What is the difference between vitamin D and D3

Camil Castelo-Branco, MD, PhD 1 Manel Ciria-Recasens, MD, PhD 2 María J. Cancelo-Hidalgo, MD, PhD 3 Santiago Palacios, MD, PhD 4 Javier Haya-Palazuelos, MD, PhD 5 Jordi Carbonell-Abelló, MD, PhD 2 Josep Blanch-Rubió, MD, PhD 2 María J. Martinez-Zapata, MD, PhD 6 José Manasanch, PhD 7 Lluís Pérez-Edo, MD, PhD 2

1 Department of Obstetrics and Gynecology, Provincial Hospital Hospital 2 Rheumatology separation, University Hospital del Mar y de la Esperança, Barcelona 3 Department of Obstetrics and Gynecology, University Hospital of Guadalajara, Universidad de Alcalá de Henares, Guadalajara 4 Palacios Institute of Women’s Health and Medicine, Madrid 5 Department of Obstetrics and Gynecology, General de Ciudad Real Hospital 6 Epidemiology and Public Health Service, CIBER of Epidemiology and Public Health (CIBERESP), Hospital de la Santa Creu i Sant Pau, Barcelona 7 Pierre Fabre Ibérica

Translation prepared by a candidate of medical sciences

Purpose. There is increasing evidence that the ossein-hydroxyapatite complex (OGK) is more effective than calcium preparations for the preservation of bone mass. The purpose of this meta-analysis is to determine if OGK has differences in the clinical effect on bone mineral density (BMD) compared with calcium carbonate (CC).

Methods A meta-analysis of randomized controlled clinical trials was conducted to assess the effect of OGK compared with QC on trabecular BMD. A search for publications of clinical studies was performed in electronic databases, including MEDLINE (1966 – November 2008), EMBASE (1974 – November 2008) and the Cochrane Controlled Clinical Research Register. The main criterion for evaluation was the percentage change in BMD compared with the initial indicator. Results are compiled into a randomization model – effect and a weighted average difference is determined. A sensitivity analysis was performed that excluded studies without a complete set of data.

Results. Of the 18 controlled studies that were found initially, 6 were included in the meta-analysis. No significant heterogeneity between the included studies was noted. The percentage change in BMD was significantly higher in the OGK group (1.02% (95% CI 0.63–1.41); p 0 (including 95% CI) indicated that OGK was more effective, and negative values ​​indicated in the benefit of QC. A value of zero meant that both treatments were equivalent in terms of effectiveness, and we also performed a secondary analysis using a fixed effects model.

Two studies [15, 16] showed average values, but not the standard deviation (S) of the percentage change in BMD, and did not indicate data that allowed us to calculate the CR. For these studies, we calculated the mean and CO using CBP, and their confidence intervals (CI) were obtained by combining data from studies that gave these indicators [17, 18, 20, 25]. The maximum value, which is a more conservative estimate of the calculated means and CO, was used for data that was lacking.

What is the difference between vitamin D and D3

To verify the reliability of the results of the basic analysis, a sensitivity analysis was conducted, in which studies without complete data were excluded [15, 16]. We also conducted a sensitivity analysis to determine whether the use of vitamin D affects the results.

results

Research description

Of the 649 publications found, 18 controlled clinical trials were selected for further review (Fig. 1). For 3 of them, additional information was obtained that was not contained in the original publications [15, 17, 20]. After evaluating the full text of the selected studies, 6 controlled RCTs were included in the meta-analysis. All of them compared WGCs with CC (Table 1). Since in one of the articles [21] the results were presented from two different groups of participants (with / without a hip fracture), the data from it were included as two separate groups. 12 studies were excluded [19, 26–36] for the reasons described in the table. 2

The quality of research was acceptable in 2 trials [18, 25], and slightly worse in 4 remaining [15–17, 20]. All trials were randomized and controlled. Other metabolic disorders in the bones, thyroid abnormalities, and a history of corticosteroid treatment were the main exclusion criteria for all studies, while screening for renal failure was present in all but one [18]. Three trials reported an assessment of the level of calcium intake at the beginning of the study [15, 17, 25], and two described the presence or absence of smoking in patients [15, 18]. Primary levels of vitamin D have not been studied in any of the studies, although it was taken by patients in 3 of them [17, 20, 25]. In 1 study, the process of randomization and blinding treatment is described. Some studies have described the details of patient exits from them [15, 17, 25].

Fig. one. Diagram of the research selection process for meta-analysis

A total of 614 participants were included in the selected studies. The average age ranged from 46 [16] to 78 years [25]. The results of the meta-analysis were based on 461 participants (14 men), 363 of whom had a significant decrease in BMD at the beginning of the study. The rest [98] had a normal BMD.

Two studies focused on primary prevention and included participants without osteopenia or osteoporosis, but with the risk of bone loss, since all participants were postmenopausal women [15, 16]. The remaining 4 studies included participants with osteopenia and osteoporosis [17, 25] or only osteoporosis [18, 20] (see Table 1). In 5 studies, BMD was measured by the spinous processes of the lumbar spine (LII–LIV) using bone absorptiometry. In the study of R. Rüegsegger and co-authors [18], peripheral quantitative computed tomography was used in the region of the distal radial bone (Table 3).

What is the difference between vitamin D and D3

Doses ranged from 3320 to 6640 mg / day for OGK and from 2000 to 3500 mg / day for KK. In the 3 included studies, participants received equivalent doses of calcium in two groups (OGK and KK) [17, 18, 25]. In the remaining 3 studies [15, 16, 20], calcium dosages were approximately 30% lower in the group receiving OGK (in the range of 712-1424 mg / day in the OGK groups and 1000-1500 mg in the KK groups). In 3 studies, all participants received simultaneously oral vitamin D3 (600 [17] IU and 400 [20] IU daily or 300 IU one-time [25]) in both subgroups.

Active treatment in the included studies lasted from 1 [16] year to 3 [20] years, the median was 2 years (see Table 1).

Evaluation of the main results

To determine the overall effect on the percentage change in BMD in trabecular bone, data from 6 RCTs [15–18, 20, 25] were combined, the total number of participants was 360 (179 in the OGC group and 181 in the CC group). There was no heterogeneity (I 2 = 0%; p = 0.84), and the results testified in favor of the group receiving OGK treatment (Fig. 2).

The weighted average difference showed that BMD increased by 1.02% (95% CI 0.63–0.41) more in the OGK group, compared with the QC group. This difference was statistically significant (p 2 = 0%; p = 0.68), and the results were in favor of the OGK group; in this case, the SVR showed that the BMD increased by 1.01% (95% CI 0.62–1.40) more in the OGK group, compared with the CC group. The result was statistically significant p0,00001 (рис. 3).

When analyzing studies on vitamin D intake, the trend was the same as in the main analysis. Studies in which vitamin D was used in both subgroups did not significantly affect the overall result (Fig. 4).

Discussion

This is the first meta-analysis comparing the effectiveness of OGK and QC in the prevention or treatment of bone loss in postmenopausal women. Results are based on data from randomized comparative clinical trials in parallel groups.

Various articles have reported on the effectiveness of calcium in the prevention or treatment of bone loss [7, 8, 37, 38] compared with placebo. However, there was not enough information indicating that calcium was sufficiently effective in reducing the risk of fractures, although according to a recent meta-analysis [38], including 63,897 participants, it was concluded that calcium or vitamin D treatment was associated with a statistically significant a 12% reduction in fracture risk compared with placebo. This decrease was even greater (24%) given the high level of compliance. For spinal BMD, treatment was associated with a 1.19% reduction in bone loss compared with placebo. The addition of vitamin D to calcium significantly influenced the results. Also, another RCT meta-analysis comparing with placebo or no treatment for postmenopausal women and / or elderly men [39] concluded that oral administration of vitamin D can reduce the risk of hip fractures only with calcium supplements.

