Characteristics of included studies [ordered by study ID]
Arora 1985
|
| Methods | Design: parallel group |
|
| | Participants | Setting: single centre, hospital, India
Incl: participants with ENL
Excl: not stated
M/F: 11/1
Age: 14 to 55
Duration: 0 to 7 years
Severity: severe
Randomised: 12 participants
Evaluable: 12 participants
Unit of analysis: individual |
|
| | Interventions | Experimental group (n=5): levamisole capsules (150 mg daily) on 3 consecutive days repeating every fortnight for 3 months
Control group (n=7): placebo capsules (dose unknown, daily) on 3 consecutive days repeating every fortnight for 3 months
Other therapy: iron for anaemic participants |
|
| | Outcomes | Improvement, defined as complete recovery from reaction, after 3 months |
|
| | Notes | - |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Unclear | Unclear, though states 'coding of drugs was done by other person and decoding at end of study' |
| Blinding?
All outcomes | Unclear | Unclear who were blinded, though states trial was double-blind |
| Incomplete outcome data addressed?
All outcomes | Unclear | No mention of attrition in text or tables, suggesting 100% follow-up |
| | Free of selective reporting? | Yes | |
| | Free of other bias? | Unclear | Not clear as to whether groups were similar at baseline; outcome measures not well-described |
|
|
Girdhar 2002
|
| Methods | Design: parallel group |
|
| | Participants | Setting: single centre, leprosy centre, India
Incl: lepromatous leprosy with recurrent ENL and on steroids for > 6 months
Excl: not stated
M/F: not stated
Age: not stated
Duration: not stated
Severity: not stated
Randomised: 10 participants
Evaluable: 9 participants (1 lost to follow-up)
Unit of analysis: individual |
|
| | Interventions | Experimental group (n=4): infusion of betamethasone in 5% dextrose daily for 3 days every 4 weeks for 6 months
Control group (n=5): infusion of 5% dextrose daily for 3 days every 4 weeks for 6 months
Other therapy: MDT with 100 mg clofazimine daily for all participants; oral steroids as per need to control ENL for participants in control group |
|
| | Outcomes | Change in severity and frequency of ENL 6 months after end of treatment
Steroid requirement
Side-effects |
|
| | Notes | - |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Unclear | No information provided |
| Blinding?
All outcomes | Unclear | No information provided |
| Incomplete outcome data addressed?
All outcomes | Unclear | No information provided |
| | Free of selective reporting? | Yes | |
| | Free of other bias? | Unclear | No information about baseline characteristics of both groups |
|
|
Helmy 1971
|
| Methods | Design: cross-over |
|
| | Participants | Setting: single centre, leprosy centre, Malaysia
Incl: not stated, though included were lepromatous or indefinite leprosy with moderately severe ENL
Excl: not stated
M/F: 10/5
Age: 17 to 67
Duration: 6 months to 2 years
Severity: moderately severe ENL
Randomised: 15 participants
Evaluable: 10 participants (5 lost to follow-up)
Unit of analysis: individual |
|
| | Interventions | Group A (n=3): clofazimine capsules (100 mg 3 times daily) in weeks 1 to 4, followed by placebo capsules (dose unknown, 3 times daily) in weeks 5 to 8
Group B (n=7): placebo capsules (100 mg 3 times daily) in weeks 1 to 4, followed by clofazimine capsules (dose unknown, 3 times daily) in weeks 5 to 8
Other therapy: dapsone (100 mg 2 times daily); stibophen if needed; paracetamol issued twice weekly to be taken freely |
|
| | Outcomes | Severity score of ENL |
|
| | Notes | The trial consisted of a first control period (2 weeks), first trial period (4 weeks), second trial period (4 weeks), second control period (4 weeks) |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Unclear | Unclear, though states "key of drug allocation was kept in sealed envelope and opened only after analysis of the results" |
| Blinding?
All outcomes | Unclear | Participant & clinician: no, outcome assessor: unclear. Trial was designed to be double-blind, but it ceased when discolouration due to clofazimine appeared |
| Incomplete outcome data addressed?
