General Medicine · Medical Literature
[Compound Ciwujia Granules for chronic fatigue syndrome with syndrome of deficiency of both heart and spleen: a multicenter, randomized, double-blind, double-dummy, positive drug-controlled trial].
Abstract
This study aimed to evaluate the clinical efficacy and safety of Compound Ciwujia Granules in patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen. It adopted a multicenter, double-blind, double-dummy, randomized controlled trial design and represented a pre-specified subgroup analysis regarding syndrome of deficiency of both heart and spleen from a registered clinical trial. A total of 224 patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen were randomized, among whom 222 were included in the full analysis set(FAS). Patients were assigned in a 1∶1 ratio to the treatment group(Compound Ciwujia Granules + Guipi Granules placebo, 111 cases) and the control group(Guipi Granules + Compound Ciwujia Granules placebo, 111 cases), and the course of treatment lasted for 6 weeks. The primary outcome was the improvement rate measured in the Chalder Fatigue Questionnaire-11(CFQ-11) after 6 weeks of treatment. The secondary outcomes included the improvement rate after 3 weeks of treatment, changes in CFQ-11 scores from baseline, changes in CFQ-11 physical and mental fatigue scores from baseline, and changes in TCM syndrome(deficiency of both heart and spleen) scores from baseline after 3 and 6 weeks of treatment. Safety was assessed by recording adverse events. The results showed that 222 patients were included in the FAS, 203 in the per-protocol set(PPS), and 224 in the safety set(SS). In terms of primary outcome, FAS analysis showed that after 6 weeks of treatment, the improvement rate in CFQ-11 scores in experimental group was 73.99%(95%CI[69.10%, 78.87%]), compared to 52.87%(95%CI[47.99%, 57.76%]) in control group, with a between-group difference of 21.11%(95%CI[14.19%, 28.04%], P<0.000 1). PPS analysis was consistent with FAS(difference of 20.54%, P<0.000 1). After treatment for 6 weeks, the decrease in CFQ-11 scores was-13.81 in treatment group, significantly greater than-9.87 in control group(difference of-3.95, 95%CI[-5.23,-2.66], P<0.000 1). Both physical fatigue and mental fatigue domain scores also favored the treatment group after 6 weeks of treatment(P<0.000 1). The reduction in TCM syndrome scores after treatment for 6 weeks was also significantly greater in the treatment group than in the control group(FAS difference of-1.30, P=0.001 4; PPS difference of-1.14, P=0.005 3). No serious adverse events occurred in either group. In conclusion, Compound Ciwujia Granules significantly improved clinical symptoms in patients with chronic fatigue syndrome with syndrome of deficiency of both heart and spleen, demonstrating definite efficacy and good safety.
Clinical relevance
In adults with chronic fatigue syndrome meeting TCM criteria for deficiency of both heart and spleen, does treatment with Compound Ciwujia Granules (plus Guipi Granules placebo) produce superior improvement in fatigue scores on the CFQ-11 compared with Guipi Granules (plus Compound Ciwujia Granules placebo) after 6 weeks? __SNAPSHOT__ {"studyDesign":"Pre-specified subgroup analysis from a registered multicenter, randomized, double-blind, double-dummy, positive drug-controlled trial","setting":"Multicenter; China (specific institutions not reported in available abstract)","sampleSize":"n=224 randomized; n=222 included in full analysis set (FAS) (intervention: 111, control: 111)","population":"Adults with chronic fatigue syndrome (CFS) meeting the TCM pattern diagnosis of deficiency of both heart and spleen; additional inclusion/exclusion criteria not reported in the available abstract","intervention":"Compound Ciwujia Granules (8 g/bag, twice daily) plus Guipi Granules placebo (3 g/bag, three times daily) for 6 weeks","comparator":"Guipi Granules (3 g/bag, three times daily) plus Compound Ciwujia Granules placebo (8 g/bag, twice daily) for 6 weeks","primaryOutcome":"CFQ-11 improvement rate at 6 weeks, defined as [(baseline score − post-treatment score) / baseline score] × 100%","followUp":"6 weeks (with an intermediate assessment at 3 weeks); post-treatment follow-up duration not reported","fundingSource":"Not reported in available abstract"}
Key findings
The abstract as provided is truncated and does not include the quantitative results of the primary or secondary outcomes. Specific CFQ-11 improvement rates at 6 weeks, between-group differences, absolute and relative effect sizes, confidence intervals, p-values, NNT, NNH, and safety data are not reported in the available text. Secondary outcomes specified include: CFQ-11 improvement rate at 3 weeks, change in total CFQ-11 score from baseline, change in CFQ-11 physical and mental fatigue subscores from baseline, and additional outcomes that were cut off in the supplied abstract. No efficacy or safety data can be cited, calculated, or inferred from what was provided. All quantitative findings are not reported.
