Development of Acupuncture and Moxibustion Protocol in a Clinical Trial for Irritable Bowel Syndrome.
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SUBMITTER: Anastasi JK
PROVIDER: S-EPMC5572756 | biostudies-literature | 2017 Jan
REPOSITORIES: biostudies-literature
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Development of Acupuncture and Moxibustion Protocol in a Clinical Trial for Irritable Bowel Syndrome.
Anastasi Joyce K JK Capili Bernadette B Chang Michelle M
Journal of acupuncture and meridian studies 20170112 1
Traditional Chinese medicine encompasses many different practices, most notably acupuncture and moxibustion. Traditionally, these modalities are used in combination to augment treatment but seldom are they tested together in clinical studies. Numerous acupuncture studies have been conducted in Asia, Europe, and the United States but there have been few randomized controlled trials utilizing moxibustion outside of East Asia. Limited studies have described the use of a moxibustion control or place ...[more]
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Project description:BACKGROUND:Irritable bowel syndrome (IBS), a functional bowel disorder with symptoms of abdominal pain and disturbed defecation experienced by 10% of U.S. adults, results in significant disability, impaired quality of life, and health-care burden. Conventional medical care focusing on pharmacological approaches, diet, and lifestyle management has been partially effective in controlling symptoms. Behavioral treatments, such as cognitive-behavioral therapy and hypnosis, are promising. This paper describes an on-going feasibility study to assess the efficacy of mindfulness training, a behavioral treatment involving directing and sustaining attention to present-moment experience, for the treatment of IBS. METHODS/DESIGN:The study design involves randomization of adult women with IBS according to Rome II criteria, to either an eight-week mindfulness training group (based on a Mindfulness-based Stress Reduction [MBSR] format) or a previously validated IBS social-support group as an attention-control condition. The primary hypothesis is that, compared to Support Group participants, those in the Mindfulness Program will demonstrate significant improvement in IBS symptoms as measured by the IBS Symptom Severity Scale [1]. DISCUSSION:214 individuals have been screened for eligibility, of whom 148 were eligible for the study. Of those, 87 were enrolled, with 21 withdrawing after having given consent. 66 have completed or are in the process of completing the interventions. It is feasible to undertake a rigorous randomized clinical trial of mindfulness training for people with IBS, using a standardized MBSR protocol adapted for those experiencing IBS, compared to a control social-support group previously utilized in IBS studies. TRIAL REGISTRATION:Clinical Trials.gov Identifier: NCT00680693.
| S-EPMC2729728 | biostudies-literature
Project description:BACKGROUND:Irritable bowel syndrome (IBS) is a worldwide disease with high morbidity. The effect of current treatment with Western medicine is not satisfactory. Although moxibustion treatment is widely used for gastrointestinal diseases, randomized controlled trials on the use of this treatment for IBS are limited. This study aims to evaluate the clinical efficacy and safety of moxibustion treatment in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). METHODS/DESIGN:A multi-center, randomized, single-blind and placebo-controlled trial is employed. 104 cases will be divided into two groups: (1) a mild-warm moxibustion group in which moxa stick is 3-5 cm away from acupuncture points and the skin temperature is maintained at 43?±?1 °C; and (2) a placebo moxibustion group in which moxa stick is 8-10 cm away from acupuncture points and the skin temperature is maintained at 37?±?1 °C. Moxibustion is performed on bilateral ST25 and ST36 in the two groups for 30 min each time, three times a week for 6 weeks. The patients are followed up at the 12th and 18th weeks. Adequate relief is used as a primary outcome measure; IBS symptom severity score, Bristol stool form scale, IBS quality-of-life questionnaire, and hospital anxiety and depression scale are used as secondary outcome measures. DISCUSSION:This study aims to demonstrate the safety and efficacy of moxibustion treatment for IBS-D, which may validate moxibustion as an effective therapy for treating IBS-D. TRIAL REGISTRATION:ClinicalTrials.gov identifier NCT02421627 (8 April 2015).
