Table 1.
Characteristics of meta-analyses and trials included for the overall dataset and main analyses
| Characteristics | Overall dataset | Main analyses* | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ia | Ib | IIa | IIb | III | |||||||||||||
| Meta-analyses | Trials | Meta-analyses | Trials | Meta-analyses | Trials | Meta-analyses | Trials | Meta-analyses | Trials | Meta-analyses | Trials | ||||||
| Outcome measures according to clinical area | 142 | 1153 | 18 | 132 | 14 | 95 | 29 | 173 | 13 | 91 | 46 | 397 | |||||
| Adverse events of treatment | 22 (15.5) | 129 (11.2) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| All cause mortality | 7 (4.9) | 143 (12.4) | 0 | 0 | 2 (14.3) | 27 (28.4) | 0 | 0 | 2 (15.4) | 27 (29.7) | 0 | 0 | |||||
| Cause specific mortality | 1 (0.7) | 11 (1.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.2) | 11 (2.8) | |||||
| Clinician assessed outcomes (eg, body mass index, blood pressure, lung function, infant weight) | 12 (8.5) | 95 (8.2) | 0 | 0 | 1 (7.1) | 11 (11.6) | 1 (3.4) | 3 (1.7) | 0 | 0 | 11 (23.9) | 92 (23.2) | |||||
| Composite endpoint (including mortality or major morbidity) | 2 (1.4) | 16 (1.4) | 0 | 0 | 2 (14.3) | 12 (12.6) | 0 | 0 | 1 (7.7) | 7 (7.7) | 1 (2.2) | 9 (2.3) | |||||
| Global improvement | 3 (2.1) | 14 (1.2) | 0 | 0 | 2 (14.3) | 5 (5.3) | 0 | 0 | 2 (15.4) | 5 (5.5) | 2 (4.3) | 12 (3.0) | |||||
| Laboratory reported outcomes (eg, blood components, tissue analysis, urinalysis) | 5 (3.5) | 45 (3.9) | 0 | 0 | 1 (7.1) | 2 (2.1) | 0 | 0 | 0 | 0 | 1 (2.2) | 4 (1.0) | |||||
| Lifestyle outcomes (including diet, exercise, smoking) | 5 (3.5) | 100 (8.7) | 1 (5.6) | 2 (1.5) | 0 | 0 | 0 | 0 | 0 | 0 | 3 (6.5) | 63 (15.9) | |||||
| Major morbidity event (including myocardial infarction, stroke, haemorrhage) | 5 (3.5) | 44 (3.8) | 0 | 0 | 3 (21.4) | 24 (25.3) | 0 | 0 | 3 (23.1) | 24 (26.4) | 5 (10.9) | 44 (11.1) | |||||
| Mental health outcomes (including cognitive function, depression and anxiety scores) | 7 (4.9) | 61 (5.3) | 2 (11.1) | 9 (6.8) | 1 (7.1) | 4 (4.2) | 0 | 0 | 0 | 0 | 5 (10.9) | 52 (13.1) | |||||
| Other outcomes (not classified elsewhere) | 15 (10.6) | 145 (12.6) | 5 (27.8) | 79 (59.8) | 1 (7.1) | 2 (2.1) | 4 (13.8) | 16 (9.2) | 2 (15.4) | 4 (4.4) | 5 (10.9) | 48 (12.1) | |||||
| Pain (extent of pain a patient is experiencing) | 5 (3.5) | 17 (1.5) | 3 (16.7) | 8 (6.1) | 0 | 0 | 0 | 0 | 1 (7.7) | 7 (7.7) | 1 (2.2) | 2 (0.5) | |||||
| Perinatal outcomes | 5 (3.5) | 34 (2.9) | 0 | 0 | 0 | 0 | 1 (3.4) | 2 (1.2) | 0 | 0 | 1 (2.2) | 9 (2.3) | |||||
| Pregnancy outcomes | 8 (5.6) | 28 (2.4) | 0 | 0 | 0 | 0 | 1 (3.4) | 3 (1.7) | 0 | 0 | 6 (13.0) | 23 (5.8) | |||||
| Quality of life (including ability to perform physical, daily, and social activities) | 3 (2.1) | 19 (1.6) | 2 (11.1) | 6 (4.5) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.2) | 13 (3.3) | |||||
| Radiological outcomes (including radiograph abnormalities, ultrasound, magnetic resonance imaging results) | 2 (1.4) | 11 (1.0) | 0 | 0 | 1 (7.1) | 8 (8.4) | 0 | 0 | 1 (7.7) | 8 (8.8) | 2 (4.3) | 11 (2.8) | |||||
| Resource use (including cost, hospital stay duration, number of procedures) | 19 (13.4) | 133 (11.5) | 0 | 0 | 0 | 0 | 19 (65.5) | 133 (76.9) | 0 | 0 | 0 | 0 | |||||
| Surgical and device related outcomes | 4 (2.8) | 20 (1.7) | 0 | 0 | 0 | 0 | 3 (10.3) | 16 (9.2) | 0 | 0 | 1 (2.2) | 4 (1.0) | |||||
| Symptoms or signs of illness or condition | 6 (4.2) | 35 (3.0) | 5 (27.8) | 28 (21.2) | 0 | 0 | 0 | 0 | 1 (7.7) | 9 (9.9) | 0 | 0 | |||||
| Withdrawals/dropouts/compliance | 6 (4.2) | 53 (4.6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| Type of experimental intervention | |||||||||||||||||
| Pharmacological | 95 (66.9) | 728 (63.1) | 12 (66.7) | 48 (36.4) | 10 (71.4) | 74 (77.9) | 19 (65.5) | 121 (69.9) | 10 (76.9) | 78 (85.7) | 25 (54.3) | 195 (49.1) | |||||