All outcomes | No | 5 participants lost to follow-up and excluded from analysis |
| | Free of selective reporting? | Unclear | No statistical analysis performed |
| | Free of other bias? | Unclear | No information about baseline characteristics of both groups; outcome measures not well-described |
|
|
Ing 1969
|
| Methods | Design: parallel group |
|
| | Participants | Setting: single centre, Singapore
Incl: lepromatous leprosy and ENL (mild, moderate, or severe)
Excl: not stated
M/F: not stated
Age: not stated
Duration: not stated
Severity: 15 mild, 9 moderate, 6 severe
Randomised: 30 participants
Evaluable: 30 participants, though one participants did not complete 4-week treatment
Unit of analysis: individual |
|
| | Interventions | Experimental group (n=16): indomethacin (25 mg 3 times daily) for 1 month
Control group (n=14): prednisolone (5 mg 3 times daily) for 1 month
Other therapy: anti-leprosy drugs were given during 4-week trial period, but no additional analgesics |
|
| | Outcomes | Improvement after 4 weeks (e.g. mean change in pain relief, subsidence of lesions)
Side-effects |
|
| | Notes | - |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Unclear | No information provided |
| Blinding?
All outcomes | Unclear | No information provided |
| Incomplete outcome data addressed?
All outcomes | Unclear | Not clear as to whether participant who did not complete treatment was included in analysis |
| | Free of selective reporting? | No | No statistical evidence, though states "indomethacin is effective in treating only mild and moderate cases of ENL" |
| | Free of other bias? | Unclear | Not clear as to whether groups were similar at baseline |
|
|
Iyer 1971
|
| Methods | Design: parallel group |
|
| | Participants | Setting: multicentre, 4 centres, India, Mali, Somalia, Spain
Incl: clearly demonstrable dermatological signs of acute lepra reactions i.e. erythema nodosum-like lesions or erythema multiforme-like lesions
Excl: severe or life-threatening lepra reactions
M/F: 92 M
Age: 15 to 55+
Duration: not stated
Severity: not stated
Randomised: 214 ENL reactions (of 92 participants)
Evaluable: 214 ENL reactions
Unit of analysis: reaction |
|
| | Interventions | Experimental group (n=116): thalidomide tablets (100 mg 4 times daily if ≥ 50 kg, or 100 mg 1 to 3 times daily if < 50 kg) for 7 days
Control group (n=98): acetylsalicyclic acid tablets (400 mg 4 times daily if ≥ 50 kg, or 400 mg 1 to 3 times daily if < 50 kg) for 7 days
Other therapy: upon admission all drug therapy had to be ceased |
|
| | Outcomes | No further reactions
Changes in temperature, skin lesions, blood pressure, pulse rate, and blood cell count after 7 days
Side-effects |
|
| | Notes | Each reaction was treated with a 7-day regimen. A new regimen was allocated to a participant if there was no improvement or if new acute reactions occurred. The statistical design provided for treatment of 4 reactions in each participant, 2 with acetylsalicyclic acid, and 2 with thalidomide, the order being random |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Yes | Confidential master sheet of drug allocation kept by WHO, bottles with tablets labelled by drug manufacturer according to master sheet |
| Blinding?
All outcomes | Unclear | Unclear who were blinded, though states trial was double-blind |
| Incomplete outcome data addressed?
All outcomes | Unclear | No mention of attrition in text or tables, suggesting 100% follow-up |
| | Free of selective reporting? | Unclear | No statistical analysis performed |
| | Free of other bias? | Unclear | No information about baseline characteristics of both groups; outcome measures not well-described |
|
|
Iyer 1976
|
| Methods | Design: parallel group |
|
| | Participants | Setting: single centre, India
Incl: male, lepromatous leprosy and prone to recurrent reactive episodes
Excl: not stated
M/F: 72 M
Age: 15 to 54
Duration: < 6 months to > 4 years
Severity: moderate, severe
Randomised: unclear, states "72 participants available for analysis"
Evaluable: 72 participants
Unit of analysis: individual |
|
| | Interventions | Experimental group (n=36): clofazimine (100 mg 3 times daily) for 8 weeks, clofazimine (100 mg once a day) for 52 weeks
Control group (n=36): thalidomide (100 mg 3 times daily) for 8 weeks, thalidomide (25 to 50 mg once a day) for 52 weeks
Other therapy: dapsone (10 mg/kg/week) during 52 weeks maintenance therapy |
|
| | Outcomes | Time-to-control reaction
Maintenance of anti-reaction effect after therapy |
|
| | Notes | First 8 weeks (part A) was acute treatment to control reaction as quickly and effectively as possible. Part B (52 weeks) was dosage aimed at maintaining effect |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Unclear | No information provided |
| Blinding?
