Non surgical therapy for anal fissure

Richard Nelson

doi:10.1002/14651858.CD003431

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Analysis 1.1

Comparison 1 GTN versus Placebo, Outcome 1 NON ‐ Healing of fissure (persistance or recurrence).

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Analysis 1.2

Comparison 1 GTN versus Placebo, Outcome 2 Headache.

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Analysis 2.1

Comparison 2 GTN versus sphincterotomy, Outcome 1 NON ‐ Healing of Fissure (persistence or recurrence_.

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Analysis 2.2

Comparison 2 GTN versus sphincterotomy, Outcome 2 Minor Incontinence.

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Analysis 2.3

Comparison 2 GTN versus sphincterotomy, Outcome 3 Headache.

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Analysis 3.1

Comparison 3 GTN versus Botox, Outcome 1 NON ‐ Healing.

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Analysis 3.2

Comparison 3 GTN versus Botox, Outcome 2 Headache.

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Analysis 4.1

Comparison 4 GTN versus Calcium Channel Blocker, Outcome 1 NON ‐ Healing.

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Analysis 4.2

Comparison 4 GTN versus Calcium Channel Blocker, Outcome 2 Adverse Events.

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Analysis 4.3

Comparison 4 GTN versus Calcium Channel Blocker, Outcome 3 Headache.

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Analysis 5.1

Comparison 5 GTN versus Patch GTN, Outcome 1 NON ‐ Healing.

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Analysis 5.2

Comparison 5 GTN versus Patch GTN, Outcome 2 Headache.

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Analysis 6.1

Comparison 6 Dilator & Normal Care versus Normal Care Alone, Outcome 1 NON ‐ Healing.

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Analysis 7.1

Comparison 7 Botox versus Placebo, Outcome 1 NON ‐ Healing.

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Analysis 7.2

Comparison 7 Botox versus Placebo, Outcome 2 Adverse Events.

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Analysis 8.1

Comparison 8 Botox versus sphincterotomy, Outcome 1 NON ‐ Healing of the fissure.

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Analysis 8.2

Comparison 8 Botox versus sphincterotomy, Outcome 2 Minor Incontinence.

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Analysis 9.1

Comparison 9 Botox dose levels: High versus Higher, Outcome 1 NON ‐ Healing.

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Analysis 10.1

Comparison 10 Nifedipine versus Hydrocortisone, Outcome 1 NON ‐ Healing (persistence and recurrence).

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Analysis 11.1

Comparison 11 Diltiazem Oral versus Topical, Outcome 1 NON ‐ Healing (persistence & recurrence).

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Analysis 11.3

Comparison 11 Diltiazem Oral versus Topical, Outcome 3 Adverse Events.

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Analysis 12.1

Comparison 12 GTN vs. Placebo in children, Outcome 1 NON ‐ Healing.

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Analysis 13.1

Comparison 13 GTN vs placebo in adults, Outcome 1 NON ‐ Healing.

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Analysis 14.1

Comparison 14 GTN vs. Lignocaine, Outcome 1 NON ‐ Healing.

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Analysis 14.2

Comparison 14 GTN vs. Lignocaine, Outcome 2 Adverse Events.

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Analysis 15.1

Comparison 15 Calcium channel blocker vs. lignocaine, Outcome 1 NON ‐ Healing.

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Analysis 16.1

Comparison 16 Surgery vs any medical therapy, Outcome 1 NON ‐ Healing (persistence or recurrence).

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Analysis 17.1

Comparison 17 Lignocaine ointment vs. placebo, Outcome 1 NON ‐ Healing.

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Analysis 18.1

Comparison 18 bran vs placebo, Outcome 1 Acute Fissure Recurrence.

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Analysis 19.1

Comparison 19 lignocaine vs bran, Outcome 1 NON ‐ Healing.

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Analysis 20.1

Comparison 20 lignocaine vs hydrocortisone, Outcome 1 NON ‐ Healing.

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Analysis 21.1

Comparison 21 bran vs hydrocortisone, Outcome 1 NON ‐ Healing.

