ABSTRACT
<p><b>Objective</b>To investigate the clinical effects of the combined therapy of Compound Xuanju Capsules (CXJC) and traditional Chinese medicinal formula on infertility in male smokers.</p><p><b>METHODS</b>A total of 176 male infertility patients were divided into a smoking and a non-smoking group and the former further divided into mild, moderate and heavy smokers according to the daily consumption of cigarettes and the length of smoking history. The patients were treated with CXJC combined with traditional Chinese medicinal formula for 3 four-week courses and the therapeutic results were evaluated by comparing the indicators of the traditional Chinese medicine (TCM) syndrome, routine semen parameters, sperm morphology, and sperm DNA fragmentation index (DFI) among different groups before and after treatment.</p><p><b>RESULTS</b>The baseline TCM syndrome scores were remarkably higher in the heavy smokers than in the non-smoking group (P < 0.05) but showed no statistically significant differences between the mild and moderate smokers (P > 0.05). The baseline percentage of sperm head defects and DFI were also markedly higher in the heavy and moderate smokers than in the non-smoking group (P < 0.05). Compared with the baseline, significant improvement was achieved after treatment in the TCM syndrome, routine semen parameters, sperm morphology and sperm DFI, especially in the heavy smokers in the percentages of grade a+b sperm (［17.12 ± 2.54］ vs ［30.15 ± 3.10］%, P < 0.05), morphologically normal sperm (［15.54 ± 1.98］ vs ［26.82 ± 3.52］%, P < 0.05), and head-defective sperm (［27.02 ± 2.14］ vs ［22.07 ± 1.52］%, P < 0.05).</p><p><b>CONCLUSIONS</b>Sperm quality is significantly decreased while the risk of infertility remarkably increased in moderate and heavy smokers. The combined therapy of CXJC and traditional Chinese medicinal formula can effectively improve semen quality, sperm morphology and sperm DFI in male smokers with infertility, though more evidence is to be collected from further studies.</p>