These results were observed in patients receiving 1200 mg of calcium, which is the recommended dose for adults, as reflected in the above publications, and by the National Osteoporosis Foundation [38, 40]. Other reviews recommend a daily intake of 1500 mg of bioavailable calcium after menopause, in the absence of estrogen replacement therapy [41, 42], although it is known that neither amount of calcium can often be taken in the normal dietary regimen. Against the risk of fracture, antiresorptive drugs are also effective when administered in combination with at least 500 mg of calcium per day [43–46]. A recent clinical study [47] showed that women over the age of 70 years who took 600 mg of calcium 2 times a day in the form of QC had a significantly lower risk of osteoporotic fracture than did placebo (10.2% compared to 15.4%). %, respectively, when analyzed according to the protocol, which included patients with ≥80% compliance). These results support the hypothesis that calcium helps reduce the risk of osteoporotic fractures.

A study conducted by the Women’s Health Initiative Group [48], aimed at examining postmenopausal women living in society and comparing calcium with vitamin D compared with placebo, reported a 29% response rate for hip fractures (risk factor 0.71; 95% CI 0.52–0.97) in the main group. It is important to note that this result was obtained only among those patients who took at least 80% of the studied drug, which underlines the importance of compliance. In this study, there was also an increase of 1.06% BMD of the hip, compared with placebo at the 9th visit after 1 year (p = 0.01), giving a significant difference between the groups starting from the 3rd year. In this meta-analysis, an increase in BMD was 1.02% for participants receiving OGK, compared with those who received QC.

The results of this first systematic review and meta-analysis comparing WGCs with QC indicate that the former provides a statistically significant advantage in terms of the percentage increase in BMD. For 2 of the initially included 6 analyzes [15, 16], it was necessary to calculate CO using data from other studies, since this information was not provided by the authors. However, we took this into account and excluded these 2 tests from the sensitivity analysis. The results of this additional analysis confirmed the results of the main study.

Although not fully understood, the observed advantage can be explained by the osteogenic effects associated with the organic component of OGK, as suggested by the authors of experimental studies in which the formation of new bones was higher in animals receiving OGK than in those that received the same amount of mineral component only in the form of hydroxyapatite [11, 12]. The same hypothesis is considered in a similar study comparing OGK and only hydroxyapatite in humans [49].

The limitations of the meta-analysis were that several studies were not blinded. Two studies [18, 25] masked the therapeutic effect: in one of them there was a significant degree of accuracy, which significantly influenced the results of the meta-analysis. In addition, studies that fully met the inclusion criteria had small sample sizes, which, in turn, limited the final sample size in the meta-analysis. Although this, of course, is a limitation, meta-analyzes provide the highest level of scientific accuracy, in particular in cases where individual studies provide limited data. Another aspect of the meta-analysis is the risk of publication inaccuracies, although it must be emphasized that the results of 2 unpublished studies were included in this meta-analysis [17, 20]. Since only 6 studies were included in the meta-analysis, we did not use the funnel map, as according to the Cochrane Library Manual [50], it is not recommended to use this technique if 10 исследований.

Among those selected for inclusion of studies, 3 in which the BMD was studied using radiographic methods [19, 29, 30] were excluded because these methods are less reliable and accurate than dual-energy X-ray absorptiometry or quantitative computed tomography techniques. The results of these studies also showed that BMD did not change or increased in the OGK group, as compared with QC. Two studies [29, 35] also showed symptomatic reduction in the severity of back pain in the group receiving OGK.

The positive effect of OGK on BMD and bone quality [11, 12, 20] compared with QC suggests that treatment may lead to a reduced risk of fractures. However, to confirm this hypothesis, it is necessary to conduct a methodologically adequate comparative clinical study with an appropriate sample size, in which the risk of fractures is the primary criterion for evaluation.

