Li-Ying Xu, Bin-Yan Yu,Lu-Sha Cen

Abstract Gastroesophageal reflux disease (GERD) has a high prevalence worldwide and limited therapeutic options. Modified Xiaochaihu decoction (MXD), a new therapy for GERD, is a well-designed study that minimizes bias of herb dose.Their research showed MXD had similar therapeutic effect to omeprazole in mildto-moderate GERD. One limitation of this study was that it lacked records of side effects and rescue medication. As a chronic disease with recurrent symptoms,GERD rehabilitation requires prolonged observation of the clinical course with MXD therapy.

Key Words: Gastroesophageal reflux disease; Xiaochaihu decoction; New treatment;Traditional medicine; Modified Xiaochaihu decoction; Chronic disease

TO THE EDlTOR

We read with interest a clinical study by Liet al[1 ]. The researchers performed a prospective, doubleblinded, and double-simulation study on the efficacy of Modified Xiaochaihu decoction (MXD) for gastroesophageal reflux disease (GERD) and its effect on esophageal motility. The study enrolled 288 participants with GERD, and then divided them into the treatment and control groups, receiving MXD plus omeprazole simulation and omeprazole plus MXD simulation, respectively, for 4 wk. The GERD-Q scale score and esophageal manometry were evaluated. The result showed that MXD had a similar ability to increase the pressure at the lower esophageal sphincter and reduce ineffective swallowing,compared with omeprazole in mild-to-moderate GERD. The recurrence rate was significantly lower than that of the control group within 3 mo, on follow-up visits. We greatly appreciate the dedication of the authors towards studying the effect of MXD on GERD as an optional therapy.

As we all know, GERD has a high global prevalence with limited therapeutic options, and its incidence is increasing annually. Patients with GERD present with variety of symptoms including heartburn, effortless regurgitation, dyspepsia, bloating, and abdominal pain or discomfort as well as cough and laryngitis, which severely impact their quality of life[2 ]. Since the 1990 s, proton pump inhibitor (PPI) therapy has evolved as the standard treatment of choice for GERD[3 ]. However, it has become evident that symptoms attributed to GERD remain despite ongoing PPI treatment in up to 40 %of patients[4 ], and PPI increases the risks of infections, osteoporosis, hepatic failure, pancreatitis,jaundice, and persistent gynecomastia[5 -7 ]. Therefore, multivariable treatment beyond PPI is urgently required.

Traditional Chinese Medicine believes that the herb Chaihu could regulate qi-flow to harmonize digestive disorders. The formula Xiaochaihu decoction, which has demonstrated therapeutic effects such as for nausea, poor appetite, and epigastric distension, has been used in treating GERD for thousands of years in Asian countries. However, high-level evidence-based Traditional Chinese medical research is still lacking and is restricted by many factors. For instance, the herb formula is customized according to patient characteristics including severity of disease, gender, and age. Besides, pharmaceutical effects may be influenced by the way Chinese herbs are decocted. Thus, it is hard to provide the same drug dose for each patient. In this research, drug selection of herbal granule makes double-blind research achievable. For the concealed allocation, herbal granules were supplied instead of traditional decoction, which greatly reduced the bias from herb treatment.

A limitation of this study was a lack of record keeping of the side effects and rescue medications.With the growing popularity of traditional Chinese medicines, reports of herbal side effects are common. Bupleurum, the main component of MXD, was found to increase the risk of chronic hepatotoxicity[8 ,9 ]. Meanwhile, Itoh et al[10 ] reported that long-term oral administration of MXD caused cholestatic liver injury, interstitial pneumonia, and even death[10 ]. Therefore, medical safety evaluation tests, such as liver and kidney function indices, should be assessed. Rescue medication or treatment for these adverse events should also be considered.

Besides, although the sample size was well calculated according to previous literature reports and formula, the sample size for esophageal manometric indicators, which was from 7 -52 , was relatively small.

The authors mainly focused on the efficiency of MXD therapy for a short duration. As we know,GERD is generally a chronic disease with recurrent symptoms and requires long-term management[11 ].Further studies are needed to evaluate the effects of prolonged MXD therapy on GERD rehabilitation.

FOOTNOTES

Author contributions:Xu LY and Cen LS designed the research; Yu BY analyzed the data; Xu LY and Cen LS performed the research, wrote the letter; Cen LS revised the letter.

Supported byScientific Research Project of Zhejiang TCM Science and Technology Programme, No. 2020 ZB067 , No.2020 ZT001 , and No. 2021 ZQ031 ; and National Natural Science Foundation of China, No. 81503522 and No. 82104862 .

Conflict-of-interest statement:The authors declare no conflicts of interest.

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Country/Territory of origin:China

ORClD number:Li-Ying Xu 0000 -0001 -8238 -106 X; Bin-Yan Yu 0000 -0001 -6680 -5133 ; Lu-Sha Cen 0000 -0001 -7223 -340 X.

S-Editor:Fan JR

L-Editor:A

P-Editor:Fan JR