Xiong 2008a.
Methods | Design: Parallel Blinding: No Attempt to confirm patient blinding?: No Dropouts/withdrawals: During the 4 weeks treatment, no drop‐outs mentioned in any of the three groups (acupuncture + Chinese herbal medicine group, Chinese herbal medicine group and acupuncture) Total duration: 4 weeks of treatment, evaluation after treatment, but the specific time point of evaluation was not stated Type of analysis reported: NA | |
Participants | Setting: Not very specific. "120 patients from outpatient or inpatient were randomly divided into 3 groups." China
Mean age (+/‐SD or Range): 39.15 (15) years for Chinese herbal medicine group, 38.3 (16) years for acupuncture group, 38.6 (15) years for acupuncture + Chinese herbal medicine group
Men/Women (n/n): 48/72
Recruitment method: "120 patients from outpatient or inpatient were randomly divided into 3 groups"
Minimum duration of IBS symptoms: 1 year Actual duration of IBS symptoms before enrollment: 53.7 (5.1) months for Chinese herbal medicine group, 52.6 (5.4) months for acupuncture group, 54.2 +/‐ 4.9 months for acupuncture + Chinese herbal medicine group Diagnosis of IBS required to be eligible? (if yes, describe how patients were verified to have IBS): Rome II criteria and diagnostic criteria of liver‐qi stagnation and spleen deficiency in "The principle of clinical research for new drug of traditional Chinese herbal medicine (in Chinese)" were used Evaluation to rule out organic gastrointestinal disease: Reported. "Subjects with other organic gastrointestinal disease were excluded" Predominant symptoms or stool patterns of participants: Diarrhea Hospital inpatients? (Y/N; if Y list number inpatients): Yes, the number of inpatients was not reported Were people with a history of acupuncture treatment excluded?: Not reported |
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Interventions | ACUPUNCTURE+ CHINESE HERBAL MEDICINE
N allocated to acupuncture: 42
Style of acupuncture: Chinese
Points selection: Fixed formula
Points stimulated: CV‐12, bilateral ST‐25, LI‐4, ST‐36, LR‐3 Ingredient of Chinese herbal medicine: Thorowax root 12 g, white peony root 15 g, bitter orange immature 6 g, turmeric root, tuckahoe 15 g, tangerine peel 6 g, divaricate saposhnikovia root 9 g, bighead atractylodes rhizome 15 g, aucklandia root 6 g, natgrass galingale rhizome 6 g, oriental waterplantain rhizome 15 g, licorice root 3 g Description of acupuncturist qualifications: No description. Total length of treatment period (weeks): 4 Number of sessions target (mean): 28 Times per week: 7 Number of points used (mean): 9 points Insertion depth: Not reported Was De Qi reportedly sought?: Yes Duration (mins): 30 min Method of stimulation: Manipulation. Moxibusiton procedure: Moxibustion with warming needle procedure were performed on bilateral ST‐25 and ST‐36 CONTROL GROUP A INTERVENTION (sham, if used): Chinese herbal medicine only group N allocated to control group A: 40 Total length of treatment period: 4 weeks Number of sessions target (mean): 28 Times per week: 7 Ingredient of Chinese herbal medicine: same as described above CONTROL GROUP B INTERVENTION (sham, if used): Acupuncture only group N allocated to control group B: 38 Points selection: Fix Points stimulated: CV‐12, bilateral ST‐25, LI‐4, ST‐36, LR‐3 Total length of treatment period: 4 weeks Number of sessions target (mean): 28 Times per week: 7 Number of points used: 9 points Insertion depth: Not stated Was De Qi sought?: Yes Duration (mins): 30 Method of stimulation: Manipulation Moxibusiton procedure: Moxibustion with warming needle procedure were performed on bilateral ST‐25 and ST‐36 Any co‐interventions in all groups?: Not reported |
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Outcomes | Quality of life: Not assessed Symptom severity: Symptom Improvement (4‐point scoring system) at end of treatment: 1) cured: 2) improved 3) effective 4) no effect "Measurements: Abdominal pain, diarrhea, abdominal distension, stool frequency and properties were assessed According to "The principle of clinical research for new drug of traditional Chinese herbal medicine (in Chinese)", no symptom (0 score) means well‐formed motions, soft stool, 1 to 2 times a day; mild symptom (1 score) means life and work are not influenced, mushy stool or stool with a little mucus, 2 to 3 times a day; moderate symptom (2 score) means the symptom influences life and work but can be tolerated, moderate mucous stool, 4 to 5 times a day; severe symptom (3 score): the symptom interfere with life and work and can not be tolerated, rice‐water stool or stool with lots of mucous, above 6 times a day" "1) Cured: disappearance of main symptoms, well‐formed stool, disappearance of mucus, improvement of score > = 95%; 2) Improved: disappearance of most main symptoms, well‐formed stool, significantly decrease of mucus, improvement of symptom score > = 70% and < 95%; 3) Effective: improvement of main symptoms, watery stool, decrease of mucus, improvement of symptom score > = 30%; 4) No effect: no improvement of symptoms, improvement of symptom score < 30% Improvement of symptom score = (total symptom score before treatment ‐ total symptom score after treatment) / total symptom score before treatment Total symptom score = abdominal pain score + abdominal distension score + diarrhea score + stool frequency score + stool properties score" Time points of symptom measurement: Before and after the treatment Additional outcomes reported in the trial but not extracted: Table 2, 3, 4 and 5 showed the number of responders of improvement of diarrhea, abdominal pain, abdominal distension and stool frequency respectively for each group after treatment Author's conclusion: "The findings indicate that the combination of acupuncture and Chinese herbal medicine shows promise in the treatment of patients with diarrhea‐predominant IBS" Adverse effects: Not reported |
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Notes | We extracted data for acupuncture + Chinese herbal medicine versus Chinese herbal medicine only Additional information in square brackets was provided by the first author Xiong, in an telephone conversation with Ke Cheng from September 18, 2009, and translated by Ke Cheng in an e‐mail to Eric Manheimer and L. Susan Wieland on February 28, 2011 Funding resources: When the first author Xiong was telephoned, she stated there was no funding supporting the trial |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "120 patients from outpatient or inpatient were randomly divided into 3 groups." [The generation of the sequence was referred to a random number table] |
Allocation concealment (selection bias) | High risk | [No, we only used the random number table, we didn't use envelope method or central allocation] |
Blinding (performance bias and detection bias) All outcomes | High risk | Open study. Treatment allocation was not blinded |
Incomplete outcome data (attrition bias) Short term | High risk | "Both trials didn't explicitly report the 100% follow up in the paper or report to me by the author." |
Selective reporting (reporting bias) | Low risk | Outcomes were reported for overall IBS symptom severity (response to treatment in four categories) at the completion of the treatment period. This categorization is a standard way of assessing treatment success in Chinese trials of IBS. Abdominal pain, diarrhea, abdominal distension, stool frequency and properties were assessed at baseline and the number of responders for each symptom were described after treatment |
Other bias | High risk | Intention‐to‐treat analysis was not reported There was a good balancing of the three groups at baseline for the age and duration of IBS, but there was no information about other baseline variables related to symptom severity |