EAL

ONC: Glutamine (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To evaluate options for management of treatment-induced oral mucositis in cancer patients.

Inclusion Criteria:

randomised controlled trials (cross-over and parallel groups)
including patients with chemotherapy or radiation therapy treatment for cancer
intervention aimed to prevent oral mucositis
outcome included prevention of mucositis, pain, amount of pain medication, difficulty swallowing, infection, length of hospitalization, cost of oral care and measure of patients quality of life.

Search strategy included:

Cochrane Oral Health Group's Trials Register (May 2002)
Cochrane Central Register of Controlled Trials
MEDLINE (from 1966 to May 2002)
EMBASE (from 1974 to June 2002)

Not limited to specific language- studies were translated into English.

Reference lists from appropriate studies were also evaluated.

Authors of trials and specialists in the field were contacted regarding further publications and unpublished trials.

Date of most recent search was June 2002.

Exclusion Criteria:

abstracts without enough information (Okuno 1998)
mucositis data presented in the form of mean scores (Jebb 1995)
mucositis data not in appropriate form other than above (Anderson 1998, Decker-Baumann 1999)
Data presented as episodes not as patients
Major change to study protocol 1/2 way through study (Okuno 1997)
Investigation of new cancer treatment with mucositis being a side effect
not RCT
RCT design fault
Comparison of XRT treatments
Qualitatitive assessment of mucositis

Description of Study Protocol:

Recruitment 109 studies were eligible for this metaanalysis. 57 were excluded. The 52 useable studies for all inventions for oral mucositis included 3594 patients. Studies included in this metaanalysis that had glutamine as the intervention include Anderson 1998, Dickson 2000, Jebb 1994, Huang 2000, and Okuno 1999.

Design

Authors were contacted for details on randomization and withdrawals. A quality assessment of each study was then completed.

Blinding used:

All information from available studies was independently abstracted by 2 reviewers.

Intervention:

Glutamine versus placebo

Statistical Analysis

Relative risk values were calculated with a 95% confidence interval.

Agreement between reviewers was checked by the kappa score.

Data Collection Summary:

Anderson 1998

This randomised, double-blind, cross-over study was conducted on 24 children and adults with solid cancers (only 13 completed the study). Patients took 4 ml/m² twice daily as a swish and swallow or placebo of glycine to test effectiveness on mucositis after 14 days of intervention.

Dickson 2000

58 BMT patients participated in this randomised, parallel group trial for 28 days or until discharge. The patients with solid and hematologic cancers received either sugar water or 30 gm glutamine/day (in 10 gm doses).

Huang 2000

17 patients with head and neck cancer were enrolled at the beginning of XRT to this randomised parallel group study. Patients received either saline placebo or 2 gm glutamine for oral swish.

Jebb 1994

This RCT enrolled 28 adults with gastrointestinal cancer getting 5FU and folic acid chemotherapy regimen. Only 11/28 completed the study with 2 cycles of chemotherapy. Patients were randomised to receive Polycal as placebo or 16 gm glutamine/day provided in 4 equal doses.

Okuno 1999

Another randomised, parallel study of 134 patients (site unclear) were given placebo or 4 gm glutamine twice daily.

Description of Actual Data Sample:

Summary of Results:

Findings

The pooled results are:

Mucositis score 0 versus 1+ OR 0.01 95% CI (0.00-4.24) p=0.14

Mucositis score 0-1 versus 2+ OR 0.70 95% CI (0.20-2.44), p=0.58

Musocitis score 0-2 versus 3+ OR 0.25 95% CI (0.03-2.16), p=0.21

Author Conclusion:

Glutamine was not found to be effective in preventing mucositis at any level of severity in this metaanalysis.

Funding Source:

Reviewer Comments:

This analyses did combine different patient populations and different treatment regimens. In addition, the dosing of glutamine was not standardized.

Quality Criteria Checklist: Review Articles
Relevance Questions
	1.	Will the answer if true, have a direct bearing on the health of patients?	Yes
	2.	Is the outcome or topic something that patients/clients/population groups would care about?	Yes
	3.	Is the problem addressed in the review one that is relevant to dietetics practice?	Yes
	4.	Will the information, if true, require a change in practice?	Yes

Validity Questions
	1.	Was the question for the review clearly focused and appropriate?	Yes
	2.	Was the search strategy used to locate relevant studies comprehensive? Were the databases searched and the search termsused described?	Yes
	3.	Were explicit methods used to select studies to include in the review? Were inclusion/exclusion criteria specified andappropriate? Wereselectionmethods unbiased?	Yes
	4.	Was there an appraisal of the quality and validity of studies included in the review? Were appraisal methodsspecified,appropriate, andreproducible?	Yes
	5.	Were specific treatments/interventions/exposures described? Were treatments similar enough to be combined?	No
	6.	Was the outcome of interest clearly indicated? Were other potential harms and benefits considered?	Yes
	7.	Were processes for data abstraction, synthesis, and analysis described? Were they applied consistently acrossstudies and groups? Was thereappropriate use of qualitative and/or quantitative synthesis? Was variation in findings among studies analyzed? Were heterogeneity issued considered? If data from studies were aggregated for meta-analysis, was the procedure described?	Yes
	8.	Are the results clearly presented in narrative and/or quantitative terms? If summary statistics are used, are levels ofsignificance and/or confidence intervals included?	Yes
	9.	Are conclusions supported by results with biases and limitations taken into consideration? Are limitations ofthe review identified anddiscussed?	No
	10.	Was bias due to the review's funding or sponsorship unlikely?	Yes