The DOI matches its Crossref record; 30 of the 30 references it cites were found in a registry or an index; 2 of the 20 sources its claims cite were checked for support.
Risk of symptomatic gallstones and cholecystectomy after a very-low-calorie diet or low-calorie diet in a commercial weight loss program: 1-year matched cohort study
Open accessAbstract
BACKGROUND: Concern exists regarding gallstones as an adverse event of very-low-calorie diets (VLCDs; <800 kcal per day). OBJECTIVE: To assess the risk of symptomatic gallstones requiring hospital care and/or cholecystectomy in a commercial weight loss program using VLCD or low-calorie diet (LCD). DESIGN: A 1-year matched cohort study of consecutively enrolled adults in a commercial weight loss program conducted at 28 Swedish centers between 2006 and 2009. A 3-month weight loss phase of VLCD (500 kcal per day) or LCD (1200-1500 kcal per day) was followed by a 9-month weight maintenance phase. Matching (1:1) was performed by age, sex, body mass index, waist circumference and gallstone history (n=3320:3320). Gallstone and cholecystectomy data were retrieved from the Swedish National Patient Register. RESULTS: One-year weight loss was greater in the VLCD than in the LCD group (-11.1 versus -8.1 kg; adjusted difference, -2.8 kg, 95% CI -3.1 to -2.4; P<0.001). During 6361 person-years, 48 and 14 gallstones requiring hospital care occurred in the VLCD and LCD groups, respectively, (152 versus 44/10 000 person-years; hazard ratio, 3.4, 95% CI 1.8-6.3; P<0.001; number-needed-to-harm, 92, 95% CI 63-168; P<0.001). Of the 62 gallstone events, 38 (61%) resulted in cholecystectomy (29 versus 9; hazard ratio, 3.2, 95% CI 1.5-6.8; P=0.003; number-needed-to-harm, 151, 95% CI 94-377; P<0.001). Adjusting for 3-month weight loss attenuated the hazard ratios, but the risk remained higher with VLCD than LCD for gallstones (2.5, 95% CI 1.3-5.1; P=0.009) and became borderline for cholecystectomy (2.2, 95% CI 0.9-5.2; P=0.08). CONCLUSION: The risk of symptomatic gallstones requiring hospitalization or cholecystectomy, albeit low, was 3-fold greater with VLCD than LCD during the 1-year commercial weight loss program.
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Written from the paper’s full text.
TL;DR
In a 1-year matched cohort in a Swedish commercial weight-loss program, VLCD (500 kcal/day) produced greater weight loss than LCD (1200–1500 kcal/day) but about a 3-fold higher risk of symptomatic gallstones requiring hospital care and/or cholecystectomy. The absolute risk remained low, and adjustment for 3-month weight loss attenuated but did not eliminate the excess gallstone risk.
Key findings
- One-year weight loss was greater with VLCD than LCD: −11.1 vs −8.1 kg; adjusted difference −2.8 kg (95% CI −3.1 to −2.4; P<0.001).
- During 6361 person–years, 48 vs 14 gallstones requiring hospital care occurred in VLCD vs LCD (152 vs 44 per 10 000 person–years; hazard ratio 3.4, 95% CI 1.8–6.3; P<0.001; number-needed-to-harm 92, 95% CI 63–168).
- Of 62 gallstone events, 38 (61%) resulted in cholecystectomy (29 vs 9; hazard ratio 3.2, 95% CI 1.5–6.8; P=0.003; number-needed-to-harm 151, 95% CI 94–377).
- Adjusting for 3-month weight loss attenuated the risks: gallstones hazard ratio 2.5 (95% CI 1.3–5.1; P=0.009 in abstract) and cholecystectomy hazard ratio 2.2 (95% CI 0.9–5.2; P=0.08).
Methods
- One-year matched cohort of consecutively enrolled adults in a commercial weight-loss program at 28 Swedish centers, 2006–2009; VLCD 500 kcal/day for 6–10 weeks vs LCD 1200–1500 kcal/day for up to 3 months, followed by the same 9-month maintenance phase.
- Matching was 1:1 by age, sex, BMI, waist circumference, and gallstone history, yielding 3320 participants per group; outcomes were retrieved from the Swedish National Patient Register.
- Main analysis used conditional Cox regression over 1-year follow-up, intention-to-treat; sensitivity analysis excluded participants with gallstones requiring hospital care in the prior 5 years, and exploratory multivariable Cox regression examined predictors.
Limitations
- The paper states the main limitation was the nonrandomized design; matching and multivariable adjustment handled some baseline differences, but residual confounding may exist.