All outcomes | No | No, open trial, blinding impossible due to skin discolouration from clofazimine |
| Incomplete outcome data addressed?
All outcomes | Unclear | No mention of attrition in text or tables, suggesting 100% follow-up |
| | Free of selective reporting? | Unclear | No statistical analysis performed |
| | Free of other bias? | Unclear | Not clear as to whether groups were similar at baseline; outcome measures not well-described |
|
|
Karat 1969
|
| Methods | Design: parallel group |
|
| | Participants | Setting: single centre, leprosy centre, India
Incl: lepromatous leprosy with ENL, > 12 years
Excl: history or radiological evidence of peptic ulcer, diabetes, TB, hypertension, severe intercurrent infection, acute peripheral nerve paralysis, medical conditions requiring use of other anti-leprosy drugs
M/F: not stated
Age: not stated
Duration: not stated
Severity: 28 mild, 22 severe
Randomised: 50 participants
Evaluable: 50 participants
Unit of analysis: individual |
|
| | Interventions | Group 1 (n=11): indomethacin orally (50 mg 3 times daily) in week 1 to 2, (25 mg 3 times daily) in week 3, (25 mg once a day) maintenance
Group 2 (n=12): chloroquine orally (250 mg 3 times daily) in week 1 to 2, (250 mg 2 times daily) in week 3, (250 mg once a day) maintenance
Group 3 (n=13): prednisolone orally (5 mg 3 times daily) in week 1 to 2, (5 mg 2 times daily) in week 3, (5 mg once a day) maintenance
Group 4 (n=14): aspirin orally (1 g 3 times daily) in week 1 to 2, (1 g 2 times daily) in week 3, (500 mg 2 times daily) maintenance
Other therapy: anti-leprosy drugs were stopped on admission; sedation with phenobarbitone or chlorpromazine if needed; diuretics only when oedema was progressive and uncontrolled by one of the given drugs |
|
| | Outcomes | Control of reaction
Recurrence of reaction
Side-effects |
|
| | Notes | Duration of trial period unclear, paper states both trial period of 90 days and 12 months |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | Unclear, though states "statistically randomised grouping" |
| | Allocation concealment? | Unclear | Unclear, though states was confidential list |
| Blinding?
All outcomes | Unclear | Unclear who were blinded, though states trial was double-blind |
| Incomplete outcome data addressed?
All outcomes | Unclear | No mention of attrition in text or tables, suggesting 100% follow-up |
| | Free of selective reporting? | Yes | |
| | Free of other bias? | Unclear | No information about baseline characteristics of both groups; outcome measures not well-described |
|
|
Karat 1970
|
| Methods | Design: parallel group |
|
| | Participants | Setting: single centre, leprosy centre, India
Incl: history of ≥ 3 severe reactions and with severe current reaction which could not be controlled by antimony, aspirin, or chloroquine
Excl: peptic ulcer, intercurrent acute infections, TB, or malignant lesions
M/F: not stated
Age: not stated
Duration: 4 to 150 months
Severity: severe
Randomised: 24 participants
Evaluable: 24 participants
Unit of analysis: individual |
|
| | Interventions | Experimental group (n=12): clofazimine (100 mg 3 times daily) for 12 weeks
Control group (n=12): prednisolone (10 mg 3 times daily) week 1, (10 mg 2 times daily) week 2, (5 mg 3 times daily) week 3, (10 mg 2 times daily) week 4, (5 mg once daily) weeks 5 to 12
Other therapy: none |
|
| | Outcomes | Treatment success at end of 12 weeks, defined as body temp < 37.2 ºC, no new ENL lesions, no pain in peripheral nerve, no progression of neurological deficit, and iritis quiescent in 2 weeks from starting treatment
Recurrence of reaction during trial
Side-effects |
|
| | Notes | - |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | Unclear, though states "list of random allocations" |
| | Allocation concealment? | Unclear | Unclear, though states "list was prepared earlier and kept confidential at pharmacy" |
| Blinding?
All outcomes | Unclear | Unclear who were blinded, though states trial was double-blind |
| Incomplete outcome data addressed?
