Interventions for preventing oral mucositis for patients with cancer receiving treatment

Helen V Worthington; Jan E Clarkson; Tim OB Eden

doi:10.1002/14651858.CD000978.pub3

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Analysis 1.1

Comparison 1 Active treatment versus placebo/no treatment, Outcome 1 Mucositis (absent versus present).

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Analysis 1.2

Comparison 1 Active treatment versus placebo/no treatment, Outcome 2 Mucositis (0‐1 versus 2+).

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Analysis 1.3

Comparison 1 Active treatment versus placebo/no treatment, Outcome 3 Mucositis (0‐2 versus 3+).

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Analysis 2.1

Comparison 2 Comparisons between active interventions, Outcome 1 Mucositis (absent versus present).

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Analysis 2.2

Comparison 2 Comparisons between active interventions, Outcome 2 Mucositis (0‐1 versus 2+).

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Analysis 2.3

Comparison 2 Comparisons between active interventions, Outcome 3 Mucositis (0‐2 versus 3+).

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Analysis 3.1

Comparison 3 Side effects, Outcome 1 Amifostine.

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Table 1. Quality assessment of trials

Study	Concealed allocation	Outcome blinded	Explanation of drop outs	Risk of bias	Withdrawals %
Ahmed 1993	B	yes	yes	M	0
Anderson 1998	B	yes	yes	M	46
Antonado 2002	B	no	yes	H	10
Attal 1993	A	unclear	yes	M	0
Biswal 2003	A (B)	unclear	yes	M	0
Borowski 1994	A	no	yes	M	7
Bourhis 2000	A	unclear	no	H	8
Brizel 2000	A	no	yes (no)	M	0
Bubley 1989	A	yes	no	M	unclear
Buentzel 2006	A (B)	yes	no	H	0
Buntzel 1998a	B	unclear	yes	H	0
Cartee 1995	A	yes	no	M	10
Carter 1999	B	yes	yes	M	0
Castagna 2001	B	yes	yes	M	3
Cascinu 1994	A (B)	no	yes	M	0
Cengiz 1999	B	unclear	yes	H	0
Cerchietti 2006	A (B)	yes	yes	L (M)	0
Crawford 1999	B	unclear	yes	H	9
Damon 2004	B	unclear	no	H	0
Dazzi 2003	A (B)	yes	yes	L	0
Dickson 2000	A (B)	yes	yes	L	0
Dodd 1996	A	yes	yes	L	0
Dozono 1989	A	unclear	yes	M	0
Duenas 1996	A (B)	yes	yes	L	0
El Sayed 2002	A (B)	yes	yes	L (M)	0
Elad 2006	A (B)	yes	yes (no)	L (M)	13
Erlichman 1988	B	unclear	no	H	4
Ertekin 2004	A (B)	yes	yes	L	10
Ferretti 1988	A (B)	yes	no	M	10
Ferretti 1990	A	yes	no	M	36
Fidler 1996	B	yes	no	H	1
Foote 1994	A	yes	no	L	0
Frazen 1995	A	yes	yes	L	10
Freytes 2004	A (B)	yes	yes	L (M)	0
Giles 2003	A	yes	yes	H	0
Giles 2004	B	yes	yes	M	0
Gurjral 2001	A	yes	no	M	1
Hartmann 2001	C (B)	unclear	yes	H	0
Huang 2000	B	unclear	yes (unclear)	H	0
Huang 2003	B	unclear	no	H	0
Hwang 2003	B	no	yes	H	2
Ifrah 1999	B	yes	no	H	unclear
Jebb 1994	A (B)	yes	no	M	39
Karacetin 2004	B	unclear	yes	H	0
Katano 1995	B	no	yes	H	0
Kaul 1999	B	no	no	H	unclear
Koukourakis 2000	B	no	no	H	3
Labar 1993	B	yes	yes	M	0
Leborgne 1997	B	yes	no	H	4
Lee 1989	A	unclear	yes	M	unclear
Lilleby 2006	B	no	yes	H	2
Lockhart 2005	A(B)	yes	yes (no)	L (M)	0
Loprinzi 1990	A (B)	yes	yes	L	0
Mahood 1991	B	no	no	H	2
Makkonen 1994	A	unclear	yes	M	0
Makkonen 2000	A	no	yes	M	0
Meropol 2003	B	yes	yes	M	0
Mills 1988	B	unclear	yes	H	0
Nemunaitis 1995	A	yes	yes	L	0
Niibe 1985	A	yes	yes	L	21
Nottage 2003	A	yes	yes	L	1
Oberbaum 2001	A	yes	yes	L	6
Okuno 1999	B	yes	yes	M	0
Papas 2003	A (B)	yes	yes (unclear)	L	2
Pfeiffer 1990	B	yes	no	H	43
Pillsbury 1986	A (B)	yes	yes	L	10
Pitten 2003	A	yes	yes	L	0
Prada 1987	B	yes	no	H	10
Rahn 1997	B	yes (unclear)	yes	M	0
Rocke 1993	B	unclear	yes	H	1
Saarilahti 2002	A	yes	yes	L	0
Scarantino 2006	A (B)	yes	no	H	1
Scherlacher 1990	B	unclear	yes	H	0
Schneider 1999	A	yes	yes	L	0
Sheih 1997	A (B)	yes (unclear)	yes	L	0
Shenep 1988	A	yes	yes	L	0
Spencer 2005	A (B)	unclear	yes	M	0
Spielberger 2004	B	yes	yes (no)	M	0
Spijkervet 1989	B	yes	yes	M	0
Stokman 2003	A	yes	yes	L	11
Su 2003	A (B)	yes	yes	L	0
Symonds 1996	B	yes	yes	M	20
Trotti 2004	A (B)	yes	yes	L	0
Van der Lelie 2001	A (B)	yes	yes	L	0
Vokurka 2005	B	unclear	no	H	4
Wahlin 1989	A (B)	yes	yes	L	0
Wang 2002	B	unclear	no	H	0
Wijers 2001	B	yes	no	H	32
Yuen 2001	B	no	yes	H	0