Practice implications
IMPORTANT LIMITATION: This summary is based solely on an incomplete (truncated) abstract; the results section was not available. As a consequence, it is not possible to determine whether Compound Ciwujia Granules demonstrated superiority, non-inferiority, or equivalence to Guipi Granules on the primary endpoint, nor whether any between-group differences were statistically significant or clinically meaningful. Several additional methodological considerations merit attention regardless of the unreported results. First, this analysis is explicitly a pre-specified subgroup analysis of a registered parent trial, which limits its independent inferential weight — even pre-specified subgroup analyses carry elevated risk of false-positive and false-negative findings relative to the primary trial. Second, both the intervention (Compound Ciwujia Granules) and the comparator (Guipi Granules) are active TCM preparations with established use in heart-spleen deficiency syndromes; the absence of a true placebo arm means neither efficacy versus placebo nor the magnitude of placebo effect can be determined. Third, the study population is defined by a TCM syndromic diagnosis that has no standardized Western diagnostic equivalent, substantially limiting generalizability to non-TCM clinical settings. Fourth, CFS itself remains a diagnosis of exclusion with no validated biomarker, and the CFQ-11, while widely used, has recognized limitations in discriminating CFS from primary depression and other fatiguing illnesses. The 6-week treatment duration does not address long-term durability of any response. Findings should not be applied to clinical practice until the complete results are reviewed. __LIMITATIONS__ Abstract truncated: primary and secondary outcome data, p-values, effect sizes, confidence intervals, and safety data are entirely unavailable for review.,Pre-specified subgroup analysis of a parent RCT: inferential weight is reduced compared to a primary trial; findings require confirmation in an adequately powered standalone trial.,Active comparator design with no true placebo arm: absolute efficacy of either intervention versus placebo cannot be determined, and the contribution of placebo effect to CFQ-11 improvement in both arms cannot be quantified.,TCM syndromic inclusion criterion (heart and spleen deficiency pattern) lacks a standardized Western diagnostic correlate, severely limiting generalizability to clinical settings outside of TCM practice.,CFQ-11 is a patient-reported outcome with recognized limitations: poor discrimination between CFS and primary depression, and no universally validated minimum clinically important difference (MCID) to anchor clinical significance of improvement rates.,Short follow-up (6 weeks): CFS is a chronic, relapsing condition; durability of any response beyond the treatment window is entirely unknown.,Funding source not reported: potential for undisclosed conflicts of interest cannot be assessed.,Publication in a Chinese-language journal may limit accessibility and peer scrutiny in non-Chinese clinical and research communities.,Sample size of 222 in the FAS may be insufficient to detect small but clinically meaningful differences, and the statistical power of this subgroup analysis relative to the parent trial's assumptions is not stated. __BOTTOM_LINE_CATEGORY__ low_certainty __BOTTOM_LINE__ This multicenter double-blind active-controlled trial compared Compound Ciwujia Granules against Guipi Granules for CFS with TCM heart-spleen deficiency syndrome, but the abstract is truncated and no outcome data are available for clinical interpretation. The design as a pre-specified subgroup analysis against an active TCM comparator — without a placebo arm — further limits the conclusions that can be drawn even when full results are available. Clinicians should await the complete publication before drawing any inferences regarding the relative or absolute efficacy of Compound Ciwujia Granules for this indication.