Peckham Emily J, Cooper Katy, Roberts E Rachel, Agrawal Anurag, Brabyn Sally, Tew Garry
Department of Health Sciences, University of York, Heslington, York, - None -, UK, Y010 5DD.
Cochrane Database Syst Rev. 2019 Sep 4;9(9):CD009710. doi: 10.1002/14651858.CD009710.pub3.
Irritable bowel syndrome (IBS) is a common, chronic disorder that leads to decreased health-related quality of life and work productivity. A previous version of this review was not able to draw firm conclusions about the effectiveness of homeopathic treatment for IBS and recommended that further high quality RCTs were conducted to explore the clinical and cost effectiveness of homeopathic treatment for IBS. Two types of homeopathic treatment were evaluated in this systematic review: 1. Clinical homeopathy where a specific remedy is prescribed for a specific condition; 2. Individualised homeopathic treatment, where a homeopathic remedy based on a person's individual symptoms is prescribed after a detailed consultation.
To assess the effectiveness and safety of homeopathic treatment for IBS.
For this update we searched MEDLINE, CENTRAL, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED), the Cochrane IBD Group Specialised Register and trials registers from inception to 31 August 2018.
Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care, in adults with IBS were considered for inclusion.
Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS as measured by an IBS symptom severity score. Secondary outcomes included quality of life, abdominal pain, stool frequency, stool consistency, and adverse events. The overall certainty of the evidence supporting the primary and secondary outcomes was assessed using the GRADE criteria. We used the Cochrane risk of bias tool to assess risk of bias. We calculated the mean difference (MD) and 95% confidence interval (CI) for continuous outcomes and the risk ratio (RR) and 95% CI for dichotomous outcomes.
Four RCTs (307 participants) were included. Two studies compared clinical homeopathy (homeopathic remedy, asafoetida or asafoetida plus nux vomica) to placebo for IBS with constipation (IBS-C). One study compared individualised homeopathic treatment (consultation plus remedy) to usual care for the treatment of IBS in female patients. One study was a three armed RCT comparing individualised homeopathic treatment to supportive listening or usual care. The risk of bias in three studies (the two studies assessing clinical homeopathy and the study comparing individualised homeopathic treatment to usual care) was unclear on most criteria and high for selective reporting in one of the clinical homeopathy studies. The three armed study comparing individualised homeopathic treatment to usual care and supportive listening was at low risk of bias in four of the domains and high risk of bias in two (performance bias and detection bias).A meta-analysis of the studies assessing clinical homeopathy, (171 participants with IBS-C) was conducted. At short-term follow-up of two weeks, global improvement in symptoms was experienced by 73% (46/63) of asafoetida participants compared to 45% (30/66) of placebo participants (RR 1.61, 95% CI 1.18 to 2.18; 2 studies, very low certainty evidence). In the other clinical homeopathy study at two weeks, 68% (13/19) of those in the asafoetida plus nux vomica arm and 52% (12/23) of those in the placebo arm experienced a global improvement in symptoms (RR 1.31, 95% CI 0.80 to 2.15; very low certainty evidence). In the study comparing individualised homeopathic treatment to usual care (N = 20), the mean global improvement score (feeling unwell) at 12 weeks was 1.44 + 4.55 (n = 9) in the individualised homeopathic treatment arm compared to 1.41 + 1.97 (n=11) in the usual care arm (MD 0.03; 95% CI -3.16 to 3.22; very low certainty evidence).In the study comparing individualised homeopathic treatment to usual care, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 237.3 + 110.22 (n = 60) in the usual care arm (MD -26.86, 95% CI -88.59 to 34.87; low certainty evidence). The mean quality of life score (EQ-5D) at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.41 (SD 23.31) in usual care participants (MD 5.66, 95% CI -4.69 to 16.01; low certainty evidence).For In the study comparing individualised homeopathic treatment to supportive listening, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 262 + 120.72 (n = 18) in the supportive listening arm (MD -51.56, 95% CI -129.94 to 26.82; very low certainty evidence). The mean quality of life score at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.09 (SD 24.38) in supportive listening participants (MD 5.98, 95% CI -8.13 to 20.09; very low certainty evidence).None of the included studies reported on abdominal pain, stool frequency, stool consistency, or adverse events.
AUTHORS' CONCLUSIONS: The results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy for IBS compared to placebo or usual care.
