Efficacy and safety of Chinese medicine combined with balloon dilatation vs. balloon dilatation alone for achalasia patients: a systematic review and meta-analysis

BACKGROUND: Balloon dilatation is widely used for patients with achalasia; however, the efficacy and safety of Chinese medicine combined with balloon dilatation for achalasia patients is still unclear. Therefore, we conducted a meta-analysis to compare the treatment effectiveness of treatment with Chinese medicine plus balloon dilatation versus balloon dilatation alone for patients with achalasia. METHODS: Randomized controlled trials (RCTs) compared the effectiveness of Chinese medicine plus balloon dilatation with balloon dilatation as examined in studies in the PubMed, Springer, Embase, Wiley-Blackwell, Chinese Journal Full-text Database, and the Cochrane library from their inception up to May 2019. The odds ratios (ORs) and weighted mean differences (WMDs) with corresponding 95% confidence intervals (CIs) were used to calculate categories and continuous outcomes using the random-effects model. The inclusion of studies according to the PICOS (participants, interventions, comparisons, outcomes) criteria, the assessment of risk of bias of included studies adhered to the Cochrane criteria guidelines. RESULTS: The initial electronic searches produced 378 records, and 10 RCTs that recruited 504 achalasia patients were included in the final quantitative analysis. Except for other potential biases with moderate to high-risk bias of 20–40%, the other six items had a low-risk bias of 80–90%. Overall, we noted that patients who received the Chinese medicine plus balloon dilatation treatment had a greater incidence of improvement at 1 year (OR: 2.20; 95% CI: 1.45–3.33; P<0.001), and 5 years (OR: 1.83; 95% CI: 1.23–2.74; P=0.003), and reduced the risk of gastroesophageal reflux (OR: 0.42; 95% CI: 0.24–0.76; P=0.004) than patients who underwent balloon dilation only. However, patients who received the Chinese medicine plus balloon dilatation treatment did not have a greater risk of perforation (OR: 0.53; 95% CI: 0.24–1.19; P=0.123) compared with patients undergoing balloon dilation. Finally, Chinese medicine plus balloon dilatation was associated with high esophageal sphincter pressure (WMD: 2.01; 95% CI: 1.19–2.84; P<0.001) compared with patients who underwent balloon dilatation only. CONCLUSIONS: Chinese medicine plus balloon dilatation had better effects after treatment than balloon dilatation alone for achalasia patients. Given the risk of bias of included studies, the conclusion should be made with cautions.