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. 2012 Jan 23;141(2 Suppl):e419S–e494S. doi: 10.1378/chest.11-2301

Table 27.

—[Section 4.3] Summary of Findings: Venoactive Medication vs No Venoactive Medication for Patients With PTSa,b,202,238

Outcomes No. of Participants (Studies), Follow-up Quality of the Evidence (GRADE) Relative Effect (95% CI) Anticipated Absolute Effects
Risk With No Venoactive Medication Risk Difference With Venoactive Medication (95% CI)
Symptomatic relief: PTS score (Villalta scale) < 5 or decreased by 30% at 12 mo compared with baseline in Frulla et al238; improved tiredness of the leg at 8 wk in de Jongste et al243,c 163 (2 studies) Lowd-g due to inconsistency, imprecision RR 1.14 (0.85-1.52) 476 per 1,000 67 more per 1,000 (from 71 fewer to 247 more)

QOL not reported Not estimable

Recurrent VTE not reported Not estimable

Ulceration not reported Not estimable

Side effects 203 (2 studies) Moderated,f-h due to imprecision RR 2.04 (0.76-5.51) 61 per 1,000 63 more per 1,000 (from 15 fewer to 275 more)

The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Working group grades of evidence are as follow: High quality, further research is very unlikely to change our confidence in the estimate of effect; moderate quality, further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate; low quality, further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate; very-low quality, we are very uncertain about the estimate. See Table 1 and 3 legends for expansion of abbreviations.

a

Patients with PTS and history of DVT in PTS leg.

b

Included studies that assessed rutosides.

c

Investigators assessed other symptoms (pain, heaviness, swelling feeling, restless legs, and cramps) but did not report a composite score. The symptom we chose to report showed the most benefit; the effect estimates for the other symptoms ranged from 0.8 to 1.4, and none were statistically significant.

d

In both studies, sequence generation and allocation concealment were unclear. Both studies blinded outcome assessors and had complete follow-up. Although de Jongste et al243 blinded patients, the authors did not adhere to the intention-to-treat principle and did not use a validated scale to measure symptomatic relief. Although Frulla et al238 adhered to the intention-to-treat principle, the author did not blind patients.

e

I2 = 77%.

f

Small number of patients. CI included both values suggesting harms and values suggesting benefits.

g

Publication bias was not detected but not ruled out given that we identified only two small studies, and it unclear whether they were funded by industry.

h

I2 = 7%.