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Analysis 22.1

Comparison 22 Sensitivity analyses, Outcome 1 Sensitivity analysis: Excluding RCTs with very low placebo repsonse rates: NON‐healing.

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Analysis 22.2

Comparison 22 Sensitivity analyses, Outcome 2 Excluding RCT in Children with very low Placebo response rate: NON‐healing.

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Analysis 22.3

Comparison 22 Sensitivity analyses, Outcome 3 Excluding RCT in Adults with very low Placebo response rate: NON‐healing.

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Analysis 22.4

Comparison 22 Sensitivity analyses, Outcome 4 Excluding RCT with very low Placebo response rate: NON‐healing; Lignocaine.

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Analysis 22.5

Comparison 22 Sensitivity analyses, Outcome 5 GTN in Chronic Adult Fissure Only ‐ Non‐healing.

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Comparison 1. GTN versus Placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing of fissure (persistance or recurrence) Show forest plot	11	859	Odds Ratio (M‐H, Fixed, 95% CI)	0.55 [0.41, 0.74]

2 Headache Show forest plot	11	767	Odds Ratio (M‐H, Fixed, 95% CI)	4.09 [2.54, 6.60]

Comparison 1. GTN versus Placebo

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Comparison 2. GTN versus sphincterotomy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing of Fissure (persistence or recurrence_ Show forest plot	4	249	Odds Ratio (M‐H, Fixed, 95% CI)	8.97 [4.75, 16.94]

2 Minor Incontinence Show forest plot	4	161	Odds Ratio (M‐H, Fixed, 95% CI)	0.23 [0.02, 2.07]

3 Headache Show forest plot	4	227	Odds Ratio (M‐H, Fixed, 95% CI)	36.65 [9.72, 138.20]

Comparison 2. GTN versus sphincterotomy

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Comparison 3. GTN versus Botox

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	2	107	Odds Ratio (M‐H, Fixed, 95% CI)	0.48 [0.21, 1.10]

2 Headache Show forest plot	2	107	Odds Ratio (M‐H, Fixed, 95% CI)	0.11 [0.01, 0.93]

Comparison 3. GTN versus Botox

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Comparison 4. GTN versus Calcium Channel Blocker

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	0.66 [0.22, 2.01]

2 Adverse Events Show forest plot	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	3.63 [1.23, 10.73]

3 Headache Show forest plot	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	4.07 [1.37, 12.14]

Comparison 4. GTN versus Calcium Channel Blocker

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Comparison 5. GTN versus Patch GTN

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	1	42	Odds Ratio (M‐H, Fixed, 95% CI)	1.0 [0.29, 3.39]

2 Headache Show forest plot	1	42	Odds Ratio (M‐H, Fixed, 95% CI)	1.54 [0.42, 5.61]

Comparison 5. GTN versus Patch GTN

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Comparison 6. Dilator & Normal Care versus Normal Care Alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	2	170	Odds Ratio (M‐H, Fixed, 95% CI)	0.86 [0.46, 1.60]

Comparison 6. Dilator & Normal Care versus Normal Care Alone

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Comparison 7. Botox versus Placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	2	74	Odds Ratio (M‐H, Fixed, 95% CI)	0.75 [0.32, 1.77]

2 Adverse Events Show forest plot	1	44	Odds Ratio (M‐H, Fixed, 95% CI)	1.0 [0.24, 4.10]

Comparison 7. Botox versus Placebo

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Comparison 8. Botox versus sphincterotomy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing of the fissure Show forest plot	1	111	Odds Ratio (M‐H, Fixed, 95% CI)	5.57 [1.52, 20.42]

2 Minor Incontinence Show forest plot	1	111	Odds Ratio (M‐H, Fixed, 95% CI)	0.05 [0.00, 0.85]

Comparison 8. Botox versus sphincterotomy

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Comparison 9. Botox dose levels: High versus Higher

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	1	150	Odds Ratio (M‐H, Fixed, 95% CI)	2.87 [0.73, 11.25]

Comparison 9. Botox dose levels: High versus Higher

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Comparison 10. Nifedipine versus Hydrocortisone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing (persistence and recurrence) Show forest plot	1	110	Odds Ratio (M‐H, Fixed, 95% CI)	0.01 [0.00, 0.04]

