Background & Aims

The potential effectiveness of gut-directed hypnotherapy (HT) is unknown for pediatric chronic nausea. This randomized controlled trial compared HT with standard medical treatment (SMT).

Methods

One hundred children (ages, 8–18 y) with chronic nausea and fulfilling functional nausea (FN) or functional dyspepsia (FD) criteria were allocated randomly (1:1) to HT or SMT, with a 3-month intervention period. Outcomes were assessed at baseline, at the halfway point, after treatment, and at the 6- and 12-month follow-up evaluation. Children scored nausea symptoms in a 7-day diary. The primary outcome was treatment success, defined as a reduction in nausea of 50% or more, at the 12-month follow-up evaluation. Secondary outcomes included adequate relief of nausea.

Results

After treatment and at the 6-month follow-up evaluation, there was a trend toward higher treatment success in the HT group compared with the SMT group (45% vs 26%, P = .052; and 57% vs 40%, P = .099, respectively). At 12 months, treatment success was similar in both groups (60% in the HT group and 55% in the SMT group; P = .667). In the FN group, significantly higher success rates were found for HT, but no differences were found in patients with FD. Adequate relief was significantly higher in the HT group than in the SMT group at the 6-month follow-up evaluation (children: 81% vs 55%, P = .014; parents: 79% vs 53%; P = .016), but not at the 12-month follow-up evaluation.

Conclusions

HT and SMT were effective in reducing nausea symptoms in children with FN and FD. In children with FN, HT was more effective than SMT during and after the first 6 months of treatment. Therefore, HT and SMT, applied separately or in combination, should be offered to children with FN as a treatment option (Clinical trials registration number: NTR5814).

中文翻译：

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技能或药丸：在功能性恶心儿童中比较催眠疗法与药物治疗的随机试验

背景与目标

肠道定向催眠疗法 (HT) 对小儿慢性恶心的潜在有效性尚不清楚。这项随机对照试验将 HT 与标准药物治疗 (SMT) 进行了比较。

方法

100 名患有慢性恶心并满足功能性恶心 (FN) 或功能性消化不良 (FD) 标准的儿童（年龄 8-18 岁）被随机分配（1:1）接受 HT 或 SMT，干预期为 3 个月。在基线、中途、治疗后以及 6 个月和 12 个月的随访评估中评估结果。儿童在 7 天的日记中对恶心症状进行评分。主要结果是治疗成功，定义为在 12 个月的随访评估中恶心减少 50% 或更多。次要结局包括充分缓解恶心。

结果

在治疗后和 6 个月的随访评估中，与 SMT 组相比，HT 组的治疗成功率有更高的趋势（45% 对 26%，P  = .052；57% 对 40%，P  = .099，分别）。在 12 个月时，两组的治疗成功率相似（HT 组为 60%，SMT 组为 55%；P  = .667）。在 FN 组中，发现 HT 的成功率明显更高，但在 FD 患者中没有发现差异。在 6 个月的随访评估中，HT 组的充分缓解显着高于 SMT 组（儿童：81% 对 55%，P  = .014；父母：79% 对 53%；P  = .016） ，但不是在 12 个月的随访评估中。

结论

HT 和 SMT 可有效减轻 FN 和 FD 儿童的恶心症状。在患有 FN 的儿童中，在治疗的前 6 个月期间和之后，HT 比 SMT 更有效。因此，HT 和 SMT，单独或联合应用，应作为 FN 儿童的治疗选择（临床试验注册号：NTR5814）。