Efficacy of SXN in the Treatment of Iron Deficiency Anemia: A Phase IV Clinical Trial

Abstract

Shengxuening (SXN) tablet is extracted from the excrement of the silkworm and has effects on hematopoiesis. The main components of SXN are chlorophyll derivatives and sodium iron chlorophyllin (SIC). The present study aims to investigate the efficiency and safety of SXN on iron deficiency anemia. This phase IV, multicenter, open-label, randomized clinical trial was conducted in 31 hospitals in China from June 2001 to April 2002. Adults and children were randomly divided into low-dose (L-SXN), medium-dose (M-SXN), and high-dose (H-SXN) groups, respectively. The course of treatment was 1 month. Peripheral hemogram levels and iron status were examined before and after treatment. Adults in all three dose groups demonstrated a significant increase in hemoglobin (HGB) concentration. Children who received SXN treatment in medium and high doses also demonstrated increased HGB concentration. Reticulocyte counts increased at the end of treatment in the M-SXN and H-SXN adult groups and in the M-SXN child group. For both children and adults, SXN in the three dose groups was found to significantly elevate red blood cell level, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. The total effective rate in the SXN-treated group reached 84.8%. The incidence of adverse events was 4.07%. The most common side effects were nausea (2.83%), diarrhea (0.74%), and rash (0.25%). SXN was proved to be efficient and safe for adults and children with iron deficiency anemia.

Shengxuening versus oral iron supplementation for the treatment of renal anemia: A systematic review

“…[26] And a series of studies showed that SXN has the lowest incidence of adverse reactions compared with ferrous sulfate, ferrous fumarate, polysaccharide iron complex capsule, ferrous succinate, and ferrous gluconate. [27][28][29] Several limitations in our systematic review should be noted. First, a publication bias was inevitable because all included studies were from the same country.…”

“…[ 26 ] And a series of studies showed that SXN has the lowest incidence of adverse reactions compared with ferrous sulfate, ferrous fumarate, polysaccharide iron complex capsule, ferrous succinate, and ferrous gluconate. [ 27 , 28 , 29 ]…”

Shengxuebao Mixture for Iron Deficiency Anemia: A Meta-Analysis and Systematic Review

“…Hence, the treatment of anemia has been paid more attention. Chinese herbals have been used in treating IDA clinically for many years [17][18][19][20]. Baishao (Radix Paeoniae Alba), a kind of Chinese medicine in SXBM, was deeply researched through network pharmacology.…”

The efficiency and safety of Shengxuening tablet on treating and preventing iron deficiency anemia: A systematic review and meta-analysis

“…Silkworm excrement is a long-history traditional Chinese medicine, which was recorded in many Chinese ancient medical books, including the Compendium of Materia Medica and Supplement to Medica ( Wei et al, 1997 ; Wei et al, 2005 ). It possesses sweet and pungent taste and is warm in nature, has effects of removing blood stasis, replenishing qi and nourishing blood and has been widely documented to treat anemia with deficiency of both qi and blood ( Chen, 2014 ; Ding et al, 2019 ). Therefore, SXN is suitable for anemia with qi and blood deficiency, it has been widely used for the treatment of hematopoietic diseases, including renal anemia, aplastic anemia, IDA, and idiopathic thrombocytopenic purpura ( Shao et al, 2007 ).…”

“…A systematic review showed that SXN administration was more effective and safer than oral iron supplementation in patients with renal anemia ( Zeng et al, 2020 ). Additionally, a phase IV clinical trial in China demonstrated that SXN was efficacious and safe for both adults and children with IDA, with a total effective rate of 84.8% ( Ding et al, 2019 ). Given the accumulating evidence, we performed a systematic review and meta-analysis of the effect and safety of SXN in patients with IDA.…”