All outcomes | Unclear | No mention of attrition in text or tables, suggesting 100% follow-up |
| | Free of selective reporting? | Yes | |
| | Free of other bias? | Yes | |
|
|
Pearson 1969
|
| Methods | Design: cross-over |
|
| | Participants | Setting: single centre, leprosy centre, Malaysia
Incl: moderately severe ENL
Excl: not stated
M/F: 11/1
Age: not stated
Duration: 10 months to 3.5 years
Severity: unclear, though title states was moderately severe ENL
Randomised: 12 participants
Evaluable: 12 participants (1 from group B withdrawn from study after 9 weeks)
Unit of analysis: individual |
|
| | Interventions | Group A (n=not stated): thalidomide tablets (100 mg 3 times daily) for 6 weeks, followed by placebo (dose and frequency unknown) for 6 weeks
Group B (n=not stated): placebo tablets (dose and frequency not stated) for 6 weeks, followed by thalidomide tablets (100 mg 3 times daily) for 6 weeks
Other therapy: prednisolone, stibophen, and paracetamol in addition to placebo |
|
| | Outcomes | Change in ENL score
Steroid requirement
Side-effects |
|
| | Notes | - |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Unclear | No information provided |
| Blinding?
All outcomes | Unclear | Participant & clinician: yes, outcome assessor: unclear |
| Incomplete outcome data addressed?
All outcomes | Yes | Intention-to-treat analysis performed; average scores for first 3 weeks of thalidomide have been inserted for weeks 10 to 12 |
| | Free of selective reporting? | No | No statistical evidence, though states "thalidomide was superior to a placebo" |
| | Free of other bias? | Unclear | No information about baseline characteristics of both groups; outcome measures not well-described |
|
|
Sales 2007
|
| Methods | Design: parallel group |
|
| | Participants | Setting: single centre, leprosy centre, Brazil
Incl: MB leprosy, males between 18 to 60 years old, females over 49 (postmenopausal), clinical and histopathological ENL
Excl: Acute neuritis requiring CS, hepatic, renal, mental diseases, diabetes, and/or immune-deficiencies related to HIV
M/F: 38/6
Age: 18 to 69
Duration: not stated
Severity: not stated
Randomised: 44 participants
Evaluable: 44 participants (8 lost to follow-up)
Unit of analysis: individual |
|
| | Interventions | Group A (n=24): pentoxifylline (1.2 g daily) for 30 days
Group B (n=20): thalidomide (300 mg daily) for 30 days
Other therapy: participants with no improvement after 15 days treatment or with severe adverse effects were removed from study and put on recommended regimen of thalidomide or corticosteroids |
|
| | Outcomes | Improvement at end of 30 days treatment, defined as complete elimination of type 2 reactional skin lesion inflammation, normal body temperature, and/or regression of systemic symptoms
Side-effects |
|
| | Notes | - |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Unclear | No information provided |
| Blinding?
All outcomes | Unclear | Unclear who were blinded, though states trial was double-blinded |
| Incomplete outcome data addressed?
All outcomes | Yes | Intention-to-treat analysis performed; participants removed from trial were categorised as treatment non-responders |
| | Free of selective reporting? | Yes | |
| | Free of other bias? | Unclear | Unclear if all relevant baseline characteristics were similar |
|
|
Sheskin 1969
|
| Methods | Design: parallel group |
|
| | Participants | Setting: single centre, hospital/ambulatory, Venezuela
Incl: lepromatous leprosy with clearly demonstrable dermatologic, neurologic, or other manifestations of ENL reaction
Excl: not stated
M/F: 37/15
Age: 17 to 58
Duration: 3 months to 9 years
Severity: not stated
Randomised: 173 ENL reactions (of 52 participants)
Evaluable: 173 ENL reactions
Unit of analysis: reaction |
|
| | Interventions | Experimental group (n=85): thalidomide tablets (100 mg 4 times daily if > 50 kg, or 6 mg/kg/day if ≤ 50 kg) for 7 days
Control group (n=88): placebo tablets (100 mg 4 times daily if > 50 kg, or 6 mg/kg/day if ≤ 50 kg) for 7 days
Other therapy: if on sulfone therapy at admission, sulfone therapy was continued; if receiving steroids or adrenocorticotropic hormone (ACTH) for prolonged periods at admission, same dosage was continued |
|
| | Outcomes | Total improvement, defined as all dermatologic manifestations in advanced state of remission, no new elements, disappearance of characteristic lepra reaction symptoms after 7 days
Side-effects |
|
| | Notes | Each reaction was treated with a 7-day regimen. A new regimen was allocated to a participant if there was no improvement. Up to 4 consecutive treatment regimens were given to each participants |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Unclear | Unclear, though states "code unknown to investigators and kept elsewhere" |
| Blinding?