| S-EPMC5075981 | biostudies-literature
Project description:BackgroundIrritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habit without organic disease. A global perspective given by the World Gastroenterology Organization (WGO) points out that IBS can impact the quality of an individual's daily life, cause socioeconomic problems and potentially impair the patient-physician relationship. It remains a problem to treat IBS due to the complicated pathophysiology. Acupuncture is an alternative therapy recommended for IBS. The aim of this study is to investigate the efficacy and safety of acupuncture therapy for patients with IBS. We also want to explore the correlation between IBS-gene subtypes and acupuncture effect.Methods/designA multicenter randomized controlled trial will be performed in seven hospitals. Six hundred participants will be stratified into two strata (IBS-C or IBS-D). Then, patients within each stratum will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture while the control group is treated with Western medicine. All the patients will receive a 6-week treatment and a 3-month follow-up. The primary outcome is the IBS-Symptom Severity Score (IBS-SSS), the secondary outcome is the score of the IBS-Quality of Life (IBS-QoL).The correlation between IBS-gene subtypes and acupuncture effect will be detected based on polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Outcome measures (including primary and secondary outcome measures) are collected at baseline,1 week, 2 weeks, 4 weeks, and 6 weeks of the intervention, and 12 weeks after the intervention.DiscussionThis is a multicenter randomized controlled trial for IBS in China. It may clarify the efficacy of acupuncture as an alternative therapy for IBS. This is the first time ever that the potential mechanism of IBS based on genomics has been investigated.Trial registrationChinese Clinical Trials Register, ID: ChiCTR-IOR-15006259 . First registered on 14 April 2015.
| S-EPMC6166287 | biostudies-literature
Project description:BackgroundMoxibustion is increasingly used for treatment of irritable bowel syndrome (IBS). This study investigated the long-term effects of moxibustion for IBS with diarrhea (IBS-D).MethodsPatients with IBS-D were assigned to receive moxibustion or sham moxibustion (52 each, 3× per week, 6 weeks) and were followed up to 24 weeks. The acupoints were bilateral ST25 and ST36, body surface temperatures at acupoints were 43°C ± 1°C and 37°C ± 1°C for the moxibustion and sham groups, respectively. Primary outcome was changes in IBS Adequate Relief (IBS-AR) from baseline to 6 weeks. Secondary outcomes included the following: IBS symptom severity scale (IBS-SSS), Bristol stool form scale (BSS), IBS quality of life (IBS-QOL), and Hospital Anxiety and Depression Scale (HADS).ResultsBased on an intention-to-treat analysis, the rate of IBS-AR in the moxibustion group was significantly higher than the sham group at 6 weeks (76.9% versus 42.3%; p < 0.001); the mean decrease of total IBS-BSS score in the moxibustion group was lower than that of the sham group (-116.9 versus -61.5; p < 0.001), both of which maintained throughout the follow-up period. Five specific domains of the IBS-SSS were lower in the moxibustion group than the sham, throughout (p < 0.001). At week 6, the rate of reduction >50 points in IBS-SSS of the treatment group was significantly higher than that of the sham (p < 0.001), which persisted throughout the follow-up period. Similar long-lasting improvements were observed in BSS, stool frequency, and stool urgency (p < 0.001). Improvements of IBS-QOL and HADS were comparable between the groups.ConclusionsMoxibustion treatment benefits the long-term relief of symptoms in IBS-D patients.Trial registrationClinical trials.gov (NCT02421627). Registered on 20 April 2015.
| S-EPMC8874177 | biostudies-literature
Project description:BackgroundIrritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders in clinical practice. IBS diagnosis is based on symptoms defined by abdominal pain or discomfort associated with defecation or changes in bowel habits. Gut-brain interaction caused by stress or depressive emotion is one of the essential pathologies. Acupuncture has been used for the treatment of internal medicine, including digestive disorders and depressive disorders in Chinese medicine. This study aims to determine whether electro-acupuncture could have significant benefits than sham acupuncture for IBS.Methods/designThis is a single-blinded randomized sham-controlled clinical trial with two arms. A total of 120 IBS patients will be recruited. After a 2-week run-in period, eligible subjects will be randomly assigned to one of two arms, acupuncture (AC) arm and sham acupuncture (SAC) arm. Each eligible subject will go through a 2-week run-in-period, 6-week treatment period, and 6-week follow-up period. Five visits in total were scheduled for each subject in week 0, week 2, week 5, week 8, and week 14. The outcomes would be measured with (1) IBS-SSS, (2) Hamilton Depression Rating Scale (HAMD-17), (3) Clinical Global Impression-Severity (CGI-S), (4) Self-Rating Depression Scale (SDS), and (5) IBS Quality of Life (IBS-QoL).DiscussionThe study will compare electro-acupuncture with sham acupuncture to explore the feasibility of electro-acupuncture in improving IBS symptoms.Trial registrationClinicalTrials.gov NCT04387383 . Registered on 13 May 2020.