肠易激综合征(IBS)是一种常见的慢性疾病,会导致健康相关生活质量下降和工作效率降低。本综述的上一版未能就顺势疗法治疗IBS的有效性得出确凿结论,并建议开展进一步的高质量随机对照试验(RCT),以探究顺势疗法治疗IBS的临床效果和成本效益。本系统综述评估了两种顺势疗法:1. 临床顺势疗法,即针对特定病症开具特定药物;2. 个体化顺势疗法,即在详细问诊后根据个人症状开具顺势疗法药物。
评估顺势疗法治疗IBS的有效性和安全性。
本次更新检索了MEDLINE、CENTRAL、Embase、护理学与健康相关学科累积索引(CINAHL)、补充与替代医学数据库(AMED)、Cochrane炎症性肠病小组专业注册库以及截至2018年8月31日的试验注册库。
纳入比较顺势疗法与安慰剂、其他对照治疗或常规护理对成年IBS患者疗效的随机对照试验(RCT)、队列研究和病例对照研究。
两位作者独立评估偏倚风险并提取数据。主要结局指标为通过IBS症状严重程度评分衡量的IBS整体改善情况。次要结局指标包括生活质量、腹痛、排便频率、大便性状及不良事件。使用GRADE标准评估支持主要和次要结局指标的证据的总体确定性。我们使用Cochrane偏倚风险工具评估偏倚风险。对于连续性结局指标,计算平均差值(MD)和95%置信区间(CI);对于二分法结局指标,计算风险比(RR)和95%CI。
纳入了4项随机对照试验(307名参与者)。两项研究比较了临床顺势疗法(顺势疗法药物阿魏或阿魏加马钱子)与安慰剂治疗便秘型肠易激综合征(IBS-C)的效果。一项研究比较了个体化顺势疗法(问诊加药物)与常规护理对女性IBS患者的治疗效果。一项研究是三臂随机对照试验,比较个体化顺势疗法与支持性倾听或常规护理的效果。三项研究(两项评估临床顺势疗法的研究以及比较个体化顺势疗法与常规护理的研究)在大多数标准上的偏倚风险不明确,其中一项临床顺势疗法研究在选择性报告方面偏倚风险较高。比较个体化顺势疗法与常规护理及支持性倾听的三臂研究在四个领域的偏倚风险较低,在两个领域(实施偏倚和检测偏倚)的偏倚风险较高。对评估临床顺势疗法的研究进行了荟萃分析(171名IBS-C参与者)。在两周的短期随访中,阿魏组73%(46/63)的参与者症状得到整体改善,而安慰剂组为45%(30/66)(RR 1.61,95%CI 1.18至2.18;2项研究,极低确定性证据)。在另一项临床顺势疗法研究中,两周时阿魏加马钱子组68%(13/19)的参与者症状得到整体改善,安慰剂组为52%(12/23)(RR 1.31,95%CI 0.80至2.15;极低确定性证据)。在比较个体化顺势疗法与常规护理的研究中(N = 20),个体化顺势疗法组12周时的平均整体改善评分(感觉不适)为1.44 + 4.55(n = 9),常规护理组为1.41 + 1.97(n = 11)(MD 0.03;95%CI -3.16至3.22;极低确定性证据)。在比较个体化顺势疗法与常规护理的研究中,6个月时个体化顺势疗法组的平均IBS症状严重程度评分为210.(此处原文可能有误,推测应为210.44)44 + 112.4(n = 16),常规护理组为237.3 + 110.22(n = 60)(MD -26.86,95%CI -88.59至34.87;低确定性证据)。顺势疗法参与者6个月时的平均生活质量评分(EQ-5D)为69.07(标准差17.35),常规护理参与者为63.41(标准差23.31)(MD 5.66,95%CI -4.69至16.01;低确定性证据)。在比较个体化顺势疗法与支持性倾听的研究中,6个月时个体化顺势疗法组的平均IBS症状严重程度评分为210.44 + 112.4(n = 16),支持性倾听组为262 + 120.72(n = 18)(MD -51.56,95%CI -129.94至26.82;极低确定性证据)。顺势疗法参与者6个月时的平均生活质量评分为69.07(标准差17.35),支持性倾听参与者为63.09(标准差24.38)(MD 5.98,95%CI -8.13至20.09;极低确定性证据)。纳入的研究均未报告腹痛、排便频率、大便性状或不良事件。
本综述评估的结局指标结果尚不确定。因此,无法就顺势疗法治疗IBS的有效性和安全性得出确凿结论。需要开展进一步高质量、有足够样本量的随机对照试验,以评估临床顺势疗法和个体化顺势疗法与安慰剂或常规护理相比治疗IBS的疗效和安全性。