All outcomes | Unclear | Unclear who were blinded, though states trial was double-blind |
| Incomplete outcome data addressed?
All outcomes | Unclear | No mention of attrition in text or tables, suggesting 100% follow-up |
| | Free of selective reporting? | Yes | |
| | Free of other bias? | Unclear | Not clear as to whether groups were similar at baseline |
|
|
Villahermosa 2005
|
| Methods | Design: parallel group |
|
| | Participants | Setting: single centre, leprosy centre, Philippines
Incl: lepromatous leprosy, ≥ 18 years, acute histologically confirmed episode of ENL consisting of ≥ 10 skin nodules, with or without systemic symptoms; women only included if evidence of non-childbearing potential
Excl: incapacitating ENL (bed ridden), severe neuritis, thalidomide ingestion within 30 days or corticosteroid ingestion within 2 weeks of enrollment
M/F: 22 M
Age: 18 to 46
Duration: 0 to 3 years
Severity: not stated
Randomised: 22 participants
Evaluable: 19 (3 lost to follow-up)
Unit of analysis: individual |
|
| | Interventions | Group A (n=12): thalidomide capsules, 100 mg daily (2x 50 mg, 4x dummy capsules) in week 1, 50 mg daily (1x 50 mg, 3x dummy capsules) in week 2 to 3, 4x dummy capsules daily in weeks 4 to 7
Group B (n=10): thalidomide capsules, 300 mg daily (6x 50 mg, 0x dummy capsules) in week 1, 200 mg daily (4x 50 mg, 0x dummy capsules) in week 2 to 3, 100 mg daily (2x 50 mg, 2x dummy capsules) in week 4 to 5, 50 mg daily (1x 50 mg, 3x dummy capsules) in week 6 to 7
Other therapy: acetaminophen for participants with fever during first 72 hours of study |
|
| | Outcomes | Resolution of inflamed ENL nodules during initial 7-day treatment
Global assessment
Re-emergence of skin lesions during taper
Week 7 lesion counts
Recurrence of lesions after taper
Safety and adverse events |
|
| | Notes | Week 1 treatment was acute treatment. Participants with complete or partial responses at week 1 were tapered from thalidomide during weeks 2 to 7 |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Yes | Adequate, coded blister packs by pharmaceutical company |
| Blinding?
All outcomes | Unclear | Participant: yes, clinician & outcome assessor: unclear; though states was double-blind |
| Incomplete outcome data addressed?
All outcomes | No | Three participants withdrawn from trial and excluded from analysis |
| | Free of selective reporting? | Yes | |
| | Free of other bias? | Unclear | Unclear if all relevant baseline characteristics were similar |
|
|
Waters 1971
|
| Methods | Design: cross-over |
|
| | Participants | Setting: single centre, leprosy centre, Malaysia
Incl: not stated, but included were participants with lepromatous leprosy and histologically confirmed moderately severe or severe chronic ENL
Excl: not stated
M/F: 10 M
Age: 19 to 56
Duration: 9 months to 3.5 years
Severity: moderately severe or severe chronic ENL
Randomised: 9 participants for first 16-week trial, 8 participants for second 24-week trial
Evaluable: 9 participants for first 16-week trial, 8 participants for second 24-week trial
Unit of analysis: individual |
|
| | Interventions | 16-week trial (n=9) and 24-week trial (n=8):
Group A (n=5 or n=3): thalidomide tablets (100 mg 3 times daily) for 4 or 6 weeks, followed by placebo tablets (dose unknown, 3 times daily) for 4 or 6 weeks
Group B (n=4 or n=5): placebo tablets (dose unknown, 3 times daily) for 4 or 6 weeks, followed by thalidomide tablets (100 mg 3 times daily) for 4 or 6 weeks
Other therapy: 100 mg dapsone twice weekly, prednisolone or corticotrophin daily, mild analgesics if needed |
|
| | Outcomes | Steroid requirement during trial period
ENL score (temperature, severity) |
|
| | Notes | First trial lasted 16 weeks (4 weeks control, 4 weeks A, 4 weeks B, 4 weeks control). The second trial started 11 weeks after completion of first trial. The trial lasted 24 weeks (6 weeks control, 6 weeks A, 6 weeks B, 6 weeks control) and included 8 participants of which 7 participated in the first trial |
|
| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Adequate sequence generation? | Unclear | No information provided |
| | Allocation concealment? | Unclear | Unclear, though states "the code of drug allocation was not revealed to anyone until after the trial was completed" |
| Blinding?
