Sindrup 2001.
Methods | Double blind placebo controlled crossover design, five weeks. Two five week periods, at least one week washout, no carry over effect Inclusion criteria: age at least 20 years, duration of symptoms at least six months |
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Participants | Polyneuropathy (diabetic 18, non‐diabetic 29). 54 participants (47 final number) Mean age 58 years (range 30 to 82), 31 male and 16 female patients Pain score 14 (25 to 75 % CI: 9 to 19), mean consumption of paracetamol 500 mg six tablets / week (25 to 75 % CI: 0 to 22) |
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Interventions | St.John's wort (total hypericin) 2700 mcg daily orally, or placebo | |
Outcomes | Pain patients reported, 6‐item global improvement, sum pain score (0 to 40), paracetamol weekly consumption (number of 500 mg tablets), overall period reference On St.John's complete or good improvement 6/47, moderate 3/47, slight 4/47, no change 22/47, worse 12/47: on placebo complete or good improvement 0/47, moderate 2/47, slight 7/47, no change 25/47, worse 13/47 Pain on St.John's 14 (25 to 75 % CI: 7 to 21), on placebo 15 (9 to 19) Paracetamol consumption on St.John's 4 (25 to 75 % CI: 0 to 21), on placebo 5 (0 to18) Overall period preference 25 for St.John's, 16 for placebo, 6 no difference |
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Notes | Dropouts 7/54;
on St John's 2 (1 SE and 1 lost to follow‐up), on placebo 4 (1 SE, 3 needed pain treatment), 1 inconsistent pain rating SE: 13/54 on St. Johns, 15/54 on placebo. Withdrawn due to SE 1/54 on St. johns, 1/54 on placebo QS = 5 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |