School of Medicine, Instituto Universitario Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
School of Medicine, Universidad de Valparaíso, Viña del Mar, Chile.
Cochrane Database Syst Rev. 2023 Jun 15;6(6):CD013323. doi: 10.1002/14651858.CD013323.pub2.
One-third of people with gastrointestinal disorders, including functional dyspepsia, use some form of complementary and alternative medicine, including herbal medicines.
The primary objective is to assess the effects of non-Chinese herbal medicines for the treatment of people with functional dyspepsia.
We searched the following electronic databases on 22 December 2022: Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Allied and Complementary Medicine Database, Latin American and Caribbean Health Sciences Literature, among other sources, without placing language restrictions.
We included RCTs comparing non-Chinese herbal medicines versus placebo or other treatments in people with functional dyspepsia.
Two review authors independently screened references, extracted data and assessed the risk of bias from trial reports. We used a random-effects model to calculate risk ratios (RRs) and mean differences (MDs). We created effect direction plots when meta-analysis was not possible, following the reporting guideline for Synthesis without Meta-analysis (SWiM). We used GRADE to assess the certainty of the evidence (CoE) for all outcomes.
We included 41 trials with 4477 participants that assessed 27 herbal medicines. This review evaluated global symptoms of functional dyspepsia, adverse events and quality of life; however, some studies did not report these outcomes. STW5 (Iberogast) may moderately improve global symptoms of dyspepsia compared with placebo at 28 to 56 days; however, the evidence is very uncertain (MD -2.64, 95% CI -4.39 to -0.90; I = 87%; 5 studies, 814 participants; very low CoE). STW5 may also increase the improvement rate compared to placebo at four to eight weeks' follow-up (RR 1.55, 95% CI 0.98 to 2.47; 2 studies, 324 participants; low CoE). There was little to no difference in adverse events for STW5 compared to placebo (RR 0.92, 95% CI 0.52 to 1.64; I = 0%; 4 studies, 786 participants; low CoE). STW5 may cause little to no difference in quality of life compared to placebo (no numerical data available, low CoE). Peppermint and caraway oil probably result in a large improvement in global symptoms of dyspepsia compared to placebo at four weeks (SMD -0.87, 95% CI -1.15 to -0.58; I = 0%; 2 studies, 210 participants; moderate CoE) and increase the improvement rate of global symptoms of dyspepsia (RR 1.53, 95% CI 1.30 to 1.81; I = 0%; 3 studies, 305 participants; moderate CoE). There may be little to no difference in the rate of adverse events between this intervention and placebo (RR 1.56, 95% CI 0.69 to 3.53; I = 47%; 3 studies, 305 participants; low CoE). The intervention probably improves the quality of life (measured on the Nepean Dyspepsia Index) (MD -131.40, 95% CI -193.76 to -69.04; 1 study, 99 participants; moderate