| S-EPMC8441043 | biostudies-literature
Project description:BackgroundAcupuncture and moxibustion have been widely used in the treatment of Irritable Bowel Syndrome (IBS). But the evidence that acupuncture and moxibustion for IBS reduction of symptom severity and abdominal pain, and improvement of quality of life is scarce.MethodsPubMed, Embase, Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), Wanfang Database, China Biomedical Literature Service System (SinoMed), and unpublished sources were searched from inception until June 30, 2022. The quality of RCTs was assessed with the Cochrane Collaboration risk of bias tool. The strength of the evidence was evaluated with the Grading of Recommendations Assessment, Development and Evaluation system (GRADE). Trial sequential analysis (TSA) was conducted to determine whether the participants in the included trials had reached optimal information size and whether the cumulative data was adequately powered to evaluate outcomes.ResultsA total of 31 RCTs were included. Acupuncture helped reduce the severity of symptoms more than pharmaceutical drugs (MD, -35.45; 95% CI, -48.21 to -22.68; I 2 = 71%). TSA showed the cumulative Z score crossed O'Brien-Fleming alpha-spending significance boundaries. Acupuncture wasn't associated with symptom severity reduction (SMD, 0.03, 95% CI, -0.25 to 0.31, I 2 = 46%), but exhibited therapeutic benefits on abdominal pain (SMD, -0.24; 95% CI, -0.48 to -0.01; I 2 = 8%) compared to sham acupuncture. Moxibustion show therapeutic benefits compared to sham moxibustion on symptom severity (SMD, -3.46, 95% CI, -5.66 to -1.27, I 2 = 95%) and abdominal pain (SMD, -2.74, 95% CI, -4.81 to -0.67, I 2 = 96%). Acupuncture (SMD, -0.46; 95% CI, -0.68 to -0.24; I 2 = 47%) and the combination of acupuncture and moxibustion (SMD, -2.00; 95% CI, -3.04 to -0.96; I 2 = 90%) showed more benefit for abdominal pain compared to pharmacological medications as well as shams. Acupuncture (MD, 4.56; 95% CI, 1.46-7.67; I 2 = 79%) and moxibustion (MD, 6.97; 95% CI, 5.78-8.16; I 2 = 21%) were more likely to improve quality of life than pharmaceutical drugs.ConclusionAcupuncture and/or moxibustion are beneficial for symptom severity, abdominal pain and quality of life in IBS. However, in sham control trials, acupuncture hasn't exhibited robust and stable evidence, and moxibustion's results show great heterogeneity. Hence, more rigorous sham control trials of acupuncture or moxibustion are necessary.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=262118, identifier CRD42021262118.
| S-EPMC9801330 | biostudies-literature
Project description:IntroductionIrritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder that presents with abdominal pain/discomfort and altered bowel patterns. IBS has multiple potential causes for which conventional medicines have had limited success, resulting in a significant number of patients who do not sensitively respond to pharmacotherapy for a period of 12 months and who develop a continuing symptom profile (described as refractory IBS) and seek help through (non)pharmacological treatments. The aim of this study is to investigate the efficacy and safety of acupuncture therapy for refractory IBS on the basis of conventional treatments.Methods and analysisA total of 170 eligible patients who meet the Rome IV criteria for refractory IBS will be randomly allocated to receive acupuncture or sham acupuncture. Each patient will receive 12 sessions of acupuncture over 4 weeks and a 4-week follow-up. The primary outcome will be the IBS Symptom Severity Score. Secondary outcomes will include the proportion of participants experiencing adequate relief of global IBS symptoms, the weekly frequency of defecation, the stool properties assessed by the Bristol Grading Scale, the Work and Social Adjustment Scale, the IBS-Quality of Life score, and the Self-Rating Depression Scale and Self-Rating Anxiety Scale anxiety and depression scores. Outcome measures will be collected at baseline, 2 and 4 weeks of the intervention, and 6 and 8 weeks after the intervention. Categorical variables will be compared with Fisher's exact test or the Wilcoxon rank-sum test, and continuous variables will be compared using Student's t-test or the Wilcoxon rank-sum test.Ethics and disseminationThe entire project has been approved by the ethics committees of Beijing University of Chinese Medicine (2020BZYLL0507) and Sichuan Province Regional Institution for Conducting Research on Traditional Chinese Medicine (2020KL-025). The outcomes of the trial will be disseminated through peer-reviewed publications.Trial registration numberNCT04276961.