| Surgical | 3 (2.1) | 12 (1.0) | 1 (5.6) | 4 (3.0) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.2) | 4 (1.0) | |||||
| Psychosocial, behavioural, or educational | 17 (12.0) | 204 (17.7) | 1 (5.6) | 42 (31.8) | 3 (21.4) | 17 (17.9) | 3 (10.3) | 10 (5.8) | 1 (7.7) | 2 (2.2) | 9 (19.6) | 101 (25.4) | |||||
| Other | 27 (19.0) | 209 (18.1) | 4 (22.2) | 38 (28.8) | 1 (7.1) | 4 (4.2) | 7 (24.1) | 42 (24.3) | 2 (15.4) | 11 (12.1) | 11 (23.9) | 97 (24.4) | |||||
| Field of experimental intervention | |||||||||||||||||
| Conventional medicine | 137 (96.5) | 1100 (95.4) | 17 (94.4) | 127 (96.2) | 14 (100.0) | 95 (100.0) | 29 (100.0) | 173 (100.0) | 12 (92.3) | 84 (92.3) | 44 (95.7) | 368 (92.7) | |||||
| Alternative/complementary medicine | 5 (3.5) | 53 (4.6) | 1 (5.6) | 5 (3.8) | 0 | 0 | 0 | 0 | 1 (7.7) | 7 (7.7) | 2 (4.3) | 29 (7.3) | |||||
| Type of comparison intervention | |||||||||||||||||
| Placebo or no treatment | 57 (40.1) | 442 (38.3) | 8 (44.4) | 36 (27.3) | 1 (7.1) | 11 (11.6) | 12 (41.4) | 47 (27.2) | 2 (15.4) | 16 (17.6) | 17 (37.0) | 160 (40.3) | |||||
| Other inactive (standard care) | 38 (26.8) | 452 (39.2) | 4 (22.2) | 76 (57.6) | 7 (50.0) | 55 (57.9) | 9 (31.0) | 84 (48.6) | 5 (38.5) | 46 (50.5) | 17 (37.0) | 176 (44.3) | |||||
| Active comparison | 47 (33.1) | 259 (22.5) | 6 (33.3) | 20 (15.2) | 6 (42.9) | 29 (30.5) | 8 (27.6) | 42 (24.3) | 6 (46.2) | 29 (31.9) | 12 (26.1) | 61 (15.4) | |||||
| Hypothesis of benefit | 114 (80.3) | 971 (84.2) | 18 (100.0) | 132 (100.0) | 14 (100.0) | 95 (100.0) | 29 (100.0) | 173 (100.0) | 13 (100.0) | 91 (100.0) | 46 (100.0) | 397 (100.0) | |||||
| Observer reported outcome† | 68 (47.9) | 640 (55.5) | 0 | 0 | 14 (100.0) | 95 (100.0) | 0 | 0 | 10 (76.9) | 73 (80.2) | 46 (100.0) | 397 (100.0) | |||||
| All cause mortality | 11 (16.2) | 170 (26.6) | 0 | 0 | 2 (14.3) | 27 (28.4) | 0 | 0 | 2 (20.0) | 27 (37.0) | 0 | 0 | |||||
| Other objective | 4 (5.9) | 39 (6.1) | 0 | 0 | 1 (7.1) | 2 (2.1) | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| Subjective | 53 (77.9) | 431 (67.3) | 0 | 0 | 11 (78.6) | 66 (69.5) | 0 | 0 | 8 (80.0) | 46 (63.0) | 46 (100.0) | 397 (100.0) | |||||
| Binary or measurement scale outcome | |||||||||||||||||
| Binary | 110 (77.5) | 885 (76.8) | 9 (50.0) | 42 (31.8) | 11 (78.6) | 78 (82.1) | 25 (86.2) | 151 (87.3) | 11 (84.6) | 82 (90.1) | 32 (69.6) | 289 (72.8) | |||||
| Continuous | 31 (21.8) | 265 (23.0) | 8 (44.4) | 87 (65.9) | 3 (21.4) | 17 (17.9) | 4 (13.8) | 22 (12.7) | 2 (15.4) | 9 (9.9) | 14 (30.4) | 108 (27.2) | |||||
| Inverse variance | 1 (0.7) | 3 (0.3) | 1 (5.6) | 3 (2.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||
| Year of publication of trial (median, IQR) | — | 2003 (1996-2008) | 2008 (2004-11) | 2005 (1997-2009) | 2011 (2005-12) | 2005 (1998-2009) | 2009 (2005-11) | 2000 (1996- 2008) | 2010 (2003-12) | 2002 (1995-09) | 2010 (2003-12) | 2003 (1996- 2008) | |||||
| Sample size of meta-analysis/trial (median, IQR) | 768 (293- 2025) | 106 (50- 270) | 706 (163-1314) |
133 (78- 234) | 809 (173- 2402) | 102 (43- 300) | 838 (323- 3103) | 139 (63- 483) | 1085 (421- 3621) | 149 (61- 370) | 599 (289- 1361) | 82 (40- 207) | |||||
IQR=interquartile range. Results are shown as number (%) unless stated otherwise.
*
Ia=Effect of blinding patients in trials with patient reported outcomes; Ib=effect of blinding patients in trials with blinded observer reported outcomes; IIa=effect of blinding healthcare providers in trials with healthcare provider decision outcomes; IIb=effect of blinding healthcare providers in trials with blinded observers or patients assessing the outcome; III=effect of blinding outcome assessors (that is, observers) in trials with subjective outcomes.
†
Judged for the whole meta-analysis, not outcomes in individual trials.