Taneja 2004.
Study characteristics | ||
Methods |
Study design: RCT Funding: Central Council for Research in Yoga and Naturopathy Published protocol/trial registration: no |
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Participants | Men with confirmed IBS‐D (Rome II criteria) Number randomised: 22 Age: mean 30.9 (SD 6.79) years % Female: 0% SES and ethnicity: 100% Indian Inclusion criteria
Exclusion criteria
Recruitment: gastroenterology clinics of All India Institute of Medical Sciences and Safdarjung Hospital Recruitment rate: not reported Region: New Delhi, India |
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Interventions |
Number of experimental conditions: 2; exercise intervention and pharmacological intervention comparator Number of participants (analysed): intervention: 9; comparator: 12 Description of exercise intervention: participants taught and advised to practice Surya Nadi pranayama (right‐nostril breathing) and a set of 12 asanas (Vajrasana, Shashankasana in 2 variations, Ushtrasana, Marjariasana, Bhujangasana, Padhastasana, Dhanurasana, Trikonasana in 2 variations, Pawanmuktasana, and Paschimottanasana) twice per day, morning and evening for 2 months. Duration: 8 weeks Number of contacts: 2: month 1 and 2 Setting: home Modality: unsupervised Interventionist: not reported Integrity: not reported Date of study: not reported Description of comparator: loperamide 2–6 mg/day |
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Outcomes |
Primary and secondary outcomes not specified Outcome relating to reported adverse events: not reported Outcome assessment time points: 8 weeks – end of intervention Preplanned subgroup analyses: not reported Unplanned subgroup analyses: not reported Lost to follow‐up: 1 Analysis: per‐protocol |
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Notes | No specific MCID stated for any of the measured outcomes. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Group allocation was not blinded to participants, clinicians or researchers. However, it was not possible to blind participants and personnel for this intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information as to how questionnaire was administered or data were analysed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 dropout in the control arm; however, no ITT analysis performed. |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration to determine whether outcomes reported were preplanned. |
Other bias | Unclear risk | Did not specify baseline characteristics of each group. |
BAQ: Body Awareness Questionnaire; BRS: Body Responsiveness Scale; CPSS: Cohen Perceived Stress Scale; CSI‐18: Child Somatization Inventory‐18; GI: gastrointestinal; HADS: Hospital Anxiety and Depression Scale; IBS: irritable bowel syndrome; IBS‐C: constipation‐predominant irritable bowel syndrome; IBS‐D: diarrhoea‐predominant irritable bowel syndrome; IBS‐M: irritable bowel syndrome with mixed episodes of diarrhoea or constipation; IBS‐QOL: Irritable Bowel Syndrome Quality Of Life; IBS‐SSS: Irritable Bowel Syndrome Severity Scoring System; IL: interleukin; ITT: intention to treat; MCID: minimal clinically important difference; NRS: Numeric Rating Scale; PSQ: Perceived Stress Questionnaire; RCT: randomised controlled trial; SD: standard deviation; SES: socioeconomic status; SF‐36: 36‐item Short Form; TNF: tumour necrosis factor; VO2max: maximal oxygen consumption.