- Participants selected and paid for treatment themselves, possibly limiting generalizability to the wider overweight and obese population.
- The National Patient Register captures inpatient and nonprimary outpatient gallstones, not primary-care visits or undetected asymptomatic gallstones, so results may not generalize to mild or asymptomatic gallstones.
Model-written summary. Check it against the paper before relying on it.
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Claims the paper makes
2 of 20 cited sources checked · 1 supported · 0 flagged · accuracy not yet measured
- Premisecitation
In a previous study of VLCD as a treatment for sleep apnea, all 3 gallstones were reported during the maintenance phase.
“This was also the case in a previous study of VLCD as a treatment for sleep apnea (3/3 gallstones reported during the maintenance phase).28, 29”
Quote in the paperNot a substantial claim2 of 2 sources checked- cites [28] Johansson K, Hemmingsson E, Harlid R, Trolle Lagerros Y, Granath F, Rossner S et al. Longer term effects of very low energy diet on obstructive sleep apnoea in cohort derived from randomised controlled trial: prospective observational follow-up study. BMJ 2011; 342: d3017. source
- cites [29] Johansson K, Neovius M, Lagerros YT, Harlid R, Rossner S, Granath F et al. Effect of a very low energy diet on moderate and severe obstructive sleep apnoea in obese men: a randomised controlled trial. BMJ 2009; 339: b4609. source
Methods > Intervention identifies this as a VLCD study of sleep apnoea and says patients were offered a one-year weight-maintenance programme. Results > Safety reports adverse events through week 9 but does not report three gallstones or their timing during maintenance; Methods > Safety mentions gallstones only as a possible VLCD adverse event. No page numbers are available in our copy. (LLM, conf=0.85)
Experimental — accuracy not yet measured
- Findingown data
The conditional hazard ratio for cholecystectomy was 3.2 (95% CI 1.5-6.8; P=0.003) comparing VLCD with LCD.
“Of the 62 gallstone events, 38 (61%) resulted in cholecystectomy (29 versus 9; hazard ratio, 3.2, 95% CI 1.5–6.8; P=0.003; number-needed-to-harm, 151, 95% CI 94–377; P<0.001).”
- Also stated in: § Risk of cholecystectomy · plain
“Including only participants who did not undergo a cholecystectomy preceding program start (n=3159 in the VLCD group and 3159 in the LCD group), 38 cases of cholecystectomy were performed during 6067 person–years of follow-up, of which 29 were in the VLCD group and 9 in the LCD group (96 versus 30 per 10 000 person–years; conditional hazard ratio, 3.2, 95% CI 1.5–6.8; P=0.003; number-needed-to-harm”
Quote in the paperSubstantial claim - Also stated in: § Risk of cholecystectomy · plain
- Findingown data
In multivariable analysis, the risk of developing gallstones requiring hospital care was higher in those with a higher baseline BMI.
“In multivariable analysis, the risk of developing gallstones requiring hospital care was higher in women than in men, in younger than in older participants, in those with a higher baseline BMI, among those who lost the most weight and in those with a history of gallstones (irrespective of cholecystectomy status; Supplementary Table 2).”
Quote in the paperNot a substantial claim - Findingown data
In multivariable analysis, the risk of developing gallstones requiring hospital care was higher in younger than in older participants.
“In multivariable analysis, the risk of developing gallstones requiring hospital care was higher in women than in men, in younger than in older participants, in those with a higher baseline BMI, among those who lost the most weight and in those with a history of gallstones (irrespective of cholecystectomy status; Supplementary Table 2).”
Quote in the paperNot a substantial claim - Findingown data
The risk difference for gallstones requiring hospital care was 108 per 10 000 person-years (95% CI 59-157; P<0.001).
“The risk difference was 108 per 10 000 person–years (95% CI 59–157; P<0.001), resulting in a number-needed-to-harm of 92 (95% CI 63–168; P<0.001).”
Quote in the paperSubstantial claim
- Findingown data
In multivariable analysis, the risk of developing gallstones requiring hospital care was higher in women than in men.
“In multivariable analysis, the risk of developing gallstones requiring hospital care was higher in women than in men, in younger than in older participants, in those with a higher baseline BMI, among those who lost the most weight and in those with a history of gallstones (irrespective of cholecystectomy status; Supplementary Table 2).”
Quote in the paperNot a substantial claim - Findingown data
In multivariable analysis, the risk of developing gallstones requiring hospital care was higher in those with a history of gallstones, irrespective of cholecystectomy status.
“In multivariable analysis, the risk of developing gallstones requiring hospital care was higher in women than in men, in younger than in older participants, in those with a higher baseline BMI, among those who lost the most weight and in those with a history of gallstones (irrespective of cholecystectomy status; Supplementary Table 2).”
Quote in the paperNot a substantial claim - Findingown data
After the initial weight loss phase (0-3 months), weight loss was 12.7 versus 7.9 kg (adjusted mean difference, 4.6, 95% CI 4.4-4.9; P<0.001).
“After the initial weight loss phase (0–3 months; baseline observation carried forward), weight loss was 12.7 versus 7.9 kg (adjusted mean difference, 4.6, 95% CI 4.4–4.9; P<0.001).”
Quote in the paperNot a substantial claim - Findingown data
Excluding participants with gallstones requiring hospital care during the 5 years preceding program start resulted in similar results for gallstones (46 versus 13; 147 versus 41 per 10 000 person-years; hazard ratio, 3.4, 95% CI 1.8-6.3; number-needed-to-harm, 94, 95% CI 65-173; P<0.001).
“Excluding participants with gallstones requiring hospital care during the 5 years preceding program start (n=58) resulted in similar results for gallstones (46 versus 13 in the VLCD and LCD group, respectively; 147 versus 41 per 10 000 person–years; hazard ratio, 3.4, 95% CI 1.8–6.3; number-needed-to-harm, 94, 95% CI 65–173; P<0.001)”
Quote in the paperNot a substantial claim - Findingown data
The conditional hazard ratio for gallstones requiring hospital care was 3.4 (95% CI 1.8-6.3; P<0.001) comparing VLCD with LCD.
“During 6361 person–years, 48 and 14 gallstones requiring hospital care occurred in the VLCD and LCD groups, respectively, (152 versus 44/10 000 person–years; hazard ratio, 3.4, 95% CI 1.8–6.3; P<0.001; number-needed-to-harm, 92, 95% CI 63–168; P<0.001).”
- Also stated in: § Risk of gallstones requiring hospital care · plain
“During 6361 person–years of follow-up, 48 gallstones occurred in the VLCD group and 14 in the LCD group (152 versus 44 per 10 000 person–years; conditional hazard ratio, 3.4, 95% CI 1.8−6.3; P<0.001; Figure 3; Table 2).”
Quote in the paperSubstantial claim - Also stated in: § Risk of gallstones requiring hospital care · plain
- Findingown data
After the entire 1-year program, weight loss was 11.1 versus 8.1 kg (adjusted mean difference, 2.8, 95% CI 2.4-3.1; P<0.001).
“One-year weight loss was greater in the VLCD than in the LCD group (−11.1 versus −8.1 kg; adjusted difference, −2.8 kg, 95% CI −3.1 to −2.4; P<0.001).”
- Also stated in: § Weight change · plain
“After the entire 1-year program, weight loss was 11.1 versus 8.1 kg (adjusted mean difference, 2.8, 95% CI 2.4–3.1; P<0.001; Figure 2).”
Quote in the paperNot a substantial claim - Also stated in: § Weight change · plain
- Findingown data
Among participants who did not undergo cholecystectomy before program start, 38 cholecystectomies occurred during 6067 person-years, with 29 in the VLCD group and 9 in the LCD group (96 versus 30 per 10 000 person-years).
“Including only participants who did not undergo a cholecystectomy preceding program start (n=3159 in the VLCD group and 3159 in the LCD group), 38 cases of cholecystectomy were performed during 6067 person–years of follow-up, of which 29 were in the VLCD group and 9 in the LCD group (96 versus 30 per 10 000 person–years; conditional hazard ratio, 3.2, 95% CI 1.5–6.8; P=0.003; number-needed-to-harm”
Quote in the paperSubstantial claim - Findingown data
For cholecystectomy, the same factors as for gallstones requiring care were associated with an increased risk for cholecystectomy.
“For cholecystectomy, the same factors as for gallstones requiring care were associated with an increased risk for cholecystectomy (Supplementary Table 3).”
Quote in the paperNot a substantial claim - Findingown data
The number-needed-to-harm for cholecystectomy was 151 (95% CI 94-377; P<0.001).
“Of the 62 gallstone events, 38 (61%) resulted in cholecystectomy (29 versus 9; hazard ratio, 3.2, 95% CI 1.5–6.8; P=0.003; number-needed-to-harm, 151, 95% CI 94–377; P<0.001).”
Quote in the paperSubstantial claim - Findingown data
The number-needed-to-harm for gallstones requiring hospital care was 92 (95% CI 63-168; P<0.001).
“During 6361 person–years, 48 and 14 gallstones requiring hospital care occurred in the VLCD and LCD groups, respectively, (152 versus 44/10 000 person–years; hazard ratio, 3.4, 95% CI 1.8–6.3; P<0.001; number-needed-to-harm, 92, 95% CI 63–168; P<0.001).”
- Also stated in: § Risk of gallstones requiring hospital care · plain
“The risk difference was 108 per 10 000 person–years (95% CI 59–157; P<0.001), resulting in a number-needed-to-harm of 92 (95% CI 63–168; P<0.001).”
Quote in the paperSubstantial claim - Also stated in: § Risk of gallstones requiring hospital care · plain
- Findingown data
Of the 62 gallstone events, 38 (61%) resulted in cholecystectomy.
“Of the 62 gallstone events, 38 (61%) resulted in cholecystectomy (29 versus 9; hazard ratio, 3.2, 95% CI 1.5–6.8; P=0.003; number-needed-to-harm, 151, 95% CI 94–377; P<0.001).”
Quote in the paperSubstantial claim - Findingown data
During 6361 person-years of follow-up, 48 gallstones requiring hospital care occurred in the VLCD group and 14 in the LCD group (152 versus 44 per 10 000 person-years).
“During 6361 person–years, 48 and 14 gallstones requiring hospital care occurred in the VLCD and LCD groups, respectively, (152 versus 44/10 000 person–years; hazard ratio, 3.4, 95% CI 1.8–6.3; P<0.001; number-needed-to-harm, 92, 95% CI 63–168; P<0.001).”
- Also stated in: § Risk of gallstones requiring hospital care · plain
“During 6361 person–years of follow-up, 48 gallstones occurred in the VLCD group and 14 in the LCD group (152 versus 44 per 10 000 person–years; conditional hazard ratio, 3.4, 95% CI 1.8−6.3; P<0.001; Figure 3; Table 2).”
Quote in the paperSubstantial claim - Also stated in: § Risk of gallstones requiring hospital care · plain
- Findingown data
Excluding participants with gallstones requiring hospital care during the 5 years preceding program start resulted in similar results for cholecystectomy (28 versus 9; 93 versus 30 per 10 000 person-years; hazard ratio, 3.2, 95% CI 1.5-6.8; number-needed-to-harm, 158, 95% CI 97-420; P=0.002).
“and cholecystectomy (28 in the VLCD group compared with 9 in the LCD group; 93 versus 30 per 10 000 person–years; hazard ratio, 3.2, 95% CI 1.5–6.8; number-needed-to-harm, 158, 95% CI 97–420; P=0.002).”
Quote in the paperNot a substantial claim - Findingown data
The majority of gallstones requiring hospital care occurred during the maintenance phase (37/48 in the VLCD group and 8/14 in the LCD group).
“The majority of the gallstones requiring hospital care occurred during the maintenance phase (37/48 in the VLCD group and 8/14 in the LCD group).”
Quote in the paperSubstantial claim - Findingown data
In multivariable analysis, the risk of developing gallstones requiring hospital care was higher among those who lost the most weight.
“In multivariable analysis, the risk of developing gallstones requiring hospital care was higher in women than in men, in younger than in older participants, in those with a higher baseline BMI, among those who lost the most weight and in those with a history of gallstones (irrespective of cholecystectomy status; Supplementary Table 2).”
Quote in the paperSubstantial claim - Findingown data
Adjustment for weight loss during the first 3 months attenuated the hazard ratio for cholecystectomy (2.2, 95% CI 0.9-5.2; P=0.08).
“Adjustment for weight loss during the first 3 months attenuated the hazard ratio (2.2, 95% CI 0.9–5.2; P=0.08).”
Quote in the paperSubstantial claim - Premisenone given
Previous studies of VLCD-induced rapid weight loss have all identified gallstone formation with ultrasonography after VLCD use.
“These previous studies have all identified gallstone formation with ultrasonography after VLCD use.”
Quote in the paperNot a substantial claim - Study design and conductnone given
Baseline differences in age, sex, BMI, waist circumference and gallstone history were handled by matching.
“Baseline differences in age, sex, BMI, waist circumference and gallstone history were handled by matching.”
Quote in the paperSubstantial claim - Interpretationreasoning
The results may not be generalizable to mild or asymptomatic gallstones.
“Our results may therefore not be generalizable to mild or asymptomatic gallstones.”
Quote in the paperSubstantial claim - Premisenone given
There are no large-scale studies on the safety of commercial weight loss programs.