Comparison 10. Nifedipine versus Hydrocortisone

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Comparison 11. Diltiazem Oral versus Topical

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing (persistence & recurrence) Show forest plot	1	50	Odds Ratio (M‐H, Fixed, 95% CI)	3.20 [1.00, 10.20]

3 Adverse Events Show forest plot	1	50	Odds Ratio (M‐H, Fixed, 95% CI)	32.48 [1.77, 597.53]

4 Mean resting pressure drop	0	0	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 11. Diltiazem Oral versus Topical

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Comparison 12. GTN vs. Placebo in children

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	4	165	Odds Ratio (M‐H, Fixed, 95% CI)	0.52 [0.29, 0.94]

Comparison 12. GTN vs. Placebo in children

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Comparison 13. GTN vs placebo in adults

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	7	694	Odds Ratio (M‐H, Fixed, 95% CI)	0.56 [0.39, 0.79]

Comparison 13. GTN vs placebo in adults

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Comparison 14. GTN vs. Lignocaine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	3	132	Odds Ratio (M‐H, Fixed, 95% CI)	0.17 [0.08, 0.38]

2 Adverse Events Show forest plot	3	132	Odds Ratio (M‐H, Fixed, 95% CI)	1.80 [0.57, 5.74]

Comparison 14. GTN vs. Lignocaine

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Comparison 15. Calcium channel blocker vs. lignocaine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	1	283	Odds Ratio (M‐H, Fixed, 95% CI)	0.05 [0.02, 0.12]

Comparison 15. Calcium channel blocker vs. lignocaine

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Comparison 16. Surgery vs any medical therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing (persistence or recurrence) Show forest plot	5	360	Odds Ratio (M‐H, Fixed, 95% CI)	0.12 [0.07, 0.22]

Comparison 16. Surgery vs any medical therapy

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Comparison 17. Lignocaine ointment vs. placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	2	78	Odds Ratio (M‐H, Fixed, 95% CI)	0.32 [0.10, 1.02]

Comparison 17. Lignocaine ointment vs. placebo

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Comparison 18. bran vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Acute Fissure Recurrence Show forest plot	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	0.1 [0.03, 0.34]

Comparison 18. bran vs placebo

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Comparison 19. lignocaine vs bran

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	1	68	Odds Ratio (M‐H, Fixed, 95% CI)	3.33 [1.14, 9.77]

Comparison 19. lignocaine vs bran

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Comparison 20. lignocaine vs hydrocortisone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	1	68	Odds Ratio (M‐H, Fixed, 95% CI)	3.33 [1.14, 9.77]

Comparison 20. lignocaine vs hydrocortisone

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Comparison 21. bran vs hydrocortisone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing Show forest plot	1	70	Odds Ratio (M‐H, Fixed, 95% CI)	1.0 [0.31, 3.23]

Comparison 21. bran vs hydrocortisone

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Comparison 22. Sensitivity analyses

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sensitivity analysis: Excluding RCTs with very low placebo repsonse rates: NON‐healing Show forest plot	9	732	Odds Ratio (M‐H, Fixed, 95% CI)	0.78 [0.56, 1.08]

2 Excluding RCT in Children with very low Placebo response rate: NON‐healing Show forest plot	3	118	Odds Ratio (M‐H, Fixed, 95% CI)	0.96 [0.48, 1.92]

3 Excluding RCT in Adults with very low Placebo response rate: NON‐healing Show forest plot	6	614	Odds Ratio (M‐H, Fixed, 95% CI)	0.73 [0.50, 1.07]

4 Excluding RCT with very low Placebo response rate: NON‐healing; Lignocaine Show forest plot	1	31	Odds Ratio (M‐H, Fixed, 95% CI)	0.55 [0.13, 2.31]

5 GTN in Chronic Adult Fissure Only ‐ Non‐healing Show forest plot	6	654	Odds Ratio (M‐H, Fixed, 95% CI)	0.64 [0.44, 0.92]

Comparison 22. Sensitivity analyses

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