XiaojiDaozhi Decoction, a prescription of Chinese herbal medicine, was found to be both safe and effective for the treatment of childhood constipation, according to study results published in Clinical and Translational Gastroenterology.

In a randomized, placebo-controlled, double-blind trial (ClinicalTrials.gov Identifier: NCT03186079), 200 participants aged between 4 and 14 years who met the Roman IV criteria for childhood constipation were enrolled. All participants maintained a fiber intake of 20 grams per day and received either XiaojiDaozhi Decoction (n=100) or placebo (n=100) twice daily for 8 weeks, with 12 weeks of follow-up.

XiaojiDaozhi Decoction consists of the following herbs: Raphanus sativus L.; Areca catechu L.; Fructus aurantll immaturus; Citrus aurantium L.; Crataegus pinnatifida; Magnolia officinalis Rehd; Cannabis sativa L.; Atractylodes macrocephala Koidz.; Semen armeniacae amarum; Paeonia lactiflora Pall; Radix et rhizoma rhei, and Honey mel.

A total of 153 participants completed the study. At the end of treatment, the response rates for XiaojiDaozhi Decoction vs placebo were 69{d847ba2f23daf15c773bda6cb71ac33aa9166b9578a171d654c6e3c528a0b6bc} and 42{d847ba2f23daf15c773bda6cb71ac33aa9166b9578a171d654c6e3c528a0b6bc}, respectively (χ2 = 14.759; P <.01) and at the end of follow-up they were 62{d847ba2f23daf15c773bda6cb71ac33aa9166b9578a171d654c6e3c528a0b6bc} and 31{d847ba2f23daf15c773bda6cb71ac33aa9166b9578a171d654c6e3c528a0b6bc}, respectively (χ2= 19.315; P <.01). Recurrence rates were 10.14{d847ba2f23daf15c773bda6cb71ac33aa9166b9578a171d654c6e3c528a0b6bc} and 26.19{d847ba2f23daf15c773bda6cb71ac33aa9166b9578a171d654c6e3c528a0b6bc} for patients in the herbal medicine vs placebo groups, respectively (χ2=4.947; P <.05). Satisfaction with bowel function at the end of treatment was reported by 67 patients in the herbal group and 38


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patients in the placebo group (χ2=16.862; P <.05). By the end of follow-up, satisfaction dropped to 56 and 25 patients in the herbal vs placebo groups, respectively (χ2=19.940; P <.05).

At the end of follow-up, 40 patients from the herbal group had increases in complete spontaneous bowel movements of ≥3 per week from baseline, while the same was true for only 19 patients receiving placebo (χ2=10.602; P <.05). During treatment, vomiting occurred in 8 patients: 5 from the herbal group and 3 from the placebo group. Among the herbal group, abdominal distention occurred in 4 patients and 2 cases of mild diarrhea were also reported. There were no adverse reactions recorded during follow-up. Routine blood tests, liver function, renal function, and blood lead tests were within the normal range for all 153 participants.

Study limitations included the use of subjective evaluations of symptoms and the bitterness of the herbal medicine leading to refusal by children to ingest it. Additionally, some parents discontinued treatment due to the belief that their child was in the placebo group.

According to researchers, “To the best of our knowledge, this is the first time that the treatment principle of childhood constipation has been proposed by relieving food stagnation, promoting Qi movement, and removing pathological heat accumulation.”

Reference

Qiao L, Wang L-J, Wang Y, Chen Y, Zhang H-L, Zhang S-C. A randomized, double-blind, and placebo-controlled trial of Chinese herbal medicine in the treatment of childhood constipation. Clin Transl Gastroenterol. 2021;12(5):e00345. doi: 10.14309/ctg.0000000000000345

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