“Further, to the best of our knowledge, there are no large-scale studies on the safety of commercial weight loss programs.”
Quote in the paperNot a substantial claim - Premisereasoning
The risk of symptomatic gallstones requiring hospital care and/or cholecystectomy after VLCD use has not been studied.
“The risk of symptomatic gallstones requiring hospital care and/or cholecystectomy, potentially serious adverse events after VLCD use, has not been studied.”
Quote in the paperSubstantial claim - Premisecitation
The safety of commercial weight loss programs has rarely been studied.
“However, the safety of commercial programs has rarely been studied”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [7] National Task Force on the Prevention and Treatment of Obesity NIoH. Very low-calorie diets. JAMA 1993; 270: 967–974. source
- cites [8] Saris WH . Very-low-calorie diets and sustained weight loss. Obes Res 2001; 9 (Suppl 4): 295S–301S. source
Checked before — its earlier verdict is held back until a new check runs.
- cites [9] Tsai AG, Wadden TA . The evolution of very-low-calorie diets: an update and meta-analysis. Obesity (Silver Spring) 2006; 14: 1283–1293. source
- Interpretationnone given
Participants had selected and paid for the treatment themselves, possibly limiting generalizability to the wider overweight and obese population.
“Second, participants had selected and paid for the treatment themselves, possibly limiting generalizability to the wider overweight and obese population.”
Quote in the paperNot a substantial claim
- Probably not a substantial claim. 21
- It may state two separate claims as one. 19
Probably not a substantial claim. The paper’s conclusions may not depend on it.
Findingown dataAfter matching, 3320 participants remained in each group.
“After matching LCD participants (n=4588) with replacement to VLCD participants (n=3773) 1:1 by age, sex, BMI, waist circumference, and previous gallstones, 3320 participants remained in each group (Figure 1).”
Quote in the paperNot a substantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it.
Findingown dataThere were fewer users in the VLCD than in the LCD group of antihypertensives (16.7% versus 19.4%; mean difference, −2.7%, 95% CI −0.8 to −4.5%; P=0.005).
“and antihypertensives (16.7% versus 19.4% mean difference, −2.7%, 95% CI −0.8 to −4.5% P=0.005; Table 1).”
Quote in the paperNot a substantial claimIt may state two separate claims as one.
Findingown dataAdjusting the main analysis for weight loss during the first 3 months attenuated the hazard ratio, but the hazard ratio for gallstones requiring hospital care remained higher with VLCD than LCD (2.5, 95% CI 1.3-5.1; P<0.001).
“Adjusting the main analysis for weight loss during the first 3 months attenuated the hazard ratio, but the hazard ratio remained higher with VLCD than LCD (2.5, 95% CI 1.3–5.1; P<0.001).”
Quote in the paperSubstantial claimIt may state two separate claims as one.
Findingown dataEighty-two percent of the VLCD group and 78% of the LCD group completed the 1-year program (odds ratio, 1.3, 95% CI 1.2-1.5; P<0.001).
“Eighty-two percent of the VLCD group and 78% in the LCD group completed the 1-year program (odds ratio, 1.3, 95% CI 1.2–1.5; P<0.001).”
Quote in the paperNot a substantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it.
Findingown dataThere were fewer users in the VLCD than in the LCD group of antidiabetes drugs (1.8 versus 3.3%; mean difference, −1.4%, 95% CI −0.7 to −2.2%; P<0.001).
“There were fewer users in the VLCD than in the LCD group of antidiabetes drugs (1.8 versus 3.3% mean difference, −1.4%, 95% CI −0.7 to −2.2% P<0.001)”
Quote in the paperNot a substantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
Findingown dataAt baseline, 0.9% (58/6640) had a history of gallstones requiring hospital care, of which 74% (43/58) had been cholecystectomized.
“At baseline, 0.9% (n=58/6640) had a history of gallstones requiring hospital care, of which 74% (n=43/58) had been cholecystectomized (Table 1).”
Quote in the paperNot a substantial claimProbably not a substantial claim. It may state two separate claims as one.
PremisecitationIncreased risk of gallstone formation during and after VLCD-induced rapid weight loss is incorporated in clinical recommendations as an adverse event, advising physicians to inform patients about this risk, but the risk magnitude has been unclear.