| S-EPMC8438864 | biostudies-literature
Project description:Background and aimsDespite occasional positive reports on the efficacy of acupuncture (AC) on functions of the gastrointestinal tract, there is no conclusive evidence that AC is effective in the treatment of irritable bowel syndrome (IBS).Patients and methodsForty three patients with IBS according to the Rome II criteria were randomly assigned to receive either AC (n = 22) or sham acupuncture (SAC) (n = 21) using the so-called "Streitberger needle". Treatment duration was 10 sessions with an average of two AC sessions per week. The primary end point was improvement in quality of life (QOL) using the functional digestive diseases quality of life questionnaire (FDDQL) and a general quality of life questionnaire (SF-36), compared with baseline assessments. QOL measurements were repeated three months after treatment.ResultsBoth the AC and SAC groups improved significantly in global QOL, as assessed by the FDDQL, at the end of treatment (p = 0.022), with no differences between the groups. SF-36 was insensitive to these changes (except for pain). This effect was partially reversed three months later. Post hoc comparison of responders and non-responders in both groups combined revealed a significant prediction of the placebo response by two subscales of the FDDQL (sleep, coping) (F = 6.746, p = 0.003) in a stepwise regression model.ConclusionsAcupuncture in IBS is primarily a placebo response. Based on the small differences found between the AC and SAC groups, a study including 566 patients would be necessary to prove the efficacy of AC over SAC. The placebo response may be predicted by high coping capacity and low sleep quality in individual patients.
| S-EPMC1856122 | biostudies-literature
Project description:Objective. To explore the efficacy of Herb-partitioned moxibustion in treating IBS-D patients. Method. 210 IBS-D patients were randomly assigned on a 3 : 3 : 2 basis to group HM, group FM, or group PB for 4-week treatment. The change of GSRS total score at weeks 4 and 8, the changes of GSRS specific scores, and adverse events were evaluated. Results. Patients in group HM and group FM had lower GSRS total score at week 4 (1.98 ± 0.303, 2.93 ± 0.302 versus 3.73 ± 0.449) and at week 8 (2.75 ± 0.306, 3.56 ± 0.329 versus 4.39 ± 2.48) as compared with patients' score in group PB. However, there was no significant difference of GSRS total score between group HM and group FM. The effect of HM was significantly greater than that of orally taking PB in ameliorating the symptoms of rugitus (0.38 versus 0.59, P < 0.05), abdominal pain (0.28 versus 0.57, P < 0.01), abdominal distension (0.4 versus 0.7, P < 0.01), and increased passage of stools (0.06 versus 0.25, P < 0.01) at the end of treatment period. In the follow-up period, patients' therapeutic effect in group HM remained greater than that in group FM (in abdominal pain, abdominal distension, and increased passage of stools) and that in group PB (in loose stools). Conclusions. HM appears to be a promising, efficacious, and well-tolerated treatment for patients with IBS-D.
| S-EPMC3880695 | biostudies-literature
Project description:BackgroundAcupuncture is used by patients as a treatment for irritable bowel syndrome (IBS) but the evidence on effectiveness is limited. The purpose of the study was to evaluate the effectiveness of acupuncture for irritable bowel syndrome in primary care when provided as an adjunct to usual care.MethodsDesignA two-arm pragmatic randomised controlled trial.SettingPrimary care in the United Kingdom.Patients233 patients had irritable bowel syndrome with average duration of 13 years and score of at least 100 on the IBS Symptom Severity Score (SSS).Interventions116 patients were offered 10 weekly individualised acupuncture sessions plus usual care, 117 patients continued with usual care alone.MeasurementsPrimary outcome was the IBS SSS at three months, with outcome data collected every three months to 12 months.ResultsThere was a statistically significant difference between groups at three months favouring acupuncture with a reduction in IBS Symptom Severity Score of -27.43 (95% CI: -48.66 to -6.21, p=0.012). The number needed to treat for successful treatment (?50 point reduction in the IBS SSS) was six (95% CI: 3 to 17), based on 49% success in the acupuncture group vs. 31% in the control group, a difference between groups of 18% (95% CI: 6% to 31%). This benefit largely persisted at 6, 9 and 12 months.ConclusionsAcupuncture for irritable bowel syndrome provided an additional benefit over usual care alone. The magnitude of the effect was sustained over the longer term. Acupuncture should be considered as a treatment option to be offered in primary care alongside other evidenced based treatments.Trial registrationCurrent Controlled Trials ISRCTN08827905.
| S-EPMC3556159 | biostudies-literature