Safety evaluation of Bon-santé cleanser® polyherbal in male Wistar rats: Further investigations on androgenic and toxicological profile.

BACKGROUND: The global increase in acceptance and use of herbal remedies in recent times is still accompanied with poor knowledge of their potential adverse effects and the toxicological implications of their use are underestimated. METHODS: Bon-santé Cleanser® (BSC), a polyherbal containing Anogeissus leiocarpus, Terminalia ivorensis, Massularia acuminate and Macuna pruriens, is an "energizer and hormone booster". We assessed the effect of BSC on reproductive function after administration for 60 days in male Wistar rats. Rats (150-300 g) were assigned into four groups of 8/group. Control received distilled water (10 ml/kg) while other groups received BSC 250, 500 and 1000 mg/kg/day p.o. respectively. Animals were euthanized by cervical dislocation and samples collected for analysis. RESULTS: BSC (250 mg/kg) elevated (p < 0.05) follicle stimulating hormone and luteinizing hormone levels respectively. BSC decreased sperm motility and the live-dead ratio at 1000 mg/kg and reduced reproductive hormone at 500 mg/kg and 1000 mg/kg respectively. BSC at 500 mg/kg increased (p < 0.05, F = 3.18-13.21) testicular reduced glutathione level (50.3%) and catalase (43.7%) but not activities of superoxide dismutase, glutathione S-transferase, and malondialdehyde level. Further, BSC influenced Mg, Zn, Cu, P, Mn, Ni and Fe levels (p < 0.05). BSC (1000 mg/kg) decreased testis weight (p < 0.05) and induced mild inflammation characterized by atrophic tubules. CONCLUSION: Overall, our data suggest BSC at low doses may increase reproductive hormones regulated by FSH and LH as observed in this study. However, BSC administration should be done with caution as it may induce reproductive toxicity in large doses.

Efficacy of garcinia Kola 0.5 aqueous eye drops in patients with primary open-angle glaucoma or ocular hypertension

PURPOSE:To evaluate the intraocular pressure (IOP) lowering efficacy of Garcinia kola 0.5% aqueous solution eye drops in patients with newly diagnosed primary open-angle glaucoma or ocular hypertension (POAG/OH).MATERIALS AND METHODS: A randomized, double-masked, multicenter, active-controlled prospective study. Patients who met the inclusion criteria were randomly assigned in equal numbers to receive Timolol 0.5% eye drops as a control medication (A = Group 1 eyes) or Garcinia kola 0.5% eye drops as the study medication (B = Group 2 eyes). All drops were instilled at 6 am and 6 pm daily. Goldman applanation tonometry was performed at 9 am, 12 pm and 3 pm at baseline, week-6, week-12 and week-24 visits. Voluntary and actively elicited reports of adverse events were documented. The mean change in IOP over 24 weeks was the primary outcome measure. Both groups were compared for statistically significant differences at all visits. A P < 0.05 was considered statistically significant.RESULTS:A total of 178 patients were randomly assigned to G. kola and Timolol groups. At baseline there were no differences in mean IOP between groups, based on age, sex, or diagnosis. At the end of the study period (24(th) week), the mean (+/- SD) reduction in IOP was 12.93 +/- 2.3 mmHg (47.8% +/- 0.8% reduction) in G. Kola group and 13.09 +/- 2.8 mm Hg (48.2% +/- 1.03% reduction) in the Timolol group (P > 0.05). Adverse events were mild in nature with no statistically significant differences between groups (P > 0.05).CONCLUSIONS:Garcinia kola ophthalmic solution significantly reduces IOP as compared to baseline. The IOP lowering effect of both treatments was equivalent

Pupillary changes among Nigerian adults following the instillation of Garcinia kola nut extracts: multicentric studies.

BACKGROUND: A multi-centre, open, within-patient controlled study was performed on 106 adult volunteers to investigate the effects of Garcinia kolanut extracts on the pupillary sizes. STUDY DESIGN: 106 participants in three Nigerian Ophthalmic Centres with no pupillary defects and associated ocular or systemic co-morbidities had their pupillary diameters measured at 0, 15, 30 and 45 minutes respectively with a pupillometer (Neuroptics model # 586009). Using the left eyes as control, Garcinia kolanut extract was instilled into the right eyes at 15 minutes intervals. RESULTS: There were 63 females and 43 males ranging in age from 18 to 58 years with the mean age of 34.9 years. Average pupillary diameter measured among participants was 4.1 - 8.4 mm with the mean value of 6.0 mm prior to garcinia kola nut extract instillation. There was a gradual reduction in the baseline pupillary size with age in years at 0.2mm per decade without garcinia extract instillation. There was a significant higher baseline pupillary diameter in males than females with males and females mean values of 6.29mm (6.00 - 6.56mm) and 5.85mm (5.60 - 6.11mm) in the right eye (p=0.026) and mean pupillary diameters 6.16mm (5.90 - 6.42mm) and 5.80mm (5.56 - 6.04mm) in the left eyes (p=0.05) respectively. There were consistent significant miosis in the right eyes with instilled Garcinia kola nut extract compared to the left eyes at 15, 30 and 45 minutes (p=0.0000). CONCLUSION: 4% Garcinia kola nut extract drop has a transient miotic effect on human pupils not sustainable for more than 45 minutes.