal: □ Include □ Exclude □ Seek further info.

Reviewer’s Comments (Including reasons for exclusion):

______________________________________________________________

______________________________________________________________

______________________________________________________________

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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:_______________________________________________________

Author’s Conclusions:

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

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Conclusions Illustration from Publication (page number)

Unequivocal

Evidence Credible

Unsupported

Extraction of findings complete: □ Yes

Reviewer’s Comments:

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________