“Increased risk of gallstone formation during and after VLCD-induced rapid weight loss is incorporated in clinical recommendations as an adverse event, advising physicians to inform patients about this risk, but the risk magnitude has been unclear.7, 16, 20”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [7] National Task Force on the Prevention and Treatment of Obesity NIoH. Very low-calorie diets. JAMA 1993; 270: 967–974. source
- cites [16] SCOOP-VLCD. SCOOP-VLCD Task 7.3. Scientific Co-operation on Questions Relating to Food: Directorate-General Health and Consumer Protection, European Union. In 2002.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites [20] Everhart JE . Contributions of obesity and weight loss to gallstone disease. Ann Intern Med 1993; 119: 1029–1035. source
Probably not a substantial claim. The paper’s conclusions may not depend on it.
Study design and conductnone givenMultivariable adjustment was used for handling remaining baseline imbalances.
“Multivariable adjustment was used for handling remaining baseline imbalances.”
Quote in the paperNot a substantial claimIt may state two separate claims as one.
Interpretationown dataAfter adjusting for weight loss during the first 3 months, the risk was attenuated but remained higher with VLCD than LCD, suggesting a direct effect of VLCD on gallstone disease.
“After adjusting for weight loss during the first 3 months, the risk was attenuated but remained higher with VLCD than LCD, suggesting a direct effect of VLCD on gallstone disease.”
- Also stated in: § Conclusion · hedged
“After adjusting for weight loss during the first 3 months, the risk was attenuated but remained higher with VLCD than LCD, suggesting a direct effect of VLCD on gallstone disease.”
Quote in the paperSubstantial claim- Also stated in: § Conclusion · hedged
It may state two separate claims as one.
PremisecitationUsing VLCD in commercial weight loss programs is a particular concern given the risk of adverse events as well as weight regain.
“using VLCD in commercial weight loss programs is a particular concern given the risk of adverse events as well as weight regain.7, 8, 9”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [7] National Task Force on the Prevention and Treatment of Obesity NIoH. Very low-calorie diets. JAMA 1993; 270: 967–974. source
- cites [8] Saris WH . Very-low-calorie diets and sustained weight loss. Obes Res 2001; 9 (Suppl 4): 295S–301S. source
Checked before — its earlier verdict is held back until a new check runs.
- cites [9] Tsai AG, Wadden TA . The evolution of very-low-calorie diets: an update and meta-analysis. Obesity (Silver Spring) 2006; 14: 1283–1293. source
Probably not a substantial claim.
Study design and conductown dataMatching was performed 1:1 by age, sex, body mass index, waist circumference and gallstone history.
“Matching (1:1) was performed by age, sex, body mass index, waist circumference and gallstone history (n=3320:3320).”
Quote in the paperSubstantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
Study design and conductown dataMortality was not analyzed due to few cases, with one death due to unknown cause occurring in the VLCD group after the weight loss phase.
“Mortality was not analyzed due to few cases (one death due to unknown cause occurred in the VLCD group after the weight loss phase).”
Quote in the paperNot a substantial claimProbably not a substantial claim.
PremisecitationRapid weight loss, either by VLCD or bariatric surgery, is a known risk factor for gallstone formation.
“Rapid weight loss, either by VLCD or bariatric surgery, is a known risk factor for gallstone formation.20”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [20] Everhart JE . Contributions of obesity and weight loss to gallstone disease. Ann Intern Med 1993; 119: 1029–1035. source
Probably not a substantial claim. The paper’s conclusions may not depend on it.
Study design and conductnone givenA sensitivity analysis was conducted restricting the study population to participants without gallstones requiring hospital care during the 5 years preceding program start.
“A sensitivity analysis was conducted restricting the study population to participants without gallstones requiring hospital care during the 5 years preceding program start.”
Quote in the paperNot a substantial claimIt may state two separate claims as one.
Study design and conductnone givenThe outcomes were prospectively reported and data were collected routinely on a nationwide level in the universally accessible Swedish health-care system, with virtually complete follow-up.
“Further, the outcomes were prospectively reported and data were collected routinely on a nationwide level in the universally accessible Swedish health-care system, with virtually complete follow-up.”
Quote in the paperSubstantial claimIt may state two separate claims as one.
PremisecitationPrevious studies of VLCD-induced rapid weight loss have generally been small, of short duration, lacked control groups and used formulations with lower amounts of fat compared with formulations used today.