CoE). Curcuma longa probably results in a moderate improvement global symptoms of dyspepsia compared to placebo at four weeks (MD -3.33, 95% CI -5.84 to -0.81; I = 50%; 2 studies, 110 participants; moderate CoE) and may increase the improvement rate (RR 1.50, 95% CI 1.06 to 2.11; 1 study, 76 participants; low CoE). There is probably little to no difference in the rate of adverse events between this intervention and placebo (RR 1.26, 95% CI 0.51 to 3.08; 1 study, 89 participants; moderate CoE). The intervention probably improves the quality of life, measured on the EQ-5D (MD 0.05, 95% CI 0.01 to 0.09; 1 study, 89 participants; moderate CoE). We found evidence that the following herbal medicines may improve symptoms of dyspepsia compared to placebo: Lafonesia pacari (RR 1.52, 95% CI 1.08 to 2.14; 1 study, 97 participants; moderate CoE), Nigella sativa (SMD -1.59, 95% CI -2.13 to -1.05; 1 study, 70 participants; high CoE), artichoke (SMD -0.34, 95% CI -0.59 to -0.09; 1 study, 244 participants; low CoE), Boensenbergia rotunda (SMD -2.22, 95% CI -2.62 to -1.83; 1 study, 160 participants; low CoE), Pistacia lenticus (SMD -0.33, 95% CI -0.66 to -0.01; 1 study, 148 participants; low CoE), Enteroplant (SMD -1.09, 95% CI -1.40 to -0.77; 1 study, 198 participants; low CoE), Ferula asafoetida (SMD -1.51, 95% CI -2.20 to -0.83; 1 study, 43 participants; low CoE), ginger and artichoke (RR 1.64, 95% CI 1.27 to 2.13; 1 study, 126 participants; low CoE), Glycyrrhiza glaba (SMD -1.86, 95% CI -2.54 to -1.19; 1 study, 50 participants; moderate CoE), OLNP-06 (RR 3.80, 95% CI 1.70 to 8.51; 1 study, 48 participants; low CoE), red pepper (SMD -1.07, 95% CI -1.89 to -0.26; 1 study, 27 participants; low CoE), Cuadrania tricuspidata (SMD -1.19, 95% CI -1.66 to -0.72; 1 study, 83 participants; low CoE), jollab (SMD -1.22, 95% CI -1.59 to -0.85; 1 study, 133 participants; low CoE), Pimpinella anisum (SMD -2.30, 95% CI -2.79 to -1.80; 1 study, 107 participants; low CoE). The following may provide little to no difference compared to placebo: Mentha pulegium (SMD -0.38, 95% CI -0.78 to 0.02; 1 study, 100 participants; moderate CoE) and cinnamon oil (SMD 0.38, 95% CI -0.17 to 0.94; 1 study, 51 participants; low CoE); moreover, Mentha longifolia may increase dyspeptic symptoms (SMD 0.46, 95% CI 0.04 to 0.88; 1 study, 88 participants; low CoE). Almost all the studies reported little to no difference in the rate of adverse events compared to placebo except for red pepper, which may result in a higher risk of adverse events compared to placebo (RR 4.31, 95% CI 1.56 to 11.89; 1 study, 27 participants; low CoE). With respect to the quality of life, most studies did not report this outcome. When compared to other interventions, essential oils may improve global symptoms of dyspepsia compared to omeprazole. Peppermint oil/caraway oil, STW5, Nigella sativa and Curcuma longa may provide little to no benefit compared to other treatments.