Table 1. Quality assessment of trials

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Comparison 1. Active treatment versus placebo/no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mucositis (absent versus present) Show forest plot	48		risk ratio (Random, 95% CI)	Subtotals only

1.1 Aclyclovir versus placebo	1	57	risk ratio (Random, 95% CI)	1.33 [0.85, 2.08]
1.2 Allopurinol versus placebo/no treatment	2	68	risk ratio (Random, 95% CI)	0.62 [0.15, 2.47]
1.3 Amifostine versus no treatment	5	632	risk ratio (Random, 95% CI)	0.95 [0.92, 0.98]
1.4 Antibiotic (pastille or paste) versus placebo	3	435	risk ratio (Random, 95% CI)	0.93 [0.83, 1.04]
1.5 Benzydamine versus placebo	1	36	risk ratio (Random, 95% CI)	0.67 [0.47, 0.96]
1.6 Chinese medicine versus control (Dobell's solution)	1	147	risk ratio (Random, 95% CI)	0.44 [0.20, 0.96]
1.7 Calcium phosphate versus placebo	1	94	risk ratio (Random, 95% CI)	0.75 [0.58, 0.99]
1.8 Camomile versus placebo	1	135	risk ratio (Random, 95% CI)	0.79 [0.58, 1.07]
1.9 Chlorhexidine versus placebo or no treatment	4	374	risk ratio (Random, 95% CI)	0.79 [0.53, 1.17]
1.10 Folinic acid versus no treatment	1	107	risk ratio (Random, 95% CI)	3.65 [2.39, 5.58]
1.11 Glutamine versus placebo	3	194	risk ratio (Random, 95% CI)	0.85 [0.57, 1.26]
1.12 GM‐CSF versus no treatment	3	299	risk ratio (Random, 95% CI)	0.67 [0.42, 1.07]
1.13 Histamine gel versus placebo	1	39	risk ratio (Random, 95% CI)	1.35 [0.91, 1.99]
1.14 Honey versus control	1	40	risk ratio (Random, 95% CI)	0.85 [0.66, 1.08]
1.15 Hydrolytic enzymes versus no treatment	2	149	risk ratio (Random, 95% CI)	0.67 [0.31, 1.44]
1.16 Ice chips versus no treatment	3	178	risk ratio (Random, 95% CI)	0.64 [0.50, 0.82]
1.17 Iseganan versus placebo	1	221	risk ratio (Random, 95% CI)	0.59 [0.43, 0.80]
1.18 Misonidazole versus control	1	40	risk ratio (Random, 95% CI)	1.19 [0.98, 1.45]
1.19 Oral care protocol versus none	1	30	risk ratio (Random, 95% CI)	0.60 [0.42, 0.85]
1.20 Pilocarpine versus placebo	2	276	risk ratio (Random, 95% CI)	0.89 [0.60, 1.32]
1.21 Povidone versus water	2	172	risk ratio (Random, 95% CI)	0.84 [0.60, 1.18]
1.22 Prednisone versus placebo	1	66	risk ratio (Random, 95% CI)	1.03 [0.85, 1.25]
1.23 Propantheline versus placebo	1	12	risk ratio (Random, 95% CI)	0.40 [0.12, 1.31]
1.24 Prostaglandin versus placebo	2	76	risk ratio (Random, 95% CI)	1.47 [0.47, 4.55]
1.25 Sucralfate versus placebo	2	182	risk ratio (Random, 95% CI)	0.96 [0.85, 1.10]
1.26 Traumeel versus placebo	1	30	risk ratio (Random, 95% CI)	0.71 [0.48, 1.04]
1.27 Zinc sulphate versus placebo	1	27	risk ratio (Random, 95% CI)	0.87 [0.72, 1.06]
2 Mucositis (0‐1 versus 2+) Show forest plot	48		risk ratio (Random, 95% CI)	Subtotals only