“Previous studies of VLCD-induced rapid weight loss have generally been small, of short duration, lacked control groups and used formulations with lower amounts of fat compared with the formulations used today.10, 11, 12, 13, 14”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [10] Broomfield PH, Chopra R, Sheinbaum RC, Bonorris GG, Silverman A, Schoenfield LJ et al. Effects of ursodeoxycholic acid and aspirin on the formation of lithogenic bile and gallstones during loss of weight. N Engl J Med 1988; 319: 1567–1572. source
- cites [11] Kamrath RO, Plummer LJ, Sadur CN, Adler MA, Strader WJ, Young RL et al. Cholelithiasis in patients treated with a very-low-calorie diet. Am J Clin Nutr 1992; 56 (1 Suppl): 255S–257S. source
- cites [12] Liddle RA, Goldstein RB, Saxton J . Gallstone formation during weight-reduction dieting. Arch Intern Med 1989; 149: 1750–1753. source
It may state two separate claims as one.
Interpretationown dataThe absolute risk of gallstones and cholecystectomy was low but approximately three times higher in the VLCD than in the LCD group during the 1-year commercial weight loss program.
“In our analysis of symptomatic gallstones requiring hospital care or cholecystectomy in participants using either VLCD or LCD for the first 3 months of a 1-year commercial weight loss program, we found the absolute risk of gallstones as well as cholecystectomy to be low but approximately three times higher in the VLCD than in the LCD group.”
- Also stated in: § Conclusion · plain
“The absolute risk of gallstones as well as cholecystectomy was found to be low but approximately three times higher in the VLCD than in the LCD group during the 1-year commercial weight loss program.”
Quote in the paperSubstantial claim- Also stated in: § Conclusion · plain
It may state two separate claims as one.
Study design and conductnone givenThe National Patient Register contains data on inpatient and nonprimary outpatient visits for gallstones, not visits in primary care or undetected asymptomatic gallstones.
“Finally, the National Patient Register contains data on inpatient and nonprimary outpatient visits for gallstones, not visits in primary care, or undetected asymptomatic gallstones.”
Quote in the paperSubstantial claimIt may state two separate claims as one.
InterpretationreasoningIncreased risk for gallstone formation during VLCDs could be explained by inadequate fat content of the diet and/or the rapid weight loss associated with VLCDs.
“Increased risk for gallstone formation during VLCDs could be explained by inadequate fat content of the diet and/or the rapid weight loss associated with VLCDs.”
Quote in the paperNot a substantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it.
PremisecitationA fat intake of 7-10 g per day has been reported as a threshold for maintaining an efficient gallbladder emptying.
“However, as described previously, a fat intake of 7–10 g per day has been reported as a threshold for maintaining an efficient gallbladder emptying.16, 26”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [16] SCOOP-VLCD. SCOOP-VLCD Task 7.3. Scientific Co-operation on Questions Relating to Food: Directorate-General Health and Consumer Protection, European Union. In 2002.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites [26] Festi D, Colecchia A, Larocca A, Villanova N, Mazzella G, Petroni ML et al. Review: low caloric intake and gall-bladder motor function. Aliment Pharmacol Ther 2000; 14 (Suppl 2): 51–53. source
It may state two separate claims as one.
Study design and conductown dataThe two treatment groups were balanced regarding circulatory disease, malignancy history and the use of lipid-lowering drugs and antidepressants.
“The two treatment groups were balanced regarding circulatory disease, malignancy history and the use of lipid-lowering drugs and antidepressants.”
Quote in the paperNot a substantial claimProbably not a substantial claim. It may state two separate claims as one.
Study design and conductnone givenThe strengths of the study include the large sample of weight loss participants in a real-life setting, with a direct VLCD and LCD comparison.
“The strengths of the current study include the large sample of weight loss participants in a real-life setting, with a direct VLCD and LCD comparison.”
Quote in the paperSubstantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it. The paper may give no reason why it holds. It may state two separate claims as one.
Premisenone givenTo the best of the authors' knowledge, this is the largest controlled study of VLCD and of the risk of severe gallstone problems and the first large-scale safety analysis of a commercial program.
“To the best of our knowledge, this is the largest controlled study of VLCD and of the risk of severe gallstone problems and the first large-scale safety analysis of a commercial program.”
Quote in the paperNot a substantial claimProbably not a substantial claim. It may state two separate claims as one.
PremisecitationThe majority of gallstones found in previous VLCD studies were asymptomatic, and few led to symptoms.
“However, the majority of the gallstones found in these studies were asymptomatic, and few led to symptoms.”
Quote in the paperSubstantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
PremisecitationThe two most commonly suggested mechanisms for gallstone formation are supersaturation of bile with cholesterol, leading to cholesterol crystallization and stone formation, and insufficient gallbladder emptying due to impaired motility.
