A Randomized, Double-Blind, and Placebo-Controlled Trial of Chinese Herbal Medicine in the Treatment of Childhood Constipation

Qiao, Lei; Wang, Luo-Jia; Wang, Yan; Chen, Ying; Zhang, Hailan; Zhang, Shucheng

doi:10.14309/ctg.0000000000000345

Cited by 8 publications

(7 citation statements)

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“…The eligibility criteria were as follows: (i) patients were 4–14 years of age; (ii) patients met the Rome IV criteria for childhood constipation (H3a) (20); (iii) at least 2 sessions of polyethylene glycol (PEG) treatment and 2 sessions of Chinese herbal medicine (CHM) treatment were ineffective (1 session equals 2 months of treatment) (PEG: the mean duration of therapy was 6.2 ± 5 months; range, 3 weeks–21 months). The mean initial dose was 0.88 g/kg/d (range, 0.26–2.14 g/kg/d); CHM: mainly XiaojiDaozhi Decoction (21); in the last week, the patients did not receive any medications; and (iv) sEMG and HR-ARM verified the diagnosis of PFD (Figure 2).…”

Section: Methodsmentioning

confidence: 99%

A Randomized, Double-Blind, Controlled Trial of Percutaneous Tibial Nerve Stimulation With Pelvic Floor Exercises in the Treatment of Childhood Constipation

Song

Qiao

et al. 2023

Am J Gastroenterol

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INTRODUCTION: The management of childhood constipation is challenging. Pelvic floor dysfunction (PFD) is one of the most common causes of childhood constipation. Percutaneous tibial nerve stimulation (PTNS) with pelvic floor exercises (PFE) has achieved a satisfactory outcome in the elderly individuals and women with PFD. The efficacy of PTNS with PFE in childhood constipation has not been established. METHODS:A randomized, double-blind, controlled trial with 84 children who met the inclusion criteria was conducted.All participants were randomly assigned to PTNS with PFE or sham PTNS with PFE groups and received their individual intervention for 4 weeks with a 12-week follow-up evaluation. The spontaneous bowel movements (SBM) ‡3 per week were the main outcomes, and the risk ratio (RR) with 95% confidence interval (CI) were calculated. High-resolution anorectal manometry and surface electromyography were used for the assessment of pelvic floor function, and the adverse effects were assessed based on symptoms.

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Section: Methodsmentioning

confidence: 99%

A Randomized, Double-Blind, Controlled Trial of Percutaneous Tibial Nerve Stimulation With Pelvic Floor Exercises in the Treatment of Childhood Constipation

Song

Qiao

et al. 2023

Am J Gastroenterol

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“…We included 15 studies; these were 2 SRs, 251,252 8 RCTs [253][254][255][256][257][258][259][260] and 5 other primary studies [261][262][263][264][265] within this synthesis.…”

Section: What Is the Effectiveness Of Complementary Therapy Intervent...mentioning

confidence: 99%

“…263 Seven studies excluded children with additional needs. 251,253,[255][256][257][258][259][260]262,264 The most common pre-specified outcome reported was stool frequency (n = 17 studies). QoL was reported by two studies 255,260 and painful defaecation by seven studies.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

“…251,253,[255][256][257][258][259][260]262,264 The most common pre-specified outcome reported was stool frequency (n = 17 studies). QoL was reported by two studies 255,260 and painful defaecation by seven studies. 252,[254][255][256][257]259,260,264 School attendance was reported in only one study.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

“…QoL was reported by two studies 255,260 and painful defaecation by seven studies. 252,[254][255][256][257]259,260,264 School attendance was reported in only one study. 261…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

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Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis

Todhunter-Brown,

Booth,

Campbell

et al. 2024

Health Technol Assess

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Background Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear. Objective To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented. Methods Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0–18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. Scoping review: We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. Systematic reviews of the evidence of effectiveness: For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. Economic synthesis: Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. Systematic review of implementation factors: Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains. Results Stakeholders prioritised outcomes, developed a model which informed evidence synthesis and identified evidence gaps. Scoping review 651 studies, including 190 randomised controlled trials and 236 primary studies, conservatively reported 48 interventions/intervention combinations. Effectiveness systematic reviews studies explored service delivery models (n = 15); interventions delivered by families/carers (n = 32), wider children’s workforce (n = 21), continence teams (n = 31) and specialist consultant-led teams (n = 42); complementary therapies (n = 15); and psychosocial interventions (n = 4). One intervention (probiotics) had moderate-quality evidence; all others had low to very-low-quality evidence. Thirty-one studies reported evidence relating to cost or resource use; data were insufficient to support generalisable conclusions. One hundred and six studies described implementation barriers and facilitators. Conclusions Management of childhood chronic functional constipation is complex. The available evidence remains limited, with small, poorly conducted and reported studies. Many evidence gaps were identified. Treatment recommendations within current clinical guidelines remain largely unchanged, but there is a need for research to move away from considering effectiveness of single interventions. Clinical care and future studies must consider the individual characteristics of children. Study registration This study is registered as PROSPERO CRD42019159008. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 128470) and is published in full in Health Technology Assessment; Vol. 28, No. 5. See the NIHR Funding and Awards website for further award information.

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Role of Traditional Chinese Herbal Medicines in Functional Gastrointestinal and Motility Disorders

Sankararaman

Velayuthan

Chen

et al. 2022

Curr Gastroenterol Rep

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A Randomized, Double-Blind, and Placebo-Controlled Trial of Chinese Herbal Medicine in the Treatment of Childhood Constipation

Cited by 8 publications

References 34 publications

A Randomized, Double-Blind, Controlled Trial of Percutaneous Tibial Nerve Stimulation With Pelvic Floor Exercises in the Treatment of Childhood Constipation

A Randomized, Double-Blind, Controlled Trial of Percutaneous Tibial Nerve Stimulation With Pelvic Floor Exercises in the Treatment of Childhood Constipation

Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis

Role of Traditional Chinese Herbal Medicines in Functional Gastrointestinal and Motility Disorders

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