All outcomes | Unclear | Participant & clinician: yes, outcome assessor: unclear |
| Incomplete outcome data addressed?
All outcomes | Unclear | No mention of attrition in text or tables, suggesting 100% follow-up |
| | Free of selective reporting? | No | No statistical evidence, though states "nine of the ten participants showed a very significant reduction in steroid requirement" |
| | Free of other bias? | Unclear | Not clear as to whether groups were similar at baseline |
|
|
Characteristics of excluded studies [ordered by study ID]
|
| Study | Reason for exclusion |
|---|
| | Anonymous 1976 | Treatment of lepromatous leprosy, not of ENL |
| | Arruda 1986 | Treatment of lepromatous leprosy, not of ENL |
| | Browne 1981 | No RCT |
| | Dawlah 2002 | No RCT |
| | de Almeida Neto 1981 | No separate results for ENL |
| | de Carsalade 2003 | No RCT |
| | Garbino 2006 | No specific treatment of ENL, but treatment of ulnar neuropathy in participants with type 1 and type 2 reactions |
| | Hastings 1970 | No RCT |
| | Huang 1987 | No RCT |
| | Imkamp 1968 | No RCT |
| | Imkamp 1973 | No RCT |
| | Jamet 1992 | Treatment of lepromatous leprosy, not of ENL |
| | Kar 1988 | Randomisation by alternation |
| | Karat 1971a | Treatment of lepromatous leprosy, not of ENL |
| | Karat 1971b | Propylaxis treatment, not treatment of ENL |
| | Levy 1973 | No RCT |
| | Manungo 1982a | Treatment of lepromatous leprosy, not of ENL |
| | Manungo 1982b | No RCT |
| | Moreira 1998 | No RCT |
| | Partida-Sanchez 1998 | No RCT |
| | Penna 2005 | Only methodology and intake results were described, trial not completed |
| | Pettit 1967 | No RCT |
| | Plock 1976 | No RCT |
| | Ramu 1979 | Randomisation by alternation |
| | Rodriguez 1974 | Treatment of lepromatous and borderline leprosy, not of ENL |
| | Sharma 1982 | No RCT |
| | Sharma 1986 | No RCT |
| | Sheskin 1969a | No RCT |
| | Sheskin 1971 | No RCT |
| | Sheskin 1983 | No RCT |
| | Sunderkotter 2005 | No RCT |
| | Vides 1999 | No RCT |
| | Zaheer 1993 | Treatment of multibacillary (MB) leprosy, not of ENL |
| | Zhang 2008 | No RCT |
|
|
Characteristics of ongoing studies [ordered by study ID]
Salim 2009
|
| Trial name or title | Montelukast in ENL Reaction |
| | Methods | design: parallel groups
randomised controlled trial
single blind |
| | Participants | MB leprosy
ENL reaction
age 15 to 65
weight > 35kg
patient willing to participate, including agreeing to investigations and admission
adequate past records
no steroid received in past 4 weeks
|
| | Interventions | 1) prednisolone alone
2) prednisolone plus montelukast
3) montelukast alone
Prednisolone starting at 40 mg daily tapered over 12 weeks. Montelukast 10 mg for 16 weeks |
| | Outcomes |
Timing of outcome assessment at 24 weeks |
| | Starting date | December 2006 |
| | Contact information | Abdul H Salim, MBBS: dfsalim@citechco.net |
| | Notes | |
|
|
Comparison 1. Thalidomide versus aspirin
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Remission of skin lesions | 1 | | Risk Ratio (M-H, Random, 95% CI) | Subtotals only |
|
|
Comparison 2. 100 mg thalidomide versus 300 mg thalidomide
Comparison 3. Pentoxifylline versus thalidomide
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Remission of skin lesions | 1 | | Risk Ratio (M-H, Random, 95% CI) | Subtotals only |
|
|
Comparison 4. Clofazimine versus prednisolone
Comparison 5. Clofazimine versus thalidomide
Comparison 6. Indomethacin versus prednisolone
Comparison 7. Indomethacin versus chloroquine
Comparison 8. Indomethacin versus aspirin
Comparison 9. Levamisole versus placebo
