International Journal of Phytomedicine and Phytotherapy
Table 4 Incidence of Adverse Events /AE) in individual studies– by system organ class (MedDRA)
From: Black cohosh (Cimicifuga racemosa) is a non-estrogenic alternative to hormone replacement therapy
System organ class | Reported incidence by treatment groups | ||||||
|---|---|---|---|---|---|---|---|
(KLI-DF-1 2001) | (BI 563.2) | ||||||
Klimadynon 40 mg | CR BNO 1055 150 mg | CR BNO 1055 300 mg | CE 0.625 mg | Placebo | Menofem /Klimadynon 40 mg | Placebo | |
N = 30 | N = 33 | N = 31 | N = 34 | N = 33 | N = 152 | N = 159 | |
N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | |
Patients with AE | 12 (40.0) | 12 (36.4) | 13 (41.9) | 13 (38.2) | 12 (36.4) | 16 (10.5) | 17 (10.7) |
Blood and lymphatic disorders | 1 (0.6) | ||||||
Cardiac disorders | |||||||
Ear and labyrinth disorders | 1 (3.3) | 1 (3.0) | |||||
Eye disorders | 1 (3.0) | ||||||
Gastrointestinal disorders | 2 (6.1) | 4 (11.8) | 2 (1.3) | 2 (1.3) | |||
General disorders and administration site conditions | 1 (0.7) | 1 (0.6) | |||||
Immune system disorders | 2 (1.3) | ||||||
Infections and infestations | 2 (6.7) | 3 (9.1) | 1 (3.2) | 6 (17.6) | 5 (3.3) | 4 (2.5) | |
Injury poisoning and procedural complications | 2 (6.7) | 1 (0.7) | |||||
Investigations | 4 (12.1) | 3 (9.7) | 1 (2.9) | 1 (0.7) | 2 (1.3) | ||
Metabolism and nutrition disorders | 1 (3.3) | 2 (6.1) | 1 (3.0) | 4 (2.6) | 5 (3.1) | ||
Musculoskeletal and connective tissue disorders | 1 (3.0) | 1 (3.2) | 2 (6.1) | 1 (0.7) | 2 (1.3) | ||
Nervous system disorders | 1 (3.3) | 1 (3.0) | 1 (0.7) | 1 (0.6) | |||
Psychiatric disorders | 1 (3.0) | ||||||
Renal and urinary disorders | |||||||
Reproductive system and breast disorders | 9 (30.0) | 11 (33.3) | 12 (38.7) | 12 (35.3) | 13 (39.4) | 1 (0.7) | 1 (0.6) |
Respiratory, thoracic and mediastinal disorders | 1 (3.3) | 1 (3.0) | |||||
Skin and subcutaneous disorders | 1 (2.9) | 1 (3.0) | |||||
Surgical and medical procedures | 1 (0.7) | ||||||
Vascular disorders | 1 (3.3) | 1 (0.6) | |||||