Table 3.
Clinical studies of mesoglycan in patients with hemorrhoidal disease
| References | Study design | Patient type | N | Mesoglycan treatment | Study duration | Main outcomes |
|---|---|---|---|---|---|---|
| Saggioro et al. [76] | Prospective, randomized, OL | Acute grade II and III HD | 71 (36 mesoglycan, 35 bilberry extract) | 24 mg TID PO | 28 days | Significantly greater reductions in severity of pain, sensation of pressure, pruritus, edema, inflammation, and rectal bleeding with mesoglycan vs bilberry extract |
| Gallo et al. [20] | Prospective, Pilot | After excisional hemorrhoidectomy in grade III and IV HD | 101 (54 mesoglycan, 47 standard carea) | 30 mg/day IM for 5 days, then 50 mg BID PO for 30 days | 40 days | Mesoglycan significantly reduced pain during rectal examination (p = 0.033) and time to return to work/normal activities (p = 0.009) vs standard carea; significantly (p < 0.001) lower rate of thrombosis on postoperative days 7–10 with mesoglycan vs standard carea |
| Gallo et al. [19] | Retrospective | After excisional hemorrhoidectomy in grade III and IV HD | 398 (206 mesoglycan, 192 standard carea) | 30 mg/day IM for 5 days, then 50 mg BID PO for 30 days | 6 weeks | Mesoglycan significantly reduced pain at rest (all p < 0.0001), after defecation (all p < 0.0001) and during examination (p < 0.0001, p < 0.0001, and p = 0.003, respectively) vs standard carea after 1, 3, and 6 weeks; mesoglycan significantly improved postoperative activities, autonomy, driving, and return to work vs standard carea after 1 (p = 0.016), 3 (p = 0.002) and 6 (p = 0.007) weeks |
BID twice daily, HD hemorrhoidal disease, IM intramuscular, OL open label, PO orally, TID three times daily
aOral dose of ketorolac 10 mg every 4–6 h, not exceeding 40 mg/day and not exceeding 5 days + stool softeners