Table 2.
Summary of findings table
| # | First author | Year | Pilot | ITT sample | PP sample | PP sample > median(43.5) | Attrition rate(%) | ‘Main’ outcome identified | Nature of ‘main’ outcome | End-point |
|---|---|---|---|---|---|---|---|---|---|---|
| A01 | Andrade | 1991 | N | 44 | 33 | N | 25.0 | Ritchie articular index | Continuous | 6 months |
| A05 | Bell | 2004 | Y | 62 | 53 | Y | 14.5 | Tender point pain on palpation | Continuous | 3 months |
| A06 | Bonne | 2003 | N | 44 | 39 | N | 11.4 | Hamilton Rating Scale for Anxiety (HAM-A) | Continuous | 10 weeks |
| A07 | Brien | 2011 | N | 32 | 23 | N | 28.1 | Proportion of patients meeting ACR 20% improvement criteria (‘ACR20 response’) | Dichotomous | 28 weeks |
| A09 | Cavalcanti | 2003 | N | 28 | 20 | N | 28.6 | Responders: patients with more than 50% reduction in pruritus score | Dichotomous | 60 days |
| A10 | Chapman | 1999 | Y | 61 | 50 | Y | 18.0 | SRH-SLPD functional assessment tool: SRS (symptoms) sub-scale | Continuous | 4 months |
| A11 | de Lange de Klerk | 1994 | N | 175 | 170 | Y | 2.9 | Daily total symptom score | Continuous | 1 year |
| A13 | Fisher | 2006 | Y | 38 | 27 | N | 28.9 | VAS of overall symptom severity | Continuous | 13 weeks |
| A14 | Frass | 2005 | N | 70 | 67 | Y | 4.3 | Patient survival | Dichotomous | 180 days |
| A16 | Gaucher | 1994 | N | 80 | 51 | Y | 36.3 | Degree of dehydration | Continuous | 12 h |
| A18 | Jacobs | 1993 | N | 34 | 33 | N | 2.9 | Number of days until fewer than 3 unformed stools for 2 consecutive days | Continuous | Up to 6 days |
| A19 | Jacobs | 1994 | N | 92 | 81 | Y | 12.0 | Number of days until fewer than 3 unformed stools for 2 consecutive days | Continuous | Up to 5 days |
| A20 | Jacobs | 2001 | Y | 75 | 75 | Y | 0.0 | Treatment failure | Dichotomous | 5 days (cumulative total) |
| A21 | Jacobs | 2000 | N | 126 | 116 | Y | 7.9 | Number of days until fewer than 3 unformed stools for 2 consecutive days | Continuous | 5 days |
| A22 | Jacobs | 2005b | Y | 53 | 33 | N | 37.7 | Hot flash severity score | Continuous | 12 months |
| A23 | Jacobs | 2005a | Y | 43 | 37 | N | 14.0 | Conners Global Index–Parent (CGI-P)—total | Continuous | 17 weeks |
| A24 | Jansen | 1992 | Y | 10 | 4 | N | 60.0 | Endoscopic appearance (grade) | Continuous | 12 months |
| A25 | Kainz | 1996 | N | 67 | 60 | Y | 10.4 | Responders: patients with at least 50% reduction in area of skin affected by warts | Dichotomous | 8 weeks |
| A26 | Katz | 2005 | Y | 7 | 3 | N | 57.1 | Hamilton Depression Scale (HAMD) | Continuous | 12 weeks |
| A30 | Naudé | 2010 | N | 33 | 30 | N | 9.1 | Sleep Impairment Index (SII) summary score | Continuous | 4 weeks |
| A31 | Rastogi (a) | 1999 | N | 50 | 42 | N | 16.0 | CD4+ T-lymphocyte counts | Continuous | 6 months |
| A31 | Rastogi (b) | 1999 | N | 50 | 38 | N | 24.0 | CD4+ T-lymphocyte counts | Continuous | 6 months |
| A32 | Sajedi | 2008 | N | 24 | 16 | N | 33.3 | Modified Ashworth Scale: measurement of muscle tone in right leg | Continuous | 4 months |
| A33 | Siebenwirth | 2009 | N | 24 | 14 | N | 41.7 | MP (multiparameter dermatitis) score | Continuous | 32 weeks |
| A34 | Steinsbekk | 2005 | N | 251 | 199 | Y | 20.7 | Parent-reported URTI total symptom score | Continuous | Duration of 12 weeks |
| A35 | Straumsheim | 2000 | N | 73 | 68 | Y | 6.8 | Frequency of migraine attacks per month | Continuous | Last month of 4-month period |
| A36 | Thompson | 2005 | Y | 53 | 45 | Y | 15.1 | MYMOP profile score | Continuous | 16 weeks |
| A37 | Walach | 1997 | N | 98 | 92 | Y | 6.1 | Frequency of headaches per month | Continuous | Last month of 3-month period |
| A38 | Weatherley-Jones | 2004 | N | 103 | 86 | Y | 16.5 | Responders: those with clinical improvement (Multidimensional Fatigue Inventory: mental fatigue) | Dichotomous | 7 months |
| A39 | White | 2003 | N | 89 | 74 | Y | 16.9 | Childhood Asthma Questionnaire (CAQ) sub-scale for severity of symptoms | Continuous | 52 weeks |
| A40 | Whitmarsh | 1997 | N | 63 | 60 | Y | 4.8 | Frequency of migraine attacks per month | Continuous | Last month of 4-month period |
| A41 | Yakir | 2001 | Y | 23 | 19 | N | 17.4 | Menstrual distress questionnaire (MDQ) score | Continuous | Duration of 3 months (last 7 days per cycle) |
ITT intention to treat, PP per protocol, Y yes, N no.