Non surgical therapy for anal fissure

Richard L Nelson

doi:10.1002/14651858.CD003431.pub2

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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 or IDN versus sphincterotomy, Outcome 1 NON ‐ Healing of Fissure (persistence or recurrence_.

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Analysis 2.2

Comparison 2 GTN or IDN versus sphincterotomy, Outcome 2 Minor Incontinence.

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Analysis 2.3

Comparison 2 GTN or IDN 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 for acute and chronic fissure, Outcome 1 NON ‐ Healing in acute and ?chronic? fissure.

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Analysis 7.1

Comparison 7 Botox versus Placebo (or Lignocaine (Colak)), Outcome 1 Non‐healing of Fissure.

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Analysis 7.2

Comparison 7 Botox versus Placebo (or Lignocaine (Colak)), 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 Topical CCB (0.3% topical Nifedipine) versus Hydrocortisone (both got Lignocaine), 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 CCB (Topical Nifedipine) vs. lignocaine + HC gel, Outcome 1 NON ‐ Healing.

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Analysis 16.1

Comparison 16 Any 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; a prophylaxis study.

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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 GTN/Placebo RCTs with very low placebo repsonse rates (<10%): 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 Excluding study with < 10% non healing.

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Analysis 22.6

Comparison 22 Sensitivity analyses, Outcome 6 Excluding Mishra to investigate heterogeneity.

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Analysis 22.7

Comparison 22 Sensitivity analyses, Outcome 7 Three Largest GTN/Placebo Studies.

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Analysis 23.1

Comparison 23 Botox versus Botox Dysport, Outcome 1 Non‐healing of fissure.

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Analysis 24.1

Comparison 24 CCB (Oral Nifidipine) versus LIS, Outcome 1 Non‐Healing of the Fissure.

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Analysis 25.1

Comparison 25 Minoxidil versus Lidocaine, Outcome 1 Non‐healing of the fissure.

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Analysis 26.1

Comparison 26 Indoramine versus placebo, Outcome 1 Non‐healing of the fissure.

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Analysis 26.2

Comparison 26 Indoramine versus placebo, Outcome 2 Headache.

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Analysis 27.1

Comparison 27 GTN Dose Comparisons, Outcome 1 Non‐healing of the fissure.

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Analysis 28.1

Comparison 28 Calcium Channel blocker (oral Nifedipine) versus Botox, Outcome 1 Non healing of the fissure.

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Analysis 29.1

Comparison 29 Long Term Follow‐up (> 1 year) ; Any Operation vs. Any Medical Therapy, Outcome 1 Non‐healing of the fissure.

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Analysis 30.1

Comparison 30 GTN vs. Patient Self Dilation (vs. both), Outcome 1 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	15	1190	Odds Ratio (M‐H, Random, 95% CI)	0.35 [0.17, 0.72]

2 Headache Show forest plot	15	1083	Odds Ratio (M‐H, Random, 95% CI)	4.39 [2.88, 6.69]

Comparison 1. GTN versus Placebo

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Comparison 2. GTN or IDN 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	6	343	Odds Ratio (M‐H, Fixed, 95% CI)	6.66 [3.76, 11.80]

2 Minor Incontinence Show forest plot	6	320	Odds Ratio (M‐H, Fixed, 95% CI)	0.56 [0.24, 1.33]

3 Headache Show forest plot	6	317	Odds Ratio (M‐H, Fixed, 95% CI)	29.94 [9.86, 90.92]

Comparison 2. GTN or IDN 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	4	187	Odds Ratio (M‐H, Random, 95% CI)	0.49 [0.15, 1.55]

2 Headache Show forest plot	3	137	Odds Ratio (M‐H, Fixed, 95% CI)	0.11 [0.02, 0.65]

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	4	205	Odds Ratio (M‐H, Fixed, 95% CI)	0.63 [0.34, 1.17]

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	2	112	Odds Ratio (M‐H, Fixed, 95% CI)	3.80 [1.63, 8.83]

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	2	131	Odds Ratio (M‐H, Fixed, 95% CI)	1.07 [0.50, 2.27]

2 Headache Show forest plot	2	131	Odds Ratio (M‐H, Fixed, 95% CI)	1.07 [0.46, 2.45]

Comparison 5. GTN versus Patch GTN

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Comparison 6. Dilator & Normal Care versus Normal Care Alone for acute and chronic fissure

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 NON ‐ Healing in acute and ?chronic? fissure 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 for acute and chronic fissure

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Comparison 7. Botox versus Placebo (or Lignocaine (Colak))

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐healing of Fissure Show forest plot	3	136	Odds Ratio (M‐H, Random, 95% CI)	0.29 [0.02, 3.61]