2.1 Aloe vera versus placebo	1	58	risk ratio (Random, 95% CI)	0.92 [0.64, 1.32]
2.2 Amifostine versus placebo or no treatment	8	753	risk ratio (Random, 95% CI)	0.88 [0.80, 0.98]
2.3 Antibiotic pastille or paste versus placebo or no treatment	2	204	risk ratio (Random, 95% CI)	1.03 [0.87, 1.22]
2.4 Calcium phosphate versus placebo	1	94	risk ratio (Random, 95% CI)	0.63 [0.42, 0.94]
2.5 Camomile versus placebo	1	164	risk ratio (Random, 95% CI)	0.63 [0.33, 1.21]
2.6 Chinese medicine versus control (Dobell's solution)	2	248	risk ratio (Random, 95% CI)	0.44 [0.33, 0.59]
2.7 Chlorhexidine versus placebo or no treatment	2	99	risk ratio (Random, 95% CI)	1.83 [0.52, 6.43]
2.8 Folinic acid versus no treatment	1	125	risk ratio (Random, 95% CI)	2.38 [1.35, 4.21]
2.9 Glutamine versus placebo	4	243	risk ratio (Random, 95% CI)	0.92 [0.75, 1.12]
2.10 GM‐CSF versus no treatment	3	230	risk ratio (Random, 95% CI)	0.81 [0.56, 1.17]
2.11 Hydrolic enzymes versus no treatment	2	149	risk ratio (Random, 95% CI)	0.52 [0.36, 0.74]
2.12 Ice chips versus no treatment	3	178	risk ratio (Random, 95% CI)	0.38 [0.23, 0.62]
2.13 Indomethacin versus placebo	1	18	risk ratio (Random, 95% CI)	0.0 [0.0, 0.0]
2.14 Iseganan versus placebo	2	926	risk ratio (Random, 95% CI)	0.97 [0.89, 1.06]
2.15 Keratinocyte GF versus placebo	3	335	risk ratio (Random, 95% CI)	0.75 [0.54, 1.06]
2.16 Misonidazole versus control	1	40	risk ratio (Random, 95% CI)	0.97 [0.66, 1.42]
2.17 Oral care protocol versus none	2	408	risk ratio (Random, 95% CI)	1.00 [0.84, 1.19]
2.18 Pentoxifylline versus no treatment	1	140	risk ratio (Random, 95% CI)	1.0 [0.68, 1.47]
2.19 Pilocarpine versus placebo	2	276	risk ratio (Random, 95% CI)	0.99 [0.78, 1.26]
2.20 Povidone versus water	2	172	risk ratio (Random, 95% CI)	0.74 [0.29, 1.88]
2.21 Prednisone versus placebo	1	66	risk ratio (Random, 95% CI)	0.71 [0.47, 1.07]
2.22 Sucralfate versus placebo	3	116	risk ratio (Random, 95% CI)	0.68 [0.41, 1.12]
2.23 Systemic antibiotic clarithromycin versus no treatment	1	70	risk ratio (Random, 95% CI)	0.69 [0.47, 1.01]
2.24 Zinc sulphate versus placebo	1	30	risk ratio (Random, 95% CI)	0.42 [0.20, 0.89]
3 Mucositis (0‐2 versus 3+) Show forest plot	59		risk ratio (Random, 95% CI)	Subtotals only

