P&G trial shows multivitamins and minerals formula increases haemoglobin in women with anaemia
The increase in haemoglobin levels was observed as early as day 14 of the trial amongst women with moderate iron deficiency anaemia (IDA).
The product studied was an iron and multivitamin formula marketed as Sangobion Iron+ (SB+) by P&G in the Philippines.
Conducted by P&G and researchers from healthcare institutions in the Philippines, including Chong Hua Hospital and Cardinal Santos Medical Centre, findings of the trial were published in Journal of Clinical & Experimental Pharmacology.
Efficacy of SB+
The study evaluated the efficacy and safety of SB+ in 97 female subjects aged 15 to 55 with mild to moderate IDA recruited from The Philippines.
The subjects were divided into two groups, with 66 of them prescribed SB+ once a day and 31 subjects twice a day.
The study period ranged from at least 30 days to up to 90 days. The results showed a significant increase in mean haemoglobin values for all subjects at day 90.
The mean haemoglobin value was significantly increased from 10.1g/dL at baseline to 12.6g/dL at day 90.
Both mild and moderate IDA subjects achieved similar haemoglobin concentrations at day 90. For instance, women with mild IDA saw their mean haemoglobin value increased from 11.5g/dL at baseline to 12.5g/dL at day 90, while those with moderate IDA reported an increase from 9.4g/dL to 12.6g/dL.
This suggests SB+ capsules offer greater therapeutic benefits to those who need it more.
“The odds of improvement in IDA at day 90 was 3.8 and 4.7 in mild and moderate IDA subjects, respectively.
“The IDA status was significantly improved at day 14, 30, 60 and 90 with 24 per cent, 45 per cent, 66 per cent, and 72 per cent subjects with no IDA, respectively, when compared to 1 per cent subjects with no IDA at baseline (P<0.0001),” the researchers wrote.
Safety analysis was also performed. Only three adverse events were suspected to be related to the study drugs. Other than that, there is no significant changes in subjects’ vital signs.
The positive outcomes underscore the importance of incorporating vitamins and minerals into iron supplements for enhanced treatment effectiveness.
Overall, the study concludes that SB+ demonstrates efficacy and safety in treating mild to moderate IDA patients, reducing their health burdens, and improving overall health.
Despite the promising results, researchers have called for further randomised controlled trials involving appropriately sized subjects across different life stages, to confirm the findings and explore the sustained benefits of SB+ supplementation beyond the initial 90 days.
Risk factors of ID / IDA
ID and IDA arise from factors such as inadequate iron intake, increased demand for iron in the body, and/or elevated iron loss. This global health concern affects 30 to 50 per cent of the world’s population, with a consistently higher prevalence in females due to gynaecological causes from menarche to menopause.
The functional and clinical implications of ID and IDA are deemed debilitating, surpassing the impact of major depression, musculoskeletal disorders, and diabetes. Surprisingly, close to 40 per cent of ID and IDA patients suffer silently, with no apparent signs and symptoms during diagnosis.
Current ID and IDA treatment involve addressing the underlying causes and oral iron supplementation. A focus on improving quality of life by replenishing iron stores, enhancing haemoglobin concentration, and normalising red blood cell indices.
Evidence from previous studies
Oral iron supplements like ferrous gluconate are preferred due to their availability and cost-effectiveness. Additionally, iron with multivitamins has shown positive outcomes in improving haemoglobin levels.
In an independent randomised controlled trial of 175 non-pregnant Asian females, the supplementation of iron, folic acid, and vitamin C resulted in a noteworthy improvement in mean haemoglobin levels at both days 30 and 100.
This improvement was significantly greater compared to those receiving supplementation with iron and folic acid alone.
Likewise, a separate, not P&G led intervention study, focusing on adolescent girls indicated that weekly supplementation of vitamin C, in conjunction with iron and folate, led to a substantial increase in haemoglobin concentration compared to those who solely received weekly supplementation of iron and folate.
Nevertheless, scientific, and clinical reports on the efficacy, safety, and benefits of ferrous gluconate in combination with multivitamins for the treatment of ID and IDA remain limited.
Source: Journal of Clinical & Experimental Pharmacology
Management of Iron Deficiency Anemia with Fixed Dose Combination of Ferrous Gluconate, Multivitamins and Multi-mineral Capsule: A 12 Week, Open Label Single Arm Prospective, Non-Interventional (Observational) Study in Philippines
Authors: Christopher Joseph L. Soriano et al.