AUTHORS' CONCLUSIONS: Based on moderate to very low-certainty evidence, we identified some herbal medicines that may be effective in improving symptoms of dyspepsia. Moreover, these interventions may not be associated with important adverse events. More high-quality trials are needed on herbal medicines, especially including participants with common gastrointestinal comorbidities.
包括功能性消化不良在内的胃肠道疾病患者中，有三分之一会使用一些形式的补充和替代药物，包括草药。
主要目的是评估非中药草药治疗功能性消化不良患者的疗效。
我们于 2022 年 12 月 22 日检索了以下电子数据库：Cochrane 对照试验中心注册库、MEDLINE、Embase、补充和综合医学数据库、拉丁美洲和加勒比健康科学文献数据库等，未对语言进行限制。
我们纳入了比较非中药草药与安慰剂或其他治疗方法治疗功能性消化不良患者的随机对照试验。
两名综述作者独立筛选参考文献、提取数据，并根据试验报告评估偏倚风险。我们使用随机效应模型计算风险比（RR）和均数差值（MD）。当无法进行meta 分析时，我们按照综合无 meta 分析（SWiM）报告指南绘制效应方向图。我们使用 GRADE 评估所有结局的证据确定性（CoE）。
我们纳入了 41 项试验，共 4477 名参与者，评估了 27 种草药。本综述评估了功能性消化不良的全球症状、不良事件和生活质量；然而，一些研究没有报告这些结局。STW5（Iberogast）与安慰剂相比，可能在 28 至 56 天内适度改善消化不良的全球症状；但证据的确定性非常低（MD-2.64，95%CI-4.39 至-0.90；I=87%；5 项研究，814 名参与者；非常低的 CoE）。STW5 与安慰剂相比，在四周至八周的随访中，可能增加改善率（RR 1.55，95%CI 0.98 至 2.47；2 项研究，324 名参与者；低 CoE）。与安慰剂相比，STW5 发生不良事件的可能性较小或无差异（RR 0.92，95%CI 0.52 至 1.64；I=0%；4 项研究，786 名参与者；低 CoE）。与安慰剂相比，STW5 可能对生活质量的影响较小或无差异（无数值数据，低 CoE）。薄荷油和茴香油与安慰剂相比，可能在四周时对消化不良的全球症状有较大改善（SMD-0.87，95%CI-1.15 至-0.58；I=0%；2 项研究，210 名参与者；中度 CoE），并增加消化不良全球症状的改善率（RR 1.53，95%CI 1.30 至 1.81；I=0%；3 项研究，305 名参与者；中度 CoE）。与安慰剂相比，该干预措施可能导致不良事件发生率较小或无差异（RR 1.56，95%CI 0.69 至 3.53；I=47%；3 项研究，305 名参与者；低 CoE）。该干预措施可能改善生活质量（用 Nepean 消化不良指数衡量）（MD-131.40，95%CI-193.76 至-69.04；1 项研究，99 名参与者；中度 CoE）。姜黄与安慰剂相比，可能在四周时对消化不良的全球症状有适度改善（MD-3.33，95%CI-5.84 至-0.81；I=50%；2 项研究，110 名参与者；中度 CoE），并可能增加改善率（RR 1.50，95%CI 1.06 至 2.11；1 项研究，76 名参与者；低 CoE）。与安慰剂相比，该干预措施发生不良事件的可能性较小或无差异（RR 1.26，95%CI 0.51 至 3.08；1 项研究，89 名参与者；中度 CoE）。该干预措施可能改善生活质量，用 EQ-5D 衡量（MD 0.05，95%CI 0.01 至 0.09；1 项研究，89 名参与者；中度 CoE）。我们发现有证据表明，与安慰剂相比，以下草药可能改善消化不良的症状：拉佛尼亚帕卡里（RR 1.52，95%CI 1.08 至 2.14；1 项研究，97 名参与者；中度 CoE）、黑种草（SMD-1.59，95%CI-2.13 至-1.05；1 项研究，70 名参与者；高 CoE）、朝鲜蓟（SMD-0.34，95%CI-0.59 至-0.09；1 项研究，244 名参与者；低 CoE）、Boensenbergia rotunda（SMD-2.22，95%CI-2.62 至-1.83；1 项研究，160 名参与者；低 CoE）、Pistacia lentiscus（SMD-0.33，95%CI-0.66 至-0.01；1 项研究，148 名参与者；低 CoE）、Enteroplant（SMD-1.09，95%CI-1.40 至-0.77；1 项研究，198 名参与者；低 CoE）、Ferula asafoetida（SMD-1.51，95%CI-2.20 至-0.83；1 项研究，43 名参与者；低 CoE）、姜黄和朝鲜蓟（RR 1.64，95%CI 1.27 至 2.13；1 项研究，126 名参与者；低 CoE）、甘草（SMD-1.86，95%CI-2.54 至-1.19；1 项研究，50 名参与者；中度 CoE）、OLNP-06（RR 3.80，95%CI 1.70 至 8.51；1 项研究，48 名参与者；低 CoE）、红辣椒（SMD-1.07，95%CI-1.89 至-0.26；1 项研究，27 名参与者；低 CoE）、Cuadrania tricuspidata（SMD-1.19，95%CI-1.66 至-0.72；1 项研究，83 名参与者；低 CoE）、jollab（SMD-1.22，95%CI-1.59 至-0.85；1 项研究，133 名参与者；低 CoE）、Pimpinella anisum（SMD-2.30，95%CI-2.79 至-1.80；1 项研究，107 名参与者；低 CoE）。Mentha pulegium（SMD-0.38，95%CI-0.78 至 0.02；1 项研究，100 名参与者；中度 CoE）和肉桂油（SMD 0.38，95%CI-0.17 至 0.94；1 项研究，51 名参与者；低 CoE）可能与安慰剂相比没有差异，Menth longifolia 可能会增加消化不良的症状（SMD 0.46，95%CI 0.04 至 0.88；1 项研究，88 名参与者；低 CoE）。除了红辣椒可能会导致更高的不良事件风险（RR 4.31，95%CI 1.56 至 11.89；1 项研究，27 名参与者；低 CoE）外，几乎所有研究都报告了与安慰剂相比不良事件发生率较低或无差异。关于生活质量，大多数研究都没有报告这一结局。与其他干预措施相比，精油可能会改善功能性消化不良患者的整体症状。薄荷油/茴香油、STW5、黑种草和姜黄可能与其他治疗方法相比没有获益。
基于中到极低确定性证据，我们确定了一些可能对消化不良症状有效的草药。此外，这些干预措施可能不会与重要的不良事件相关。需要更多高质量的试验来研究草药，特别是包括常见胃肠道合并症的参与者。
