Efficacy and safety of botulinum toxin in treatment of anismus: A systematic review

Table 1 Assessment of the methodological qualities of the comparative studies included in the review

Items	Farid et al[12], 2009	Farid et al[20], 2009
Inclusion criteria	1	1
Exclusion criteria	1	1
Comparable demographics	1	1
Number of participating centers is stated?	1	1
The number of surgeons is stated	0	0
Reporting where the authors were on the learning curve	0	0
Clearly stated diagnostic criteria for clinical outcomes	1	1
Adequate description of surgical technique	1	1
Standard surgical technique	1	1
Standard perioperative care	0	0
Age and range are given for patients in BTX-A group	1	1
Statement about any missing data	0	0
Age and range are given for patients in the comparative group	1	1
Patients in each group treated along similar timelines	1	1
The patients asking to enter the study, did they actually take part to it?	0	0
Statement about drop-out rates	0	0
Clearly defined outcomes	1	1
Availability of blind assessors	0	0
Assessment tools were standardized	1	1
Was the analysis by intention to treat?	0	0
Score	12	12

Yes = 1, no (not reported) = 0; Total score = 21, < 8 = poor quality; 8-14 = fair quality and > 14 = good quality. BTX-A: Botulinum toxin type A.

Table 2 Assessment of the methodological qualities of case-series studies included in the review

Items	Shafik et al[17]	Ron et al[18]	Maria et al[19]	Hompes et al[21]	Zhang et al[22]
Multi-center study	0	0	0	0	0
Clearly defined objective	1	1	1	1	1
Reported inclusion exclusion criteria	0	1	1	0	0
Clearly defined outcomes	0	1	1	1	1
Prospective data collection	1	1	1	1	1
Patients were recruited consecutively	0	1	0	0	0
Clearly described results of the study?	1	1	1	1	1
Stratified outcomes	1	1	1	1	1
Total Score	4	7	6	5	5

Yes = 1, no (not reported) = 0; Total score, 8; ≤ 3 = poor quality; 4-6 = fair quality; ≥ 7 = good quality.

Table 3 Characteristics of the studies included

Ref.	Country	Type	n	Male	Mean age (yr)	Duration of complaint (mo)	Follow up (mo)	Dose of BTX-A (IU)	Site of injection
Shafik et al[17]	Egypt	Prospective	15	2	41.2	105.6	14.6	25	Lateral (3, 9 o’clock)
Ron et al[18]	Israel	Prospective	24	9	23.7	Not reported	61.0	10-20	Lateral and posterior
Maria et al[19]	Italy	Prospective	24	10	56.0	28.0	39.0	60	Lateral (3, 9 o’clock)
Farid et al[12]	Egypt	Prospective RCT	15	15	34.7	71.1	14.7	100	Lateral (5, 7 o’clock)
Farid et al[20]	Egypt	Prospective RCT	24	7	34.7	Not reported	12.0	100	Lateral (5, 7 o’clock)
Hompes et al[21]	United Kingdom	Retrospective	56	20	47.5	Not reported	19.2	100	Lateral (3, 9 o’clock)
Zhang et al[22]	China	Retrospective	31	18	50.1	67.2	8.4	100	Lateral and posterior (3, 6, 9 o’clock)

RCT: Randomized controlled trial; BTX-A: Botulinum toxin type A.