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 (or Lignocaine (Colak))

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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	3	235	Odds Ratio (M‐H, Fixed, 95% CI)	8.36 [3.50, 19.93]

2 Minor Incontinence Show forest plot	2	191	Odds Ratio (M‐H, Fixed, 95% CI)	0.07 [0.01, 0.56]

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. Topical CCB (0.3% topical Nifedipine) versus Hydrocortisone (both got Lignocaine)

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. Topical CCB (0.3% topical Nifedipine) versus Hydrocortisone (both got Lignocaine)

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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]

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, Random, 95% CI)	0.45 [0.05, 4.30]

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	11	1025	Odds Ratio (M‐H, Random, 95% CI)	0.32 [0.15, 0.69]

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. CCB (Topical Nifedipine) vs. lignocaine + HC gel

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. CCB (Topical Nifedipine) vs. lignocaine + HC gel

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Comparison 16. Any 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	11	741	Odds Ratio (M‐H, Random, 95% CI)	0.09 [0.04, 0.20]

Comparison 16. Any 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; a prophylaxis study 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 GTN/Placebo RCTs with very low placebo repsonse rates (<10%): NON‐healing Show forest plot	13	1063	Odds Ratio (M‐H, Random, 95% CI)	0.49 [0.25, 0.96]

2 Excluding RCT in Children with very low Placebo response rate: NON‐healing Show forest plot	3	118	Odds Ratio (M‐H, Random, 95% CI)	1.03 [0.11, 9.91]

3 Excluding RCT in Adults with very low Placebo response rate: NON‐healing Show forest plot	10	913	Odds Ratio (M‐H, Random, 95% CI)	0.37 [0.17, 0.78]

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 Excluding study with < 10% non healing Show forest plot	3	137	Odds Ratio (M‐H, Fixed, 95% CI)	0.75 [0.37, 1.51]

6 Excluding Mishra to investigate heterogeneity Show forest plot	9	537	Odds Ratio (M‐H, Fixed, 95% CI)	0.12 [0.07, 0.19]

7 Three Largest GTN/Placebo Studies Show forest plot	3	636	Odds Ratio (M‐H, Fixed, 95% CI)	1.11 [0.76, 1.63]

Comparison 22. Sensitivity analyses

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Comparison 23. Botox versus Botox Dysport

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐healing of fissure Show forest plot	1	100	Odds Ratio (M‐H, Fixed, 95% CI)	1.36 [0.29, 6.43]

Comparison 23. Botox versus Botox Dysport

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Comparison 24. CCB (Oral Nifidipine) versus LIS

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐Healing of the Fissure Show forest plot	1	132	Odds Ratio (M‐H, Fixed, 95% CI)	142.48 [34.81, 583.12]

Comparison 24. CCB (Oral Nifidipine) versus LIS

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Comparison 25. Minoxidil versus Lidocaine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐healing of the fissure Show forest plot	1	64	Odds Ratio (M‐H, Fixed, 95% CI)	1.04 [0.35, 3.12]

Comparison 25. Minoxidil versus Lidocaine

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Comparison 26. Indoramine versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐healing of the fissure Show forest plot	1	14	Odds Ratio (M‐H, Fixed, 95% CI)	2.4 [0.16, 34.93]

2 Headache Show forest plot	1	23	Odds Ratio (M‐H, Fixed, 95% CI)	3.5 [0.53, 23.14]

Comparison 26. Indoramine versus placebo

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Comparison 27. GTN Dose Comparisons

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐healing of the fissure Show forest plot	4	324	Odds Ratio (M‐H, Fixed, 95% CI)	0.91 [0.57, 1.45]

Comparison 27. GTN Dose Comparisons

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Comparison 28. Calcium Channel blocker (oral Nifedipine) versus Botox

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non healing of the fissure Show forest plot	1	50	Odds Ratio (M‐H, Fixed, 95% CI)	3.50 [0.92, 13.31]

Comparison 28. Calcium Channel blocker (oral Nifedipine) versus Botox

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Comparison 29. Long Term Follow‐up (> 1 year) ; Any Operation vs. Any Medical Therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐healing of the fissure Show forest plot	3	204	Odds Ratio (M‐H, Random, 95% CI)	0.06 [0.02, 0.18]

Comparison 29. Long Term Follow‐up (> 1 year) ; Any Operation vs. Any Medical Therapy

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Comparison 30. GTN vs. Patient Self Dilation (vs. both)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non Healing Show forest plot	1	32	Odds Ratio (M‐H, Fixed, 95% CI)	2.83 [0.67, 12.02]

Comparison 30. GTN vs. Patient Self Dilation (vs. both)

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