“The two most commonly suggested mechanisms for gallstone formation are supersaturation of bile with cholesterol, leading to cholesterol crystallization and stone formation, and the insufficient gallbladder emptying due to impaired motility.25”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [25] Maddrey WC, Schiff ER, Sorrell MF . Ovid. Schiff's diseases of the liver. In: Chapter 22 Gallstone Disease: Pathogenesis and Treatment 10th ed. Lippincott Williams & Wilkins: Philadelphia, 2007. pp p.640–663.
Probably not a substantial claim. It may state two separate claims as one.
Study design and conductnone givenAnalyses included all matched patients and were analyzed by intention to treat.
“Analyses included all matched patients and were analyzed by intention to treat.”
Quote in the paperSubstantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it.
Study design and conductreasoningResidual confounding may exist.
“However, residual confounding may exist.”
Quote in the paperNot a substantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
PremisecitationRapid weight loss induced by VLCDs is believed to affect both mechanisms: supersaturation is believed to be caused by decreased bile salt levels and increased cholesterol levels, and impaired motility due to reduced gallbladder stimulation because of the low-fat content.
“Rapid weight loss induced by VLCDs is believed to affect both the mechanisms: Supersaturation is believed to be caused by decreased bile salt levels and increased cholesterol levels, and impaired motility due to reduced gallbladder stimulation because of the low-fat content.26, 27”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [26] Festi D, Colecchia A, Larocca A, Villanova N, Mazzella G, Petroni ML et al. Review: low caloric intake and gall-bladder motor function. Aliment Pharmacol Ther 2000; 14 (Suppl 2): 51–53. source
- cites [27] Erlinger S . Gallstones in obesity and weight loss. Eur J Gastroenterol Hepatol 2000; 12: 1347–1352. source
Probably not a substantial claim.
Premisenone givenA commonly described adverse event after rapid weight loss, including very-low-calorie diets, is gallstones.
“A commonly described adverse event after rapid weight loss (including VLCD) is gallstones.”
Quote in the paperSubstantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it.
Study design and conductnone givenThe main limitation of the study was the nonrandomized design.
“The main limitation was the nonrandomized design.”
Quote in the paperNot a substantial claimProbably not a substantial claim. The paper’s conclusions may not depend on it.
Study design and conductown dataThe results appeared to be robust in the sensitivity analyses.
“The results appeared to be robust in our sensitivity analyses.”
Quote in the paperNot a substantial claim
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Conflicting P-values for the weight-loss-adjusted gallstone result
MinorThe abstract reports P=0.009 for the adjusted gallstone hazard ratio, while the Results section reports P<0.001 for the same hazard ratio and confidence interval.
“risk remained higher with VLCD than LCD for gallstones (2.5, 95% CI 1.3–5.1; P=0.009)”
“the hazard ratio remained higher with VLCD than LCD (2.5, 95% CI 1.3–5.1; P<0.001)”
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Metadata
- Authors
- Johansson, K., Sundström, J., Marcus, C., Hemmingsson, E., & Neovius, M.
- Affiliations
- Karolinska Institutet (SE)
- Uppsala University (SE)
- Corresponding author
- Johansson, K
- Venue
- International Journal of Obesity
- Published
- 2013-05-22
- Volume
- 38
- Issue
- 2
- Pages
- 279-284
- ISSN
- 0307-0565 (ISSN-L)
- 1476-5497
- PMC
- PMC3921672
- OpenAlex
- W2031993190
- Semantic Scholar
- cb8deb94cdf2444d23a691703f7648c08ca68705
- Cited by
- 89
- References
- 29
- Citations by year
- 2026: 6 · 2025: 15 · 2024: 5 · 2023: 7 · 2022: 6 · 2021: 8 · 2020: 8 · 2019: 7 · 2018: 5 · 2017: 6 · 2016: 6 · 2015: 4 · 2014: 5 · 2013: 1
- FWCI
- 4.07
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- International Journal of Obesity (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gallbladder and Bile Duct Disorders
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Physiology (medical) › Diet and metabolism studies
- Keywords
- very low calorie diet, hypocaloric diet, symptomatic gallstones, cholecystectomy, weight loss, commercial weight loss programs, adverse events, weight maintenance, bariatric surgery, gallstone risk, matched cohort, number needed to harm, obesity treatment
- MeSH terms
- Adult, Energy Intake, Cholecystectomy, Female, Follow-Up Studies, Humans, Male, Middle Aged, Obesity, Risk Factors, Sweden, Time Factors, Cohort Studies, Weight Loss, Case-Control Studies, Treatment Outcome, Risk Assessment, Caloric Restriction, Gallstones, Weight Reduction Programs
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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