Finally, although this was not the goal of the present analysis, several studies also demonstrated that OGC has a very good tolerance for long-term use, with a frequency of side effects 4% (3,2% — запор) [26, 29]. Хотя прямым образом не сравнивалось, но частота побочных эффектов, связанных с КК (в частности запор) была на уровне от 13,4% [47] до 18% [51] в рандомизированных клинических исследованиях.

Conclusion

In conclusion, we can say that this meta-analysis showed that OGK is more effective than QC to maintain or increase BMD in patients with normal or reduced BMD.

References

1. Marshall D., Johnell O., Wedel H. (1996) Meta-analysis of bone mineral density prediction of occurrence of osteoporotic fractures. BMJ, 312: 1254-1259. 2. Schott

Camil Castelo-Branco, Manel Ciria-Recasens, María J. Cancelo-Hidalgo, Santiago Palacios, Javier Haya-Palazuelos, Jordi Carbonell-Abelló, Josep Blanch-Rubió, María J. Martínez-Zapata, José Manasanch, Llues-séphés, María J. Martínez-Zapata

Summary. Meta. ANNOUNCEMENT IS EVERYTHING BETTER THAN DANIH, JACQUES AREA ABOUT THESE, THERE ARE THE SEEKING-HYDROXY-PATH COMPLEX (OGK) BELSH EFFECTIVE, UNDER THE CALCULATION FOR THE BACKGROUND MAX. Meta of meta-analysis carried out is attributed to a person who has been sent to OGK in the context of a clinical examination of the mineral fitness of the tissue tissue (MShKT) is based on calcium carbonate (CK).

Method. For the assessment of the OGK porovennya s KK on the trabecular MShKT held metaanaliz randomized control of the clinics doslіdzhen. Publishing of privately held information in the electronic databases of Danish, including MEDLINE (1966 – leaf fall 2008), EMBASE (1974 – leaf fall 2008) and the Cochrane Register of Controlled Graduate Dosch. The main criterion of interest is the percentage of MShKT is reproduced with a display. The result is chosen in the randomization model – the effect is assigned to the middle manager. An analysis has been conducted of sensitivity, a dilemma among the participants without a set of tributes.

What is the difference between vitamin D and D3

Result. From 18 controllable doslіzhen, knowing the primary, in the metaanalysis was included 6. Not revealed sufficiently heterogeneous with the inclusion of doslendzhennymi. The percentage rate of the MShKT was significantly higher in the WGC group (1.02% (95% CI, 0.63–1.41); p0,00001). Ці результати підтверджено в аналізі чутливості.

Visnovki. OGK є is significantly more effective in reserve vratu kistokovo masi, nizhzh KK.

Key words: mineralnaya kistvenko tissue, calcium carbonate, metaanaliz, axial-hydroxyapatite complex, preventive osteoporosis.

Camil Castelo-Branco, Manel Ciria-Recasens, María J. Cancelo-Hidalgo, Santiago Palacios, Javier Haya-Palazuelos, Jordi Carbonell-Abelló, Josep Blanch-Rubió, María J. Martínez-Zapata, José Manasanch, Llues-séphés, María J. Martínez-Zapata

Summary. Objective. It is more important that calcium supplements are maintained. It has been shown that it has been compared with calcium carbonate (CC).

Methods. A trio-versus CC on trabecular BMD was carried out. We identified publications on clinical trials, including MEDLINE (1966-November 2008), EMBASE (1974-November 2008), and the Cochrane Controlled Clinical Trials.

Results. Of the 18 controlled trials initially identified, 6 were included in the meta-analysis. There was no significant heterogeneity among the included trials. The percent change in BMD significantly favored the OHC group (

Key words: bone mineral density; calcium carbonate; meta-analysis; ossein-hydroxyapatite complex; osteoporosis prevention.

Publication provided by Euromedex.

Like this post? Please share to your friends:
Leave a Reply