3.1 Amifostine versus no treatment	10	808	risk ratio (Random, 95% CI)	0.70 [0.49, 1.00]
3.2 Antibiotic pastille or paste versus placebo	3	272	risk ratio (Random, 95% CI)	0.87 [0.73, 1.04]
3.3 Beta carotene versus control	1	20	risk ratio (Random, 95% CI)	0.38 [0.14, 1.01]
3.4 Calcium phosphate versus placebo	1	94	risk ratio (Random, 95% CI)	0.42 [0.23, 0.76]
3.5 Camomile versus placebo	1	164	risk ratio (Random, 95% CI)	1.14 [0.43, 3.00]
3.6 Chinese medicine versus control (Dobell's solution)	2	248	risk ratio (Random, 95% CI)	0.16 [0.07, 0.35]
3.7 Chlorhexidine versus placebo or no treatment	3	110	risk ratio (Random, 95% CI)	0.98 [0.76, 1.27]
3.8 Folinic acid versus no treatment	1	125	risk ratio (Random, 95% CI)	8.58 [0.47, 155.98]
3.9 Glutamine versus placebo	5	240	risk ratio (Random, 95% CI)	0.57 [0.23, 1.38]
3.10 GM‐CSF versus placebo	6	358	risk ratio (Random, 95% CI)	0.69 [0.36, 1.32]
3.11 Histamine gel versus placebo	1	39	risk ratio (Random, 95% CI)	1.05 [0.16, 6.74]
3.12 Honey versus control	1	40	risk ratio (Random, 95% CI)	0.27 [0.11, 0.66]
3.13 Hydrolytic enzymes versus no treatment	2	149	risk ratio (Random, 95% CI)	0.17 [0.06, 0.52]
3.14 Ice chips versus no treatment	3	178	risk ratio (Random, 95% CI)	0.24 [0.12, 0.48]
3.15 Iseganan versus placebo	2	926	risk ratio (Random, 95% CI)	1.00 [0.85, 1.19]
3.16 Keratinocyte GF versus placebo	2	254	risk ratio (Random, 95% CI)	0.69 [0.41, 1.15]
3.17 Misonidazole versus control	1	40	risk ratio (Random, 95% CI)	0.68 [0.17, 2.65]
3.18 Oral care protocol versus none	2	408	risk ratio (Random, 95% CI)	1.06 [0.68, 1.64]
3.19 Pilocarpine versus placebo	1	34	risk ratio (Random, 95% CI)	0.90 [0.58, 1.38]
3.20 Povidone versus water	2	172	risk ratio (Random, 95% CI)	0.57 [0.20, 1.62]
3.21 Prednisone versus placebo	1	66	risk ratio (Random, 95% CI)	0.64 [0.17, 2.46]
3.22 Prostaglandin versus placebo	2	78	risk ratio (Random, 95% CI)	1.06 [0.66, 1.70]
3.23 Sucralfate versus placebo	6	423	risk ratio (Random, 95% CI)	0.78 [0.61, 1.00]
3.24 Zinc sulphate	1	27	risk ratio (Random, 95% CI)	0.05 [0.00, 0.78]

Comparison 1. Active treatment versus placebo/no treatment

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Comparison 2. Comparisons between active interventions

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mucositis (absent versus present) Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 Cryotherapy: 30 min versus 60 min	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Etoposide: bolus versus continuous	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Mucositis (0‐1 versus 2+) Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Cryotherapy: 30 min versus 60 min	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Etoposide: bolus versus continuous	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 GM‐CFS versus sucralfate	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.4 Keratinocyte: 50 mg versus 25 mg	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Mucositis (0‐2 versus 3+) Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 Cryotherapy: 30 min versus 60 min	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 Etoposide: bolus versus continuous	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 GM‐CSF versus sucralfate	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.4 Keratinocyte: 50 mg versus 25 mg	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 2. Comparisons between active interventions

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Comparison 3. Side effects

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Amifostine Show forest plot	6		risk ratio (Random, 95% CI)	Subtotals only

1.1 Survival at 24 months	1	66	risk ratio (Random, 95% CI)	1.14 [0.88, 1.48]
1.2 Recurrence at 18 months after cancer treatment	2	213	risk ratio (Random, 95% CI)	1.04 [0.70, 1.55]
1.3 Incomplete response to radiotherapy	2	69	risk ratio (Random, 95% CI)	0.70 [0.33, 1.50]
1.4 Delay to radiotherapy	1	39	risk ratio (Random, 95% CI)	0.44 [0.19, 1.01]
1.5 Hypotension	4	536	risk ratio (Random, 95% CI)	2.32 [1.40, 3.84]
1.6 Nausea	4	500	risk ratio (Random, 95% CI)	1.69 [0.61, 4.67]
1.7 Vomiting	3	370	risk ratio (Random, 95% CI)	5.95 [1.03, 34.29]

Comparison 3. Side effects

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